Published by Globes [online], Israel business news - Biological surgical sealant developer Lifebond Ltd. has raised $20 million.Giza Venture Capital and Aurum Ventures MKI Ltd., the venture capital arm of Morris Kahn, led the round, and were joined by current investors Pitango Venture Capital, GlenRock Israel, Zitelman Group Inc., and Robert Taub, the founder and CEO of Omrix Pharmaceuticals, which he sold to Johnson & Johnson (NYSE: JNJ) for $425 million in 2008.
Lifebond co-founder and CEO Issay Attar told "Globes", "When the current investors are excited about a company, it's a lot easier to hold another financing round."
Lifebond was named one of Israel's most promising start-ups for 2010 by "Globes".
Lifebond's flagship product is a surgical sealant for tissue after surgery to shorten the bowel. The product is undergoing a Phase I clinical trial in Brazil, and is due to begin a larger trial in Europe later this year.
"Globes": The clinical trial you're planning costs less than $20 million.
Attar: "It's always a good idea to raise a lot of money in the life sciences, if possible. This amount will be enough for us to complete an US Food and Drug Administration (FDA) trial, which we'll conduct after the European trial.
"I believe that an investment of this size by Israeli venture capital funds at this stage was made possible because the company achieved good clinical results in the Brazilian trial, and because the difference between animals and people for a product like this is not great. Therefore, the risk-reward profile is attractive."
As for raising capital only from Israeli funds, Attar said, "We also spoke with foreign funds, but it's easier to talk with someone in your own language, and we gave them preference. Obviously, foreign funds have advantages and I hope to work with them later."
Lifebond is also developing the LifePatch, a biological hemostats to stop bleeding, and a product for hernias, both of which are just beginning clinical trials.
Monday, May 23, 2011
Tuesday, May 17, 2011
Dural repair with four spinal sealants: focused review of the manufacturers' inserts and the current literature.
Abstract
BACKGROUND CONTEXT:
Deliberate or traumatic dural fistulas are typically augmented by a "sealant" or "fibrin glue" to enhance the strength of dural closure.
PURPOSE:
Little is known about the risks and complications associated with two specific "sealants" and two specific "fibrin glues" used for dural closure.
STUDY DESIGN/SETTING:
Review of the manufacturers' inserts and a focused review of the literature concerning the pros and cons for two "sealants" (DuraSeal [Confluent Surgical Inc., Waltham, MA, USA] and BioGlue [Cryolife, Kennesaw, GA, USA]) and two "fibrin glues" (EVICEL [Johnson and Johnson Wound Management, Ethicon Inc., Somerville, NJ, USA] and Tisseel [fibrin sealant; Baxter International Inc., Westlake Village, CA, USA]) were assessed.
PATIENT SAMPLE:
A focused review of the literature using four different "sealants" or "fibrin glues" was performed.
OUTCOME MEASURES:
Documentation of persistent/recurrent postoperative cerebrospinal fluid fistulas was an end point for failure for the four different "sealants" and "fibrin glues."
METHODS:
Manufacturers' inserts and a focused review of the literature concerning the relative safety and efficacy of two "sealants" (DuraSeal and BioGlue) and two "fibrin glues" (EVICEL and Tisseel) used to augment dural closure were assessed.
RESULTS:
Although DuraSeal is approved by the Federal Drug Administration (FDA) for intracranial and spinal application, two instances of paralysis are described in the literature. BioGlue is classified by the manufacturer as neurotoxic. EVICEL, one of the "fibrin glues," appeared in just two animal studies, whereas Tisseel, the other "fibrin glue," has been used in many large clinical series without adverse events.
CONCLUSION:
Despite the lack of FDA approval, Tisseel (fibrin glue) has seen wide adoption in "off-label" use. DuraSeal, which is FDA approved, was associated with two instances of paralysis. Alternatively, BioGlue was described as neurotoxic even by the manufacturer.
Stryker Announces Definitive Agreement to Acquire Orthovita, Inc. for $3.85 Per Share in Cash
Kalamazoo, Michigan - May 16, 2011- Stryker Corporation (NYSE:SYK) announced today a definitive agreement to acquire Orthovita, Inc. (Nasdaq:VITA), a global developer and manufacturer of orthobiologic and biosurgery products through an all cash tender offer. Orthovita competes in the $5 billion orthobiologics market and is a global leader in synthetic bone grafts with its Vitoss(TM) product offering, and also competes in vertebral augmentation with its Cortoss(TM) product offering. In addition, the company's Biosurgery business manufactures hemostasis products such as Vitagel(TM) which are designed to control intra-operative and post-operative bleeding. Combined, Orthovita's product portfolio achieved sales of $95 million in 2010. The acquisition of Orthovita is highly complementary to Stryker's existing orthobiologics offering, which is currently sold through multiple Stryker divisions.
Under the terms of the agreement, Orthovita shareholders will receive $3.85 for each outstanding Orthovita share of common stock. The value of the transaction is estimated at $316 million, based upon Orthovita's 79 million fully diluted shares outstanding as well as net debt of $12 million.
"With this acquisition we are meaningfully expanding our orthobiologics product portfolio and strengthening our competitive position in key segments of the Spine, Orthopaedics and Biosurgery markets," said Stephen P. MacMillan, Chairman, President and Chief Executive Officer of Stryker. "We believe the collective talent of our sizable sales forces across multiple franchises positions us to build on Orthovita's success and accelerate sales growth."
The boards of directors at Stryker and Orthovita have approved the transaction, and the board of directors of Orthovita resolved to recommend that Orthovita shareholders tender their shares to Stryker in the tender offer. In addition, shareholders holding approximately 14.5% of the outstanding shares of Orthovita common stock have entered into agreements with Stryker to support the transaction and to tender their shares in the offer.
