CryoLife protocol for EU rollout of BioFoam, Click Thumbnail to view.
ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.
Tuesday, October 26, 2010
Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA
MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- Tenaxis Medical submitted its PMA to the FDA on July 27, 2010 and has now received confirmation from the FDA that "we have made a threshold determination that the PMA is sufficiently complete to permit a substantive review and is, therefore, suitable for filing."In the pivotal study designed to demonstrate superiority, the ArterX Surgical Sealant was compared to a thrombin soaked gelatin-sponge hemostat to reduce or eliminate suture line bleeding. President & Chief Executive Officer, David Smithcommented, "We are delighted that the FDA has made the determination to substantively review the PMA. We are continuing to prepare for our US launch and this was an important milestone."
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance sealants for use in vascular and general surgery. In addition to the ArterX Surgical Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
CONTACT: Ronald Dieck, +1-650-691-9016, ext. 110, for Tenaxis Medical, Inc.
Monday, October 25, 2010
Study shows use of superglue in chest surgery cuts recovery time in half
Victor Haddad used Krazy Glue in his woodworking shop for years to mend his accidental wounds. Then last year, as he awaited a heart operation, he discovered on the Internet that a Calgary doctor was using a superglue to fuse bones together after chest surgeries.The minute he read about the experimental procedure, he says, “I wanted it.”
He became a patient of Paul Fedak, a cardiac surgeon who pioneered the technique in 2009 at Calgary’s Foothills Hospital Medical Centre. In June of this year, Dr. Fedak replaced Mr. Haddad’s aortic valve and joined his sternum using steel wire, and then sealed the bones with a sticky paste called Kryptonite.
Mr. Haddad was out of the hospital in seven days. Within six weeks, the 59-year-old resident of Milk River, Alta., was back to work as a real-estate broker. Mr. Haddad didn’t bother to fill his prescription for pain meds, he says. “I’ve been pain free since before I left hospital.”
His surgery was standard except that Dr. Fedak took a few minutes to apply adhesive to the ends of the chest bones before stitching up the soft tissue. According to Dr. Fedak, breastbones heal much faster when secured with wire as well as Kryptonite glue.
Instead of it taking six to eight weeks for the bone to fuse back together, “we do it in 24 hours.” The glue makes it rock solid within a day.
A study released Sunday suggests the use of adhesive in chest surgery reduces the normal recovery time by half. Patients have less physical disability in the first six weeks after surgery and can breathe deeply sooner, Dr. Fedak reports. He adds that patients are able to cough with less discomfort and require significantly less medication such as narcotics to manage pain.
No complications or side effects from the glue were reported among the 55 patients in the randomized controlled trial.
The procedure has the potential to improve post-operative care for an estimated 1.4 million open-chest surgeries performed worldwide each year, according to the Heart and Stroke Foundation of Canada.
Dr. Fedak has applied to the Canadian Institutes of Health Research to fund a larger clinical trial involving 2,000 patients throughout North America, which should start in six months, he says.
Although medical adhesives are widely used in hip replacements and other procedures, most bone cements contain toxic ingredients that are dangerous for use in the chest, notes Dr. Fedak. In contrast, Kryptonite is an adhesive polymer composed of calcium carbonate and fatty acids derived from castor bean oil. It is “bio-compatible” and turns into a porous bonelike substance as it cures, he says.
Dr. Fedak doesn’t recommend the adhesive for patients at high risk for internal bleeding and other complications after surgery, because doctors might need to re-enter the breastbone and the procedure would take longer if the breastbone is well-bonded. Otherwise, he says, “you could use this on almost any patient.”
Regulators in Canada and the United States have approved the use of Kryptonite, which is made by the Doctors Research Group in the United States.
The glue is expensive, adding $700 to $1,000 to the cost of performing surgery. The need for public funding is a barrier to routine use, Dr. Fedak says. But he suggests that using Kryptonite could result in net savings to the health-care system by reducing recovery time and major post-op complications, including breastbones that separate after surgery.
“If a patient leaves the hospital a day early, that would be thousands of dollars of savings,” he points out.
Patients from around the world have contacted him, seeking repairs to sternums that didn’t heal properly after surgery, Dr. Fedak says. Although he is cautious about expanding the use of Kryptonite prematurely, he adds, reconstructions to damaged sternums “work very well.”
Mr. Haddad says he’s been the envy of his friends since he was glued back together with Kryptonite. He mentions a neighbour who took more than six months to bounce back after recent heart surgery.
“He is absolutely annoyed that he wasn’t in the [Kryptonite] study.”
Thursday, October 21, 2010
Vascular Solutions Announces Record Third Quarter Results. Edited
Vascular Solutions, Inc. (Nasdaq: VASC) today reported financial results for the third quarter ended September 30, 2010. Highlights of the third quarter include:
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....
Sunday, October 17, 2010
Robotic technology speeds recovery and improves outcomes
■ Robotic surgery reduces blood loss, decreases length of hospital stay, decreases postoperative pain, and improves recovery time.
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two- dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two- dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
Thursday, October 14, 2010
Stöpler to Distribute Z-Medica QuikClot Products for the First Time to Hospitals in The Netherlands
WALLINGFORD, Conn.--(Healthcare Sales & Marketing Network)-- Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Stöpler, a supplier of medical instruments, equipment and disposables to hospitals in the Netherlands, Belgium and Luxembourg. Stöpler will have the exclusive rights to sell and distribute Z-Medica’s full line of QuikClot® hemostatic agents to hospitals and healthcare professionals in The Netherlands.
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
Wednesday, October 13, 2010
Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients
Danny Bluestein, Ph.D., Professor of Biomedical Engineering at Stony Brook University, has been awarded a five-year, $7.5 million grant by the National Institutes of Health. The award marks the first time a Stony Brook professor has received a Phase II Quantum Grant, given by The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a division of the NIH, to make a profound improvement—or quantum leap forward—in health care.
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Hemostatic Powder Market - Cook Rollout of Endoscopic Application
Novel application of powder could eventually replace endoscopic surgical procedure
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
Heart Surgery Transfusions - at best a waste of resources
"We don't know whether the variability is potentially harming patients," said lead author Elliott Bennett-Guerrero, M.D., director of Perioperative Clinical Research at Duke Clinical Research Institute and Professor of Anesthesiology/Critical Care. "Even if more liberal transfusion is not harmful to patients, it may represent a significant waste of scarce resources and money."
The researchers didn't find any link between patient mortality rates after surgery and whether the hospital was a high-transfusion site or a low-transfusion site, Bennett-Guerrero said.
The work was published in the Journal of the American Medical Association (JAMA) online on Oct. 12.
"To our knowledge there has never been a published large randomized trial in surgical patients looking at the impact of blood transfusion to determine whether we should be more restrictive or liberal with these transfusions," Bennett-Guerrero said. "Despite the fact that we spend billions of dollars on health care and research, we spend comparatively little on clinical effectiveness trials, which are gaining recognition as an informed way to change clinical practice."
Even when centers performing fewer operations were excluded, the researchers found that transfusion rates among the patients at hospitals ranged from 7.8 percent to 92.8 percent for red blood cells, 0 percent to 97.5 percent for fresh-frozen plasma, and 0.4 percent to 90.4 percent for platelets. The average cost of a unit of RBCs including direct and indirect costs was $761 in a 2010 study published in Transfusion journal.
The team, which included researchers from other institutions, found variation in RBC use based on geographic region, as well as higher RBC usage at academic hospitals and hospitals that performed the fewest number of coronary artery bypass graft (CABG) operations. Taken together, however, these three characteristics only accounted for 11.1 percent of variation in red-blood cell use.
The research team assessed data from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database kept by the Duke Clinical Research Institute, which captures clinical information from the majority of U.S. cardiac surgical procedures (up to 80 percent of all surgical data available).
