Musculoskeletal News Roundup 19-Mar-09
BY LAUREN UZDIENSKI, MARCH 19, 2009
Earnings
TiGenix announced 2008 financial results this week, reporting a widening net loss as the company prepares to launch ChondroCelect in Europe. The company's net loss was EUR 15.2 million ($21.4 million), an increase of 27% over 2007. As the company has no products on the market, revenue was limited to EUR 0.32 million ($0.45 million) in grants.
Funding
DGIMED Ortho, Inc. closed a $3.4 million Series A round, which the company plans to use to support the development of a drill and intramedullary nail system. The company acquired the technology rights from the Midwest Orthopedic Research Foundation, Devicix LLC and Ramon B. Gustilo, M.D. last year. Cedar Point Capital, LLC was the company's sales agent for the funding.
Regulatory
Xylos Corporation received expanded 510(k) clearance for its Securian Tissue Reinforcement Matrix. Indications for use include reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery.
Product Introduction and Update
German-based Ziehm Imaging launched the Solo C-arm, which the company says is designed to fit in small spaces and targeted especially at orthopedic, trauma and spine surgeons. According to the company, the CCD Camera can produce more than 4,000 gray scales and features a metal correction program that limits overexposure caused by metal implants.
Clinical
BioSyntech announced plans to analyze interim data from 40 patients in its 80-patient, randomized clinical trial for BST-CarGel. The study compares the application of BST-CarGel after microfracture to microfracture alone for the treatment of cartilage lesions. The primary endpoint is cartilage repair at 12 months, as measured by the quality and quantity of repaired tissue based on MRI scans. The ongoing trial, whose results are expected to be finalized in 2010, is intended to support marketing applications in Canada and Europe.
Cayenne Medical announced that a study conducted at Harvard University found that the company's AperFix System and double-bundle ACL reconstruction technique offered "significantly superior kinematic results" when compared to a single-bundle technique.
