Insurance Company offers screened blood

ALC Health has signed an agreement with the Blood Care Foundation (BCF) to provide clients with screened blood, in the event of a medical emergency, from a network of blood banks around the world.
The service will be added as a new free benefit to all of the company's policies, including travel insurance, from 1 June 2010. ALC Health will be the only international medical provider offering the service across all of its policy products.
Andrew Apps, director at ALC Health commented:"The increase in incidences of people being given infected blood meant that many of our members were requesting a service of this type. We are delighted to be working with the BCF and now, at no extra cost to our customers, they can be assured that in the event of requiring a blood transfusion the blood will be available within a short space of time and will have been fully screened."
The BCF is a Sussex based charity that has been established since 1991 to provide a solution to the problems of sourcing and supplying screened blood in the case of emergencies. The BCF has built up a network of blood banks to overcome the demand where blood is in short supply, or the local blood does not meet US, UK and EU standards. All blood supplied by BCF is drawn from internationally recognised blood centres, which meet the highest international standard. BCF also supplies immunoglobulin and vaccine for the treatment of rabies.

Potential Risk to Blood Supply Probed

An infectious virus linked to two diseases is drawing the attention of public-health officials, who are investigating the potential threat to the nation's blood supply.
It isn't clear if the virus, known as XMRV, poses a danger, and public-health officials say there isn't evidence of spreading infection. But because of concern over the potential for widespread infection and preliminary evidence that XMRV is transmitted similarly to HIV, officials are quickly trying to determine if action is needed to protect the blood supply.
XMRV was discovered in 2006 when it was found in tumor samples from men with a rare form of familial prostate cancer. Research has also linked the virus to chronic fatigue syndrome and found it in measurable levels in the blood of healthy people. But the evidence isn't conclusive, as several other studies failed to find XMRV in the blood of people with chronic fatigue syndrome, and it isn't known how prevalent the virus is or whether it causes disease.
"These are early days trying to understand the public health significance of XMRV," said Jay Epstein, director of the Office of Blood Research and Review at the Food and Drug Administration.
Efforts are under way to find effective tests for the virus and determine its prevalence, led by a working group funded by the National Institutes of Health and including federal agencies such as the FDA and the Centers for Disease Control and Prevention. Blood banks, academic institutions and at least one advocacy group are also involved.
The focus on XMRV is part of a growing effort to better monitor emerging infections—disorders that have either increased in humans in recent decades or are deemed a potential threat. Currently there are 12 tests used to block infectious agents from entering the blood supply, such as HIV or hepatitis C, and more screens are under study, including those for dengue, human variant Creutzfeldt-Jakob disease and agents that cause malaria. There is no FDA-licensed lab test for XMRV, and officials say they are still setting standards for diagnosing it.
Public-health officials increasingly recognize that even infections not typically found in the U.S. can quickly come here because of global travel. Many viruses also have long incubation periods, making it harder to recognize that the virus was transmitted by a blood transfusion. In an October 2009 report, a federal advisory committee on blood safety and availability concluded that biovigilance in the U.S. is a "patchwork of activities, not a cohesive national program."
The incidence of infectious diseases being transmitted through transfusions is small, typically only a handful each year, according to the American Red Cross and data reported to the FDA. About 16 million units of whole blood and red blood cells were donated in the U.S. in 2006, the latest data available, according to the 2007 National Blood Collection and Utilization Report. The American Red Cross, which collects almost half of blood donations in the U.S., estimated that about 10,000 donors a year turn out to be infected with pathogens that officials screen for. Nearly half are hepatitis C virus.
Michael P. Busch, who runs the Blood Systems Research Institute in San Francisco and is a member of the XMRV working group, notes that everyone harbors benign viral infections. These viruses are transmitted in every blood transfusion, but aren't known to cause diseases in recipients, says Dr. Busch. Even if XMRV is found to be present in large numbers of blood donors, Dr. Busch notes, it is still necessary to determine if XMRV causes diseases.
The working group was established after a paper was published in October in the journal Science, where researchers reported finding the virus in a majority of 101 patients with chronic fatigue syndrome. The study's co-authors at the Whittemore Peterson Institute for Neuro-Immune Disease, the National Cancer Institute and the Cleveland Clinic,also found the virus in nearly 4% of 218 healthy people used as controls in the study.
Extrapolating from those numbers, public-health officials estimated that up to 10 million people in the U.S. and hundreds of millions of people globally could be infected with XMRV, or xenotropic murine leukemia virus-related virus.
The apparent link to CFS, which affects an estimated 17 million people world-wide, and has no specific treatments, has been closely followed by the patient advocacy community. The Whittemore Peterson institute, established by the family of a chronic fatigue patient, has started collecting blood from CFS patients who got their diagnosis following a blood transfusion and plan to launch their own study of the issue, says Annette Whittemore, founder and president of the institute.
The CFIDS Association of America, an advocacy group for chronic fatigue syndrome, set up a bank to collect biospecimens to be used in potential studies about CFS, including XMRV-related ones. Researchers at Emory University and the University of Utah published a study last week showing that XMRV may be treatable with drugs that treat HIV.
The AABB, an association of facilities that collect virtually all of the U.S. blood supply, has also set up an XMRV task force, although the virus doesn't appear on a list of infectious agents evaluated by a special AABB transfusion-risk committee, as concerns came out after the latest list was put together.
Labs in Europe reported earlier this year that they haven't been able to replicate the XMRV findings in patients with chronic fatigue syndrome or prostate cancer. And public-health experts say a key issue in sorting out the disparate findings is to reach agreement on tests that are sensitive and reliable in identifying XMRV in the blood.
The federal working group's project has three phases. First, labs at six participants—including the FDA, the National Cancer Institute, the CDC, and the Whittemore Peterson lab—are using a panel of blood samples to try to establish which of the labs' tests are sensitive and reliable enough to find XMRV in the blood. Results are expected in a few weeks.
In the second phase, also launched, a panel of around 350 different blood samples developed by Dr. Busch's team will be sent to four different labs. Some of the samples are from chronic fatigue patients known to have XMRV. Others from healthy donors have been spiked with the virus or have tested negative. All the samples are blinded, and the study will see whether the different labs can agree on XMRV positive status for chronic fatigue patients.
A third phase may be launched later, using frozen specimens in federal repositories dating to the 1970s. These repositories link donors to recipients and will allow researchers to see if XMRV was transferred in transfusions and help determine prevalence in the past as well as today, as well as geographical clusters or associations with age and gender.
"There is a balance to what we are doing," says Simone A. Glynn, branch chief of transfusion medicine and cellular therapies at the National Heart, Lung and Blood Institute and chairperson of the XMRV working group. "You do not want to transfuse an infectious agent that causes problems. But you do not want to take blood out of the system that is not causing any problems."

