Conference Calendar

March 6-9 - Orthopaedic Research Society (ORS) Annual Meeting

March 7-10 - The McGowan Institute for Regenerative Medicine Scientific Retreat

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Earnings Calendar

Mar 8 @ 4:30 PM ET - MAKO Surgical Corp.

Complete Calendar »

Orthopedic and Dental Industry News Complete Archive »

Medtronic/Sofamor Danek

Musculoskeletal News Roundup 25-Feb-10 BY LAUREN UZDIENSKI

xray_small.jpgAlphatec Spine reported 4Q:09 revenues of $36.6 million, an increase of 29% from the $28.4 million reported in 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. Asian revenues were $6.6 million, an increase of 38% from the $4.8 million reported for 4Q:08. European revenues in 4Q:09 were $1.7 million. more

Musculoskeletal News Roundup 25-Nov-09 BY LAUREN UZDIENSKI

Earnings ArthroCare reported 3Q:09 sales of $76.4 million, representing an increase of 8% over 3Q:08. Analysts had forecast total revenues of $84.3 million. Sports medicine contributed $50.6 million in sales, up 11% over the year-ago period, and spine contributed $4.5... more

Musculoskeletal News Roundup 19-Nov-09 BY LAUREN UZDIENSKI

Earnings ArthroCare restated its earnings from 2004 through 2Q:09. The company reported total revenue for 2008 of $314.2 million, up 12% over 2007. Relative to prior-year periods, 1Q:09 revenues increased 2% to $78.8 million; 2Q:09 revenues decreased 6% to $80.8... 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

Musculoskeletal News Roundup 15-Oct-09 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ1:10 revenues of $630.0 million, a 7% increase over the year-ago period. Excluding dental, recon sales increased by 9%, with knee up 10%, hip up 6% and extremity up 23%. Dental decreased by 5%. All rates exclude... more

Musculoskeletal News Roundup 8-Oct-09 BY LAUREN UZDIENSKI

Earnings TranS1 pre-announced 3Q:09 revenues, saying sales for the quarter would be in the range of $6.8 to $6.9 million. This represents a 15% increase over year-ago sales, though it is below 3Q:09 guidance of $7.4 to $7.9 million. Analysts... more

Musculoskeletal News Roundup 1-Oct-09 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 24-Sept-09 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 10-Sept-09 BY LAUREN UZDIENSKI

M&A Kapstone Medical acquired exclusive rights to Spherofix's screw-locking technology, which the company plans to incorporate into a line of spinal implants. Terms of the deal were not disclosed. Regulatory Covidien received FDA approval to market its DuraSeal spine sealant,... more

Musculoskeletal News Roundup Aug-27-09 BY LAUREN UZDIENSKI

Earnings Corin reported 1H:09 sales of GBP 20.1 million ($33.0 million), down 25% over 1H:08 after adjusting for currency and beating estimates by GBP 2.1 million ($3.5 million). Outside the U.S., revenues increased by 10%, which the company attributed to... more

Medtronic's FQ1:10 Shows Stability in Spine BY LAUREN UZDIENSKI

Medtronic announced their FQ1:10 results on Tuesday, which included $915 million in spine revenues. This reflects an 8% (constant currency) increase over the year-ago period, though it should be noted that Medtronic had about an extra week of selling days... more

Musculoskeletal News Roundup 13-Aug-09 BY LAUREN UZDIENSKI

Earnings BioMimetic Therapeutics reported 2Q:09 royalty and sublicense revenue of $0.4 million, missing estimates by $0.1 million. The company reported a net loss of $6.3 million, or $0.32 per share, beating estimates by $0.17. Among the highlights for the quarter... more

NEJM Studies Challenge the Efficacy of Vertebroplasty BY LAUREN UZDIENSKI

Two studies published this week in the New England Journal of Medicine cast doubts over the efficacy of vertebroplasty. The first study, conducted in Australia, randomized 78 patients in a multicenter, double-blind, placebo-controlled trial in which participants with one or... 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