The patients included in the study all had the same operation, a first-time, isolated coronary artery bypass graft (CABG), and all were on a heart-lung pump during surgery.
Differences in surgical techniques may help explain some of the variability. "There is a reasonable chance that some patients are getting transfused more because they are bleeding more during surgery, which could be linked to differences in surgical technique among the doctors," Bennett-Guerrero said.
Another likely difference is simply the transfusion culture at an institution. This may also have to do with early medical education and training, as some institutions pass along a pro-transfusion culture to those in training, he said.
argely circumstantial evidence suggests excessive blood transfusion for a patient may be harmful, Bennett Guerrero says. Everyone agrees that transfusion is needed when an injured person has lost most of their blood or has severe anemia. "It is difficult to get agreement, however, in situations where the patient has moderate blood loss or anemia," he said. "No one has yet proven that more liberal transfusion is harmful, and in the absence of results from high-quality randomized clinical studies, it is not surprising that there is variation in transfusion rates."
This work was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute.
Other authors include Yue Zhao and Sean M. O'Brien of the biostatistics division and Eric D. Peterson in the cardiology division of the Duke Clinical Research Institute; T.B. Ferguson of the Department of Cardiovascular Sciences, at the East Carolina Heart Institute, in Greenville, N.C.; James S. Gammie of the Division of Cardiac Surgery at the University of Maryland Medical Center in Baltimore; and senior author Howard K. Song of the Division of Cardiothoracic Surgery, Oregon Health and Science University in Portland.
Tuesday, October 12, 2010
Pfizer will buy King Pharmaceuticals for $3.6B
NEW YORK -- Pfizer Inc., the world's largest pharmaceutical company by revenue, said Tuesday it will buy pain drug makerKing Pharmaceuticals Inc. for $3.6 billion in cash.
Pfizer ( PFE - news - people ) is paying $14.25 per share for King. That's a premium of 40 percent to the stock's Monday closing price of $10.15. In the deal Pfizer gains products including the pain drug Avinza and EpiPen, a pre-filled injection designed to quickly treat serious allergic reactions.
The deal is Pfizer's largest since it bought rival Wyeth ( WYE - news -people ) for $68 billion in 2009. That deal closed last October.
King has struggled in recent years as patents on several of its key drugs have expired or been thrown out. But the Bristol, Tenn., company is heavily involved in developing pain drugs that are intended to be abuse-resistant. Abuse of pain drugs like oxycodone has become a major concern for health officials and regulators in recent years. The drugs are often crushed or dissolved to defeat their time-release mechanisms, allowing users to get high.
King's Embeda is one pain treatment that is designed to resist abuse attempts. King plans to file new applications for two similar drugs in the next few months, filing for approval of Remoxy in the fourth quarter of 2010 and Acurox in the first quarter of 2011. Remoxy and Embeda are extended-release drugs, while Acurox releases its painkilling ingredient immediately.
King's other products include the bleeding control drug Thrombin-JMI and the Flector pain patch.
Pfizer ( PFE - news - people ) is paying $14.25 per share for King. That's a premium of 40 percent to the stock's Monday closing price of $10.15. In the deal Pfizer gains products including the pain drug Avinza and EpiPen, a pre-filled injection designed to quickly treat serious allergic reactions.
The deal is Pfizer's largest since it bought rival Wyeth ( WYE - news -people ) for $68 billion in 2009. That deal closed last October.
King has struggled in recent years as patents on several of its key drugs have expired or been thrown out. But the Bristol, Tenn., company is heavily involved in developing pain drugs that are intended to be abuse-resistant. Abuse of pain drugs like oxycodone has become a major concern for health officials and regulators in recent years. The drugs are often crushed or dissolved to defeat their time-release mechanisms, allowing users to get high.
King's Embeda is one pain treatment that is designed to resist abuse attempts. King plans to file new applications for two similar drugs in the next few months, filing for approval of Remoxy in the fourth quarter of 2010 and Acurox in the first quarter of 2011. Remoxy and Embeda are extended-release drugs, while Acurox releases its painkilling ingredient immediately.
King's other products include the bleeding control drug Thrombin-JMI and the Flector pain patch.
Major medical devices maker invests €900,000 in R&D
A US$10bn supplier of healthcare products is to invest €900,000 with the National University of Ireland in two major R&D projects that will influence the future of surgery and wound healing.
Healthcare supply company Covidien has announced the €900,000 investment in medical technologies research and development projects with NUI Galway over the next two years, which is the first phase of a multi-part investment of €1.8m with Irish academic institutions announced by Covidien last July.
Covidien employs 2,000 people in Ireland and recently opened a 200-job European Services Centre in Cherrywood, Dublin. Some €11m has been invested in the state-of-the-art operation.
Covidien's chief technology officer Paul Hermes toldSiliconrepublic that innovation is at the heart of the company's efforts and that it holds more than 10,000 patents with a further 8,000 patents pending. “We have found Ireland to be the ideal environment for medical devices and healthcare research. From what we can tell, Ireland boasts the highest per capita presence of medical devices industries anywhere in the world.”
He said the company was focused on discovering "disruptive" technologies that will change the shape of healthcare for ever and that the company invests US$400m per annum in R&D.
Investment to aid patient health and safety
Minister for Health and Children Mary Harney TD described the investment as enabling the further development of patient health and safety through innovation and maintains it will yield high quality researchers.
“University-based facilities enabled by this collaboration with Covidien will help to ensure that Ireland continues to produce high-quality researchers who can innovate new technologies and design robust scientific research. This ultimately produces the valuable data that furthers patient health and safety,” she said.
Covidien hopes to incentivise students to choose science as a career and promote the continued growth and prosperity of the medical devices sector in Ireland.
“We believe the medical devices and health sectors will be a thriving part of Ireland’s business growth and high-technology job creation in the future,” said Scott Flora, president, surgical devices, Covidien.
Barry O’Leary, CEO, IDA Ireland, added: “Ireland is recognised as a key global hub for medical technologies, employing the highest medical technologies personnel per capita in Europe. Nearly 60pc of the sector’s companies are now carrying out R&D functions here ... industry and academia in Ireland can assist global companies such as Covidien to meet their R&D needs.”
NUI Galway's work
NUI Galway has investigated in situ forming biomaterial delivery systems that can be coupled with biologic factors. These materials may be delivered to soft tissue defects and can deploy growth factors and/or other biologics of interest to promote wound healing and tissue regeneration. The aim of the first project is to develop, characterise, and optimise the use of material systems containing microspheres for growth factor delivery and to develop assays to test the efficacy of these systems in promoting local wound healing.
NUI Galway also has significant experience with developing models to test the efficacy of novel compounds and medical devices. Covidien is interested in the design of specific, anatomically relevant models for products under development which can then be used for proof of concept, and generation of efficacy and regulatory data. The aim of the second project is to model conditions created during surgery and understand how product concepts perform under these conditions.
Healthcare supply company Covidien has announced the €900,000 investment in medical technologies research and development projects with NUI Galway over the next two years, which is the first phase of a multi-part investment of €1.8m with Irish academic institutions announced by Covidien last July.
Covidien employs 2,000 people in Ireland and recently opened a 200-job European Services Centre in Cherrywood, Dublin. Some €11m has been invested in the state-of-the-art operation.
Covidien's chief technology officer Paul Hermes toldSiliconrepublic that innovation is at the heart of the company's efforts and that it holds more than 10,000 patents with a further 8,000 patents pending. “We have found Ireland to be the ideal environment for medical devices and healthcare research. From what we can tell, Ireland boasts the highest per capita presence of medical devices industries anywhere in the world.”
He said the company was focused on discovering "disruptive" technologies that will change the shape of healthcare for ever and that the company invests US$400m per annum in R&D.