Biotechnology a boon to Textile Industry

The biotechnology has prefabricated rapid developments in genetic engineering with a possibility of ‘tailoring’ organisms in order to optimize production of established or novel metabolites of commercial importance and of transferring genetic material (genes) from one organism to another. It has economized developing industrial processes with less energy and renewable raw materials thus it is an effective interdisciplinary and integrate natural and engineering sciences. Few textile industrial uses are focused here.

Fibers and Biopolymers: Cotton, wool and silk natural textile fibers are an calibre but biotechnology producing one-of-a-kind fibers and improve yields of existing fibers. Cotton is leading worldwide textile fiber with ca 20 million tons grown/year by about 85 countries but it is vulnerable to many insects, and to maintain yields, massive amounts of pesticides are in use. Cotton is prone to infestation by weeds under intense irrigation conditions and needs throughout its growth cycle, and has poor tolerance to any of the herbicides. Hence biotechnologists have place forward short-term objectives on genetically engineering insect, disease and herbicide resistance into cotton plant along with modification of fiber calibre and properties to have high performance cottons. Naturally colored cottons are attracting the world market hence transgenic intensely colored cottons (blues and vivid reds) is dream of the day that can replace bleaching and dyeing.

Biotechnology has largely influenced animal fiber production, in vitro fertilization and embryo transfer, diagnostics, genetically engineered vaccines and therapeutic drugs are other catchments of it. CSIRO, Australia’s national research organization is place up efforts for genetic modification of sheep to resist attack from blowfly larvae by engineering a sheep that secretes an insect repellent from its hair follicles and ‘biological wool shearing’’. And is expected to artificial epidermal growth bourgeois which on injection into sheep disturbs hair growth, within a month, it breaks up in wool fiber and fleece can be pulled off whole in half the time it takes to shear a sheep.

