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October 08, 2015 10:23 PM ET

Healthcare Equipment and Supplies

Company Overview of Cohera Medical, Inc.

Company Overview

Cohera Medical, Inc., doing business as Cohera Biomedical Adhesives, Inc., develops absorbable surgical adhesives and sealants for surgical procedures, applications, and specialties. It offers synthetic adhesives and sealants (to facilitate natural healing processes), and component adhesives (for hernia mesh fixations). The company also provides ordering services in Germany. It serves clinicians and surgeons. The company was founded in 2003 and is based in Pittsburgh, Pennsylvania.

209 Sandusky Street

Pittsburgh, PA 15212

United States

Founded in 2003





Key Executives for Cohera Medical, Inc.

Chief Executive Officer, President and Director
Co-Founder and Member of Clinical Advisory Board
Co-Founder and Member of Clinical Advisory Board
Chief Financial Officer and Vice President of Finance
Vice President of Clinical, Regulatory & Legal Affairs
Compensation as of Fiscal Year 2015.

Cohera Medical, Inc. Key Developments

Cohera Medical, Inc. Receives Expedited Access Pathway Designation from FDA for Sylys Surgical Sealant

Cohera Medical, Inc. announced that its Sylys Surgical Sealant has received Expedited Access Pathway designation and priority processing status from the U.S. Food and Drug Administration (FDA). Sylys is a resorbable synthetic sealant designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. Anastomotic leakage, which occurs in three to 23% of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered, and frequently results in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and death{Alberts, 2003 #1}. At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries. The Expedited Access Pathway is a finalized on April 13, 2015 program at the FDA designed to help patients gain more timely access to critical medical devices by expediting their development, assessment, and review. The worldwide market for Sylys Surgical Sealant is significant, with more than one million procedures per year representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys represents a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.

Cohera Medical, Inc. Receives U.S. Food and Drug Administration Approval of First Tissue Adhesive for Internal Use in the United States

Cohera Medical, Inc. announced that the U.S. Food and Drug Administration has approved its TissuGlu Surgical Adhesive. The approval allows the company to begin commercial distribution of TissuGlu in the United States. TissuGlu is the first tissue adhesive for internal use approved by the FDA in the United States. TissuGlu is approved to adhere tissue layers and close dead space in abdominoplasty procedures. In clinical trials, surgeons were able to eliminate the need for post-surgical drains by using TissuGlu, reducing the need for invasive treatments for their abdominoplasty patients, and improving the patient recovery process. The PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains. The primary clinical data supporting the FDA approval was from a 130 patient study where half of the participants received drains and the other half received TissuGlu and no drains. The study results showed that 73% of participants who received TissuGlu required no postoperative interventions to manage postoperative fluid. Study participants who received TissuGlu without drains were generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had drains. TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7% that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu, bringing great benefit to patients, surgeons, and caregivers. Commercial launch for TissuGlu in the U.S. is scheduled to begin in the upcoming months.

Cohera Medical, Inc. Enters Agreement with B. Braun Surgical, S.A. for Distribution of TissuGlu® Surgical Adhesive in Select European Countries

Cohera Medical, Inc. announced that it has entered into an exclusive sales and marketing distribution agreement with B. Braun for its TissuGlu® Surgical Adhesive in Germany, Spain and Portugal. The Agreement outlines a relationship between the two companies wherein B. Braun Surgical S.A. will exclusively market and sell TissuGlu in the territories of Germany, Spain and Portugal through its existing Closure Technologies commercial teams. TissuGlu has been CE approved and for sale in Germany through a Cohera direct sales force since 2012 and has been used in over 2,000 surgical procedures since that time. TissuGlu is indicated in Europe for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in large flap surgical procedures such as abdominoplasty. TissuGlu is designed to meet surgeons' need for a strong, biocompatible, and easytouse surgical adhesive. TissuGlu is targeted for use in large flap procedures in which drains are used to control fluid output and seroma formation. TissuGlu is currently being utilized in Europe to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. Over 2,000 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.

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