AMMD Inks Research Contract

Leading pelvic-health devices provider American Medical Systems (AMMD) recently signed a research grant contract for six sites to analyze safety, anatomical and functional results of two alternative treatments for vaginal prolapse. The Anterior Colporrhaphy is a technique that utilizes traditional suture placation compared with the Elevate Anterior and Apical Prolapse Repair System.   

The Elevate system is an element of American Medical’s composite portfolio of products intended to treat women’s pelvic floor collapse and incontinence. Elevate is a less invasive and thorough solution for treatment of apical and anterior problems. The complete trans-vaginal methodology is intended to reduce trauma to tissue by providing precise, uncomplicated and safe apical mesh positioning in the sacrospinous ligament and obturator internus muscle through one vaginal incision. Elevate is the most popular vaginal mesh kit with over 35,000 patients treated since its launch in 2008.   

Past studies of mesh reinforcement for repairs have mainly concentrated on vaginal anatomy. The purpose of the current study is to address lower urinary tract and vaginal functions in addition to efficacy and safety. The objective, after 12 months to 24 months of follow up, is to gather evidence for the selection of the best surgical procedure for patients facing transvaginal prolapse repair. 

This study, involving a total of 214 patients, will be randomized, single blinded, and prospective, and will be conducted at half a dozen participating centers. The managing site will be the Mayo Clinic and it has selected six independent implanting sites, five of which are located in the U.S. and one in Germany.   

American Medical is slated to be acquired by specialty healthcare solutions company Endo Pharmaceuticals (ENDP - Analyst Report), in the third quarter of 2011. Under the deal, announced in April 2011, Endo Pharmaceuticals will buy American Medical for $2.9 billion (or $30.00 per share in cash).

The consideration includes the assumption of $312 million of debt. The deal has been approved by the boards of both companies and is subject to the approval of American Medical’s shareholders, antitrust clearance and attainment of other closing conditions. The company will announce a special shareholder meeting, in due course, to secure stockholder clearance of the proposed deal. Currently, we have a Neutral rating on American Medical.

Read the full analyst report on ENDP

Read the full analyst report on AMMD