Investment to aid patient health and safety
Minister for Health and Children Mary Harney TD described the investment as enabling the further development of patient health and safety through innovation and maintains it will yield high quality researchers.
“University-based facilities enabled by this collaboration with Covidien will help to ensure that Ireland continues to produce high-quality researchers who can innovate new technologies and design robust scientific research. This ultimately produces the valuable data that furthers patient health and safety,” she said.
Covidien hopes to incentivise students to choose science as a career and promote the continued growth and prosperity of the medical devices sector in Ireland.
“We believe the medical devices and health sectors will be a thriving part of Ireland’s business growth and high-technology job creation in the future,” said Scott Flora, president, surgical devices, Covidien.
Barry O’Leary, CEO, IDA Ireland, added: “Ireland is recognised as a key global hub for medical technologies, employing the highest medical technologies personnel per capita in Europe. Nearly 60pc of the sector’s companies are now carrying out R&D functions here ... industry and academia in Ireland can assist global companies such as Covidien to meet their R&D needs.”
NUI Galway's work
NUI Galway has investigated in situ forming biomaterial delivery systems that can be coupled with biologic factors. These materials may be delivered to soft tissue defects and can deploy growth factors and/or other biologics of interest to promote wound healing and tissue regeneration. The aim of the first project is to develop, characterise, and optimise the use of material systems containing microspheres for growth factor delivery and to develop assays to test the efficacy of these systems in promoting local wound healing.
NUI Galway also has significant experience with developing models to test the efficacy of novel compounds and medical devices. Covidien is interested in the design of specific, anatomically relevant models for products under development which can then be used for proof of concept, and generation of efficacy and regulatory data. The aim of the second project is to model conditions created during surgery and understand how product concepts perform under these conditions.
Saturday, October 9, 2010
German Company Biocer, Advances Plant Based Hemostatic Powder Technologies
BioCer Entwicklungs GmbH is a young and innovative company. Now on the basis of its comprehensive knowledge our developer team succeeded to provide health care with two seminal products according to the model of the nature.
With the help of a nanotechnological surface coating, implant materials are modified in a way that the medical devices grow in faster and more optimized. These biocom-patible coatings are now applied for the first time to polymer meshes, which are used as soft tissue reinforcement for hernia repair. In cooperation with experts from the textile branch BioCer Entwicklungs GmbH managed to develop a medical device which fulfills together with its optimized surface all demands of a modern mesh im-plant.
Also the development of our innovative hemostatic powder HaemoCer® was per-formed according to nature. HaemoCer® consists of plant based particles with an extremely high hygroscopicity, so that the natural coagulation cascade is accelerated. Hemostasis occurs within short time and HaemoCer® will be completely absorbed from the body within a few days.
With its new products BioCer Entwicklungs GmbH supports the surgeon as well as the patient in healing and restoration of the health.
Click Thumbnail Below for Presentation (note this presentation has been updated at the companies request)
BIOCER ENTWICKLUNGS-GMBH
Ludwig-Thoma Straße 36c
95447 Bayreuth
Telefone: +49 (0) 921 78 77 70 0
Telefax: +49 (0) 921 78 77 70 79
info@biocer-gmbh.de
With the help of a nanotechnological surface coating, implant materials are modified in a way that the medical devices grow in faster and more optimized. These biocom-patible coatings are now applied for the first time to polymer meshes, which are used as soft tissue reinforcement for hernia repair. In cooperation with experts from the textile branch BioCer Entwicklungs GmbH managed to develop a medical device which fulfills together with its optimized surface all demands of a modern mesh im-plant.
Also the development of our innovative hemostatic powder HaemoCer® was per-formed according to nature. HaemoCer® consists of plant based particles with an extremely high hygroscopicity, so that the natural coagulation cascade is accelerated. Hemostasis occurs within short time and HaemoCer® will be completely absorbed from the body within a few days.
With its new products BioCer Entwicklungs GmbH supports the surgeon as well as the patient in healing and restoration of the health.
Click Thumbnail Below for Presentation (note this presentation has been updated at the companies request)
BIOCER ENTWICKLUNGS-GMBH
Ludwig-Thoma Straße 36c
95447 Bayreuth
Telefone: +49 (0) 921 78 77 70 0
Telefax: +49 (0) 921 78 77 70 79
info@biocer-gmbh.de
Friday, October 8, 2010
Arterial Closure Device Recommendations
The number and quality of clinical studies on arterial closure devices for cardiovascular procedures limits their widespread use, but new recommendations issued by the American Heart Association are intended to aid cardiologists considering use of these technologies. The recommendations were published online Oct. 4 in Circulation.
(HealthDay News) — The number and quality of clinical studies on arterial closure devices (ACDs) for cardiovascular procedures limits their widespread use, but new recommendations issued by the American Heart Association are intended to aid cardiologists considering use of these technologies. The recommendations were published online Oct. 4 in Circulation.
Manesh R. Patel, M.D., chair of the American Heart Association writing committee issuing the statement, and colleagues summarized the current state of vascular access, including patient risks, the evidence for use of various ACDs, and recommendations for their use. Seven million invasive cardiovascular procedures are performed each year, with numbers expected to increase in the future, and vascular access complications may be as high as 6 percent, the authors write.
After an extensive literature review of both passive and active closure devices, the committee issued five recommendations regarding ACD use. According to the recommendations, patients considered for use of femoral ACDs should undergo a femoral angiogram to ensure anatomic suitability for their use; facilities using manual compression should aim to achieve low vascular complication rates (below 1 percent); ACDs should not be used routinely, but can reasonably be used for faster hemostasis, and possibly improved patient comfort, as long as risks are weighed against benefits; and data on complications should be systematically collected via registry and reported to the U.S. Food and Drug Administration. Click Thumbnail below to view.
(HealthDay News) — The number and quality of clinical studies on arterial closure devices (ACDs) for cardiovascular procedures limits their widespread use, but new recommendations issued by the American Heart Association are intended to aid cardiologists considering use of these technologies. The recommendations were published online Oct. 4 in Circulation.
Manesh R. Patel, M.D., chair of the American Heart Association writing committee issuing the statement, and colleagues summarized the current state of vascular access, including patient risks, the evidence for use of various ACDs, and recommendations for their use. Seven million invasive cardiovascular procedures are performed each year, with numbers expected to increase in the future, and vascular access complications may be as high as 6 percent, the authors write.
After an extensive literature review of both passive and active closure devices, the committee issued five recommendations regarding ACD use. According to the recommendations, patients considered for use of femoral ACDs should undergo a femoral angiogram to ensure anatomic suitability for their use; facilities using manual compression should aim to achieve low vascular complication rates (below 1 percent); ACDs should not be used routinely, but can reasonably be used for faster hemostasis, and possibly improved patient comfort, as long as risks are weighed against benefits; and data on complications should be systematically collected via registry and reported to the U.S. Food and Drug Administration. Click Thumbnail below to view.
Romed to Distribute Z-Medica QuikClot Products for the First Time to Hospitals in Belgium
WALLINGFORD, Conn.--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Romed, a medical device distribution company focused on providing products and services to cardiac surgery, general surgery and anesthesia professionals. Romed will have the exclusive rights to sell and distribute Z-Medica’s full line of QuikClot® hemostatic agents to hospitals and healthcare professionals throughout Belgium.
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Romed in European markets since then.
“We are pleased to enter the Belgium market through our partner Romed, one of the most well -respected medical device distributors in the country,” said Brian Herrman, Chief Executive Officer, Z-Medica. “Through the success of this agreement we take another step closer to our goal of global distribution of QuikClot’s growing line of life-saving hemostatic gauze products.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are pleased to be able to offer healthcare professionals and emergency personal throughout Belgium QuikClot’s line of innovative life-saving hemostatic dressings,” said Patrick Rosa, CEO of Romed. “We are impressed with what we have seen from QuikClot and we anticipate strong demand throughout our network of medical care providers.”
