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
Earnings MEDICREA reported revenues of EUR 6.1 million ($8.6 million) in 1H:09, representing a 32% increase over 1H:08, which the company attributed to growth in sales from direct subsidiaries, primarily in the United States. Net loss was EUR 1.5 million... more
Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more
Earnings Alphatec Spine, Inc. announced financial results for FQ2:09. Consolidated revenues for the second quarter 2009 were $32.3 million, an increase of 35% from 2Q:08 and an increase of 5% over first quarter 2009. Adjusted EBITDA reached $2.8 million in... more
Earnings Biomet reported FQ4:09 sales of $639.3 million, representing a 7% increase over the year-ago period. Among segments, hip increased 9%; knee increased 11%; extremity increased 18%; dental decreased 13%; fixation increased 5%; and spine increase 18%. All growth rates... more
According to the Report on Medicare Compliance, the DOJ is conducting an investigation into Medicare inpatient claims for kyphoplasty at hospitals nationwide. The probe stems from a whistleblower lawsuit from two former Kyphon sales and reimbursement managers who claimed that... more
Funding BioMimetic Therapeutics raised approximately $17.0 million in a rights offering that closed on Wednesday. The company offered 2,000,000 shares at $8.50 per share in May. The company plans to use the funds for general corporate purposes, including to product... more
M&A The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT... more
Earnings Medtronic reported FQ4:09 revenue of $3.8 billion, representing a 5% increase (constant currency) over FQ4:08 and in line with estimates. Adjusted EPS for the quarter was $0.82, also in line with estimates. Spine and biologics revenue was $881.0 million,... more
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
Earnings Alphatec Spine reported record consolidated revenue of $30.6 million reported in 1Q:09, which represents 32% growth over 1Q:08 and 8% sequential growth over revenues reported in 4Q:08. U.S. revenue growth of 28% over prior year was approximately three times... more
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
The WSJ published additional details of its investigation into ReGen Biologics' FDA clearance for its Menaflex meniscal implant. New information out this morning includes details of campaign donations from ReGen executives to the New Jersey politicians who stood behind ReGen... more
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
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
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
Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more
Earnings Medtronic reported FQ2:09 revenues of $3.57 billion, up 14% (8% constant currency) over the year-ago period and missing estimates by $0.12 billion. Non-GAAP net earnings and diluted earnings per share were $758.0 million, or $0.67 per diluted share, missing... more
Last fall, Biomet, Medtronic, Smith & Nephew, Stryker and Zimmer announced they were under investigation by the SEC for possible violations of the Foreign Corrupt Practices Act (FCPA), which is designed to prevent U.S. companies from making payments to foreign... 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
Earnings DJO Inc., formerly ReAble Therapeutics, reported 4Q:07 net sales of $170.7 million, a 97% increase over 4Q:06; the growth rate was due primarily to acquisitions, including ReAble's merger with DJO. The company reported an actual net loss of $57.3... more
Earnings Biomet announced preliminary FQ3:08 revenues of $603.1 million, an increase of 14% over the year-ago period. By segment, reconstructive device sales increased 19% worldwide and 13% in the U.S.; knee sales increased 24% worldwide and 21% in the U.S.,... 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 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 Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... 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
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
Wright Medical announced late yesterday that the company received a DOJ subpoena requesting documents on any surgeon consulting and professional service agreements dating from 1998 to the present. The company said the subpoena pertained specifically to agreements relating to hip... more
Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more
Available on Biomet, DePuy, Smith & Nephew, Stryker and Zimmer's websites today are disclosures of the companies' payments to consultants. The public disclosure of consultant payments was among the terms in the deferred prosecution agreements (in Stryker's case, a non-prosecution... 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
Biomet announced yesterday in a preliminary earnings release for FQ1:08 that the company was under investigation for possible violations of the Foreign Corrupt Practices Act (FCPA). The investigation was said to be informal and involve other companies in addition 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
Federal prosecutors announced today the terms of a settlement with Zimmer, Depuy, Biomet, Smith & Nephew and Stryker following an investigation into physician kickbacks. Zimmer, Depuy, Biomet and Smith & Nephew entered into deferred prosecution agreements (where a company can... 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
