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March 14-18 - American Association of Orthopaedic Medicine Annual Meeting 2017

March 14-December 31 - Canaccord Genuity Musculoskeletal Conference

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Orthopedic and Dental Industry News Complete Archive »

Medtronic/Sofamor Danek

K2M to Acquire e-Fellow and Launches Implant and Services Platform, Balance ACS BY BLAKE MOSSY, MARCH 7, 2017

K2M entered into an agreement to acquire e-Fellow, a mobile software platform that aims to streamline the patient billing and care process. e-Fellow offers service-based technology that provides real-time automated solutions that gathers and secures patient data, insurance preauthorization documentation,... more

Medtronic Launches its Orthopedic Solutions Initiative BY ANDREW VAHRADIAN, NOVEMBER 14, 2016

Medtronic launched its Medtronic Orthopedic Solutions initiative, a comprehensive offering that seeks to improve patient outcomes and reduce costs for hospitals/patients across an entire episode of care of total joint replacement procedures. The company has developed this new offering in... more

Medtronic Completes the $20M Second Tranche of its Equity Investment in Mazor Robotics BY ANDREW VAHRADIAN, AUGUST 17, 2016

Medtronic completed the second tranche of its equity investment in Mazor Robotics, an Israeli surgical robotics company. Pursuant to a previously executed agreement between the parties, Mazor issued new securities representing 3.40% percent of the company's issued and outstanding share... more

FDA Approves Medtronic's Two-Level Prestige LP Cervical Disc BY ANDREW VAHRADIAN, JULY 25, 2016

Medtronic received clearance from the FDA for its Prestige LP Cervical Disc, indicated for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments of the neck. Prestige has a... more

Zimmer Biomet Acquires 59% Stake in Medtech SA with Plans to Buy the Remaining Stake in the Future BY ANDREW VAHRADIAN, JULY 19, 2016

Zimmer Biomet acquired a 59% stake in Medtech Société Anonyme, a French-based company that develops surgical robotic technologies to assist surgeons during medico-surgical interventions. The transaction values the business at an approximate enterprise value of $123.5 million, or 9.9x LTM... more

Bioventus Proposes $150M IPO BY ANDREW VAHRADIAN, JULY 5, 2016

Bioventus Inc. filed an S-1 to raise up to $150 million through an initial public offering (IPO) of common shares. The price range and number of shares to be sold in the offering has not yet been determined. The company... more

Medtronic Outlines Certain Details of its Strategic Initiatives in Robotics BY ANDREW VAHRADIAN, JUNE 21, 2016

Along with entering into a two-stage, multi-faceted, commercial agreement with Mazor Robotics for the co-promotion, co-development of robotic-based spine systems and applications, Medtronic outlined other strategic initiatives within the robotics marketplace, including certain parameters on the launch of its proprietary... more

Medtronic to Acquire Responsive Orthopedics BY ANDREW VAHRADIAN, JUNE 7, 2016

Medtronic announced the acquisition of Responsive Orthopedics, a developer of low-cost primary joint replacement systems. In order to address the various macroeconomic changes taking place in the U.S. health care system, Responsive Orthopedics has focused on developing a platform of... more

Mazor Enters into Co-development and Equity Purchase Agreements with Medtronic BY ANDREW VAHRADIAN, MAY 19, 2016

Mazor Robotics entered into two strategic agreements with Medtronic. The first being a co-development and distribution agreement, and the second being an equity investment of up to $52 million, which could see Medtronic own up to a 15% stake in... more

Medtronic to Acquire Smith & Nephew's Gynecology Portfolio for $350M BY ANDREW VAHRADIAN, MAY 19, 2016

Medtronic entered into an agreement to acquire Smith & Nephew's gynecology (GYN) portfolio for approximately $350 million. Under the terms of the transaction, Medtronic acquires Smith & Nephew's TRUCLEAR System, a platform used to remove abnormal uterine tissue like polyps... more

Medtronic Prices $3.0 Billion Tender Offer BY ANDREW VAHRADIAN, APRIL 20, 2016

Medtronic plc published the pricing terms of a $3.0 billion cash tender offer of various debt securities. The senior notes will be issued by two of Medtronic's wholly-owned subsidiaries, Medtronic, Inc., and Covidien International Finance S.A. (CIFSA). The new set... more

Medtronic Receives Expanded Clearance from the FDA for INFUSE BY ANDREW VAHRADIAN, DECEMBER 14, 2015

Medtronic received an expanded clearance from the FDA for additional spine surgery indications for its INFUSE Bone Graft. INFUSE is Medtronic's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2), which stimulates bone growth in anterior lumbar interbody fusion and... more

Medtronic Restructuring Frees Up $9.3B in Assets for General Corporate Purposes BY ANDREW VAHRADIAN, OCTOBER 7, 2015

As part of its $47 billion acquisition of Covidien PLC, Medtronic re-domiciled its legal headquarters from Fridley, MN, to Ireland earlier this year. The company cites that this move enhances spending flexibility and confidence in its ability to meet financial... more

Medtronic to Acquire RF Surgical for $235M BY ANDREW VAHRADIAN, JULY 14, 2015

Medtronic entered into a definitive agreement to acquire RF Surgical Systems, a medical device company that has developed a platform for the detection and prevention of retained surgical items such as sponges, towels and gauzes, helping surgeons avoid leaving such... more

Leading Western Medical Device Companies Form the First Asian-Pacific Industry Trade Group BY ANDREW VAHRADIAN, APRIL 30, 2015

Leading medical technology companies including Abbott, Baxter, B. Braun, Becton Dickinson, Boston Scientific, Cardinal Health, GE Healthcare, Johnson & Johnson, Medtronic, Philips, Siemens, Stryker and Zimmer, have formed the first industry trade group focused solely on the Asian-Pacific healthcare market.... more

Medtronic Receives Regulatory Clearances for Covidien Acquisition BY ANDREW VAHRADIAN, DECEMBER 4, 2014

Medtronic announced it has received antitrust clearances from the U.S. Federal Trade Commission (FTC), European Commission (EC), Canadian Competition Bureau (CCB), Chinese Ministry of Commerce (CMC) and South Korean Fair Trade Commission (SKFTC), regarding its $43 billion pending acquisition of... more

Medtronic to Utilize External Debt to Finance Its Acquisition of Covidien BY ANDREW VAHRADIAN, OCTOBER 6, 2014

Medtronic disclosed that it intends to use approximately $16 billion in external financing to complete its previously announced $43 billion acquisition of Covidien plc, rather than utilizing a combination of a $13.5 billion intercompany loan from a foreign subsidiary, and... more

Integra to Acquire Medtronic ENT and Laparoscopy Instrumentation Lines for $60M BY ANDREW VAHRADIAN, SEPTEMBER 23, 2014

Integra LifeSciences entered into an agreement with Medtronic to acquire Medtronic's MicroFrance and Xomed manual Ear, Nose & Throat (ENT) and laparoscopy instrumentation lines for approximately $60 million in cash. Under the terms of the agreement, Integra acquires a portfolio... more

Medtronic to Acquire Covidien for $42.9B BY MATTHEW JAFFE, JUNE 16, 2014

Medtronic announced that they have entered a definitive agreement to acquire Covidien in a total cash and stock transaction of $42.9 billion. Under the terms of the transaction, for each share held, a Covidien shareholder will receive $35.19 in cash... more

Humana Sues Medtronic Over Marketing Strategy of INFUSE BY ANDREW VAHRADIAN, JUNE 9, 2014

Last week, Humana filed a lawsuit against Medtronic accusing the defendant of falsely representing its INFUSE Bone Graft product as "safe and effective" in spinal fusion surgeries. INFUSE is Medtronic's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2), which... more

Medtronic Reported to be Considering an Acquisition of Smith & Nephew BY ANDREW VAHRADIAN, JUNE 5, 2014

Medtronic is reported to be considering an acquisition of Smith & Nephew. Presently, no offer is imminent as Medtronic's bid preparations are believed to be at an early stage. The transaction would impart greater leverage to Medtronic with payor and... more

Medtronic CEO Discusses the Company's Growth Vectors BY ANDREW VAHRADIAN, JANUARY 17, 2014

Medtronic Chairman & CEO, Omar Ishrak, highlighted the company's strategic initiatives at J.P. Morgan's Healthcare Conference earlier this week in San Francisco. Mr. Ishrak outlined the three growth vectors driving Medtronic's overall strategy: therapy innovation, globalization and economic value. He... more

Medtronic Presents 7-year Clinical Data for Artificial Disc Replacement BY ANDREW VAHRADIAN, DECEMBER 12, 2013

Medtronic presented 7-year clinical and radiographic outcomes of artificial disc replacement procedures with its PRESTIGE Cervical Disc, which is a stainless steel device that articulates through a ball and trough mechanism. The study enrolled a total 541 patients and compared... more

Partnerships & Startups Helping to Expand Med Device Industry into the Emerging Markets BY ANDREW VAHRADIAN, DECEMBER 3, 2013

The once U.S.-centric medical device industry is maturing into a more globally connected industry as a greater number of U.S. medtech manufacturers are seeking to expand into emerging markets like China, India and Israel through investments in startups or partnering... more

Hospitals to Settle with Federal Government over Fraudulent Billing Scheme BY ANDREW VAHRADIAN, JULY 9, 2013

