Cohera Medical Receives FDA Approval to Begin U.S. Clinical Trials of its Sylys Surgical Sealant

Cohera Medical Inc., a developer of absorbable surgical adhesives and sealants, has received Investigational Device Exemption (IDE) approval from the U.S. 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 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, Mass.
 
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 joint efforts by the company and the FDA to move forward on the clinical evaluation of this 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 (Alberts, 2003 #1). 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 1 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.

Cohera Medical Inc. develops and commercializes 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 United States for the approximation of tissue planes in abdominoplasty procedures. TissuGlu is currently approved for sale in Europe 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 there 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 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 FDA.