Musculoskeletal News Roundup 9-Jul-09 BY LAUREN UZDIENSKI

Earnings Exactech announced that 2Q:09 revenues would be approximately $43.0 million, below earlier guidance and analyst expectations of approximately $45.0 million. The range for full-year 2009 revenue guidance has also been lowered to $167-$173 million. The company attributed 2Q's sales... more

Musculoskeletal News Roundup 2-Jul-09 BY LAUREN UZDIENSKI

Earnings Biomet reported net sales of $639.0 million for FQ4:09, which represents an increase of 1% as reported and 7% when adjusting for currency. Among segments, recon, excluding dental, increased 3% as reported and 11% constant currency. Dental decreased by... 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

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 18-Jun-09 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 4-Jun-2009 BY LAUREN UZDIENSKI

Funding Active Implants raised $10.0 million in a Series C preferred stock offering. The company is developing the TriboFit Hip and NUsurface implant systems based on its polycarbonate urethane technology. In conjunction with the financing round, the company appointed Charles... more

Medtronic Holds Analyst Day BY JOHN MCCORMICK

Yesterday, medical device giant Medtronic, Inc. held an "analyst day" in Minneapolis for equity analysts to comb over numbers and get a hearing with management on new strategies and technologies. The key theme was innovation. Given Medtronic's multi-dimensional nature, the... more

FDA Approves Medtronic's Bryan Cervical Disc BY JOHN MCCORMICK

Medtronic received long-awaited FDA approval for its Bryan cervical disc on May 12. The device received a favorable FDA panel recommendation in July of 2007, just a day after Medtronic's Prestige disc was approved for market launch. Under the conditions... more

Musculoskeletal News Roundup 28-May-09 BY LAUREN UZDIENSKI

Regulatory Blackstone Medical received an FDA warning letter relating to the ICON Modular Spinal Fixation System, which the company voluntarily recalled in December of 2005. The FDA said Blackstone failed to adhere to its own risk management procedures and failed... more

Musculoskeletal News Roundup 21-May-09 BY LAUREN UZDIENSKI

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

More Trouble for InFuse as Fraudulent Data Makes Headlines BY LAUREN UZDIENSKI

The New York Times reported last week that a former surgeon at Walter Reed Army Medical Center falsified data on InFuse that was published in (and later retracted by) JBJS. The study in question evaluated the use of InFuse for... 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 7-May-09 BY LAUREN UZDIENSKI

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

Medtronic Talks "Disappointing" Kyphon Acqusition and Future Growth BY LAUREN UZDIENSKI

In recent interviews, Medtronic CEO Bill Hawkins discussed some of the challenges associated with the company's $4.2 billion acquisition of Kyphon in 2007 as well as plans for future acquisitions. Kyphon brought innovative products and an entree into new markets,... more

Musculoskeletal News Roundup 9-Apr-09 BY LAUREN UZDIENSKI

Earnings Biomet reported FQ3:09 revenues of $615 million, a 7% (constant currency) increase over FQ3:08. Among segments, recon reported growth of 7%, with hip up 10%, knee up 9%, fixation up 4% and dental down 10%, which the company attributed... more

Judge Dismisses Whistleblower Lawsuit Against Medtronic Surgeons BY JOHN MCCORMICK

Last Friday, federal judge Richard Stearns dismissed the well-publicized whistleblower lawsuit alleging that certain spine surgeons accepted kickbacks for using Medtronic's spinal implants. He also blocked a motion by the two women to file an amended complaint. The lawsuit accused... 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

Musculoskeletal News Roundup 26-Feb-09 BY LAUREN UZDIENSKI

Earnings Artimplant reported 4Q:08 revenues of SEK 4.6 million ($0.6 million), down from SEK 5.0 million ($0.8 million) in 4Q:07. During the quarter, the company reported sales of 900 Artelon Spacers (down from 1,100 in 4Q:07) and 300 units of... more

