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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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 New York Times call for GPO reform. Takeaway: GPO market reform will change your... more
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
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
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
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
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
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
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
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
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
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
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
[Update: We're moving this entry to the top of the blog since it is sparking a lot of interest from our readers.] more
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
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 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
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
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
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
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
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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