Surgical adhesive specialist Cohera Medical, Inc.®, has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures. The company says approval is expected by the end of 2014.
Cohera Medical is targeting the money shots with its adhesive/sealant range. It’s first product, TissuGlu® Surgical Adhesive,targets elimination of drains in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, and latissimus dorsi. Now they’re going for another unmet need, sealing of gastrointestinal anastomoses, which has long been the subject of development work by other companies, all of whom have found the challenge of dealing with this delicate and dynamic tissue too tough a nut to crack.
Anastomotic leakage is a significant problem if you get one. At least one-third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries. The additional care required to manage this serious complication can cause up to a five-fold increase in patient management costs.
Sylys is designed to help reduce anastomotic leakage in intestinal procedures by providing additional support during the first few days of healing, when the development of leaks is most likely to occur.
Unlike other surgical sealant chemistry, Sylys is the first to utilize triethoxysilane in combination with urethane chemistry to produce a rapid curing, single-part moisture cure sealant with good adherence to tissue. No mixing or complicated preparation is required. The sealant is applied as a viscous fluid that cures rapidly to create a flexible, elastic seal over the anastomosis site.
Establishing whether a sealant works on the bowel is a tricky business and Cohera is relying on a single mouse study to support its claims for Sylis. It would appear that an incomplete anastomosis model delivers a statistically significant reduction in leak rate.
The market for Sylys is significant, with several hundred thousand procedures a year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that could lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
“Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James McCormick, DO, FACS, FASCRS, Chief, Division of Colorectal Surgery, The Western Pennsylvania Hospital. “We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety.”
“The preparation and filing of the CE Mark application for Sylys, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera Medical,” said Chad A. Coberly, JD, Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. “The submission signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities, and we look forward to working with our notified body during the approval process.”
“Submitting the SylysCE Mark application represents a significant milestone towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors,” said Patrick Daly, Cohera Medical president and CEO. “We look forward to making Sylys available to surgeons and patients throughout the world.”
Source: Cohera Medical, Inc.