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Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI

OR_small.jpg The latest news from AAOS! VITA and MAKO report 4Q09 . . . ETEX receives 510(k) . . . DePuy, Integra, Medtronic, Smith & Nephew and more announce product launches . . . SEC Drops Wright Medical Investigation . . . BioMimetic Therapeutics shares study results . . . Long-term use of bisphosphonates may increase fracture risk . . . NeoStem wins research grant more

Musculoskeletal News Roundup 18-Feb-10 BY LAUREN UZDIENSKI

Earnings DJO reported 4Q:09 revenues of $257.2 million, up 5% over 4Q:08, with domestic rehab sales up 3% and domestic surgical implant sales up 8%. The company attributed the latter largely to "strong sales of our Reverse Shoulder Prosthesis." Net... more

Musculoskeletal News Roundup 11-Feb-10 BY LAUREN UZDIENSKI

Earnings Nobel Biocare reported 4Q:09 revenues of EUR 156.0 million ($213.6 million), flat over the year-ago period and missing estimates by EUR 5.0 million ($6.9 million.) EPS of EUR 0.21 ($0.29) missed estimates by EUR 0.05 ($0.07). The company called... more

Musculoskeletal News Roundup 4-Feb-10 BY LAUREN UZDIENSKI

Earnings CONMED reported 4Q:09 sales of $190.6 million, up 3% over the year-ago period and beating estimates by $6.0 million. Arthroscopy sales rose 3% to $75.7 million. All growth rates exclude the effects of currency. 4Q:09 EPS of $0.37 beat... more

Musculoskeletal News Roundup 21-Jan-10 BY LAUREN UZDIENSKI

Earnings MEDICREA reported 4Q:09 sales of EUR 3.9 million ($5.6 million) and 2009 sales of EUR 13.1 million ($18.8 million), representing a 45% increase over 2008. The company said their sales development in the U.S. has been "successful" and a... more

Musculoskeletal News Roundup 14-Jan-10 BY LAUREN UZDIENSKI

Earnings aap Implantate reported preliminary sales of EUR 7.4 million ($10.6 million) in 4Q:09, down 4% from the year-ago period. Full year sales were up 3% to EUR 33.0 million ($47.3 million). Company highlights for the year include "optimizing its... more

Musculoskeletal News Roundup 7-Jan-10 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ2:10 (ended November 30, 2009) revenues of $696.0 million, up 5% over the year-ago period. Recon sales increased 6% to $528.4 million, with hip up 4%, knee up 8%, dental down 8% and extremity up 27%. Additionally,... more

Musculoskeletal News Roundup 17-Dec-09 BY LAUREN UZDIENSKI

M&A Alphatec Holdings, Inc. announced that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France. The transaction is structured as an all-stock transaction such that 100% of outstanding Scient'x stock... more

Musculoskeletal News Roundup 10-Dec-09 BY LAUREN UZDIENSKI

M&A The Yorkshire Post reported that DePuy Orthopaedics acquired Finsbury Orthopaedics. Finsbury has a range of hip, knee and small joint replacement products, including a hip resurfacing device. No details of the transaction were disclosed. Funding BioMedFlex raised $0.25 million... more

Musculoskeletal News Roundup 5-Nov-09 BY LAUREN UZDIENSKI

Earnings aap Implantate reported nine-month revenue of EUR 25.6 million ($37.4 million), which represents a 6% increase over the year-ago period. The company said third-quarter highlights included the signing of several IP agreements that emphasize orthopedics, trauma ad spine. Artimplant... more

Musculoskeletal News Roundup 29-Oct-09 BY LAUREN UZDIENSKI

Earnings Anika Therapeutics reported 3Q:09 revenues of $10.1 million, representing an 18% increase over the year-ago period and missing estimates by $0.3 million. Joint Health sales, including the Orthovisc and Monovisc products, were up 31% to $6.1 million. Anika noted... more

Musculoskeletal News Roundup 22-Oct-09 BY LAUREN UZDIENSKI

Earnings CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.... more

Musculoskeletal News Roundup 15-Oct-09 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ1:10 revenues of $630.0 million, a 7% increase over the year-ago period. Excluding dental, recon sales increased by 9%, with knee up 10%, hip up 6% and extremity up 23%. Dental decreased by 5%. All rates exclude... more