Fifty-five hospitals in 21 states will be paying a total of $34 million to the federal government in order to settle allegations that they overcharged Medicare and other government healthcare programs for kyphoplasty back procedures. The settlements were the result... more

Medtronic Announces the Publication of the Yale Review of INFUSE BY ANDREW VAHRADIAN, JUNE 19, 2013

Medtronic announced the publication of two highly anticipated independent reviews overseen by Yale University regarding its INFUSE Bone Graft product, the company's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2). The results of both analyses, published in the June... more

Musculoskeletal News Roundup 23-May-2013 BY LAUREN UZDIENSKI, MAY 23, 2013

MDT reports earnings ... OsteoGeneX receives SBIR grant ... FDA panel votes to reclassify pedicle screws for the thoracolumbosacral class II ... Depuy Synthes to discontinue ULTAMET Metal-on-Metal Articulation and COMPLETE Ceramic-on-Metal hip systems ... KFx receives new patents ... Benvenue Medical completes follow-up for KAST study ... Globus files suit against Depuy Synthes ... Blue Belt partners with DJO ... EOS announces Asia expansion ... Stryker and OrthoSensor extend co-marketing agreement for VERASENSE more

Medtronic Reports Stabilizing Spine Division BY LAUREN UZDIENSKI, MAY 23, 2013

Medtronic reported fiscal fourth-quarter earnings on Tuesday, with revenues of $4.5 billion and adjusted EPS of $1.03 beating analysts' expectations by $0.1 billion and $0.07, respectively. Spine sales were flat overall at $811 million, with CEO Omar Ishrak noting on the call that segments of Core Spine were "not only stabilizing but actually growing." more

Medtronic CEO Discusses Strategy in India BY ANDREW VAHRADIAN, APRIL 24, 2013

Medtronic CEO, Omar Ishrak, sat down for an interview with the Economic Times and discussed the company's strategy regarding the Indian marketplace. Medtronic's devices are generally utilized by developed economies as they are perceived to be premium segment products. The... more

Medtronic CEO, Omar Ishrak, Discusses Future Plans BY ANDREW VAHRADIAN, JANUARY 16, 2013

At the J.P. Morgan Healthcare Conference in San Francisco last week, Medtronic CEO, Omar Ishrak, proclaimed that the company will devote its energies in 2013 to exploring M&A opportunities, accelerating the company's global expansion strategy and adjusting to the health... more

Medtronic and Weigao End Distribution Joint Venture BY ANDREW VAHRADIAN, DECEMBER 3, 2012

Medtronic and Weigao have decided on an early end for their distribution joint venture, Medtronic Weigao Orthopaedic ("JV"), which distributes orthopedic implants, instruments and devices in China, initiated in December 2007. This realignment by Medtronic is not surprising as the... 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

Medtronic to Acquire China Kanghui for $816M BY LAUREN UZDIENSKI, SEPTEMBER 28, 2012

Medtronic announced yesterday plans to acquire China Kanghui Holdings, a move that will strengthen the company's presence in the emerging markets. Medtronic will pay $816 million in cash for Kanghui, or or $30.75 per American depositary receipt. Net of cash, the deal is valued at $755 million, which is about 11.9x estimated 2012 revenues of $63.6 million, and represents a 22% premium over yesterday's closing price. 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

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

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 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

Report: Medtronic Weighing Indian Investment BY LAUREN UZDIENSKI, JULY 24, 2012

MedCity News reported that Medtronic is reportedly in talks to make an investment in Chennai, India-based Trivitron Healthcare. The report follows last year's comments from Medtronic CEO Omar Ishrak that India was Medtronic's "biggest hole" and a geography in which the company was actively trying to invest. more

Musculoskeletal News Roundup 31-May-12 BY LAUREN UZDIENSKI, MAY 31, 2012

Globus Medical files amended S-1 ... Medtronic receives CE mark for SHILLA scoliosis system ... Zimmer launches Sidus Stem-Free Shoulder and TM Ardis Interbody System ... House and Senate pass user fee legislation ... Orthofix's Phoenix MIS and Firebird Pedicle Screw Systems to be integrated with Brainlab navigation systems ... TransCorp Spine names President and CEO more

Medtronic Talks Spine on F4Q:12 Earnings Call BY LAUREN UZDIENSKI, MAY 24, 2012

On Tuesday Medtronic announced earnings results from its F4Q:12, which included improving sales in spine. The company reported quarterly spine revenue of $818 million, which declined by 6% overall and 2% after excluding the negative impact U.S. sales of INFUSE. The company benefited from international sales, with OUS spine up 8%, including over 20% growth in the Japanese market. On the call, management added that "business is particularly strong in China, where our joint venture with Weigao is delivering solid results." more

Musculoskeletal News Roundup 24-May-12 BY LAUREN UZDIENSKI, MAY 24, 2012

Medtronic reports earnings ... AxioMed closes Series D round ... Mazor launches C-OnSite ... BlueCross BlueShield of Tennessee announces bundled payments for hip and knee replacements ... Baxano completes enrollment on iO-Flex study ... Benvenue announces Board appointments more

Musculoskeletal News Roundup 19-Apr-12 BY LAUREN UZDIENSKI, APRIL 19, 2012

JNJ, Stryker announce earnings ... EU approves JNJ's acquisition of Synthes ... DePuy launches VIPER F2 Transfacet Pedicular System ... IART introduces Vu aPOD Prime IBD ... Mesoblast reaches 50% enrollment on phase II study ... OREF announces $3.1 million in grants more

Musculoskeletal News Roundup 22-Mar-12 BY LAUREN UZDIENSKI, MARCH 22, 2012

KH reports earnings ... Tepha raises $11M ... Anulex resolves FDA warning letter ... IART launches PyroTITAN Humeral Resurfacing Implant ... Benvenue Medical begins enrollment on Luna Interbody System study more

Musculoskeletal News Roundup 16-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 16, 2012

co.don, CNMD, DJO and Synthes report ... Baxter closes Synovis acquisition ... Amedica announces $30M debt financing, launches Valeo VBR ... Cayenne Medical raises $10M ... SNN introduces POLARCUP Dual Mobility Hip ... Medtronic seeking royalties, interest relating to NUVA patent case ... Amedica appoints CEO 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

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

Musculoskeletal News Roundup 8-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 7, 2011

Mazor reports earnings . . . HealthpointCapital acquires Blue Belt Technologies . . . DFINE receives regulatory clearance in Canada and Mexico . . . LDR approved to market ROC-C cervical cage, ROI-A ALIF cage in China . . . Ranier receives CE mark for Cadisc-C . . . DePuy launches Expedium Neuromuscular System . . . Exactech extends DPA . . . CA sobpoenas MDT over Infuse . . . IART opens China office . . . JNJ names Michel Orsinger worldwide chairman of its Global Orthopedics Group more

Medtronic to Cut Another 25% from Production Costs BY LAUREN UZDIENSKI, NOVEMBER 29, 2011

Seeking to improve efficiency and make the company more competitive in emerging markets, Medtronic CEO Omar Ishrak plans to reduce cost-of-goods-sold by 25% over the next five years. This announcement comes in the last year of a prior five-year program to lower product costs, which has saved the company around $1 billion. more

Musculoskeletal News Roundup 23-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 23, 2011

MDT reports F2Q . . . TSON gives reimbursement update . . . Expanding Orthopedics comments on XPED expandable pedicle screw study . . . NREF and OREF to establish Collaborative Spine Research Foundation more

Medtronic Reports Better-than-Expected Spine Sales BY LAUREN UZDIENSKI, NOVEMBER 22, 2011

Medtronic announced sales from its second fiscal quarter this morning, and spine's performance was generally better than most analysts anticipated. Spine sales declined by 3% on a constant currency basis to $839 million. Core Spinal contributed $631 million and declined by 3% during the quarter, while biologics contributed $208 million and declined by 4% during the quarter. more

Infuse Linked to Cancer BY LAUREN UZDIENSKI, NOVEMBER 7, 2011

Eugene Carragee, who devoted the entire June issue of his Spine journal to concerns about Infuse, has now identified a link between cancer and the graft material. He presented his data at NASS last week. more

MDT's Ishrak: U.S. Should "Absolutely" Adopt EU Regulatory System BY LAUREN UZDIENSKI, OCTOBER 5, 2011

In comments to the Financial Times, Medtronic CEO Omar Ishrak criticized the FDA for a slow regulatory process that limits patient access to care. In the EU, "the response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers are less stringent," Mr Ishrak told the FT. He also spoke in favor of adopting a regulatory process more like the Europe's, adding, "It will certainly put products on the market more quickly, so from a very selfish device manufacturer perspective, absolutely." more

First Round Concludes in Medtronic/NuVasive Patent Lawsuit BY SANDER DUNCAN, SEPTEMBER 21, 2011

A jury ruled that NuVasive infringed on three of Medtronic's patents, while Medtronic was also guilty of infringing on one of NuVasive's. NuVasive was ordered to pay $101 million in damages and royalties on each of the three patents in question, while Medtronic must pay NuVasive $660,000. more

Medtronic's "Biggest Hole": Omar Ishrak's Plans for India BY SANDER DUNCAN, SEPTEMBER 13, 2011

In a recent interview, Medtronic CEO Omar Ishrak outlined his push into the Asia Pacific region and his particular focus on India as a source of growth. These plans follow Medtronic's recently-announced intentions to double their workforce in China by 2016. more

