Saturday, March 14, 2015

Medafor Injunction Holds Up US Perclot Topical

CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, today provided an update on its ongoing litigation with C.R. Bard, Inc. and certain of its subsidiaries regarding PerClot. The U.S. District Court for the District of Delaware (the "Court") has allowed CryoLife's declaratory judgment lawsuit against C.R. Bard's Medafor, Inc. subsidiary ("Medafor") to proceed. The Court also granted Medafor's motion for a preliminary injunction with respect to CryoLife's marketing and sale of PerClot Topical in the U.S. CryoLife is currently awaiting the Court's order, which it expects will provide details regarding the scope of the injunction.
Pat Mackin, CryoLife President and Chief Executive Officer, said, "While we are disappointed with the District Court's ruling on the preliminary injunction motion, we continue to believe we have a strong case and remain focused on securing the best long-term outcome in the litigation for our shareholders. We remain on track to begin enrollment in our PerClot IDE clinical trial for surgical applications during the first half of 2015, which would position us for potential FDA approval in the second half of 2017."
In April 2014, CryoLife filed a declaratory judgment lawsuit against C.R. Bard and certain of its subsidiaries, including Medafor, requesting that the Court declare that CryoLife's manufacture, use, offer for sale, and sale of PerClot in the U.S. does not and would not infringe Medafor's U.S. Patent No. 6,060,461 (the "'461 Patent"). In addition CryoLife requested that the Court declare that the claims of the '461 Patent are invalid. In September 2014, Medafor filed a motion for a preliminary injunction against CryoLife.
The preliminary injunction applies to PerClot Topical, which is in the early stages of launch in the U.S. CryoLife included approximately$1.5 million in PerClot Topical sales in its previously announced 2015 financial guidance. At this low-volume level, the Company was anticipating the gross margin for PerClot Topical to be approximately breakeven. The Company's previously announced earnings per share guidance for 2015 included $3 million to $4 million in expense related to the litigation with C.R. Bard. The Company continues to expect that this represents the high end of potential litigation expenses for the year related to this matter, and it will re-assess its litigation strategy and provide appropriate updates to its financial guidance, if any, after receiving the Court's order.

Wednesday, February 11, 2015

Cohera Medical, Inc.® Enters Agreement with B. Braun Surgical, S.A. for Distribution of TissuGlu® Surgical Adhesive in Select European Countries

PITTSBURGHJan. 21, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has entered into an exclusive sales and marketing distribution agreement with B. Braun for its TissuGlu® Surgical Adhesive in GermanySpain and Portugal.
The Agreement outlines a relationship between the two companies wherein B. Braun Surgical, S.A. will exclusively market and sell TissuGlu in the territories of GermanySpain and Portugal through its existing Closure Technologies commercial teams. TissuGlu has been CE approved and for sale in Germany through a Cohera direct sales force since 2012 and has been used in over 2,000 surgical procedures since that time. TissuGlu is indicated in Europe for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in large flap surgical procedures such as abdominoplasty.
"Cohera is excited to enter the relationship with B. Braun for the marketing of TissuGlu in these European countries," said Patrick Daly, Cohera Medical President and CEO. "We are looking forward to working with such a great organization and to making our breakthrough TissuGlu product available to more surgeons and patients in Europe."
TissuGlu is designed to meet surgeons' need for a strong, biocompatible, and easy-to-use surgical adhesive. TissuGlu is targeted for use in large flap procedures in which drains are used to control fluid output and seroma formation. TissuGlu is currently being utilized in Europe to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. Over 2,000 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.

Tuesday, January 6, 2015

Cohera Medical, Inc.® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive

PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable.  The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks.

"The receipt of the PMA Approvable Letter is a truly significant milestone for the Company," said Patrick Daly, Cohera Medical President and CEO. "We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States."

TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty.  Upon approval, TissuGlu will be the first internal surgical adhesive of its kind approved in the United States.

Mr. Daly will be presenting on this latest milestone and other significant updates at the J.P. Morgan Healthcare Conference on January 13th at 4:00pm PST.

TissuGlu is designed to meet a surgeon's need for a strong, biocompatible, and easy-to-use surgical adhesive. The Approvable PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in abdominoplasty procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.

"TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures," said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. "When approved, it will bring great benefits to both patients and surgeons."

"Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team," said Chad Coberly, JD, Vice President of Clinical, Regulatory & Legal Affairs for Cohera.

TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.

About Cohera Medical Cohera Medical, Inc. is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical's products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. The Company's lead product, TissuGlu® Surgical Adhesive, is indicated in the EU for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.  TissuGlu is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures.  The Company's second product, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process.  TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. Outside of the EU, TissuGlu and the other Cohera Medical products are currently indicated for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S. or in any other market.

Sunday, November 16, 2014

Comparison of methods to achieve artery closure following coronary angiography

Stefanie Schulz-Schupke, M.D., of the Deutsches Herzzentrum Munchen, Technische Universitat, Munich, Germany and colleagues assessed whether vascular closure devices are noninferior (not worse than) to manual compression in terms of access site-related vascular complications in patients undergoing diagnostic coronary angiography. The study appears in the November 19 issue of JAMA, a cardiovascular disease theme issue.

Percutaneous (through the skin) coronary angiography and interventions have become a cornerstone in the diagnosis and treatment of coronary artery disease. A substantial proportion of the adverse effects associated with these procedures is related to access-site complications. The common femoral artery (a large artery in the groin) is still the most frequently used access site. After the procedure, closure of the artery access site is usually achieved by manual compression. Since the mid-1990s, however, vascular closure devices (VCDs) have been introduced into clinical practice with the aim of improving efficacy and safety. Different types of VCDs have been developed, including intravascular and extravascular. However, concern exists about the safety of VCDs in comparison with manual compression, according to background information in the article.
For this study, conducted at four centers in Germany, 4,524 patients undergoing coronary angiography via the common femoral artery were randomly assigned to receive an intravascular VCD (n = 1,509), extravascular VCD (n = 1,506), or manual compression (n = 1,509) to achieve hemostasis (defined as no bleeding or only light superficial bleeding and no expanding hematoma [a localized swelling filled with blood]). Before hospital discharge, imaging of the access site was performed in 4,231 (94 percent) patients.
The primary end point (the composite of access site-related vascular complications at 30 days after randomization with a two percent noninferiority margin) was observed in 208 patients (6.9 percent) assigned to receive a VCD and 119 patients (7.9 percent) assigned to manual compression (difference, -1.0 percent). In addition, the time to hemostasis was significantly shorter with VCD compared with manual compression; time to hemostasis was shorter with intravascular VCD vs extravascular VCD; and device failures were less frequent with intravascular VCD vs extravascular VCD.
The authors write that the results of this trial may represent an important development for the clinical use of these devices. "Overall, the increase in efficacy of VCD use, with no trade-off in safety, provides a sound rationale for the use of VCD over manual compression in daily routine."

Start-up pitches high-tech glue for surgical leaks

TEL AVIV — An Israeli medical-device start-up is tackling one of the most dangerous occurrences in surgery — and it's doing it with glue.

LifeSeal is a glue-like substance that augments and, in some surgeries like hernias, replaces the traditional and painful sealing procedures of staples, tacks and sutures.

The privately-owned Israeli company behind the high-tech glue, LifeBond, says it should help in the treatment of post-operative leaks in closures of gastrointestinal and other surgical wounds. Patients get back up to speed more quickly and are more comfortable as they do.

Orahn Preiss-Bloom, one of LifeBond's co-founders, says the company's proprietary materials, which combine gelatin and an enzyme and are delivered by an applicator, were inspired by two sources: research by Professor Gregory Payne at the University of Maryland and the use of the enzyme for food applications in Asia.

The company is backed by some of Israel's top venture-capital firms as well as by Robert Taub, a prominent medical-innovation investor. And the idea is strong enough that Johnson & Johnson (TICKER: JNJ), the New Jersey-based international health-care giant, has put money down on LifeBond.

The technology is currently in European clinical trials. And with an eye to entering the U.S. market as well, CEO Gideon Sturlesi and Preiss-Bloom are looking for partners and raising capital.


Started in 2007 and employing 35 people from headquarters in Caesarea, Israel, LifeBond for now is focusing the technology's application on gastrointestinal surgery and bariatric weight-loss procedures as well as in hernia surgery.

Colon-cancer surgeries require what the doctors call anastomosis, removal of diseased intestine and reattachment to restore the gastronintestinal tract's functionality. The further down in the colon a surgeon must work, the higher the risk that a seal will leak, Sturlesi says. In some 15% to 25% of lower-colon operations, the seals leak, exposing the patients to infection and additional surgery, even death.