Fermentation is developing biopolymers at large-scale i.e. bacterial storage compound polyhydroxybutyrate (PHB) is developed by Zeneca Bioproducts and is as produced ‘Biopol’. It high molecular weight linear polyester and thermoplastic (melts at 180°C) and can be melt spun into biocompatible and biodegradable fibers suitable for surgical use where human body enzymes slowly degrade sutures. Biopol is being used as conventional plastics for shampoo bottles but it is not economic, research is on to produce Biopol from plants, probably from genetically engineered variety of rape. Polysaccharides chitin, alginate, dextran and hyaluronic acid biopolymers are of interest in wound healing as chitin and its derivative chitosan are important components of fungal cell walls, at present manufactured from sea food (shellfish) wastes. Patents taken out by Asian Unitika cite a use of fibers prefabricated out of chitin in wound dressings. At BTTG, research has been directed for use of intact fungal filaments as a direct source of chitin or chitosan fiber to produce affordable wound dressings and other novel materials. Tests are carried out at Welsh School of Pharmacy indicate that these products have wound healing acceleration properties. Wound dressings based on calcium alginate fibers have already been developed by Courtaulds and are marketed as ‘Sorbsan’. Present supplies of this polysaccharide rely on its extraction from brown seaweed’s. However, a polymer of similar structure can also be produced by fermentation from certain species of bacteria. Dextran, which is manufactured by fermentation of sucrose by Leuconostoc mesenteroides or related species of bacteria, is also being developed as a fibrous non-woven for specialty end-uses such as wound dressings. Additional one-of-a-kind biopolymers are now coming onto market thanks to biotechnology e.g. hyaluronic acid a polydisaccharide of D-glucuronic acid and N-acetyl glucosamine found in connective tissue matrices of vertebrates and is also present in capsules of some bacteria. The original method of production by extraction from rooster combs was very inefficient requiring 5 kg of rooster combs to wage 4 g of hyaluronic acid. Fermentech, a British biotechnology company, is now producing hyaluronic acid by fermentation. The same amount of high calibre purified hyaluronic acid can be obtained from 4 liters of fermentation broth as opposed to 5 kg of rooster combs.

Different biotechnological routes for cellulose production are being worked out globally, cellulose is produced as an extra cellular polysaccharide by several bacteria in form of ribbon-like micro fibrils, and can be used to produce moulded materials of relatively high strength. Sony, a Asian electronics company has patented a way of making hi-fi loudspeaker cones and diaphragms from bacterial cellulose. An substitute route to cellulose, still at a very primeval stage of development, concerns in vitro cultivation of plant cells. Culturing cells of various strains of Gossypium can produce cotton fibers in vitro include a more uniform product displaying particularly desirable properties. Plant tissue culture can wage a steady, all year supply of products without climatic or geographic limitations free of contamination from pests. Proteins are interesting biopolymers for utilizing new genetic manipulation techniques where animal and plant proteins genes (e.g. collagen, various silks) can now be transferred into suitable microbial hosts and proteins produced by fermentation. US army is taking up spider silk as a high performance fiber for bulletproof vests.

Enzymes

Chemical reactions by catalytic proteins (enzymes) are a central feature of living systems, living cells makes enzymes even though the enzymes themselves are not alive and we can encourage living cells to make more enzymes than they would normally make. Or to make a slightly different enzyme (protein engineering) with improved characteristics of specificity, stability and performance in industrial processes and operate under mild conditions of pH and temperature. Many enzymes exhibit great specificity and stereo selectivity. With a notable exception of starch-size removal by amylases, however, scant attention is given to application of enzymes in textile processing for preparation textile fibers e.g. flax and hemp by dew retting involves action of pectolytic enzymes from various microorganisms, which degrade pectin in middle lamella of these plant fibers. Yet no attempts appear to be taken to use isolated enzyme preparations for desired effects even though their effectiveness has been demonstrated in the laboratory.

Use of isolated enzymes to remove fats and waxes, pectin’s, seed-coat material and colored impurities from loom say cotton and cotton/polyester fabrics, leading to a novel, low-energy fabric-preparation process, (replace scouring and bleaching) is investigated at BTTG. Only partial success is prefabricated using existing commercial enzyme preparations due to the recalcitrant nature of some of components and process was found to be too slow and therefore uneconomic for current applications. Enzyme that is being applied in textile processing for removal of hydrogen peroxide prior to dyeing is catalase. Undoubtedly, use of microbial enzymes can be expected to expand into many other areas of textile industry replacing existing chemical or mechanical processes in not too distant future.

Contrary to textile processing enzymes are used in detergents since their inception in 1960’s, and washing powders are referred to as ‘biological’, and degrade stains with milder washing conditions at lower temperatures saving energy and protects fabric. Cellulose enzymes could replace pumice stones used to produce ’stone-washed’ denim garments, stones can alteration clothes, particularly the hems and waistbands, and most manufacturers are now using enzyme treatment. Cellulose enzymes are in biopolishing, a removal of fuzz from surface of cellulosic fibers, which eliminates pilling making fabrics smoother and cleaner looking. Similarly protease enzymes are developed for wool.

