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Orthopedic and Dental Industry News

January 2012

Dental News Roundup - January 2012 BY MATTHEW JAFFE, JANUARY 31, 2012

Earnings Align Technology announced 4Q:11 net revenues of $128.9 million, up 38.8% from the quarter a year ago and beating analyst estimates by $0.03 per share. Net profit for 4Q:11 was $20.4 million, or $0.25 per diluted share, compared to... more

Symmetry Resolves SEC Investigation BY LAUREN UZDIENSKI, JANUARY 31, 2012

Symmetry Medical announced after the close on Monday that the SEC has settled an investigation into accounting irregularities at the company's Sheffield, UK manufacturing site, which were first exposed in 2007. Four finance executives were implicated in the SEC's probe, and in a separate clawback action, Symmetry's former CEO and current CFO were ordered to repay compensation associated with the faulty accounting. more

Report from the 16th Annual ArgoSpine Symposium BY LAUREN UZDIENSKI, JANUARY 27, 2012

We're in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging). Industry presence is much lighter than is typical at these events, with commercial exhibits limited to single tables from the handful of sponsoring companies. The focus is instead clinical - surgical technique, treatment modalities and optimizing outcomes. more

Musculoskeletal News Roundup 26-Jan-12 BY LAUREN UZDIENSKI, JANUARY 26, 2012

DJO, JNJ, SYK, ZMH report 4Q sales ... FDA clears Interventional Spine's Opticage Expandable device ... Medtronic receives FDA clearance for newest Aquamantys device ... KFx Medical receives new patent ... Judge dismisses motions in MDT/NUVA case ... Pioneer Surgical announces grand opening of new N.C. manufacturing facility more

An Inteview with Paul Nichols BY EDITOR, JANUARY 25, 2012

We spoke with Paul Nichols, the current Executive Chairman of Bio2 Technologies who formerly worked with HealthpointCapital as President and CEO of Nexa Orthopedics. Learn what he has to say about the opportunities and challenges of the musculoskeletal and his advice for young companies. more

Journal of Dental Technology Features DTI President and CEO Kim Bradshaw BY EDITOR, JANUARY 23, 2012

HealthpointCapital is proud to announce that Kim Bradshaw, President and CEO of DTI, is featured in this month's Who's Hot issue of JDT Unbound: The Journal of Dental Technology. The article is reproduced below.

In 2007, when Bradshaw arrived at DTI's flagship laboratory, MicroDental in Dublin, Calif., as the senior vice president for the dental services division, the situation was far from ideal. Many were not thrilled by her arrival. She came from a different industry and she spoke what seemed like a different language. She put a spotlight on things that most wanted left alone and her beginning to this new industry was off to a difficult start. more

Alphatec Spine Appoints New Senior Director of Investor Relations BY EDITOR, JANUARY 19, 2012

Alphatec Spine announced today that Mark Francois has been named the Company's Senior Director of Investor Relations. more

Musculoskeletal News Roundup 19-Jan-12 BY LAUREN UZDIENSKI, JANUARY 19, 2012

ZMH acquires Synvasive Technology ... Carticept, DiFusion announce funding rounds ... KFx announces ACL study results ... MedShape launches ExoShape Soft Tissue Fastener ... VG Innovations releases VerteLoc v2.5 ... Stryker settles OP-1 charges ... Zyga Technology appoints president and CEO more

FDA Warns DePuy Over Custom Devices BY LAUREN UZDIENSKI, JANUARY 18, 2012

An FDA warning letter sent to DePuy in December alleges that the company has been manufacturing custom hip and knee components in violation of FDA regulations. Custom devices are intended to be manufactured for one patient, and such devices are generally exempt from market clearance. more

"Rapid Growth" of Knee Replacement in Younger Patients BY LAUREN UZDIENSKI, JANUARY 17, 2012

Researchers in Finland have identified a 130-fold increase in incidence of total knee arthroplasty among Finnish patients younger than 59 years of age between 1980 and 2006. These data help to quantify the trend of younger patients undergoing knee replacement procedures while illustrating the need for more data on the long-term durability of knee devices. more

As Deadline Passes, User Fee Negotiations Continue BY LAUREN UZDIENSKI, JANUARY 17, 2012

Last Friday, the FDA announced agreements on user fee programs for drugs, generics and biosimilars, in time for a January 15th deadline for submitting the plans to Congress. The reauthorization for medical device user fees was not completed by the deadline and remains under negotiation. Bloomberg is now reporting that the FDA and device industry must come to a deal by February 15th, the date of a House Energy and Commerce health subcommittee meeting on the fees, or risk Congress taking over negotiations. more

Musculoskeletal News Roundup 12-Jan-12 BY LAUREN UZDIENSKI, JANUARY 12, 2012

MAKO, NUVA, OFIX, SYK, TRNX pre-announce ... FDA clears Biomet's E1 humeral bearing and Comprehensive Segmental Revision System ... Ortho Kinematics receives 510(k) clearance ... Lanx announces 100th implantation of Durango ... Mazor receives EU patent ... SNN announces VISIONAIRE study ... Arthrex to market ThermoGenesis PRP, bone marrow concentrate product ... Pioneer Surgical promotes Daniel Webber to CEO more

Medtronic Seeking International Acquisitions BY LAUREN UZDIENSKI, JANUARY 11, 2012

Medtronic CEO Omar Ishrak has spoken extensively about his vision for the company, a pillar of which is "accelerating globalization". At this week's JP Morgan Healthcare Conference in San Francisco, Mr. Ishrak addressed how M&A fit into the company's strategy. more

Orthofix Announces Expanded MTF Agreement BY LAUREN UZDIENSKI, JANUARY 11, 2012

Orthofix announced yesterday that the company will collaborate with tissue provider MTF to co-develop and commercialize a new bone technology that will be "complementary" to Trinity Evolution. Further, the company extended their MTF agreement, which supports Trinity Evolution, by an... more

Musculoskeletal News Roundup 5-Jan-12 BY LAUREN UZDIENSKI, JANUARY 5, 2012

IART pre-announces . . . China Kanghui subsidiary receives FDA clearance for hip and knee systems . . . first procedure performed with Ellipse Technologies device . . . Pioneer Surgical announces first clinical use of nanOss Bioactive 3D . . . Wright Medical launches ORTHOLOC 3Di Ankle Fracture System and the QUICKDRAW Knotless Soft Tissue Fixation System . . . Globus appoints SVP and CFO . . . Vexim appoints CEO more

Smith & Nephew, CONMED Ink Biologics Deals BY LAUREN UZDIENSKI, JANUARY 4, 2012

Both Smith & Nephew and CONMED announced biologics deals today, with Smith & Nephew spinning off their biologics division and CONMED signing an allograft and PRP distribution deal. more

FDA Requests More Info from BMTI BY LAUREN UZDIENSKI, JANUARY 4, 2012

Seven months after an FDA panel issued a tentative positive recommendation for approval for BioMimetic Therapeutics' Augment, the FDA has followed up with a request for more information on the bone graft substitute. more


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