Zymogenetics - Webcast

Full webcast available at www.zymogenetics.com

CryoLife Announces First Clinical Use of BioFoam

ATLANTA and LONDON, Sept. 10 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced the first clinical implant of its BioFoam(R) Surgical Matrix, which received CE mark approval in August 2009. BioFoam was used in a liver resection procedure following tumor removal as a supplemental measure to promote hemostasis (a complex process that stops bleeding) by sealing vessels. "Despite advances in surgical technique, bleeding complications continue to be a problem in liver resection surgery and can be life-threatening," said Professor Brian Davidson, MD,

FRCS, Professor of Surgery, Department of Surgery, Royal Free Hospital in London who performed the procedure on September 9. "We are very hopeful that BioFoam will reduce the time required to achieve hemostasis during liver resection surgery and will reduce the number of complications following surgery."

CryoLife is conducting a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. The objectives of this 45-patient controlled launch, in which BioFoam is used as a surgical hemostatic adjunct in the open repair of liver parenchyma following liver resection and/or liver transplant surgery, are to (1) collect additional clinical data supporting the safety and performance of BioFoam and (2) further refine the optimal application technique. "The clinical availability of BioFoam is another milestone in the company's corporate objective of providing world-class surgical options for the control of intraoperative bleeding," said Steven G. Anderson, CryoLife president and chief executive officer. "We believe the unique adherence and expansion characteristics of this product make it useful for organ sealing and other future surgical applications. It is a wonderful complement to our existing hemostasis products, BioGlue(R) and HemoStase(TM)." In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process and expects to start enrollment in Q4 2009. During the European Association of Cardio-Thoracic Surgery (EACTS) annual meeting in Vienna, Austria Oct. 17-21, booth 43, CryoLife will be soliciting input from the attendees on potential future clinical applications for the use of BioFoam in cardiothoracic surgery. About BioFoam BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and can be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future reoperations in liver resections. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE mark approval 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.

Haemacure announces its presentation at the Rodman Renshaw 11th Annual Healthcare Conference

MONTREAL, Sept. 8/PRNewswire-FirstCall/ - Haemacure Corporation (TSX:HAE), a specialty bio-therapeutics company, announces that its Chairman and CEO, Mr. Joseph Galli, will present at the Rodman Renshaw 11th Annual Healthcare Conference onSeptember 9, 2009 at 2:00 p.m. at the New York Palace Hotel in New York.
The presentation will be live by webcast at http://www.wsw.com/webcast/rrshq15/hae.to. Please visit the site at least five minutes prior to start time for instructions.

DuraSeal Spine Sealant Receives FDA Approval

WALTHAM, Mass.--(Business Wire)--
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal spine sealant for use in the United States. This is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.
DuraSeal spine sealant has been shown in a U.S. pivotal study to deliver an intra-operative watertight seal 100% of the time1. In the same study, commonly used sealing methods achieved an intra-operative watertight seal only 64% of the
time. The remaining patients were treated with additional products and/or techniques to achieve a watertight seal.
"DuraSeal continues Covidien`s dedication to scientific, evidence-based innovation that improves patient outcomes," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien.
"There`s a critical need to resolve cerebrospinal fluid leaks within the OR. We cannot continue with the procedure until we`ve dealt with the leak," said Dr. Neill Wright, Associate Professor, Neurological & Orthopedic Surgery, Washington University School of Medicine.
The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods, for surgeons who are faced with a dural tear:
* The fast-acting, self-contained sealant gives surgeons the only FDA-approved, easy-to-use solution for sutured dural tears, which occur in nearly 10% of all spinal surgeries.
* The DuraSeal spinal sealant only takes two minutes to prepare for use and three seconds to set, so surgeons can quickly complete an intra-operative dural seal.
* The same formulation was approved by the FDA in 2005 and is currently on the market for cranial procedures. Since its approval, more than 210,000 units have been sold worldwide. DuraSeal Cranial and DuraSeal Xact ABS (spine) are also available in Europe and other international markets.
Covidien expects to launch DuraSeal spine sealant in the next few weeks.

