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Orthopedic and Dental Industry News

August 2012

Musculoskeletal News Roundup 30-Aug-12 BY LAUREN UZDIENSKI, AUGUST 30, 2012

Axial Biotech sells ScoliScore for $4.4 million ... Nextremity Solutions closes funding round ... FH Orthopedics announces FDA approval ... Osseon appoints COO more

Medtronic Opens Shanghai R&D Center BY LAUREN UZDIENSKI, AUGUST 29, 2012

Medtronic announced the official opening of its Shanghai Innovation Center on Monday. The facility is located within the company's China headquarters and will be Medtronic's first R&D center outside the U.S. and Europe. The new center reflects a continued commitment to China and the emerging markets, and CEO Omar Ishrak adds that it supports "our work to transform ourselves into a truly global organization." The Innovation Center will work with Medtronic's global R&D teams, but an additional goal of the facility is to partner with local universities, research centers and physicians to develop new technologies. more

Tornier to Acquire OrthoHelix Surgical Designs BY LAUREN UZDIENSKI, AUGUST 27, 2012

Tornier announced on Friday that the company would acquire OrthoHelix Surgical Designs for $135 million in cash and stock. OrthoHelix designs and manufactures plate technology for the foot and ankle market, broadening Tornier's presence in the extremities space. more

Alphatec Spine Launches New MIS Device, the BridgePoint Spinous Process Fixation System BY EDITOR, AUGUST 23, 2012

Alphatec Holdings announced today that it has launched its newest Minimally Invasive Surgery (MIS) device, which is called the BridgePoint Spinous Process Fixation System. more

Musculoskeletal News Roundup 23-Aug-12 BY LAUREN UZDIENSKI, AUGUST 23, 2012

KH, Globus, MDT report sales ... ATEC launches BridgePoint Spinous Process Fixation System ... Bonovo launches Cross-Fuse ... Synthes issues recall for hemostatic bone putty more

TKA Improves Function, Irrespective of BMI BY LAUREN UZDIENSKI, AUGUST 22, 2012

A new study demonstrates that obese patients who undergo total knee arthroplasty for the treatment of OA report similar functional improvements following surgery as normal-weight patients. The data challenges recent U.K. policies limiting access to the procedure based on BMI. The paper's introduction states that U.K. healthcare organizations have recommended "arbitrary thresholds [for surgical candidacy] unsupported by the literature and based on body mass index," which the U.K. implemented to help reduce healthcare costs. more

FDA Publishes Draft Guidance on "Refuse to Accept" 510(k) Policy BY LAUREN UZDIENSKI, AUGUST 21, 2012

The FDA released draft guidance last week on a new "refuse to accept" policy for 510(k)s. The policy would implement an additional layer of preliminary review for 510(k)s to certify that an application "meets a minimum threshold of acceptability and should be accepted for substantive review." The initial review is largely administrative and designed to identify missing or incomplete components of an application. The FDA said they would notify the applicant of the outcome of this preliminary review within 15 days of receiving the 510(k). more

Musculoskeletal News Roundup 16-Aug-12 BY LAUREN UZDIENSKI, AUGUST 16, 2012

aap Implantate, Mazor announce 2Q revenues ... Spinal Elements announces first surgeries with MIS lumbar system ... Lanx receives patent ... K2M partners with Cadwell Laboratories on neuromonitoring ... SpineMark centers implementing spine protocol more

Smart Devices Empower Patients, Simplify Care BY LAUREN UZDIENSKI, AUGUST 15, 2012

Innovative prosthetic and bracing products were highlighted in the Wall Street Journal yesterday, which used Orthocare Innovations' app-controlled leg prosthesis as an example of "smart" devices that give patients a level of control previously reserved for physicians. more

Mazor Raises $15M for U.S. ADR Program BY LAUREN UZDIENSKI, AUGUST 14, 2012

Israeli company Mazor Robotics, which currently trades on the Tel Aviv Stock Exchange under the symbol MZOR, announced a $15 million private placement that the company will use to support an ADR program. ADRs allow non-U.S. companies to trade on U.S. exchanges. The investment, led by Oracle Investment Management, consists of two tranches of $7.5 million each. more

Medtronic's China Strategy BY LAUREN UZDIENSKI, AUGUST 14, 2012

China Daily is reporting that Medtronic is seeking an acquisition in China, stating that they are "the first multinational medical device company that has publicly said it will make M&A one of its key strategies in China." Medtronic has emphasized acquisitions in emerging markets since Omar Ishrak assumed the CEO role last year, and the China Daily report follows rumors from a few weeks ago that Medtronic was looking to acquire an India-based device manufacturer. more

Musculoskeletal News Roundup 9-Aug-12 BY LAUREN UZDIENSKI, AUGUST 8, 2012

ATEC, TRNX announce earnings ... DePuy receives 510(k) for adolescent idiopathic scoliosis products ... ulrich medical launches golden gate Lateral Plate System ... WMGI subpoenaed over Profemur more

Gel-One HA Injection Found Not to Infringe BY JOHN MCCORMICK, AUGUST 7, 2012

Last week, Hyaluronic acid (HA) manufacturer Seikagaku and its distribution partner Zimmer were determined by a U.S. federal jury not to infringe on Genzyme's Synvisc-One HA injection. more

Alphatec Spine Appoints Luke T. Faulstick to Board of Directors BY EDITOR, AUGUST 7, 2012

Alphatec Holdings today announced the appointment of Luke T. Faulstick to the Company's Board of Directors. The appointment increases the size of Alphatec Spine's Board of Directors to eight and increases the number of independent directors to five. more

2013 Reimbursement Rates Finalized, Higher than Proposed Rates BY LAUREN UZDIENSKI, AUGUST 7, 2012

CMS, which sets annual reimbursement rates for Medicare, released last week the final 2013 pay rates. The final rule was generally in line to slightly improved from rates proposed in the spring. more

Globus Medical Debuts on the New York Stock Exchange BY LAUREN UZDIENSKI, AUGUST 3, 2012

Globus Medical (GMED) began trading on the New York Stock Exchange this morning, opening at $13.10 per share after pricing 8.3 million Class A common shares at $12 per share last night. The stock is up 17% in mid-morning trading. Globus has said they will use proceeds from the offering to expand its sales and for investments in research and development. more

Musculoskeletal News Roundup 2-Aug-12 BY LAUREN UZDIENSKI, AUGUST 2, 2012

ANIK, ARTC, DJO, EXAC, MAKO, RTIX, SNN, SMA, WMGI report 2Q:12 ... Medtronic launches Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting ... NewVert completes biomechanical testing for Octopus Spinal Annular Repair System ... Spinal Elements introduces Lucent Ti-Bond ... Benvenue Medical completes KAST enrollment ... TranS1 announces study results more

Dental News Roundup BY MATTHEW JAFFE, AUGUST 1, 2012

Earnings Align Technology announced 2Q:12 revenues for the quarter were $145.6 million, compared to $120.1 the same quarter last year. Diluted EPS was $0.34 up from $0.14 in 2Q:11 and beat analyst estimates of $0.27. The company cited strong volume... more

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