RALEIGH, NC, July 12, 2017 – Several clinical study data sets documenting outcomes in drain-free mastectomy using TissuGlu were reported at a meeting last week of the German Senology (Breast) Association in Berlin. Two retrospective cohort studies and 1 prospective randomized trial were presented, totaling 236 patients in 2 separate institutions over the course of 3+ years. All three studies demonstrated significant reductions in length of hospital stay and improved patient recovery with the use of TissuGlu.
“The patient comfort aspects of using TissuGlu in a drain-free mastectomy vs the ‘standard of care’ with drains have been clear from the start, but in order to change practice in a national healthcare system like Germany, multiple sets of evidence are required. At this meeting a lot of evidence was presented, opening the door to discussions of new guidelines and possibly new procedure definitions”, said Dr. Stefan Paepke of the Interdisciplinary Breast Center at the Technical University of Munich, lead author, presenter and one of the pioneers in the use of TissuGlu in mastectomy.
In Germany, mastectomy is generally performed as an in-patient procedure with an average length of stay in excess of 6 days, with drain removal generally being the trigger for patient discharge. All 3 studies documented reductions of 2 or more days in the drain-free cohorts.
Other reported outcomes:
- Overall reduced ‘invasiveness’ of the drain-free procedure
- Less patient reported pain and discomfort
A retrospective comparison cohort study and a prospective randomized study supported and added to the extensive historical data sets presented by Dr. Paepke. Both studies were presented by Julia Unger on behalf of Prof. Ralf Ohlinger and his team at the Women’s Hospital, Interdisciplinary Breast Center, Medical University Greifswald, Germany.
Mart Pearson, VP Europe for Cohera Medical, Inc., said: “The results presented at this meeting represent further evidence that holding tissue planes together with TissuGlu Surgical Adhesive can facilitate the wound healing process in this type of surgery. Similar outcomes in other surgical procedures involving tissue ‘flaps’, ranging from latissimus dorsi or abdominal donor sites to surgical repair of advanced decubitus (pressure sore) ulcers, have been presented at other meetings in Europe. We look forward to making this technology more widely available.”
TissuGlu is a surgical adhesive designed to hold tissues together and facilitate healing after surgeries which require “undermining” between tissue planes, such as abdominoplasty (tummy tuck).
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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.