RALEIGH, N.C., April 26, 2017 — Cohera Medical, Inc. announced enrollment completion in a clinical series comparing two drain-free abdominoplasty techniques: TissuGlu Surgical Adhesive and Progressive Tension Suturing (PTS). Cohera, a leading innovator and developer of absorbable surgical adhesives and sealants, partnered with Dr. Michelle Spring of Glacier View Plastic Surgery in Kalispell, MT to investigate the impact of TissuGlu on operative time.
TissuGlu is the first and only FDA-approved synthetic surgical adhesive for internal approximation of tissue layers in abdominoplasty. TissuGlu is applied in a precise grid pattern, creating many points of mechanical fixation that minimize dead space created between tissue planes during surgery. This clinically proven technology eliminates the need for fluid management with postsurgical drains in most cases, allowing a less invasive recovery for patients.
PTS is an abdominoplasty technique utilizing sutures applied by hand to anchor the abdominal flap during advancement and closure. These sutures create points of secure fixation to help relieve tension from the incision and reduce dead space, therefore reducing the potential for fluid accumulation.
While both techniques allow the advantages of abdominoplasty without postsurgical drains in recovery, it is important to further understanding the differences in these techniques in terms of patient outcomes and OR efficiency.
“For my patients, the ability to have an abdominoplasty without the anxiety and burden of recovery with drains is a big deal, and I wanted to further explore the difference between offering TissuGlu versus the Progressive Tension Suture Technique without drains,” said Dr. Michelle Spring. “Although it is still early, I do see that I can apply more points of contact in a shorter amount of time, which is better for the patient and more time efficient in the OR.”
“Cohera Medical is actively working to broaden the understanding of TissuGlu in real-world practice,” said Patrick Daly, Cohera Medical CEO. “To our customers and patients, demonstrated economic value is important, just as are the clinical benefits. When follow-up of this study is complete, there are plans for publication and presentation of this research work to the plastic surgery medical community.”
TissuGlu® Surgical Adhesive is has been approved for sale in the United States since 2015 for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty. The opportunity for TissuGlu is significant, as there are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 percent. TissuGlu® Surgical Adhesive received European CE Mark in 2011, where it is approved for large flap surgical procedures, and has shown great benefit to patients, surgeons, and caregivers.
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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.