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Orthopedic and Dental Industry News Complete Archive »

International

Danaher to Acquire Nobel Biocare for $2.2B BY ANDREW VAHRADIAN, SEPTEMBER 15, 2014

Danaher Corporation entered into an agreement to acquire the Zürich, Switzerland-based Nobel Biocare, the second largest dental implant developer, in an all cash transaction valued at an enterprise value of $2.2 billion, or 3.0x LTM revenues, or 16.0x LTM EBITDA.... more

Mazor Robotics' Renaissance Guidance System Receives Approval in China BY ANDREW VAHRADIAN, SEPTEMBER 9, 2014

Mazor Robotics received approval from the China Food & Drug Administration (CFDA) for its Renaissance surgical guidance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain... more

FDA Approves the ReWalk Robotic Exoskeleton BY ANDREW VAHRADIAN, JULY 2, 2014

ReWalk Robotics received marketing approval from the U.S. FDA for its ReWalk Personal System for home and community use. The ReWalk device is a custom-fit, wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with lower... more

Orthocell Limited Announces IPO BY ANDREW VAHRADIAN, JUNE 2, 2014

Orthocell Limited announced its intention to list on the Australian Securities Exchange (ASX) by launching an initial public offering (IPO) process, proposing to raise $8 million by offering 20 million shares at an offer price of $0.40 a share. Orthocell... more

Smith & Nephew's Proposed Acquisition of ArthroCare Approved by UK Antitrust Regulatory Authority BY ANDREW VAHRADIAN, MAY 27, 2014

Smith & Nephew's proposed acquisition of ArthroCare received "unconditional clearance" from the United Kingdom's Competition & Markets Authority, after the regulatory body concluded its Phase I procedure. Subsequent to receiving clearance from the relevant authorities in the United States and... more

MHRA Notes a Decline in Overall Medical Device Adverse Events BY ANDREW VAHRADIAN, MAY 6, 2014

According to data published by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), the number of reported adverse incidents in the UK have declined 32% over the past three years from 21,729 in 2011 to 14,819 in 2013.... more

Drug Device Combination Product Market to Grow to $115B BY ANDREW VAHRADIAN, JANUARY 7, 2014

According to a new report from Transparency Market Research, the global market for drug device combination products is anticipated to grow from $66 billion in 2012 to $115.1 billion by 2019. According to the FDA, drug device combination products are... more

Blue Belt Technologies Announces First Navio Unicondylar Knee Replacement Performed in France BY EDITOR, DECEMBER 23, 2013

Blue Belt Technologies announces the first Navio unicondylar knee replacement (UKR) procedures performed in France, completed on September 30th, October 15th and Nov 4th 2013 by Professor Philippe Neyret and Dr. Sébastien Lustig at Hospices Civils de Lyon in France.... 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

UK Moves to Ban Metal-on-Metal Hip Implants in NHS Hospitals BY ANDREW VAHRADIAN, NOVEMBER 20, 2013

Due to high failure rates and toxicity concerns, the United Kingdom has decided to ban metal-on-metal (MoM) hip implants in hip replacement surgeries performed at publicly funded National Health Service (NHS) hospitals. This announcement came after the National Institute for... more

Mazor Robotics Files for Public Offering of American Depositary Shares BY ANDREW VAHRADIAN, OCTOBER 22, 2013

Mazor Robotics filed a preliminary prospectus with the US Securities and Exchange Commission (SEC) to issue two million American Depository Shares (ADSs) in a public offering to raise approximately $40-46 million. The shares would trade on the NASDAQ Stock Market... more

European Union Committee Votes in Favor of a Stricter Regulatory Process for Medical Devices BY ANDREW VAHRADIAN, OCTOBER 3, 2013

Members of the European Union parliament's Environment Committee (Committee), voted in favor of a new pre-market authorization (PMA) system that would employ randomized clinical trials for Class III, or high-risk, implantable devices under the oversight of the European Medicines Agency... more

Harvard to Collaborate with Charité on Musculoskeletal Tissue Engineering BY ANDREW VAHRADIAN, OCTOBER 2, 2013

The Wyss Institute for Biologically Inspired Engineering at Harvard University has entered into a collaboration agreement with Charité - Universitätsmedizin Berlin, in order to expedite clinical translation of new materials and tissue engineering technologies for the orthopedics and connective tissue... more

Taiwan Legislature to Ratify Additional Tax Reductions and Subsidies for Medical Device Manufacturers BY ANDREW VAHRADIAN, SEPTEMBER 4, 2013

The Taiwanese legislature is likely to ratify a draft bill in the upcoming session allowing manufacturers of high-risk medical devices to receive tax reductions and government subsidies. There is currently a consensus among legislators for such an initiative and if... more

Chinese Research Team Conducting Study on 3D Printed Spinal Implants BY ANDREW VAHRADIAN, AUGUST 15, 2013

At the Peking University Third Hospital in Beijing, Dr. Liu Zhongjun, Chairman of the Department of Orthopedic surgery and the Research Center of Spinal Surgery, Peking University, is leading a team of researchers in the process of conducting human clinical... more

Positive Outlook Predicted for European Medtech Industry BY ANDREW VAHRADIAN, AUGUST 1, 2013

Through various market reports, researchers and industry professionals are predicting an overall positive outlook for the medtech industry in the European Union. The European Medtech Market is estimated at a size of €100 billion ($133 billion) and is growing approximately... more

Smith & Nephew to Acquire Assets from Plato Grup BY ANDREW VAHRADIAN, JULY 11, 2013

Smith & Nephew announced an agreement to acquire certain assets related to the distribution of its orthopedic reconstruction, trauma and sports medicine products in Turkey, currently conducted through Plato Grup. The acquisition is being made through the local subsidiary of... more

Australia and New Zealand Launch Initiatives to Improve Quality Use of Medical Devices BY ANDREW VAHRADIAN, JULY 2, 2013

In recent weeks, both the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) regulatory bodies have launched two initiatives to help support the quality use of medical devices and therapeutic products in... more

Wright Medical to Divest OrthoRecon Business to MicroPort BY ANDREW VAHRADIAN, JUNE 20, 2013

Wright Medical announced it has entered a definitive agreement with MicroPort Medical, a subsidiary of MicroPort Scientific Corporation (HK: 0853), for the acquisition of Wright's OrthoRecon business at a cash purchase price of $290 million, valuing the unit at 1.1x... more

Medical Device Sector Projected to Grow in Taiwan BY ANDREW VAHRADIAN, MAY 30, 2013

According to a recent study published by the Industry and Technology Intelligence Services (ITIS), a research institute of Taiwan's Ministry of Economic Affairs, the production value of the medical device sector in Taiwan is expected to grow 7.1% in 2013... more

Stryker Has Appetite for More Acquisitions BY ANDREW VAHRADIAN, MAY 29, 2013

At the recent Bank of America Merrill Lynch 2013 Health Care Conference, Stryker CEO Kevin Lobo discussed how highly focused M&A is the first priority of the company's capital allocation approach. In the presentation, Mr. Lobo detailed the significance of... more

Israel's Emerging Medical Device Marketplace BY ANDREW VAHRADIAN, MAY 16, 2013

Israel's medical device industry has become an exciting and promising marketplace due to the breadth of innovation taking place within it. Despite the domestic industry only accounting for 0.6% of the global medical device market in 2011, the country is... more

Chinese Governmental Expenditure on Healthcare Anticipated to Rise BY ANDREW VAHRADIAN, APRIL 25, 2013

Two independent industry reports illustrate encouraging signs regarding the development of the healthcare industry in China, indicating that healthcare spending in the country will increase substantially in future years. Industry analysts at KPMG anticipate that Chinese governmental expenditure on pharmaceuticals,... 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

The MHRA Launches "Innovation Office" to Promote the Development of Novel Medicines and Devices in the UK BY ANDREW VAHRADIAN, MARCH 18, 2013

As part of the UK government's Life Sciences Strategy, the Medicines and Healthcare products Regulatory Agency (MHRA), has launched a virtual "Innovation Office" online in order to provide advice and assistance to companies developing innovative products or exploring innovative approaches... more

FDA Seeks to Maintain Consistent Clinical Data Requirements BY ANDREW VAHRADIAN, MARCH 8, 2013

The FDA has published a proposed rule that would require the clinical studies conducted outside the U.S. supporting medical device product registrations to be in accordance with Good Clinical Practice (GCP). These are standards upheld by the International Conference on... more

Medical Device Regulation Change in Argentina BY ANDREW VAHRADIAN, FEBRUARY 28, 2013

The Administracion Nacional de Medicamentos, Alimentos and Tecnologia Medica (ANMAT), the Argentinean medical device market regulator, has ratified a number of modifications regarding the country's General Law for Medical Devices, affecting various components of the device registration process and approval... more

European Medical Device Industry Scrutinizes Proposed European Commission Regulatory Modifications BY ANDREW VAHRADIAN, FEBRUARY 20, 2013

Through the industry association Eucomed, the European medical device industry (Industry) has issued a position paper that assesses a number of modifications the European Commission has proposed to assimilate within the European Union's Medical Device Directives. In the paper, Eucomed... more

Japanese Regulators Call for Swifter Device Approval Timeframes BY ANDREW VAHRADIAN, FEBRUARY 12, 2013

The Health, Labor & Welfare Ministry of Japan plans to propose a bill allowing up to 60% of the country's Class III medical devices such as kidney dialysis machines and generic dental implant products, to be eligible for the new... more

Samsung Looks to Move Further Into the Medical Device Marketplace BY ANDREW VAHRADIAN, JANUARY 30, 2013

With the recently announced acquisition of NeuroLogica, a maker of computed tomography (CT) machines, Samsung further reinforced its desire to make a name for itself in the medical equipment sector. Earlier this month, the head of Samsung’s consumer electronics division,... 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

International Market Prospects for Robotics BY ANDREW VAHRADIAN, DECEMBER 18, 2012

Through telemedicine, robotics give surgeons the ability to perform minimally invasive and complex surgeries precisely from anywhere in world. This kind of versatility and acclimation has much to offer emerging markets still developing their medical systems, a trend that is... more

Australia and New Zealand Progress with Plan to Implement Joint Regulatory System for Medical Devices BY ANDREW VAHRADIAN, DECEMBER 17, 2012

Australian and New Zealander ministers reported progress from a second meeting of the Implementation Ministerial Council. This group aims to launch a new medical device regulatory body called the Australia New Zealand Therapeutic Products Agency (ANZTPA). Once operational, ANZTPA will... 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

Emerging Market Trends: Pakistan Regulatory Overhaul BY ANDREW VAHRADIAN, NOVEMBER 29, 2012

The Pakistani government has signed legislation establishing the Drug Regulatory Authority of Pakistan, which will regulate the medical device and pharmaceutical products sold in the country. The Authority will not only issue guidelines, but also monitor enforcement of device manufacturing... more

Medical Device Regulation Change in Russia BY ANDREW VAHRADIAN, NOVEMBER 20, 2012

A meaningful overhaul in the structure of how medical devices are regulated in Russia is expected to take place in early 2013. The Russian Ministry of Health has approved new guildelines regarding medical device classification, importation and adverse event handling.... more

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

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

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

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

Musculoskeletal News Roundup 13-Sept-12 BY LAUREN UZDIENSKI, SEPTEMBER 12, 2012

FDA clears Iconacy Orthopedic Implants' I-Hip system ... Precision Spine's Slimplicity Solo Anterior Cervical Plate System 510(k)-cleared ... Amedica studies find "superior osseointegration and bacterial-resistant properties" of silicon nitride ... Ascendx Spine begins commercial shipments to Europe ... Osseon launches Osseoflex SN+ ... Smith & Nephew releases LEGION HK Hinge Knee ... NuVasive signs Premier agreement 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

Musculoskeletal News Roundup 14-Jun-12 BY LAUREN UZDIENSKI, JUNE 14, 2012

J&J/Synthes transaction closes ... ConforMIS raises $73M ... Mazor announces Korean regulatory approval for Renaissance ... FDA clears TransCorp's SpinePort Spinal Access System ... SANUWAVE announces preclinical osteoarthritis results ... Internal Fixation System launches GoDirect sales program ... Premier awards spine contracts more

Mindray Medical to Acquire Controlling Stake in Wuhan Dragonbio Surgical Implant Co. BY LAUREN UZDIENSKI, JUNE 8, 2012

Yesterday Mindray Medical announced plans to acquire a controlling stake of Wuhan Dragonbio Surgical Implant Co., Ltd., a Chinese medical orthopedic products provider that specializes in trauma, spine, joint and other surgical products. Mindray will pay approximately $35.5 million in cash for the share in Dragonbio, which recorded $7.7 million in sales in 2011. 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 29-Mar-12 BY LAUREN UZDIENSKI, MARCH 29, 2012

Mazor reports earnings .... Omni Surgical raises $27M ... Relievant Medsystems raises $30M ... FDA warning letters for Lucero Medical, Orthopedic Alliance and Spinal Solutions ... Benvenue Medical launches Blazer Vertebral Augmentation System ... Aperion Biologics completes enrollment in Z-Lig ACL study ... Benvenue Medical announces enrollment of 250th patient in KAST (Kiva System) study ... Ascendx Spine inks distribution deal in Austria, Germany and Switzerland more

Musculoskeletal News Roundup 9-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 9, 2012

Product launches from AAOS ... Nobel Biocare announces 4Q ... Hospitals settle Medicare fraud claims over kyphoplasty billing ... Updates on the American Joint Replacement Registry ... Stryker announces inventory management system rollout more

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

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

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

Musculoskeletal News Roundup 1-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 1, 2011

IlluminOss raises $4M . . . Nextremity Solutions gets CE mark . . . ArthroSurface announces HemiCAP milestones . . . ARTC to settle class action securities suit . . . Zimmer to establish R&D center in Beijing more

Bonovo's New Focus on Hips and Knees BY SANDER DUNCAN, JUNE 27, 2011

Bonovo Orthopedics is launching Bonovo Recon, a new division dedicated solely to hip and knee products. Operations will begin this year with a suite of hip and knee implants available to Chinese markets. more

Musculoskeletal News Roundup 2-Jun-11 BY LAUREN UZDIENSKI, JUNE 2, 2011

BioPoly receives CE mark for knee resurfacing system . . . ConforMIS receives CE mark for the iTotal CR . . . FDA clears Nimbic Systems' Air Barrier System . . Exactech launches the Proliant Polyaxial Pedicle Screw system . . . Zimmer showcases new products at EFORT 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

How the Japan Earthquake Will Affect the Musculoskeletal Industry BY LAUREN UZDIENSKI, MARCH 15, 2011

The devastating earthquake in Japan has left the nation in crisis. Even when the country begins to recover, there could be a lingering impact on medical device sales, which some estimates place at up to 10% of the worldwide device market. more

Musculoskeletal News Roundup 16-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 16, 2010

Theken Spine wins Ohio grant . . . Ellipse Technologies receives CE mark for the PRECICE limb lengthening device . . . Memometal Technologies launches MemoDerm Acellular Dermal Matrix and Smart Toe II Hammertoe Fixation System . . . Zimmer receives reimbursement premium from Japan for the Trabecular Metal Modular Cup . . . Stryker files patent infringement suit against Zimmer . . . Lanx appoints CEO 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 23-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 23, 2010

M&A Amedica acquired US Spine for an undisclosed amount. The target company manufactures a range of fusion products as well as the Facet Fixation System, which features the Facet Gun to lock the facet joint. Amedica says that with the... more

Musculoskeletal News Roundup 2-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 2, 2010

Sanofi-aventis makes bid for Genzyme . . . Orthofix obtains new credit facility . . . Mazor Surgical adds 3D imaging to SpineAssist . . . CDRH's 510(k) director to retire . . . Amedica, TiGenix announce new U.S. patents . . . U.S. News and World Report names top orthopedic hospitals more

Zimmer Expanding China Presence BY JOHN MCCORMICK, JULY 22, 2010

Zimmer's data rich earnings announcement this mornining contained an interesting nugget about their China plans. Zimmer announced that they have completed a definitive agreement to acquire Beijing Montagne Medical Device Co., Ltd. a 360-employee company that develops large joint implants... more

Chinese Device maker Trauson to IPO BY JAKE NORD, JUNE 21, 2010

Chinese orthopedic device manufacturer Trauson (Jiangsu) Holdings Company Limited announced details of their planned IPO on the Hong Kong stock exchange on June 14th, 2010. Trauson, founded in 1986 and based in Changzhau, China, manufactures more than 2,000 devices for... more

Musculoskeletal News Roundup 13-May-2010 BY LAUREN UZDIENSKI, MAY 13, 2010

aap Implantate, ATEC, ANIK, BMTI, OSTE report Q1 earnings . . . SBi announces Olympus investment . . . Aesculap launches pedicle screw system . . . data on B Braun's Targon screw . . . BioSyntech files for bankruptcy more

"Scorecard" for Device Markets Forthcoming from PWC BY LAUREN UZDIENSKI, MAY 12, 2010

pwc.gifPricewaterhouseCoopers announced that they're working on an "independent study of international market conditions for medical device innovation" in the key markets of Brazil, China, France, Germany, Israel, India, Japan, United Kingdom and the United States. PWC will score each region's device climate based on regulatory policy, patient access to technologies, demographics and "market factors." 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

Orthopedics in China and the U.S.: An Interview with HealthpointCapital's Chinese Research Scholar BY JOHN MCCORMICK, FEBRUARY 8, 2010

Starting in October 2009, HealthpointCapital initiated a one-year Research Scholarship at the Hospital for Special Surgery (HSS) for a select oprthopedic surgeon from China. This month, we checked in with our Research Scholar, Dr. Xiaodong Ju, to see how he... more

Musculoskeletal News Roundup 17-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 17, 2009

M&A Alphatec Holdings, Inc. announced that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France. The transaction is structured as an all-stock transaction such that 100% of outstanding Scient'x stock... more

China to Relax Regulatory Process for Foreign Device Companies BY LAUREN UZDIENSKI, NOVEMBER 3, 2009

Last week's Joint Commission on Commerce and Trade meeting between the U.S. and China in Hangzhou resulted in a number of changes to China's regulatory process, which has historically been costly and time-consuming for foreign companies. In the past, the... more

Musculoskeletal News Roundup 20-Aug-09 BY LAUREN UZDIENSKI, AUGUST 20, 2009

Earnings aap Implantate reported 1H:09 sales of EUR 14.7 million ($20.7 million), representing a 10% decreased from 1H:08. Adjusting for one-time income, sales were down 3%, and in the second half of 2009, the company "anticipates a recovery in demand... 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-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

Musculoskeletal News Roundup 19-Mar-09 BY LAUREN UZDIENSKI, MARCH 19, 2009

Earnings TiGenix announced 2008 financial results this week, reporting a widening net loss as the company prepares to launch ChondroCelect in Europe. The company's net loss was EUR 15.2 million ($21.4 million), an increase of 27% over 2007. As 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 22-Jan-08 BY LAUREN UZDIENSKI, JANUARY 22, 2009

Earnings aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners"... 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

South Korea Drawing Medical Tourists BY LAUREN UZDIENSKI, NOVEMBER 18, 2008

While India and Singapore may be among the most common destinations for medical tourism, South Korea has been stepping up its public outreach in an effort to draw patients for orthopedic and other surgeries. The New York Times describes the... more

Greetings from Suzhou: Notes from Third International Congress of the Chinese Orthopedic Association BY JOHN MCCORMICK, NOVEMBER 17, 2008

Greetings from Suzhou! Yes that Suzhou - in China. To follow the orthopedic surgeon, China was the place to be this month. While we know this formidable nation always surpasses expectations, we were truly blown away by the Chinese Orthopedic... more

Musculoskeletal News Roundup 13-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 13, 2008

Earnings aap Implantate AG reported sales for the first nine months of 2008 of EUR 24.2 million ($35.0 million), up 30% from the same period last year. The company attributed the sales growth to the Traumatology & Orthopaedics division, where... more

Musculoskeletal News Roundup 6-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 6, 2008

Earnings Alphatec Spine, Inc. announced that consolidated revenues for 3Q:08 were $25.8 million, an increase of 27.1% from the $20.3 million reported for the 3Q:07. U.S. revenues for 3Q:08 were $21.5 million, an increase of 27.7% from the $16.8 million... more

Musculoskeletal News Roundup 4-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 4, 2008

Earnings Inion reported 2Q:08 sales of EUR 1.8 million ($2.8 million), up 34% over 2Q:07. 1H:08 sales were EUR 2.59 ($4.1 million), a 12% increase over 1H:07. Operating loss for 1H:08 was EUR 4.85 million ($7.6 million), a 20% decrease... more

NY Times Calls for National Joint Registry BY LAUREN UZDIENSKI, JULY 29, 2008

Following Zimmer's announcement that the company would suspend sales of the Durom acetabular cup, the New York Times suggested this morning that the concerns about Durom could've been identified sooner if the U.S. had a national joint registry in place.... more

China Aims to Smooth the Way for International Investors BY LAUREN UZDIENSKI, JUNE 23, 2008

Last week's In3 Medical Device Industry Summit featured a talk on opportunities for device manufacturers in China, and we came away with a sense for the country's efforts to step up regulatory and legal practices to better reflect U.S. and... more

Musculoskeletal News Roundup 19-June-08 BY LAUREN UZDIENSKI, JUNE 19, 2008

Funding Exactech received a $40.0 million syndicated line of credit which will be used to fund future acquisitions and refinance debt, among other expenses. SunTrust Bank served as lead agent with participation by Compass Bank. M&A clickNsettle announced plans... more

SEC's Foreign Sales Probe Widens to Include Wright Medical BY LAUREN UZDIENSKI, JUNE 18, 2008

Last fall, Biomet, Medtronic, Smith & Nephew, Stryker and Zimmer announced they were under investigation by the SEC for possible violations of the Foreign Corrupt Practices Act (FCPA), which is designed to prevent U.S. companies from making payments to foreign... more

New Swiss Spine Registry Could Shape Practice Habits, Reimbursement BY LAUREN UZDIENSKI, MAY 27, 2008

In Switzerland, more than 135 surgeons are contributing data to a newly-implemented spine registry, reporting cost, efficacy and performance information on cervical and lumbar total disc arthroplasty and kyphoplasty procedures. The Swiss government started the program in December 2007 to... more

Despite the Hype, Few Go Abroad for Medical Care BY LAUREN UZDIENSKI, MAY 19, 2008

Anecdotal accounts of medical tourism often describe significant cost savings and suggest that the volume of patients who seek care overseas is climbing rapidly. Over the past few years, medical tourism has been depicted as a fast-growing trend to keep... more

Amid China Fears, the White House Seeks to Broaden FDA's Access to Foreign Plants BY LAUREN UZDIENSKI, FEBRUARY 26, 2008

Baxter's heparin has been in the news lately following four deaths and hundreds of bad reactions, and with it the revelation that the Chinese plant that manufactured some of the heparin's ingredients had not been inspected by the FDA. Similarly,... 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 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

JBJS: U.K. NICE Guidelines Have "Little Impact" on Surgeons' Product Selection BY LAUREN UZDIENSKI, SEPTEMBER 10, 2007

The July U.K. edition of JBJS reported results of a study evaluating the impact of the U.K.'s National Institute for Health and Clinical Excellence (NICE) guidelines for hip replacements. NICE publishes guidelines to promote "good health and the prevention and... more

Nobel Throws an Implant Party BY DAVID KRESSEL, JUNE 25, 2007

Nobel Biocare held its biannual World Conference in Las Vegas earlier this month. Typically, implant-focused organizations like the American Academy of Implant Dentistry typically have less than 5,000 attendees at their meetings, but Nobel hosted 10,000 in the largest implant-focused... more

Orthopedic News Roundup 29-Mar-07 BY LAUREN UZDIENSKI, MARCH 29, 2007

Earnings BioMimetic Therapeutics announced 4Q:06 financial results, reporting a net loss of $5.3 million or $0.34 per share and beating analysts' estimates of a loss of $0.37 per share. This compares to a net loss of $9.2 million, or $5.82... more

Orthopedics News Roundup 1-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 1, 2007

Earnings Kyphon Inc. announced 4Q:06 sales totaling $112.6 million, an increase of 31% over the $85.8 million in net sales reported for the 4Q:05. Net income for 4Q:06 increased 228% to $12.2 million, or $0.26 per diluted share, compared to... more

Mexico's $1.9 billion Medical Device Market BY LAUREN UZDIENSKI, JANUARY 18, 2007

Research and Markets has released a new report on the medical device industry in Mexico. In their press release, Research and Markets cited Mexico's population of 100 million, earning their place as the second-largest device market in the Americas (the... more

Israel As a Source of Life Science Innovation BY ARIELLA P. GOLOMB, MD, JANUARY 3, 2007

Kyphon's pending acquisition of Israeli-based Disc-O-Tech's Assets for $240 million is only a part of the dollar volume of Israeli technology M&A activity in 2006. The Israeli Venture Capital Research Center reported that in 2006, 76 M&A technology deals involving... more

Orthopedic News Roundup 28-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 28, 2006

M&A Kyphon has signed definitive agreements to acquire all spine-related assets of Israeli company Disc-O-Tech Medical Technologies, Ltd. in a multi-stage transaction. Terms are summarized as follows: Kyphon will pay Disc-O-Tech $60 million upon execution of the definitive agreements; Kyphon... more

Medical Device Regulatory Updates in China and Japan BY HUYEN NGUYEN, OCTOBER 9, 2006

Asia's continued economic growth makes it an attractive market for both the sale and manufacture of medical devices. Pacific Bridge Medical, a medical consulting firm focusing on business development and regulatory affairs in Asia, recently published an article on the... more

India's New Medical Device Regulations And Proposed Price Controls BY ARIELLA P. GOLOMB, MD, JULY 7, 2006

In-Pharma Technologist.com reported on Tuesday, that new Central Drugs Standard Control Organization (CDSCO) guidelines came into effect on June 29, 2006. These guidelines will regulate the import, manufacture and sale of sterile devices in India, including bone cements and orthopedic... more

Orthopedic Surgeons & Supplies Needed for Indonesian Quake Victims BY KARYN OLSON, MAY 31, 2006

Indonesia has seen a lot of seismic activity in the past few months. The latest was a 6.3 earthquake that hit the island of Java, creating an enormous medical emergency. Thus far, the quake has killed 5,700 people and over... more

Medical Device Trade in Foreign Markets -- Investigation BY HUYEN NGUYEN, APRIL 5, 2006

The U.S. International Trade Commission (ITC) issued a press release yesterday announcing the launch of a fact-finding investigation into conditions affecting U.S. trade of medical devices and equipment in principal foreign markets, particularly the Japanese market. The House Ways and... more

Dubai Healthcare City-DHCC BY SHELLY ACHAIBAR, DECEMBER 7, 2005

Dubai, known as the shopping capital of the Middle East famed for its gold market and often referred to as "the city of gold", is now establishing a new presence in healthcare. Dubai Healthcare City (DHCC), an estimated 4.1 million... more

IsoTis Appoints Jim Hart to Board BY JOHN MCCORMICK, JUNE 27, 2005

At a recent shareholders' meeting IsoTis OrthoBiologics announced that it appointed James (Jim) Hart to its Board of Directors. Jim is familiar to many of you as the former CEO of Opus Medical which was sold to ArthroCare for over... more


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