Tuesday, October 14, 2008
Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant (Human)
NEW YORK - (Business Wire) OMRIX Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received approval from the European Medicines Agency (EMEA) for Evicel, the Company’s liquid fibrin sealant.
The EMEA’s approval permits EVICEL to be marketed in Europe under the following indication, “As a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery.”
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a general hemostasis in surgery indication.
With an EMEA approval, EVICEL is licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix’ and ETHICON’s supply and distribution agreement, ETHICON has the marketing rights for the EU.
EVICEL™ is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL™ is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing.
St. Jude Medical Announces U.S. and European Approval of Angio-Seal Evolution Vascular Closure Device
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approval of the Angio-Seal(TM) Evolution(TM) Vascular Closure Device. The approval and global launch was announced at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.
The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner.
The Angio-Seal Evolution platform features an entirely new delivery system that significantly reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system. Consistent with its Angio-Seal predecessors, Angio-Seal Evolution achieves hemostasis through the deployment of an anchor, suture and collagen seal (each of which is bioabsorbable). With Evolution, however, single-handed deployment has been made possible for the first time, which enables physicians to more easily support the puncture site. The new device's automated collagen compaction system ensures consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.
"The Angio-Seal Evolution takes a major step forward by automatically compacting the collagen," said Robert J. Applegate, M.D., Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "The confidence it provides physicians in closing the puncture in such a short period of time with such effectiveness is outstanding."
More than 13 million catheterizations are performed worldwide each year to open narrowed or blocked arteries and perform other cardiovascular procedures. During catheterizations, physicians insert a catheter (a thin tube) through a puncture made in the femoral artery in the upper thigh and guide it through the blood vessels to the point of care. Treatments such as balloons, stents and medications are then delivered through the catheter. Once a procedure is complete and the catheter is removed, bleeding from the puncture in the femoral artery must be stopped quickly.
Unlike most vascular closure devices, the Angio-Seal Evolution closure system is fully absorbed by the body within 60 to 90 days. This reduces risks associated with foreign material left permanently in the body and allows for repeat procedures without concerns about prior placement of closure devices.
"The Angio-Seal Evolution embodies St. Jude Medical's commitment to providing physicians with more control over patient outcomes while reducing procedural variability," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "We are confident the Evolution platform will further enhance Angio-Seal's position as the recognized leader in vascular closure and provide physicians with increased confidence in the ease of device deployment and predictability."
LOS ANGELES, Oct 14, 2008 /PRNewswire via COMTEX/ -- Ceremed Inc. announced today that its collaborative effort with ApaTech Limited, a London based manufacturer of products for bone grafting, has resulted in the launch of ApaTech's latest product, Actifuse(TM) Shape, a novel, formable bone grafting solution. The new product combines Ceremed's AOC(TM) Biosoluble(TM) polymer with ApaTech's proprietary Actifuse(TM) microgranules. The resulting product's biostimulative properties are optimized by AOC's ability to be molded or cut to the contours of the grafting site.
The synthetic blend of alkylene oxide copolymers in AOC(TM) is water soluble allowing them to dissolve. The unique properties of the product include the dissolution of the product without swelling or inflammation as seen with some implant materials. The dissolved product is then eliminated from the body without further breakdown.
The launch of Actifuse Shape represents the culmination of a two year collaborative effort between the companies. The product will be manufactured in Ceremed's Los Angeles facility and shipped to ApaTech's distribution points in the UK and US. Ceremed has licensed the AOC(TM) technology to ApaTech Limited as the first of many projects in which the AOC(TM) technology is used as a passive carrier for bioactive materials and therapeutic agents. Several other derivative products related to the AOC(TM) technology are planned for release in the coming year. Ceremed currently distributes its Ostene(TM) bone hemostasis product in the United States and Europe.
"Ceremed is committed to the design and development of unique medical polymers to enhance the effectiveness of surgical procedures," says Tadeusz Wellisz, M.D., CEO of Ceremed. "We are actively seeking strategic alliances that greatly expand the impact of our products on the medical market. Ceremed's ability to rapidly bring products to market combined with the expertise in developing unique polymer blends makes us an exceptional partner for co-development."