Orthopedic News Roundup 12-Apr-07
BY LAUREN UZDIENSKI, APRIL 12, 2007
Earnings
Vertebron announced in a press release that 1Q:07 was its most profitable quarter ever. The Company attributes the growth to a significant sales increase over the comparable quarter last year as well as a company-wide restructuring in 3Q:06. Vertebron did not disclose financial data.
M&A
Wright Medical Group, Inc. completed its acquisition of assets from Darco International, Inc.'s reconstructive foot surgery line for approximately $17 million in cash. Assets include several plating systems, among them the MRS (Modular Rearfoot), MFS (Modular Forefoot) and FRS (Forefoot Reconstructive) Systems.
Teleflex, Inc. acquired the assets of HDJ Company, Inc. and its wholly owned subsidiary, Specialized Medical Devices, Inc. HDJ provides engineering and manufacturing services to makers of orthopedic components, devices, implants and instruments. In 2006, HDJ's annual revenues for these product lines were approximately $14 million. The terms of the agreement were not disclosed.
INBONE Technologies completed its merger with Reiley Orthopedic, the maker of an intra-medullary fusion system. Formerly Topez Orthopedics, INBONE manufactures a Total Ankle system. The merged company will be based in Berkeley, CA, with engineering and manufacturing operations located in Boulder, Colorado.
Regulatory
Tepha, Inc., a privately-held medical device company, received FDA clearance for its TephaFLEX® Absorbable Suture product. According to the press release, the TephaFLEX Absorbable Suture is the first medical device derived from a new class of biopolymers. The biopolymers are the product of patented recombinant DNA technology developed by Tepha and licensed from the Massachusetts Institute of Technology (MIT). The Company is pursuing further medical device applications for the TephaFLEX technology.
The FDA announced this week the launch of a new website that will provide the public with information about post-marketing clinical studies. The website names the manufacturer, device, study description and study status and demonstrates the FDA's increased attention to device safety and performance post-approval. Companies with studies currently monitored by the FDA include Biomet, Depuy, Zimmer, Kyphon and Smith & Nephew.
Funding
Tutogen Medical Inc. is planning a private offering to sell about 1.6 million common shares for $7.38 per share. The Company expects net proceeds from the sale to total about $11.5 million, and proceeds will be used for working capital and general corporate purposes. The offering is is expected to close on or before April 30, and institutional investors participating in the sale include HealthCor Management LP acting on behalf of funds managed by HealthCor, Visium Asset Management LLC and Deerfield Capital Management LP.
ReGen Biologics, Inc. completed an additional $2.7 million private equity placement. Combined with equity placements in December 2006 and March 2007, the Company will receive a total of approximately $12.7 million in equity financing and up to a total of approximately $12.7 million more upon exercise of options. The options become exercisable upon FDA clearance of the Company's collagen scaffold 510(k). The recent placement was led by Ivy Capital Partners, LLC.
Spine Wave completed a new $45 million round of equity financing. The Series D round was led by the Compass Global Fund, LTD, an investment fund of the Cotrel family, along with a syndicate of individuals led by and including Ron Pickard.
Applied Spine Technologies, Inc. closed on a $28.0 million Series C round of financing led by Investor Growth Capital. MB Venture Partners also participated in the round. A portion of the proceeds will be used to finance a U.S. IDE clinical trial. This pivotal study is now under way comparing posterior dynamic stabilization using AST's Stabilimax NZ™ Dynamic Spine Stabilization System to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis.
Service Agreements
Alphatec Holdings, Inc. announced that it has entered into a license agreement with Roger P. Jackson, M.D. for the global rights to use certain polyaxial screw, helical flange and instrumentation technology designed by Dr. Jackson. The technology license enables Alphatec to rapidly develop a second-generation polyaxial pedicle screw system that will be manufactured via a proprietary bottom-loaded process. Terms of the agreement, which were not disclosed, include royalties on net sales of products incorporating the licensed technology.
Product Introduction and Update
Wright Medical Group Inc. launched the Charlotte 7mm multi-use compression screw system for foot and ankle surgery. According to the Company, the new screw features a headless design that resides completely within the bone and is capable of producing increased compression values when compared to traditional, headed screw designs.
DePuy launched the VERSALOK next-generation rotator cuff anchor. The Company said that VERSALOK was developed to provide greater versatility in rotator cuff repair. The device is designed to allow surgeons to address various tear pathologies with one implant and a variety of suture passing configurations including single row, dual row and suture spanning.
Miscellaneous
Globus Medical, Inc. announced what it believes to be the first implantation ever of a total disc replacement device utilizing a posterior approach. The surgery was performed by Drs. Luiz Pimenta and Paul McAfee in Sao Paulo, Brazil. Dr. McAfee said that the benefits of a posterior approach include: "It does not require an access surgeon; it is a much safer procedure in that the iliac veins and inferior vena cava are protected; bail-out and revision procedures are much easier; and the ability to decompress the nerve roots" makes the procedure appropriate for a larger number of patients.
