Musculoskeletal News Roundup 11-Jun-09
BY LAUREN UZDIENSKI, JUNE 11, 2009
Funding
Alphatec Spine, Inc. has successfully completed a private placement of $10.0 million of shares of its common stock to one of its existing shareholders, HealthpointCapital Partners II, L.P. Alphatec plans to use the net proceeds of the private placement for general working capital purposes. The net proceeds to the Company pursuant to the offering are expected to be approximately $9.9 million. Thomas Weisel Partners acted as sole placement agent in connection with this transaction.
Scient'x Groupe, S.A.has closed a combined growth credit facility with Oxford Credit Corporation and an incremental equity investment by the Company's principal shareholder, HealthpointCapital, LLC. The total credit and equity package amounts to $12.5 million. Terms were not disclosed.
ThermoGenesis Corp. received a two-year, $0.5 million NIH grant to study applications for placental stem cells in bone repair and regenerative medicine. The study will be conducted at the company's stem cell research laboratory and in collaboration with the University of California, Davis.
Regulatory
Bone Solutions Inc. received 510(k) clearance for OsteoCrete, a magnesium-based bone void filler indicated for use in the long bones and pelvis.
Orthovita has received 510(k) clearance to market Cortoss Bone Augmentation Material for the treatment of vertebral compression fracture. Among the results from its pivotal study, which compared Cortoss to PMMA, Orthovita achieved non-inferiority at 24 months, with a composite success rate of 77% for patients treated with Cortoss and 73% for PMMA patients. Additionally, ODI scores at 24 months improved by 97% for Cortoss patients and 88% for PMMA, which represented a statistically significant benefit. Earlier results showed a statistically significant benefit for pain relief, with VAS scores at three months improved by 87% for Cortoss and 75% for PMMA. Finally, Cortoss was correlated with a 43% reduction in adjacent-level vertebral fractures, though this finding was not statistically significant. Cortoss is the first cement other than PMMA to be cleared for use in the treatment of VCF fractures.
Spinal Restoration submitted six-month primary endpoint data from its Biostat System pilot study to the FDA. The system treats chronic low back pain attributable to internal disc disruptions by sealing them with BIOSTAT BIOLOGX Fibrin Sealant. The company currently has 15 patients enrolled at three sites and awaits FDA approval to expand the study.
Xylos received 510(k) clearance for its Xylos Porous Surgical Mesh, which is intended for soft tissue reinforcement across a number of indications, including muscle flap reinforcement, suture-line reinforcement and reconstructive procedures.
Product Introduction and Update
SpineMatrix Inc. introduced the Lumbar Matrix Scan to help physicians locate the source of low back pain. The company says the imaging system tracks bioelectric signals from the paraspinal neuromuscular system using 63 sensors placed on the back.
Intellectual Property
Impliant received two new U.S. patents. One pertains to the company's TOPS system for dynamic stabilization, and the other covers a translateral spinal disc replacement. Additionally, the company also defended one of its patents in Germany following an opposition by Archus Orthopedics.
NuOrtho Surgical received a U.S. patent protecting an electrosurgical device the company is developing for arthroscopic procedures, which the company says will focus on "agent delivery" and "bone fusion."
Operations
An Indiana newspaper is reporting that Zimmer laid off about 100 Warsaw-based employees this week. According to a statement obtained by the South Bend Tribune, Zimmer has "initiated modest changes in our work force, which include the elimination of positions in some areas and increases in others to balance requirements necessary to support strategic priorities."
Appointments
Life Spine appointed Todd P. Fanning Vice President of Sales. Previously, Mr. Fanning held roles at Spinal Concepts, Fziomed, Sulzer Orthopedics and Baxter Healthcare Corporation.
