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Stryker

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI

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 4-Mar-10 BY LAUREN UZDIENSKI

knee.jpg Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more

Musculoskeletal News Roundup 11-Feb-10 BY LAUREN UZDIENSKI

Earnings Nobel Biocare reported 4Q:09 revenues of EUR 156.0 million ($213.6 million), flat over the year-ago period and missing estimates by EUR 5.0 million ($6.9 million.) EPS of EUR 0.21 ($0.29) missed estimates by EUR 0.05 ($0.07). The company called... more

Musculoskeletal News Roundup 28-Jan-10 BY LAUREN UZDIENSKI

Earnings Johnson & Johnson reported 4Q:09 revenues of $16.5 billion, representing a 9% increase over the year-ago period and beating estimates by $0.8 billion. DePuy reported $1.5 billion in sales, up 10% over the year-ago period, with hip up 12%,... more

Musculoskeletal News Roundup 14-Jan-10 BY LAUREN UZDIENSKI

Earnings aap Implantate reported preliminary sales of EUR 7.4 million ($10.6 million) in 4Q:09, down 4% from the year-ago period. Full year sales were up 3% to EUR 33.0 million ($47.3 million). Company highlights for the year include "optimizing its... more

Stryker Pre-Announces 4Q:09; Files $1B Debt Financing BY LAUREN UZDIENSKI

Stryker Corporation pre-announced 4Q:09 revenues of $1.8 billion, up 7% over 4Q:09 as reported and 3% when excluding the effects of currency. Revenues are about $35 million above analysts' estimates. Orthopedic implant sales were $1.1 billion in 4Q:09, up 10%... more

Musculoskeletal News Roundup 7-Jan-10 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ2:10 (ended November 30, 2009) revenues of $696.0 million, up 5% over the year-ago period. Recon sales increased 6% to $528.4 million, with hip up 4%, knee up 8%, dental down 8% and extremity up 27%. Additionally,... more

Musculoskeletal News Roundup 3-Dec-09 BY LAUREN UZDIENSKI

M&A Stryker entered into a definitive agreement to acquire Ascent Healthcare Solutions, a medical device reprocessing company, for $525.0 million in cash. Ascent describes its operations as including the "cleaning, testing/verifying, packaging and sterilizing" or devices, as well as "remanufacturing,"... more

Stryker to Acquire Ascent Healthcare Solutions BY LAUREN UZDIENSKI

Stryker announced yesterday that they would acquire Ascent Healthcare Solutions, a device reprocessing company, from RoundTable Healthcare Partners. Stryker will pay $525 million in cash for the company, which had about $100 million in revenues in 2008. Ascent will become... more

Musculoskeletal News Roundup 12-Nov-09 BY LAUREN UZDIENSKI

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

Stryker Acquires OtisMed BY LAUREN UZDIENSKI

Stryker announced the acquisition of OtisMed, a software company that manufactures custom cutting guides for total knee replacements. Financial terms of the deal were not specifically disclosed, but Stryker simultaneously announced the acquisition of the Sonopet Ultrasonic Aspirator, and the... more

Wright Medical Receives FDA Approval for Conserve Plus Hip Resurfacing Device BY LAUREN UZDIENSKI

Wright Medical announced that their Conserve Plus hip resurfacing device received long-awaited FDA approval, which the company said was supported by clinical data on over 1,300 patients with up to eight years of follow-up. The company plans to initiate surgeon... more

Stryker Biotech Indicted Over OP-1 Marketing BY LAUREN UZDIENSKI

Stryker Biotech is facing a federal indictment after a long investigation into its sales of OP-1 (BMP-7), which was approved by the FDA under an HDE. An HDE stipulates that a device will be used in less than 4,000 patients... more

Musculoskeletal News Roundup 22-Oct-09 BY LAUREN UZDIENSKI

Earnings CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.... more

Musculoskeletal News Roundup 23-Jul-09 BY LAUREN UZDIENSKI

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

BMPs Increase Complications for Cervical Fusion Patients BY LAUREN UZDIENSKI

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

New Studies Question Efficacy of Hip Resurfacing BY LAUREN UZDIENSKI

The promise of hip resurfacing seems to have faded somewhat with the publication of some new studies showing that outcomes for the procedure are similar to those associated with a traditional hip replacement. Additionally, the surgery has been found to... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI

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 23-Apr-09 BY LAUREN UZDIENSKI

Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more

Musculoskeletal News Roundup 16-Apr-09 BY LAUREN UZDIENSKI

Earnings JNJ reported 1Q:09 sales of $15.0 billion, missing estimates by $0.4 billion and representing a 7% decline over 1Q:08, which the company attributed mostly to unfavorable exchange rates. Net income was $3.5 billion, or $1.26 per diluted share, beating... more

Musculoskeletal News Roundup 2-Apr-09 BY LAUREN UZDIENSKI

Earnings Corin reported 2008 revenues of GBP 39.8 million ($57.6 million), an 8% increase over 2007 sales. The company also reported a pretax loss of GBP 3.9 million ($5.6 million), which reflected a GBP 5.2 million ($7.2 million) inventory write-down... more

Stryker's OP-1 Putty Not Approvable According to FDA Panel BY ARIELLA P. GOLOMB, MD

Yesterday an FDA advisory panel voted 6-1 that Stryker's PMA for its OP-1 Putty for uninstrumented posterolateral fusion for the treatment of lumbar spondylolisthesis was "not approvable." Stryker was seeking this approval based on 24 months of clinical outcome data... more

Four of Big Five Settle with DOJ; Compliance Monitors Leave BY DAVID KRESSEL

Eighteen months after the Department of Justice entered into Deferred Prosecution Agreements (DPA) with Smith & Nephew, Johnson & Johnson (Depuy), Zimmer and Biomet, and a Non-Prosecution Agreement with Stryker, the DOJ has announced it has dismissed the criminal charges... more

Musculoskeletal News Roundup 26-Mar-09 BY LAUREN UZDIENSKI

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

Stryker Facing Federal Grand Jury Investigation Over the Marketing of OP-1 BY LAUREN UZDIENSKI

As Stryker's long-awaited FDA panel session for OP-1 approaches, the company announced that it's facing a federal grand jury investigation into marketing practices surrounding the device. Specifically, allegations include the illegal promotion of OP-1 products and Calstrux, misbranding of devices... more

Musculoskeletal News Roundup 12-Mar-09 BY LAUREN UZDIENSKI

Earnings BioMimetic Therapeutics reported a net loss in 4Q:08 of $12.2 million, or $0.65 per share, widening from a net loss of $6.9 million, or $0.37 per share, in 4Q:07. Analysts had forecast a net loss of $0.53 per share.... more

Musculoskeletal News Roundup 12-Feb-09 BY LAUREN UZDIENSKI

Earnings Nobel Biocare reported 4Q:08 revenue of EUR 162.6 ($229.2 million), down 13% from 4Q:07. 4Q net profit of EUR 24.9 million ($32.3 million) was down 45% from the year-ago period and missed estimates of EUR 29.0 million ($40.9) million.... more

Musculoskeletal News Roundup 29-Jan-09 BY LAUREN UZDIENSKI

Earnings Kensey Nash reported FQ2:09 revenues of $20.8 million, up 6% over the year-ago period and beating estimates by $0.4 million. Net income for the quarter was $5.2 million, or $0.44 per diluted share, beating estimates by $0.04 and representing... more

NASS Announces More Stringent Disclosure Policy BY LAUREN UZDIENSKI

The North American Spine Society (NASS) adopted a new transparency policy requiring surgeons presenting at conferences to disclose both industry relationships and the dollar amount of any payments. Failure to disclose information could result in sanctions including suspension or expulsion... more

Musculoskeletal News Roundup 15-Jan-08 BY LAUREN UZDIENSKI

Earnings Alphatec Spine announced that, based on preliminary financial data, the company will report record consolidated quarterly revenues for 4Q:08 of approximately $28.4 million, an increase of approximately 33% over revenues from the prior year fourth quarter. For the year... more

