Cohera Medical Raises $17 Million Series D Round

coheraCohera Medical, an innovator and developer of absorbable surgical adhesives and sealants, announced today that it has secured $17 million towards Series D financing through private investors. The milestone comes from raising an additional $7.3 million in the Company’s latest offering, in addition to the $9.7 million raised in 2012.

The Company will use the funds to expand adoption in Germany and additional European markets for its TissuGlu® Surgical Adhesive, an internal surgical adhesive for large flap surgeries that eliminates or reduces fluid accumulation and the need for post surgical drains allowing for more natural healing and potentially faster recovery. Additionally, the funds raised will support the first No-Drain Clinical Study for TissuGlu in the United States, which was approved by the FDA late last year.

Cohera also plans to begin human clinical trials in Europe for its Sylys™ Surgical Sealant, designed to help surgeons performing colorectal procedures reduce anastomotic leakage. Such leakage is considered the most serious complication of bowel repair, causing one third of mortalities occurring after colorectal surgery.

Read the entire press release here. Listen to a TechVibe Radio interview with CEO Patrick Daly.

 

Cohera Medical Receives IDE Approval to Begin First No-Drain Clinical Study of TissuGlu

coheraCohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received approval from the United States Food and Drug Administration (“FDA”) to begin the first no-drain clinical trial for its TissuGlu® Surgical Adhesive product in the U.S. The randomized, controlled, prospective multicenter non-inferiority study will compare the standard wound closure technique with drains (control) to the standard wound closure technique including TissuGlu and no drains (test) during abdominoplasty procedures.

The study will begin in early 2013 and take place at five prominent surgery centers in the following regions: Washington, DC; Baltimore, MD; Charlotte, NC; Los Angeles, CA; and Dallas, TX. A total of 130 patients undergoing abdominoplasty procedures will be randomized and divided into either a treatment group with the application of TissuGlu or a control group without the use of TissuGlu.

“Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications,” said Joseph P. Hunstad MD, FACS, of the The Hunstad-Kortesis Center, Charlotte, N.C. “We are excited to begin enrolling patients and we believe that completely eliminating the use of drains would significantly improve patient care and satisfaction.”

“IDE approval to begin the first ‘no drain’ trial in the U.S. represents a significant step for the Company,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “We believe that the elimination of post-surgical drains has the potential to positively impact surgeries and the recovery of millions of patients worldwide.”

Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. The drains are often painful for the patient and can lead to infection and impact the recovery process.

TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space during healing and ultimately reducing the need for postoperative drains to remove the fluid. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients. Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011.

An earlier no-drain study of 30 patients was successfully completed in Germany in July 2012. In the U.S., Cohera recently completed enrollment of a clinical trial for TissuGlu. TissuGlu has been used successfully in over 600 various surgical procedures by leading surgeons.

Cohera Medical Completes Enrollment of U.S. Clinical Trial of TissuGlu® Surgical Adhesive

 

Cohera Medical

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive in the United States.

The study is evaluating the effectiveness of TissuGlu on the reduction of wound drainage and post-surgical complications in abdominoplasty surgeries.  The study included 150 patients enrolled at five sites throughout the U.S., including Atlanta, Baltimore, Charlotte, St. Louis, and Washington DC.

“We are delighted to complete enrollment in this critical trial for TissuGlu, which has the potential to eliminate wound drainage issues from large flap procedures,” said Dr. Joseph Hunstad of the Hunstad-Kortesis Center for Plastic Surgery, Charlotte, NC. “The trial results so far are very promising for both the surgeons and the patients.”

Completion of enrollment of the study marks a significant milestone in Cohera Medical’s progression of its lead product toward commercialization in the United States. The Company will use the results from the study to submit a PMA application for TissuGlu with the FDA. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.

“We are extremely pleased to have reached this very significant milestone in our clinical study,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical.  “It is a testament to the surgeons and the Cohera team to enroll 150 patients in 90 days.  We are encouraged by the positive feedback from the TissuGlu investigators and look forward to our work with the FDA to make TissuGlu available to surgeons and patients throughout the U.S.”

Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. To date, TissuGlu has been used successfully in over 500 surgical procedures in Germany by leading plastic and reconstructive surgeons.

Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space and ultimately reducing the time to drain removal. The use of TissuGlu may shorten the length of time that drains need to be in place, leading to a more comfortable recovery and a quicker return to normal activity for patients.

First Patients Treated in No-Drain Clinical Study of Cohera Medical’s TissuGlu

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the start of a no-drain clinical trial in 30 patients at two prominent surgery centers in Germany. The study will investigate the safety and effectiveness of TissuGlu® Surgical Adhesive in the reduction of wound drainage, post operative seroma and related complications in abdominoplasty patients without the use of drains.

Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. The drains are often painful for the patient, can lead to infection and can impact the recovery process. TissuGlu adheres the tissue flap created during the surgical procedure to the underlying tissue, helping to reduce the space where fluids can accumulate thereby eliminating the need to use surgical drains. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients.

“We are excited to be part of this study utilizing TissuGlu to eliminate postoperative drains,” said Dirk Richter, MD, of Wesseling, Germany. “We look forward to enrolling more patients and believe that conducting abdominoplasty procedures without the need for drains would represent a significant improvement in patient care and comfort in these procedures. The initial patients enrolled appear to be doing very well, with no seromas or complications reported in the first 48 hours after surgery.”

“Initiation of this ‘no drain’ trial represents a major goal for TissuGlu,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “We continue to make positive patient outcomes a priority and believe the elimination of post-surgical drains is an important milestone.” Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications. In addition, complication rates from seroma formation range from 15% to 52% following abdominoplasty procedures. PR Newswire (http://s.tt/1hEXz)

Cohera Medical Raises Over $8 Million in Series D Round

Cohera Medical, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has secured over $8.4 million towards the Series D financing through private investors.

The Company will use the funds to expand adoption in Germany and additional European markets for its lead product, TissuGlu® Surgical Adhesive. The funds will also be used to support the clinical trials for TissuGlu in the United States, as well as the development and advancement of pipeline products, including FlexSil™ Surgical Sealant, an innovative surgical sealant for bowel repair with a billion dollar market potential.

“Cohera Medical has done a remarkable job of attracting world-class plastic and reconstructive surgeons in Germany who are successfully using TissuGlu,” said John C. Kern, Founder and General Partner of Kern Whelan Capital, LLC, and Manager of Kern Medical III.  We are excited that Cohera is also pursuing the development of FlexSil, a unique and proprietary bowel sealant with over a billion dollar market potential.  Both first-of-its-kind technologies represent very attractive investment opportunities.”

“The convertible note portion of the Series D round is a reflection of our investor’s confidence that we continue to meet our key milestones, including the start of our clinical trial for TissuGlu in the U.S.,” said Patrick Daly, President and CEO of Cohera Medical.  “I believe that Cohera Medical is at the forefront of bringing some of the most exciting surgical products to market that have the potential to change the way patients recover from so many types of large flap procedures — from abdominoplasties and mastectomies to lymph node dissection in cancer patients, bowel procedures and reconstruction of sternal defect in open-heart surgery.”

Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011.  The Company plans to expand the commercial availability of TissuGlu to additional European markets in 2012.  TissuGlu has been used successfully in over 450 surgical procedures in Germany by leading plastic and reconstructive surgeons. The product is currently undergoing clinical trials in the U.S. and is covered by 61 issued and pending patents worldwide.