Interesting uses of enzymes are in biotransformation with biocatalytic transformation of one chemical to another. In practice, either intact cells, an extract from such cells or an isolated enzyme might be used as the catalyst system of a specific reaction. Concentration of individual enzymes in cells is typically less than 1 per cent this can now be increased using gene increment techniques. Bulk chemical production by oil-based processes is being replaced by biotransformations, biotechnology competes with chemical synthesis. For example, optical activity of chemicals as of polymer precursors is likely to grow and biotransformation has a particular edge over traditional chemical methods.

Textile Auxiliaries: These are dyes produced by fermentation or from plants in future in the nineteenth century many of colors used to dye textiles came from plants e.g. woad, indigo and madder. Many microorganisms produce pigments during their growth, which are substantive as indicated by permanent staining and associated with mildew growth on textiles and plastics. Some species produce up to 30% of their dry weight as pigment, such microbial pigments are benzoquinone, naphthoquinone, anthraquinone, and perinaphthenone and benzofluoranthenequinone derivatives, resembling in some instances the important group of vat dyes. Microorganisms offer great potential for direct production of novel textile dyes or dye intermediates by controlled fermentation techniques replacing chemical synthesis. Production and evaluation of microbial pigments as textile colorants is currently being investigated at BTTG. Another biotechnological route for producing pigments for use in food, cosmetics or textile industries is from plant cell culture, e.g. red pigment shikonin (cosmetics) is being commercially produced since 1983 in Japan. Shikonin was extracted from roots of five-year-old Lithosperum erythrorhiz plants where it makes up about 1 to 2 percent of dry weight of roots. In tissue culture, pigment yields of about 15 percent of dry weight of root cells have been achieved.

New Analytical Tools: Work on molecular biology at BTTG has led to development of species-specific DNA probes for animal fibers to detect adulteration of high value specialty fibers such as cashmere by much cheaper fibers e.g. wool and yak hair. Rapid methods are being evolved to assist in primeval detection of biodeterioration of textile and other materials. BTTG have shown that presence of viable microorganisms on textiles can be assessed using enzyme luciferase isolated from firefly (Photinus pyralis), which releases light (bioluminescence) in combination with ATP produced by the microorganisms.

Waste Management: Microbes or their enzymes are being used to degrade toxic wastes instead of traditional processes, thus waste treatment is useful industrial calibre of biotechnology. In textile industry color removal from dyehouse effluent, toxic heavy metal compounds and pentachlorophenol used overseas as a rot-proofing treatment of cotton fabrics but washed out during subsequent processing in the UK pose a challenge for disposal. Currently efforts are on to resolve such problems perhaps biotechnology would appear to offer the most effective solutions.

Conclusions: Biotechnology is being treated as upcoming science with enormous commercial implications for many industrial sectors in years to come. It has successfully developed new products, opened up new doors, expedited production and helped to clean up environment. Mainly biotechnology is contributing a lot to textile industries but it current awareness is low. Michael Heseltine recently launched ‘Biotechnology Means Business’ initiative in the UK to inform companies about biotechnology and place them in touch with experts to deploy biotechnology to give a competitive edge to their business to win new markets. E.g. downstream processing after fermentation accounts for at least 70 percent of production costs in biotechnology and there is the need for improved filtration and separation techniques. Hollow fibers and membranes, which separate molecules according to size, are finding increased application in this area.

Enzymes are used in detergents e.g. protease removes stains caused by proteins such as blood, grass, egg and human sweat. Amylase removes starch-based stains such as those prefabricated by potatoes, pasta, rice and custard. Lipase breaks down fats, oils and greases removing stains based on salad oils, butter, fat-based sauces and soups, and certain cosmetics such as lipstick. Cellulase brightens and softens the fabric, and release particles of dirt trapped in the fibers. Briefly biotechnology improves plant varieties used in production of textile fibers and in fiber properties, and derives fibers from animals and health care of the animals along with novel fibers from biopolymers and genetically altered microorganisms. The survismeter is a effective tool to characterize broth fermentation.

References

Biotechnology Means Business: say of the art report on ‘The Textile & Clothing Industries’, 1995, The Biotechnology Unit, DTI, LGC, Queens Rd., Teddington, Middlesex, TW11 0LY, UK. Tiny Book on Enzymes and the Environment, 1993, NovoNordisk A/S, DK – 2880, Bagsvaerd, Denmark.