Musculoskeletal News Roundup 19-Feb-09 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 24-Dec-08 BY LAUREN UZDIENSKI

M&A Medtronic completed its minority investment in Shandong Weigao Group. As a result of the investment, Medtronic now holds a 15 percent equity stake in Weigao. Medtronic purchased its 15 percent equity interest in Weigao for approximately HK$1.7 billion (or... more

Medtronic Completes Minority Investment in China BY JOHN MCCORMICK

Medtronic announced today that it had completed its long-awaited minority investment in Shandong Weigao Group. As a result of the investment, Medtronic now holds a 15 percent equity stake in Weigao. To facilitate the equity investment, Medtronic purchased its 15... more

Musculoskeletal News Roundup 18-Dec-08 BY LAUREN UZDIENSKI

Funding In addition to its regularly scheduled payments, Orthofix International will make a $10 million debt prepayment on December 29th in advance of the scheduled maturity. According to Executive Vice President and CFO Bob Vaters, "This is a good time... more

Musculoskeletal News Roundup 11-Dec-08 BY LAUREN UZDIENSKI

Earnings Wright Medical reiterated 4Q:08 revenue and earnings guidance on a call this week and lowered 2009 guidance based on less favorable foreign exchange rates. The company is now calling for 2009 revenues in the range of $510 million 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 20-Nov-08 BY LAUREN UZDIENSKI

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

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

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 31-July-08 BY LAUREN UZDIENSKI

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

Ex-Medtronic Employees File Whistleblower Lawsuit BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 22-May-08 BY LAUREN UZDIENSKI

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

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 1-May-08 BY LAUREN UZDIENSKI

Earnings Anika Therapeutics reported 1Q:08 total revenues of $8.55 million, an increase of 46% over the year-ago period, which the company attributed to strong domestic and international sales of ORTHOVISC. Revenues beat analysts' expectations by $0.2 million. Net income for... more

Cervical Artificial Discs Reduce Costs for Patients BY LAUREN UZDIENSKI

A new study funded by Medtronic and presented at this week's AANS meeting showed that compared to fusion, patients who underwent cervical disc replacement saved an average of $6,000 in the two years following treatment. 541 patients received either the... more

Musculoskeletal News Roundup 21-Feb-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 7-Feb-08 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 27-Dec-07 BY LAUREN UZDIENSKI

M&A Sandvik AB said its Sandvik Materials Technology division has acquired Medtronic's specialty instrument manufacturing plant in Memphis. Medtronic plans to move the plant's purchasing, receiving and quality functions to the company's development and logistics center nearby. The transaction is... more

Musculoskeletal News Roundup 20-Dec-07 BY LAUREN UZDIENSKI

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

Medtronic Expands in China with Weigao Joint Venture BY LAUREN UZDIENSKI

Medtronic announced plans yesterday to bring spine and orthopedic therapies to the Chinese market through a joint venture with Shandong Weigao Group Medical Polymer Company Limited. Under the joint venture agreement, the companies will sell spine and orthopedic products, including... 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 21-Nov-07 BY LAUREN UZDIENSKI

Earnings Medtronic reported FQ2:08 revenue of $3.12 billion, beating estimates by $0.02 million and representing a 2% increase over the year-ago period. Net earnings for FQ2:08 were $666.0 million, or $0.58 per diluted share, beating estimates by $0.02 but down... more

Musculoskeletal News Roundup 8-Nov-07 BY LAUREN UZDIENSKI

Earnings Anika reported 3Q:07 product revenues of $7.28 million, up from $5.49 million in 3Q:06. The company attributed the sales growth to strong domestic and international sales of ORTHOVISC®. Net income for 3Q:07 was $1.8 million, or $0.16 per diluted... more

