Orthovita Introduces VITASURE™ Absorbable Hemostat

Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced today that it has obtained certain rights to distribute an absorbable hemostat product developed by Medafor, Inc., a Minneapolis-based medical device company. The product is approved for use as a hemostat in certain surgical procedures under a pre-market approval granted by the U.S. Food and Drug Administration in 2006 and a CE Mark granted in 2003. Orthovita plans to rebrand the product as VITASURE™ Absorbable Hemostat.

VITASURE’s hemostatic mechanism of action is based on Medafor’s exclusively licensed microporous polysaccharide hemosphere technology. Through this technology, VITASURE acts as a molecular sieve to instantly extract fluids from blood, creating a powerful osmotic action that causes the particles to swell and concentrates serum proteins, platelets, and other formed elements on its surface. The VITASURE particles and their coating of compacted cells then create a matrix for the formation of a tenacious fibrin clot. The VITASURE particles are fully absorbed and enzymatically cleared within 24-48 hours.
Under its distribution agreement with Medafor, Orthovita has the non-exclusive right to sell VITASURE in the spine and orthopedic field in the United States, and certain territories outside of the United States. Medafor has responsibility for manufacturing and maintaining regulatory approvals for the product. The initial term of the agreement is scheduled to expire in December 2013 and Orthovita has the right to renew the agreement for an additional three year period if certain purchase obligations are met during the fifth year of the agreement.

Japan - Infected Fibrin glue believed used at 550 hospitals

The Health, Labor and Welfare Ministry announced Friday that 556 medical institutions nationwide are believed to have used fibrin glue, some of which is believed to have been made with tainted fibrinogen blood-clotting agents.
The medical glue, which is manufactured using fibrinogen and other chemicals, is widely used to suture and halt bleeding during medical procedures including cardiac surgery and operations to treat bone fractures and burns. Fibrin glue made with fibrinogen manufactured by Green Cross Corp., the predecessor of Mitsubishi Tanabe Pharma Corp., is suspected of having caused hepatitis C infections.
Fibrin glue is estimated to have been used in the treatment of about 79,000 people, according to surveys by drugmakers. But the names of all the medical institutions that might have used fibrin glue have not been identified, and surveys looking to reveal this information have been delayed.
According to the documents the ministry released, the usage of the glue by large-scale medical institutions, such as university hospitals, stands out as a trend.
Breaking down the figures according to area, Tokyo ranked top with 46 institutions named in the documents, followed by Hokkaido, with 43, and Osaka and Aichi prefectures, with 39 and 28 institutions, respectively.
A ministry official said: "The list of medical institutions released this time does not comprehensively cover all the institutions that might have used fibrin glue. But we hope that people will take an examination as soon as possible to see if they have been infected on the basis of the information released."
The cases of hepatitis C infections are most likely to stem from the use of fibrin glue made using Green Cross fibrinogen between 1981 and 1987.
(Apr. 12, 2008)

Baxter's Tisseel Prep

Czech company Synthesia celebrate Gelita shipment

First oxidized cellulose left Synthesia in final medical device packaging (06.06.2007)
We shipped the first completely packed delivery of oxidized cellulose to our customer! So far deliveries have left Synthesia not finally packed, but as raw material intended for further processing. Production of finally packed product is a major milestone in Synthesia´s history.
In the future only finally packed product will be leaving Synthesia´s gates. It is packed in a primary and secondary packaging, intended for use on operating rooms, labeled by trademark of our exclusive partner and worldwide distributor company called Gelita Medical. Gelitacel is distributed directly to end users, surgeons in hospitals worldwide. Click here and find more information on oxidized cellulose.

