Tissue Glue Rather Than Drains (?!)

 

Cohera Medical Inc announced the treatment of the first patient in a study of its lead surgical adhesive product, TissuGlu®. Initiation of the study marks a major milestone in the company's progression of the lead product toward clinical practice.

The clinical investigation is a prospective, open-label, randomized study to investigate the safety of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty, or "tummy tuck," surgeries. The study will compare standard wound closure techniques to standard wound closure techniques plus the application of TissuGlu in 40 patients at three sites near Bonn, Frankfurt and Freiburg, Germany.

"We are delighted to have treated the first patient in the TissuGlu study," said Klaus Walgenbach, M.D., Ph.D., of the Universitatsklinikum Bonn and the principal investigator for the study. "We were very pleased with the procedure and look forward to enrolling more patients."

Currently, patients who undergo abdominoplasty 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 called seroma requires an additional procedure for removal. TissuGlu adheres the tissue flaps created during the procedure to reduce fluid accumulation, and, ultimately, the duration of use of the surgical drains. With the use of TissuGlu, patients may experience a significant reduction of fluid accumulation and a more comfortable recovery, which may lead to a quicker return to normal activity.

"Our transition into the clinical development phase brings us closer to helping plastic surgeons to address a critical unmet need and improve patient care," said Patrick Daly, president and chief executive officer of Cohera Medical. "Furthermore, the market opportunity for our company with TissuGlu is very significant, ranging between $500 million and $750 million from 2011 to 2015. If you add the additional applications such as facelift, breast reconstruction and body contouring that we will pursue with TissuGlu, the opportunity increases to between $700 million to more than $1 billion over the same five-year period."

Chad Coberly, J.D., vice president of clinical, regulatory and legal affairs of Cohera Medical, added: "Initiation of this study culminates significant preclinical work by our company and investigators and demonstrates the primary safety profile of this product. This study will enable us to move closer to CE Mark application in Europe and will provide important data in application for a larger U.S.-based trial in 2010."

Preclinical data published in the July 2008 issue of Plastic and Reconstructive Surgery show that TissuGlu prevented seroma formation in an animal abdominoplasty model. Summarized in a paper titled "Lysine-Derived Urethane Surgical Adhesive Prevents Seroma Formation in a Canine Abdominoplasty Model," (Plast. Reconstr. Surg. 2008; Vol. 122, Issue 1: 95-102) the results demonstrated that TissuGlu successfully prevented the formation of seroma in a novel large-animal model designed to evaluate seroma formation. While the control side in all seven animals used in the study demonstrated large, clinically significant seromas, the side treated with TissuGlu showed little or no evidence of fluid accumulation. In addition, histologic analysis of tissue samples from the animals showed no signs of inflammation or foreign body reaction associated with the adhesive.

"The progress with the development of TissuGlu represents a significant next step in the value creation for Cohera Medical's investors," said Doros Platika, M.D., the company's chairman. "Most importantly, it signifies a potential major advance for surgical patients that may help to decrease complications and improve clinical outcomes."

About Cohera Medical

Cohera Medical Inc. is a Pittsburgh-based company that is developing a revolutionary line of surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is an adhesive for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation, small bone fixation and other plastic surgery indications that will fill similar market needs in plastic, orthopedics and general surgery.

Certain statements made throughout this news 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.

Source: Cohera Medical Inc

Breast Reductions Reduce Pain...In 16 Year Olds

I'm almost 16 and I have a 36DD breast size.  Do I need to wait to have a breast reduction?

- Carla

No!  But there are caveats....

Breast reductions are fantastic operations.  Of all the surgeries and procedures that I routinely perform, breast reductions have the highest rate of satisfaction.  Not only are breasts reconstructed to be higher and cuter, but also the patient receives significant symptom relief.

Carla, what are your goals?  Are you interested in...?

• decreasing pain in your neck, upper back, and shoulders
• minimizing sweating and rashes in the folds beneath your breasts
• feeling more confident around your peers, especially in a bathing suit

If yes, then breast reductions are a great option--regardless of age.

The big issue with breast surgery at 16 years old, Carla, is that your breasts will continue to change.  (Of course, breasts are going to change from any age.  Ask any 45-year-old woman who has had kids!  She probably wished that her breasts had not changed!)  Nevertheless, 16-year-old women will probably experience more change than 25 year olds.

I have performed breast reductions on 16 year olds, and they have been thrilled.  But, in a few cases, the breasts continued to grow.  Then, I had to perform a second breast reduction on those patients (even though the patients and their mothers thought that the breasts had been fully developed before the first surgery).

Also, you must realize that your smaller breasts will have scars and that you will be having a major surgery.  I am not trying to dissuade you, but just want you to be fully informed.

Check out these before and after pics of a recent patient--in her early 20s--who underwent breast reductions.  She couldn't be happier:  less neck and back pain, less shoulder grooving and discomfort, less sweating and rashes, and more self-confidence.

 

Breast Reductions on Smokers: Proceed with Caution

Recently, I refused to perform breast reductions because the patient was a heavy smoker.  My concern was for her well-being.  Smoking is the single greatest contributor to complications after all types of plastic surgery.

However, one of my colleagues did reduce this patient's breasts, and the patient healed uneventfully.  She sent me the following note:

I have heard all of the issues related to smoking and breast reduction.  In fact, you told me personally you would not perform a reduction on me unless I stopped smoking.

I had a reduction in October.  I had cut down to two cigs a day, and I have had NO problems at all.

My question is...

• Do you think everyone is different in healing?
• Or did I just get lucky?

My plastic surgeon has 34 years of experience, and he didn't seem too worried that I smoked!