While Some Sectors Struggle, Early 4Q Results Show Stability for Ortho BY LAUREN UZDIENSKI

Over the weekend, Slate.com posted a report on some of the reasons why the healthcare industry may be more vulnerable to a recession now than in the past. However, the article also helped to highlight the ways in which orthopedics... more

Musculoskeletal News Roundup 8-Jan-09 BY LAUREN UZDIENSKI

Earnings CONMED Corp. lowered 4Q:08 revenue projections to $176-$178 million, 9% lower than forecast and approximately 7% lower than 4Q:07. Reduced revenues were attributed to unfavorable foreign currency exchange fluctuations and lower than anticipated sales of capital equipment to hospitals.... more

Stryker Reduces 2008 Guidance BY LAUREN UZDIENSKI

Last night, Stryker announced that the company is reducing its revenue and earnings outlook for 2008 on account of the "unprecedented weakening" of the U.S. economy. Constant-currency revenue growth, previously forecast to be 11-12% over 2007, is now expected to... more

Musculoskeletal News Roundup 4-Dec-08 BY LAUREN UZDIENSKI

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 13-Nov-08 BY LAUREN UZDIENSKI

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

Squeaky-Hip Case Against Stryker Dismissed in Colorado BY LAUREN UZDIENSKI

A Colorado judge dismissed Jama Parker's lawsuit against Stryker over a squeaky ceramic-on-ceramic hip. The court determined that since the Trident system has PMA clearance, Parker's claims were preempted. Last February, an 8-1 Supreme Court decision upheld preemption in Reigel... more

Musculoskeletal News Roundup 22-Oct-08 BY LAUREN UZDIENSKI

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

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

What's in Store for Stryker? 07 Settlement Gives Clues BY LAUREN UZDIENSKI

Stryker's bold move a few weeks ago of suing the DOJ over an ongoing investigation has been the subject of wide speculation, and while little is known for sure about what prompted their action, last year's settlement offers some insight.... more

Stryker Sues DOJ Over "Oppressive" and "Overly Broad" Subpoenas BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 21-Aug-08 BY LAUREN UZDIENSKI

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 17-July-08 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ4:08 revenues of $635.6 million, an increase of 16% (10% constant currency) over the year-ago period. Sales increased 10% in the U.S and 24% (11% constant currency) OUS. Recon sales increased 17% worldwide (12% constant currency) to... more

Stryker's Resurfacing Sales Disappoint; Corin Shares Plummet BY LAUREN UZDIENSKI

Stryker announced last week that sales of Corin's Cormet hip resurfacing system, which Stryker distributes exclusively in the U.S., were not meeting expectations. The company will not order more Cormet systems until December. Shares of both Stryker and Corin fell... more

New York Times, FDA Perk Up Their Ears for Squeaky Hips BY LAUREN UZDIENSKI

Stryker's ceramic-on-ceramic hip, the Trident, came to market in 2003 with the promise of providing a more durable alternative for younger patients seeking a THA. A traditional metal/poly hip lasts about ten years, so ceramic seemed to be the answer... more

Musculoskeletal News Roundup 8-May-08 BY LAUREN UZDIENSKI

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 17-Apr-08 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ3:08 net sales of $603.1 million, a 14% increase over the year-ago period. Excluding the impact of foreign currency, net sales increased 10%. U.S. revenue was $351.6 million. Adjusted net income for the third quarter was $25.2... more

Musculoskeletal News Roundup 13-Mar-2008 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 31-Jan-08 BY LAUREN UZDIENSKI

Earnings Kensey Nash reported FQ2:08 total revenues of $19.6 million, missing estimates by $0.05 million and up 14% over the year-ago period. Net sales of biomaterials products increased 15% to $11.5 million, which the company attributed to orthopedic sales. The... more

Musculoskeletal News Roundup 25-January-08 BY LAUREN UZDIENSKI

Earnings JNJ reported 4Q:07 revenues of $15.96 billion, up 17% over the year-ago period and beating consensus estimates of $15.4 billion. Net income was $2.37 billion, or $0.82 per share, missing estimates by $0.04. Depuy reported 4Q:07 sales of $1.21... more