In such procedures, after a surgeon applies staples to close the colon, he or she spreads LifeSeal – using a glue-like applicator – along the line of the closure. The sealant provides a secure and elastic barrier to infection while the body heals. Tissue grows in and the sealant gradually dissipates.

LifeBond's second current major application, which the company calls LifeMesh, targets another very common surgery: hernias, the breaks in people's abdominal walls.

To secure a protruding intestine back into the abdomen, surgeons usually tack a mesh into place to close the break. These tacks cause inflammation and pain.

Here, the same proprietary material used in LifeSeal becomes an adhesive. In both open hernia surgery and procedures with a laparascope, the surgeon coats a standard mesh patch with LifeSeal and places it to secure the abdominal wall. The surgeon can reposition the mesh if and when necessary. LifeBond says the product keeps the patch in place as the body's tissues grow in and then dissipates.

LifeBond's two co-founders are Preiss-Bloom, 32, a New Yorker who is chief technology officer; and Ishay Attar, 42, who was vice president of business development at what is now Trendlines Medical, a tech-firm incubator. Both have master's degrees in biomedical engineering from the Technion, the Israel Institute of Technology. Attar remains a shareholder but doesn't hold a position with LifeBond.

CEO Sturlesi, 53, joined the company two years ago. Previously he was executive vice president at Lumenis, the producer of laser equipment for medical and cosmetic applications, and he was a co-founder of Galil Medical, a producer of cryosurgical technology. LifeBond's chairman is Ittai Harel, general partner of Pitango, a Herzliya, Israel, venture-capital firm and investor in LifeBond.

Worldwide market: $450 mln

LifeBond's first two target markets are substantial. The company estimates that annually in the U.S., 300,000 colorectal anastomosis procedures are done each year. The company pegs the worldwide market for this application at $450 million, a third of it in the U.S. And LifeBond says 2 million hernia repairs are done annually worldwide, half of them in the U.S. That's overall also a $450 million market.

LifeBond's investors include the Israeli venture-capital firms Aurum, Giza and Pitango. Also an investor, and a director, is Robert Taub, who founded Omrix, a producer of sealant used to control bleeding during surgery. J&J acquired Omrix in 2007.

In 2011, when LifeBond raised $20 million in a third-round financing, the New Brunswick, N.J., health-care giant J&J joined the round. Its specific investment hasn't been disclosed. LifeBond previously raised $1.5 million and $8.5 million in its Series A and Series B rounds respectively.

LifeBond is now in a Series D round, aiming to raise a total of $25 million by early 2015, and current investors have committed about half that figure.

In first-half 2013, LifeBond did a first clinical study in Sweden to test the application method for LifeSeal and to evaluate the product for safety. That study met its goals and this year LifeBond enrolled patients in a second study at eight centers in Belgium, Israel and Sweden. The company is expecting the results of that trial in November. The study's goal is to receive the CE Mark, which means that the product meets EU standards.

Sturlesi says the company has started the U.S. Food and Drug Administration process to develop the studies it needs to gain clearance to market LifeSeal in the U.S.

The company sees additional applications for LifeBond's system in surgeries involving the eye, brain, lungs, spine, urological system, and ear, nose and throat.

"We are there to support the natural healing process of the body," Sturlesi says.

Synthetic platelets helps clot blood faster

New York: Taking a cue from the human body’s own blood-clotting process, researchers at University of California, Santa Barbara have developed synthetic platelets that can do more than clot blood.
By creating nanoparticles that mimic the shape, flexibility and surface biology of the body’s own platelets, the team was able to accelerate natural healing processes while opening the door to therapies and treatments that can be customised to specific patient needs.
“This is a significant milestone in the development of synthetic platelets, as well as in targeted drug delivery,” said Samir Mitragotri, director of Center for Bioengineering (CBE) who specialises in targeted therapy technologies.
In case of blood loss due to minor injury, platelets release chemicals that “call” other platelets to the site, eventually plugging the wound.
But what happens when the injury is too severe or the patient is on anti-coagulation medication or is otherwise impaired in his or her ability to form a clot, even for a modest or minor injury?
That’s where platelet-like nanoparticles (PLNs) come in.
“These tiny, platelet-shaped particles that behave just like their human counterparts can be added to the blood flow to supply or augment the patient’s own natural platelet supply, stemming the flow of blood and initiating the healing process,” researchers emphasised.
“We were actually able to render a 65 percent decrease in bleeding time compared to no treatment,” said graduate student researcher Aaron Anselmo, lead author of the study.
With PLNs, emergency situations can be brought under control faster, injuries can heal more quickly and patients can recover with fewer complications, he added.
The results appeared in the journal ACS Nano.

