RSSThere's no question that both 2015 and 2016 were blockbuster years for surgical sealant maker Cohera Medical Inc. During the two-year period, the company brought in significant funding and received its first FDA device approval. The private company is getting off to a strong start in 2017 with the enrollment of the first patient in the clinical trial for the Sylys surgical sealant. The company said Sylys will serve as an adjunct to standard closure techniques in colorectal and ileorectal anastomosis procedures.
"Sylys is a synthetic sealant and when using it, we're not asking doctors to change their technique," Patrick Daly, president and CEO of Raleigh, N.C.-based Cohera, told Medical Device Daily. "Sylys goes around the staple of the suture line."
The sealant is 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. At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries.
The randomized 80-patient clinical study evaluating Sylys 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.
Daly said if all goes well, the company could start a U.S. pivotal study of the device early next year. He said Cohera could likely submit for FDA approval of Sylys between late 2018 and 2019.
According to the company, the market for the Sylys surgical sealant represents a multibillion dollar opportunity.
Key players in the surgical adhesive and sealant market include Baxter International Inc., B Braun Melsungen AG, Johnson and Johnson Corp., Medtronic plc, Sanofi SA, Cryolife Inc. and Vivostat A/S, according to a November report from Mordor Intelligence.
BLOCKBUSTER YEARS
Cohera, formerly known as Cohera Biomedical Adhesives Inc., was founded in 2003, and had two of its best years performance-wise in 2015 and 2016. The firm kicked off 2015 with news of its FDA approval for Tissuglu. (See Medical Device Daily, Feb. 10, 2015.) FDA approved Tissuglu as a device to adhere tissue layers and close dead space in abdominoplasty procedures. In clinical trials of the device, surgeons were able to eliminate the need for post-surgical drains, reducing the need for invasive treatments.
The company launched Tissuglu in June of 2016 and received expedited access pathway status from the FDA for Sylys. (See Medical Device Daily, June 10, 2015.)
Cohera gained CE mark for Sylys shortly after Tissuglu received FDA approval. (See Medical Device Daily, Aug. 14, 2015.) Despite being green lit to sell the product in Europe, Cohera has not launched Sylys on the market. That could change once the company is able to gain a nod from the FDA for Sylys.
Daly said Cohera topped off 2015 by closing in on a $50 million in equity funding led by Kohlberg Kravis Roberts & Co., L.P. (KKR), an investment firm, with participation from other investors. (See Medical Device Daily, Oct. 23, 2015.)
"We have our plans in place and we'll have a better idea if we need additional funding in the near future," Daly said, when asked about the possibility of a new funding round. "We're in a good spot and we're always interested in working with people, but we have a really good [investment] partner in KKR."
The company had a huge milestone in July of last year, when FDA granted Cohera IDE approval for Sylys. Daly points to a strong working relationship with the FDA for the firm's success.
"I think the most important thing is that we've worked very closely with the FDA and not at the expense of the FDA," Daly said. "We have a really good relationship with the regulatory body and have worked really hard on developing [that relationship]."