Musculoskeletal News Roundup 8-Oct-09 BY LAUREN UZDIENSKI

Earnings TranS1 pre-announced 3Q:09 revenues, saying sales for the quarter would be in the range of $6.8 to $6.9 million. This represents a 15% increase over year-ago sales, though it is below 3Q:09 guidance of $7.4 to $7.9 million. Analysts... more

ChrondroCelect Receives First-of-Its-Kind EU Market Clearance BY LAUREN UZDIENSKI

TiGenix announced that ChondroCelect, its ACI treatment for cartilage regeneration, has been cleared by the European Commission for sale on the EU market. This is the first product to be approved in the EU as an advanced therapy medicinal product,... more

Musculoskeletal News Roundup 1-Oct-09 BY LAUREN UZDIENSKI

Earnings MEDICREA reported revenues of EUR 6.1 million ($8.6 million) in 1H:09, representing a 32% increase over 1H:08, which the company attributed to growth in sales from direct subsidiaries, primarily in the United States. Net loss was EUR 1.5 million... more

Musculoskeletal News Roundup 24-Sept-09 BY LAUREN UZDIENSKI

Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more

Musculoskeletal News Roundup 17-Sept-09 BY LAUREN UZDIENSKI

M&A Integra LifeSciences acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Last year the company recorded $2.2 million in revenues, though they ceased operations in January and went into liquidation in May. This transaction... more

Musculoskeletal News Roundup 3-Sept-09 BY LAUREN UZDIENSKI

Regulatory Active Implants Corporation received a CE Class III Certificate for its TriboFit Hip System. The system is made from a low-wear polycarbonate-urethane material that the company says shares some of the characteristics of human cartilage. MEDICREA received 510(k) clearance... more

Musculoskeletal News Roundup Aug-27-09 BY LAUREN UZDIENSKI

Earnings Corin reported 1H:09 sales of GBP 20.1 million ($33.0 million), down 25% over 1H:08 after adjusting for currency and beating estimates by GBP 2.1 million ($3.5 million). Outside the U.S., revenues increased by 10%, which the company attributed to... more

Musculoskeletal News Roundup 23-Jul-09 BY LAUREN UZDIENSKI

Earnings Anika Therapeutics reported 2Q:09 revenue of $9.5 million, representing a 5% increase over 2Q:08 and missing estimates by $0.4 million. The company attributed revenue growth to both the ORTHOVISC and MONOVISC product lines, which contributed $5.6 million to total... more

Muscloskeletal News Roundup 16-Jul-09 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ4:09 sales of $639.3 million, representing a 7% increase over the year-ago period. Among segments, hip increased 9%; knee increased 11%; extremity increased 18%; dental decreased 13%; fixation increased 5%; and spine increase 18%. All growth rates... more

Musculoskeletal News Roundup 2-Jul-09 BY LAUREN UZDIENSKI

Earnings Biomet reported net sales of $639.0 million for FQ4:09, which represents an increase of 1% as reported and 7% when adjusting for currency. Among segments, recon, excluding dental, increased 3% as reported and 11% constant currency. Dental decreased by... more

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI

Funding BioMimetic Therapeutics raised approximately $17.0 million in a rights offering that closed on Wednesday. The company offered 2,000,000 shares at $8.50 per share in May. The company plans to use the funds for general corporate purposes, including to product... more

Musculoskeletal News Roundup 23-Apr-09 BY LAUREN UZDIENSKI

Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more

Musculoskeletal News Roundup 16-Apr-09 BY LAUREN UZDIENSKI

Earnings JNJ reported 1Q:09 sales of $15.0 billion, missing estimates by $0.4 billion and representing a 7% decline over 1Q:08, which the company attributed mostly to unfavorable exchange rates. Net income was $3.5 billion, or $1.26 per diluted share, beating... more

With Applications Beyond Vertebroplasty, Bone Cement Offers Pain Relief for Cancer Patients BY LAUREN UZDIENSKI

Patients suffering crippling pain from metastatic cancer or even "benign" conditions like rheumatoid arthritis may find relief in a minimally-invasive treatment called osteoplasty. Similar to vertebroplasty, osteoplasty is the injection of bone cement into cancerous lesions in the skeleton, and... more

Musculoskeletal News Roundup 26-Mar-09 BY LAUREN UZDIENSKI

Regulatory Bonesupport received the CE mark for Cerament Bone Void Filler, a ceramic bone substitute primarily used for the treatment of osteoporotic fractures. IlluminOss Medical received the CE mark for its Photodynamic Bone Stabilization System. According to the company, the... more

