Cohera Medical Begins Clinical Trial of Surgical Sealant
By Barry Teater, NCBiotech writer
|Cohera President and CEO Patrick Daly -- Cohera photo|
Cohera Medical Inc., a medical-device company that relocated to Raleigh from Pittsburgh a year ago, has enrolled the first patient in a clinical trial of its Sylys Surgical Sealant.
The product is the first synthetic sealant designed to help reduce anastomotic leaks, the medical term for leaks that occur where cut tissues have been rejoined.
“Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James McCormick, DO, FACS, FASCRS, program director for general surgery at Allegheny Health Network in Pittsburgh. “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.”
Anastomotic leaks occur in up to 23 percent of patients undergoing colorectal surgery and frequently result in severe peritonitis, septic shock, multiple organ dysfunction, and death. At least one-third of post-surgical deaths are attributed to leaks.
The multi-center, randomized clinical study will compare patients undergoing colorectal and ileorectal surgeries with and without the sealant, the company said in a news release. The study is the first phase of a clinical trial program designed to demonstrate the sealant’s safety and efficacy in reducing the leak rate in these procedures.
U.S. testing marks 'major milestone'
“The start of our U.S. clinical trial for Sylys Surgical Sealant is another major milestone for Cohera,” said Patrick Daly, the company’s president and CEO. “The hard work and dedication of the entire team and our clinical partners is paying dividends now and we believe will provide patient and surgeon benefits in the future with reduced leaks and co-morbidities.”
Sylys is intended to be used in tandem with standard closure techniques.
More than one million colorectal and ileorectal surgeries are performed worldwide each year, representing a multi-billion dollar market opportunity for Sylys.
“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,” the company said.
The U.S. Food and Drug Administration paved the way for the clinical trial in 2016 by giving Cohera Investigational Device Exemption approval for Sylys and in 2015 by granting Expedited Access Pathway status, recognizing the product’s potential to meet a serious unmet clinical need.
Already approved and used in Europe
Sylys has received CE Mark approval in Europe, allowing its sale and use there as an adjunct to standard closure in ileostomy-reversal procedures.
In addition to Sylys, Cohera has developed TissuGlu Surgical Adhesive, the first synthetic adhesive approved in the U.S. for internal use in abdominoplasty, or “tummy tuck” surgery, a cosmetic surgical procedure that removes excess skin to thin and firm the abdomen. In a randomized clinical study TissuGlu was shown to eliminate the need for postoperative surgical drains by reducing dead space where fluid may accumulate in most tummy tuck procedures, the company said.
Like Sylys, TissuGlu is broken down into safe components and eliminated naturally by the body after use. Both products are made of a lysine-based urethane developed at the University of Pittsburgh and do not include any animal or human components.
TissuGlu's strength helps body heal naturally
TissuGlu is 10 times stronger than fibrin-based sealants that are sometimes confused with TissuGlu, the company said. This strength allows the adhesive to bond the tissue layers that were separated during surgery. Maintaining a connection of the tissue layers reduces space where fluid may collect and facilitates the body’s natural healing process.
TissuGlu is also approved and available for sale in the European Union to eliminate drains or reduce complications in patients undergoing abdominoplasty, mastectomy, ventral hernia repair, decubitus and latissimus dorsi flap procedures.
A recent German study of 40 patients undergoing surgical repair of advanced decubitus ulcers, more commonly known as bed sores, was published in the Journal of Spine. The study demonstrated that using TissuGlu reduced the need for follow-up surgeries by 50 percent and shortened hospital stays by 35 percent following the surgical flap repair.
TissuGlu and Sylys are the first products in a pipeline that includes adhesives for surgical mesh fixation, meniscal repair and other orthopedic indications, the company said.
Company backed by $50 million financing led by KKR
Cohera was founded in 2006 and is backed by $50 million in a recent equity financing led by KKR, a global investment firm, with participation from other private investors.
The company employs 37 people and plans to hire more as sales of TissuGlu grow and the Sylys clinical trial ramps up, said Lindsay Koren, Cohera’s senior marketing manager.
“We are excited to be in Raleigh and the RTP area, as it has allowed us to attract top talent and grow the company,” Koren said.
The company chose Raleigh “because it is a top destination for medical device and biotech companies,” Daly said when the relocation was announced a year ago.