Musculoskeletal News Roundup 17-Jan-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 13-Dec-07 BY LAUREN UZDIENSKI

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 15-Nov-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI

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 28-Sept-07 BY LAUREN UZDIENSKI

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 26-July-07 BY LAUREN UZDIENSKI

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

Orthopedic News Roundup 5-July-07 BY LAUREN UZDIENSKI

Regulatory Corin received FDA approval for its Cormet Hip Resurfacing System on Tuesday, following an approval recommendation from an FDA Advisory panel back in February. Conditions of the official approval include the creation of a surgeon education protocol that emphasizes... more

Cormet Gets FDA Approval, Stryker To Market As Early As 3Q:07 BY ARIELLA P. GOLOMB, MD

On Tuesday the FDA approved Corin's Cormet Hip Resurfacing System, introducing competition for Smith & Nephew's Birmingham Hip Resurfacing System in the U.S. Prior to Tuesday's announcement, the BHR was the only resurfacing system approved for the U.S. market. An... more

Orthopedic News Roundup 21-June-07 BY LAUREN UZDIENSKI

Regulatory TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was... more

Orthopedic News Roundup 7-June-07 BY LAUREN UZDIENSKI

M&A The private equity consortium set to acquire Biomet increased its buyout offer to $46.00 per share in cash, or an equity value of $11.4 billion. The new offer represents a 32.3% premium over the April 2006 common stock closing... more

Star-Ledger: DOJ Settlement Could Come this Summer BY LAUREN UZDIENSKI

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

"Significant" Delay for Stryker's OP-1 Putty BY LAUREN UZDIENSKI

Stryker's 1Q:07 earnings call last week highlighted strong profits, but Chief Executive Stephen MacMillan noted a potential snag in its pipeline - OP-1 putty, the company's bone morphogenic protein for spinal fusion indications, may not reach the market until late... more

Society for Biomaterials a Product Pipeline Crystal Ball BY DAVID KRESSEL

Last week, we attended the Society for Biomaterials' annual conference. The event showcases the latest academic research and its broad applications across medical specialties. Roughly a third of the poster presentations focused on orthopedics, and most of the rest related... more

Orthopedic News Roundup 29-Mar-07 BY LAUREN UZDIENSKI

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

WSJ: Orthopedics a "Hip Bet" BY LAUREN UZDIENSKI

Today's Wall Street Journal features an article on growth in the orthopedic market. Journalist Karen Richardson indicates that innovative, long-lasting and high-margin products are driving investment opportunities. An aging population and increased life expectancy bode well for manufacturers like Stryker... more

2007 AAOS Busy as Ever BY ELIZABETH VARLEY CAMP

Sunny San Diego hosted this year's AAOS meeting, and with more than 470 exhibitors wall-to-wall on the Convention Center floor, it was the biggest Academy yet. One of our cab drivers said, as we were driving away from the conference... more

Merrill Lynch Analyst Joins Stryker BY DAVID KRESSEL

Stryker today announced the appointment of Katherine Owens as Vice President, Strategy and Investor Relations. Katherine Owens made a name for herself (formerly Katherine Martinelli) as Merrill Lynch's orthopedics analyst for the past 8 years. She has been a regular... more

Orthopedics News Roundup 18-Jan-07 BY LAUREN UZDIENSKI

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

Orthopedic News Roundup 7-Dec-06 BY LAUREN UZDIENSKI

Earnings Stryker announced this week that the Board of Directors has declared a year-end cash dividend of $0.22 per share, an increase of 100% over the $0.11 dividend declared in December 2005. The dividend is payable January 31, 2007 to... more

SNN Issued a Statement Re: BMET Acquisition Rumors BY HUYEN NGUYEN

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 19-Oct-06 BY HUYEN NGUYEN

Earnings Dental: Lifecore Biomedical announced that 1Q:07 net sales increased 12% to $15 million. Net income for the quarter was $1.1 million, representing a year-over-year increase of 9%. The Company was in-line with analysts' estimates and reported earnings of $0.08... more

