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Orthopedic and Dental Industry News

October 2012

HealthpointCapital Readership Survey + Win an Amazon Gift Certificate! BY EDITOR, OCTOBER 30, 2012

We want to hear from you. We're conducting a short readership survey to help shape our blog coverage and better report on the news that matters to you. more

FDA Announces Plans to Reduce 510(k) Assessment Timeframes BY ANDREW VAHRADIAN, OCTOBER 29, 2012

Following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year, the FDA has published guidance regarding reformed review timeframes and performance goals for 510(k) premarket notification of medical devices. The new targets are... more

New Solutions to Address Implant Related Bacterial Infections BY ANDREW VAHRADIAN, OCTOBER 26, 2012

Presently, Surgical Site Infections (SSI's) are a top concern of orthopedic and oral surgery as bacteria such as methicillin-resistant staphylococcus aureus (MRSA), can initiate severe implant infections and lead to biofilm adhesion. MRSA is quite difficult to manage clinically due... more

Musculoskeletal News Roundup 26-Oct-12 BY ANDREW VAHRADIAN, OCTOBER 26, 2012

CONMED, Integra LifeSciences, NuVasive, Orthofix, Ossur, RTI Biologics, Zimmer report 3Q:12 financial results...CD Diagnostics acquires Citrano Medical Laboratories...Aesculap Implant, Choice Spine, DePuy Orthopaedics, DePuy Synthes, ECA Medical, Medtronic, Misonix, Orthofix International, OsetoMed Spine, Precision Spine, ulrich announce new products. more

Senate Committee Releases Report on Medtronic's Infuse BY LAUREN UZDIENSKI, OCTOBER 25, 2012

The Senate Finance Committee released a report on bias in literature relating to Medtronic's Infuse, concluding that the company was "heavily involved in drafting, editing and shaping the content of medical journal articles" supporting the use of Infuse. Documents subpoenaed by the Senators reportedly indicate that Medtronic urged authors to under-report adverse events associated with Infuse or emphasize the benefit of a bone graft substitute in preventing donor-site pain. As documented previously, Medtronic paid millions to the researchers aiding the development of Infuse. more

Alphatec Spine to Showcase New Products at the Upcoming 27th Annual North American Spine Society (NASS) Meeting in Dallas, Texas BY EDITOR, OCTOBER 23, 2012

Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today that it will showcase several new... more

Alphatec Spine Signs New Exclusive Supply Agreement for an Anchored, Zero-Profile Anterior Cervical Interbody Device BY EDITOR, OCTOBER 23, 2012

Alphatec Holdings announced that the company has signed a new supply agreement that provides the company with exclusive worldwide rights to market, sell and distribute an anchored, zero-profile anterior cervical interbody device. The device's 510(K) application is currently under review... more

China's Domestic Medical Device Industry is Set for Expansion BY ANDREW VAHRADIAN, OCTOBER 19, 2012

As the average age of China's vast population rises and the government strengthens its reimbursement programs, greater opportunities will be thrust upon the country's fledgling and domestic medical device industry. According to the Beijing-based consultancy S&P Consulting Inc, by... more

Musculoskeletal News Roundup 19-Oct-12 BY ANDREW VAHRADIAN, OCTOBER 19, 2012

Johnson & Johnson reports 3Q:12 results...Medicrea International reports 3Q:12 results...Stryker reports 3Q:12 results...Lanx Inc. receives $8.7 million in funding...Captiva Spine receives FDA clearance for TowerLOX...Intelligent Implant Systems receives FDA clearance for Active Bone Screw...Paradigm Spine receives FDA premarket approval for Coflex device...Smith & Nephew announce ENDOBUTTON CL 10 mm fixation device...Wright Medical initiates voluntary Field Safety Corrective Action...KFx receives favorable ruling on patent infringement lawsuit with Arthrex...Spinelab and Biomet announce distribution agreement...Expanding Orthopedics appoints Dr. Hansen Yuan to its Board of Directors...Orthofix announces promotion of Brian McCollum to President of Spine Global Business Unit...Osseon Therapeutics names Doug Clark to Board of Directors as well as making further appointments more

Medical Device M&A Activity Gaining Momentum BY ANDREW VAHRADIAN, OCTOBER 16, 2012