The tender offer is scheduled to commence within 10 business days and is expected to close in the second quarter of 2011. The tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Orthovita common stock on a fully diluted basis and the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period. Following the tender offer, Stryker will acquire the remaining outstanding shares of Orthovita common stock through a second step merger. Upon closing, the transaction is expected to be neutral to Stryker's 2011 earnings per share excluding acquisition and integration-related charges.
Citi served as Stryker's exclusive financial advisor in connection with this transaction.
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.
Under the terms of the agreement, Orthovita shareholders will receive $3.85 for each outstanding Orthovita share of common stock. The value of the transaction is estimated at $316 million, based upon Orthovita's 79 million fully diluted shares outstanding as well as net debt of $12 million.
"With this acquisition we are meaningfully expanding our orthobiologics product portfolio and strengthening our competitive position in key segments of the Spine, Orthopaedics and Biosurgery markets," said Stephen P. MacMillan, Chairman, President and Chief Executive Officer of Stryker. "We believe the collective talent of our sizable sales forces across multiple franchises positions us to build on Orthovita's success and accelerate sales growth."
The boards of directors at Stryker and Orthovita have approved the transaction, and the board of directors of Orthovita resolved to recommend that Orthovita shareholders tender their shares to Stryker in the tender offer. In addition, shareholders holding approximately 14.5% of the outstanding shares of Orthovita common stock have entered into agreements with Stryker to support the transaction and to tender their shares in the offer.
The tender offer is scheduled to commence within 10 business days and is expected to close in the second quarter of 2011. The tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Orthovita common stock on a fully diluted basis and the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period. Following the tender offer, Stryker will acquire the remaining outstanding shares of Orthovita common stock through a second step merger. Upon closing, the transaction is expected to be neutral to Stryker's 2011 earnings per share excluding acquisition and integration-related charges.
Citi served as Stryker's exclusive financial advisor in connection with this transaction.
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.
Monday, May 16, 2011
A Revolutionary Femoral Access Device Delivering Rapid and Secure, Implant-Free Arterial Closure
REDWOOD CITY, Calif., May 16, 2011 /PRNewswire/ -- Arstasis is pleased to announce the U.S. launch of its latest commercial product - the AXERA™ Access Device. The AXERA Device enhances insertability into the femoral artery and overall procedural usage while continuing to deliver the clinical benefits of the implant-free Arstaotomy Procedure.
Since 1959, physicians have been using the Modified Seldinger Technique for femoral artery access. At the end of every such case, patients are left with a substantial hole in the femoral artery which can command significant effort and cath lab resources to close. The AXERA™ Access Device is a breakthrough femoral artery access tool that quickly creates a longer and shallower angle arteriotomy, the Arstaotomy, resulting in significant tissue-upon-tissue overlap through the artery. Upon sheath removal at the end of the procedure, arterial pressure is decreased across this longer Arstaotomy channel intended to provide an excellent environment for clot formation and rapid femoral artery hemostasis.
The AXERA Device's Arstaotomy Procedure requires only minimal manual compression to provide secure closure with no foreign body implants - eliminating the risk of infections and thromboembolic events related to a vascular implant. The Arstaotomy Procedure promotes rapid hemostasis resulting in excellent patient comfort with decreased bed rest and quicker ambulation.
"The AXERA Access Device delivers a truly unique way to gain access into the femoral artery for diagnostic and cath-possible procedures," commented Dale Wortham, MD from the University of Tennessee Medical Center, Knoxville. "Unlike vascular closure implants, the AXERA Device delivers rapid arterial hemostasis but does not deposit any foreign material into the patient. Our results have been excellent with patients generally sitting up in 15 minutes and ambulating in 1 hour. It really has improved our cath lab throughput and patient satisfaction."
Physicians have also been noting that the new AXERA Device allows them to perform Arstaotomy procedures in almost all patients, instead of having to potentially exclude patients with complex anatomy. "In my opinion, all patients are candidates for the AXERA Access Device. The new AXERA Device is sturdier and allows me to more easily gain femoral artery access, even in the more complicated patient subsets of the obese and those with heavily diseased vessels," said Dr. Greg Sampognaro, a practicing interventional cardiologist at the P&S Surgical Hospital in Monroe, Louisiana.
Patient enrollment continues in the RECITAL study, a multi-center, prospective registry that is overseen by a medical monitor and anticipated to enroll up to 500 patients in at least seven U.S. hospitals.
ABOUT ARSTASIS, INC.
Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative arterial access devices to cardiologists, interventional radiologists, their staffs, and patients. Detailed information about the AXERA Access Device and the Arstaotomy procedure is available at www.arstasis.com.
Since 1959, physicians have been using the Modified Seldinger Technique for femoral artery access. At the end of every such case, patients are left with a substantial hole in the femoral artery which can command significant effort and cath lab resources to close. The AXERA™ Access Device is a breakthrough femoral artery access tool that quickly creates a longer and shallower angle arteriotomy, the Arstaotomy, resulting in significant tissue-upon-tissue overlap through the artery. Upon sheath removal at the end of the procedure, arterial pressure is decreased across this longer Arstaotomy channel intended to provide an excellent environment for clot formation and rapid femoral artery hemostasis.
The AXERA Device's Arstaotomy Procedure requires only minimal manual compression to provide secure closure with no foreign body implants - eliminating the risk of infections and thromboembolic events related to a vascular implant. The Arstaotomy Procedure promotes rapid hemostasis resulting in excellent patient comfort with decreased bed rest and quicker ambulation.
"The AXERA Access Device delivers a truly unique way to gain access into the femoral artery for diagnostic and cath-possible procedures," commented Dale Wortham, MD from the University of Tennessee Medical Center, Knoxville. "Unlike vascular closure implants, the AXERA Device delivers rapid arterial hemostasis but does not deposit any foreign material into the patient. Our results have been excellent with patients generally sitting up in 15 minutes and ambulating in 1 hour. It really has improved our cath lab throughput and patient satisfaction."
