Wound-Sealing, Self-Assembling, Nanoscale Technology

A super-stealthy MIT (Massachusetts Institute of Technology) spinoff is poking its head out today to announce that it has finalized a licensing agreement with the Institute. The pact gives Arch Therapeutics rights to a family of clear liquids developed by research scientist Rutledge Ellis-Behnke that stanch or prevent bleeding after an injury or during surgery.

Ellis-Behnke and his colleagues had started out working with the liquids, which are packed with tiny protein fragments, or peptides, as potential aids to the regeneration of damaged neural tissue; they discovered in the course of brain surgeries on lab animals that some of the peptides stopped bleeding—within just 15 seconds. It turned out that what was happening was the nanoscale peptides were self-assembling into a biodegradable gel that sealed the wound on contact.

Around the same time as that work was published in 2006, Ellis-Behnke founded Arch—which then went by the perhaps-too-literal Clear Nano Solutions—with healthcare investment veteran Terrence Norchi and Steve Kelly, a serial entrepreneur and founding CEO of Myomo, another MIT spinoff. (Both Myomo’s founders and Ellis-Behnke have received grants from MIT’s Deshpande Center for Technological Innovation.) The company still has yet to ink any venture financing deals; in an article in Mass High Tech written shortly after the company’s founding, Kelly was identified as the sole investor in the firm.

It’s still early days, but Arch materials might eventually be used in the operating room, on the battle field, or even in first-aid kits. Says former Cleveland Clinic head and Arch advisor Floyd D. Loop in a press release: “Discovering ways to control something so fundamental as bleeding has potentially huge implications for the medical field.”
I had trouble viewing the 2006 Pdf full description at its web location so I have made it public hosting it at http://www.adrive.com/ and it is available HERE.

Cryolife BioGlue for Abdominal Aortic Aneurysm Repair

10% of people given fibrinogen have HCV

The Yomiuri Shimbun
About 10 percent of the 7,400 or so patients who were administered the blood product fibrinogen were infected with hepatitis C, a Health, Labor and Welfare Ministry study team announced Tuesday.
The team has been investigating patient records kept at medical institutions to which fibrinogen was shipped. The product was made by Green Cross Corp., a predecessor of Mitsubishi Tanabe Pharma Corp.
An estimated 10,000 people are thought to have been infected with the hepatitis C virus after the blood product fibrinogen was used in surgical operations involving about 280,000 people. However, the results of the investigation suggest this percentage of infection, 3.6 percent, could be lower than the true figure, medical sources said.
In its interim report, the study team found 99 people infected after being treated with fibrinogen have died from hepatitis-related diseases.
Fibrin glue, used as a surgical adhesive, was the most common use of fibrinogen among patients, making up about 40 percent of cases. Direct intravenous injection of fibrinogen as a hemostat agent in operations, including parturitions, accounted for 30 percent of treatments involving the product.
The survey results prompted the ministry to renew its call for people who have had surgery to have hepatitis checkups.
Out of 6,609 medical institutions to which Green Cross delivered the product, 644 institutions that kept individual patients' records of administration of fibrinogen were surveyed at the end of February. Of them, 475 institutions provided valid responses.
According to the survey, 7,406 patients were administered fibrinogen, and 741 of them were found to have been infected with HCV. Of them, 12 also had been infected with the hepatitis B virus, while 40 others had been infected with HBV alone.
Hospitals are unsure whether 4,908 of the 7,406 patients have hepatitis. The number of people found to have been infected likely will further rise as the investigation progresses, the medical sources said.
Of patients administered fibrinogen, 1,817, or 24.5 percent, have already died. Of them, 99 died from hepatitis-related diseases.

Entegrion achieve FDA approval

Entegrion, Inc., a privately owned life sciences product development company specializing in technologies for hemorrhage control, resuscitation, and tissue repair, announced that it has received 510(k) market approval from the U. S. Food and Drug Administration (FDA) for its hemostatic medical textile technology. The first application of the technology is Stasilon FR – hemostatic wound dressings for first responders. This market includes EMS workers, police officers, emergency personnel and fire fighters. The Stasilon FR – hemostatic wound dressing was approved by the FDA for use by medical professionals under prescription and “over-the-counter” by consumers to control bleeding resulting from “minor cuts and abrasions” as well as “lacerations, punctures and incisions.” Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon OR – hemostatic surgical pads.
Entegrion 510K available HERE

CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label

ATLANTA, April 17 /PRNewswire/ --
CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue
processing company, announced today that it has signed an exclusive
three-year agreement with Minneapolis-based Medafor, Inc.

Under terms of the agreement CryoLife will distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. and for cardiac, vascular and general surgery, other than orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China). CryoLife expects to begin distributing Hemostase MPH in the U.S. in the second quarter of 2008, except to approximately 41 hospitals for which Medafor will retain distribution rights until no later than December 31, 2008. Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, United Kingdom and Germany in the second quarter of 2008, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agreement, but Veterans' Administration Hospitals are included. The unique, absorbable powder hemostat, which received CE Mark approval in 2003 and FDA pre-market approval in September 2006, will be distributed by CryoLife under the private label name Hemostase MPH. Hemostase MPH is developed using Medafor's exclusive, licensed Microporous Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. When used as directed, this highly effective hemostatic agent facilitates the formation of a resilient, natural clot within just a few minutes. Available in a convenient ready-to-use applicator, Hemostase MPH, unlike many hemostatic agents, does not require additional preparation steps in the operating room or special storage conditions thereby saving valuable operating room time and resources. Pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24-48 hours of application at the wound site, compared to other surgical hemostats which can take 3-8 weeks or more to fully break down. "Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, making it the perfect complement to CryoLife's BioGlue(R) product line, which is much stronger and provides both tissue reinforcement and sealant capabilities," stated Steven G. Anderson, president and chief executive officer. "Hemostase MPH also allows us to compete in the surgical hemostat market, which we believe totaled approximately US$380 million in the U.S. in 2007." Gary Shope, Medafor's chief executive, said, "We are pleased to be working with CryoLife as a major distribution partner. CryoLife is a world leader in its chosen areas, and its strength in sales, marketing and distribution in the cardio and vascular fields should provide great impetus to Medafor's market penetration." The agreement allows for a three-year extension at the option of CryoLife if certain minimum purchases are met.

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.

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