The QuikClot line of products to be distributed by Romed includes:
QuikClot® Combat Gauze™ is a soft, white, sterile, nonwoven 3” by 12 feet rolled or z-folded gauze impregnated with kaolin. Each roll of QuikClot Combat Gauze is individually wrapped in an easy rip, military grade foil pouch. Indicated for temporary external control of traumatic bleeding, QuikClot Combat Gauze is flexible and pliable and contours to all wounds. Recommended as the number one hemostatic agent by the COTCCC (Committee on Tactical Combat Casualty Care Committee), QuikClot Combat Gauze is the only product carried by all branches of the US Military to control life-threatening hemorrhage.
QuikClot® Emergency Dressing™ is an easy-to-use dressing which can achieve hemostasis in as little as three minutes, helping to prevent loss of life and limb. Because QuikClot requires very little training to administer, it can be effectively used by medical personnel, civilian first-responders and medical professionals in the field and in clinical environments. This dressing comes in various sizes, including a 4-ply 4” by 4” (10cm x 10cm) and a 6-ply 2”x2” (5cm x 5cm) format.
QuikClot® Interventional™ Hemostatic Bandage consists of a soft, white, double sterile, hydrophilic pad impregnated with kaolin. It is double-wrapped in a blister package and foil pouch for aseptic technique. QuikClot Interventional Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of external bleeding from vascular access sites and percutantous catheters or tubes utilizing sheaths up to 12 Fr.
QuikClot® Pad™ consists of a soft, white, double sterile, three-ply 12”x12” (30cm x 30cm) pad impregnated with kaolin. It is double-wrapped in a peelable foil package for aseptic technique. QuikClot Trauma Pad is indicated for temporary external use to control traumatic bleeding and is also x-ray detectable to ensure proper removal.
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Romed in European markets since then.
“We are pleased to enter the Belgium market through our partner Romed, one of the most well -respected medical device distributors in the country,” said Brian Herrman, Chief Executive Officer, Z-Medica. “Through the success of this agreement we take another step closer to our goal of global distribution of QuikClot’s growing line of life-saving hemostatic gauze products.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are pleased to be able to offer healthcare professionals and emergency personal throughout Belgium QuikClot’s line of innovative life-saving hemostatic dressings,” said Patrick Rosa, CEO of Romed. “We are impressed with what we have seen from QuikClot and we anticipate strong demand throughout our network of medical care providers.”
The QuikClot line of products to be distributed by Romed includes:
QuikClot® Combat Gauze™ is a soft, white, sterile, nonwoven 3” by 12 feet rolled or z-folded gauze impregnated with kaolin. Each roll of QuikClot Combat Gauze is individually wrapped in an easy rip, military grade foil pouch. Indicated for temporary external control of traumatic bleeding, QuikClot Combat Gauze is flexible and pliable and contours to all wounds. Recommended as the number one hemostatic agent by the COTCCC (Committee on Tactical Combat Casualty Care Committee), QuikClot Combat Gauze is the only product carried by all branches of the US Military to control life-threatening hemorrhage.
QuikClot® Emergency Dressing™ is an easy-to-use dressing which can achieve hemostasis in as little as three minutes, helping to prevent loss of life and limb. Because QuikClot requires very little training to administer, it can be effectively used by medical personnel, civilian first-responders and medical professionals in the field and in clinical environments. This dressing comes in various sizes, including a 4-ply 4” by 4” (10cm x 10cm) and a 6-ply 2”x2” (5cm x 5cm) format.
QuikClot® Interventional™ Hemostatic Bandage consists of a soft, white, double sterile, hydrophilic pad impregnated with kaolin. It is double-wrapped in a blister package and foil pouch for aseptic technique. QuikClot Interventional Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of external bleeding from vascular access sites and percutantous catheters or tubes utilizing sheaths up to 12 Fr.
QuikClot® Pad™ consists of a soft, white, double sterile, three-ply 12”x12” (30cm x 30cm) pad impregnated with kaolin. It is double-wrapped in a peelable foil package for aseptic technique. QuikClot Trauma Pad is indicated for temporary external use to control traumatic bleeding and is also x-ray detectable to ensure proper removal.
Cytomedix Secures $13 Million in Committed Funding
GAITHERSBURG, Md., Oct 8, 2010 (GlobeNewswire via COMTEX) -- Cytomedix, Inc. (GTF 0.44, -0.03, -5.75%), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced today that the Company has secured approximately $13 million in current and future funding via a registered direct offering and commitments under two separate equity purchase agreements.
The Company has entered into a securities purchase agreement with certain existing shareholders and a new institutional investor for the sale of 3,727,677 shares of its common stock in a registered direct offering priced at $0.40 per share for non-affiliates and $0.53 for affiliates. In addition, warrants to purchase an aggregate of 1,863,839 shares of common stock will be issued to the investors. The warrants are exercisable beginning April 6, 2011, expire five years after initially exercisable and have an exercise price of $0.60 per share. Lincoln Park Capital Fund, LLC ("LPC" or "Lincoln Park") led the transaction with a $500,000 investment in this registered direct offering. Gross proceeds of the offering, before agent fees and offering expenses, are expected to be approximately $1.50 million. Subject to customary closing conditions, this transaction is expected to close on or before October 11, 2010. These securities were offered through a prospectus supplement pursuant to the Company's effective shelf registration statement and base prospectus contained therein.
"We are pleased to have secured this funding as it provides us with the immediate capital to honor our commitment to the Sorin Group and provides us incremental capital to pursue our business strategy," said Martin P. Rosendale, President and Chief Executive Officer. "Over 35% of the capital raised came from significant shareholders, insiders, and employees. We appreciate the continued support of these existing shareholders and welcome our new ones. "
In addition, the Company entered into two separate purchase agreements with Lincoln Park. The first is for $10 million for which a new registration statement will be filed and the second is for $1.5 million using the existing shelf registration. The pricing terms, maturity, and other relevant economic terms are consistent across the two agreements.
Under the existing shelf registration statement, in the case of the $1.5 million purchase agreement, and after the SEC has declared the registration statement effective, in the case of the $10 million purchase agreement, the Company has the right over the 25 month period to sell 150,000 shares of common stock to LPC every other business day. The Company will control the timing and amount of any sales of shares to LPC and in neither agreement, is the Company obligated at any time to sell shares to LPC. Should the Company elect to sell shares to LPC under either of the agreements, the purchase price would be fixed on the date of sale and based on the prevailing market prices of the Company's shares for a period immediately preceding the sale.
In consideration for entering into the $10 million purchase agreement, the Company issued 305,944 of unregistered shares of common stock. The Company further agreed to issue up to 428,322 shares of common stock on a pro-rata basis as commitment shares in connection with LPC purchases up to $7 million of the aggregate $11.5 million commitment amount. Sale or transfer of the commitment shares, when they are issued, is prohibited until the expiration of the term or Company termination of the agreement. There are no warrants associated with any purchases under the agreement and the agreements prohibit any shorting or hedging by LPC.
The net proceeds from these financings will be used for continuing product development, sales and marketing, and general corporate purposes.
Mr. Rosendale further commented, "We are pleased by the commitment from Lincoln Park, a fundamentally oriented investor. We are under no obligation to utilize the facility, but plan to use any proceeds to support and accelerate the development of our regenerative therapies and to expand our marketing efforts."