Physicians have also been noting that the new AXERA Device allows them to perform Arstaotomy procedures in almost all patients, instead of having to potentially exclude patients with complex anatomy. "In my opinion, all patients are candidates for the AXERA Access Device. The new AXERA Device is sturdier and allows me to more easily gain femoral artery access, even in the more complicated patient subsets of the obese and those with heavily diseased vessels," said Dr. Greg Sampognaro, a practicing interventional cardiologist at the P&S Surgical Hospital in Monroe, Louisiana.
Patient enrollment continues in the RECITAL study, a multi-center, prospective registry that is overseen by a medical monitor and anticipated to enroll up to 500 patients in at least seven U.S. hospitals.
ABOUT ARSTASIS, INC.
Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative arterial access devices to cardiologists, interventional radiologists, their staffs, and patients. Detailed information about the AXERA Access Device and the Arstaotomy procedure is available at www.arstasis.com.
Sunday, May 15, 2011
Public Increasingly Aware of Meat-Glue in Food - Health Industry Use Certain to be Debated?
As public awareness increases of the use of meat glue (animal derived thrombin) within the food industry, it seems inevitable that the use of similar products in surgery will become a discussion point. Particularly when perfectly viable alternatives are available, it will certainly impact the healthcare sector. Below is an excerpt of a commentary on this practice with further links below. We in the industry are fully aware of the risks associated with bovine thrombin... and this
Not to mention the public belief in regulatory protection
"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"
Meat what are you getting now?
The commercial meat packing industry and restaurants around the U.S. have found a new way to increase profits by using meat scraps to make filet mignons as well as hot dogs, sausages and stew meat. Powdered meat glue binds scraps of beef, lamb, chicken or fish, that would normally be thrown out, into solid pieces of meat. According to its manufacturer, meat glue can be used to produce new kinds of mixed meats (for example combining beef and fish seamlessly).
Meat glue permits restaurants and butchers to sell their meat scraps as premium meat. Once you cook the glued meat, even a professional butcher or chef can’t tell the difference.
This Franken-food is sold as imitation crabmeat, ham, hot dogs, sausage, fish balls, for making milk, making noodles firmer and making yogurt (water loss) creamier. It is also used for more expensive products such as filet mignons and veal steaks and products labeled as beef steak, chopped meat, shaped meat, frozen meat, pork or chicken as well as minute steak, formed meat, wafer sliced meat, frozen meat, beef added products, chopped meat, molded meat, cubed or frozen beef, chicken and pork as well as some Hydrolyzed plant protein.
So how do they glue meat together and make it look just like filet mignons? Super glue? No! A new miracle glue from 3M? No! The industry uses a pseudo-coagulant called Thrombin or Fibrimex, which were initially banned in Europe but now sold in the EU, Australia, Canada and the U.S.
Thrombin is sold under the brand names Activa RM and Fibrimex. The products derive from pig or bovine blood. The active ingredient is called transglutaminase. When sold in a store, products containing transglutaminase are labeled as “composite meat product”. However there are no labeling or disclosure requirements placed on restaurants.
But meat glue sold as Thrombin and transglutaminase have a different enzyme makeup. Transglutaminase is the enzyme that cross-links proteins in “meat glues.” Thrombin is a different protein, a protease that causes increased transglutaminase activity. Thrombin can be hazardous to use because if it enters a cut it can cause extensive blood clotting.
Thrombin contains Maltodextrin and sodium caseinate which contain (without disclosure) Ajinomoto’s MSG. Blood carries bacterias, toxins and viruses causing infections and autoimmune responses in animals as they do in humans.
Factory farms also use growth hormones (steroids) that require daily doses of antibiotics in an effort to control or minimize illnesses. Animal feed used in CAFOs contains pesticide residues that also contribute to illness. The use of antibiotics signals an admission that factory farmed animals are sick or become sick. Why would you give daily doses of antibiotics to an animal or human being unless they were sick?
The infectious agent that leads to mad cow disease can also be passed through animal blood meal. As a result of mad cow’s disease cases in 2004, the Bush administration’s FDA said it “would ban animal blood in cattle feed, while dietary supplements and cosmetics would be kept free of materials from cattle too sick or hurt to walk.” Consumer groups said the protections did not go far enough. Why does the food industry and the USDA think animal blood meal is now safe for human consumption? What has changed since 2004?
The commercial meat packing industry and restaurants around the U.S. have found a new way to increase profits by using meat scraps to make filet mignons as well as hot dogs, sausages and stew meat. Powdered meat glue binds scraps of beef, lamb, chicken or fish, that would normally be thrown out, into solid pieces of meat. According to its manufacturer, meat glue can be used to produce new kinds of mixed meats (for example combining beef and fish seamlessly).
Meat glue permits restaurants and butchers to sell their meat scraps as premium meat. Once you cook the glued meat, even a professional butcher or chef can’t tell the difference.
This Franken-food is sold as imitation crabmeat, ham, hot dogs, sausage, fish balls, for making milk, making noodles firmer and making yogurt (water loss) creamier. It is also used for more expensive products such as filet mignons and veal steaks and products labeled as beef steak, chopped meat, shaped meat, frozen meat, pork or chicken as well as minute steak, formed meat, wafer sliced meat, frozen meat, beef added products, chopped meat, molded meat, cubed or frozen beef, chicken and pork as well as some Hydrolyzed plant protein.
So how do they glue meat together and make it look just like filet mignons? Super glue? No! A new miracle glue from 3M? No! The industry uses a pseudo-coagulant called Thrombin or Fibrimex, which were initially banned in Europe but now sold in the EU, Australia, Canada and the U.S.
Thrombin is sold under the brand names Activa RM and Fibrimex. The products derive from pig or bovine blood. The active ingredient is called transglutaminase. When sold in a store, products containing transglutaminase are labeled as “composite meat product”. However there are no labeling or disclosure requirements placed on restaurants.