Omar Ishrak Striving to Restore Growth at Medtronic BY LAUREN UZDIENSKI, AUGUST 24, 2011

On Medtronic's Tuesday earnings call, new CEO Omar Ishrak announced that his top priority was restoring growth to the company, which he said was achievable by improving execution, optimizing innovation and accelerating globalization. more

Medtronic to Double Chinese Workforce BY SANDER DUNCAN, AUGUST 11, 2011

Medtronic sees a bright future in China, seeking to double its workforce there by 2016. Meanwhile, it's new Asia-Pacific headquarters recently opened in Shanghai along with a globally-focused R&D center. more

Medtronic Funds Yale Reviews of Infuse BY SANDER DUNCAN, AUGUST 5, 2011

Following significant media and academic backlash against Infuse, Medtronic is taking several novel steps toward developing data transparency and defending the science behind its product. more

Musculoskeletal News Roundup 4-Aug-11 BY LAUREN UZDIENSKI, AUGUST 4, 2011

ATEC, ANIK, ARTC, BMTI, EXAC, SNN, SMA announce earnings . . . Ellipse Technologies announces series C round . . . CMS announces IPPS final rule . . . KFx Medical sues Arthrex . . . Tornier initiates IDE study 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

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

Musculoskeletal News Roundup 30-Jun-11 BY LAUREN UZDIENSKI, JUNE 30, 2011

Stryker completes Orthovita tender offer . . . ConforMIS to raise $68M . . . FDA clears Corin's highly cross-linked polyethylene liners and large diameter CoCr and BIOLOX Delta Ceramic heads . . . Aesculap launches Hydrolift Vertebral Body Replacement System . . . Cayenne Medical debuts the CrossFix II Meniscal Repair System . . . Mesoblast receives FDA clearance to begin phase II DDD study more

Spine Journal Dedicates Latest Issue to Infuse Controversy BY LAUREN UZDIENSKI, JUNE 29, 2011

The backlash against Infuse is escalating this week with the announcement that the Spine Journal would dedicate its June issue to bias in published data on Infuse. In addition to highlighting the under-reporting of adverse events, the journal argues for improvements in transparency and disclosure requirements in the scientific literature. more

Senators Request Infuse Documents from Medtronic BY LAUREN UZDIENSKI, JUNE 22, 2011

In a letter to Medtronic, Senators Baucus and Grassley requested documentation relating to Infuse consultants, adverse events, FDA reporting and journal articles. The investigation follows recent news concerning a link between Infuse and male sterility. more

Infuse Linked to Infertility in Men BY LAUREN UZDIENSKI, MAY 25, 2011

A retrospective review of Medtronic's Infuse study published in the Spine Journal this week showed a correlation between male patients treated with Infuse and sterility. Medtronic and the surgeon investigators in the study attributed the side effect to surgeon technique and not Infuse itself, which is why it had generally been excluded in previously published studies. more

Medtronic Names New Chairman and CEO BY LAUREN UZDIENSKI, MAY 10, 2011

This morning Medtronic named Bill Hawkins' successor, appointing Omar Ishrak as the company's chairman and chief executive officer. more

Senator Questions Medtronic Over Canceled GPO Contracts BY LAUREN UZDIENSKI, MAY 4, 2011

When Medtronic canceled certain contracts with GPOs Novation in Premier back in March, they alleged that ending these relationships would save the company money. Now the government is worried that move will cost Medicare money, and Senate finance committee chairman Max Baucus has announced plans to investigate the company's choice to cancel what was reportedly $2 billion in contracts with Novation and Premier. more

Musculoskeletal News Roundup 24-Mar-11 BY LAUREN UZDIENSKI, MARCH 24, 2011

China Kanghui reports earnings, announces acquisition . . . FlexFix to acquire assets from Novalign . . . Newly-formed Rachiotek to acquire Applied Spine Technologies . . . Core Essence raises $11.5M . . . LDR submits PMA for two-level Mobi-C . . . FDA clears TSON's AxiaLIF 1L+ . . . FDA approves Seikagaku's single-injection HA . . . Pioneer Surgical launches the the Streamline TL Spinal Fixation System . . . Spinal Kinetics announces 10,000th implantation of M6 Disc . . . Medtronic of Canada releases data from study on kyphoplasty in cancer patients . . . Zimmer signs Department of Defense contract more

Medtronic CFO Comments on Canceling GPO Contracts BY LAUREN UZDIENSKI, MARCH 21, 2011

In response to reports that severing certain device contracts with GPOs Novation and Premier represents a sea change for device distribution, Medtronic replied, not so fast. CFO Gary Ellis sat down at the Barclay's Capital Investors Conference last week to quiet rumors that the company is shying away from GPOs and address some of the speculation about their GPO strategy. more

FDA Issues Non-Approvable Letter for Medtronic's Amplify BY SANDER DUNCAN, MARCH 11, 2011

Medtronic disclosed in its 10-Q on Wednesday that the FDA issued a non-approvable letter for Amplify, its new BMP-2 product. Medtronic was seeking a postero-lateral fusion indication for Amplify, for which Infuse, its other BMP product, is already widely-used off-label. more

Musculoskeletal News Roundup 10-Mar-11 BY LAUREN UZDIENSKI, MARCH 10, 2011

ANIK, BMTI, VITA report 4Q . . . Global Biotech to take minority position in BoneGrafix . . . ConforMIS to raise $1.8M . . . Medtronic launches ATLANTIS VISION ELITE cervical plate system . . . Wright Medical launches PRO-TOE VO . . . OFIX receives subpoena . . . Vertos announces mild clinical data . . . GenOsteo and SpineSmith to collaborate on stem cell scaffold . . . RegeneCure licenses synthetic membrane for use with stem cells . . . Bacterin now trading on NYSE Amex more

Musculoskeletal News Roundup 24-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 24, 2011

ATEC, MDT, NUVA report on 4Q spine market . . . IART, SMA report 4Q:10 . . . Mazor Robotics raises $6.3M . . . FDA clears Zimmer's TM-S Trabecular Metal Cervical Interbody Fusion Device . . . Smith & Nephew receives premium reimbursement in Japan for Oxinium hip . . . Intrinsic Therapeutics enrolls first patient in Barricaid study for anular closure . . . Zimmer reports clinical results for DeNovo NT Graft and the MotionLoc Screws more

Musculoskeletal News Roundup 17-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 17, 2011

ARTC, DJO, GENZ, OFIX and Synthes report earnings . . . Sonoma raises $22 million . . . Anika provides FDA update . . . AAOS product launches . . . Medtronic announces kyphoplasty data more

Medtronic Chairman and CEO Bill Hawkins to Retire BY LAUREN UZDIENSKI, DECEMBER 20, 2010

Medtronic announced this morning that Chairman and CEO Bill Hawkins would retire on April 29, 2011, the end of the company's fiscal year. No successor has been named, and the company said Mr. Hawkins would stay with Medtronic through the transition period. An external search has been initiated. more

Musculoskeletal News Roundup 24-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 24, 2010

MDT reports F2Q:11 . . . Bacterin, Sonoma Orthopedics announce financing rounds . . . curasan AG receives Health Canada approval for Cerasorb M ORTHO . . . Medtronic launches SOVEREIGN Spinal System in Europe . . . Blue Cross Blue Shield of North Carolina releases new lumbar spinal fusion guidelines . . . Stryker supports South Carolina medtech development consortium more

Medtronic CEO Speaks Out on the Spine Market BY LAUREN UZDIENSKI, NOVEMBER 18, 2010

At the Wall Street Journal CEO Council event this week, Medtronic CEO Bill Hawkins addressed some of the challenges in the spine market. more

Musculoskeletal News Roundup 18-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 18, 2010

MDT closes OSTE acquisition . . . Replication Medical receives grant for GelStix development . . . RepRegen raises $1.6M . . . SI-BONE receives CE mark for iFuse . . . FDA clears Titan Spine's Endoskeleton TO . . . Mazor announces clinical results . . . Amedica/US Spine to distribute BioDlogics stem cell products more

Musculoskeletal News Roundup 4-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 4, 2010

ARTC, DJO, EXAC, MAKO, VITA, OSTE, RITX, SNN, SMA report 3Q . . . Xylos receives grant funding . . . FDA clears ArthroCare's SpeedFix Suture Anchor . . . NeoStem receives Chinese reimbursement for an orthopedic stem cell treatment . . . Salient Surgical announces 500,000th patient treated with Transcollation . . . CA judge throws out CareFusion's anti-trust suit against Medtronic more

Musculoskeletal News Roundup 16-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 16, 2010

NUVA lowers guidance . . . HydroCision acquired by three VC firms; new President and CEO appointed . . . TiGenix closes seed financing round for new pharma spinoff . . . Creaspine, Ranier Technology receive CE mark clearances . . . Medtronic introduces Kyphon Cement Delivery System in Europe . . . SpineAlign Medical introduces European Observational Registry for the VerteLift System . . . Medtronic wins certain rulings in ongoing patent infringement suit brought by Synthes . . . Synthes sues Biomet, former sales rep more