A more detailed description of the agreements with Lincoln Park is set forth in the Company's current Report on Form 8-K, as filed earlier today with the SEC.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
The Company has entered into a securities purchase agreement with certain existing shareholders and a new institutional investor for the sale of 3,727,677 shares of its common stock in a registered direct offering priced at $0.40 per share for non-affiliates and $0.53 for affiliates. In addition, warrants to purchase an aggregate of 1,863,839 shares of common stock will be issued to the investors. The warrants are exercisable beginning April 6, 2011, expire five years after initially exercisable and have an exercise price of $0.60 per share. Lincoln Park Capital Fund, LLC ("LPC" or "Lincoln Park") led the transaction with a $500,000 investment in this registered direct offering. Gross proceeds of the offering, before agent fees and offering expenses, are expected to be approximately $1.50 million. Subject to customary closing conditions, this transaction is expected to close on or before October 11, 2010. These securities were offered through a prospectus supplement pursuant to the Company's effective shelf registration statement and base prospectus contained therein.
"We are pleased to have secured this funding as it provides us with the immediate capital to honor our commitment to the Sorin Group and provides us incremental capital to pursue our business strategy," said Martin P. Rosendale, President and Chief Executive Officer. "Over 35% of the capital raised came from significant shareholders, insiders, and employees. We appreciate the continued support of these existing shareholders and welcome our new ones. "
In addition, the Company entered into two separate purchase agreements with Lincoln Park. The first is for $10 million for which a new registration statement will be filed and the second is for $1.5 million using the existing shelf registration. The pricing terms, maturity, and other relevant economic terms are consistent across the two agreements.
Under the existing shelf registration statement, in the case of the $1.5 million purchase agreement, and after the SEC has declared the registration statement effective, in the case of the $10 million purchase agreement, the Company has the right over the 25 month period to sell 150,000 shares of common stock to LPC every other business day. The Company will control the timing and amount of any sales of shares to LPC and in neither agreement, is the Company obligated at any time to sell shares to LPC. Should the Company elect to sell shares to LPC under either of the agreements, the purchase price would be fixed on the date of sale and based on the prevailing market prices of the Company's shares for a period immediately preceding the sale.
In consideration for entering into the $10 million purchase agreement, the Company issued 305,944 of unregistered shares of common stock. The Company further agreed to issue up to 428,322 shares of common stock on a pro-rata basis as commitment shares in connection with LPC purchases up to $7 million of the aggregate $11.5 million commitment amount. Sale or transfer of the commitment shares, when they are issued, is prohibited until the expiration of the term or Company termination of the agreement. There are no warrants associated with any purchases under the agreement and the agreements prohibit any shorting or hedging by LPC.
The net proceeds from these financings will be used for continuing product development, sales and marketing, and general corporate purposes.
Mr. Rosendale further commented, "We are pleased by the commitment from Lincoln Park, a fundamentally oriented investor. We are under no obligation to utilize the facility, but plan to use any proceeds to support and accelerate the development of our regenerative therapies and to expand our marketing efforts."
A more detailed description of the agreements with Lincoln Park is set forth in the Company's current Report on Form 8-K, as filed earlier today with the SEC.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
U.Va. Start-Up HemoSonics Secures $2M in Federal Funding
HemoSonics LLC, a medical device company founded on technology developed at the University of Virginia, recently secured three federal grants worth nearly $2 million.
The funding came from two highly competitive programs administered by the U.S. Small Business Administration. Small Business Innovation Research, known as SBIR, and Small Business Technology Transfer, known as STTR, seek to further economic development by awarding funding from participating federal agencies to small businesses conducting high-tech research with commercial potential.
Founded in 2004 by U.Va. researchers William F. Walker, Francesco Viola and Michael B. Lawrence, HemoSonics is developing technology to rapidly assess patients' blood for abnormal clotting characteristics. This information could allow physicians to respond more effectively to patients with excessive bleeding or overactive clotting in the operating room, the emergency room and many other clinical settings.
"Most people don't realize that bleeding and blood clots are the main causes of death in the developed world," said Walker, president of HemoSonics and U.Va. professor of biomedical engineering and of electrical and computer engineering. "Heart attack, stroke and pulmonary embolism are all conditions that kill via a blood clot, and studies indicate that pulmonary embolism kills more people than breast cancer.
"Our technology will shed new light on these problems and, we believe, have a notable impact on human health."
HemoSonics' platform technology, sonorheometry, is a novel, ultrasound-based tool developed by the researchers to ascertain specific information about a patient's blood. In determining the time it takes blood to clot, the firmness of a clot and the rates at which a clot forms and dissolves, this technology could enable physicians to identify specific clotting defects and treat them effectively.
The U.Va. Patent Foundation has filed two international patent applications on this technology, which it licensed to HemoSonics for further development and commercialization.
"The research and innovations developed at the University of Virginia are of the highest caliber," said Miette H. Michie, executive director and CEO of the Patent Foundation. "HemoSonics' technology has the potential to have a dramatic, positive impact on patients, and we are proud to be a partner in bringing this technology forward."
Since July, HemoSonics has been awarded nearly $2 million in federal funding through the SBIR and STTR programs, including $1.6 million from the National Institute of Diabetes and Digestive and Kidney Diseases; $298,000 from the National Heart, Lung and Blood Institute; and $70,000 from the Office of Naval Research.
Thomas C. Skalak, U.Va. vice president for research, said such major federal awards are critical to new technology-based ventures. "We are very proud to see this U.Va. research being moved to the marketplace, where it will have an impact on people's health and potentially create new jobs," he said.
He added, "The accelerated pace of HemoSonics' growth is a tribute to the vision and persistence of its technical leaders: Bill Walker, Francesco Viola and Mike Lawrence."
With its new funding, HemoSonics plans to develop a point-of-care diagnostic device called the Global Hemostasis Analyzer, which will bring the technology to the patient's bedside and seek to eliminate the guesswork associated with treating bleeding conditions.
"In patient care settings, bleeding patients are often treated by blind administration of blood products," said Viola, HemoSonics' vice president of engineering and technology and research assistant professor of biomedical engineering at U.Va. "This process is clearly inefficient, often resulting in wasted resources, increased costs and even harmful consequences for the patient.
"Our initial product will quickly provide the necessary information to guide transfusion, therefore saving lives, money and resources," added Viola, who is the principal investigator of the grants.
This technology has also been funded by the Wallace H. Coulter Translational Research Partnership, the National Institutes of Health and angel investors.
Skalak said, "The researchers' original work inside of the University was a team effort that exemplifies the U.Va. translational research partnership with the Wallace H. Coulter Foundation, which is committed to realizing the dream of science serving humanity."
The funding came from two highly competitive programs administered by the U.S. Small Business Administration. Small Business Innovation Research, known as SBIR, and Small Business Technology Transfer, known as STTR, seek to further economic development by awarding funding from participating federal agencies to small businesses conducting high-tech research with commercial potential.
Founded in 2004 by U.Va. researchers William F. Walker, Francesco Viola and Michael B. Lawrence, HemoSonics is developing technology to rapidly assess patients' blood for abnormal clotting characteristics. This information could allow physicians to respond more effectively to patients with excessive bleeding or overactive clotting in the operating room, the emergency room and many other clinical settings.
"Most people don't realize that bleeding and blood clots are the main causes of death in the developed world," said Walker, president of HemoSonics and U.Va. professor of biomedical engineering and of electrical and computer engineering. "Heart attack, stroke and pulmonary embolism are all conditions that kill via a blood clot, and studies indicate that pulmonary embolism kills more people than breast cancer.
"Our technology will shed new light on these problems and, we believe, have a notable impact on human health."
HemoSonics' platform technology, sonorheometry, is a novel, ultrasound-based tool developed by the researchers to ascertain specific information about a patient's blood. In determining the time it takes blood to clot, the firmness of a clot and the rates at which a clot forms and dissolves, this technology could enable physicians to identify specific clotting defects and treat them effectively.
The U.Va. Patent Foundation has filed two international patent applications on this technology, which it licensed to HemoSonics for further development and commercialization.