Ozone Injections Could Reduce Back Pain BY LAUREN UZDIENSKI

Yes, that ozone. The molecule that filters UV rays in the atmosphere and is a pollutant on the ground could have applications for reducing back pain, according to new studies out of Europe. Over the past five years, it is... more

Musculoskeletal News Roundup 26-Feb-09 BY LAUREN UZDIENSKI

Earnings Artimplant reported 4Q:08 revenues of SEK 4.6 million ($0.6 million), down from SEK 5.0 million ($0.8 million) in 4Q:07. During the quarter, the company reported sales of 900 Artelon Spacers (down from 1,100 in 4Q:07) and 300 units of... more

Musculoskeletal News Roundup 19-Feb-09 BY LAUREN UZDIENSKI

Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more

Musculoskeletal News Roundup 29-Jan-09 BY LAUREN UZDIENSKI

Earnings Kensey Nash reported FQ2:09 revenues of $20.8 million, up 6% over the year-ago period and beating estimates by $0.4 million. Net income for the quarter was $5.2 million, or $0.44 per diluted share, beating estimates by $0.04 and representing... more

Musculoskeletal News Roundup 30-Oct-08 BY LAUREN UZDIENSKI

Earnings Exactech reported 3Q:08 revenues of $37.9 million, missing revenues by $0.9 million and representing an increase of 27% over the year-ago period. Among segments, knee revenue increased 16%; organic hip implant revenue increased 8%; biologic services revenue increased 12%;... more

Musculoskeletal News Roundup 9-Oct-08 BY LAUREN UZDIENSKI

M&A Life Spine, Inc. has acquired the "majority" of the intellectual property of Spinal Generations, LLC. Neither details on the acquired technology nor terms of the transaction were disclosed. Funding Harvard received a $125 million donation from Synthes Chairman Hansjorg... more

Musculoskeletal News Roundup 11-Sept-08 BY LAUREN UZDIENSKI

M&A Wright Medical Group, Inc. acquired the RAYHACK System for wrist reconstruction, which consists of "procedure-specific bone-cutting guides and fixation plates that allow precise shortening and repositioning of the radius and ulna." The system will be available in the U.S.... more

Musculoskeletal News Roundup 28-Aug-08 BY LAUREN UZDIENSKI

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

New Report Finds Dental Amalgam Safe BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 7-Aug-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 31-July-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 26-Jun-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 19-June-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 12-June-08 BY ARMELLE WIART

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

Revised European Medical Device Directive: Omissions and a Contentious Addition BY ARMELLE WIART

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

Musculoskeletal News Roundup 25-January-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 10-Jan-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 3-Jan-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 11-Oct-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 4-Oct-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 6-Sept-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 9-Aug-07 BY LAUREN UZDIENSKI

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

Orthopedic News Roundup 28-June-07 BY LAUREN UZDIENSKI

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

Orthopedic News Roundup 21-June-07 BY LAUREN UZDIENSKI

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

Changes to European Device Safety Regulations; Reprocessing, Biologics to be Addressed in Future Legislation BY ARMELLE WIART

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

Orthopedic News Roundup 3-May-07 BY LAUREN UZDIENSKI

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

Orthopedics News Roundup 25-Jan-07 BY LAUREN UZDIENSKI

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

Synvisc To Share Reimbursement Code BY ARIELLA P. GOLOMB, MD

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

Orthopedic News Roundup 21-Sept-06 BY HUYEN NGUYEN

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

Orthopedic News Roundup 7-Sept-06 BY HUYEN NGUYEN

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

Orthopedic News Roundup 1-Jun-06 BY HUYEN NGUYEN

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

HealthpointCapital Attends the 5th Annual Inspiration Meeting in France BY TIM BERKOWITZ

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

Orthopedic News Roundup 01-Sept-05 BY HUYEN NGUYEN

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

IsoTis Appoints Jim Hart to Board BY JOHN MCCORMICK

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

Ranier Technology Secures $7.3m Funding BY JOHN MCCORMICK

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

Hip Resurfacing in the U.S.? BY JOHN CHOPACK

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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Introductory Guide to Intellectual Property for Medical Devices

Dr. Gary Michelson knows his patent rights. Medtronic made him a billionaire for it. Knowing the rules of intellectual property is just as important for any device firm. It's such a critical factor in firm valuations: affecting cash flow timelines, product development, partnering, and many other competitive factors. Purchase this report for $295 »