M&A BoneSupport acquired Ultrazonix, the developer of an ultrasound-based treatment for alleviating pain associated with herniated discs. The product is FDA-cleared and CE-marked. Financial terms were not disclosed. Funding Formae received an investment of $0.5 million from BioAdvance, the Biotechnology... more
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
Earnings Integra LifeSciences reported its financial results for the first quarter ending March 31, 2008. Total revenues were approximately $156.0 million, reflecting an increase of $33.0 million, or 27%, over the first quarter of 2007. Adjusted net income for the... more
Earnings Medtronic reported FQ4:08 revenue of $3.86 billion, representing an 18% increase over the year-ago period and beating estimates by $0.14 billion. Currency translation had a positive impact of $160.0 million. Adjusted net earnings for the quarter were $884.0 million,... more
Earnings Alphatec Holdings reported consolidated revenues for 1Q:08 of $23.2 million, an increase of 19% from the year-ago period. U.S. revenues for the first quarter of 2008 were $18.6 million, an increase of 12% from the year-ago period. Asia revenues... more
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
BioMimetic Therapeutics' shares dove sharply last week (and recovered somewhat less sharply) because the FDA raised the possibility that the active ingredient of all of the company's products, PDGF (Platelet-Derived Growth Factor), caused cancer. From Thursday's intraday high price per... 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 Anika Therapeutics reported 4Q:07 product revenue of $7.9 million, in line with estimates and up from $5.08 million for the same period last year. The revenue growth was attributed to domestic and international sales of the ORTHOVISC product line,... more
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
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 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 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
This week J&J held a third quarter earnings meeting and Medical Device & Diagnostics Business review in New York. We thought we’d share some highlights from the DePuy franchise for our orthopedic audience. Overall, DePuy saw operational growth (excluding the... more
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
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
Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... 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 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
M&A Biomet Inc. shareholders accepted an $11.4 billion buyout offer from a private equity consortium attempting to acquire the medical device maker. The consortium, LVB Acquisition LLC, announced Thursday that nearly 83 percent of Biomet's shares were tendered. The company... more
Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more
According to an article in the latest edition of BusinessWeek, J&J's aspirations for the device space could predict a new string of acquisitions ranging from small firms to major players, with the magazine naming Boston Scientific as a potential target.... 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
Earnings Medtronic reported FY2007 earnings of $12.3 billion, an increase of 9% over FY2006. Adjusted income was up 10% to $2.8 billion, or $2.41 per share, an increase of 15% over the previous year. For the fourth quarter, revenue was... more
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
Earnings Stryker announced 1Q:07 earnings on Wednesday. Net income increased to $243.5 million, or $0.59 per share, beating analysts' estimates of $0.58 per share. In the comparable quarter, net income was $147.5 million, or $0.36 per share. Revenues increased 13%... 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
With a small market and conditions that are relatively rare, pediatrics hasn't drawn a lot of product development in the device space. As a result, children may receive devices that aren't appropriately sized for them or are lacking in data... more
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
There is much developmental focus in the orthopedic industry on creating products that treat patients earlier in the continuum of care with the goal of slowing irreversible disease progression. When earlier intervention is dramatic, it is necessary to have a... more
Earnings Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million... more
Earnings Orthofix International N.V. announced 4Q:06 revenue of $116.1 million, an increase of 45% over 4Q:05 and just missing estimates of $116.6 million. $28.1 million of 4Q:06's revenue can be attributed to the September 2006 acquisition of Blackstone Medical, Inc.... more
Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... more
Last July, we reported on a Connecticut lawsuit against the Healthcare Research and Development Institute (H.R.D.I), a for-profit consulting firm that advised pharmaceutical, medical device and financial services companies on selling their products to hospitals. Yesterday, following an investigation by... more
Johnson & Johnson reported 4Q:06 financials yesterday. As part of the report they provided insights into DePuy Orthopedics. Generally speaking, DePuy's 4Q:06 were mediocre at best. DePuy reported revenues of $1.06 billion for the 4Q:06 which was an 8% increase... more
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
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
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
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
Today Johnson & Johnson announced record sales of $13.4 billion for 2Q:06, an increase of 4.7% compared to 2Q:05, and slightly higher than analysts' $13.13 billion expectations. DePuy, Inc., one of the overall family of J&J companies, experienced a reported... 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
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
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
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
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
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
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
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
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
DePuy's acquisition of Hand Innovations is significant in the orthopedic space for several reasons. First, it marks the third acquisition of the year already following both Stryker's acquisition of PlasmaSol and Kyphon's purchase of InnoSpine. We, along with several other... more
[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