Comparitive Presentation of Human Derived Thrombin vs. Bovine

Pathogen Safety of Evithrom

UK - vCJD Testing by Coroners called for...

Coroners are refusing to carry out post-mortem tests for an infection that

causes the human form of mad cow disease, despite pleas that they could help to monitor the disease.

Professor John Collinge, a leading expert on variant Creutzfeldt-Jakob Disease (vCJD), warned that systematic testing was vital to find out whether many people were “silently infected” with the potentially fatal condition.So far 164 people are confirmed to have died of the disease but scientists say that there is no accurate indication of how many people may be carrying it.“There is a concern that what we have seen so far may be the first wave, occurring in individuals who are particularly genetically susceptible, but there may be more people who are silently infected in the community than the number of clinical cases we have seen would suggest,” Professor Collinge told BBC Radio 4’sToday programme. But experts in the law governing coroners courts say that the tests can be ordered only if the Government changes the law. The Spongiform Encepalopathy Advisory Committee (SEAC), whose job is to monitor the progress of the disease and advise the Government, has been warning for two years that it was important to find out how many people were carrying the infection. The only reliable way of doing that, SEAC says, would be to ask coroners to test the brain and spleen of young people during post-mortem examinations so that they could be tested for the presence of the infectious agent, a protein known as a prion. Professor Collinge, a member of SEAC, said that systematic testing was needed to establish how many more people were likely to get the disease and whether the current measures to protect the spread of infection were appropriate. He urged coroners to request the test when ordering post-mortem examinations. “I would hope that they would be able to help with this because I don’t see any other way for us to get this information at the moment,” he said. “We have been very vocal in terms of saying these data are absolutely vital if we really want to manage the process properly," said Professor Graham Medley, another member of SEAC. “My understanding is the Department of Health is very keen to push this forward, it’s really just using coroners as an opportunity to do some sampling. I’m not sure why there has been some apparent reluctance on behalf of coroners.” In response, Dr Michael Powers, QC, an expert in coronial law, said that coroners would be happy to order the test if the Government changed the law. He told Today that at present they are able to order a post-mortem examination only to find the cause of death, and not test for other infections that may have been present. Dr Powers said: “This is a function which is outside the coroners’ statutory authority. Because they are not, those tests, directed to ascertaining the death in an individual case.” The Coroners and Justice Bill going through Parliament could be altered to put a duty on coroners to order the test, he said. “That would completely solve the problem,” he said. Christine Lord, whose son Andy Black died of vCJD, told Today: “This is a public health issue. I, as a mum, have lost a child, a very dear, loved child, through an avoidable disease. “The coroners, by actually blocking this, are actually not protecting public health. They just seem to be protecting their particular role in Government. “At the end of the day, they are public servants and their job is to protect us.” A Department of Health spokesman said that a pilot study will take place later this year, with the co-operation of some coroners, to obtain tissue samples from post-mortem examinations. “It is important to obtain a better understanding of the prevalence of vCJD so that we can prevent secondary transmission from person to person,” the spokesman said. “SEAC has recommended that studies of tissues, such as spleen, collected at post-mortem would provide important data on the prevalence of vCJD infection in the population. “The Health Protection Agency is running the pilot with the co-operation of NHS Bereavement Services and NHS Blood and Transplant’s consent team. “Some coroners have agreed to participate in the pilot study and appropriate funding will be made to them and to the other organisations incurring additional costs.”

