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

FibroGen - a company trying to commercialize synthetic collagens and gelatins

Recombinant human collagens and gelatins
Based on expertise in collagen and the role of prolyl hydroxylase enzymes in the formation of collagen, FibroGen has developed the first known recombinant methodology for making fully synthetic collagens that are essentially identical to those found in nature. By making and testing different types of collagen that exist in nature, FibroGen scientists have demonstrated that recombinant type III collagen persists longer in tissue than any form of human or animal type I collagen. This unique characteristic of type III collagen serves as the basis for FibroGen's dermal filler product candidate for cosmetic applications.
Focused efforts over several years have also led to the development of a highly efficient production system employed by FibroGen to supply recombinant human collagens and gelatins (collagen fragments) as biomaterials for use in a variety of pharmaceutical and medical device applications. FibroGen produces recombinant human type III collagen (never before available in commercial quantities), recombinant human type I collagen, and distinct recombinant gelatin molecules optimized for specific applications. FibroGen's biomaterials address the needs of a wide range of customers in the pharmaceutical and medical device industries for safer, highly pure, and fully characterized alternatives to animal-sourced collagen and gelatin.

FDA moves to prevent Mad Cow Disease infecting Hemostat's and other Devices

The FDA is moving (some would say with glacier-like speed) to barr deadly prions from contaminating humans and animals via prohibiting the use of "high risk" animal products being used in drugs, biologics and medical devices (e.g. hemostat's) intended for humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
FULL TRANSCRIPT HERE

Collagen from Plants

CollPlant Ltd. is a biotechnology company specializing in the development and commercialization of safe, plant-derived collagen and protein-based biomaterials for the healthcare industry.

Collagen is one of the primary materials found in a variety of medical products including bone growth matrices, facial aesthetics, wound dressings, hemostats and sealants. During the last few years public awareness of the potential hazards of animal-derived collagen has begun to drive the healthcare industry to seek alternative sources for collagen.

CollPlant has developed a proprietary transgenic plant-based expression and production system for safe, high-quality, Type I recombinant human collagen. The Company's plant-derived collagen has an enhanced safety profile, as it is free of potential viral and other animal-derived hazards such as prions associated with Mad Cow Disease. In addition, CollPlant's transgenic plants are grown and cultivated within a completely sealed, environmentally-safe greenhouse.

In addition to its Type I collagen product, CollPlant is developing an extensive pipeline of additional high value, plant-derived protein polymers and composites with a variety of specialized characteristics tailored to specific markets such as orthopedics, aesthetic medicine, urinary incontinence, and wound healing.

CollPlant was founded in 2004 by a group of leading scientists, and is spearheaded today by experienced market-oriented executives from the global biotechnology arena.

Baxters Heparin worries cause concern for many Animal derived products

The US Food and Drug Administration (FDA) has received hundreds of reports of serious injuries and/or deaths in patients who have been administered heparin made by Baxter containing this contaminant - Baxter had sourced its API from SPL, who had sourced it from China. The lots in question were recalled in February.

SPL said it voluntarily initiated the nationwide withdrawal of the API as a precaution following the recent health scare involving Baxter's heparin, although as yet, no new adverse events related to this latest issue have been reported.

The voluntary recall also affects 23 finished product lots of heparin sodium in 5% dextrose and 0.9% sodium chloride injection solution manufactured and distributed by B. Braun Medical within the US and Canada. The company pulled these products from the market after it was notified by SPL of the API contaminant.

After weeks of investigations, the FDA has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.

It has been revealed as oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved use in medicine, said Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.

"It doesn't appear to be a natural contaminant that got in there," said the agency, but a man-made compound that had been chemically modified to mimic raw heparin, the API used in a finished heparin product.

SPL supplies a refined form of the heparin API to Baxter and other firms from a plant it partly owns in China, called Changzhou SPL, along with a facility it owns in Wisconsin, US.


The contamination was present in the powdered form of raw heparin that was purchased by SPL's suppliers in China, according to Robert Rhoades, a pharmaceutical consultant for Becker & Associates, speaking on behalf of SPL.

Heparin Recall

PolyHeme

PolyHeme® is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute in development for the treatment of life-threatening blood loss when an oxygen-carrying fluid is required and red blood cells are not available.

PolyHeme® is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
PolyHeme’s characteristics include:
Simultaneously restores lost blood volume and hemoglobin levels
Universally compatible (does not require typing or cross-matching before infusion)
Immediately available
Has extended shelf life in excess of 12 months
Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.