RALEIGH, N.C., May 24, 2017 — The potential of drain-free mastectomy attracted wide attention at the UK meeting of the Association of Breast Surgeons (ABS Belfast, May 15-17). A body of evidence supporting the use of TissuGlu Surgical Adhesive for the fixation of the skin flap after removal of breast tissue was presented as a poster by a “German Working Group on Drain-Free Mastectomy”. TissuGlu is a surgical adhesive designed to hold tissues together and facilitate healing after surgeries which require “undermining” between tissue planes. The group suggested that the use of TissuGlu allows for the elimination of drain use, without an increase in the need for fluid-related clinical procedures. An ongoing international, multi-center, prospective, randomized trial in Germany and the UK will provide additional clinical evidence upon completion.
Currently, there are two options for managing postoperative fluid accumulation in mastectomy: surgical drains or repeat needle aspirations performed in office or in seroma clinics. Each option has drawbacks. In addition to making the early recovery period uncomfortable for patients, drain use has been associated with increased hospital stays, increased complications such as infections, and potential delay of adjuvant therapy. Alternatively, closing the wound without drains may require repeat visits for drainage which is an additional burden for recovering patients. Seroma rates as high as 80% have been reported; however, the repeated needle aspirations are considered by many to be a ‘normal’ part of the mastectomy recovery process.
“There is a lack of consensus on the question of drain use after mastectomy. Drains are clearly not favored by patients or the breast care nurses, as they are uncomfortable and require attention, draining, and disinfection,” said Assoc. Prof. Amit Goyal of Royal Derby Hospital in England, the Coordinating Investigator for the UK part of the prospective clinical study. “Alternatives proposed to date have not proven to be effective, so this study using TissuGlu is of great interest. If the results confirm what we have seen reported by our colleagues in Germany, it could become a new standard of care, much to the advantage of both patients and the NHS system overall.”
Mart Pearson, VP Europe for Cohera Medical, Inc. said: “TissuGlu has been used for flap fixation after mastectomy in Germany for a few years now and the level of clinical evidence available is growing. The ABS meeting has provided an opportunity for the German teams to share their experience and to propose to their British colleagues a solution to a need that has been recognized in the UK health care system. We are excited by the opportunities that this presents for improved patient care as well as improved use of health care resources in the UK market.”
Cohera Medical, Inc.
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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.