But meat glue sold as Thrombin and transglutaminase have a different enzyme makeup. Transglutaminase is the enzyme that cross-links proteins in “meat glues.” Thrombin is a different protein, a protease that causes increased transglutaminase activity. Thrombin can be hazardous to use because if it enters a cut it can cause extensive blood clotting.
Thrombin contains Maltodextrin and sodium caseinate which contain (without disclosure) Ajinomoto’s MSG. Blood carries bacterias, toxins and viruses causing infections and autoimmune responses in animals as they do in humans.
Factory farms also use growth hormones (steroids) that require daily doses of antibiotics in an effort to control or minimize illnesses. Animal feed used in CAFOs contains pesticide residues that also contribute to illness. The use of antibiotics signals an admission that factory farmed animals are sick or become sick. Why would you give daily doses of antibiotics to an animal or human being unless they were sick?
The infectious agent that leads to mad cow disease can also be passed through animal blood meal. As a result of mad cow’s disease cases in 2004, the Bush administration’s FDA said it “would ban animal blood in cattle feed, while dietary supplements and cosmetics would be kept free of materials from cattle too sick or hurt to walk.” Consumer groups said the protections did not go far enough. Why does the food industry and the USDA think animal blood meal is now safe for human consumption? What has changed since 2004?
Sunday, May 8, 2011
Police Department of Fairfield Township, NJ Relies on QuikClot® Hemostatic Dressing to Save the Lives of an Officer and Civilian
WALLINGFORD, Conn.--(BUSINESS WIRE)--A Fairfield NJ township police officer, mandated to carry QuikClot® Combat Gauze® at all times after it saved the life of a township police officer, used the life-saving gauze to stop the severe arterial bleeding of an 82 year-old dialysis patient, based on a recent article in The Progress Newspaper. It was reported that the elderly man’s source of profuse bleeding was through an access port in his arm, typically used during a dialysis procedure. Z-Medica Corporation, a medical device company developing innovative hemostatic agents, is the maker of QuikClot, the life-saving technology which was used to save the man’s life.
“We are always grateful to learn that QuikClot continues to save lives in various settings and situations”
The article also noted that the Fairfield NJ Police Department credited the use of QuikClot Combat Gauze with saving the life of a township police officer who was shot in the line of duty. According to Chief Charles Voelker, following that event all Fairfield officers were mandated to carry QuikClot Combat Gauze. QuikClot is used by first responders around the country to stop traumatic bleeding and stabilize patients in a wide variety of non-sterile, emergency situations, because of its high effectiveness and ease of use.
“We are always grateful to learn that QuikClot continues to save lives in various settings and situations,” said Brian Herrman, Chief Executive Officer of Z-Medica. “This officer should be commended since his quick decision to apply QuikClot reflects great situational awareness. The Fairfield Township Police Department perfectly illustrates the many ways in which QuikClot is currently utilized – by first responders at the scene of an incident, by police officers who are injured in the line of duty, and all the way through to health care providers in a medical or post-treatment setting.”
“We realized the value in having every officer carry QuikClot first-hand after one of our neighboring police officers was able to successfully control the bleeding of one of our officers following a shooting,” said Chief Charles Voelker, Fairfield Township Police Department. “We encourage other law enforcement agencies to consider providing their officers with this life-saving technology. It’s amazing what a potential difference this small piece of gauze can make in our community, and we are already seeing examples of this, such as with the recent case involving an 82-year old dialysis patient.”
“We are always grateful to learn that QuikClot continues to save lives in various settings and situations”
The article also noted that the Fairfield NJ Police Department credited the use of QuikClot Combat Gauze with saving the life of a township police officer who was shot in the line of duty. According to Chief Charles Voelker, following that event all Fairfield officers were mandated to carry QuikClot Combat Gauze. QuikClot is used by first responders around the country to stop traumatic bleeding and stabilize patients in a wide variety of non-sterile, emergency situations, because of its high effectiveness and ease of use.
“We are always grateful to learn that QuikClot continues to save lives in various settings and situations,” said Brian Herrman, Chief Executive Officer of Z-Medica. “This officer should be commended since his quick decision to apply QuikClot reflects great situational awareness. The Fairfield Township Police Department perfectly illustrates the many ways in which QuikClot is currently utilized – by first responders at the scene of an incident, by police officers who are injured in the line of duty, and all the way through to health care providers in a medical or post-treatment setting.”
“We realized the value in having every officer carry QuikClot first-hand after one of our neighboring police officers was able to successfully control the bleeding of one of our officers following a shooting,” said Chief Charles Voelker, Fairfield Township Police Department. “We encourage other law enforcement agencies to consider providing their officers with this life-saving technology. It’s amazing what a potential difference this small piece of gauze can make in our community, and we are already seeing examples of this, such as with the recent case involving an 82-year old dialysis patient.”
Thursday, May 5, 2011
Stanford Studies Document Widespread, Risky Use Clotting Drug On Non-Hemophilia Patients
An expensive blood-clotting drug that is intended only for hemophilia patients is being used in hospitals predominantly to treat patients without this disorder, despite evidence suggesting that it could harm them, according to a pair of studies from the Stanford University School of Medicine.
In fact, the studies estimate that only 4 percent of the powerful drug's use in U.S. hospitals from 2000 through 2008 was for treating hemophilia patients, while an enormous 96 percent involved cases of heart surgery, trauma, intracranial hemorrhages (bleeding in or near the brain) and a host of other surgical and medical problems. There are few studies examining these broader uses of the drug, known as recombinant factor 7a, and what little evidence does exist reveals a serious problem: The drug can increase the risk of blood clots, which can lead to heart attacks and strokes.
What's more, RF7a is pricey — it costs an estimated $10,000 for an average dose.
"The stakes are high with this one," said Veronica Yank, MD, an instructor in medicine and the first author of one of the studies. "Because it's such a powerful clotting agent, it has the potential when used off-label to damage the lives of patients without providing any real benefit."
