Earnings AOI Medical Inc. reported a 1H:08 loss of $3.5 million, widening from a loss of $1.8 million in 1H:07. The company added in the press release that they're conducting a new clinical study for their Ascendex tools for the... more
A European investigation of dental amalgam, undertaken in an effort to evaluate the safety concerns associated with the material's mercury content, found that the product was safe. The European Commission's (EC) Scientific Committee on Emerging and Newly Identified Health Risks... more
Earnings Alphatec Spine, Inc. reported consolidated revenues for 2Q:08 of $23.9 million, an increase of 27% from the $18.8 million reported in 2Q:07. U.S. revenues for 2Q:08 were $19.4 million, an increase of 20% from the $16.2 million reported in... more
Earnings Cryolife reported 2Q:08 revenues of $27.2 million, up 18% over the year-ago period and beating estimates by $1.4 million. Orthopedic tissue processing revenues declined 76% to $0.3 million, as the company has discontinued that segment of the business. Net... more
Earnings Symmetry Medical reported 1Q:08 revenue of $101.9 million, up 57% from the year-ago period. Revenue was positively affected by the recent acquisitions of TNCO, Inc., Specialty Surgical Instrumentation Inc. and DePuy Orthopaedics, Inc.'s Massachusetts manufacturing facility. Net income for... more
Funding Exactech received a $40.0 million syndicated line of credit which will be used to fund future acquisitions and refinance debt, among other expenses. SunTrust Bank served as lead agent with participation by Compass Bank. M&A clickNsettle announced plans... more
M&A Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The... more
After four years of back and forth between the European Parliament, European Commission and the European Counsel, the revised Medical Device Directive (MDD) was eventually published in the Official Journal of the European Communities on September 21st, 2007. The amendments... more
Earnings JNJ reported 4Q:07 revenues of $15.96 billion, up 17% over the year-ago period and beating consensus estimates of $15.4 billion. Net income was $2.37 billion, or $0.82 per share, missing estimates by $0.04. Depuy reported 4Q:07 sales of $1.21... more
M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more
M&A Curis, Inc. entered into an agreement to sell and assign its remaining BMP-7 technologies to Stryker Corporation. Curis will receive an initial payment of $1.0 million as well as additional cash payments based on specified clinical, regulatory and sales... more
Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more
M&A With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced... more
M&A Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix... more
Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... more
Earnings Biologics: Orthovita reported 2Q:07 revenues of $14.85 million, beating estimates of $14.13 million and reflecting a 33% increase over 2Q:06. Sales growth was attributed to increased U.S. sales of VITOSS® FOAM and VITAGEL® products. Net loss decreased to $3.17... more
Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more
Regulatory TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was... more
The European Parliament recently approved 141 amendments to the Medical Device Directive, the legal framework created in 1990 to regulate device safety throughout Europe. The approval follows a public comment period on the first draft of the Directive, which was... more
Earnings Spine Kyphon reported that worldwide revenues in 1Q:07 increased 40% to $128.1 million, which includes $18.1 million in X-STOP® Interspinous Process Decompression (IPD®) sales from the St. Francis acquisition. In the U.S., revenues increased 34% to $101.1 million, while... more
Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... more
In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... more
Earnings: Biomet reported its 1Q:07 earnings totaled $0.44 per share (excluding the adoption of the share-based payment) which was $0.01 more than what analysts were expecting. Revenues increased by 5% to $508 million (foreign currency had a $3 million favorable... more
Appointment: Ranier Technology Limited has appointed John C. Moran to its Board of Directors. Previously, Mr. Moran was a President of Synthes Spine and a Director of Spine Solutions, Inc. Active Implants Corporation (AIC) has hired Richard Treharne, PhD. as... more
Appointment: A medical imaging company ONI Medical appointed Victor Ruiz to Vice President, of the Corporate Strategy and Marketing division. Mr. Ruiz's past experience include world-famous imaging companies: GE Medical Systems and Cardinal Health Inc. Clinical Update: LDR Spine announced... more
Posted by Tim Berkowitz and Anne Villeneuve. We attended late last week the Inspiration (International Spine Research and Innovation) meeting in Cannes. More than 70 spine surgeons from twenty-three countries discussed: cervical spinal tumors canalar stenosis with degenerative scoliosis in... more
This week, we decided to post the Orthopedic News Roundup for Thursday, instead of Friday due to the upcoming holiday. Clearly the biggest headline this week is the announcement of a take-over bid by Musculoskeletal Transplant Foundation ("MTF") for Osteotech... more
At a recent shareholders' meeting IsoTis OrthoBiologics announced that it appointed James (Jim) Hart to its Board of Directors. Jim is familiar to many of you as the former CEO of Opus Medical which was sold to ArthroCare for over... more
Today Ranier Technology Limited, a UK based artificial disc manufacturer announced that it received £4 million ($7.3 million) in an institutional venture capital round. The funding was provided by FNI Venture Capital, which was a previous investor in Ranier's first... more
About six months ago I had an individual come into my office asking about an article he had recently read in a local newspaper regarding hip resurfacing. The man was approximately 40 years old and was too young for a... more
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