Musculoskeletal News Roundup 30-Sept-10
BY LAUREN UZDIENSKI, SEPTEMBER 29, 2010
Funding
InVivo Therapeutics announced plans to go public via a reverse merger, which they're expecting to raise $5.0 million. The company is developing a polymer scaffold for the treatment of spinal cord injuries.
MiMedx Group announced plans to raise $5.0 million through a PIPE. Proceeds will be used to fund sales and marketing for the company's HydroFix Vaso Shield and HydroFix Spine Shield products as well as further development of the company's other HydroFix and CollaFix platform products.
The Shiley Center for Orthopaedic Research and Education, a division of the Scripps Clinic, received an NIH grant of $0.7 million for research relating to an electronic knee. The press release describes the device as containing a computer chip that measures forces inside the knee, and the new grant will enable the researchers to create computer-generated models depicting this activity. The center hopes to use the data to better understand how force affects the knee, develop better knee implants and improve rehab protocols following surgery.
Regulatory
ArthroCare received FDA clearance to market the Parallax Contour Vertebral Augmentation Device for the treatment of VCFs. The system is used to create a void in a vertebral body, which is then filled with bone cement. The Contour was previously cleared as an osteotome.
Wenzel Spine received 510(k) clearance to market the VariLift Expandable Interbody Fusion System as a stand-alone interbody fusion device for use in L2 to S1. The device is intended for use at one to two contiguous levels with up to grade I spondylolisthesis. The device can be implanted with a TLIF, PLIF or ALIF approach.
Product Introduction and Update
ArthroCare's sports medicine division launched the Ambient ArthroWand collection, a line of radiofrequency devices that the company says provide "accurate, real-time temperature monitoring of the circulating fluid within the arthroscopic operative environment."
Artimplant announced results from two in vitro and animal studies evaluating the use of their Artelon scaffold in cartilage repair. The company reports that "newly-formed tissue is improved with the use of the product," a synthetic biomaterial. The results were presented this week at the World Congress of the International Cartilage Repair Society in Barcelona.
Ascension Orthopedic announced the first implantations of the TITAN Modular Total Shoulder at the University of Mississippi Medical Center in Jackson, Mississippi. The company says the TITAN system is fully interchangeable, allowing surgeons to select from a range of distal stems and proximal bodies, and can be used as a bone-preserving option for patients needing total or hemi shoulder arthroplasty.
Osseon Therapeutics announced that 1,000 patients have been treated with the Osseoplasty System since the product's FDA clearance in January 2009 and CE mark clearance in February 2010. The system is indicated for the treatment of vertebral compression fractures, and the company notes that the device enables a physician to "access the entire vertebral body with a unipedicular approach."
Clinical
AAOS released clinical practice guidelines for vertebral compression fractures. Based on the NEJM studies and three level II studies, the group made a recommendation against the use of vertebroplasty. Kyphoplasty earned a "weak recommendation" based on two level II studies comparing kyphoplasty to conservative treatment and three "inconsistent" studies comparing kyphoplasty to vertebroplasty.
ProChon Biotech announced results from a retrospective follow-up analysis of 31 commercial patients who were treated with the BioCart Autologous Cartilage System. At four years, these patients demonstrated improvements measured by the International Knee Documentation Committee knee evaluation form and MRI mapping.
RepRegen announced three and six-month results from an in vivo study of StronBone, a bioactive glass. Compared to TCP, StronBone was associated with stiffer and denser bone at three and six months. Additionally, there was significantly less soft tissue in the defect at three and six months compared to the control.
Appointments
InVivo Therapeutics appointed Sean Moran to the role of Chief Financial Officer. According to the press release, Mr. Moran has 26 years of experience in financial management and 16 years of experience as a CFO, a post he has held at Celsion Corporation, Sontra Medical, SatCon Technology Corporation and Anika Therapeutics.