Given the safety issues and the expense of RF7a, Yank and her colleagues are urging physicians to exercise greater caution in using the drug until its safety is effectively evaluated for these broader uses.
The studies will be published in the April 19 issue of Annals of Internal Medicine, along with an accompanying editorial by Harvard Medical School researchers commending the Stanford team for providing "compelling data … about the runaway use, uselessness and risk for this expensive treatment."
The editorial goes on to question whether "improper promotion" of RF7a by its maker, Novo Nordisk, led to the rapid expansion of its use. While the company has denied such practices, it is being investigated by the Defense Department for the use of the drug in overseas combat operations, the editorial reports.
The Stanford authors say RF7a provides a good example of what happens when physicians latch onto a "wonder" drug for uses distinctly different from its original purpose. In this case, the medication was developed to treat a small subset of hemophilia patients. In these genetic disorders, the body is deficient in producing specific proteins, or factors, that aid the blood-clotting process. It primarily affects males, and is estimated to occur in one in 5,000 live male births. There are two main forms of the disorder: hemophilia A (a deficiency in factor 8) and hemophilia B (a deficiency in factor 9).
To curtail bleeding in hemophilia patients, physicians usually administer doses of either factor 8 or factor 9, but this treatment doesn't work for the small group of patients whose antibodies see these factors as foreign substances and attack them. RF7a, approved by the U.S. Food and Drug Administration in 1999, was developed for this group.
Despite the limited range of patients for whom the drug was approved, the Stanford authors noted that physicians and surgeons quickly started using RF7a to either prevent or stop heavy bleeding in patients who didn't have hemophilia. It's a practice known as off-label prescribing, meaning that physicians use medications to treat conditions other than those approved by the FDA. While there is nothing illegal about off-label prescribing — and, in fact, it can be invaluable in treating diseases for which few therapies exist — senior author Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, said the danger is that the drug hasn't been rigorously tested for these new uses or with broad ranges of patients.
"Many patients and physicians wrongly assume that the FDA has scrutinized all of the different ways a drug can be used, but they've only examined those uses that have gone through the approval process," Stafford said.
A few previously published studies had raised concerns that RF7a increased the risk of blood clots, and so in 2008 the U.S. Agency for Healthcare Quality and Research, which funded both Stanford studies, asked researchers to probe the issue. The agency specifically wanted to know what kind of clinical evidence existed for five off-label uses of RF7a: heart surgery, intracranial hemorrhage, body and brain trauma, liver transplantation and prostate surgery.
Yank, Stafford and their colleagues searched 10 widely used databases for clinical trials and observational studies of the drug for the five indications. They then rated the available clinical evidence and focused on the randomized clinical trials and observational studies, excluding those that did not directly address clinical outcomes. For the meta-analyses in the first paper, the researchers ended up using data from 16 randomized clinical trials and 10 observational studies.
The researchers found that RF7a didn't reduce mortality rates for any of the five off-label uses, although Yank noted that most of the studies tracked patients for only 30-90 days following the administration of the drug. For the top two uses of the drug, the analyses showed heart-surgery patients who were given RF7a had a 5 percent higher risk of developing blood clots, and intracranial hemorrhage patients had a 3 percent higher risk of developing clots. There was no increased risk of blood clots for body trauma patients, and the evidence was too limited to determine the clotting risks for brain trauma, liver transplants and prostate surgeries.
For the second study, first author Aaron Logan, MD, PhD, a postdoctoral scholar in hematology and bone marrow transplantation, joined Yank and Stafford in analyzing another database to determine how the drug was being used in U.S. hospitals. The data came from Premier Perspectives and includes information from 615 non-federal hospitals throughout the country.
In reviewing records from 2000 to 2008, the researchers found that the use of RF7a grew 140-fold, from 125 cases in 2000 to 17,813 in 2008, primarily for off-label indications. The researchers also noted that of the five off-label uses the AHRQ wanted the team to investigate, three of them — heart surgery, intracranial hemorrhage and trauma — were among the top uses of the drug. "This type of assessment can be quite eye-opening about the real-world use of these medications on the basis of extremely weak evidence," Logan said.
He also noted that the off-label use of RF7a has spread beyond academic medical centers where new or experimental therapies are often tested. The data showed the proportion of RF7a use in non-academic hospitals grew from 11 percent in 2000 to 67 percent in 2008. "This suggests wide adoption of RF7a as a therapy despite concerns about its efficacy and safety," the authors wrote.
Yank said she and her colleagues hope the two studies will prompt physicians and surgeons to be more cautious about the off-label use of RF7a. "Despite the miraculous ability of this drug to stop bleeding, we have an obligation to 'first do no harm,'" she said.
That sentiment was echoed in the accompanying editorial, by Harvard's Jerry Avorn, MD, professor of medicine, and Aaron Kesselheim, MD, JD, research associate in health policy and management, who wrote that, "Allowing physician autonomy to choose medications is appealing, but not when it results in such useless, dangerous and costly decisions."
In fact, the studies estimate that only 4 percent of the powerful drug's use in U.S. hospitals from 2000 through 2008 was for treating hemophilia patients, while an enormous 96 percent involved cases of heart surgery, trauma, intracranial hemorrhages (bleeding in or near the brain) and a host of other surgical and medical problems. There are few studies examining these broader uses of the drug, known as recombinant factor 7a, and what little evidence does exist reveals a serious problem: The drug can increase the risk of blood clots, which can lead to heart attacks and strokes.
What's more, RF7a is pricey — it costs an estimated $10,000 for an average dose.
"The stakes are high with this one," said Veronica Yank, MD, an instructor in medicine and the first author of one of the studies. "Because it's such a powerful clotting agent, it has the potential when used off-label to damage the lives of patients without providing any real benefit."
Given the safety issues and the expense of RF7a, Yank and her colleagues are urging physicians to exercise greater caution in using the drug until its safety is effectively evaluated for these broader uses.