Musculoskeletal News Roundup 26-Aug-10 BY LAUREN UZDIENSKI, AUGUST 26, 2010

Corin, Medtronic, TiGenix report . . . DePuy warned over TruMatch Personalized Solutions System and Corail Hip System . . . FDA clears Medyssey's Zenius Thoracolumbar Spinal System . . . Binder Biomedical launches NEWTON Intervertebral Body Spacer System . . . CareFusion launches AVAmax Vertebral Balloon . . . DePuy recalls ASR system . . . Benvenue Medical enrolls first patient in VCF study . . . MAKO Surgical appoints Director more

Medtronic Reports "Difficult" Quarter BY LAUREN UZDIENSKI, AUGUST 25, 2010

Medtronic reported a disappointing F1Q:11 on Tuesday, missing analysts' revenue estimates and depicting slowing growth in their spine division. Spine sales declined by 9% as reported, to $829 million, though adjusting for currency shifts and extra selling days in fiscal 2010, revenues decreased by 5%. more

Musculoskeletal News Roundup 19-Aug-10 BY LAUREN UZDIENSKI, AUGUST 19, 2010

Medtronic to acquire Osteotech . . . Stryker may buy Boston Scientific's neuromodulation unit . . . SI-Bone raises $11M . . . Aesculap received 510(k) clearance for the A-Fix Spinal System . . . Biomet responds to FDA warning letter . . . Benvenue Medical announces first U.S. use of the Blazer system for treating VCFs . . . Cytori receives patent for stem cell use in musculoskeletal applications . . . NuOrtho Surgical announces pre-clinical results . . . RTI Biologics reports "no change" to Medtronic supply agreement more

Medtronic to Acquire Osteotech for $123M BY LAUREN UZDIENSKI, AUGUST 17, 2010

Medtronic and Osteotech have signed a definitive agreement under which Medtronic will acquire Osteotech in an all-cash transaction valued at approximately $123 million, or $6.50 per share. This represents a 65% premium over yesterday's close of $3.94 and around a 1.3x multiple on trailing 12-month revenues. more

FDA Panel Recommends Medtronic's Amplify BY LAUREN UZDIENSKI, JULY 28, 2010

An FDA panel voted 6-5 yesterday in favor of approving Medtronic's Amplify, a BMP-2 with a different formulation and carrier than InFuse. Heading into the meeting, concerns circulated over a higher incidence of cancer in patients treated with Amplify, though the panel ultimately voted 9-4 in support of safety (with 1 abstention) and 10-3 (with 1 abstention) on efficacy. more

Musculoskeletal News Roundup 1-Jul-10 BY LAUREN UZDIENSKI, JULY 1, 2010

Biomet and RSB Spine announce revenues . . . Bacterin announces reverse merger, private placement . . . FDA begins review of BioMimetic's Augment . . . Cerapedics receives CE mark for iFactor bone graft . . . DFine signs distribution agreements for Italy and Morocco . . . Michael DeMane declines CEO, Chairman role at Lanx more

FDA Sets Panel Date for Amplify, Medtronic's Other BMP-2 BY LAUREN UZDIENSKI, JUNE 28, 2010

The FDA announced that on July 27, a CDRH panel will convene to discuss the PMA for Medtronic's Amplify, a BMP-2 matrix designed for single-level posterolateral lumbar fusions. The material has a different formulation and carrier than InFuse and is indicated as a treatment for degenerative disc disease. more

Musculoskeletal News Roundup 24-Jun-10 BY LAUREN UZDIENSKI, JUNE 24, 2010

Baxano closes $30M series C . . . SpineForm, Lanx, OrthoHelix receive $1M Ohio Third Frontier Commission awards . . . Aesculap launches S4 MIS Cannulated Pedicle Screw Spine Fusion System . . . Medtronic launches KYPHON ActivOs 10 Bone Cement with Hydroxyapatite . . . SNN granted injunction against Arthrex . . . Senate passes Medicare pay patch . . . Kensey Nash, Arthrex sign agreement over KNSY's ECM . . . Therapure, ProChon Biotech ink manufacturing deal . . . NuVasive leases NJ office space . . . BioTime creates new stem cell subsidiary more

Medtronic Analyst Day 2010: Reporting on MDT's Spinal Unit and Acquisition Activity BY SANDER DUNCAN, JUNE 8, 2010

Medtronic (MDT) centered its June 7, 2010 analyst day on how to leverage its size and scale in an increasingly competitive market. MDT does not plan to grow through large-scale acquisition, with chairman and chief executive Bill Hawkins noting that... more

Musculoskeletal News Roundup 3-Jun-10 BY LAUREN UZDIENSKI, JUNE 3, 2010

Mazor announces first German GO-LIF sales . . . OrthoDynamix launches the ArthroSteer Biter . . . Osprey Biomedical introduces the Eagle Cervical Allograft Series . . . DOJ settles with Idaho orthopedists . . . Stryker and Wright Medical settle knee infringement suit . . . Amedica awarded patent . . . AOFAS releases position paper on total ankle replacement . . . Pioneer Surgical announces NuBac data . . . RepRegen reports StronBone data . . . Medtronic to report physician payments greater than $5,000, and Steve La Neve steps down from spine & biologics more

Musculoskeletal News Roundup 27-May-10 BY LAUREN UZDIENSKI, MAY 27, 2010

Medtronic announces FQ4 . . . Exactech acquires Brighton Partners, supplier of Optetrak knee material . . . VentureMD closes funding round . . . KFx cleared to market AppianFx knee products . . . X-spine receives FDA clearance for Fixcet Spinal Facet Screw System . . . Applied Spine awarded patents . . . DFine, Vertos release clinical data . . . curasan collaborates with Matricel on bone graft substitute . . . SpineGuard appoints Alan Olsen Chairman of the Board more

CareFusion Sues Medtronic BY JOHN MCCORMICK, MARCH 25, 2010

logo_care_fusion.gifYesterday the news circulated that CareFusion, an upstart in the vertebral compression fracture market, has sued Medtronic for violating antitrust laws. With a 619-page complaint in a Federal Court no less. Antitrust? A newcomer suing the incumbent right out of the box? Talk about going against a time-honored tradition! more

Musculoskeletal News Roundup 25-Mar-10 BY LAUREN UZDIENSKI, MARCH 25, 2010

Bovie Medical, Custom Spine receive FDA clearances . . . Stryker resolves an FDA warning letter . . . Aesculap launches Spyder MIS retractor system . . . RTI Biologics opens reimbursement hotline . . . NASS surveys spine physicians about Medicare cuts . . . ConMed, Smith & Nephew and Stryker ink deals with Premier Purchasing Partners more

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI, MARCH 11, 2010

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 25-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 25, 2010

xray_small.jpgAlphatec Spine reported 4Q:09 revenues of $36.6 million, an increase of 29% from the $28.4 million reported in 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. Asian revenues were $6.6 million, an increase of 38% from the $4.8 million reported for 4Q:08. European revenues in 4Q:09 were $1.7 million. more

Musculoskeletal News Roundup 25-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 25, 2009

Earnings ArthroCare reported 3Q:09 sales of $76.4 million, representing an increase of 8% over 3Q:08. Analysts had forecast total revenues of $84.3 million. Sports medicine contributed $50.6 million in sales, up 11% over the year-ago period, and spine contributed $4.5... more

Musculoskeletal News Roundup 19-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 19, 2009

Earnings ArthroCare restated its earnings from 2004 through 2Q:09. The company reported total revenue for 2008 of $314.2 million, up 12% over 2007. Relative to prior-year periods, 1Q:09 revenues increased 2% to $78.8 million; 2Q:09 revenues decreased 6% to $80.8... more

Musculoskeletal News Roundup 12-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 12, 2009

Earnings Alphatec Holdings, Inc. announced record consolidated revenue of $32.7 million in 3Q:09, which represents 27% growth over 3Q:08. U.S. revenue increased 21% over the prior-year third quarter and 28% over the first nine months of 2008. International revenue was... more

Musculoskeletal News Roundup 15-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 15, 2009

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, OCTOBER 8, 2009

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

Musculoskeletal News Roundup 1-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 1, 2009

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, SEPTEMBER 24, 2009

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 10-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 10, 2009

M&A Kapstone Medical acquired exclusive rights to Spherofix's screw-locking technology, which the company plans to incorporate into a line of spinal implants. Terms of the deal were not disclosed. Regulatory Covidien received FDA approval to market its DuraSeal spine sealant,... more

Musculoskeletal News Roundup Aug-27-09 BY LAUREN UZDIENSKI, AUGUST 27, 2009

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

Medtronic's FQ1:10 Shows Stability in Spine BY LAUREN UZDIENSKI, AUGUST 26, 2009

Medtronic announced their FQ1:10 results on Tuesday, which included $915 million in spine revenues. This reflects an 8% (constant currency) increase over the year-ago period, though it should be noted that Medtronic had about an extra week of selling days... more

Musculoskeletal News Roundup 13-Aug-09 BY LAUREN UZDIENSKI, AUGUST 13, 2009

Earnings BioMimetic Therapeutics reported 2Q:09 royalty and sublicense revenue of $0.4 million, missing estimates by $0.1 million. The company reported a net loss of $6.3 million, or $0.32 per share, beating estimates by $0.17. Among the highlights for the quarter... more

NEJM Studies Challenge the Efficacy of Vertebroplasty BY LAUREN UZDIENSKI, AUGUST 7, 2009

