New clinical evidence supports expanded indications
Raleigh, NC (GLOBE NEWSWIRE) - Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has submitted a Premarket Approval Application (PMA) supplement to the U.S. Food and Drug Administration (FDA) for its TissuGlu Surgical Adhesive. The supplement contains new clinical evidence supporting a review by the FDA to expand the indication for TissuGlu in the United States.
TissuGlu is currently approved in the U.S. for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty. TissuGlu Surgical Adhesive was the first 100% synthetic internal surgical adhesive approved for sale in the United States.
The Company recently completed multiple favorable clinical studies and compiled its real-world evidence collected in over six years of use outside the U.S. to support the application of expanded indication to use TissuGlu in all large tissue flap surgeries.
“The submission of the PMA supplement to expand the U.S. indications of TissuGlu is a significant milestone for the Company,” said Patrick Daly, Cohera Medical President and Chief Executive Officer for Cohera. “We are excited about the potential to make TissuGlu available to more surgeons and patients in the United States.”
TissuGlu is designed to meet a surgeon’s need for a strong, biocompatible, and easy-to-use surgical adhesive. The primary evidence included in the supplement application consists of data from a multi-center, prospective clinical trial comparing the use of TissuGlu to the standard of care in mastectomy procedures. The results of this study concluded that TissuGlu is a safe and effective alternative to the use of postoperative fluid collection drains in mastectomy surgeries. This evidence is combined with recent clinical studies in DIEP flap and decubitus pressure sore flap procedures.
“This PMA supplement for TissuGlu culminates several years of work by the company, its clinical partners, and customers,” said Chad Coberly, JD, Chief Clinical & Legal Officer for Cohera. “The company looks forward to working with the FDA and its review team during the review of this important application.”
TissuGlu is targeted for use in large flap procedures where elimination of deadspace created between the tissue layers is beneficial to facilitate natural healing of the tissues. The product has been on the market in the EU since 2011, and currently more than 5,000 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.
About Cohera Medical
Cohera Medical, Inc. is a growing medical device company that is developing and commercializing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, and easy-to-use. 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, ventral hernia repair, 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 adhesives for surgical mesh fixation, meniscal repair and other orthopedic indications. 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.
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.
©2018 Cohera Medical, Inc. All Rights Reserved. Cohera Medical, Inc.®, TissuGlu®, and Sylys® are registered trademarks of Cohera Medical, Inc.
TissuGlu® Surgical Adhesive is covered by one or more of the following U.S. Patents 7,264,823; 8,182,647; 8,652,293; 8,950,629. Other Patents Pending.
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SOURCE: Cohera Medical, Inc.