Glossary: Biotechnology: Use of living organisms or their cellular, sub cellular or molecular constituents to manufacture products and establish processes. DNA: Deoxyribonucleic acid, chemical molecule to carry hereditary information to pass from parent to offspring. DNA Probe: Single DNA strand used to detect a presence of complementary strands of DNA. Enzymes: Protein molecules that speed up specific chemical reactions and remain unchanged. Gene: Unit of heredity composed of DNA.

Genetic Engineering: A range of techniques for manipulating DNA and thereby modifying the genetic structure of living organisms. Transgenesis: Stable incorporation of foreign DNA from one species into another. For example, incorporating genes from a bacterium has developed insect resistant transgenic plants.

Early Clinical Evidence Demonstrates Incisionless Procedure Stops Life-Threatening Bleeding From Stomach Ulcers

According to early clinical evidence from a safety study, a new endoscopic spray from Cook Medical may offer a new surgery-free procedure for treating potentially fatal acute bleeding of peptic ulcers. The early results, collected at the Chinese University of Hong Kong by lead investigators Dr. Joseph Sung of the Chinese University and Dr. Sam Giday of Johns Hopkins University, suggest an alternative to currently available endoscopic and surgical intervention for major gastrointestinal (GI) bleeds.

"Peptic ulcer bleeds are medical emergencies that require swift action and the most effective treatment possible," said Dr. Giday. "This hemostatic spray shows promise for a faster, easier and less invasive procedure than currently available treatment modalities, which requires expert precision and a certain degree of endoscopic expertise."

The hemospray, a proprietary powder with unique clotting abilities, can be sprayed directly onto a bleeding peptic ulcer through the channel of an endoscope, a hollow tube with a camera attached that is guided down a patient's throat and into the stomach. In the safety study to date, the spray has been delivered to ten patients with acute GI bleeding. Patient bleeding was controlled in nine of 10 patients observed in the study, and after 72 hours eight patients were released with no apparent signs of rebleeding. A total of 20 patients will be enrolled in this initial study, the results of which will be used to decide whether further clinical trials will be conducted. The investigators expect to release final results of the study at the 2010 Digestive Disease Week conference in New Orleans in May.

"These results suggest that this hemostatic spray could be an important innovation in helping to control this dangerous complication of peptic ulcers," said Barry Slowey, global business unit leader for Cook Medical's Endoscopy strategic business unit. "The safety study to-date has demonstrated that the spray has the potential to improve the care of patients suffering from peptic ulcers while greatly simplifying the treatment procedure."

Between 4 to 5 million1 people are treated annually around the globe for GI bleeds, with the most difficult to treat being peptic ulcers: open sores in the lining of the stomach, esophagus or duodenum. Peptic ulcer bleeding typically afflicts individuals over the age of 60 and causes death in approximately eight percent of cases. Current treatment involves using dual endoscopic modalities such as clips, injection and thermoelectric probes. If proven safe and effective in ongoing clinical studies, this will be the first hemostatic spray to offer a viable alternative to the current endoscopic and surgical treatment modalities.

In a previous controlled animal trial on induced arterial bleeds in heparinized animals, the spray stopped 100 percent of bleeding with no recurrent bleeds observed during a seven-day follow up [Giday et al. DDW 2009]. Digestive Disease Week ranked the summary of this animal model study as one of its top abstracts of 2009, signaling its importance to endoscopic physicians. Dr. Giday is a paid consultant of Cook Medical in the development of the hemospray project.

Surgical Device Company Wins 2010 NJTC "Best Early Stage Company" Award

At the 12th Annual New Jersey Technology Council (NJTC) Venture Conference in Somerset, NJ on March 26, Endomedix, Inc. (www.endomedix.com) unveiled a sprayable surgical hemostat that promises to change the way surgeons control bleeding during surgeries such as craniotomy and Ear, Nose & Throat (ENT) sinus procedures. The company’s proprietary technology will also lead to flowable hemostats for use in most other surgeries as well for military, first responder and ER applications. The Company’s product portfolio and business plans were key factors that led to the selection of Endomedix as the recipient of the "Best Early Stage Company" Award by judges at the Conference, where more than 65 companies showcased a broad spectrum of leading edge new technologies, products and services.