The studies will be published in the April 19 issue of Annals of Internal Medicine, along with an accompanying editorial by Harvard Medical School researchers commending the Stanford team for providing "compelling data … about the runaway use, uselessness and risk for this expensive treatment."
The editorial goes on to question whether "improper promotion" of RF7a by its maker, Novo Nordisk, led to the rapid expansion of its use. While the company has denied such practices, it is being investigated by the Defense Department for the use of the drug in overseas combat operations, the editorial reports.
The Stanford authors say RF7a provides a good example of what happens when physicians latch onto a "wonder" drug for uses distinctly different from its original purpose. In this case, the medication was developed to treat a small subset of hemophilia patients. In these genetic disorders, the body is deficient in producing specific proteins, or factors, that aid the blood-clotting process. It primarily affects males, and is estimated to occur in one in 5,000 live male births. There are two main forms of the disorder: hemophilia A (a deficiency in factor 8) and hemophilia B (a deficiency in factor 9).
To curtail bleeding in hemophilia patients, physicians usually administer doses of either factor 8 or factor 9, but this treatment doesn't work for the small group of patients whose antibodies see these factors as foreign substances and attack them. RF7a, approved by the U.S. Food and Drug Administration in 1999, was developed for this group.
Despite the limited range of patients for whom the drug was approved, the Stanford authors noted that physicians and surgeons quickly started using RF7a to either prevent or stop heavy bleeding in patients who didn't have hemophilia. It's a practice known as off-label prescribing, meaning that physicians use medications to treat conditions other than those approved by the FDA. While there is nothing illegal about off-label prescribing — and, in fact, it can be invaluable in treating diseases for which few therapies exist — senior author Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, said the danger is that the drug hasn't been rigorously tested for these new uses or with broad ranges of patients.
"Many patients and physicians wrongly assume that the FDA has scrutinized all of the different ways a drug can be used, but they've only examined those uses that have gone through the approval process," Stafford said.
A few previously published studies had raised concerns that RF7a increased the risk of blood clots, and so in 2008 the U.S. Agency for Healthcare Quality and Research, which funded both Stanford studies, asked researchers to probe the issue. The agency specifically wanted to know what kind of clinical evidence existed for five off-label uses of RF7a: heart surgery, intracranial hemorrhage, body and brain trauma, liver transplantation and prostate surgery.
Yank, Stafford and their colleagues searched 10 widely used databases for clinical trials and observational studies of the drug for the five indications. They then rated the available clinical evidence and focused on the randomized clinical trials and observational studies, excluding those that did not directly address clinical outcomes. For the meta-analyses in the first paper, the researchers ended up using data from 16 randomized clinical trials and 10 observational studies.
The researchers found that RF7a didn't reduce mortality rates for any of the five off-label uses, although Yank noted that most of the studies tracked patients for only 30-90 days following the administration of the drug. For the top two uses of the drug, the analyses showed heart-surgery patients who were given RF7a had a 5 percent higher risk of developing blood clots, and intracranial hemorrhage patients had a 3 percent higher risk of developing clots. There was no increased risk of blood clots for body trauma patients, and the evidence was too limited to determine the clotting risks for brain trauma, liver transplants and prostate surgeries.
For the second study, first author Aaron Logan, MD, PhD, a postdoctoral scholar in hematology and bone marrow transplantation, joined Yank and Stafford in analyzing another database to determine how the drug was being used in U.S. hospitals. The data came from Premier Perspectives and includes information from 615 non-federal hospitals throughout the country.
In reviewing records from 2000 to 2008, the researchers found that the use of RF7a grew 140-fold, from 125 cases in 2000 to 17,813 in 2008, primarily for off-label indications. The researchers also noted that of the five off-label uses the AHRQ wanted the team to investigate, three of them — heart surgery, intracranial hemorrhage and trauma — were among the top uses of the drug. "This type of assessment can be quite eye-opening about the real-world use of these medications on the basis of extremely weak evidence," Logan said.
He also noted that the off-label use of RF7a has spread beyond academic medical centers where new or experimental therapies are often tested. The data showed the proportion of RF7a use in non-academic hospitals grew from 11 percent in 2000 to 67 percent in 2008. "This suggests wide adoption of RF7a as a therapy despite concerns about its efficacy and safety," the authors wrote.
Yank said she and her colleagues hope the two studies will prompt physicians and surgeons to be more cautious about the off-label use of RF7a. "Despite the miraculous ability of this drug to stop bleeding, we have an obligation to 'first do no harm,'" she said.
That sentiment was echoed in the accompanying editorial, by Harvard's Jerry Avorn, MD, professor of medicine, and Aaron Kesselheim, MD, JD, research associate in health policy and management, who wrote that, "Allowing physician autonomy to choose medications is appealing, but not when it results in such useless, dangerous and costly decisions."