Irish HIQA will look at prion test for vCJD

Ireland - The Health Information and Quality Authority (HIQA) is to examine the introduction of prion testing and prion filtration to safeguard against the transmission of variant Creutzfeldt Jakob disease (vCJD) from blood donations.
Irish Medical Times has learned that the Chief Medical Officer of the Department of Health, Dr Tony Holohan, is due to discuss with HIQA the question of an ‘appropriate assessment with regard to the potential introduction of these technologies in the future’.
Such a review is likely to take the form of a Health Technology Assessment (HTA), designed to inform decision makers on safe and effective health policies that are patient-focused and achieve best value for money. The Irish Blood Transfusion Service (IBTS) has already estimated that introducing the technologies could cost up to E75 million over the next five years.
However, it believes applying formal evaluations to the cost of prion filtration and prion testing is ‘fraught with difficulty’.
IBTS Medical and Scientific Director Dr Willie Murphy told IMT that blood products had a ‘special status’, equivalent more to pharmaceuticals than healthcare interventions. “We don’t say to the pharmaceutical manufactures that we’ll leave out that safety step, or drop that quality control, to take 10 cent off the price.
“If a new, better test for HIV becomes available, of course we spend the money to do it. As a nation, we would be appalled if we didn’t,” Dr Murphy added.

Zymogenetics - Webcast

SEATTLE--(Business Wire)--
ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that senior executives will provide updates on company activities at two upcoming investor conferences. James A. Johnson, Executive Vice President and Chief Financial Officer, will
present at the Thomas Weisel Partners Healthcare Conference in Boston on Thursday, September 10, 2009 at 3:15 p.m. Eastern Time. Douglas E. Williams, Ph.D., Chief Executive Officer, will present at the UBS Global Life Sciences Conference in New York City on Wednesday, September 23, 2009 at 9:30 a.m. Eastern Time.

Live webcasts of the presentations can be accessed by going to:
www.zymogenetics.com. The webcasts will be archived for 30 days.

Accumetrics, Inc. Forms Partnership With Grifols as Its Distributor in Spain, Portugal...

SAN DIEGO, Sept. 2 /PRNewswire/ -- Accumetrics, Inc. has announced the signing of a new exclusive distribution agreement for its VerifyNow(R) System in Spain, Portugal and Chile with Grifols S.A.. This distribution agreement will continue to expand Accumetrics' reach in both scope and geography, and add to the growing numbers of countries where physicians have access to the VerifyNow System. The VerifyNow System assesses response to life-saving antiplatelet therapies, such as aspirin, Plavix(R), Effient(R) and GP IIb/IIIa inhibitors. Patients respond to antiplatelet medications differently and these tests help physicians ensure their patients are receiving the optimal treatment. "We're extremely excited to see distribution of our VerifyNow System reach Spain, Portugal and Chile. We have chosen Grifols as our exclusive partner based on their demonstrated market development expertise as well as their existing customer base," said Timothy I. Still, President and CEO of Accumetrics. "This partnership continues to emphasize our focus on expanding our global distribution channels, and supports our vision to provide

physicians access to critical information for managing their cardiovascular patients on antiplatelet therapies." "We are pleased to join forces with Accumetrics in the distribution of the VerifyNow System in the Spanish, Portuguese and Chilean markets. This system perfectly complements Grifols' Hemostasis line of products and aligns with our marketing and sales strategy," added Ramon Riera, Vice President of Grifols S.A.
About Accumetrics (www.accumetrics.com) Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment. Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(R)) and clopidogrel (Plavix)), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help physicians make informed treatment decisions. The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Lilly-Daiichi Sankyo.
About Grifols (www.grifols.com) Grifols is a Spanish-based holding company specializing in the pharmaceutical-hospital sector and is present in more than 90 countries. Since 2006, the company has been listed on the Spanish Continuous Market and forms part of the Ibex-35. Currently it is the first company in the European sector in plasma derivatives and the fourth in production worldwide. In upcoming years, the company will strengthen its leadership in the industry as a vertically integrated company, thanks to recent investments and those which will be carried out in 2008-2012, representing 400 million euros. In terms of raw materials, Grifols has ensured its plasma supply with 80 plasmapheresis centers in the United States and in terms of fractionation, its plants in Barcelona (Spain) and Los Angeles (United States) will allow the company to respond to the growing market demand. Nevertheless, the company is preparing for sustained growth in the following 8-10 years and has launched an ambitious investment plan. Grifols has created three divisions to offer specialized products and services grouped according to the distinctive needs they serve: Bioscience, Hospital and Diagnostics. Distribution of the VerifyNow System will complement its Diagnostics division as well as provide significant leverage to its Hospital Supply division.