Two studies published this week in the New England Journal of Medicine cast doubts over the efficacy of vertebroplasty. The first study, conducted in Australia, randomized 78 patients in a multicenter, double-blind, placebo-controlled trial in which participants with one or... more

Musculoskeletal News Roundup 23-Jul-09 BY LAUREN UZDIENSKI, JULY 23, 2009

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

Musculoskeletal News Roundup 9-Jul-09 BY LAUREN UZDIENSKI, JULY 9, 2009

Earnings Exactech announced that 2Q:09 revenues would be approximately $43.0 million, below earlier guidance and analyst expectations of approximately $45.0 million. The range for full-year 2009 revenue guidance has also been lowered to $167-$173 million. The company attributed 2Q's sales... more

Musculoskeletal News Roundup 2-Jul-09 BY LAUREN UZDIENSKI, JULY 2, 2009

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

BMPs Increase Complications for Cervical Fusion Patients BY LAUREN UZDIENSKI, JULY 1, 2009

A study published in JAMA reviewed use of BMPs in spinal fusion surgeries, and outcomes included higher complication rates for off-label use in cervical fusions and increased charges for all procedures. Researchers at Brigham and Women's Hospital in Boston conducted... more

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI, JUNE 25, 2009

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 18-Jun-09 BY LAUREN UZDIENSKI, JUNE 19, 2009

M&A The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT... more

Musculoskeletal News Roundup 4-Jun-2009 BY LAUREN UZDIENSKI, JUNE 4, 2009

Funding Active Implants raised $10.0 million in a Series C preferred stock offering. The company is developing the TriboFit Hip and NUsurface implant systems based on its polycarbonate urethane technology. In conjunction with the financing round, the company appointed Charles... more

Medtronic Holds Analyst Day BY JOHN MCCORMICK, JUNE 3, 2009

Yesterday, medical device giant Medtronic, Inc. held an "analyst day" in Minneapolis for equity analysts to comb over numbers and get a hearing with management on new strategies and technologies. The key theme was innovation. Given Medtronic's multi-dimensional nature, the... more

FDA Approves Medtronic's Bryan Cervical Disc BY JOHN MCCORMICK, MAY 29, 2009

Medtronic received long-awaited FDA approval for its Bryan cervical disc on May 12. The device received a favorable FDA panel recommendation in July of 2007, just a day after Medtronic's Prestige disc was approved for market launch. Under the conditions... more

Musculoskeletal News Roundup 28-May-09 BY LAUREN UZDIENSKI, MAY 28, 2009

Regulatory Blackstone Medical received an FDA warning letter relating to the ICON Modular Spinal Fixation System, which the company voluntarily recalled in December of 2005. The FDA said Blackstone failed to adhere to its own risk management procedures and failed... more

Musculoskeletal News Roundup 21-May-09 BY LAUREN UZDIENSKI, MAY 21, 2009

Earnings Medtronic reported FQ4:09 revenue of $3.8 billion, representing a 5% increase (constant currency) over FQ4:08 and in line with estimates. Adjusted EPS for the quarter was $0.82, also in line with estimates. Spine and biologics revenue was $881.0 million,... more

More Trouble for InFuse as Fraudulent Data Makes Headlines BY LAUREN UZDIENSKI, MAY 20, 2009

The New York Times reported last week that a former surgeon at Walter Reed Army Medical Center falsified data on InFuse that was published in (and later retracted by) JBJS. The study in question evaluated the use of InFuse for... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more

Musculoskeletal News Roundup 7-May-09 BY LAUREN UZDIENSKI, MAY 7, 2009

Earnings Alphatec Spine reported record consolidated revenue of $30.6 million reported in 1Q:09, which represents 32% growth over 1Q:08 and 8% sequential growth over revenues reported in 4Q:08. U.S. revenue growth of 28% over prior year was approximately three times... more

Medtronic Talks "Disappointing" Kyphon Acqusition and Future Growth BY LAUREN UZDIENSKI, APRIL 15, 2009

In recent interviews, Medtronic CEO Bill Hawkins discussed some of the challenges associated with the company's $4.2 billion acquisition of Kyphon in 2007 as well as plans for future acquisitions. Kyphon brought innovative products and an entree into new markets,... more

Musculoskeletal News Roundup 9-Apr-09 BY LAUREN UZDIENSKI, APRIL 9, 2009

Earnings Biomet reported FQ3:09 revenues of $615 million, a 7% (constant currency) increase over FQ3:08. Among segments, recon reported growth of 7%, with hip up 10%, knee up 9%, fixation up 4% and dental down 10%, which the company attributed... more

Judge Dismisses Whistleblower Lawsuit Against Medtronic Surgeons BY JOHN MCCORMICK, MARCH 27, 2009

Last Friday, federal judge Richard Stearns dismissed the well-publicized whistleblower lawsuit alleging that certain spine surgeons accepted kickbacks for using Medtronic's spinal implants. He also blocked a motion by the two women to file an amended complaint. The lawsuit accused... more

Musculoskeletal News Roundup 26-Mar-09 BY LAUREN UZDIENSKI, MARCH 26, 2009

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

Musculoskeletal News Roundup 26-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 26, 2009

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, FEBRUARY 20, 2009

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 24-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 23, 2008

M&A Medtronic completed its minority investment in Shandong Weigao Group. As a result of the investment, Medtronic now holds a 15 percent equity stake in Weigao. Medtronic purchased its 15 percent equity interest in Weigao for approximately HK$1.7 billion (or... more

Medtronic Completes Minority Investment in China BY JOHN MCCORMICK, DECEMBER 18, 2008

Medtronic announced today that it had completed its long-awaited minority investment in Shandong Weigao Group. As a result of the investment, Medtronic now holds a 15 percent equity stake in Weigao. To facilitate the equity investment, Medtronic purchased its 15... more

Musculoskeletal News Roundup 18-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 18, 2008

Funding In addition to its regularly scheduled payments, Orthofix International will make a $10 million debt prepayment on December 29th in advance of the scheduled maturity. According to Executive Vice President and CFO Bob Vaters, "This is a good time... more

Musculoskeletal News Roundup 11-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 12, 2008

Earnings Wright Medical reiterated 4Q:08 revenue and earnings guidance on a call this week and lowered 2009 guidance based on less favorable foreign exchange rates. The company is now calling for 2009 revenues in the range of $510 million to... more

Musculoskeletal News Roundup 4-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 4, 2008

Earnings Stryker announced a 2008 dividend of $0.40 per share, an increase of 21% over the 2007 dividend, which is payable January 30, 2009. President and CEO Stephen MacMillan said the increased dividend reflects the company's continued growth and strong... more

Musculoskeletal News Roundup 20-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 20, 2008

Earnings Medtronic reported FQ2:09 revenues of $3.57 billion, up 14% (8% constant currency) over the year-ago period and missing estimates by $0.12 billion. Non-GAAP net earnings and diluted earnings per share were $758.0 million, or $0.67 per diluted share, missing... more

Musculoskeletal News Roundup 22-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 22, 2008

Earnings CONMED reported 3Q:08 revenues of $179.4 million, up 9% over the year-ago period and beating estimates by $2.95 million. Arthroscopy was up 18% (17% constant currency), contributing $69.5 million to total sales. On a non-GAAP basis, diluted earnings per... more

Musculoskeletal News Roundup 16-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 16, 2008

Earnings Biomet reported FQ1:09 revenues of $607.0 million, up 13% (9% constant currency) over the year-ago period. Excluding special charges, adjusted operating income was $171.6 million for FQ1:09, up 12% over FQ1:08. Among segments, reconstructive reported $449.3 million in sales,... more

Musculoskeletal News Roundup 21-Aug-08 BY LAUREN UZDIENSKI, AUGUST 21, 2008

Earnings Kensey Nash reported FQ4:08 revenues of $22.0, representing a 29% increase over FQ4:07 and beating estimates by $1.0 million. Biomaterials were up 37% to $13.3 million, which was attributed to strong growth in the orthopedic and cardiovascular product lines.... more

Musculoskeletal News Roundup 31-July-08 BY LAUREN UZDIENSKI, JULY 31, 2008

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

Ex-Medtronic Employees File Whistleblower Lawsuit BY LAUREN UZDIENSKI, JULY 31, 2008

Two former Medtronic employees filed a qui tam lawsuit in a Boston federal court, alleging that more than 100 spine surgeons, neurosurgeons and distributors colluded with Medtronic to defraud Medicare and accepted kickbacks from the company. These are the same... more

Musculoskeletal News Roundup 22-May-08 BY LAUREN UZDIENSKI, MAY 22, 2008

Earnings Medtronic reported FQ4:08 revenue of $3.86 billion, representing an 18% increase over the year-ago period and beating estimates by $0.14 billion. Currency translation had a positive impact of $160.0 million. Adjusted net earnings for the quarter were $884.0 million,... more

Musculoskeletal News Roundup 8-May-08 BY LAUREN UZDIENSKI, MAY 8, 2008

Earnings Artimplant announced 1Q:08 revenues of SEK 2.1 million ($0.35 million), down from SEK 3.9 million ($0.66 million) in 1Q:07. Net loss for the quarter was SEK 6.2 million ($1.04 million), or SEK 10 ($1.68) per share, a deterioration from... more