Medtronic and Kyphon Complete Merger BY LAUREN UZDIENSKI

Medtronic announced today the completion of their acqusition of Kyphon. News of the closing comes earlier than expected; at the time the merger was first announced, Medtronic anticipated a 1Q:08 closing. Stockholders will receive $71.00 per share in cash for... more

Musculoskeletal News Roundup 1-Nov-07 BY LAUREN UZDIENSKI

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

Synthes Gets Approvable Letter from FDA for ProDisc®-C BY LAUREN UZDIENSKI

Synthes announced this morning that they received an Approvable Letter from the FDA regarding their PMA application for the ProDisc®-C, the company's artificial cervical disc. A full approval order will be made once Synthes' manufacturing processes are reviewed by the... 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 11-Oct-07 BY LAUREN UZDIENSKI

M&A With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced... 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 20-Sept-07 BY LAUREN UZDIENSKI

Earnings AOI Medical reported a 1H:07 loss of $1.8 million, increasing from a loss of $0.97 million in the comparable half. The company attributed the loss to increased expenses. They expect their product, the Balloon Assisted Management of Spine Fractures,... more

Medtronic to Market the Prestige Disc to Hispanics BY LAUREN UZDIENSKI

Following recent FDA approval of its Prestige artificial cervical disc, Medtronic announced the launch of a new advertising campaign aimed at Hispanics. The campaign, which was announced in a press release, features a Spanish-language website. In the press release, Dr.... more

Musculoskeletal News Roundup 23-Aug-07 BY LAUREN UZDIENSKI

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

Musculoskeletal News Roundup 2-August-07 BY LAUREN UZDIENSKI

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

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

Musculoskeletal News Roundup 19-July-07 BY LAUREN UZDIENSKI

M&A DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded... more

FDA Panel Supports BRYAN Cervical Disc, but not Superiority Claim BY JOHN MCCORMICK

Today was a long day in Gaithersburg, Maryland exploring the ins and outs of wear debris and Bayesian statistics. Luckily the dirty work was left to an 11-member panel of sober experts appointed by the FDA to make recommendations on... more

Medtronic's Prestige Cervical Disc Receives FDA Approval BY ARIELLA P. GOLOMB, MD

Medtronic announced yesterday that the company received conditional FDA approval for its Prestige® Cervical Disc, the first cervical disc to be marketed in the U.S. Approval is contingent upon a seven-year post-approval study to evaluate long-term safety and effectiveness. The... more

Supreme Court to Hear Medtronic Case; Charite Liability Claims Dismissed in CA BY LAUREN UZDIENSKI

The Supreme Court announced yesterday that it will hear a Medtronic case involving a failed balloon catheter. The decision could have broader implications for the FDA's authority and product liability. The lawsuit emerged from a catheter failure during Charles Riegel's... more

Orthopedics News Roundup 24-May-07 BY LAUREN UZDIENSKI

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

J&J Bets on Prognostic Tests in Ortho BY ARIELLA P. GOLOMB, MD

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

Orthopedic News Roundup 22-Mar-07 BY LAUREN UZDIENSKI

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

Orthopedic News Roundup 15-Mar-07 BY LAUREN UZDIENSKI

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

FDA Approves Medtronic's INFUSE For Certain Oral Maxillofacial and Dental Applications BY ARIELLA P. GOLOMB, MD

Medtronic announced yesterday that they received FDA approval to market INFUSE for oral maxillofacial and dental regenerative bone grafting procedures. This news follows the FDA Dental Products Advisory Panel recommendation for approval last fall. INFUSE has already been FDA approved... more

Orthopedic News Roundup 1-Mar-07 BY LAUREN UZDIENSKI

Earnings Biologics LifeCell reported 4Q:06 product revenues of $39.3 million, an increase of 45% over $27.0 million in 4Q:05, but missed analysts' estimates of $39.5 million. The growth was attributed to increased demand for the Company's AlloDerm® Regenerative Tissue Matrix.... more