Ten days ago California's Blue Cross and Blue Shield met and, based on the available evidence, decided they would not cover artificial disc replacements at this time. Some interesting technical discussions are posted here: Blue Cross Blue Shield April 2005... more
Another cloud is on the horizon for lumbar artificial discs. This time, injury lawyers Bagolie Friedman announced in the wee hours of this morning that it has formed the International Charite Artificial Disc Practice Group based on their belief there... more
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
By Kelli Hallas Vice President of Field Reimbursement Services Emerson Consultants, Inc. [Editor's note: We welcome consultant Kelli Hallas as a guest blogger. See a profile of Emerson Consultants, Inc. here.] Last month CMS issued a National draft non-coverage decision... more
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
[Update: We're moving this entry to the top of the blog since it is sparking a lot of interest from our readers.] more
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
In an unambiguous statement yesterday, CMS took a hard line and denied add-on payments for J&J's Charite artificial lumbar disc. In this document on pages 309 - 322, CMS balanced numerous comments, studies and outcomes against each other and came... more
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
Perhaps the most startling innovation of this years AOSSM sports medicine conference was a palm pilot kiosk where surgeons and exhibitors could beam the entire conference program and floorplan into their cellphones and PDAs in about 30 seconds. Immediately addicted,... more
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
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
In our efforts to poll surgeons on the subject of artificial lumbar discs, we have been tracking down advocates as well as dissenters in order to get a balanced view. Last month at AANS we interviewed Dr. Fred Geisler who... more
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
Last week, the United States Centers for Medicare & Medicaid Services (CMS) issued a "hold" decision on whether or not to issue 2006 add-on payments for procedures using J&J's Charité artificial lumbar disc.' This flies in the face of apparently... more
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
Last week we joined the droves of neurosurgeons at AANS in New Orleans to check out papers, presentations, posters and product. Always a quiet and less populated conference compared to the annual NASS spine meeting, AANS offers a hard science... more
Last week I caught up with Dr. Fred Geisler at AANS in New Orleans to discuss artificial disc clinical trials and surgeon adoption of artificial discs. Throughout the week, Dr. Geisler led the Academy as the principal thought leader on... 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
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
JNJ reported revenues of $12.8 billion for the 4Q:04 which was a 13% increase over the 4Q:03. DePuy, JNJ's orthopedic division, reported revenues of $952 million for the 4Q:04. This was a 19% increase as reported and a 15% increase... more
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
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
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
Two weeks ago, the Centers for Medicare and Medicaid Services (CMS) published its most recent ruling concerning reimbursement for the $10,600 disc replacement implant (versus, by the way, $4,800 for a BAK cage). CMS ruled that disc arthroplasty products like... more
We now have data from the early disc arthroplasty patients. The good news is that a 17 year follow-up study of 51 disc arthroplasty (non-fusion) patients was presented at the recent EuroSpine conference in Porto, Spain. The bad news is... more
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
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
The FDA panel's recommendation was unanimous. That's the bottom line. Based on a single clinical trial, each member of that panel voted for eventual commercialization of the Charité disc arthroplasty. And what a clinical trial: 304 patients, randomized, prospective, lead... more
On Wednesday of last week, (June 2/2004) an FDA panel recommended to down classify both the tricompartmenal and unicompartmental mobile bearing knee by a vote of 6 to 2 and 5 to 3, respectively. Although this doesn't guarantee that the... more
Despite being implanted in several thousand patients over the course of the past decade, it was a group of 205 Charité patients that the FDA panel scrutinized today before arriving at its recommendation to approve the Charité for commercial sale... more
Insufficient data from manufacturers forced the Center for Medicare and Medicaid Services (CMS) last week to set payment rates for Disc Arthroplasty at rates far, far below the true cost of a disc arthroplasty procedure. For Spinal repair, CMS has... more
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
For the quarter ended this past March, JNJ's DePuy spine division reported that sales growth rates for that division were slowing. For 2004, we forecast, sales of spinal implants industry-wide will rise 24% from last year's $2.9 billion to $3.6... more
Phase III clinical trial data for JNJ's Charite artificial lumbar disc was presented last week at the AANS/CNS conference in San Diego. This equivalency study compared patients having the Charite with patients with the BAK Intervertebral body cage (see table... more
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
Currently, DePuy is the only orthopedic manufacturer FDA approved to market a mobile bearing knee in the U.S. While a majority of manufacturers market their mobile knee prosthesis overseas, most have been content on waiting for the FDA to down... more
In last week's JNJ conference call with analysts, management stated that its DePuy Spine division was expecting FDA approval for the Charité Artificial Disc in the United States by the first half of 2005. The Charité Disc, which was obtained... more
GenSci Orthobiologics is in the final stages of emerging from Chapter 11 bankruptcy. ISOTIS, the Netherlands based tissue engineering company, is merging with GenSci and setting the stage for a dramatic and interesting rebirth of this company that many, including... more
This week the DePuy division of Johnson and Johnson reached an agreement to purchase the Link Spine Group of Bramford, CT, a unit of the Waldemar LINK GmbH company, Hamburg, Germany for $325 million plus future payments. Link Spine Group's... more
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
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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