The time has finally come for this company. Entered at $4.09 today.
Novel Synthetic Biocompatible Sealing Agent Offers Innovative Alternative In Sealing Vascular Reconstructions
PALO ALTO, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Cohesion Technologies, Inc. (Nasdaq: CSON), a leader in developing and commercializing Biosurgical products and medical devices, today announced the launch of CoSeal(R), the first completely synthetic biocompatible vascular sealing agent. Approved by the U.S. Food and Drug Administration (FDA) on December 14, 2001, CoSeal is an innovative adjunct to conventional methods of surgical closure, such as sutures and staples, and is indicated for use in vascular reconstruction to achieve hemostasis by mechanically sealing areas of leakage. Compared to currently available surgical glues and adhesives, CoSeal offers distinct benefits by minimizing response time, eliminating the risk of viral transmission and offering quick and easy preparation, which may ultimately provide surgeons with improved outcomes and optimal patient healing.
Comprised of two distinct polyethylene glycol polymers, CoSeal is a resorbable, fast-acting sealing agent. Following application via a dual chamber applicator device, CoSeal typically forms a flexible seal within seconds on the tissue surface that remains intact through the critical wound-healing period and is totally resorbed within four to six weeks of application. And, because CoSeal is a completely synthetic, latex-free material that contains no human blood products, it carries no risk of viral transmission.
Unlike currently available glues and surgical adhesives, CoSeal is quick and easy to prepare. This novel hydrogel minimizes response time as it can be prepared, applied and achieve adjunctive hemostasis in approximately three minutes. It does not need to be thawed or heated and because it is self-polymerizing, CoSeal requires no light activation.
"Controlling blood loss quickly during any surgical procedure is critical. The ability of CoSeal to establish strong sealing properties between tissue and its synthetic components almost immediately should certainly help improve surgical outcomes. Faster hemostatic control may ultimately translate into better outcomes or results for the patient," said Marc Glickman, M.D., Virginia Vascular Associates in Norfolk, Virginia, and one of the CoSeal clinical investigators. "Additionally, CoSeal's quick preparation time provides therapeutic benefits over traditional hemostatic devices, such as gelatin sponges with or without thrombin, and currently available fibrin glues, which are often difficult to manage or apply during procedures and take substantial time to prepare or mix, potentially affecting patient outcomes."
Cohesion submitted a Premarket Approval (PMA) application for CoSeal in April 2001. The PMA data demonstrated safety and effectiveness in sealing arterial or venous grafts compared with a commercially available hemostatic agent. Data was obtained from 264 treated sites involving 148 patients in a prospective, randomized, controlled clinical study conducted at nine hospitals across the U.S. Overall, subjects treated with CoSeal achieved immediate sealing at more than twice the rate of subjects treated with the compared hemostatic agent. The study was conducted under an FDA-approved Investigational Device Exemption protocol with appropriate Institutional Review Board approval at each clinical site.
"With the launch of CoSeal, Cohesion has brought advanced, revolutionary surgical care to market," said William G. Mavity, Cohesion Chief Executive Officer and President. "Cohesion Technologies is committed to the further development and marketing of safe and effective Biosurgical technologies to help surgeons improve healing times and achieve optimal patient care."
Independent research reports estimate that there are approximately 250,000 surgical procedures performed each year in the U.S. in which CoSeal could potentially be used under its current indications. |