"The research and innovations developed at the University of Virginia are of the highest caliber," said Miette H. Michie, executive director and CEO of the Patent Foundation. "HemoSonics' technology has the potential to have a dramatic, positive impact on patients, and we are proud to be a partner in bringing this technology forward."
Since July, HemoSonics has been awarded nearly $2 million in federal funding through the SBIR and STTR programs, including $1.6 million from the National Institute of Diabetes and Digestive and Kidney Diseases; $298,000 from the National Heart, Lung and Blood Institute; and $70,000 from the Office of Naval Research.
Thomas C. Skalak, U.Va. vice president for research, said such major federal awards are critical to new technology-based ventures. "We are very proud to see this U.Va. research being moved to the marketplace, where it will have an impact on people's health and potentially create new jobs," he said.
He added, "The accelerated pace of HemoSonics' growth is a tribute to the vision and persistence of its technical leaders: Bill Walker, Francesco Viola and Mike Lawrence."
With its new funding, HemoSonics plans to develop a point-of-care diagnostic device called the Global Hemostasis Analyzer, which will bring the technology to the patient's bedside and seek to eliminate the guesswork associated with treating bleeding conditions.
"In patient care settings, bleeding patients are often treated by blind administration of blood products," said Viola, HemoSonics' vice president of engineering and technology and research assistant professor of biomedical engineering at U.Va. "This process is clearly inefficient, often resulting in wasted resources, increased costs and even harmful consequences for the patient.
"Our initial product will quickly provide the necessary information to guide transfusion, therefore saving lives, money and resources," added Viola, who is the principal investigator of the grants.
This technology has also been funded by the Wallace H. Coulter Translational Research Partnership, the National Institutes of Health and angel investors.
Skalak said, "The researchers' original work inside of the University was a team effort that exemplifies the U.Va. translational research partnership with the Wallace H. Coulter Foundation, which is committed to realizing the dream of science serving humanity."
Thursday, October 7, 2010
The Business of Recombinant Protein Production
Since the development of recombinant technology in the late 1970s, the use of recombinant proteins in therapeutics has become an attractive strategy for altering the biology of disease progression. In the early 1980s, recombinant human insulin from Escherichia colibecame the first recombinant pharmaceutical to enter the market. Development of several growth hormones produced in bacteria followed, as did production of monoclonal antibodies such as infliximab and ritxumiab from mammalian cell lines. By January of 2009, the number of protein-based recombinant pharmaceuticals licensed by the U.S. Food and Drug Administration and European Medicines Agency reached 151.1
Although recombinant protein technology provides a wealth of commercial opportunities, bringing a recombinant protein to the marketplace requires a substantial investment of time and resources. Because the synthesis and purification processes are technically complex and vary with each protein, estimating resources and timelines can be challenging at best. Yet for small companies, meeting these challenges is vital, says Vladimir Kostyukovsky, senior technical manager at Kymanox, Inc. “With start ups, you need to hit your milestones by a certain date, or you’re out of business.”
The most common expression systems for recombinant pharmaceuticals are derived from bacteria (usually E. coli), yeast (usually Saccharomyces cerevisiae), or mammalian cells. Key properties of individual expression systems affect convenience and quality of production. Characteristics inherent to a target protein also affect production capabilities. Making the transition from producing a laboratory stock of protein to commercial quantities also requires strategic planning and flexibility.
Protein synthesis and purification Microbial systems versus mammalian systems
Recombinant protein production in microbial systems (mainly bacteria or yeast) tends to be faster and cheaper than in mammalian systems. The robust cellular structure of bacteria and yeast make them amenable to culturing, but mammalian cells—derived from multicellular organisms—are not adapted to survive outside the body and are thus sensitive to external conditions like shear stress and osmotic shock. Bacteria and yeast replicate every 20 minutes to 2 hours, while mammalian cells do so every 24 hours to 2 days. Mammalian cells require complex—often proprietary—media with amino acids. Bacterial cell medium consists of simple carbon and nitrogen sources and inorganic salts. The cost for bacterial cell media is 90% lower than for mammalian Chinese hamster ovary (CHO) media. Fermentation or bioreactor runs take 24 to 72 hours in bacteria or yeast versus 14 days to 3 weeks in CHO cells.
Yeast and mammalian cell lines have inherent mechanisms for secreting properly folded, active proteins in culture medium. In E. coli, synthesized protein accumulates internally, and cell lysis is required to isolate the target protein. The process of lysis releases intracellular contents such as proteases or endotoxins, which can decrease yield and complicate purification. Recently, a strain of the gram-positive Corynebacterium glutamicum, which does not have endotoxins, has been engineered to express correctly folded, active recombinant proteins directly into the extracellular fermentation broth.
The following characteristics of target proteins influence their likelihood of being expressed and purified in a functionally active state:
Protein size. Eukaryotic cells, such as mammalian and yeast, have the advantage of being able to express proteins of 200 to 250 kDa, the size of most monoclonal antibodies. In some cases, expression of proteins as large as 400 kDa is possible. In E. coli, it is difficult to obtain proteins larger than 60 kDa in soluble forms.
Protein complexity. The number of protein subunits is inversely related to the likelihood of functional expression. Again, eukaryotic cells have a greater advantage in producing fully assembled, functional, multidomain proteins. Monoclonal antibodies, which consist of 4 subunits, can be secreted by eukaryotic cells as fully assembled complexes. E. coli can be used to express multidomain proteins, but they often lack activity.
Glycosylation. Posttranslational addition of sugar motifs to proteins profoundly affects biological activity, function, clearance from circulation, and antigenicity. Patterns of glycosylation are highly species-specific, and mammalian cell lines have glycosylation repertoires most similar to humans.
Common Challenges
Potential complications lie at every step of the process of recombinant protein expression and purification. The complications vary with each specific protein, but because proteins share common motifs, certain technical pitfalls are encountered frequently.
Protein aggregation. Suboptimal conditions during protein expression, purification, or storage can alter structure and result in aggregation or loss of activity. In bacterial expression systems, intracellular accumulation of protein can lead to formation of inclusion body aggregates.
Aggregation can sometimes be reversed by adjusting media composition, growth temperature, inducer concentration, promoter strength, or plasmid copy number. However, inclusion bodies formed by proteins native to eukaryotes but produced in bacteria tend to be resistant to solubilization. Even proteins that are successfully solubilized can become denatured and thus require potentially complicated in vitro refolding processes.
Refolding. The process of refolding is often preceded by a partial purification to remove host cell proteins that could aggregate with the target protein. Because refolding techniques vary and are often empirical, the online database REFOLD provides refolding protocols that have been successful for a wide range of proteins.2
Proteolytic degration. Host proteases, which can degrade the target protein, are commonly active during cell disruption, as intracellular contents are released. Genetic engineering can be used to remove a host’s more active proteases.
Disulfide bond generation. Disulfide bridges, which stabilize protein structure, are often abundant in secreted proteins. As with refolding, disulfide bond generation and maintenance are achieved through empirical processes. Possible strategies include targeting a specific extracellular excretion pathway or overexpression of chaperones or foldases.
Contamination. Contaminants can originate from host cells or from growth medium. Contaminants can interfere with protein function or cause adverse reactions in human consumers, such as through human pathogens harbored in mammalian expression systems or endotoxins in gram-negative bacteria. The process of removing contaminants can be extensive—often involving several rounds of chromatography—and each additional step diminishes yield.
Making the Transition to Clinical Production
The early steps in developing a recombinant pharmaceutical often require multiple iterations to optimize expression and purification of functionally active protein. As development moves closer to commercialization, schedules, pricing, and other aspects of managing a supple chain become paramount. This transition from focusing on technical concerns to the context of the clinic and broader marketplace can be challenging.
