Orthopedic News Roundup 7-Dec-06
BY LAUREN UZDIENSKI, DECEMBER 7, 2006
Earnings
Stryker announced this week that the Board of Directors has declared a year-end cash dividend of $0.22 per share, an increase of 100% over the $0.11 dividend declared in December 2005. The dividend is payable January 31, 2007 to shareholders of record at the close of business on December 29, 2006.
Regulatory
Interventional Spine (formerly Triage Medical) received CE Mark approval for the Percutaneous Dynamic Stabilization System (PDS) for early-stage treatment of spinal disorders. This approval will allow the Company to market the PDS System within the European Union and other countries that recognize the CE Mark. To the Company's knowledge, the PDS System is the only procedure available that can provide dynamic stabilization of the spine via a percutaneous access puncture. All other dynamic stabilization systems and procedures require a major or minimally invasive surgical incision.
Funding
BoneSupport AB, a Lund, Sweden-based maker of injectable ceramic bone substitutes, has raised around $19.79 million from HealthCap and NBGI Ventures. The Company develops synthetic, injectable ceramic bone substitute, and the new funds will mainly be used for the impending launch of BONESUPPORT's first product, Cerament™ Bone Void Filler, to expand patient studies of the main product Cerament™ Spine Support and to continue developing the company's R&D pipeline.
OrthoMimetics completed a Series A funding round totaling around $9.6 million, which will help the company advance its orthobiologic scaffold products to CE Mark approval, including ChondroMimetic and LigaMimetic for cartilage and ligament repair, respectively. Participants include Oxford Capital Partners, Schroders Investment Management, and Sloane Robinson Private Equity, as well as clients of Eden Financial, the placement agent. Joining the board will be Heidi Hsueh of Sloan Robinson and Dr. Martin Hall of Eden Financial.
Vertebral Technologies, Inc. intends to raise ~$3 million to help develop spinal restoration products. Launched earlier this year, Vertebral Technologies is working to develop biocompatible polymers for structural restoration of spinal discs, according to the filings. Proceeds from the round will go toward research and development. The Company already has raised about $1 million.
Private Placements
ReGen Biologics completed a $6.95 million private equity placement. The terms of the transaction include 30% warrant coverage with a 5-year term and an exercise price of $0.55 per share, as well as an option to each purchaser to purchase the number of common shares purchased at closing, exercisable for cash at $0.37 per share within 15 days of FDA clearance of the Company's collagen scaffold device.
M&A
Kyphon signed a definitive agreement to acquire St. Francis Medical Technologies in 1Q:07 for $525 million in cash, plus additional revenue-based contingent payments of up to $200 million in cash or cash and stock. St. Francis manufactures the X STOP® Interspinous Process Decompression System. Following the announcement, Kyphon's stock rose 30%.
Andover Medical signed a letter of intent to purchase 15% of 4B Med'Concept, a French durable medical equipment distribution supply company. Andover hopes that the purchase will allow the Company to explore prospective outlets for its products and services in the European market.
Clinical
Panelists in a Medicare Coverage Advisory Committee voiced concerns over study design for lumbar spinal fusion. In scored responses to questions, the majority of panelists expressed a lack of confidence in evidence, particularly as it relates to long-term safety and long-term clinical outcomes.
The University of Manchester reports that one of its researcher has developed a tissue engineering approach based on use of a patient's own stem cells to regenerate damaged intervertebral discs. In collaboration with Arthro Kinetics, pre-clinical trials are anticipated to begin in 2007. The University states that the trials are, "expected to rapidly yield a marketable product which will revolutionise treatment of long-term low back pain."
A new Danish report suggests that circumferential fusion may provide significantly better function and less pain than posterolateral fusion for patients with severe lumbar conditions. The University Hospital of Aarhus analyzed postoperative surveys of more than 100 patients who were randomized to receive either circumferential lumbar fusion or posterolateral lumbar fusion (PLF) between 1996 and 1999. The researchers found that the circumferentially fused group had significantly better results on the Dallas Pain Questionnaire compared to the PLF cohort at 5 to 9 years post-op.
Product Introduction and Update
Integra LifeSciences announced the first patient surgery as part of an FDA-approved Investigational Device Exemption in a clinical trial of DuraGen Plus® Adhesion Barrier Matrix for use in spinal surgery. The device is designed to provide a prophylactic treatment option for the prevention of adhesions and protect the nerve root from post-operative scar formation. The randomized, multi-center clinical trial will be conducted at 30 investigational sites and include 500 patients.
Service Agreements
AlloSource and Community Tissue Services formed the Joint Restoration Foundation (JRF), a non-profit organization focused on processing technologies and promoting the uses of joint restoration allograft tissue (e.g. fresh osteochondral allografts, tendons and meniscus). Among the details: the partners will fund, through JRF, R&D projects that enhance graft safety and provide for new tissue applications; consistent quality standards will be set and monitored by JRF; allografts will be provided under the single JRF brand name.
Clearant signed a multi-year distribution agreement with Tissue Banks International for the supply of Clearant Process® sports medicine implants, bringing Clearant into a $350 million per year market.
Orthofix signed a three-year agreement to provide bone growth stimulators for spinal fusion and nonunion bone fracture applications to UnitedHealth Group. The agreement covers UnitedHealthcare's commercial and government programs and is effective March 1, 2007.
Orthovita entered into a Royalty Sale Agreement with Angiotech Pharmaceuticals. Orthovita will pay $9 million to purchase the profit-sharing royalty rights for its VITAGEL™ Surgical Hemostat and CELLPAKER® Collection Device products under its License Agreement with Angiotech. The license agreement has been extended to July 2017, and the closing of the transaction is scheduled for Dec. 29.
Appointments
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced that Angela Byland has joined the firm as Director, Biologics Regulatory Affairs. Ms. Byland has specialized in managing regulatory affairs and quality systems for medical devices for more than 12 years, and she has supported regulatory activities for technologies including spinal system devices.
Miscellaneous
Dr. Andrew von Eschenbach's nomination for FDA chief is scheduled for a procedural vote in the Senate today. If von Eschenbach secures the support of 60 senators, the nomination will proceed to a full vote. A cancer surgeon, von Eschenbach has served as acting FDA commissioner since September 2005.
Langer announced Tuesday that Chief Financial Officer and Vice President Sara Cormack has resigned for personal reasons. The Deer Park, N.Y., medical products company said Cormack agreed to remain with the company through Jan. 5th. Langer hired Heidrick & Struggles to help find her replacement. Cormack joined the company in September.
