Musculoskeletal News Roundup 29-May-08
BY ARMELLE WIART, MAY 29, 2008
M&A
Kinetic Concepts, Inc. announced that it completed its acquisition of LifeCell Corporation. At the time of the expiration of the tender offer, 31.1 million shares of LifeCell common stock had been tendered representing approximately 90.75% of the outstanding shares of LifeCell common stock. As a result of the merger, LifeCell common stock will cease to be traded on the NASDAQ Global Select Market.
Royal DSM N.V., a global Life Sciences and Materials Sciences company headquartered in the Netherlands, announced that it has closed the acquisition of The Polymer Technology Group, Inc. (PTG), headquartered in Berkeley, CA. The acquisition follows DSM's launch of a research and development program specifically aimed at extending their orthopedic product offering which already includes Dyneema Purity, a high performance polyethylene fiber technology used in orthopedic implants. PTG will now be known as DSM PTG and Bob Ward, founding member and CEO of PTG has agreed to stay on as President of DSM PTG in order to secure a smooth integration. No financial terms were disclosed.
Regulatory
Integra LifeSciences received a Nasdaq notice of non-compliance for failing to timely file its 10-Q Form for the quarter ending March 31, 2008, with the SEC. Integra plans to make a written submission to NASDAQ to request continued listing pending the filing of the 10-Q Form. Integra had already received a notice of non-compliance from NASDAQ in March of 2008 when it failed to file its 10-K report on time.
Collagen Matrix, Inc. announced that it has received 510(k) clearance of its TenoMend Collagen Tendon Wrap. The device is a conformable, nonfriable, self-curling collagen sheet designed for easy placement under, around or over the injured tendon. TenoMend provides a protected environment and gliding surface of the sheath for tendon healing.
Impliant, Inc., announced that it has received FDA approval to restart patient enrollment in a pivotal IDE trial of its TOPS System, a Total Posterior Arthroplasty device. Impliant voluntarily suspended enrollment in the study in September 2007 following one device-related failure. As a result of an investigation conducted to understand the failure, Implant has made design and manufacturing changes to the TOPS device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion. To date, 74 patients have been enrolled into the study which aims to compare the TOPS System to a traditional posterior fusion.
Product Introduction & Update
Interventional Spine Inc. announced that medical devices using its proprietary compression technology have now been implanted in over 6,000 patients. Interventional Spine has two products, the PercuDyn and PERPOS PLS systems, of which only the latter is currently available in the US.
Atlas Spine, Inc., announced today the U.S. launch of the STATURE Vertebral Body Replacement System, a radiolucent spacer system manufactured from PEEK Optima and whose geometry and self-distracting capabilities are compatible with minimally invasive surgery treatment of thoracic and lumbar spine disorders.
LDR announced today that it has begun the U.S. launch of its ROI-T partial vertebral body replacement device following recent 510(k) clearance from the FDA. The ROI-T is made of PEEK-Optima and uses a transforaminal and minimally invasive approach for insertion.
A study conducted by the University of Alabama in Birmingham on 19 patients undergoing total knee replacement shows that OtisKnee Custom Fit Knee Replacement system may have a positive impact on length of hospital stay, range of motion, pain level and patient satisfaction over a period of six weeks following surgery.
Legal
Zimmer, Inc. revealed in its 10-Q form for the quarter ending March 31, 2008, that it and two of its subsidiaries were named as defendants in a complaint filed on April 24, 2008, in a U.S. District Court of New York. Thorpe v. Zimmer, Inc. et al relates to a class action on behalf of residents of New York who had hip or knee implant surgery involving Zimmer products over an unspecified period of time. The complaint alleges that the company's relationships with orthopaedic surgeons and others violated the New York deceptive practices statute and unjustly enriched Zimmer. Named plaintiff Lola B. Thorpe is asking the court for class certification, an award of actual damages or $50.00, whichever is greater, on behalf of each member of the proposed class and a permanent injunction barring the defendants from continuing or renewing the alleged conspiracy. Zimmer has not yet been served with process or filed any response.
Distribution
Acrobot Company Limited has signed an exclusive distribution agreement with Corin Group PLC to distribute the Acrobot Navigation System for hip resurfacing procedures in several countries including the UK, Germany and Australia. Under the terms of the agreement, Corin will purchase systems from Acrobot and market them through its own in-country sales infrastructure. According to Acrobot, the Navigation System tracks conventional surgical instruments relative to the patient to achieve high surgical accuracy.
