PITTSBURGH, PA., October 21, 2015 – Cohera Medical, a leading innovator and developer of absorbable surgical adhesives and sealants, announced closing the first tranche of a $50 million equity financing led by KKR, a leading global investment firm, with participation from existing private investors.
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 U.S. 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 U.S. 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 Co. LP (NYSE: KKR).
About Cohera Medical
Cohera Medical, Inc. is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. 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, lymph node dissection, 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 surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. 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. or in any other market.
KKR is a leading global investment firm that manages investments across multiple asset classes including private equity, energy, infrastructure, real estate, credit, and hedge funds. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and driving growth and value creation at the asset level. KKR invests its own capital alongside its partners’ capital and brings opportunities to others through its capital markets business. References to KKR’s investments may include the activities of its sponsored funds. For additional information about KKR & Co. L.P. (NYSE: KKR), please visit KKR’s website at www.kkr.com.
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