Musculoskeletal News Roundup 1-May-08 BY LAUREN UZDIENSKI, MAY 1, 2008

Earnings Anika Therapeutics reported 1Q:08 total revenues of $8.55 million, an increase of 46% over the year-ago period, which the company attributed to strong domestic and international sales of ORTHOVISC. Revenues beat analysts' expectations by $0.2 million. Net income for... more

Cervical Artificial Discs Reduce Costs for Patients BY LAUREN UZDIENSKI, APRIL 29, 2008

A new study funded by Medtronic and presented at this week's AANS meeting showed that compared to fusion, patients who underwent cervical disc replacement saved an average of $6,000 in the two years following treatment. 541 patients received either the... more

Musculoskeletal News Roundup 21-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 21, 2008

Earnings ArthroCare reported 4Q:07 revenues of $87.5 million, beating estimates by $1.7 million, representing a 25% increase over the year-ago period. Net income was $14.5 million, or $0.50 per diluted share, missing estimates by a penny and representing a 78%... more

Musculoskeletal News Roundup 7-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 7, 2008

Earnings Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... more

Musculoskeletal News Roundup 27-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 27, 2007

M&A Sandvik AB said its Sandvik Materials Technology division has acquired Medtronic's specialty instrument manufacturing plant in Memphis. Medtronic plans to move the plant's purchasing, receiving and quality functions to the company's development and logistics center nearby. The transaction is... more

Musculoskeletal News Roundup 20-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 20, 2007

M&A BioMimetic announced the impending sale of its dental business and GEM 21S product to Luitpold Pharmaceuticals. Luitpold, who has been distributing the product since 2003, will pay BioMimetic $40.0 million in addition to ongoing royalty and milestone payments. The... more

Medtronic Expands in China with Weigao Joint Venture BY LAUREN UZDIENSKI, DECEMBER 19, 2007

Medtronic announced plans yesterday to bring spine and orthopedic therapies to the Chinese market through a joint venture with Shandong Weigao Group Medical Polymer Company Limited. Under the joint venture agreement, the companies will sell spine and orthopedic products, including... more

Musculoskeletal News Roundup 13-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 13, 2007

Earnings Tutogen reported FY07 revenues of $53.8 million, an increase of 42% over FY06. The Company reported net income of $6.8 million, or $0.36 per fully diluted share in fiscal year 2007 compared to a net loss of $0.6 million,... more

Musculoskeletal News Roundup 21-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 21, 2007

Earnings Medtronic reported FQ2:08 revenue of $3.12 billion, beating estimates by $0.02 million and representing a 2% increase over the year-ago period. Net earnings for FQ2:08 were $666.0 million, or $0.58 per diluted share, beating estimates by $0.02 but down... more

Musculoskeletal News Roundup 8-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 8, 2007

Earnings Anika reported 3Q:07 product revenues of $7.28 million, up from $5.49 million in 3Q:06. The company attributed the sales growth to strong domestic and international sales of ORTHOVISC®. Net income for 3Q:07 was $1.8 million, or $0.16 per diluted... more

Medtronic and Kyphon Complete Merger BY LAUREN UZDIENSKI, NOVEMBER 2, 2007

Medtronic announced today the completion of their acqusition of Kyphon. News of the closing comes earlier than expected; at the time the merger was first announced, Medtronic anticipated a 1Q:08 closing. Stockholders will receive $71.00 per share in cash for... more

Musculoskeletal News Roundup 1-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 1, 2007

Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more

Synthes Gets Approvable Letter from FDA for ProDisc®-C BY LAUREN UZDIENSKI, OCTOBER 25, 2007

Synthes announced this morning that they received an Approvable Letter from the FDA regarding their PMA application for the ProDisc®-C, the company's artificial cervical disc. A full approval order will be made once Synthes' manufacturing processes are reviewed by the... more

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

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, OCTOBER 11, 2007

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 28-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 28, 2007

Legal Federal prosecutors announced on Thursday the terms of a settlement with Zimmer, Depuy, Biomet, Smith & Nephew and Stryker following an investigation into physician compensation practices. Zimmer, Depuy, Biomet and Smith & Nephew entered into deferred prosecution agreements and... more

Musculoskeletal News Roundup 20-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2007

Earnings AOI Medical reported a 1H:07 loss of $1.8 million, increasing from a loss of $0.97 million in the comparable half. The company attributed the loss to increased expenses. They expect their product, the Balloon Assisted Management of Spine Fractures,... more

Medtronic to Market the Prestige Disc to Hispanics BY LAUREN UZDIENSKI, SEPTEMBER 5, 2007

Following recent FDA approval of its Prestige artificial cervical disc, Medtronic announced the launch of a new advertising campaign aimed at Hispanics. The campaign, which was announced in a press release, features a Spanish-language website. In the press release, Dr.... more

Musculoskeletal News Roundup 23-Aug-07 BY LAUREN UZDIENSKI, AUGUST 23, 2007

Earnings aap Implantate announced 38% growth in revenues following its consolidation with Fame Medical Group. Revenues in 1H:07 totaled EUR 12.7 million. Highlights from 2Q:07 include a reported double-digit increase in international sales in the Trauma & Joint Reconstruction segment... more

Musculoskeletal News Roundup 2-August-07 BY LAUREN UZDIENSKI, AUGUST 2, 2007

Earnings Large Joint: Exactech announced 2Q:07 revenue of $31.6 million, beating estimates of $29.9 million and up 19% from the comparable quarter. CEO Bill Petty attributed the growth to "acceptance of our new products and continuing success of our products... more

Musculoskeletal News Roundup 26-July-07 BY LAUREN UZDIENSKI, JULY 26, 2007

Earnings Stryker reported revenues of $1.46 billion, beating estimates of $1.44 billion and increasing 16% from $1.26 billion in 2Q:06. 2Q:07 earnings were $269.1 million, or $0.65 per share, beating estimates of $0.61 and up from $0.52 in the comparable... more

Musculoskeletal News Roundup 19-July-07 BY LAUREN UZDIENSKI, JULY 19, 2007

M&A DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded... more

FDA Panel Supports BRYAN Cervical Disc, but not Superiority Claim BY JOHN MCCORMICK, JULY 17, 2007

Today was a long day in Gaithersburg, Maryland exploring the ins and outs of wear debris and Bayesian statistics. Luckily the dirty work was left to an 11-member panel of sober experts appointed by the FDA to make recommendations on... more

Medtronic's Prestige Cervical Disc Receives FDA Approval BY ARIELLA P. GOLOMB, MD, JULY 17, 2007

Medtronic announced yesterday that the company received conditional FDA approval for its Prestige® Cervical Disc, the first cervical disc to be marketed in the U.S. Approval is contingent upon a seven-year post-approval study to evaluate long-term safety and effectiveness. The... more

Supreme Court to Hear Medtronic Case; Charite Liability Claims Dismissed in CA BY LAUREN UZDIENSKI, JUNE 26, 2007

The Supreme Court announced yesterday that it will hear a Medtronic case involving a failed balloon catheter. The decision could have broader implications for the FDA's authority and product liability. The lawsuit emerged from a catheter failure during Charles Riegel's... more

Orthopedics News Roundup 24-May-07 BY LAUREN UZDIENSKI, MAY 24, 2007

Earnings Medtronic reported FY2007 earnings of $12.3 billion, an increase of 9% over FY2006. Adjusted income was up 10% to $2.8 billion, or $2.41 per share, an increase of 15% over the previous year. For the fourth quarter, revenue was... more

J&J Bets on Prognostic Tests in Ortho BY ARIELLA P. GOLOMB, MD, MARCH 28, 2007

There is much developmental focus in the orthopedic industry on creating products that treat patients earlier in the continuum of care with the goal of slowing irreversible disease progression. When earlier intervention is dramatic, it is necessary to have a... more

Orthopedic News Roundup 22-Mar-07 BY LAUREN UZDIENSKI, MARCH 22, 2007

Earnings Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million... more

Orthopedic News Roundup 15-Mar-07 BY LAUREN UZDIENSKI, MARCH 14, 2007

Earnings Orthovita reported 4Q:06 revenues of $13.81 million, beating analysts' estimates of $13.76 million and reflecting 38% growth compared to $9.97 million in 4Q:05. Orthovita attributed the growth to increased U.S. sales of VITOSS® FOAM and VITAGEL®. OrthoLogic announced 2006... more

FDA Approves Medtronic's INFUSE For Certain Oral Maxillofacial and Dental Applications BY ARIELLA P. GOLOMB, MD, MARCH 14, 2007

Medtronic announced yesterday that they received FDA approval to market INFUSE for oral maxillofacial and dental regenerative bone grafting procedures. This news follows the FDA Dental Products Advisory Panel recommendation for approval last fall. INFUSE has already been FDA approved... more

Orthopedic News Roundup 1-Mar-07 BY LAUREN UZDIENSKI, MARCH 1, 2007

Earnings Biologics LifeCell reported 4Q:06 product revenues of $39.3 million, an increase of 45% over $27.0 million in 4Q:05, but missed analysts' estimates of $39.5 million. The growth was attributed to increased demand for the Company's AlloDerm® Regenerative Tissue Matrix.... more

Medtronic Names New CEO and COO BY ARIELLA P. GOLOMB, MD, FEBRUARY 28, 2007

Following Biomet's appointment of Jeffery Binder as CEO, Medtronic today announced their own succession plans for CEO and COO. In August, William A. Hawkins, III, will replace Arthur D. Collins, Jr. as president and CEO. Mr. Hawkins is currently Medtronic's... more