With approximately $50 billion in excess cash currently on the books of major medical device companies, increasing domestic and international market share and attaining ownership of innovative technology through M&A has come into secular favor versus the approach of returning... more

Musculoskeletal News Roundup 11-Oct-12 BY ANDREW VAHRADIAN, OCTOBER 12, 2012

Biomet announces 1Q:13 results...Medtronic initiates U.S. commercialization of its ACD Instrument Set...Baxano receives FDA clearance for iO-Tome...Globus Medical awarded pre-market approval from FDA for Secure-C...Integra receives FDA clearance for VuaPOD...U.K. MHRA questions European Commission...Wright Medical DPA expires...JNJ expands Puerto Rican operations...NuVasive announces resignation of its President of Global Sales...TranS1 announces distribution agreement in China...New company, SkelRegen forms...U.K. MHRA appoints new Medical Director...Sonoma appoints President and CEO more

Medical Device Tax Repeal Gaining Momentum BY ANDREW VAHRADIAN, OCTOBER 9, 2012

During the 2012 AdvaMed conference in Boston last week, the medical device industry expressed its optimism that there are enough votes in the U.S. Senate to a repeal the 2.3% medical device tax scheduled to go into effect January 2013.... more

China & India Launch New Medical Device Regulations BY ANDREW VAHRADIAN, OCTOBER 9, 2012

China and India have launched new regulatory guidelines for medical device companies conducting business within their respective countries. China's State Food & Drug Administration (SFDA) released instructions governing a standardized manner in which foreign medical device manufacturers must label and... more

Dental News Roundup - September 2012 BY MATTHEW JAFFE, OCTOBER 8, 2012

Henry Schein acquires Exan Group... Patterson acquires Iowas Dental Supply... Japanese research team develops synthetic tooth enamel more

Alphatec Spine Appoints New Senior Vice President of U.S. Commercial Operations BY EDITOR, OCTOBER 4, 2012

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine,... more

Musculoskeletal News Roundup 4-Oct-12 BY ANDREW VAHRADIAN, OCTOBER 4, 2012

NuVasive pre-announces expected revenue for 3Q:12...Interventional Spine raises $1.6 million...Mainstay Medical raises $20.0 million...Mazor Robotics finalizes $7.5 million investment tranche...Zimmer receives FDA warning...Pinnacle Spine receives FDA approval...ConforMIS annouces iTotal G2 Knee Replacement System...DePuy Mitek announces HEALIX ADVANCE...Humble Surgical Hospital acquires Mazor's Renaissance(TM) system...Smith & Nephew launch TRIGEN Low-Profile Screw...Spinal Elements launch Hero Allograft...Orthopeutics, LP receives patent...SpineSmith receives patent...Reno Orthopaedic Clinic and University of Nevada conduct two independent generics studies...Microbion Corporation's topical BisEDT in Phase 2 trials for post-surgical infections...Alphatec Spine announces new SVP of U.S. Commercial Operations. more

Knee Replacements Double Over Past Two Decades BY LAUREN UZDIENSKI, OCTOBER 4, 2012

New data from CMS shows that knee replacements are on the rise, doubling over the past two decades. More TKAs are now performed than coronary-artery bypass surgeries or hysterectomies, with the absolute numbers of knee replacements increasing from 93,230 cases in 1991 to 243,802 in 2010. Over the same period, a total of 3.6 million knee replacements have been performed on Medicare patients, and projections show that 3.5 million knee replacements may be performed annually by 2030. more

Forbes Features Alphatec CEO Les Cross BY EDITOR, OCTOBER 1, 2012

This week Forbes asked Alphatec CEO Les Cross "What makes a public company successful?" Mr. Cross, who is credited with increasing DJO's annual sales from $24 million annually to $1 billion over ten years, gives five key tips for making a company profitable. more

Kevin Lobo Appointed CEO of Stryker BY ANDREW VAHRADIAN, OCTOBER 1, 2012

Stryker announced today that effective immediately, Kevin A. Lobo, most recently Group President of Stryker Orthopaedics, has been named the Company's President and CEO. In conjunction to this announcement, Curt Hartman, the current CFO, has decided to leave in order... more

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