RALEIGH, N.C., July 12, 2016 (GLOBE NEWSWIRE) -- Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, today announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Sylys® Surgical Sealant device.
Sylys® Surgical Sealant is intended to be used as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in colorectal and ileorectal anastomosis procedures. Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.
“It is tremendous that the FDA has given investigational approval to this novel device that may help reduce the incidence of anastomotic leaks and their devastating impact,” said Dr. Deborah Nagle, Chief, Colon and Rectal Surgery, Beth Israel Deaconess Medical Center in Boston, MA. Sylys® Surgical Sealant received Expedited Access Pathway (EAP) status from the FDA in 2015, which recognizes the potential of the product to meet a serious unmet clinical need. This IDE approval represents the culmination of significant joint efforts by the company and the FDA to move forward on the clinical evaluation of this important technology.
“Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James McCormick, DO, FACS, FASCRS, Program Director, General Surgery, Allegheny Health Network in Pittsburgh, PA. “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 randomized clinical study will compare patients undergoing colorectal and ileorectal anastomosis after resection with and without the sealant. The study is the first phase of a clinical trial program designed to support the safety and efficacy of the sealant in reducing the leak rate in these procedures.
Anastomotic leakage, which occurs in up to 23 percent of patients undergoing colorectal surgery, is considered to be the most serious surgical complication encountered, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and death. At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries.
“We are pleased that the FDA has approved this IDE. This approval validates the Sylys® Surgical Sealant biocompatibility, pre-clinical safety profile, and clinical trial design of the study,” said Chad Coberly, JD, Chief Clinical and Legal Officer of Cohera. “The Company greatly appreciates the cooperation and high level of interaction with the FDA during the review of this potentially life-saving healthcare innovation.”
The market for Sylys® Surgical Sealant is significant, with more than one million procedures per year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
About Cohera Medical
Cohera Medical, Inc. is a growing medical device company that is developing and commercializing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, and easy-to-use. The Company’s lead product, TissuGlu® Surgical Adhesive, is indicated for use in the U.S. for the approximation of tissue planes in abdominoplasty procedures. Refer to the complete Directions for Use information available at TissuGlu.com for a full description of use information including the contraindications, warnings, precautions, benefits, and risks of use of TissuGlu® Surgical Adhesive. TissuGlu is currently approved for sale in the EU for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty and is being utilized in Europe to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty, mastectomy, ventral hernia repair, decubitus and latissimus dorsi flap procedures. The Company’s second product under development, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, has received CE Mark approval in Europe as an adjunct to standard closure in ileostomy reversal procedures. TissuGlu and Sylys are the first products in a pipeline of technology that includes adhesives for surgical mesh fixation, meniscal repair and other orthopedic indications. Sylys and the other Cohera Medical products are currently available for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S.
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
©2016 Cohera Medical, Inc. All Rights Reserved. Cohera Medical, Inc®, TissuGlu® and Sylys® are registered trademarks of Cohera Medical, Inc.
TissuGlu® Surgical Adhesive is covered by one or more of the following U.S. Patents 7,264,823; 8,182,647; 8,652,293; 8,950,629. Other Patents Pending.