Medtronic Names New CEO and COO BY ARIELLA P. GOLOMB, MD

Following Biomet's appointment of Jeffery Binder as CEO, Medtronic today announced their own succession plans for CEO and COO. In August, William A. Hawkins, III, will replace Arthur D. Collins, Jr. as president and CEO. Mr. Hawkins is currently Medtronic's... more

Orthopedics News Roundup 8-Feb-07 BY LAUREN UZDIENSKI

Earnings Biologics Regeneration Technologies, Inc. reported 4Q:06 revenues of $19.1 million, down 5% from $20.1 million in 4Q:05. The Company reported net loss of $6.7 million, compared to a net lossn of $1.7 million for 4Q:05. Net loss per diluted... more

Orthopedic News Roundup 30-Nov-06 BY LAUREN UZDIENSKI

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

Medtronic Sofamor Danek's Spinal Business Continues To Grow BY ARIELLA P. GOLOMB, MD

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

Orthopedic News Roundup 16-Nov-2006 BY LAUREN UZDIENSKI

Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more

INFUSE Moves into Dental BY JOHN CHOPACK

Medtronic, Inc. announced yesterday that the FDA Dental Products Advisory Panel had unanimously voted to recommend approval of INFUSE Bone Graft for certain oral and maxillofacial procedures. If the FDA agrees with that panel's recommendation, the US indications for INFUSE... 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 12-Oct-06 BY HUYEN NGUYEN

Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more

Orthopedic News Roundup 5-Oct-06 BY HUYEN NGUYEN

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

NASS Notes BY ARIELLA P. GOLOMB, MD

With the 2006 NASS meeting winding down, we thought we'd share some highlights from Seattle. SPORT Clinical Trial Session a Tease On Wednesday, the two-hour, much-anticipated session on SPORT results focused on SPORT background information - but not the data... more

MDT Spinal & Navigation Business Update at NASS BY HUYEN NGUYEN

Yesterday, Medtronic Spinal and Navigation business division hosted an analyst meeting during the North American Spine Society (NASS) meeting in Seattle to provide an update on its current operations. Given the recent FDA panel recommendation for approval of their cervical... more

Orthopedic News Roundup 21-Sept-06 BY HUYEN NGUYEN

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

Medtronic's Disc Recommended for FDA Approval BY ARIELLA P. GOLOMB, MD

Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System. After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded... more

Orthopedic News Roundup 14-Sept-06 BY HUYEN NGUYEN

Appointment: Orthovita, Inc. has appointed Albert J. Pavucek, Jr. Vice President Corporate Controller. Mr. Pavucek was with PDI, Inc. serving as Vice President, Finance and Operations. Awards & Recognition: Smith & Nephew plc announced that two of its products, the... more

Regeneration Technologies Continues To Break Its Chains BY HUYEN NGUYEN

After the market closed yesterday, Regeneration Technologies (RTI) announced it amended a prior distribution agreement with its largest distributor, Medtronic Sofamor Danek USA, Inc. (MSD) regarding domestic spinal allograft distribution. Currently, RTI derives 60% of its annual revenues (~$45 million)... more

Orthopedic News Roundup 7-Sept-06 BY HUYEN NGUYEN

Appointment: Ranier Technology Limited has appointed John C. Moran to its Board of Directors. Previously, Mr. Moran was a President of Synthes Spine and a Director of Spine Solutions, Inc. Active Implants Corporation (AIC) has hired Richard Treharne, PhD. as... more

Orthopedic News Roundup 24-Aug-06 BY HUYEN NGUYEN

Appointment: IsoTis OrthoBiologics has hired Gene B. Reu as Vice President of Operations. Prior to joining IsoTis, Mr. Reu served as Vice President & General Manager of Coblation Technologies with Arthrocare, Inc. Business Update: ArthroCare Corp. announced it has received... more

FDA Panel to Vote On Medtronic's Cervical Disc BY ARIELLA P. GOLOMB, MD

The FDA's Orthopaedic and Rehabilitation Devices Panel will be meeting on September 19, 2006. The committee will discuss, make recommendations and vote on a premarket approval application for Medtronic's Prestige ST artificial cervical disc. This metal on metal, ball and... more

