Orthopedics News Roundup 24-May-07
BY LAUREN UZDIENSKI, MAY 24, 2007
Earnings
Medtronic reported FY2007 earnings of $12.3 billion, an increase of 9% over FY2006. Adjusted income was up 10% to $2.8 billion, or $2.41 per share, an increase of 15% over the previous year. For the fourth quarter, revenue was $3.28 billion and adjusted earnings were $767.0 million, or $0.66 per share, beating analysts' estimates on both revenue and income. The company reported annual revenue of $2.42 billion in their Spinal division, an increase of 13% for the year and 10% for the fourth quarter. Growth in Spinal revenue was attributed to sales of the InFuse product line, CD HORIZON LEGACY Peek Rod System and Verte-Stack Crescent Vertebral Body Spacer.
Initial Public Offering
Amedica has filed a registration statement with the SEC for an initial public offering of its common stock. The proposed maximum aggregate offering price is $74.75 million. The Company intends to apply to list its common units on the NASDAQ Global Market under the symbol "AMCA." The offering is being made through Morgan Stanley, Jefferies & Co and CIBC World Markets.
Funding
On May 15th, Amedica announced the completion of a private placement of its Series D Convertible Preferred Stock, raising $13.2 million in gross proceeds. Including this financing round, Amedica has raised over $44 million since November 2003. Creation Capital LLC served as the placement agent for the financing, which Amedica plans to use to expand its manufacturing facilities for medical ceramics, continue product development, hire additional personnel, pursue patent protection for its technologies and products and for working capital purposes.
Regulatory
Medtronic's Bryan® Cervical Disc System will be reviewed by FDA's Orthopedic and Rehabilitation Devices advisory panel on July 17, 2007. The FDA will consider the panel's recommendation when deciding on approval for the device. The Bryan Cervical Disc System is the second disc arthroplasty system for the cervical spine to be reviewed by an FDA panel. The first, Medtronic's Prestige® Cervical Disc, is currently under evaluation by the FDA.
Inion was granted the CE mark this week for the FreedomPlate biodegradable implant. The implant is used for fixing fractures and osteotomies in the skeleton, excluding the spine.
Product Introduction & Launch
Medtronic launched its bone graft substitute and bone void filler Progenix™ DBM Putty. The product is being distributed through Medtronic's wholly-owned subsidiary SpinalGraft Technologies LLC. In their press release, Medtronic praised the product's "proven bone formation, certified osteoinductivity, validated viral inactivation and device-level sterility."
DePuy Spine launched the VERTIGRAFT® VG2® TLIF Allograft. The product is designed to facilitate graft insertion and bone growth during transforaminal lumbar spinal fusion (TLIF) surgery. Developed in partnership with LifeNet®, the VG2 TLIF ALLOGRAFT is, according to the press release, "the only machined allograft comprised of both [cortical and cancellous] bone," the latter of which can promote osteoconduction.
Service Agreement
IsoTis, Inc. is expanding its existing private label agreement with AlloSource, IsoTis' primary supply partner. Under the agreement AlloSource receives an exclusive license to use the intellectual property necessary to manufacture products similar to IsoTis' first generation DBM products in North America and a non-exclusive license to market them to and through AlloSource's own distribution or private label partners.
Biomet announced the creation of a strategic research alliance with Massachusetts General Hospital. The Hospital will manage global multi-center prospective clinical studies for Biomet's Regenerex™ and E-Poly™ technologies. Biomet will fund the studies, which are expected to include surgeons from the United States, Sweden, United Kingdom, Denmark, Germany and the Netherlands.
BioE signed an agreement with Phillips Plastics to collaborate on stem cell therapeutics for orthopedic applications. These stem cell therapeutics will consist of BioE's Multi-Lineage Progenitor Cell™ (MLPC) stem cells derived from human umbilical cord blood and Phillips Plastics' growth structures. According to BioE, Early development studies showed that the MLPC differentiated into osteoblasts and chondrocytes, along with other cell and tissue precursors.
Legal
Federal prosecutors are seeking to destroy 273 boxes of medical implants seized in 2005 from REO Spineline. REO owner Thomas Bradley Harris pleaded guilty last year to participating in a smuggling scheme with Eurosurgical, and the 273 boxes contain implants that may have been part of this scheme.
Operations
AxioMed Spine will add a second manufacturing site to its new facility in Garfield Heights, Ohio. The facility will be used to manufacture the company's spinal disc replacement products. AxioMed collaborator the Polymer Technology Group (PTG) of Berkeley, California will continue its manufacturing capability in Berkeley. AxioMed has established proprietary manufacturing processes for the artificial discs and holds an exclusive license for PTG's patented polymer for applications in the lumbar and cervical spine.
Appointment
Vertebron announced the appointment of Alexander R. Vaccaro, M.D., F.A.C.S. to its Medical Advisory Council. Dr. Vaccaro is Professor of Orthopaedic and Professor of Neurosurgery at Thomas Jefferson University Hospital in Philadelphia, PA where he is also Co-Director of the Regional Spinal Cord Injury Center of Delaware Valley, and Director, Spine Fellowship Program. In addition, Dr. Vaccaro serves as Attending Orthopaedic Surgeon and Co-Director of the Reconstructive Spine Service Rothman Institute at Jefferson.
In further Amedica news, the company appointed Mr. Bradford S. Goodwin to its Board of Directors as of May 6, 2007. Mr. Goodwin is currently a director of PDL BioPharma and Rigel, Inc. Prior to that he was the Chairman of the Board of CoTherix, Inc. and from 2001 to 2006 he was Chief Executive Officer and Director of Novacea, Inc. He has also held various senior executive positions with Genentech, Inc., including Vice President of Finance, with responsibility for treasury, purchasing, risk management, real estate, controllership, tax and long-range planning.
