Cohera Medical has made significant strides in the last year, achieving FDA approval for its lead product, TissuGlu® Surgical Adhesive, as well as CE Marking in Europe for its second product, Sylys® Surgical Sealant.
The company will use the funds to launch US commercial sales of TissuGlu, the first synthetic adhesive approved by the FDA for internal use. In addition, the company intends to advance clinical trials for Sylys, an innovative surgical sealant under development for bowel repair with significant market potential.
"In clinical trials, surgeons were able to eliminate the need for post-surgical drains by using TissuGlu, reducing the need for invasive treatments for their abdominoplasty patients, and improving the patient recovery process. The Premarket Approval (PMA) supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains," said Patrick Daly, president and CEO of Cohera Medical.
"We are excited to partner with KKR as we initiate commercialization of TissuGlu in the US and believe that the company’s pipeline of products holds great promise for both patients and surgeons."
As part of the transaction, Ali Satvat, Director on KKR’s health care investing team, will join the Company’s Board of Directors.
"We look forward to partnering with Patrick and his experienced team," said Mr. Satvat. "Cohera Medical has demonstrated an impressive ability to innovate transformational health care products and is at the forefront of new technologies in the expanding surgical adhesives and sealants market."
Cohera Medical recently received PMA approval for TissuGlu Surgical Adhesive indicated for the approximation of tissue planes in abdominoplasty procedures. Currently, most patients who undergo abdominoplasty procedures and other flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site.
TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space. In clinical trials, surgeons were able to eliminate the need for post-surgical drains in most abdominoplasty cases by using TissuGlu, reducing the need for invasive treatments for their abdominoplasty patients and improving the patients’ ability to return to normal activities.
Cohera’s product pipeline also includes Sylys, a resorbable synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.
Anastomotic leakage, which occurs in three to twenty-three percent of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered. The FDA has designated Sylys Surgical Sealant as an Expedited Access Pathway device due to its potential to address the unmet need related to gastrointestinal leaks.
For KKR, the investment is part of the firm’s health care growth equity strategy, which is focused on high-growth companies for which KKR can be a unique partner in helping reach scale. KKR is funding the investment primarily from the balance sheet of KKR & Co. LP.
