Company receives CE Mark approval to extend shelf life of TissuGlu
PITTSBURGH – Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it received approval from The British Standards Institution (BSI), to extend the shelf life of its TissuGlu® Surgical Adhesive in the EU from 7 to 18 months. The shelf life extension was granted based on modifications to product packaging only, and did not require any changes to the adhesive or applicator. The extended shelf life applies to all TissuGlu product being marketed in the EU.
Cohera Medical will begin immediately producing the TissuGlu product in the new packaging, and will begin shipping product in this configuration with the next lot of product produced.
“We are pleased with the CE Mark approval to extend the shelf life of TissuGlu in Europe,” said Mart Pearson, Cohera Medical VP of Europe. “The growing number of hospitals and surgeons who utilize TissuGlu will be pleased with the change as well.”
“The extended shelf life for TissuGlu represents significant work by the entire Cohera Medical team,” said Patrick Daly, Cohera Medical president and CEO. “The shelf life extension, which provides greater flexibility, is one more distinctive benefit this product brings to our customers and ultimately the patients.”
TissuGlu is targeted for use in large flap surgery procedures where pockets are created between planes of soft tissue. The adhesive is designed to hold the planes together during the healing process, in many cases eliminating the need for surgical drains, which are associated with discomfort, greater risk of infection, and longer hospital stays. The recently completed U.S. clinical trial showed the elimination of drains in 73 percent of abdominoplasty patients using TissuGlu, with no additional measures needed to address fluid accumulation.
There are approximately 1M US-based large flap procedures per year, growing at an annual rate of 4.8 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.
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 the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. TissuGlu is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. The Company’s second product, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process. TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. Outside of the EU, TissuGlu and the other Cohera Medical products are currently indicated 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.
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.