Orthopedics News Roundup 8-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 8, 2007

Earnings Biologics Regeneration Technologies, Inc. reported 4Q:06 revenues of $19.1 million, down 5% from $20.1 million in 4Q:05. The Company reported net loss of $6.7 million, compared to a net lossn of $1.7 million for 4Q:05. Net loss per diluted... more

Orthopedic News Roundup 30-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 30, 2006

Earnings ORTHOsoft reported 3Q:06 revenues of CAN $3.8 million (US $3.3 million), up 59% from CAN $2.4 million (US $2.1 million) in 3Q:05. ORTHOsoft manufactures computer aided orthopedic surgery devices, and they attribute the 3Q:06 growth to increased navigation systems... more

Medtronic Sofamor Danek's Spinal Business Continues To Grow BY ARIELLA P. GOLOMB, MD, NOVEMBER 21, 2006

For 2Q:07, Medtronic reported overall revenue of $3.08 billion, which represented year over year growth of 11% (10% on a constant currency basis), beating analyst estimates of $2.97 billion. During the quarter spinal instrumentation generated revenues of $421 million, an... more

Orthopedic News Roundup 16-Nov-2006 BY LAUREN UZDIENSKI, NOVEMBER 16, 2006

Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more

INFUSE Moves into Dental BY JOHN CHOPACK, NOVEMBER 10, 2006

Medtronic, Inc. announced yesterday that the FDA Dental Products Advisory Panel had unanimously voted to recommend approval of INFUSE Bone Graft for certain oral and maxillofacial procedures. If the FDA agrees with that panel's recommendation, the US indications for INFUSE... more

SNN Issued a Statement Re: BMET Acquisition Rumors BY HUYEN NGUYEN, NOVEMBER 2, 2006

This morning Smith & Nephew issued a statement confirming speculations that it has been speaking with Biomet. The Company stated that it, "it has held very preliminary talks with the US medical devices company, Biomet Inc. No agreement has been... more

Orthopedic News Roundup 12-Oct-06 BY HUYEN NGUYEN, OCTOBER 12, 2006

Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more

Orthopedic News Roundup 5-Oct-06 BY HUYEN NGUYEN, OCTOBER 5, 2006

Earnings Update: Tutogen Medical, Inc. provided an update on its 4Q:06 projected revenues which are estimated at ~$10.8 million, representing a 36% increase over the comparable quarter of 2005. Revenues for the fiscal year will be ~$38 million, an increase... more


With the 2006 NASS meeting winding down, we thought we'd share some highlights from Seattle. SPORT Clinical Trial Session a Tease On Wednesday, the two-hour, much-anticipated session on SPORT results focused on SPORT background information - but not the data... more

MDT Spinal & Navigation Business Update at NASS BY HUYEN NGUYEN, SEPTEMBER 29, 2006

Yesterday, Medtronic Spinal and Navigation business division hosted an analyst meeting during the North American Spine Society (NASS) meeting in Seattle to provide an update on its current operations. Given the recent FDA panel recommendation for approval of their cervical... more

Orthopedic News Roundup 21-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 21, 2006

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

Medtronic's Disc Recommended for FDA Approval BY ARIELLA P. GOLOMB, MD, SEPTEMBER 20, 2006

Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System. After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded... more

Orthopedic News Roundup 14-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 14, 2006

Appointment: Orthovita, Inc. has appointed Albert J. Pavucek, Jr. Vice President Corporate Controller. Mr. Pavucek was with PDI, Inc. serving as Vice President, Finance and Operations. Awards & Recognition: Smith & Nephew plc announced that two of its products, the... more

Regeneration Technologies Continues To Break Its Chains BY HUYEN NGUYEN, SEPTEMBER 12, 2006

After the market closed yesterday, Regeneration Technologies (RTI) announced it amended a prior distribution agreement with its largest distributor, Medtronic Sofamor Danek USA, Inc. (MSD) regarding domestic spinal allograft distribution. Currently, RTI derives 60% of its annual revenues (~$45 million)... more

Orthopedic News Roundup 7-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 7, 2006

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 24-Aug-06 BY HUYEN NGUYEN, AUGUST 24, 2006

Appointment: IsoTis OrthoBiologics has hired Gene B. Reu as Vice President of Operations. Prior to joining IsoTis, Mr. Reu served as Vice President & General Manager of Coblation Technologies with Arthrocare, Inc. Business Update: ArthroCare Corp. announced it has received... more

FDA Panel to Vote On Medtronic's Cervical Disc BY ARIELLA P. GOLOMB, MD, AUGUST 23, 2006

The FDA's Orthopaedic and Rehabilitation Devices Panel will be meeting on September 19, 2006. The committee will discuss, make recommendations and vote on a premarket approval application for Medtronic's Prestige ST artificial cervical disc. This metal on metal, ball and... more

Orthopedic News Roundup 3-Aug-06 BY HUYEN NGUYEN, AUGUST 3, 2006

Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... more

Medical Device Space Breathes Sigh of Relief as CMS Issues Inpatient Reimbursement Revisions BY TODD BARTELS, AUGUST 3, 2006

As we have previously discussed in several posts, since April the Center for Medicare and Medicaid Services (CMS) has planned to release new Inpatient Prospective Payment System (IPPS) regulations for FY 2007. Late Tuesday CMS issued this much-anticipated IPPS rule,... more

Medtronic Whistleblower Suit Won't Go Away Easily BY DAVID KRESSEL, AUGUST 2, 2006

As we reported last week, Medtronic settled its whistleblower law suit with the DOJ. One condition of this settlement was that the DOJ would move to have a second similar whistleblower suit dismissed. Now, the lawyer representing the second plaintiff... more

Medtronic Settles with DOJ on Kickbacks for $40 Million BY DAVID KRESSEL, JULY 18, 2006

Medtronic announced yesterday that it has settled with the Department of Justice regarding a qui tam lawsuit related to sales and marketing practices in its Spine group, particularly kickbacks to surgeons. Qui tam lawsuits are better known as whistleblower suits.... more

Orthopedic News Roundup 12-Jul-06 BY HUYEN NGUYEN, JULY 12, 2006

Appointment: Biomet, Inc. appointed Charles E. Niemier as President of EBI's operations following the resignation of its former president, Bart J. Doedens, M.D. Mr. Niemier has been a member of the senior management team and Board of Directors for more... more

FDA Grants IDE For Medtronic's DIAM(TM) Spinal Stabilization System BY ARIELLA P. GOLOMB, MD, JULY 10, 2006

Medtronic, Inc. announced today that the FDA granted an investigational device exemption (IDE) to the DIAM(TM) Spinal Stabilization System for use in a clinical safety and effectiveness study. The DIAM System will be measured against posterior lumbar interbody fusion, the... more

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN, JUNE 29, 2006

Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's... more

Orthopedic News Roundup 25-May-06 BY HUYEN NGUYEN, MAY 25, 2006

Appointment: IsoTis OrthoBiologics appointed Barbara Boyan to its Board of Directors. Ms. Boyan is a co-founder of OsteoBiologics, Inc. (OBI) and a professor in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and at... more

1Q:06 Final Performance Summary BY HUYEN NGUYEN, MAY 25, 2006

Final results for the 26 publicly-traded orthopedic companies* in 1Q:06 showed that orthopedic sales for first quarter increased by 9.2%, as reported. Now that Medtronic has reported its spine revenues, total aggregated sales for those 26 companies came in at... more

Medtronic Spine Grows 17% BY JOHN MCCORMICK, MAY 24, 2006

Medtronic is trading up this morning after yesterday afternoon's announcement of double digit across the board revenue and earnings growth. Spine revenues notably grew at 17%. With fiscal 2006 ending on April 28, 2006, companywide revenue for the 2006 fiscal... more

Medtronic Countersues Kyphon BY DAVID KRESSEL, APRIL 19, 2006

As we reported in March, Kyphon and Dr. Harvinder Sandhu filed an IP suit against Medtronic, and now Medtronic has parried with its own lawsuit. Medtronic has countersued Kyphon, claiming Kyphoplasty infringes on 3 patents relating to balloons for use... more

Medtronic Bets On Itself BY DAVID KRESSEL, APRIL 12, 2006

Medtronic, parent of orthopedic giant Sofamor Danek, has decided to rejigger its capital structure. It is offering $4 billion in convertible bonds, and using $2.5 billion of the proceeds to repurchase common stock, which comes out to about 4% of... more

Orthopedic News Roundup 9-Mar-06 BY HUYEN NGUYEN, MARCH 9, 2006

Although management teams are preparing for AAOS, a few more companies reported earnings this week. We did a quick calculation and found that our internal Orthopedic Index PE year-to-date has stayed relatively flat at 27x. We expect that the AAOS... more

Medtronic Reports 3Q:06 Financials: Earnings In-line BY JOHN CHOPACK, FEBRUARY 23, 2006

Medtronic reported that earnings totaled $670 million or $0.55 per diluted share which was in-line with analysts' expectations and represented a 22% increase over the 3Q:05. However, the Company's reported revenues for the 3Q:06, which totaled $2.77 billion was slightly... more

