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Orthopedic and Dental Industry News

July 2011

BioHorizons, a Leading Dental Implant Manufacturer, Announces $50 Million Credit Facility BY EDITOR, JULY 29, 2011

BioHorizons, Inc. today announced that it has closed on a five year $50 million subordinated secured credit facility provided by funds affiliated with Deerfield Management and Piper Jaffray & Co. more

IOM Calls 510(k) Process "Flawed", Recommends FDA Develop New System BY LAUREN UZDIENSKI, JULY 29, 2011

The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system. Less expected was the recommendation that the 510(k) was beyond repair and the FDA should just start over. more

Dental News Roundup - July 2011 BY MATTHEW JAFFE, JULY 29, 2011

Dentsply and Zimmer Dental announce earnings . . . Straumann makes investment in Dental Wings . . . Study shows cavities, missing teeth correlated to diabetes more

Musculoskeletal News Roundup 28-Jul-11 BY LAUREN UZDIENSKI, JULY 28, 2011

CNMD, IART, NUVA, OFIX, RTIX, WMGI and ZMH report 2Q . . . FDA releases draft guidance on device modifications . . . Osseon launches in India . . . Carbylan Biosurgery announces results from viscosupplement study . . . Lanx comments on data at IMAST more

Robert H. Blankemeyer Joins Board of Directors for BioHorizons, a Leading Dental Implant Manufacturer BY EDITOR, JULY 27, 2011

BioHorizons, Inc., a medical device company that designs, develops, manufactures and markets a broad and comprehensive line of innovative, proprietary and evidence-based dental implants, as well as hard and soft tissue regeneration products for the replacement of missing teeth, announced today that Robert H. Blankemeyer has been elected to the BioHorizons Board of Directors. more

Synthes Sues Globus (Again) BY LAUREN UZDIENSKI, JULY 25, 2011

In 2007, Globus paid $13.5 million to settle a series of patent infringement allegations brought by Synthes. Now Synthes has filed another lawsuit, this time alleging that Globus' spacer technology infringes Synthes patents. more

SNN Reorganizing; Mike Frazzette to Lead New Advanced Surgical Devices Division BY LAUREN UZDIENSKI, JULY 25, 2011

Several Memphis-based publications are reporting today on a restructuring plan underway at Smith & Nephew. Among the changes is the creation of a new business unit called Advanced Surgical Devices. more

FDA Studies Criticized by Editors of Leading Medical Journals BY LAUREN UZDIENSKI, JULY 21, 2011

Ahead of yesterday's House hearing, entitled Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs, Democrats asked the editors of leading medical journals to review two studies suggesting that the FDA is impeding U.S. device innovation. Their responses were scathing. more

Musculoskeletal News Roundup 21-Jul-11 BY LAUREN UZDIENSKI, JULY 21, 2011

JNJ, SYK announce 2Q . . . Ascension raises $18.6M . . . ATEC receives Japanese regulatory approval for the Illico SE . . . FDA clears Carticept Medical's Navigator Delivery System . . . DJO Global launches Turon Modular Shoulder . . . U.S. News and World Report ranks the top orthopedic hospitals more

Industry Urges Repeal of Device Tax BY LAUREN UZDIENSKI, JULY 19, 2011

Over 400 companies and trade associations, including MDMA, the U.S. Chamber of Commerce and a number of musculoskeletal companies, made up a coalition urging Congress to repeal the $20 billion medical device tax. Dated July 18th, the letter states that the tax will "adversely impact patient care and innovation, and will substantially increase the costs of health care." more

Alphatec Spine, Inc. Receives Japanese Regulatory Shonin Approval for Illico SE Posterior Fixation Percutaneous Screw System for Minimally Invasive Surgery BY EDITOR, JULY 18, 2011

Alphatec Holdings, Inc. today announces the Japanese launch of its Illico SE Posterior Fixation Percutaneous Screw System for minimally invasive surgery. more

Hamburg Appoints New Leadership at FDA BY LAUREN UZDIENSKI, JULY 14, 2011

The Wall Street Journal reports this morning that FDA commissioner Margaret Hamburg has created several new deputy commissioner roles, continuing to fill the responsibilities left vacant since former deputy commissioner Joshua Sharfstein's resignation. more

Musculoskeletal News Roundup 14-Jul-11 BY LAUREN UZDIENSKI, JULY 14, 2011

Biomet announces F4Q:11 . . . ConforMIS gets $1.4M loan . . . IlluminOss announces first treatment of a fibula fracture . . . SpinalCyte receives patent, publishes research paper . . . Vertos Medical study results . . . Stryker no longer distributing Corin's Cormet system . . . Wright Medical announces distribution agreement with ArthroCare more

KCI to Be Acquired for $5B BY LAUREN UZDIENSKI, JULY 13, 2011

Kinetic Concepts Inc. announced this morning that they had agreed to be taken private for $4.98 billion in a leveraged acquisition led by private equity firm Apax Partners. more

WSJ: JNJ Facing $1+ Billion in ASR Costs BY LAUREN UZDIENSKI, JULY 11, 2011

A Wall Street Journal article on Friday highlighted three companies facing "mass litigation": Toyota for unintended acceleration, BP for last year's massive oil spill and, now, DePuy and the ASR XL hip. more

Medtronic Announces Two Surgical Device Acquisitions BY SANDER DUNCAN, JULY 7, 2011

Medtronic agreed today to acquire the remaining stakes in two "energy surgical technology" companies, Salient Surgical Technologies and PEAK Surgical, for a total of about $585 million. more

Olympus Biotech Launches Opgenra, Formerly OP-1 BY LAUREN UZDIENSKI, JULY 7, 2011

Olympus Biotech announced this week that the company launched their BMP-7 product, which they've named Opgenra, in Europe. Olympus acquired Opgenra, formerly OP-1, from Stryker late last year, paying $60 million for the OP-1 portfolio and the New Hampshire facility that manufactures it. more

Musculoskeletal News Roundup 7-Jul-11 BY LAUREN UZDIENSKI, JULY 7, 2011

Amplitude sold to Apax France . . . ARTC sells vertebroplasty products . . . SpineVision raises $5M . . . Medtronic launches CD HORIZON Fenestrated Screw in Europe . . . RTI Biologics launches BioAdapt DBM Foam . . . DFINE study suggests lower cement leakage rate for Radiofrequency Targeted Vertebral Augmentation . . . MEDICREA to launch pilot study for GRANVIA-C cervical disc more

Synthes' Michel Orsinger Set to Be Named Chairman at Nobel Biocare BY LAUREN UZDIENSKI, JULY 5, 2011

Nobel Biocare announced plans to appoint Michel Orsinger, President and CEO of Synthes, as Chairman of the Board. This announcement comes in advance of the March 2012 annual general meeting, when the Board is expected to formally elect Orsinger to the post. The press release notes that, "Due to his commitments at Synthes, Michel Orsinger will only become available as of early 2012." more


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