Shailesh Maingi, CEO and president of Kineticos Life Sciences, suggests there are key issues to consider throughout the process of production. First, are you going to make the protein yourself or outsource production? “From a business perspective, this decision is probably the most critical,” Maingi says. “If you want to produce it yourself, there is a huge investment required, not only in money, but in time and resources. If you’re a small, virtual company, you’re almost always going to outsource. If you’re a large company, you’re almost always going to insource because you have the capability and you have the technology.”
Smaller companies have the option of producing a lab supply of protein that can be used in preclinical toxicology studies. Outsourcing for larger-scale production can be done prior to initiating clinical trials.
If you decide to outsource, how do you choose a vendor? At the stages of protein expression and purification, working with a vendor that is flexible in its approach is important, because it is impossible to predict how complex the process will be for a given protein. Any vendor should be able to provide a clear proof of concept and performance history of the technology. Cost, quality, and convenience are important considerations as well. During the expression phase, proximity to the vendor can provide convenience for evaluating efficiency and yield of the process.
In summary, while the path to producing a functionally active and meaningful recombinant pharmaceutical can lead to great commercial opportunity, it can also be plagued with technical pitfalls and failures. Careful consideration of various strategies at every step of the process can optimize use of time and resources.
Although recombinant protein technology provides a wealth of commercial opportunities, bringing a recombinant protein to the marketplace requires a substantial investment of time and resources. Because the synthesis and purification processes are technically complex and vary with each protein, estimating resources and timelines can be challenging at best. Yet for small companies, meeting these challenges is vital, says Vladimir Kostyukovsky, senior technical manager at Kymanox, Inc. “With start ups, you need to hit your milestones by a certain date, or you’re out of business.”
The most common expression systems for recombinant pharmaceuticals are derived from bacteria (usually E. coli), yeast (usually Saccharomyces cerevisiae), or mammalian cells. Key properties of individual expression systems affect convenience and quality of production. Characteristics inherent to a target protein also affect production capabilities. Making the transition from producing a laboratory stock of protein to commercial quantities also requires strategic planning and flexibility.
Protein synthesis and purification Microbial systems versus mammalian systems
Recombinant protein production in microbial systems (mainly bacteria or yeast) tends to be faster and cheaper than in mammalian systems. The robust cellular structure of bacteria and yeast make them amenable to culturing, but mammalian cells—derived from multicellular organisms—are not adapted to survive outside the body and are thus sensitive to external conditions like shear stress and osmotic shock. Bacteria and yeast replicate every 20 minutes to 2 hours, while mammalian cells do so every 24 hours to 2 days. Mammalian cells require complex—often proprietary—media with amino acids. Bacterial cell medium consists of simple carbon and nitrogen sources and inorganic salts. The cost for bacterial cell media is 90% lower than for mammalian Chinese hamster ovary (CHO) media. Fermentation or bioreactor runs take 24 to 72 hours in bacteria or yeast versus 14 days to 3 weeks in CHO cells.
Yeast and mammalian cell lines have inherent mechanisms for secreting properly folded, active proteins in culture medium. In E. coli, synthesized protein accumulates internally, and cell lysis is required to isolate the target protein. The process of lysis releases intracellular contents such as proteases or endotoxins, which can decrease yield and complicate purification. Recently, a strain of the gram-positive Corynebacterium glutamicum, which does not have endotoxins, has been engineered to express correctly folded, active recombinant proteins directly into the extracellular fermentation broth.
The following characteristics of target proteins influence their likelihood of being expressed and purified in a functionally active state:
Protein size. Eukaryotic cells, such as mammalian and yeast, have the advantage of being able to express proteins of 200 to 250 kDa, the size of most monoclonal antibodies. In some cases, expression of proteins as large as 400 kDa is possible. In E. coli, it is difficult to obtain proteins larger than 60 kDa in soluble forms.
Protein complexity. The number of protein subunits is inversely related to the likelihood of functional expression. Again, eukaryotic cells have a greater advantage in producing fully assembled, functional, multidomain proteins. Monoclonal antibodies, which consist of 4 subunits, can be secreted by eukaryotic cells as fully assembled complexes. E. coli can be used to express multidomain proteins, but they often lack activity.
Glycosylation. Posttranslational addition of sugar motifs to proteins profoundly affects biological activity, function, clearance from circulation, and antigenicity. Patterns of glycosylation are highly species-specific, and mammalian cell lines have glycosylation repertoires most similar to humans.
Common Challenges
Potential complications lie at every step of the process of recombinant protein expression and purification. The complications vary with each specific protein, but because proteins share common motifs, certain technical pitfalls are encountered frequently.
Protein aggregation. Suboptimal conditions during protein expression, purification, or storage can alter structure and result in aggregation or loss of activity. In bacterial expression systems, intracellular accumulation of protein can lead to formation of inclusion body aggregates.
Aggregation can sometimes be reversed by adjusting media composition, growth temperature, inducer concentration, promoter strength, or plasmid copy number. However, inclusion bodies formed by proteins native to eukaryotes but produced in bacteria tend to be resistant to solubilization. Even proteins that are successfully solubilized can become denatured and thus require potentially complicated in vitro refolding processes.
Refolding. The process of refolding is often preceded by a partial purification to remove host cell proteins that could aggregate with the target protein. Because refolding techniques vary and are often empirical, the online database REFOLD provides refolding protocols that have been successful for a wide range of proteins.2
Proteolytic degration. Host proteases, which can degrade the target protein, are commonly active during cell disruption, as intracellular contents are released. Genetic engineering can be used to remove a host’s more active proteases.
Disulfide bond generation. Disulfide bridges, which stabilize protein structure, are often abundant in secreted proteins. As with refolding, disulfide bond generation and maintenance are achieved through empirical processes. Possible strategies include targeting a specific extracellular excretion pathway or overexpression of chaperones or foldases.
Contamination. Contaminants can originate from host cells or from growth medium. Contaminants can interfere with protein function or cause adverse reactions in human consumers, such as through human pathogens harbored in mammalian expression systems or endotoxins in gram-negative bacteria. The process of removing contaminants can be extensive—often involving several rounds of chromatography—and each additional step diminishes yield.
Making the Transition to Clinical Production
The early steps in developing a recombinant pharmaceutical often require multiple iterations to optimize expression and purification of functionally active protein. As development moves closer to commercialization, schedules, pricing, and other aspects of managing a supple chain become paramount. This transition from focusing on technical concerns to the context of the clinic and broader marketplace can be challenging.
Shailesh Maingi, CEO and president of Kineticos Life Sciences, suggests there are key issues to consider throughout the process of production. First, are you going to make the protein yourself or outsource production? “From a business perspective, this decision is probably the most critical,” Maingi says. “If you want to produce it yourself, there is a huge investment required, not only in money, but in time and resources. If you’re a small, virtual company, you’re almost always going to outsource. If you’re a large company, you’re almost always going to insource because you have the capability and you have the technology.”
Smaller companies have the option of producing a lab supply of protein that can be used in preclinical toxicology studies. Outsourcing for larger-scale production can be done prior to initiating clinical trials.
If you decide to outsource, how do you choose a vendor? At the stages of protein expression and purification, working with a vendor that is flexible in its approach is important, because it is impossible to predict how complex the process will be for a given protein. Any vendor should be able to provide a clear proof of concept and performance history of the technology. Cost, quality, and convenience are important considerations as well. During the expression phase, proximity to the vendor can provide convenience for evaluating efficiency and yield of the process.
In summary, while the path to producing a functionally active and meaningful recombinant pharmaceutical can lead to great commercial opportunity, it can also be plagued with technical pitfalls and failures. Careful consideration of various strategies at every step of the process can optimize use of time and resources.
