Tuesday, September 23, 2008
Hemostase MPH in Canada
Monday, CryoLife, Inc. a medical appliances and equipment provider, announced that it has begun distribution of Hemostase MPH in Canada, through Sorin Group Canada, Inc. Unique hemostatic powder is used to control bleeding in general, cardiac and vascular surgery, and is available in ready-to-use applicator.The Kennesaw, Georgia-based CryoLife stated that it began distributing Hemostase MPH in the U. S., the U.K., and Germany in the second quarter of 2008. Distribution will continue to expand to additional markets later in 2008 and in 2009, the company added.
Delivery of certain drugs in a fibrin sealant
ZURICH, Switzerland & WOBURN, Mass., Sep 23, 2008 (BUSINESS WIRE) -- Kuros Biosurgery AG and Aeris Therapeutics, Inc., both privately held biotech companies, announced today that Kuros has granted Aeris an exclusive license in the field of lung volume reduction to certain patent rights Kuros exclusively licensed from the American Red Cross that cover the delivery of certain drugs in a fibrin sealant. In return for the license, Kuros will receive upfronts, milestones and royalties on the sale of Aeris' lead product, the AeriSeal(TM) Biologic Lung Volume Reduction (BLVR) System, a novel investigational emphysema treatment. Aeris is currently preparing for the initiation of Phase 3 clinical trials for the AeriSeal BLVR system.
Commenting on the license, Dr. David Dove, CEO of Aeris, said: "The licensing of this IP from Kuros is an important step in the continued development of our unique Biologic Lung Volume Reduction System. We believe that BLVR has the potential to offer patients suffering from emphysema a treatment option that can alleviate their symptoms of shortness of breath and improve quality of life."
The AeriSeal Biologic Lung Volume Reduction System is a non-surgical treatment in which a bronchoscope is used to deliver a proprietary mixture of drugs and biologics that form a bio-absorbable gel to diseased areas of the lungs. The gel is composed of a mixture of a fibrin sealant as a drug delivery system, an antibiotic to prevent infection and drugs designed to cause a reaction in targeted areas of the lungs. A unique element of the BLVR System is its use of the body's natural scar formation response to permanently collapse diseased areas of the lungs. This reduction in lung volume allows the less diseased parts of the lungs to function more effectively and thereby improves the breathing of patients with emphysema.
Commenting on the license, Dr. David Dove, CEO of Aeris, said: "The licensing of this IP from Kuros is an important step in the continued development of our unique Biologic Lung Volume Reduction System. We believe that BLVR has the potential to offer patients suffering from emphysema a treatment option that can alleviate their symptoms of shortness of breath and improve quality of life."
The AeriSeal Biologic Lung Volume Reduction System is a non-surgical treatment in which a bronchoscope is used to deliver a proprietary mixture of drugs and biologics that form a bio-absorbable gel to diseased areas of the lungs. The gel is composed of a mixture of a fibrin sealant as a drug delivery system, an antibiotic to prevent infection and drugs designed to cause a reaction in targeted areas of the lungs. A unique element of the BLVR System is its use of the body's natural scar formation response to permanently collapse diseased areas of the lungs. This reduction in lung volume allows the less diseased parts of the lungs to function more effectively and thereby improves the breathing of patients with emphysema.
Omrix Biopharmaceuticals Completes Enrollment of Initial 90 Patients Needed to Conduct Interim Analysis in Fibrin Pad U.S.
Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The Company expects to release 90 patient interim efficacy analysis by the end of October 2008.
The Fibrin Pad is a breakthrough convergence product being developed by Omrix in collaboration with ETHICON, INC., a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to SURGICEL. The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized 2 to 1 so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with SURGICEL.
The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to SURGICEL. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.
About the Fibrin Pad
The Fibrin Pad is being developed in collaboration with ETHICON, Inc., a Johnson & Johnson company, and builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.
The Fibrin Pad is a breakthrough convergence product being developed by Omrix in collaboration with ETHICON, INC., a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to SURGICEL. The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized 2 to 1 so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with SURGICEL.
The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to SURGICEL. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.
About the Fibrin Pad
The Fibrin Pad is being developed in collaboration with ETHICON, Inc., a Johnson & Johnson company, and builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.
TraumaCure Receives CE Mark Clearance to Sell WoundStat in Europe
TraumaCure Inc. announced today that its ground-breaking hemostatic agent, WoundStat™, has received CE Mark approval, clearing the way for sales in the European Union and all countries recognizing the CE Mark. CE Mark approval from the European Union certifies WoundStat has met health, safety and environmental requirements for consumer safety.
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