Arista Newsclip

Saving Blood Product From Human Form Of Mad Cow Disease

Amid concern that recipients of certain blood transfusions may risk infection with a deadly protein responsible for the human form of mad cow disease, researchers in Canada now report development of a special filter that quickly and effectively removes the protein from blood. In addition to causing mad cow disease, these so-called prion proteins cause a variant form of the human neurological disorder, Creutzfeldt-Jakob disease. Termed variant Creutzfeldt-Jakob Disease (vCJD), its emergence triggered recent bans on exportation of beef from Europe. Variant CJD also can be transmitted in blood transfusions. "The use of the device will significantly decrease the risk of acquiring vCJD through blood transfusions," co-author Patrick V. Gurgel, Ph.D., reported at the 235th national meeting of the American Chemical Society. The device has been approved for use in Europe "and has no competitor at the moment," said Gurgel. About the size of a person's hand, the device contains a specially-designed material that recognizes and binds to prions. "This technology adds a needed layer of protection against the transmission of vCJD through blood transfusion," said Gurgel, senior research scientist at ProMetic Life Sciences in Mont-Royal, Quebec, Canada. "Our research shows that it works." The new filter can remove prions from red blood cell concentrate in less than an hour. Transfusions of red blood cells go to thousands of patients with chronic anemia resulting from kidney failure, cancer, gastrointestinal bleeding, and acute blood loss resulting from trauma. The researchers needed five years to develop the device and are now working on ways to remove prion proteins from other blood components, including plasma and plasma proteins, Gurgel said. In previous studies, the scientists showed that the device could successfully remove prions from the blood of infected hamsters and that the disinfected blood could be injected into healthy hamsters without causing disease. More recently, the researchers demonstrated that the device can also filter healthy human blood without damaging the red blood cells and other blood components, a finding that demonstrates that the technique is safe for use on human blood, they said. Human clinical studies using the device, called the P-Capt® Prion Capture Filter, are now underway in Europe, where it has received approval for commercialization, the scientists say. The first commercialization will be in Ireland and the United Kingdom (UK) and is expected in mid 2008, in an effort to help safeguard blood supplies, Gurgel suggested. Experts believe that vCJD is acquired from eating beef from prion-infected cattle. As in cows, the disease is characterized by a slow destruction of the brain tissue, which results in nerve damage, paralysis, and eventually death. So far, vCJD has killed at least 200 people in Europe alone. Health officials are increasingly concerned that the disease may spread elsewhere, including the United States, through blood transfusions from infected individuals. There is currently no reliable blood test for detecting the disease or a way of destroying the infectious prion proteins in blood. As a result, blood donation centers in the U.S. have imposed restrictions on blood donations from individuals who have lived in Europe for at least five years, particularly in the UK, where most vCJD cases have occurred.

Hemostasis LLC

Minneapolis based Hemostasis LLC has a technology very similar to Medafor Inc.'s Arista although it is unclear which applications or countries their products are approved for? The company website says the company............. "designs and manufactures advanced Natural Clotting Polymers (NCP™) and applicators for the treatment of severe externally bleeding lacerations for first aid kits, military, civilian and emergeny room trauma. Combined disciplines of R&D experience from our MTRC™ (Medical Technology Research Center) within the medical device industry, have developed an advanced, biocompatible, natural biopolymer which revolutionizes the way hemorrhaging is treated.
Hemostasis LLC's; BleedArrest™ CP (Clotting Powder) and BleedArrest™ CF (Clotting Foam) are two new hemorrhaging and bleeding control technologies that are changing the way medical professionals are stopping bleeding in seconds. "
Their website does not disclose a lot of information, I will update as further news becomes available.
Patent info is available HERE and HERE and the 510k from the FDA HERE

Haemacure Reveals Positive Results Of Preclinical Study Of Fibrin Sealant In Adhesion Prevention

Haemacure Corp. (HAE.TO) on Thursday revealed the results of a preclinical study it recently conducted on the use of its proprietary lead product candidate, the human fibrin sealant HemaseelHMN, in preventing the formation of post-surgical adhesions. In preclinical testing, Hameacure's fibrin sealant was found to be significantly superior to the control group in preventing the formation of post-surgical tissue adhesion. It was also found to be superior to historical data disclosed in published literature for GYNECARE INTERCEED Absorbable Adhesion Barrier, marketed by Ethicon, Inc. The company said the preclinical results are strategically significant as Haemacure's current fibrin sealant haemostasis formulation was used in this study. Initial analysis indicates that no change in the formulation or the manufacturing of Haemacure's fibrin sealant would be required to pursue an adhesion prevention indication. The company noted that the U.S. market for adhesion prevention products is estimated currently at $100 million and is expected to grow to US$150-200 milion in fibrin sales.