Stryker US Revenues Up; OP-1 Given 2008 Timeframe BY HUYEN NGUYEN

On Tuesday, Stryker Corp. reported $1.3 billion in sales and $188 million in earnings in 3Q:06. Excluding the impact of foreign currency, sales were up by 9.8%, or 10.4% on a reported basis. Net income for the quarter was strong,... more

Orthopedic News Roundup 31-Aug-06 BY HUYEN NGUYEN

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

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

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

Orthopedic News Roundup 27-Jul-06 BY HUYEN NGUYEN

Earnings Results: Biologics: Anika Therapeutics announced 2Q:06 net sales increased 11% to $7.1 million. Product revenues grew 74% while licensing, milestone and contract revenue was down 77%. The large product sales growth was partially driven by higher demand for OrthoVisc®;... more

Zimmer Provides More Info: DOJ Investigating Price-Fixing BY ARIELLA P. GOLOMB, MD

In yesterday's quarterly report press release Zimmer shared more information on the nature of the recent DOJ investigations into the Orthopedics Industry. The ongoing investigation is related to a price-fixing scheme, initiated by one of Zimmer's competitors at a specific... more

Stryker Reports 2Q:06 Earnings, States DOJ Probe Narrowed BY ARIELLA P. GOLOMB, MD

Thursday, Stryker Corporation reported its 2Q:06 operating results. Net sales increased 9.0% to $1.33 billion, slightly below analysts' expectations of $1.34 billion. Operating income rose 16% and net income more than 20%. Diluted EPS for 2Q:06 increased 20.9% to $0.52,... more

Orthopedic News Roundup 12-Jul-06 BY HUYEN NGUYEN

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

Smith & Nephew Receives DOJ Subpoena BY ARIELLA P. GOLOMB, MD

Smith & Nephew announced today that it had received a subpoena from the U.S. Department of Justice, Antitrust Division, for documents relating to possible antitrust issues over the manufacture and sale of orthopedic implant devices, joining its peers Zimmer, Biomet,... more

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN

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

1Q:06 Final Performance Summary BY HUYEN NGUYEN

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

Orthopedic News Roundup 27-Apr-06 BY HUYEN NGUYEN

Appointment: Stryker Corp. appointed three officers to the company: Luciano Cattani, Vice President, Group President, International; Elizabeth A. Staub, Vice President of Regulatory Affairs and Quality Assurance, Stryker Corporation and Bronwen R. Taylor, Chief Compliance Officer, Stryker Corporation. Mr. Cattani... more

1Q:06 Preliminary Earnings Summary BY HUYEN NGUYEN

The first group of orthopedic companies reported their 1Q:06 this week and took in $5.3 billion so far. The total aggregated revenues for the quarter were up by 7% from $4.9 billion in 1Q:05. The industry netted $637.8 million, a... more

Orthopedic News Roundup 20-Apr-06 BY HUYEN NGUYEN

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

Analyst Meetings during AAOS BY KAREN FEDER

Looking ahead to the AAOS 73rd Annual Meeting on March 22-26, 2006 taking place at the McCormick Place Convention Center in Chicago, we wanted to post the latest information on Company Analyst meetings that will be held in Chicago: -... more

Surgeon Choice and Pricing BY LAING RIKKERS

There has been a lot of focus over the past six months on pricing in the orthopedic device market. Two topics generating fear have been (1) HCA's purchasing practices and (2) gainsharing. This week, Melissa Davis of The Street.com wrote... more

4Q:05 Earnings Season Begins: DePuy Down; Stryker In-Line BY JOHN CHOPACK

Johnson & Johnson began the earnings season earlier this week and disappointed investors with a rather strange phenomenon. Every one of JNJ's reporting divisions' revenue growth rates were significantly lower than their year-end growth rates. DePuy was no exception. DePuy... more

Stryker Announces Acquisition of PlasmaSol Corporation BY JOHN CHOPACK

On Tuesday, Stryker announced that it had acquired PlasmaSol Corporation on December 30, 2005 for approximately $17.5 million in an upfront payment and the assumption of certain liabilities. Stryker stated that the transaction will result in a 4Q:05 charge of... more