Tuesday, May 3, 2011
Cotton candy-like glass nanofibers appear to speed healing in initial venous stasis wound trial
Imagine a battlefield medic or emergency medical technician providing first aid with a special wad of cottony glass fibers that simultaneously slows bleeding, fights bacteria (and other sources of infection), stimulates the body's natural healing mechanisms, resists scarring, and-because it is quickly absorbed by surrounding tissue - may never have to be removed in follow-up care.Or, imagine diabetics with hard-to-heal wounds finding a source of relief from the battle against infections and limb amputation.Those scenarios are the hope of the developers of a revolutionary borate glass nanofiber material, which appears have sped and helped the final of healing long-term wounds in eight out of 12 venous stasis wound sufferers in a recent clinical trial held at a medical center in Rolla, Mo.Details about the trials and the glass fiber material were published today in the May issue of the American Ceramic Society's Bulletin magazine.The story reports on the discovery of the fibers and on an empirical study that began late in the fall of 2010 supervised by the internal review board of the Phelps County Regional Medical Center. The trial groups originally had 13 volunteer members, but one dropped out during the early stages.According to Peggy Taylor, the PCRMC registered nurse who administered the treatments, all of the volunteers in the trial are enthusiastic about the use of the glass fiber product, which she says "looks like cotton candy.""All of the participants had diabetes and several of them had wounds that had been unhealed for more than a year," says Taylor, a specialist in wound care. "One patient had the same wound for three years. After using the glass fiber product for a few months, we were able to repair the skin in eight of the patients. Remarkably, the other four have made a lot of progress and all of their wounds should be healed soon, too."All of the patients suffered from problems associated with venous stasis, a condition where blood circulation in extremities is poor. As the blood pools, typically in lower legs, fluids accumulate causing unusual pressure on skin tissues. Sores and wounds can then develop when the fluid "weeps" from skin cracks, cuts or abrasions.Because of an enzyme in the weeping fluid, the skin surrounding small venous stasis injuries can quickly erode and turn into large and deep wounds. Even small bruises can eventually develop into bone-deep openings.The goal of the PCRMC trial was to provide an initial evaluation of the effects of the novel fibrous glass material produced by the Mo-Sci Corporation, a Rolla company already known for creating glass-based materials for medical applications."Bioglass" materials aren't particularly new to the medical field, but thus far all bioglass has been formed from a silica-based glass composition, and these primarily have been used in hard-tissue regeneration, such as bone repair.Glass scientist Steve Jung, who helped develop the new material, says he and co-developer Delbert Day had wondered whether a different type of bioactive glass material could be used for soft-tissue regeneration. "We felt from our in-vitro studies that bioactive glasses containing boron would react to body fluids much faster than silicate glasses," says Jung, who obtained his Ph.D from Missouri University of Science and Technology, where he conducted his research with Day, a professor at the university. "We also knew that an in-vitro study of lithium borate glasses had showed it to have beneficial effects against bacteria, such as E. coli, salmonella and staphylococcus microbes."Lastly, Jung and Day recall they were interested in a composition that was rich in calcium. "Previously, investigators have reported that calcium is important for wound healing. It appears to assist the migration of epidermal cells and help the body regulate the healing process of open wounds," says Jung.Besides composition, Jung and Day thought the structure of the material may be important to consider, too, and suspected that providing a healing "scaffold" might be beneficial. "We thought it might be advantageous to have a material that could mimic the microstructure of fibrin that forms the basis of a blood clot. We reasoned that if the structure could imitate fibrin, it might trap blood platelets and allow the formation of a wound cover that could support the healing process."Jung and Day finally settled on a particular borate glass composition - called 13-93B3 glass - one that Mo-Sci, a company founded by Day, already knew how to form into cottony glass fibers, 300 nanometers to 5 micrometers in diameter.
ProFibrix Secures Funding for Progression of Lead Product Into Late Stage Clinical Development and Announces Management and Supervisory Board Appointments
LEIDEN, The Netherlands and SEATTLE, May 3, 2011 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products that help stop bleeding (hemostasis) after surgery, today announced the successful closing of a series B follow-on financing. In conjunction with the financing and to support the company's next stage of development towards commercialization, ProFibrix also announced several management and Supervisory Board appointments.
The Supervisory Board will be chaired by independent director Leonard Kruimer, Chief Financial Officer of Crucell. Over the past decade, Mr. Kruimer has been instrumental in building Crucell from an entrepreneurial start-up into a global vaccine company, taking the company public and leading a number of large and successful M&A transactions. Also joining the Supervisory Board as an independent director is Vic Schmitt. Mr. Schmitt has been a long-time senior executive at Baxter International, a key player in the hemostasis market, where he last served as President of Venture Management.
In addition to these high profile appointments to the Supervisory Board, Jan Ohrstrom, has been named Chief Executive Officer. Before joining ProFibrix, Dr. Ohrstrom was a senior executive at ZymoGenetics, where he was responsible for the development of several products, and a member of the team that took the company public. Dr. Ohrstrom started his career at Novo Nordisk.Jaap Koopman, founding CEO of ProFibrix, will become Chief Scientific Officer.
In addition to the private funding the company was awarded a government credit, bringing the total new funds available to the company for the progression of Fibrocaps(TM) to EUR 15 million (USD 22 million). New investors Vesalius Biocapital and INKEF Capital co-led the financing round, while existing investors Index Ventures and Gilde Healthcare Partners also participated. Alain Parthoens from Vesalius Biocapital, Dirk Kersten from Gilde Healthcare Partners, and Francesco De Rubertis from Index Ventures will also hold seats on the board of ProFibrix.
The proceeds of the financing will be used to progress the company's lead product Fibrocaps into late stage clinical development, as well as to support the company's other pipeline programs. Fibrocaps is currently being investigated in a prospective, multi-center Phase II study in multiple surgical indications at up to 20 sites, including major U.S. and Dutch academic medical centers. If this study confirms the positive results of the first Phase II trial, ProFibrix anticipates initiating a pivotal Phase III trial in early 2012, and file for approval by the U.S. Food and Drug Administration in early 2013.
Jan Ohrstrom, MD, said: "We are very pleased to welcome Vesalius Biocapital and INKEF Capital to our investor base. Our successful financing and strengthened Supervisory Board and leadership team should put ProFibrix in an excellent position to continue the development of Fibrocaps and prepare for its commercial launch. We would like to extend our gratitude to the parting board members for their contribution and commitment to the early development of ProFibrix."
Jaap Koopman said: "Jan Ohrstrom has played a key role in transitioning ProFibrix to a market-focused company. He has the capabilities and skills to take ProFibrix through its next stages of growth to become a leading hemostasis company. I look forward to seconding him in his new role as CEO, and to continue to contribute to the development of new products based on our fibrinogen technology platform."