The Endomedix device sprays on the surgical site and forms a hydrogel in seconds, leading to the rapid formation of a mechanical clot. The hydrogel also contains a natural hemostat to amplify the natural cascade of coagulation. The device can produce effective hemostasis, or control of bleeding, much faster and is easier to use than competitive products. Since many surgeries require that bleeding be controlled many times during a procedure, the new device will save hospitals thousands of dollars per case in OR and anesthesia charges alone.

"Our technology is based on natural materials with a long history of use in FDA-regulated products, and our intellectual property is based on the innovative treatment and processing of these materials", explains Richard Russo, Chief Executive Officer. "Surgeons will be able to spray on our devices precisely, with almost immediate effect, so they can continue the surgery without having to wait a long time for bleeding to stop. Our product is also transparent, so unlike products currently available, the surgeon can see through it to confirm that bleeding has stopped."

Unlike many companies that try to invent something totally new, such as cure for a disease, Endomedix is developing products with improved performance and ease of use for procedures that surgeons perform every day. "It’s exciting to develop a device for a billion dollar plus market that both performs better and costs less to produce than the devices currently available," says Russo. "We’re in a strong position given what’s happening in medical care delivery systems around the world."

The daylong annual NJTC meeting is the largest of its kind on the East Coast. More than 65 companies showcased technologies and products from various sectors, including life sciences, information technology, energy/environmental management, telecommunications and nanotechnology. "Participants included a new crop of vibrant startup companies" said Aron Spencer, CEO of InVenture LLC, a firm that helps startups leverage inventions into viable companies, and Professor of Entrepreneurship at New Jersey Institute of Technology. "Selecting a single winner this year was not easy, but the combination of its experienced management, technology and business opportunity certainly qualifies Endomedix as the Best Early Stage Company of 2010".

"We are moving steadily toward commercialization, and one of the key challenges that every firm in our situation must overcome is obtaining additional investment funds in this very difficult business environment", noted Russo. "We are making use of the experience and talents of the New Jersey Entrepreneurs Forum (www.NJEF.org) to provide insight on how to navigate the world of professional investors interested in private companies and startups. Their advice has helped us enhance our investment appeal, as evidenced by this Award."

FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery

Blood-clotting patch is absorbed by the body

SILVER SPRING, Md., April 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical. TachoSil is a ready-to-use surgical patch composed of a dry collagen sponge made from horse tendons, and coated with fibrinogen and thrombin. At the site of a wound, the two proteins, through a series of chemical reactions, produce fibrin, a stringy, white, insoluble protein that allows a clot to form. The TachoSil patch is biodegradable and breaks down inside the body within four to six months. TachoSil is not intended for use within blood vessels.
"This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.
The plasma used to manufacture TachoSil is collected from U.S. donors who have been screened and tested for diseases transmitted by blood. The fibrinogen and thrombin used in the surgical patch undergo additional manufacturing processes to remove impurities, including bloodborne viruses. The collagen taken from horse tendons undergoes a separate step to remove impurities, including equine viruses.
The effectiveness of TachoSil manufactured by Nycomed Austria GmbH of Linz, Austria was evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters (74.6 percent) of those who received TachoSil, stopped bleeding within three minutes compared with 33.3 percent in the control group.
Hypersensitivity to product components or allergic reactions may occur with TachoSil. The adverse reaction rates were not statistically different between the study and control groups.

CryoLife Files for Preliminary Injunction Against Medafor

CryoLife Believes Attempt to Terminate Distribution Agreement Is Improper

ATLANTA, GA…(March 30, 2010)…CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it filed an emergency motion for a preliminary injunction against Medafor, Inc. in the United States District Court for the Northern District of Georgia, Atlanta division. CryoLife contends that Medafor is improperly attempting to terminate the exclusive distribution agreement ("EDA”) between the parties, and CryoLife has requested that the Court enjoin Medafor from proceeding with the termination.

CryoLife believes that Medafor’s attempt to terminate the EDA is wrongful for several reasons. Primarily, Medafor ignored the fact that the parties contracted away any right to apply the adequate assurances statute that Medafor is now invoking to attempt to terminate the EDA. Even if the statute applied, CryoLife believes Medafor failed to meet the statutory prerequisites for termination, for numerous reasons, including those described below.

Specifically, the statute is only available to a party with a reasonable basis for insecurity regarding the other party’s future performance, and CryoLife’s adherence to the contract has never been in legitimate doubt. The statute requires that any assurances demanded by a party with an insecurity be reasonable. CryoLife believes that Medafor’s requested assurances were not reasonable and in fact were designed to be overreaching and abusive. Perhaps most importantly, the statute demands that the party invoking it do so in absolute good faith, and CryoLife believes Medafor’s invocation of the statute was made in bad faith, as a pretextual scheme to get out of a contract that Medafor found itself unable and unwilling to honor.

