MOUNTAIN VIEW, Calif. – Based on its recent analysis of the surgical adhesives market, Frost & Sullivan recognizes Cohera Medical, Inc.® with the 2010 Frost & Sullivan Award for New Product Innovation of the Year Award for TissuGlu® Surgical Adhesive. With surgeons looking for better surgical adhesive options than the currently available superglue-type products and fibrin sealants, Cohera Medical’s revolutionary line of internal surgical adhesives, with TissuGlu as the lead product, could not have been timelier.
While superglue-type products are known for their adhesive strength, in general they do not degrade and so they cannot be used inside the body. Fibrin sealants, on the other hand, can be used for internal applications, but create a weak bond and are expensive. They also need to be prepared prior to use and can be difficult to use during surgery. As a logical derivative, surgeons want a product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. TissuGlu, a urethane adhesive suited for plastic surgery procedures, is both biocompatible and resorbable, making it ideal for internal applications. It is also strong, user-friendly, and does not contain human/animal product derivatives.
“Although the medical adhesives industry is regarded as an exciting, emerging market in the world today, there are only a few manufacturers that actually research technologies that are capable of clinical feasibility,” says Frost & Sullivan Senior Research Analyst Christina Priya Dhanuja. “For the development of TissuGlu, Cohera Medical has keenly worked on the modification of the urethane chemistry to suit the needs of a surgical adhesive requirement.”
By efficiently adhering flaps of tissue, TissuGlu is particularly useful in preventing the formation of seroma in abdominoplasty. One of the five most common plastic surgery procedures performed in the United States, abdominoplasty has a reported post-operative complication rate from 15 to 52 percent – the formation of seroma being the most likely complication. Usual methods to combat seroma formation include the placement of closed suction drains, use of compression garments around the tissue, use of progressive tension sutures, and use of fibrin sealants to reduce fluid accumulation. However, most of these methods can lead to further complications such as leakage from drain sites, skin necrosis and inconsistent adhesion.
Using TissuGlu not only reduces the fluid drainage that can lead to formation of seroma but also reduces the need for post-surgical drains. The adhesive is molecularly designed to bond biological tissue in the presence of moisture, and then later degrade by hydrolysis into benign components. This is a key criterion in determining the biocompatibility of an internally used adhesive. In contrast, cyanoacrylates – the widely used adhesive in medical applications – has been restricted to just topical use, because it yields formaldehyde as a result of hydrolytic degradation of the polymer main chain.
According to the most recent preclinical testing data, TissuGlu has prevented the formation of seroma in an animal model of abdominoplasty. In-vivo studies have also shown that TissuGlu is biodegradable and safe for internal use. The adhesive passed all biocompatibility tests to establish safety prior to human clinical trials. In particular, a 13-week sub-chronic toxicity study found TissuGlu to be a non-irritant, comparable to saline. A human feasibility trial demonstrating the safety of the adhesive material was just completed for the abdominoplasty indication in Germany.
Apart from the adhesive being effective in minimizing post-operative wound drainage, histological analysis of the tissue samples from the pre-clinical study showed no signs of inflammation or foreign body reaction associated with the adhesive. The lysine-derived urethane works to reduce fluid accumulation by eliminating the dead space in the wound and avoiding a foreign body response, which may otherwise lead to post-operative complications.
“On account of its biocompatibility, adhesive strength, degradation profile and safety, the new product is positioned to set an industrial standard for medical adhesive manufacturers,” says Dhanuja. “From the surgeon’s standpoint, this new adhesive material is a better alternative as the basic chemistry can be formulated for use in an array of surgical applications, including plastic surgery, general surgery and orthopedic surgery.”
Overall, TissuGlu addresses the key challenges of biocompatibility and adhesive strength, and it has a higher customer acquisition potential than the currently available cyanoacrylate and fibrin sealant technologies. Based on these criteria and its best practices approach to medical product development, Cohera Medical is the recipient of the 2010 Frost & Sullivan New Product Innovation of the Year Award.
Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leverage leading edge technologies. The award recognizes the value added features/benefits of the product and the increased ROI it offers customers, which in turn increases customer acquisition and overall market penetration potential.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
About Cohera Medical, Inc.
Headquartered in Pennsylvania, USA, Cohera Medical has been actively developing a line of surgical adhesives based on polyurethane chemistry. To the company’s credit, Cohera Medical currently has 36 pending-patent applications in the U.S. and abroad. The company’s first patent was issued in June 2007 followed by successive applications covering dispenser design and adhesive material technology. Its product pipeline and technology expertise is indicative of a strong R&D force that is committed to offering the best and the safest solutions for the surgeon and patient in the medical adhesive industry. Given the pace at which pre-clinical studies and trials are being conducted for Cohera Medical’s products, it is expected that the commercialization path is shorter for the company’s disruptive technology to hit the market. TissuGlu and the other Cohera products are currently indicated for investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other market. For more information, visit http://www.coheramed.com/.
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Patrick Daly, President and CEO of Cohera Medical, receives the 2010 North American Surgical Adhesives New Product of the Year Award.
Disclaimer:TissuGlu Surgical Adhesive is not currently approved for sale or marketing in the United States or any other country. TissuGlu Surgical Adhesive is currently approved for Investigational Use Only in humans outside of the United States.