Musculoskeletal News Roundup 30-Jun-11
BY LAUREN UZDIENSKI, JUNE 30, 2011
M&A
Stryker completed its tender offer for all outstanding shares of common stock of Orthovita, Inc. for $3.85 per share.
Funding
ConforMIS announced plans to raise $68.0 million in a series E-1 and E-2 convertible preferred stock offering. Funds will be used for working capital.
Tenex Health raised $5.0 million in a Series A financing led by VCI Partners. The company plans to use the proceeds for product manufacturing, development of a sales force and marketing initiatives. Tenex manufactures the TX1 Tissue Removal System, a portable, self-contained system utilized in the FAST (Focused Aspiration of Soft Tissue) procedure for removal of diseased tendon tissue and related musculoskeletal tissue with intended use in the elbow, knee, ankle, foot and shoulder.
Regulatory
Corin received 510(k) clearance for its highly cross-linked polyethylene liners and large diameter CoCr and BIOLOX Delta Ceramic heads for its Trinity acetabular system. The company says the larger bearing sizes in the Trinity system are compatible with Corin's MiniHip and MetaFix hip stems.
Stanmore Implants received 510(k) clearance for its Juvenile Tumour System ("JTS"), a non-invasive extendable distal femoral replacement, for use in pediatric orthopedic oncology surgery.
Product Introduction and Update
Aesculap Implant Systems launched the Hydrolift Vertebral Body Replacement (VBR) System. The device features "hydrostatic distraction and [a] unique endplate design" that allows tactile feedback during expansion. The Hydrolift VBR is indicated for use in the thoracolumbar spine, T1 to L5.
Bonovo Orthopedics is launching Bonovo Recon, a new division dedicated solely to hip and knee products. Operations will begin this year with a suite of hip and knee implants available to Chinese markets, including cemented and uncemented hip and knee implants currently undergoing clinical trials in China.
Cayenne Medical launched the CrossFix II Meniscal Repair System, its second-generation device for treatment of traumatic meniscal tears. Features of the new system include sharper, stiffer suture delivery needles, which enable a simpler technique for needle insertion into the joint space and the meniscus, and increased suture strength.
DFINE announced that the first patient has been successfully treated using the Spinal Tumor Ablation with Radiofrequency (STAR) System in a prospective clinical trial to evaluate the safety and efficacy of targeted radiofrequency spinal tumor ablation and cement augmentation in patients with metastatic spinal tumors.
Medtronic launched the the Kyphon Xpander II IBT System, which consists of the Kyphon Xpander II Inflatable Bone Tamp (IBT) and the Kyphon Inflation Syringe, for the treatment of VCFs. The company says the new balloon material in the Kyphon Xpander II IBT System "offers control during inflation and greater lifting force" than the prior generation of the device. As part of a physician preference testing program, the system has been used in more than 180 cases in the U.S. since November 2010.
Pioneer Surgical launched nanOss Bioactive Loaded. The mixing syringe is pre-filled with nanOss Bioactive, a resorbable, porous calcium phosphate bone void filler. The company says the system is designed to "enhance the delivery of bone grafts during minimally invasive procedures as well as enhance the sterile mixing of bone grafts during surgery."
Clinical
Mesoblast Limited received FDA clearance to begin a Phase 2 study of its proprietary adult Mesenchymal Precursor Cell (MPC) product for the treatment of degenerative disc disease. The study will enroll 100 patients in the U.S. and Australia. Patients will be randomized to receive either the MPC product combined with hyaluronic acid carrier or either hyaluronic acid or saline alone.