The Supervisory Board will be chaired by independent director Leonard Kruimer, Chief Financial Officer of Crucell. Over the past decade, Mr. Kruimer has been instrumental in building Crucell from an entrepreneurial start-up into a global vaccine company, taking the company public and leading a number of large and successful M&A transactions. Also joining the Supervisory Board as an independent director is Vic Schmitt. Mr. Schmitt has been a long-time senior executive at Baxter International, a key player in the hemostasis market, where he last served as President of Venture Management.
In addition to these high profile appointments to the Supervisory Board, Jan Ohrstrom, has been named Chief Executive Officer. Before joining ProFibrix, Dr. Ohrstrom was a senior executive at ZymoGenetics, where he was responsible for the development of several products, and a member of the team that took the company public. Dr. Ohrstrom started his career at Novo Nordisk.Jaap Koopman, founding CEO of ProFibrix, will become Chief Scientific Officer.
In addition to the private funding the company was awarded a government credit, bringing the total new funds available to the company for the progression of Fibrocaps(TM) to EUR 15 million (USD 22 million). New investors Vesalius Biocapital and INKEF Capital co-led the financing round, while existing investors Index Ventures and Gilde Healthcare Partners also participated. Alain Parthoens from Vesalius Biocapital, Dirk Kersten from Gilde Healthcare Partners, and Francesco De Rubertis from Index Ventures will also hold seats on the board of ProFibrix.
The proceeds of the financing will be used to progress the company's lead product Fibrocaps into late stage clinical development, as well as to support the company's other pipeline programs. Fibrocaps is currently being investigated in a prospective, multi-center Phase II study in multiple surgical indications at up to 20 sites, including major U.S. and Dutch academic medical centers. If this study confirms the positive results of the first Phase II trial, ProFibrix anticipates initiating a pivotal Phase III trial in early 2012, and file for approval by the U.S. Food and Drug Administration in early 2013.
Jan Ohrstrom, MD, said: "We are very pleased to welcome Vesalius Biocapital and INKEF Capital to our investor base. Our successful financing and strengthened Supervisory Board and leadership team should put ProFibrix in an excellent position to continue the development of Fibrocaps and prepare for its commercial launch. We would like to extend our gratitude to the parting board members for their contribution and commitment to the early development of ProFibrix."
Jaap Koopman said: "Jan Ohrstrom has played a key role in transitioning ProFibrix to a market-focused company. He has the capabilities and skills to take ProFibrix through its next stages of growth to become a leading hemostasis company. I look forward to seconding him in his new role as CEO, and to continue to contribute to the development of new products based on our fibrinogen technology platform."
Monday, May 2, 2011
CryoLife, Inc. (CRY) Downgraded by The Benchmark Company to “Hold”
CRY executives say no more Hemostats....
PerClot and HemoStase [More on that HERE and HERE]
Revenues from the sale of PerClot and HemoStase increased 17% for the three months ended March 31, 2011 as compared to the three months ended March 31, 2010. This increase was primarily due to a 40% increase in the volume of grams sold, which increased revenues by 34%, partially offset by a decrease in average selling prices, which decreased revenues by 17%...
Revenues from the sale of PerClot and HemoStase increased 17% for the three months ended March 31, 2011 as compared to the three months ended March 31, 2010. This increase was primarily due to a 40% increase in the volume of grams sold, which increased revenues by 34%, partially offset by a decrease in average selling prices, which decreased revenues by 17%...
CryoLife may begin manufacturing PerClot from plant starch modified by Starch Medical Inc. under the terms of the License Agreement, which is anticipated to occur sometime in late 2011 or in 2012. The License Agreement extends for an indefinite period. Following the start of manufacturing and U.S. regulatory approval... [after transition from the current Chinese site of manufacture].Excerpt Benchmark Cryolife Q1
Operator
Our next question comes from Raymond Myers with Benchmark. Please proceed with your question.
Raymond Myers – Benchmark
Great, thank you. Most of my questions have been answered, but let me ask this one. PerClot revenue in Q1 was 660,000. We’ll have a lot to compare that with except for Q4 where……(technical difficulty)
Steve Anderson
We lost you.
Ashley Lee
We lost you Ray.
Raymond Myers – Benchmark:
…… after having a very strong $660,000 in Q1, is any of that due to stocking and what does that tell you about the potential for the product over the course of the year?
Ashley Lee
We have actually seen the majority of our distributors reorder already. So we remain very optimistic about PerClot revenues for the balance of this year and our expectations are included in the guidance that we gave for all powdered hemostats that we talked about earlier.
Raymond Myers – Benchmark
I guess what I’m driving at is trying to understand how contributed that guidance is. I’m assuming, for starters, we’re not going to sell any more hemostats, correct?
Steve Anderson
That is correct.
Raymond Myers – Benchmark
And PerClot increased by well over 200% sequentially from Q4 to Q1. Was any of that due to stocking orders that you don’t expect to repeat in Q2?
Steve Anderson
No, most of the distributors have reorders by this time. Not all, but most.
Raymond Myers – Benchmark
So with that kind of a quarter-on-quarter growth rate, what kind of PerClot revenue would we expect in Q2?
Ashley Lee
We don’t give quarterly guidance out Ray, but again we gave for powdered HemoStase, it could be as much as 5 million for the full year and we would expect to see sequential growth in PerClot revenues over the balance of this year, so we’ll leave it to that.
Steve Anderson
One of the things that we have pointed in the previous calls is that our R&D people feel that the PerClot absorbs two to three times the amount of fluid that the prior product absorbed and I can tell you that the difference in the activity of the product is striking, but you exhibit them side by side. Now it’s very hard to describe that conversationally. But what I would suggest is the next time we have a booth at a convention that you ask to personally see the demonstration of the two products side by side because the doctors’ reaction to the activity, the chemical activity of PerClot has been extraordinary, and we are very, very enthusiastic about that product.
Raymond Myers – Benchmark
Well, that sounds great. I’ll do that and look forward to growth in that area. Thanks.
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