Orthopedic News Roundup 23-Feb-06 BY LAING RIKKERS, FEBRUARY 23, 2006

Financing: BioMimetic Therapeutics, Inc. filed a registration statement for an Initial Public Offering. Earnings: Medtronic 3Q Earnings climb 23 percent. CryoLife fourth quarter 2005 revenues increased 13% over fourth quarter 2004 Gross margins for full year 2005 increased to 53%... more

Polynovo Partnering with Medtronic BY SHELLY ACHAIBAR, FEBRUARY 13, 2006

Polynovo Biomaterials signed a partnering and licensing agreement with Medtronic for the development of a drug-eluting polymer stent to treat vascular diseases. Medtronic will hold equity in the company and pay royalties on the commercialization of the technology. PolyNovo Biomaterials... more

Medtronic Surpasses Milestone with TSRH Spinal Systems BY SHELLY ACHAIBAR, FEBRUARY 13, 2006

Medtronic announced today that the TSRH Spinal System implants have surpassed the 2.5 million mark worldwide. Medtronic in conjunction with the Scottish Rite Hospital (TSRH), one of the nation's leading pediatric centers for the treatment of orthopedic conditions, created the... more

Medtronic Continues to Fight Whistle-Blower Suit BY SHELLY ACHAIBAR, JANUARY 24, 2006

Medtronic, one of the nation's leading device makers, is facing continued charges of payoffs to surgeons, as written about today in the New York Times. To summarize, a lawsuit filed against the company two years ago, was brought on by... more

Kyphon/Sandhu Lawsuit against Medtronic Announced BY JOHN MCCORMICK, JANUARY 17, 2006

The spine patent dispute du jour isn't about "555" these days: it's about "665". Today, an intellectual property lawsuit between Kyphon and Sofamor Danek filed in November of last year was unsealed (at Kyphon's request) after the two parties were... more

Orthopedic News Roundup 8-Dec-05 BY HUYEN NGUYEN, DECEMBER 8, 2005

Due to last week's Merrill Lynch investor conference (subscription may be required), investors have regained confidence in the orthopedic sector after the industry faced some hurdles within the past few months. In our HealthpointCapital Weekly Valuation Index, P/E (price-to-earnings) jumped... more

Orthopedic News Roundup 1-Dec-05 BY HUYEN NGUYEN, DECEMBER 1, 2005

Appointment: OrthoSoft announced that Max Link has joined its Boards of Directors. With over 25 years of experience, Mr. Link is a very well-recognized individual in the medical device and pharmaceutical industry. He was CEO and Chairman of Centerpulse when... more

Orthopedic News Roundup 17-Nov-05 BY HUYEN NGUYEN, NOVEMBER 17, 2005

Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices... more

Department of Justice Questioning the Selling Practices of Medtronic, Guidant and St. Jude BY JOHN CHOPACK, OCTOBER 26, 2005

Medtronic, Guidant and St. Jude Medical said they each received subpoenas from the U.S. Attorney in Massachusetts related to their heart devices. Medtronic also stated that the subpoenas sought documents related to people in a position to recommend purchase of... more

Orthopedic News Roundup 06-Oct-05 BY HUYEN NGUYEN, OCTOBER 6, 2005

While Medtronic was the big winner this week, Wright Medical ("WMGI") captured more headlines with two important news items that have negatively impacted their stock price. On Wednesday, WMGI's stock price suffered a huge loss with 20% decline intraday due... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

Orthopedic News Roundup 19-Aug.-05 BY HUYEN NGUYEN, AUGUST 19, 2005

Earnings: The world's largest spinal implant technology player, Medtronic, reported 1Q:06 with revenues of $2.7 billion, a 15% increase from 1Q:05. Net income (excluding extraordinary charges) was $616 million compared to $530 million, which is a 16% increase YOY. Spinal... more

Orthopedic News Roundup 8-Jul-05 BY HUYEN NGUYEN, JULY 8, 2005

The NYT runs an astute roundup (registration required) of the the "depressing" delay by some insurers to cover Charite surgery. they note the market tumult that might be caused by possible FDA approval of Synthes' ProDisc, Medtronic's Maverick, and Stryker's... more

SpinalMotion Receives $20 million in Funding BY HUYEN NGUYEN, MAY 2, 2005

In the past few years, we have seen many new spine companies emerge with innovative technologies in the disc arthroplasty market. We did a quick search in our own HealthpointCapital proprietary orthopedic database and found that there are approximately 35... more

Medtronic and Michelson Finally Settle for $1.35 billion BY JOHN MCCORMICK, APRIL 25, 2005

The four year spine patent dispute between Dr. Gary Michelson and Medtronic, Inc. came to a mind-boggling conclusion on Friday when Medtronic announced that it would settle for a cool $1.35 billion - the largest one-time intellectual property award in... more

AANS 2005: A Trip Report BY JOHN MCCORMICK, APRIL 25, 2005

Last week we joined the droves of neurosurgeons at AANS in New Orleans to check out papers, presentations, posters and product. Always a quiet and less populated conference compared to the annual NASS spine meeting, AANS offers a hard science... more

Troubling Consistency at Sofamor Danek BY ROBIN R. YOUNG CFA, OCTOBER 25, 2004

Two whistle blower lawsuits in the last 13 months. Two court rulings in favor of Dr. Gary Michelson's claim that Sofamor Danek infringed his property rights. A court ordered permanent injunction against Sofamor Danek last month in a patent case.... more

Spine Wars: Michelson vs. the Industry? BY ROBIN R. YOUNG CFA, OCTOBER 4, 2004

If we've heard it once, we've heard it a dozen times. Gary Michelson, with attorneys in tow, haunts spine company booths at conferences like the upcoming NASS or CNS informing them of patent violations on the fly. Yikes! And last... more

Now, Here's an Issue: Payments by medical device manufacturers to surgeons BY ROBIN R. YOUNG CFA, SEPTEMBER 13, 2004

Last week, Sofamor Danek disclosed in an SEC filing that a second "whistle-blower" lawsuit had been filed against it regarding payments to physicians. The case is under seal in Federal Court in Minneapolis. The first lawsuit against Sofamor Danek on... more

Is Kyphon #2 Behind Sofamor Danek in terms of Spine Industry Market Power? BY ROBIN R. YOUNG CFA, AUGUST 16, 2004

On the heels of its first $50 million quarter, Rich Mott, Kyphon's CEO, predicted that his firm would post revenues between $210 and $212 million for the year ending this December. Three years ago, in 2001, Kyphon booked sales of... more

InFuse® Add-On Payment Extended One Year by CMS - Good News for an Estimated 500 Patients (About 2% of the Infuse® Patient Population) BY ROBIN R. YOUNG CFA, MAY 24, 2004

The InFuse® add-on payment of $8,900 was extended for one year by the Centers for Medicare and Medicaid Services last week. Medicare, which provides supplemental healthcare cost reimbursement for American elderly patients, directly affects an estimated 15% of the spine... more

Medtronic's InFuse® cutting into DePuy Spine's Sales BY ROBIN R. YOUNG CFA, APRIL 19, 2004

For the quarter ended this past March, JNJ's DePuy spine division reported that sales growth rates for that division were slowing. For 2004, we forecast, sales of spinal implants industry-wide will rise 24% from last year's $2.9 billion to $3.6... more

$1 Million per Day in InFuse BY EDITOR, MARCH 29, 2004

We think it's true. Of course, Medtronic isn't saying anything outside of its well crafted public comments, but our informal content analysis of surgeon and sales commentary have us betting that Sofamor Danek has, indeed, crossed the $1 million per... more

Use of InFuse' expanded to include... BY EDITOR, DECEMBER 15, 2003

...more metal cages. Our friends in high places at Medtronic tell us that Sofamor Danek is considered to be Medtronic's best acquisition-ever. A worthy competitor calls the boys in Memphis “the machine.” Indeed. No doubt Mike DeMane's “threat” to replace... more

What is your business? BY EDITOR, DECEMBER 1, 2003

Peter Drucker asked that question fifty years ago in his seminal book The Practice of Management. While his generic answer (“the only function of a business is to create customer value and to innovate.”) remains as valuable in 2004 as... more

In a testament to second chances, InFUSE gets CMS approval for $8,900. BY EDITOR, AUGUST 4, 2003

Rejected one year ago... Medtronic came back with new data and CMS, while rejecting InFuse again using one analytical approach found another way to show that InFUSE does indeed meet the threshold requirement for receiving a new technology add-on payment.... more

Sofamor Danek increases the size of its Bryan and Prestige Cervical Disc trials, we think. BY EDITOR, JULY 21, 2003

We have been hounding the overworked folks in Medtronic's investor relations department about last week's Bryan® and Prestige™ Cervical Disc clinical trial press release. Apparently, we were the only people who called with a question. All other Analysts calling in... more

METRx X-Tube is Cool BY EDITOR, JUNE 16, 2003

Sofamor Danek didn't pay us to say that, we just like the look of this new product. 250,000 patients a year decide to undergo a discectomy operation to “deflate the tire” of a herniated disc. Satisfaction rates are routinely 95%+.... more

Who is listening to those earnings calls? BY EDITOR, APRIL 14, 2003

Earnings season starts this week with the Tuesday, April 15th release of DePuy/Acromed's first quarter results (as buried in JNJ's release) and continues until mid-May when Sofamor Danek's numbers for the April quarter (Medtronic, Sofamor Danek's parent, is on an... more

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