Orthopedic News Roundup 24-Aug-06
BY HUYEN NGUYEN, AUGUST 24, 2006
Appointment: IsoTis OrthoBiologics has hired Gene B. Reu as Vice President of Operations. Prior to joining IsoTis, Mr. Reu served as Vice President & General Manager of Coblation Technologies with Arthrocare, Inc.
Business Update: ArthroCare Corp. announced it has received an inquiry from the Securities and Exchange Commission (SEC) requesting certain documents and information related to the Company's stock option grant practices. Prior to receiving this inquiry, the Company conducted an internal review relating to all of its equity compensation activities from the time of its initial public offering to the present. Based upon its review, ArthroCare found no unusual patterns in the timing or pricing of its equity awards and that there is no evidence of backdating of option awards. The Company intents to fully cooperate with the SEC.
Earnings: Medtronic, Inc. reported 1Q:07 total sales of $2.9 billion (currency translation added $6 million to sales), or an increased of 8% over 1Q:06. The Company reported net income of $599 million, or $0.51 per diluted share, failing to meet analysts' expectations by $0.03. During the quarter, its Spinal and Navigation business took in $599 million, representing an increase of 14% over the comparable period in 2006. Sector highlights include: the launch of the CD HORIZON® SEXTANT® II system, INFUSE®'s 25% revenue growth, FDA IDE approval for DIAMT(TM) Spinal Stabilization System and increased international momentum from its artificial discs technologies, the MAVERICK™ Artificial Lumbar Disc family and the PRESTIGE® LP Cervical Disc.
Financing: Flexuspine Inc.has raised $3.12 million of a $9.1 million Series B round of financing. Investors included Warburg Pincus, The Vertical Fund, Onset Venture Partners and Morningstar Asset Management.
Mergers & Acquisitions: HealthpointCapital announced the purchase of BioHorizons Implant Systems, Inc. BioHorizons designs, produces and distributes oral reconstructive devices including dental implants and tissue regeneration products. BioHorizons, located in Birmingham, Alabama, is one of the fastest-growing companies in the dental industry. HealthpointCapital also announced that it has acquired DTI Dental Technologies Inc. DTI custom designs and fabricates crowns, bridges, dentures, cosmetic appliances and orthodontic appliances for its customers, dentists serving patients in need of restorative and cosmetic dentistry. DTI, headquartered in Vancouver, British Columbia, Canada, is one of the largest companies in the dental laboratory industry. Paragon Medical Inc. has acquired the Medical Metal Finishing Division of Hand Industries Inc. for an undisclosed amount. Hand Industries Inc. specializes in metal finishing for orthopedic implants.
Operational Update: LDR announced it has combined two separate organizations: LDR Medical, a French-based organization, and LDR Spine, a U.S.-based organization, to create LDR Holding Corporation. This new entity will be headquartered in Austin, Texas and led by Christophe Lavigne, who was the original founder of LDR Medical. LDR is a privately held company with products both in non-fusion and fusion spinal implants. Facet Solutions, Inc. announced that it has moved into a new corporate headquarters in Logan, Utah.
Product Development Agreement: PrimeCell™ Therapeutics LLC and Regeneration Technologies, Inc. (RTI) announced an agreement to pursue orthopedic applications using PrimeCell™'s germ cell reprogramming technology. The research will focus on utilizing reprogrammed germ line stem cells from a donor source mixed with Demineralized Bone Matrix to develop orthopedic grafts with potentially increased therapeutic value.
Product Introduction: Wright Medical Group, Inc. announced the launch of its CLAW™ Plate for foot and ankle surgery. The CLAW™ is part of Wright's CHARLOTTE™ product lines, which includes screws, plates and staples for use in reconstructive foot and ankle procedures. The Company estimates that the CLAW™ may be suitable for fixation in 25-40% of the of the 100,000 foot and ankle osteotomies and fusions that are performed annually in the U.S.
Regulatory Update: Impliant, Inc. announced it has received Conditional Approval from the FDA to enroll patients in a pivotal IDE trial for its TOPS™ System. The Company plans to enroll patients in a randomized study comparing its TOPS™ System to traditional fusion.
Miscellaneous: The FDA's Orthopaedic and Rehabilitation Devices Panel will be meeting on September 19, 2006. The committee will discuss, make recommendations and vote on a premarket approval application for Medtronic's Prestige ST artificial cervical disc. This metal on metal, ball and trough prosthesis is intended to treat degenerative disc disease at one level from C3-C7.
