RALEIGH, NC, October 17, 2017
Painful post-surgical drains may become unnecessary for breast cancer patients who undergo a mastectomy procedure (removal of the breast). A level I clinical study seeks to provide evidence that the skin flap can be adhered to the chest wall with TissuGlu Surgical Adhesive® after removal of the breast tissue, assisting the healing process and eliminating the need for drains. A drain-free recovery could help to make the experience easier for both mastectomy patients and their care providers.
The European study, with 4 centers in Germany and 7 in the UK, started in February and has completed enrollment of nearly 80 patients, with half of the patients treated with post-surgical drains and the other half treated with TissuGlu and no drains. After a 90 day follow up period, the study will assess the number of clinical interventions related to wound healing and fluid management in both groups. Preliminary assessments indicate that the outcomes of the study are positive.
“Our patients have been very enthusiastic about participating in the study when they hear about the chance of a drain-free procedure,” says Ms. Polly King, Principal Investigator at the Royal Cornwall hospital in the UK, which recruited the highest number of patients for the study. “Patients without drains feel more comfortable about going home sooner than those who wake up from surgery with a drain.”
“TissuGlu has been used for flap fixation after mastectomy and several other ‘flap procedures’ in Europe for a few years now. The body of evidence required to bring this new approach into the mainstream has been steadily growing, and this multinational prospective randomized study really represents the ‘Gold Standard’ of clinical evidence,” says Mart Pearson, VP Europe for Cohera Medical, Inc. “We hope that these results will open the door for many other breast cancer patients who would greatly prefer a recovery without drains.”
This study adds to the growing body of evidence of positive TissuGlu outcomes.
Cohera Medical, Inc.
Sr. Marketing Manager
(984) 222-0400 (office)
Senior Account Executive
(919) 926-3628 (office)
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.
©2017 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.