Cryolife, Bioglue - Chronic Inflammation and Foreign-Body Reaction

Vascular Solutions and Orthovita to present at UBS Global Life Sciences Conference

MINNEAPOLIS, Sept. 15, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 2009 UBS Global Life Sciences Conference in New York City on Tuesday, September 22, 2009 at 8:00am (EDT). Howard Root, Chief Executive Officer of Vascular Solutions, will deliver the Company's presentation. To hear the live audio webcast and view the slides of the Vascular Solutions' presentation, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

MALVERN, Pa.--(Business Wire)-- Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, September 21st, at 1:00 p.m. Eastern Time, at the Grand Hyatt New York, 109 East 42nd Street at Grand Central Terminal, New York, New York. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=67_MRUUVNQ.

Thrombin in Children

Please find below another reader supplied paper. Thanks to contributor's for assisting further understanding for our community. If you have further articles you consider valuable inclusions for our Clinical Papers Section of the blog please forward to me for review. Of course you can post your own thoughts directly in the forum, available for direct communication with other users.

Thanks HG

Haemacure presentation

MONTREAL, Sept. 14 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE) reported today on current activities and released the financial results of its third quarter endedJuly 31.
Current Activities
Haemacure and Angiotech Pharmaceuticals, Inc. started work pursuant to the strategic collaboration entered into inJune 2009, including the shipment of product to Angiotech. This collaboration provides Angiotech with license, distribution and supply rights for Haemacure's all-human fibrin sealant and thrombin products, both of which are in development.
Haemacure is actively preparing for the pivotal phase II/III clinical trials for its fibrin sealant and is seeking additional financing.
"We are very pleased with the strategic collaboration Haemacure entered into with Angiotech, which provides liquidity and an important validation of our company and its product candidates." said Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "In addition, we are in discussion with other parties who need fibrin sealant and thrombin to enable their products." concluded Mr. Galli.
Financial Position
Cash, cash equivalents and investments amounted to$336,598 as at July 31, 2009, as compared to $4.6 million as at October 31, 2008. Haemacure estimates that it has cash, and access to liquidity as a result of the transaction with Angiotech, to enable it to operate until the end of calendar year 2009.
Results
Revenues amounted to $15,390, as compared to $25,593 for the same quarter last year. Revenues were exclusively derived from the sale of legacy fibrin sealant application devices. Operating expenses amounted to $824,634, down from $2 million for the same quarter last year. The decrease was mainly attributable to foreign exchange fluctuation and the major cost cutting measures implemented in February 2009 to preserve cash. The consolidated net loss for the quarter amounted to $798,852, or nil per share, as compared to $2 million, or $0.01 per share, for the same quarter last year.

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