The statute is also not available to a party who itself is in breach of its obligations. CryoLife is aware of numerous breaches by Medafor of the EDA, including: promoting and marketing product on its website for use in CryoLife’s exclusive Field in violation of the EDA; failing to prevent its Brazilian distributor from marketing and promoting the product on its website; failing to respond to notice letters of prohibited conduct in 17 instances, along with failing to respond to many of the allegations contained in the complaint filed against it by CryoLife; failing to respond to CryoLife’s notice letters regarding Medafor’s breaches of conduct in Spain; and refusing to protect the intellectual property rights of Medafor’s MPH technology in accordance with the terms of the EDA.

Steven G. Anderson, CryoLife’s chairman, president and chief executive officer, commented, “CryoLife has assiduously followed the terms of the EDA and has repeatedly communicated to Medafor its intention to continue to honor the terms of the EDA. We believe that Medafor’s request for assurances was not made in good faith and that it was simply a pretext to terminate a contract that they cannot consistently comply with, as evidenced by their repeated breaches. Unfortunately, in attempting to repudiate the EDA, we believe Medafor has put itself and its shareholders at great risk. Should this gambit fail, Medafor has exposed itself to significant damages in addition to the damages arising under the complaint previously filed by CryoLife and the substantial litigation costs this process will accrue.”

In the event an injunction is not granted, however, CryoLife will pursue its rights with respect to the EDA vigorously, including claims, for among other things, breach of contract, fraud and negligent misrepresentation and violation of the Georgia RICO provisions, and CryoLife will consider all avenues open to it to protect its interests and those of its shareholders and recover appropriate compensation from Medafor for its reckless actions.

CryoLife believes that it currently has enough inventory, with or without the fulfillment of the March 16, 2010 purchase order that was disputed by Medafor, to meet its business needs through the end of May 2010. CryoLife is optimistic that the court will rule on its motion for preliminary injunction prior to that time.

Shareholders may continue to visit www.cryolife.com/medaforoffer for additional information about CryoLife and its relationship with Medafor. Additional detail regarding the litigation between CryoLife and Medafor is also available in CryoLife’s filings with the Securities and Exchange Commission.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company's CryoValve^® SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft^® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. The Company’s CryoPatch^® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. The Company's BioGlue^® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company's BioFoam™ Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. BIOGLUE Aesthetic^® Medical Adhesive is CE marked in the European Community for periosteal fixation following endoscopic browplasty (brow lift) in reconstructive plastic surgery and is distributed by a third party for this indication. CryoLife distributes HemoStase^®, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions.

Crabs and eyeballs not usually a good mix

Australian scientists have developed a new type of surgical glue, made from crab shells, that could replace stitches now used in eye surgery.
The liquid, which is painted onto a wound or incision and then heat sealed with an infrared laser, cuts the risk of infection and scarring that can cause vision loss.
Co-inventor of "SurgiLux", Associate Professor John Foster who leads the University of NSW's Biopolymer Research Group, said it could also be used safely in brain and nerve surgery.
"Some glue technologies rely upon ultra-violet for wound bonding but aren't really suitable because UV-rays damage living cells," Dr Foster said in a statement.
"The beauty of SurgiLux is that an infrared laser doesn't cause tissue damage ... better still, it has inherent anti-microbial properties, which discourage post-operative infections."
The green-coloured polymer is made from crab-shell extract and it is biodegradable.
A commercial backer for the product is now being sought, to fund further clinical trials ahead of a possible launch on the global tissue sealants market.
This market was estimated at more than $500 million in 2008, with an eight per cent annual growth rate.
NewSouth Innovations (NSi), the university's commercialisation body, controls the rights to the invention.
"NSi and the inventors of SurgiLux are seeking partners to clinically and commercially develop this proprietary technology," said NSi Business Development Manager Dr Alfredo Martinez-Coll.
"The nature of the investment would be through collaborative research and or a licence deal.

Maryland and Arkansas Teams Win ORNL Global Venture Challenge

OAK RIDGE, Tenn., March 26, 2010 — OAK RIDGE, Tenn., March 26, 2010 -- Graduate students from the University of Arkansas and the University of Maryland received first place at the 2010 Global Venture Challenge that was hosted at Oak Ridge National Laboratory March 24-26. The challenge is a competition that brings together students developing new technology in the two tracks of energy and security and venture investors with expertise in the marketplace.

