PITTSBURGH, Jan. 22, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has secured an additional $9.3 million to close its Series D financing, raising its total for the round to $26.3 million. The Company will use the funds to drive toward U.S. regulatory approval for its TissuGlu® Surgical Adhesive and CE Marking approval for its Sylys® Surgical Sealant.
The funding comes at a pivotal time, as Cohera Medical submitted its fourth and final module for TissuGlu in a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) at the end of last year. Additionally, the funds raised will support the CE Marking approval pathway for Sylys, a surgical sealant designed to significantly reduce anastomotic leakage in gastrointestinal procedures.
"Our goal is to improve patient care and recovery time through natural healing and reduced post-operative treatments, so patients can quickly resume normal activities," said Patrick Daly, President and CEO of Cohera Medical. "The continued support from our investors is a testament to our significant milestones of 2013, which included the completion of our pivotal 'No-Drain' study for TissuGlu and our first in human study for Sylys."
Currently, most patients who undergo abdominoplasty procedures or other large flap procedures, such as mastectomy or inguinal lymph node dissection, require the insertion of drains to remove fluid that accumulates under the skin at the surgical site. Drains are often uncomfortable for the patient and can lead to additional complications. TissuGlu forms a strong bond between tissue layers, helping to reduce the fluid that can accumulate during healing.
Cohera Medical received CE Marking approval for TissuGlu Surgical Adhesive and began selling product to hospitals and surgeons in Germany in 2011. TissuGlu has been used successfully in more than 1,000 various surgical procedures by leading surgeons. In the U.S., Cohera Medical submitted the fourth and final module in a PMA application to the FDA. The submission comprised data from Cohera Medical's 'No Drain' study, which demonstrated that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In the pivotal clinical trial, when TissuGlu was used, patients required fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
Cohera's second product, Sylys Surgical Sealant, has the potential to make an enormous impact on an estimated $1-4B surgical market. On average, anastomotic leaks occur in 3-15% of colorectal procedures, and are the cause of one-third of the mortalities following colorectal surgery. Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic closure techniques, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing, when leaks are most likely to occur. At the end of last year, Cohera Medical successfully completed a human clinical trial confirming the safety of Sylys.
About Cohera Medical
Cohera Medical, Inc. is a leading innovator and developer of absorbable surgical adhesives and sealants. The Company's first product, TissuGlu Surgical Adhesive, is an internal surgical adhesive for large flap surgeries, such as abdominoplasty (tummy tuck), that eliminates or reduces fluid accumulation and the need for post surgical drains. TissuGlu's chemical composition is resorbable, non-toxic, forms a strong bond between tissue layers and allows for natural healing, which ultimately may enable faster recovery. TissuGlu has received CE Marking approval to be sold in the European Union (EU). Cohera Medical is also developing a unique and proprietary gastrointestinal sealant, and a strong adhesive for mesh fixation. Outside of the EU, TissuGlu and the other Cohera products are currently indicated for investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other market. For more information, visit www.coheramed.com.
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
SOURCE Cohera Medical, Inc.