Update on Surgeons' Subpoenas (DOJ Investigations) BY SUSAN BERSON

[Editor's note: We welcome attorney Susan Berson of Mintz, Levin as a guest blogger. See her profile here.] Earlier this year, the government announced investigations of several device manufacturers charging that the manufacturers were offering inappropriate incentives to referring physicians... more

Orthopedic Fundamentals Remain Strong BY HUYEN NGUYEN

This article was co-authored by Huyen Nguyen and John McCormick. As we move into the fourth quarter earnings calendar, we look back to third quarter reported earnings with some interesting thoughts. (1) Due to natural disasters, some major orthopedic players... more

Insiders Buying Stryker's Shares (EDITORIAL) BY JOHN MCCORMICK

It has never been empirically proven that insider (e.g. management and director) buying of a company's stock guarantees that the stock poised to rise, but it has also never been proven to be a bad sign. That's stating the obvious.... more

Implant Pricing: Not Black and White (EDITORIAL) BY JOHN MCCORMICK

Is Wall Street's shrill reaction to hip and knee implant pricing concerns overblown? Even with sophisticated econometric tools such a question is difficult to evaluate because we are dealing with an expectations driven phenomenon. So we have our doubts about... more

Orthopedic News Roundup 20-Oct-05 BY HUYEN NGUYEN

Some orthopedic stocks declined as two of the big five ortho-companies reported their 3Q:05 earnings this week. Stryker Corp. and DePuy (division of JNJ) both reported top line sales growing at 14%. On Tuesday, Stryker reported below street's estimates by... more

News Flash: Stryker Corp Misses 3Q:05 BY JOHN CHOPACK

Stryker released its 3Q:05 earnings report after the close of trading today. The Company reported revenues of $1,172 million which was a 14% increase over the 3Q:04. Adjusted earnings-per-share (diluted) totaled $0.40 which was a 21% increase over the 3Q:04,... more

Orthopedic Stocks Decline: Our Thoughts BY JOHN CHOPACK

The decline in the valuations of the orthopedic stock prices has reached epic proportions. The 7 leading orthopedic companies which derive a majority of their revenues from hip and knee sales are on average 30% off their 52-Week Highs. Biomet... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN

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

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

Novel Products to Rejuvenate Hip Market Growth BY JOHN CHOPACK

The rate of growth in the hip market has been somewhat lackluster since the 2Q:04. That quarter marked the first two FDA approvals for ceramic-on-ceramic hips for Stryker and Wright Medical. For the 12 months prior to the 2Q:04, Stryker... more

Earning Calls Replay Info BY HUYEN NGUYEN

Thanks to one of our readers who reminded me that I should add international dial-in numbers to the conference calls list. Since most of the companies have already reported their earnings, I am providing you with replay information in case... more

Orthopedic News Roundup 22-Jul-05 BY HUYEN NGUYEN

Appointment: Tutogen Medical appointed Terry Hill, MD to Director of Quality Assurance and Quality Control. He has worked with various tissue banks prior to joining Tutogen. Clinical Update: At the 12th International Meeting on Advanced Spine Techniques (IMAST) Conference, Dr.... more

Orthopedic News Roundup 8-Jul-05 BY HUYEN NGUYEN

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

Hip Resurfacing in the U.S.? BY JOHN CHOPACK

About six months ago I had an individual come into my office asking about an article he had recently read in a local newspaper regarding hip resurfacing. The man was approximately 40 years old and was too young for a... more

1Q:05 Large Joint Review: Knees Remain Strong while Hips Weaken BY JOHN CHOPACK

With most of the major large joint market share leaders reporting their 1Q:05 financials, we examine the strength of the market. At first glance revenue growth of hip products seems to be slowing while knee growth accelerates. Hips We estimate... more

SpinalMotion Receives $20 million in Funding BY HUYEN NGUYEN

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

Stryker Corp. (SYK:NYSE) Reports 1Q:05 Financials; Beats the Street by $0.02 BY JOHN CHOPACK