Douglas Hutchings, Stephen Ritterbush and Seth Shumate, a doctoral student in microelectronics and photonics, from the University of Arkansas won first place in the energy division for their energy company Silicon Solar Solutions.

"Our method replaces the expensive top layer of solar cells with a thinner, large- grain polysilicon at lower temperatures, which reduces cost and is appealing to manufacturers," said Ritterbush, an M.B.A. student.

Matthew Dowling, Peter Thomas and Oluwatosin Ogunsola of the University of Maryland won first place in the security division for their company Remedium Technologies, Inc,, which produces a sprayable hemostat. Dowling and Thomas, doctoral students in bioengineering, said that, unlike hemostats that treat superficial wounds, their Kytoclot technology is a portable, pressurized foam that provides needed compression and protection to wounds within the body cavity. Traditionally, intracavitary wounds have almost always required surgery to prevent hemorrhage-related deaths.

"Currently there is no market for a product like this. The Department of Defense, the military, would be our first potential customer because they have a great need for this sort of product, which can sustain a lot of different temperatures and quickly stops bleeding," Dowling said.

Twenty-two teams of graduate students from five countries traveled to Oak Ridge to present new technology products that satisfy current market demands. In its fourth year, Global Venture Challenge has grown significantly in the last year.

"We have really expanded our reach globally with applications from 44 teams in eight countries, and that's a record," said Tom Rogers, director of the Industrial and Economic Development Partnerships Directorate, said. "Many of the judges have said that the technology this year is far superior to prior years. Every year it gets bigger and better."

More than 50 judges, including judges from 15 venture capital firms, selected winners based on the quality of the technology and the product's projected strength in the marketplace.

Rogers said several teams from past years are now in business and several of the teams that presented this year are already on their way. Dowling said Remedium Technologies, Inc. has already garnered capital from start-up investors, and Silicon Solar Solutions is in the process of speaking with manufacturers.

During the three-day competition, students toured ORNL facilities, met with Lab Director Thom Mason and attended a Venture showcase highlighting cutting-edge technology being developed at ORNL.

The two first-place teams were awarded $25,000 each. First runner-up teams EconoSun of Purdue University and Delta R Detection of the University of Florida received $10,000 each. Second runner-up teams GLADteam of the University of Alberta, Carnegie Mellon University, Maastricht University and Indentizyme Defense Tech of the University of North Carolina, Chapel Hill received $5,000, and six honorable-mention teams received $1,000 each.

Prize money and travel stipends were funded by sponsors, including the Department of Energy's Industrial Technology Program, the Department of Homeland Security's Community & Regional Resilience Institute, Oak Ridge Associated Universities, Battelle Ventures, The National Institute for Hometown Security, the National Venture Capital Association, the East Tennessee Economic Council and Meritus Ventures. ORNL is managed by UT-Battelle for the Department of Energy's Office of Science.

Cryolife withdraw Medafor offer

ATLANTA, GA…(March 24, 2010)…CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has withdrawn its $2.00 per share proposal to acquire Medafor, Inc. CryoLife previously notified the Medafor board of its intention to withdraw its offer in five business days. Based on the limited information that Medafor has made available to its shareholders, CryoLife continues to believe that the Medafor board’s stated strategic rationale for entering into the Magle transaction does not justify the significant dilution suffered by Medafor shareholders. “It is clear by the recent actions of Medafor’s board and management team that they are committed to entrenchment, even if it means further dilution and the destruction of shareholder value,” said Steven G. Anderson, CryoLife’s chairman, president and chief executive officer. “We continue to believe that Medafor is mismanaged and in poor financial condition. As Medafor’s largest shareholder, we are deeply concerned by Medafor’s recent statement that it currently holds only $1,000,000 in cash. We believe that Medafor’s limited capital is wholly insufficient to sustain the company’s growth and defend its intellectual property. Although we are withdrawing our offer, we intend to pursue all actions necessary to preserve the value of our investment.” “We encourage existing Medafor shareholders to continue to reach out to Medafor’s board and management team and voice their concerns. Based on our recent conversations with fellow Medafor shareholders, we believe many shareholders share our frustrations with Medafor’s actions and have deep concerns about the future of the company under its existing leadership,” concluded Anderson.

Medafor shareholders may continue to visit www.cryolife.com/medaforoffer for additional information about CryoLife and its thoughts on the appropriateness and effectiveness of Medafor’s management’s actions and the company’s performance and outlook.