Wednesday, October 8, 2014

HaemoCer approved for use in China and Canada

BioCer Entwicklungs GmbH (BCE), a German implantable biological medical device development and manufacturing company, announced today that it has achieved approval to commence sales of HaemoCer™, an Absorbable Polysaccharide Hemostat (APH), in the People's Republic of China.
"BioCer has now achieved near comprehensive Asia-Pacific regional representation, and the addition of the PRC approval of HaemoCer™ is a significant milestone," Dr Markus Heinlein, Managing Director stated. "The entry into China of our first product HaemoCer™ has been assisted by the early establishment of regional sales representation in the Asia-Pacific region. BCE are pleased Chinese surgeons and patients will now share the benefits of our technology. Our new Health Canada approval is also further evidence of strong international acceptance of our technology."
The PRC approval of HaemoCer™ expands an international sales network encompassing AustraliaHong KongIndia, Korea,MalaysiaNew ZealandSingapore and Thailand within the APEC region. BCE will be exhibiting at the EACTS, Milan, Italy, 11-15thOctober and the CMEF, Chongqing, China, 23-26th October 2014

Tuesday, August 19, 2014

Cardiva Medical, Inc. Announces Completion of the first two tranches of Series 3 Private Equity Financing and the Closing of a Senior Secured Debt Facility with GE Capital

SUNNYVALE, Calif.Aug. 19, 2014 /PRNewswire/ -- Cardiva Medical, Inc. announced today that it has closed the first two tranches of a$16.5 million Series 3 private equity financing and a $12.5 million senior secured facility with GE Capital. The Company will use the proceeds of the Series 3 private equity financing and debt facility to expand commercial efforts for its VASCADE® Vascular Closure System in the United States.
Investing in Series 3 private equity financing was a new investor, Canepa Advanced Healthcare Fund, L.P., who joined existing investors PTV Sciences, AmKey Ventures and TriVentures II Fund L.P.  Mr. Paul Enever from Canepa U.S., LLC, which serves as Investment Advisor to Canepa Advanced Healthcare Fund, L.P., has joined the Cardiva Board of Directors.
"We are extremely pleased that Canepa Advanced Healthcare, L.P. has joined Cardiva's current investors in this financing and that Paul Enever has joined our Board of Directors," said Charles Maroney, CEO. Maroney continued, "With the Series 3 equity financing and GE debt facility, Cardiva now has the financial resources to establish VASCADE as a leading extravascular closure technology which we believe can benefit both patients and healthcare providers in the United States by minimizing complications and associated costs and improving patient care when compared to conventional vascular closure devices."
"Cardiva's product platform offers the potential to transform the vascular closure market by improving both patient safety and comfort", said Paul Enever of Canepa U.S., LLC. Enever continued, "VASCADE leverages Cardiva's Catalyst® platform that has been utilized effectively in more than 400,000 procedures since its initial launch into the U.S. market in 2007". We are delighted to add Cardiva to our investment portfolio of emerging growth medical device companies that are focused on improving patient outcomes while reducing the cost of medical care."

Tuesday, August 5, 2014

Transluminal Tech’s velox CD Arterial Closure Device Gets EU Approval

velox CD Transluminal Techs velox CD Arterial Closure Device Gets EU Approval (VIDEO)
squeeze velox CD Transluminal Techs velox CD Arterial Closure Device Gets EU Approval (VIDEO)Transluminal Technologies LLC. out of Syracuse, New York won the CE Mark for its velox CD Vascular Closure Device used to close arteriotomies following percutaneous femoral procedures. Closing arteries can be a challenge, eating up surgeons’ time just when it’s optimal to move the patient out of the OR. The velox CD device speeds up this process by delivering an implant that plugs the vessel wall from within.
The implant consists of an intraluminal footplate that absorbs within about 24 hours and a extraluminal plug that takes two weeks to absorb. The components are made of a proprietary magnesium alloy that breaks up and bioabsorbs safely into the body, leaving a clean repaired artery without the surgeon having to manually apply pressure during closure.
Here’s a video from a real procedure utilizing the velox CD: