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

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Orthopedic and Dental Industry News Complete Archive »

Major News

President Obama Nominates Dr. Robert Califf as FDA Commissioner BY ANDREW VAHRADIAN, OCTOBER 15, 2015

President Obama has nominated Dr. Robert Califf as the next commissioner of the U.S. Food & Drug Administration (FDA), replacing Margaret Hamburg who resigned in March of this year. Dr. Robert Califf's nomination is subject to Senate confirmation, but if... more

FDA on Track for Expediting Access to Medical Devices BY ANDREW VAHRADIAN, AUGUST 12, 2015

According to an EP Vantage report, the FDA has cleared 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE) in 1H:15, putting the regulatory agency on track this year to approve the most medical devices than... 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

Zimmer to Acquire Biomet for $13.4B BY ANDREW VAHRADIAN, APRIL 24, 2014

Zimmer and Biomet announced that each of their respective Boards of Directors have approved a definitive agreement under which Zimmer will acquire Biomet in a cash and stock transaction valued at approximately $13.35 billion, including the assumption of net debt,... more

CMS to Begin Disclosing Medicare Procedure Data Publicly BY ANDREW VAHRADIAN, APRIL 10, 2014

The Centers for Medicare & Medicaid Services (CMS) announced a new policy in which the federal agency will begin publicly disclosing data on Medicare services and procedures furnished by individual physicians and other professionals in order to make the U.S.... more

Henry Schein Completes Strategic Investment in Dental Implant Manufacturer BioHorizons BY EDITOR, JANUARY 2, 2014

Henry Schein, Inc., the world's largest provider of health care products and services to office-based dental, animal health and medical practitioners, announced the completion of a 60% equity investment in BioHorizons, Inc., a U.S.-based manufacturer of advanced dental implant technology... more

Henry Schein Signs Agreement To Invest In BioHorizons BY EDITOR, NOVEMBER 26, 2013

Company Advances Strategy to Enhance Position in Dental Specialty Markets With Investment in Implant Manufacturer Henry Schein, Inc. (NASDAQ: HSIC), the world's largest provider of health care products and services to office-based dental, animal health and medical practitioners, announced today... more

Researchers Discover New Knee Ligament BY ANDREW VAHRADIAN, NOVEMBER 5, 2013

Two orthopedic surgeons at University Hospitals Leuven have discovered a previously undescribed ligament in the human knee, first documented in a 1879 article by French surgeon Paul Segond, who postulated the existence of an additional ligament located on the anterior... more

Advancement in Negotiations Regarding a Repeal of the Medical Device Tax BY ANDREW VAHRADIAN, OCTOBER 10, 2013

In recent weeks, House Republicans have made the repeal of the 2.3% medical device excise tax a prime focus in their larger opposition towards President Barack Obama's Affordable Care Act (ACA). They are seeking repeal or at least a delay... 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

Cholesterol-lowering Statins Could Lead to Musculoskeletal Injuries BY ANDREW VAHRADIAN, JUNE 25, 2013

A report published by JAMA Internal Medicine determined that while utilizing cholesterol-lowering statins can lower cardiovascular illnesses and death, it could also lead to musculoskeletal arthropathies and injuries associated with a wide variety of clinical presentations, including muscle weakness, muscle... 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

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

FDA to Tighten Regulation on Metal-on-Metal Hip Implants BY ANDREW VAHRADIAN, JANUARY 24, 2013

In order to close a loophole in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, the FDA has issued a proposed order that will require metal-on-metal (MoM) hip arthroplasty implant manufacturers to... more

Year in Review: M&A Takes Off BY LAUREN UZDIENSKI, DECEMBER 19, 2011

This has been a banner year for musculoskeletal consolidation, with a number of landmark deals taking place in spine, biologics and dental. Our analysis shows that there were 35 significant transactions announced in the musculoskeletal space this year, which compares to 25 in 2010 and just 15 in 2009. 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

Smith & Nephew's CEO to Retire in April BY SANDER DUNCAN, FEBRUARY 11, 2011

Smith & Nephew announced yesterday that David Illingworth, CEO, will retire from the company following their annual meeting on April 14th. Illingworth made the announcement during the company's annual earnings call, reporting a "strong finish to 2010." more

Healthcare IPO Market Heats Up This Week BY SANDER DUNCAN, JANUARY 31, 2011

The US IPO market is heating up as 12 companies are set to price this week. The largest contingent in this group comprises seven healthcare companies, including private equity-backed medical device companies Tornier and BioHorizons, a HealthpointCapital portfolio company. more

Tornier Files for IPO BY JOHN MCCORMICK, JUNE 8, 2010

Despite recent market turmoil, fast-growing extremities implant leader Tornier made a confident statement about its business outlook by filing for a $205 million initial public offering (IPO) yesterday. After a 16-month nuclear winter, healthcare IPOs came back with a vengeance... more

Industry Reaches Out to Help Haiti BY LAUREN UZDIENSKI, JANUARY 20, 2010

A week after a catastrophic earthquake in Haiti, the orthopedic industry is mobilizing to help. Alphatec Spine, DePuy, Medtronic, Smith & Nephew and Synthes are among the companies contributing money and surgical supplies in the wake of the crisis. Synthes... more

Muscloskeletal News Roundup 16-Jul-09 BY LAUREN UZDIENSKI, JULY 16, 2009

Earnings Biomet reported FQ4:09 sales of $639.3 million, representing a 7% increase over the year-ago period. Among segments, hip increased 9%; knee increased 11%; extremity increased 18%; dental decreased 13%; fixation increased 5%; and spine increase 18%. All growth rates... more

Payers, Trade Groups and Physicians Pledge to Curb Growth of Healthcare Costs BY LAUREN UZDIENSKI, MAY 12, 2009

President Obama is moving ahead with U.S. healthcare reform, and yesterday he provided an overview of part of his plan with a coalition of insurers, industry groups and physicians behind him. During the 1990s, President Clinton's push for a healthcare... more

With Polls Closed and Votes Counted, What's in Store for the Device Industry? BY LAUREN UZDIENSKI, NOVEMBER 5, 2008

The morning after this historic election, President-Elect Barack Obama and an incoming Democratic Congress promise government-wide change and progress. How will the medical device industry be affected by the new administration? While details of the new administration's healthcare proposals are... more

The End of an Era on Wall Street BY LAUREN UZDIENSKI, SEPTEMBER 22, 2008

The market turmoil that started last week with the collapse of Lehman Brothers, the sale of Merrill Lynch and AIG's need for a cash infusion culminated with the government's $700 billion market bailout plan and the end of the traditional... more

As Tensions Mount on Wall Street, Orthopedics Offers Stability BY LAUREN UZDIENSKI, SEPTEMBER 15, 2008

A handful of big headlines rocked the financial sector this weekend, sending the S&P 500 down 3% at midday and compounding months of write-offs, bailouts and mergers that created a cloud of decline within the banking industry. To recap, Lehman... more

DJO to sell for $1.6 Billion BY JOHN MCCORMICK, JULY 16, 2007

This morning DJO Incorporated (formerly known as DJ Orthopedics), the largest bracing company in the land, announced that it has agreed to be sold for $1.6 billion to Austin, Texas-based ReAble Theraputics, Inc. (formerly known as Encore Medical). As opposed... more

Star-Ledger: DOJ Settlement Could Come this Summer BY LAUREN UZDIENSKI, MAY 24, 2007

A DOJ investigation into surgeon compensation practices by Biomet, Depuy, Smith & Nephew, Stryker and Zimmer in 2005 could reach a settlement "as soon as this summer," according to the Star-Ledger's John P. Martin. Current terms of the settlement are... more

Amedica Files for $75 Million IPO BY JOHN MCCORMICK, MAY 23, 2007

Yestderday, Utah-based Amedica Corp. filed an initial public offering Securities and Exchange Commission to sell up to $74.75 million in common stock. The company's technology platform is in silicon nitride ceramics as applied to various types of orthopedic implants including... more

FDA Makes Post-Approval Device Study Info Public BY LAUREN UZDIENSKI, APRIL 10, 2007

Plans for more rigorous post-marketing policy are underway at the FDA with a new website that tracks post-approval device studies. The website names the manufacturer, device, study description and study status. There is no specific info on clinical studies because... more

MDMA Looks Ahead: MDUFMA, Reimbursement, Gainsharing and More BY LAUREN UZDIENSKI, JANUARY 22, 2007

This afternoon MDMA held its monthly call, outlining policy changed that are on the horizon for 2007. We've outlined some of their comments below: MDUFMA Negotations for MDUFMA II have been ongoing since February of 2006. The FDA has recently... more

Clinical Trials a Struggle for Blood Substitutes; Navy Study Blocked Again BY LAUREN UZDIENSKI, JANUARY 2, 2007

Following up on an earlier blog about orthopedics' demand for a blood substitute, new research developments don't bode well for two synthetic products. Elective orthopedic surgery has one of the highest rates of patient blood loss; an effective blood substitute... more

Nature Drops Open-Editing Trial, Citing Lack of Interest BY LAUREN UZDIENSKI, DECEMBER 29, 2006

Last October, we discussed the prestigious journal Nature's open-editing initiative, which would allow scientists to submit their research for an informal public review, separate from the traditional peer review process. This project has been scrapped due to lack of author... more

Orthopedic News Roundup 21-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 20, 2006

M&A Biomet has agreed to a $10.9 billion buyout from a consortium of private investors, including Biomet founder and former CEO Dane Miller, the Blackstone Group, Goldman Sachs Capital Partners, Kohlberg Kravis Roberts and the Texas Pacific Group. The consortium... more

MCAC Debates Clinical Research Coverage BY LAUREN UZDIENSKI, DECEMBER 19, 2006

We attended last Wednesday's MCAC panel in Baltimore, convened to discuss revisions to CMS' clinical research policy. The panel recommended changes to the terminology and scope of CMS coverage; voting questions covered the definition of a good clinical study, changes... more

Dane Miller to buy Biomet for $10.9 billion: 10 Months to Close BY JOHN MCCORMICK, DECEMBER 18, 2006

This morning Biomet's board of directors announced an agreement to be acquired by Dane A. Miller, the company's longtime CEO who was pushed aside in March of this year. Miller and his backers - a consortium of private equity firms... more

Congress Delays Medicare Cuts to Physician Income; Will Reward for Data Reporting BY LAUREN UZDIENSKI, DECEMBER 12, 2006

In its final hours, the 109th Congress passed a bill reversing a reimbursement decision that would have resulted in a 5.1% percent cut in Medicare payments to physicians. The cut was scheduled to take effect Jan. 1. We first covered... 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

Intial SPORT Trial Outcomes Subject to Interpretation, but Tend to Favor Surgery BY JOHN MCCORMICK, NOVEMBER 22, 2006

The first arm of the Spine Patients Outcome Research Trial ("SPORT") study was released by the Journal of the American Medical Association yesterday. The $13.5 million NIH funded SPORT study has been designed to determine the efficacy of spine surgery... more

With a Democratic Congress, What's in Store for Medical Devices? BY LAUREN UZDIENSKI, NOVEMBER 14, 2006

With the Democrats taking over the House and Senate, new healthcare priorities are bound to emerge: an early target is pharma, specifically regarding legislation that would allow the government to negotiate directly with drug companies over prices as well as... more

Study Finds Medical Spending Worth the Investment BY LAUREN UZDIENSKI, SEPTEMBER 26, 2006

The New England Journal of Medicine recently published a study (subscription required) on the value of medical spending in the U.S. - concluding that while concerns about healthcare efficiency are warranted, the continual increase in life expectancy can be attributed... 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

Red Cross Fined over Blood Collection Violations; What Does It Mean for Orthopedics? BY LAUREN UZDIENSKI, SEPTEMBER 13, 2006

As the Wall Street Journal (subscription required) reported this week, the American Red Cross will be fined $4.2 million for failing to honor federal blood-collection regulations. More than 12,000 units of blood were recalled during 2002 and 2005, and these... more

Group Purchasing Organizations and Market Reform: What's Ahead for Device Companies? BY EDITOR, SEPTEMBER 5, 2006

February 2010 update: This report is no longer available for purchase. Learn more here.     Fact: GPO-negotiated contacts drive more than $100 billion in device purchases by hospitals.     News Item: The DOJ, the Connecticut Attorney General, three U.S. Senators, and the... more

McClellan to Leave CMS BY ARIELLA P. GOLOMB, MD, SEPTEMBER 5, 2006

In an email to his staff today, Mark B. McClellan, MD, PhD, Administrator of the Center for Medicare and Medicaid Services (CMS) since March 2004 announced that he will be leaving CMS by early October. Dr. McClellan did not announce... more

Journal Editor's Departure Shines Light on Conflicts of Interest BY LAUREN UZDIENSKI, AUGUST 30, 2006

The journal Neuropsychopharmacology is looking for a new editor this week, as well as refining its policy on academics who fail to reveal their financial ties. Respected psychiatrist and editor-in-chief Charles B. Nemeroff is stepping down from his post after... more

Private Equity Firm to Buy Encore for $870mm BY JOHN MCCORMICK, JULY 3, 2006

After the market close on Friday, a unit of the mega-sized private equity firm Blackstone Group (not to be confused with the spine company) offered Encore Medical Corporation shareholders a 36% premium to take the company private. The enterprise valuation... 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 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

CMS Changes its Charite Decision BY DAVID KRESSEL, MAY 17, 2006

In a surprising but welcome change of heart, the Centers for Medicare and Medicaid Services revised its proposed National Noncoverage Decision and will reimburse the Charite in specific circumstances. In the February draft of the NCD, CMS proposed national noncoverage... more

Orthopedic News Roundup 30-Mar-06 BY HUYEN NGUYEN, MARCH 30, 2006

Dane Miller of Biomet called it quits a week after releasing its 3Q:06 earnings report. Last week, the Company reported earnings per share (EPS) of $0.43 which was in line with Street's estimate but did not meet analysts' expectation for... more

Dane Miller to Retire BY JOHN MCCORMICK, MARCH 27, 2006

This morning, legendary orthopedic CEO, Dane A. Miller, Ph.D., Biomet's President and Chief Executive Officer and co-founder, announced his decision to retire. He will remain a Director and serve as a consultant. The Biomet Board has appointed Senior Vice President... more

Zimmer Wins Battle with HCA BY JOHN CHOPACK, FEBRUARY 8, 2006

Tuesday seemed to bring to an end a battle that has been brewing behind the scenes since early in the fall and began in the press a week ago. In the end, Zimmer hit HCA right between the eyes and... 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

CMS (Medicare) opens a National Coverage Determination (NCD) request to review coverage of the lumbar artificial disc BY BARB PETERSON, SEPTEMBER 14, 2005

[Update: We're moving this entry to the top of the blog since it is sparking a lot of interest from our readers.] more

Osteotech: Hostile to Shareholders? BY JOHN MCCORMICK, AUGUST 30, 2005

As many of you now know, the venerable (and world's largest) non-profit tissue bank Musculoskeletal Transplant Foundation (MTF) announced on Monday that is had proposed to acquire all of the outstanding common stock of Osteotech, Inc. (Nasdaq: OSTE) for $6.25... 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

The Industry Subpoenaed: Our Perspective BY JOHN MCCORMICK, APRIL 4, 2005

The healthcare industry has long been the subject of regulation by complex laws that do not exist in other industries and which, under certain circumstances, may seem almost excessive and counter-intuitive. The enforcement of these laws has been significant and... more

The Shot Heard Around the World: Inion goes Public BY JOHN MCCORMICK, DECEMBER 6, 2004

Europe stole the headlines last week when Finnish implant manufacturer Inion (LSE: IIN LN) went public raising £30 million (US$58 million) on the London Stock Exchange. Immediately following the offering, valuation shot up 30% to a staggering 19x estimated 2004... more

The FDA Approves Charite Disc Arthoplasty BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

Hats off to DePuy Spine for winding this approval through the FDA so masterfully. The timing (to coincide with NASS) was exactly right. The website is excellent and we repeat some key points from it later in this commentary. Future... more

Medicare (CMS) Adds Express Lane for New Orthopedic Technology BY ROBIN R. YOUNG CFA, OCTOBER 11, 2004

The Center for Medicare and Medicaid Services announced on October 6 that it is going to implement seven new and specific improvements which, in the aggregate, should speed up development of new technology codes as well as simplify coverage and... more

HealthpointCapital Announces Purchase of 33% share in Scient'X S.A., Developer of Innovative Spinal Implant Technologies BY EDITOR, JUNE 28, 2004

Scient'X is leader in the developing fieldof motion preservation and dynamic stabilization for spine surgeries New York, NY., USA and Paris, France, June 29 -- HealthpointCapital Partners L.P., the private equity affiliate of HealthpointCapital, and Scient'x S.A., the spinal implant... more

Bye-Bye Interpore Cross BY ROBIN R. YOUNG CFA, MARCH 8, 2004

The last remaining, full line public spinal implant company is gone. This morning Biomet agreed to pay $280 million or 3.6x 2004 revenues (36x expected 2004 EBITDA) for Interpore Cross. This transaction, assuming it is completed, will vault Biomet into... more

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