Orthofix announced via an 8-K filing that its Blackstone Medical subsidiary received a subpoena from the Department of Health and Human Service's Office of the Inspector General (OIG). The 8-K stated the investigation concerns physician consultant compensation as it relates... more
Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more
Just as one DOJ investigation seemed to be coming to a close, Biomet reported late last week that the company is facing new subpoenas from federal prosecutors. The government is requesting documents from as far back as 1999 relating to... 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 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
Preliminary findings from an investigation into Biomet's options backdating announced last week showed a $50 million discrepancy between 1996 and 2006, and CFO Gregory D. Hartman and Exective Vice President of Administration Daniel P. Hann have both resigned. What does... 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
This week CMS proposed a 5.1% reduction in payments to physicians for 2007. The proposal will impact the 875,000 doctors who care for the elderly and disabled in the US. The explanation for the cut is that spending on physician... more
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
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
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
Medtronic, Inc. announced today that the FDA granted an investigational device exemption (IDE) to the DIAM(TM) Spinal Stabilization System for use in a clinical safety and effectiveness study. The DIAM System will be measured against posterior lumbar interbody fusion, the... 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
This morning, Biomet announced that it has a subpoena from the Department of Justice, Antitrust Division, requesting documents regarding possible violations of federal criminal law, including possible violations of the antitrust laws, relating to the manufacture and sale of orthopedic... more
Zimmer Holdings Inc. said Friday the Justice Department's antitrust division subpoenaed company documents pertaining to an investigation of possible violations of federal criminal law, including possible violations of antitrust laws, involving the manufacture and sale the Company's standad lines of... more
Each year, hundreds of millions of people injure the cartilage in their knees, shoulders and other joints. Today Zimmer Holdings and ISTO Technologies announced that the U.S. Food and Drug Administration (FDA) has approved ISTO's Investigational New Drug (IND) application... more
A Single Codon Mutation Causes A Debilitating Disease Fibrodysplasia Ossificans Progressiva (FOP) is a rare autosomal dominant genetic disorder that causes muscles and other connective tissue to turn into bone and is estimated to affect one in two million patients... more
The U.S. International Trade Commission (ITC) issued a press release yesterday announcing the launch of a fact-finding investigation into conditions affecting U.S. trade of medical devices and equipment in principal foreign markets, particularly the Japanese market. The House Ways and... more
This week at HealthpointCapital, we compiled a brief synopsis of the 2006 Orthopedic Industry, projecting that total revenue in 2006 will grow by 12% for the year. Appointment: Two notable extremities companies named their new CEOs this week: Wright Medical... more
Financing: BioMimetic Therapeutics, Inc. filed a registration statement for an Initial Public Offering. Earnings: Medtronic 3Q Earnings climb 23 percent. CryoLife fourth quarter 2005 revenues increased 13% over fourth quarter 2004 Gross margins for full year 2005 increased to 53%... more
Doctors pushed back against marketing and commercial pressures from the pharmaceutical and medical device industries last week. On January 25, the American Medical Association (JAMA) published "Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical... 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
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
In the wake of an FDA, NYPD and Brooklyn district attorney's investigation into Biomedical Tissue Services, Lifecell has recalled and halted sales of all tissue from BTS. BTS's CEO is under investigation for illegally harvesting tissue from cadavers at a... more
Last week I listened in on an audio conference regarding the DOJ investigations. Certain comments by Jim Sheehan, AUSA for the Eastern District of Pennsylvania were quite interesting and provide some guidance... more
An inquiry requested by Wyoming Senator Mike Enzi, concluded yesterday clearing acting Food and Drug Administration Commissioner Lester Crawford of having an extramarital affair with an agency employee. The inquiry was conducted by the inspector general of the Department of... 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
CryoLife reported a loss of $22.3 million on sales of $15.7 million for the quarter ended June 30. Orthopedic sales, which amounted to $280,000, were less than we'd expected and appear to have been delayed from management's earlier forecasts. But... more
Complete Archive
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 