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.

Cohera Medical Receives IDE Approval to Begin Pivotal Clinical Trial for TissuGlu® Surgical Adhesive

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (“FDA”) to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive in the United States.

The study will investigate the effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries. 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 pleased to have FDA approval to begin this pivotal trial that validates the biocompatibility, pre-clinical testing profile and clinical trial design of TissuGlu,” said Chad Coberly, Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. “Initiation of this study is planned in the first quarter of 2012 and will be conducted at five clinical sites with 150 patients, and upon favorable conclusion will allow the company to complete a PMA application for TissuGlu with the FDA.”

“IDE approval of the TissuGlu study is a significant strategic milestone for Cohera and its investors,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “We are encouraged by the initial positive outcomes with TissuGlu in clinical studies and commercial use outside the U.S., and we look forward to working with the FDA to bring this breakthrough technology to clinicians and patients here in the United States.”

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 early 2012.

Arnie Whitman Named to ReGear Life Sciences Board of Advisors

 ReGear Life Sciences, Inc. today announced that Arnold Whitman has joined ReGear’s Board of Advisors.

“Arnie brings a breadth and depth of experience in the senior care market that will have a significant impact on our business,” remarked Jeff Swoveland, CEO of ReGear.  “Arnie’s insight and advice will be a potent accelerator in expanding the use of ReBoundTM portable therapeutic heat in nursing homes and other senior care organizations”

Arnold Whitman is the founder and Chairman of Formation Capital and Co-Chairman of Genesis HealthCare. Over the past 25 years, Mr. Whitman has been an industry leader and is closely involved in the National Investment Center for Seniors Housing and Care Industries where he is a board member and Chairman Emeritus.

“ReBound offers a competitive advantage to senior care organizations looking for improved outcomes and better reimbursement.  I have personally experienced the benefits ReBound delivers by using it to treat an Achilles injury that I have struggled with for quite some time and I am a firm believer that it will be a definite plus for the organizations that adopt it.”

 

Cohera Medical Raises Over $25 Million in Series C Round

Cohera Medical, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has secured over $25 million Series C financing through private investors.  A total of $16.5 million was raised through existing investors and over $9 million was raised through new investors, which significantly bolstered the round.

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.  TissuGlu is an internal surgical adhesive for large flap surgeries, such as abdominoplasty (tummy tuck), that helps reduce fluid accumulation and the need for postsurgical drains.

“In its first two months, TissuGlu has been used successfully in over 160 plastic surgery procedures in Germany by leading plastic and reconstructive surgeons,” said John C. Kern, Founder and General Partner of Kern Whelan Capital, LLC, and Manager of Kern Medical III “We believe that TissuGlu has the potential to fundamentally transform the patient recovery process worldwide, across many types of surgical procedures, while saving surgeons significant time and money through the reduction of post-surgical complications.”

“In just five years, we have taken TissuGlu from a benchtop experiment to a commercially viable product – a significant achievement for our company,” said Patrick Daly, President and CEO of Cohera Medical.  “We have reached several major milestones this year, and our ability to attract both new and existing investors is a reflection of their confidence that we can generate long-term and sustainable growth.”

Cohera Medical recently received CE Mark 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 early 2012.  Cohera Medical is also actively pursuing U.S. FDA approval.

Currently, most patients who undergo abdominoplasty procedures and other 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) often requires additional procedures for removal. TissuGlu adheres the tissue flap to the underlying tissue (which is created during the procedure) to reduce fluid that can accumulate in the space and ultimately reduce the time to drain removal. With the use of TissuGlu, patients may have drains removed faster, which may lead to a more comfortable recovery and a quicker return to normal activity.

According to the American Society of Plastic Surgeons, the global market for cosmetic surgery and treatments now exceeds $30 billion, with a sustainable compound annual growth rate in the range of 25%. In Europe, the market for cosmetic surgery is about $2.2 billion with a compound annual growth rate of 19% (Frost & Sullivan), and total sales of wound closure devices are expected to reach approximately $740 million in 2012 (Medtech Insight).

Sticky Situation: Cohera Medical Commercializes TissuGlu® Surgical Adhesive in Germany

Cohera Medical, a rapidly growing medical device company, announced today that it has begun selling its lead product, TissuGlu® Surgical Adhesive, to hospitals and surgeons in three pilot territories in Germany.  This regional launch will document and highlight the advantages of TissuGlu and will be used to drive a wider expansion throughout Germany and to additional European markets in early 2012.

In a limited pre-launch phase started in September 2011, a select group of leading plastic and reconstructive surgeons performed over 80 plastic surgery procedures with TissuGlu.

“I am very excited for the benefits that TissuGlu will bring not only to the patients in my practice, but to plastic and reconstructive surgeons worldwide performing large-flap plastic surgery procedures,” said Professor Axel-Mario Feller, an internationally renowned leader in reconstructive breast surgery based in Munich, Germany. “By reducing fluid accumulation and shortening time to drain removal, patient satisfaction and outcomes will be improved and costs of care will be reduced.”

During the pre-launch, the clinical experience from using TissuGlu was shared during the ÖGPÄRC/DGPRÄC/VDÄPC Congress in Innsbruck, Austria, an international meeting held in late-September, attended by over 800 plastic and reconstructive surgeons. Cohera Medical also sponsored a scientific symposium that generated significant visibility and interest in the product. The resulting discussion also highlighted the potential for TissuGlu to play an important role in surgeries beyond the aesthetic field.

“The reaction to TissuGlu among the top plastic surgeons in Germany has been great.  Initial uptake by many of the most respected plastic surgeons have exceeded our initial forecast during this portion of our launch,” said Patrick Daly, President and CEO of Cohera Medical. “Our focus continues to be on excellent patient outcomes and expanding the number of surgeons who utilize TissuGlu.  We look forward to continuing the rollout in additional European markets in 2012.”

Currently, most patients who undergo abdominoplasty and other 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) often requires additional procedures for removal. TissuGlu adheres the tissue flap to the underlying tissue (which is created during the procedure) to reduce fluid that can accumulate in the space and ultimately reduce the time to drain removal. With the use of TissuGlu, patients may have drains removed faster, which may lead to a more comfortable recovery and a quicker return to normal activity.

According to the American Society of Plastic Surgeons, the global market for cosmetic surgery and treatments now exceeds $30 billion, with a sustainable compound annual growth rate in the range of 25%. In Europe, the market for cosmetic surgery is about $2.2 billion with a compound annual growth rate of 19% (Frost & Sullivan), and total sales of wound closure devices are expected to reach approximately $740 million in 2012 (Medtech Insight).