RALEIGH, NC, August 15, 2017 – Six postmarket clinical series studying outcomes associated with the use of TissuGlu Surgical Adhesive in a variety of surgical procedures are nearing completion in Europe. The studies, involving over 200 patients in four European countries, all evaluate TissuGlu in surgical procedures adhering a skin flap to the underlying tissue to minimize dead space and facilitate the healing process. In some procedures, the use of postsurgical drains to manage fluid during recovery were eliminated. These studies will expand the growing body of evidence of positive TissuGlu outcomes and will support future indication expansions into the US market. TissuGlu Surgical Adhesive is approved in the EU for the approximation of tissue layers where subcutaneous deadspace exists between the tissue planes in large flap surgical procedures such as abdominoplasty.
Mastectomy: Two prospective, randomized Level I studies evaluated TissuGlu in mastectomy procedures with positive preliminary outcomes. Both compared overall invasiveness of standard mastectomies with subcutaneous drains, which generally stay in place from 4-9 days, vs. drain-free mastectomies in which TissuGlu was used to adhere the tissue flap. The first is a single center randomized trial with 61 patients at a German university hospital. Enrollment was completed in May and the study is nearing the end of the patient follow-up period. The second mastectomy trial involved 84 patients from 11 investigator sites in Germany and the UK.
DIEP: Breast reconstruction using an abdominal tissue flap, in a procedure similar to a “tummy tuck”, is considered the gold standard for breast cancer patients in Europe. Prof. Chris Andree of the SANA Clinic in Gerresheim, Germany, an international thought leader in this procedure, has been documenting outcomes using TissuGlu to eliminate drain use in the abdominal donor site. He and his team are nearing completion of a series of 50 patients using this drain-free technique and expect to present their promising outcomes in a publication this fall.
Decubitus: Grade IV decubitus (pressure sores) often require flap surgery for repair, leading to long recoveries. Dr. Reto Wettstein of the Swiss Paraplegic Center in Nottwil, Switzerland is nearing completion of a 15 patient pilot series evaluating TissuGlu for its potential to improve postoperative recovery in decubitus patients. The Center is internationally recognized for their specialization in the management of wheelchair-bound patients.
Ventral Hernia: A pilot series of 10 high BMI patients undergoing open ventral hernia repair (OVHR) is near completion in Germany. The patients are being followed after use of TissuGlu to eliminate postsurgical drain placement. This patient group is at particularly high risk of postoperative wound healing complications, and use of the adhesive without drains may be able to improve outcomes. Similarly, in the Netherlands another pilot series of 15 OVHR patients have undergone procedures using TissuGlu without drain placement. Data from this series is favorable and is expected to be submitted for publication soon.
Mart Pearson, VP Europe for Cohera Medical, Inc. said, “We are very fortunate to be able to work with such an impressive group of clinicians and researchers. This broad range of studies is indicative of the need to improve the wound healing process after flap surgeries and the postoperative recovery for patients. Generating this clinical data will help surgeons everywhere better understand how TissuGlu can help improve their patients’ recovery.”
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.