Orthopedic News Roundup 3-Aug-06 BY HUYEN NGUYEN

Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... 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

Medtronic Whistleblower Suit Won't Go Away Easily BY DAVID KRESSEL

As we reported last week, Medtronic settled its whistleblower law suit with the DOJ. One condition of this settlement was that the DOJ would move to have a second similar whistleblower suit dismissed. Now, the lawyer representing the second plaintiff... more

Medtronic Settles with DOJ on Kickbacks for $40 Million BY DAVID KRESSEL

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

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

FDA Grants IDE For Medtronic's DIAM(TM) Spinal Stabilization System BY ARIELLA P. GOLOMB, MD

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

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

Orthopedic News Roundup 25-May-06 BY HUYEN NGUYEN

Appointment: IsoTis OrthoBiologics appointed Barbara Boyan to its Board of Directors. Ms. Boyan is a co-founder of OsteoBiologics, Inc. (OBI) and a professor in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and at... 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

Medtronic Spine Grows 17% BY JOHN MCCORMICK

Medtronic is trading up this morning after yesterday afternoon's announcement of double digit across the board revenue and earnings growth. Spine revenues notably grew at 17%. With fiscal 2006 ending on April 28, 2006, companywide revenue for the 2006 fiscal... more

Medtronic Countersues Kyphon BY DAVID KRESSEL

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

Medtronic Bets On Itself BY DAVID KRESSEL

Medtronic, parent of orthopedic giant Sofamor Danek, has decided to rejigger its capital structure. It is offering $4 billion in convertible bonds, and using $2.5 billion of the proceeds to repurchase common stock, which comes out to about 4% of... more

Orthopedic News Roundup 9-Mar-06 BY HUYEN NGUYEN

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

Medtronic Reports 3Q:06 Financials: Earnings In-line BY JOHN CHOPACK

Medtronic reported that earnings totaled $670 million or $0.55 per diluted share which was in-line with analysts' expectations and represented a 22% increase over the 3Q:05. However, the Company's reported revenues for the 3Q:06, which totaled $2.77 billion was slightly... more

Orthopedic News Roundup 23-Feb-06 BY LAING RIKKERS

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

Polynovo Partnering with Medtronic BY SHELLY ACHAIBAR

Polynovo Biomaterials signed a partnering and licensing agreement with Medtronic for the development of a drug-eluting polymer stent to treat vascular diseases. Medtronic will hold equity in the company and pay royalties on the commercialization of the technology. PolyNovo Biomaterials... more

Medtronic Surpasses Milestone with TSRH Spinal Systems BY SHELLY ACHAIBAR

Medtronic announced today that the TSRH Spinal System implants have surpassed the 2.5 million mark worldwide. Medtronic in conjunction with the Scottish Rite Hospital (TSRH), one of the nation's leading pediatric centers for the treatment of orthopedic conditions, created the... more

Medtronic Continues to Fight Whistle-Blower Suit BY SHELLY ACHAIBAR

Medtronic, one of the nation's leading device makers, is facing continued charges of payoffs to surgeons, as written about today in the New York Times. To summarize, a lawsuit filed against the company two years ago, was brought on by... more

Kyphon/Sandhu Lawsuit against Medtronic Announced BY JOHN MCCORMICK

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

Orthopedic News Roundup 8-Dec-05 BY HUYEN NGUYEN

Due to last week's Merrill Lynch investor conference (subscription may be required), investors have regained confidence in the orthopedic sector after the industry faced some hurdles within the past few months. In our HealthpointCapital Weekly Valuation Index, P/E (price-to-earnings) jumped... more

Orthopedic News Roundup 1-Dec-05 BY HUYEN NGUYEN

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

Orthopedic News Roundup 17-Nov-05 BY HUYEN NGUYEN

Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices... more

Department of Justice Questioning the Selling Practices of Medtronic, Guidant and St. Jude BY JOHN CHOPACK