SYK reported 1Q:05 revenues of $1.2 billion which was a 16% increase over the 1Q:04 and beat analyst expectations by $2 million. The Company reported earnings of $0.42 per diluted share which was $0.02 better than analyst were forecasting. The... more

The Industry Subpoenaed: Our Perspective BY JOHN MCCORMICK

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

4Q:04 Orthopedic Wrap-up BY JOHN CHOPACK

We have aggregated the 4Q:04 and 3Q:04 reported revenues (includes the effects of foreign currency) for 16 public orthopedic companies. Although we would have liked to use revenue growth rates which excluded foreign currency, a majority of the companies report... more

2005 AAOS Analyst Meeting Reviews BY JOHN CHOPACK

This year we attended Smith & Nephew's, Biomet's, Stryker's, and Encore Medical's analyst meetings. All were very professional and well attended. Here are our notes from each: Smith & Nephew Overview: Although Smith & Nephew posted the best large joint... more

Stryker Corp. (NYSE:SYK) Reports 4Q:04 and 2004 Financials BY JOHN CHOPACK

Stryker reported 4Q:04 revenues of $1.156 billion which was an increase of 15% on a reported basis over the 3Q:04. This was slightly below analyst expectations of $1.158 billion in revenues. Earnings for the 4Q:04 totaled $0.40 per diluted share... more

Direct-to-Consumer Advertising Takes Hold in Orthopedics | EDITORIAL | BY JOHN CHOPACK

Direct-to-consumer advertising has become the most powerful means of marketing pharmaceuticals over the last decade. For years we have seen these strange advertisements which typically only mention the name of a drug and the manufacturer, but withhold any information regarding... more

The John Brown Era Comes to an End at Stryker BY ROBIN R. YOUNG CFA

He doesn't look old enough to retire. And when he started, he didn't look old enough to be CEO. Yet 27 years after becoming Stryker's CEO, John Brown is letting go and stepping down. The man walking in the door... more

The 3Q:04 Earnings Season is Half-way Completed for Large Joint Manufacturers: Any Trends? BY JOHN CHOPACK

Three of the seven leading large joint orthopedic manufacturers have reported their 3Q:04 financials. So far, market growth rates on a constant currency basis remain in-line with the growth rates reported by industry leaders DePuy, Biomet and Stryker in the... more

What is the Second Generation Disc Arthroplasty Implant? BY ROBIN R. YOUNG CFA

Last week Stryker announced it was offering $120 million in cash, plus as much as double that amount in future royalties to buy a 'second generation' disc arthroplasty implant. The implant, developed by SpineCore, is a single piece (three components... more

We Pause to Examine the Large Joint Market Ahead of the Conclusion of Earnings Season BY JOHN CHOPACK

With DePuy, Stryker and Biomet reporting during the last three weeks, this is a good time to identify specific topics imperative to the remainder of the sector's earnings releases over the next several weeks. Large Joint Companies Earnings 2Q:04 Reports... more

Stryker Corp. (SYK:NYSE) 2Q:04 Earnings Increase by 42%which Beats the Street by $0.03 BY JOHN CHOPACK

SYK reported earnings totaled $152.7 million or $0.37 per diluted share during the 2Q:04. This 42% increase over the 2Q:03 beat analyst expectations by $0.03. It also triggered several analyst downgrades including First Albany, Wells Fargo and Bank of America.... more

We Use RTI for Soft Tissue and LifeCell for DBM? BY ROBIN R. YOUNG CFA

We couldn't help but come to the following conclusion after reading RTI's Stryker notice last week: Stryker has accomplished the interesting task of contracting with the industry's #2 bone void fill supplier for soft tissue, and the industry's soft tissue... more

DePuy, Stryker and Synthes Receive Most FDA Approvals YTDwhile Zimmer lags BY ROBIN R. YOUNG CFA

Fill the salesman's bag. Advance the art and practice of orthopedics. Create superior returns for your shareholders. None of these are possible without the FDA's initial and ongoing approval. So far this year, the FDA has granted 214 orthopedic device... more