Source: Joel White, Business Manager, Biotechnology; Ajinomoto AminoScience, Raleigh, North Carolina
Drug Discovery & Development - October 07, 2010
Ceremed's AOC® Awarded Best New Technology in Biomaterials for Spine Care in 2010
ORLANDO, Fla., Oct. 5 /PRNewswire/ -- Ceremed's patented implantable polymer material known as AOC® won Orthopedics This Week's annual award for Best New Technology for Spine Care in 2010 in the Biomaterials category. AOC® was selected winner by a panel of neurosurgeons, orthopedic surgeons and veteran clinical buyers, based on the technology's originality, clinical relevance, and the likelihood that it will improve current standards of care.
"I am proud of AOC®'s success," said Ceremed's chairman, Tadeusz Wellisz, M.D. "AOC® is a versatile technology that has been well received by physicians and scientists. This award serves as continued validation for AOC® as Ceremed strives to develop more products that aid the surgeon and improve the patient's quality of care."
About AOC®:
AOC® is Ceremed's proprietary implantable polymer material. It is composed of a blend of Alkylene Oxide Copolymers that are commonly used in the medical field. This unique blend is an ideal carrier because it dissolves without swelling and is eliminated from the body within 48 hours. Unlike most resorbable polymers, AOC® does not require metabolic or inflammatory processes to break down. AOC® is synthetic and can be formulated in a range of consistencies with a unique combination of properties, including anhydrous formulations, making it an ideal carrier for compounds that are not stable in aqueous solutions. The material is proving to be a versatile, soluble carrier that delivers a broad range of therapeutics to the surgical site without compromising the healing process.
AOC® is already used in spinal fusion products, as a soluble coating system for orthopedic and neurosurgical implants, and for bone hemostasis. Ceremed is able to custom-manufacture compounds using any OEM proprietary material in combination with the AOC® biomaterial.
About Ceremed:
Ceremed, Inc. is a privately held medical device corporation founded in Los Angeles, California in 2002. Ceremed's mission is to utilize its proprietary implantable polymer formulations to enhance the "Standard of Care" by replacing aging and possibly harmful materials with safe and effective materials and devices that provide for better patient outcomes by improving healing and reducing post-surgical complications. The company manufactures a variety of surgical implantable devices marketed both directly and through partnership licensing and manufacturing arrangements. Ceremed's signature product is the highly successful Ostene® Bone Hemostasis material (www.ostene.com).
"I am proud of AOC®'s success," said Ceremed's chairman, Tadeusz Wellisz, M.D. "AOC® is a versatile technology that has been well received by physicians and scientists. This award serves as continued validation for AOC® as Ceremed strives to develop more products that aid the surgeon and improve the patient's quality of care."
About AOC®:
AOC® is Ceremed's proprietary implantable polymer material. It is composed of a blend of Alkylene Oxide Copolymers that are commonly used in the medical field. This unique blend is an ideal carrier because it dissolves without swelling and is eliminated from the body within 48 hours. Unlike most resorbable polymers, AOC® does not require metabolic or inflammatory processes to break down. AOC® is synthetic and can be formulated in a range of consistencies with a unique combination of properties, including anhydrous formulations, making it an ideal carrier for compounds that are not stable in aqueous solutions. The material is proving to be a versatile, soluble carrier that delivers a broad range of therapeutics to the surgical site without compromising the healing process.
AOC® is already used in spinal fusion products, as a soluble coating system for orthopedic and neurosurgical implants, and for bone hemostasis. Ceremed is able to custom-manufacture compounds using any OEM proprietary material in combination with the AOC® biomaterial.
About Ceremed:
Ceremed, Inc. is a privately held medical device corporation founded in Los Angeles, California in 2002. Ceremed's mission is to utilize its proprietary implantable polymer formulations to enhance the "Standard of Care" by replacing aging and possibly harmful materials with safe and effective materials and devices that provide for better patient outcomes by improving healing and reducing post-surgical complications. The company manufactures a variety of surgical implantable devices marketed both directly and through partnership licensing and manufacturing arrangements. Ceremed's signature product is the highly successful Ostene® Bone Hemostasis material (www.ostene.com).
CryoLife Gets Japanese Regulatory Approval For BioGlue
(RTTNews) - CryoLife, Inc. (CRY: News) said its BioGlue Surgical Adhesive has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare, or MHLW, for use in the repair of aortic dissections.
CryoLife's partner Century Medical, Inc., or CMI, will distribute BioGlue in Japan for use in this subset of cardiac surgery. Prior to distribution, MHLW will need to complete certain additional steps, most notably an on-site inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities.
As a result, management estimates that distribution in Japan will begin in the first half of 2011. CryoLife will remain the exclusive supplier of BioGlue to CMI.
CryoLife's partner Century Medical, Inc., or CMI, will distribute BioGlue in Japan for use in this subset of cardiac surgery. Prior to distribution, MHLW will need to complete certain additional steps, most notably an on-site inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities.
As a result, management estimates that distribution in Japan will begin in the first half of 2011. CryoLife will remain the exclusive supplier of BioGlue to CMI.
Tuesday, October 5, 2010
CryoLife Appoint D.P. Lang - VP Market Development
ATLANTA, Oct 04, 2010 /PRNewswire via COMTEX/ -- CryoLife, Inc. (CRY 6.17, +0.17, +2.83%)
A graduate of Harvard University with a degree in economics, Mr. Lang began his career at Medtronic in 1970 and has held sales and marketing positions of increasing responsibility throughout his medical device marketing and management career. From 2008 to 2010, Mr. Lang served as the president and was a consultant to Starch Medical Inc. He served as vice president of international sales and marketing for Medafor, Inc. from 2001 to 2008, where he established their European, Latin American and Asian distribution networks.
A graduate of Harvard University with a degree in economics, Mr. Lang began his career at Medtronic in 1970 and has held sales and marketing positions of increasing responsibility throughout his medical device marketing and management career. From 2008 to 2010, Mr. Lang served as the president and was a consultant to Starch Medical Inc. He served as vice president of international sales and marketing for Medafor, Inc. from 2001 to 2008, where he established their European, Latin American and Asian distribution networks.
Kraig Biocraft Laboratories Announces Application for Trademark of Spider Silk ...
LANSING, MI, Oct 05, 2010 (MARKETWIRE via COMTEX) -- Kraig Biocraft Laboratories, Inc.(KBLB 0.15, +0.03, +22.92%) announced today that that it has filed intent to use applications with the US Patent and Trademark office seeking registration of numerous marks for the purpose of branding recombinant silk fibers.
"The Company views branding of our recombinant silk to be just as important as it is with any other product line. It is anticipated that the proposed marks will enhance product marketability and distinguish our advanced technology from other fibers in the marketplace," said Kim Thompson, the Company's CEO and founder. "This is just the beginning of the Company's efforts to further distinguish itself in the market place as we move toward the commercialization of our technology."
The intent to use applications included seven separate proposed marks including Spiderpillar(TM) and Monster Silk(TM).
The Company recently announced the successful development of recombinant spider silk based fibers using genetic engineering.
The Company will also hold a shareholder press conference on Friday, October 8, 2010 at 4:30 p.m. EDT and will issue a reminder press release the morning of the conference call, which will include the phone number and access code instructions.
"The Company views branding of our recombinant silk to be just as important as it is with any other product line. It is anticipated that the proposed marks will enhance product marketability and distinguish our advanced technology from other fibers in the marketplace," said Kim Thompson, the Company's CEO and founder. "This is just the beginning of the Company's efforts to further distinguish itself in the market place as we move toward the commercialization of our technology."
The intent to use applications included seven separate proposed marks including Spiderpillar(TM) and Monster Silk(TM).
The Company recently announced the successful development of recombinant spider silk based fibers using genetic engineering.
The Company will also hold a shareholder press conference on Friday, October 8, 2010 at 4:30 p.m. EDT and will issue a reminder press release the morning of the conference call, which will include the phone number and access code instructions.
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