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

Orthopedic News Roundup 06-Oct-05 BY HUYEN NGUYEN

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

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

Orthopedic News Roundup 19-Aug.-05 BY HUYEN NGUYEN

Earnings: The world's largest spinal implant technology player, Medtronic, reported 1Q:06 with revenues of $2.7 billion, a 15% increase from 1Q:05. Net income (excluding extraordinary charges) was $616 million compared to $530 million, which is a 16% increase YOY. Spinal... 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

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

Medtronic and Michelson Finally Settle for $1.35 billion BY JOHN MCCORMICK

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

AANS 2005: A Trip Report BY JOHN MCCORMICK

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

Troubling Consistency at Sofamor Danek BY ROBIN R. YOUNG CFA

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

Spine Wars: Michelson vs. the Industry? BY ROBIN R. YOUNG CFA

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

Now, Here's an Issue: Payments by medical device manufacturers to surgeons BY ROBIN R. YOUNG CFA

Last week, Sofamor Danek disclosed in an SEC filing that a second "whistle-blower" lawsuit had been filed against it regarding payments to physicians. The case is under seal in Federal Court in Minneapolis. The first lawsuit against Sofamor Danek on... more

Is Kyphon #2 Behind Sofamor Danek in terms of Spine Industry Market Power? BY ROBIN R. YOUNG CFA

On the heels of its first $50 million quarter, Rich Mott, Kyphon's CEO, predicted that his firm would post revenues between $210 and $212 million for the year ending this December. Three years ago, in 2001, Kyphon booked sales of... more

InFuse® Add-On Payment Extended One Year by CMS - Good News for an Estimated 500 Patients (About 2% of the Infuse® Patient Population) BY ROBIN R. YOUNG CFA

The InFuse® add-on payment of $8,900 was extended for one year by the Centers for Medicare and Medicaid Services last week. Medicare, which provides supplemental healthcare cost reimbursement for American elderly patients, directly affects an estimated 15% of the spine... more

Medtronic's InFuse® cutting into DePuy Spine's Sales BY ROBIN R. YOUNG CFA

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

$1 Million per Day in InFuse BY EDITOR

We think it's true. Of course, Medtronic isn't saying anything outside of its well crafted public comments, but our informal content analysis of surgeon and sales commentary have us betting that Sofamor Danek has, indeed, crossed the $1 million per... more

Use of InFuse' expanded to include... BY EDITOR

...more metal cages. Our friends in high places at Medtronic tell us that Sofamor Danek is considered to be Medtronic's best acquisition-ever. A worthy competitor calls the boys in Memphis “the machine.” Indeed. No doubt Mike DeMane's “threat” to replace... more

What is your business? BY EDITOR

Peter Drucker asked that question fifty years ago in his seminal book The Practice of Management. While his generic answer (“the only function of a business is to create customer value and to innovate.”) remains as valuable in 2004 as... more

In a testament to second chances, InFUSE gets CMS approval for $8,900. BY EDITOR

Rejected one year ago... Medtronic came back with new data and CMS, while rejecting InFuse again using one analytical approach found another way to show that InFUSE does indeed meet the threshold requirement for receiving a new technology add-on payment.... more

Sofamor Danek increases the size of its Bryan and Prestige Cervical Disc trials, we think. BY EDITOR

We have been hounding the overworked folks in Medtronic's investor relations department about last week's Bryan® and Prestige™ Cervical Disc clinical trial press release. Apparently, we were the only people who called with a question. All other Analysts calling in... more

METRx X-Tube is Cool BY EDITOR

Sofamor Danek didn't pay us to say that, we just like the look of this new product. 250,000 patients a year decide to undergo a discectomy operation to “deflate the tire” of a herniated disc. Satisfaction rates are routinely 95%+.... 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 »