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.

Endoscopic ligation plus terlipressin prevents rebleeding of esophageal varices

NEW YORK (Reuters Health) - Combining the vasoconstrictor terlipressin with endoscopic variceal ligation reduces very early bleeding of esophageal varices significantly more than terlipressin alone, Taiwanese researchers report in the September issue of Gut.
"Acute esophageal variceal hemorrhage is a dreadful complication of portal hypertension," note Dr. Gin-Ho Lo and co-researchers at I-Shou University in Taipei. Even after treatment, "a high frequency of early rebleeding (30%-50%) may still be encountered in the first few days of acute hemostasis."
To see if dual therapy would lessen that risk, the research team studied 93 adult patients with cirrhosis who did not have active variceal bleeding at initial emergency endoscopy, comparing endoscopic variceal ligation plus two days of terlipressin infusion (intravenous infusion 1 mg every 6 hours for 48 hours) with five days of

terlipressin alone. Between February 2005 and January 2007, the study recruited patients from 18 to 75 years old, with 46 randomized to the terlipressin-only group and 47 assigned to the combination-therapy group.
Very early rebleeding (within 48 to 120 hours) was seen in seven patients in the terlipressin-only group, but in none of the patients who also received endoscopic variceal ligation (p = 0.006).
Treatment failure, defined as failure to control acute bleeding episodes or very early rebleeding or death within five days, occurred in 24% of the terlipressin-only group and only 2% of the combined-therapy group (p = 0.002). In addition, the need for transfusion was significantly lower in the terlipressin-plus-ligation group, as was the likelihood of needing intensive care.
Three patients died in the terlipressin group (two from variceal hemorrhage and aspiration pneumonia in one), and one patient in the combined group died of sepsis.
Nonetheless, the researchers noted that complication rates and 6-week survival were similar in both groups.
Although endoscopic therapy plus vasoconstrictors is the standard therapy for acute variceal hemorrhage, Dr. Lo told Reuters Health, there has been concern that the use of endoscopic therapy could increase adverse events.
An accompanying editorial by Drs. Francesco Salerno and Massimo Cazzaniga of the University of Milan, Italy, noted that the risk of death from shock, terminal liver failure, kidney failure, sepsis or multiorgan failure is "markedly increased by early rebleeding."
Both the report and the editorial noted that, considering the reasons for which patients were excluded from the study (such as hepatocellular carcinoma, age over 75 or taking beta-blockers), the results apply only to the specific subpopulation studied.
Gut 2009;58:1182-1183,1275-1280.

Safety of topical thrombins: the ongoing debate

Until recently, only bovine-derived thrombin was available for use as a stand-alone topical hemostat or as a component of other hemostatic devices. Concerns over a number of case reports of immune-mediated coagulopathies associated with the use of bovine-derived thrombin resulted in a United States Food and Drug Administration warning letter being issued in 1996 and the later addition of a boxed warning ("Black Box Warning") to all bovine-derived thrombin products.

Since 2007, both a human-pooled plasma thrombin product and a recombinant thrombin have entered the market.With the addition of these two products to the topical thrombin class, a unique situation has developed in which only a single member (bovine-derived thrombin) within the class carries the Food and Drug Administration's strongest cautionary language about possible adverse events related to an agent's use. Neither the human-pooled plasma thrombin nor the recombinant thrombin products have a boxed warning; although, the human-pooled plasma product does include a precaution/warning about infectious agent transmission - a warning common to products derived from human sources.

This report will address this unique situation and the impact, clinical and non-clinical, that thrombin choice may have. Since alternatives are now available, institutions may need to revisit their formulary choice of thrombin preparation, taking into consideration the potential risks associated with bovine-derived products.