Canadian Government Drops Remaining Charges Against Former Red Cross Director

Nearly two years after the criminal trial first began on February 2006, prosecutors for the Canadian government have dropped all remaining charges against Roger Perrault, former director of the Canadian Red Cross (CRC). The charges stem from Canada’s contaminated blood scandals of the 1980s and early 1990s.
Approximately 1,000 Canadians were infected with HIV and an additional 20,000 with hepatitis C (HCV) when they inadvertently used contaminated blood and blood products. The majority of the HIV infections occurred in the 1980s, while the HCV infections occurred from the 1970s to the early 1990s. Complications related to HIV and HCV have resulted in the deaths of at least 3,000 Canadians.
In May 2005, CRC pled guilty to federal charges filed in 2002 under Canada’s Food and Drug Act for distributing products tainted with HIV and HCV from 1983 to 1990. It paid the maximum fine allowed under the offense. In addition, CRC agreed to contribute 1.5 million Canadian dollars ($1.4 million) to the University of Ottawa; with half the money going to a scholarship fund for victims and their families and the other half to a “national medical error project” to prevent such a crisis in the future.
In 1998, the Canadian government established a one billion Canadian dollars ($970 million) trust for HCV victims. The fund, initially open only to those infected with HCV from 1986-1990, was expanded in 2006 to include all Canadian citizens who contracted HCV from contaminated blood or blood-derived products.
While the compensation packages were welcome developments, the existing charges against Perrault represented for many a chance for accountability. Instead, Perrault’s “exoneration” is difficult for victims and their advocates to accept. They hold the former CRC blood transfusion service director largely responsible for allowing contaminated blood products to infect patients in the 1980s and early 1990s.
Also acquited in that decision were John Furesz, former director of the Bureau of Biologics at Health Canada; Wark Boucher, former chief of the blood products division of the Bureau of Biologics; Michael Rodell, former Armour Pharmaceutical vice president; and Armour Pharmaceutical, the New Jersey-based manufacturer of Factorate, the factor VIII product sold in Canada. In November 1987, Armour withdrew Factorate from the Canadian market in response to evidence that the heat-based, viral inactivation process being used did not adequately kill HIV.
The Canadian Hemophilia Society (CHS), which represents the country’s bleeding disorders population, reacted to the government’s latest move with indignation.
“A lot of money and time was spent and it all just ended today with a 10-minute speech from the Crown,” said John Plater of CHS. “There are a lot of people out there that are hurting as a result of what happened and they are going to walk away from this very confused, very upset, with a lot of questions. People can say that the system has failed them once again.”
Source: The Toronto Star (online), January 19, 2008, and Medical News Today, January 24, 2008

Japanese Victims of HCV Blood Scandal To Receive Compensation

New legislation in Japan will require the government and manufacturers of hepatitis C-contaminated blood products to compensate those infected with the virus years ago. The manufacturers of the contaminated products are expected to jointly administer a compensation fund with the government. The law, which was enacted by the Japanese Parliament on December 28, 2007, was followed by a statement from Yasuo Fukuda, Japanese Prime Minister.
“We must frankly admit the state’s responsibility for causing huge harm to the victims and for failing to prevent the harm from spreading,” said Fukuda. “I express my apologies from my heart.”
Momentum had been building in favor of the law as a group of approximately 200 HCV patients had brought multiple successful suits to several district courts during the past five years. The plaintiffs claim that the government’s failure to properly regulate blood products from the 1970s to early 1990s demonstrated clear negligence, resulting in as many as 10,000 HCV infections. Some Japanese media outlets report an even higher number--upwards of two million people infected. According to the Health Ministry, approximately 1,000 individuals are eligible to file a claim. They will receive $109,450-$365,000, depending on how severely they were affected.
“Our five-year battle was finally rewarded,” said Michiko Yamaguchi, leader of the plaintiffs nationwide. The case for government culpability was made stronger in light of events abroad. In 1977, a plasma-derived fibrinogen concentrate lost U.S. Food and Drug Administration approval after it became clear that the product could transmit HCV. Nonetheless, the Japanese government continued to approve the product long after the U.S. ban. Fibrinogen and other plasma products were commonly used in the 1970s by Japanese obstetricians, gynecologists and surgeons to treat hemophilia or simply stop hemorrhaging during childbirth or surgeries.
Several pharmaceutical companies also share a significant responsibility for failure to use viral-inactivation technologies that had become available by the late 1970s. Although these technologies, which included heat and solvent-detergent treatment, effectively eliminated HCV from plasma-derived products, pharmaceutical companies were reluctant to implement them, citing cost and efficacy concerns. Nihon Pharmaceutical Co. and Mitsubishi Tanabe Pharma (formerly Mitsubishi Pharma Corp.), along with Mitsubishi’s subsidiary, Benesis Corp., are all expected to contribute to Japan’s HCV compensation fund.
Sources: ABC news (online), December 28, 2007; BBC news (online), January 8, 2008; and International Herald Tribune, January 11, 2008