510(k) Approvals BY EDITOR

  Device Applicant 510(k) Decision Date 1 acumed lower extremity congruent plate s acumed llc K033639 1/15/2004 2 titanium cannulated interference screw advanced biomaterial K033749 2/23/2004 3 aesculap absorbable craniofix aesculap, inc. K040080 3/31/2004 4 abc caudal and cranial extension... more

A Review of the Five Largest Orthopedic Companies' 1Q:04 Financial Results BY JOHN CHOPACK

We tabulated the five largest general orthopedic companies' financial results for the 1Q:04. The companies include Stryker, Zimmer, Biomet, Smith & Nephew and Wright Medical, each of which has a market capitalization in excess of $1 billion. Although many subscribers... more

Stryker Corp & DePuy Report 1Q:04 Earnings and Provide Insight into Strength of Large Joint Reconstructive Market BY JOHN CHOPACK

DePuy and Stryker Corp. both reported their 1Q:04 earnings during the last week of trading activities. This provided some insight into both the strength of the Large Joint Orthopedic market and how the additional orthopedic companies will report during the... more

FDA Approves Second Growth Factor for the Spine BY ROBIN R. YOUNG CFA

With InFuse® (BMP 2) selling at a rate of $1 million per day for Medtronic's Sofamor Danek subsidiary, the news that Stryker Corporation has received approval to sell OP-1 (BMP 7) for spinal indications is significant news. Three years ago,... more

A Random Walk Down the Academy's Halls BY JOHN CHOPACK

Stryker Corp. (SYK:NYSE), in similar fashion to last year, brought and introduced a majority of its operational leaders of its various operating divisions. However, a significant portion of the analyst meeting, especially Q&A, centered around Stephen MacMillan, President & COO,... more

Stryker Corp Reports 21% Sales Rise in 4th quarter BY JOHN CHOPACK

Stryker (SYK) reported that revenues totaled $1.1 billion in 4Q:03 and $3.63 billion for the full year 2003. This represented a 21% and a 20% increase over the respective periods last year. The increase in revenues helped drive a 27%... more

Conference Focus on Materials BY EDITOR

At the 78th annual reunion of the Société Française de Chirurgie Orthopédique et Traumatologique (SO.F.C.O.T.) held last week in Paris, the focus was clearly on new materials - ceramics, plastics and biologics. And among the most successful new materials companies... more

Stryker adds $107 million in new orthopedic implant sales for the quarter. BY EDITOR

That's a 26% year-over-year rate of revenue growth. On a constant currency basis, the growth rate was 19%. To put this in context, for all of 2003, Stryker's orthopedic revenue growth was 18%, on a constant currency basis 17%. For... more

What's an Orthopedic Implant Manufacturer worth? BY EDITOR

The most valuable orthopedic company in world according to Wall Street is Stryker (SYK:NYSE) at $13.9 billion. With sales this year expected to top $3.5 billion and earnings to clear $2.15 per share, Wall Street is willing to pay 32x... more

Rumors of the death of Product Mix price increases greatly exaggerated BY EDITOR

Exhibit A: Stryker Exhibit B: Interpore Cross Not to pick on Merrill Lynch... but, and we quote, "Product mix benefit may slow a tad... we suspect this mix benefit has been largely realized." Cementless hip stems, metal on metal components... more

First Quarter's Recon Revenue Growth Rate - so far 20-24% BY EDITOR

As the following table illustrates, revenue growth rates for the first week of earnings season are ranging from 15% for Interpore Cross to 32% for Synvisc' (sold by Genzyme Biosurgery). The DePuy and Stryker (#1 and #2 orthopedic market share,... more

Who is listening to those earnings calls? BY EDITOR

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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Introductory Guide to Intellectual Property for Medical Devices

Dr. Gary Michelson knows his patent rights. Medtronic made him a billionaire for it. Knowing the rules of intellectual property is just as important for any device firm. It's such a critical factor in firm valuations: affecting cash flow timelines, product development, partnering, and many other competitive factors. Purchase this report for $295 »