Almost a year following the settlement in its physician-payment investigation, the DOJ just won't leave Stryker alone, or so Stryker claims in a new legal action revealed this week. The company filed suit in U.S. District Court in Newark, NJ,... more
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
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
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
Regulatory Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to... more
The Philadelphia Inquirer reported this week that Katrina McKenzie has filed a lawsuit against Jonathan Garino, M.D. and the University of Pennsylvania Health System following a hip replacement she received as a participant in a clinical trial. The suit alleges... more
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
M&A Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The... more
M&A Kinetic Concepts, Inc. announced that it completed its acquisition of LifeCell Corporation. At the time of the expiration of the tender offer, 31.1 million shares of LifeCell common stock had been tendered representing approximately 90.75% of the outstanding shares... more
M&A Kinetic Concepts, Inc. announced plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading price. KCI... more
Earnings BioMimetic Therapeutics reported 4Q:07 revenues of $4.5 million, up from $1.9 million in 4Q:06 but missing analysts' estimates by $1.1 million. Revenues included $3.6 million of product sales of GEM 21S to Luitpold, $0.7 million of royalty income and... more
Earnings Artimplant reported 4Q:07 revenues of SEK 5.0 million ($0.8 million), up from SEK 1.6 million ($0.25 million) in the year-ago period. The net loss for 4Q:07 was SEK 2.1 million ($0.34 million), improved from a loss of SEK 9.5... more
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
In an 8-1 decision, the Supreme Court ruled in favor of Medtronic in the Reigel v. Medtronic case. As we reported in June, Charles Reigel sued Medtronic after a balloon catheter failed during his angioplasty. Medtronic argued successfully in several... more
Earnings Biomet reported earnings for 2FQ:08 last week, with net sales up 11% to $578.1 million over the comparable quarter. Worldwide, knee sales were up 17%, and hip was up 12%. Extremity sales increased 11% and bone cements and accessories... more
M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more
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
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
Earnings Artimplant announced 3Q:07 revenue of SEK 2.6 million, up from SEK 0.9 million in the year-ago period. 3Q:07 net loss was SEK 3.6 million, down from SEK 10.4 in 3Q:06. Earnings per share, including a non-recurring item, amounted to... more
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
Earnings Globus Medical announced 2Q:07 revenues of $30.2 million, an increase of 52% over the comparable quarter. The company attributes the revenue growth to the expansion of its sales and distribution footprint, product introductions in its fusion, MIS and biomaterials... more
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
Yesterday, the Philadelphia Inquirer (article here) reported that Synthes and Globus have settled their long running legal dispute for an undisclosed amount. The agreement stipulates that Globus that it will not solicit or hire Synthes employees for one year. This... more
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
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
Earnings aap Implantate AG announced 2006 revenues of EUR 18.5 million, up 38% from the previous year. The aap Group attributed the growth to the Biomaterials segment, where sales increased by 64% to EUR 12.2 million. Biomaterials now generates two... more
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
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
Earnings Lifecore Biomedical reported earnings for the second quarter ending December 31, 2006. Net income fell to $1.37 million, or $.10 per diluted share during the quarter from $1.39 or $.10 per diluted share, in the quarter ending December 31,... 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
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
Earnings Biologics: Orthovita reported 3Q:06 product sales came in at $11 million, up 32% compared to 3Q:05. Net loss for the quarter was $3.7 million, or a loss of $0.07 per share. The Company beat analysts' EPS estimates by $0.02,... more
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
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
Appointment: SpineVision® SA has hired Julian Mackenzie as its new Chairman and CEO. Previously, Mr. Mackenzie was with Wright Medical serving as Director General and CFO. Business Update: Donor Referral Services of North Carolina is at the center of a... more
Earnings: Biologics: Tutogen reported 3Q:06 sales of $10 million and a net loss of $1.1 million, or $0.07 per fully diluted share compared to the same quarter last year. The Company would have experienced breakeven results without ~$1.1 million in... more
Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more
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
An article in yesterday's New York Times provides a useful summation of the kickback controversy surrounding the Healthcare Research and Development Institute, or H.R.D.I., a for-profit consulting firm owned by about three dozen hospital executives that advises pharmaceutical, medical device,... more
Appointments: Tutogen Medical appointed Dr. Karl Koschatzky to the position of Managing Director. Dr. Koschatzky will replace Manfred Kruger, who was Tutogen's President of International operations and Managing Director of the German subsidiary. IsoTis OrthoBiologics appointed James William (Jim) Poser,... 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
In contrast to the prevailing trend of limiting the access of pharmaceutical representatives to physician offices, medical device representatives are often a welcome addition in the operating room. Many surgeons have come to rely on the service they provide during... more
Many orthopedic companies will be reporting their 1Q:06 results in the next few weeks. The table below provides a listing of conference call dial-in numbers and webcasts for the investment community. How the overall orthopedic industry fared in the first... more
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
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
The issue of patent protection is high on the minds of people in both the orthopedics industry and US business. Today the lead editorial in the Wall Street Journal (subscription required) ranted about how the patent system, designed to spur... more
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
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
The allograft industry was scrutinized recently due to the highly publicized case of Biomedical Tissue Services (BTS). The company is being investigated by the Brooklyn district attorney's office for operating a scam to profit from body parts. The first company... 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
The FDA Orthopedic and Rehabilitation Devices Panel held a meeting September 8th and 9th to rule on two important issues: Smith & Nephew's hip resurfacing device and the design of clinical studies for spinal devices. You can find background information... more
This week we finish off the first half of 2005 reporting season with 17 orthopedic companies* released their financial numbers. In 2Q:05, in an aggregated total, orthopedic revenues increased 16% ($3.8 billion vs. $3.2 billion) and a 25% increased in... more
Earnings: Please refer to the table (below) for individual company sales and earnings. It's all about earnings this week... Biologics: Clearly, the big winner this week is LifeCell Corp. who reported strong earnings on Monday stock was up 24% at... more
[Editor's note: We welcome attorney Richard Zall of Mintz, Levin as a guest blogger to answer a question posed by a reader in response to Joane Goodroe's Gainsharing post earlier this week. See Zall's profile here.] Interested in your thoughts... more
The New York Times covers (registration required) the obstacles facing evidence-based medicine in a cardiac-centric article that touches on orthopedics. Hospitals are pressuring device prices down, and TheStreet.com gives a good quick treatment to the the reimbursement issue we cover... 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
You can always tell what managers are really thinking by the order of their comments on conference calls. For the quarter just ended (September 30/2004) Kyphon reported a 59% jump in net sales $55.8 million. Earnings soared to $6.1 million,... more
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
The U.S. Court of Appeals for the Third Circuit (Pennsylvania and New Jersey) breathed new life last week into an otherwise moribund case against Zimmer. In remanding the case back to a lower court, which had dismissed it earlier, the... more
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
It was middle of the afternoon at Kyphon's headquarters, but after 6pm Eastern Standard Time when Kyphon issued an announcement that it was suing start-up company Disc-O-Tech in both U.S. District Court and at the International Trade Commission for patent... more
We didn't specifically see this coming, but we're not surprised. A seriously disgruntled group of Genzyme Biosurgery's shareholders have filed suit against Genzyme Biosurgery. We commented on Genzyme's ending of the tracking stock mechanism three weeks ago as follows: “Some... more
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