Conference Calendar

December 4-6 - Cervical Spine Research Society

December 4-7 - AAOMS Dental Implant Conference

Complete Calendar »

Earnings Calendar

No Upcoming Events Scheduled
Complete Calendar »

Read our research via:
email art

Weekly Email

rss art

RSS



app icon

iPhone

app store icon

Kindle



Orthopedic and Dental Industry News Complete Archive »

Johnson & Johnson

DePuy Synthes Announces Agreement with Blue Belt Technologies, Inc. Agreement enables access to the SIGMA HP Partial Knee on the Navio Surgical System BY EDITOR, SEPTEMBER 17, 2014

DePuy Synthes, the world's largest provider of orthopaedic and neurological solutions, announced today a worldwide commercial agreement with Blue Belt Technologies, a global medical technology company specializing in enabling technologies for orthopaedic surgery. The agreement will enable orthopaedic surgeons to... more

Johnson & Johnson Plans to Develop a Line of 3-D Printed Reconstructive Implants BY ANDREW VAHRADIAN, JUNE 26, 2014

Last month, Johnson & Johnson (JNJ) announced that the company plans to file for more than 30 major product approvals within its Medical Device & Diagnostic (MD&D) unit by the end of 2016, in order to bolster the segment's overall... more

Johnson & Johnson Plans to Launch 30 New Medical Devices by 2016 BY ANDREW VAHRADIAN, MAY 30, 2014

In the 2013 fiscal year, Johnson & Johnson's Pharmaceutical business grew 12% on a constant currency basis, outstripping the company's Medical Device & Diagnostic (MD&D) segment, which grew at 6%. Therefore, in order to bolster growth to its MD&D unit,... more

Johnson & Johnson Optimistic on Orthopedic Market Outlook BY ANDREW VAHRADIAN, JANUARY 24, 2014

Earlier this week, Johnson & Johnson reported financial results for 4Q:13 and FY2013. During the 4Q:13 earnings call, J&J management expressed an optimistic viewpoint regarding the outlook of the global orthopedic marketplace, noting that they expect utilization rates to increase... more

Partnerships & Startups Helping to Expand Med Device Industry into the Emerging Markets BY ANDREW VAHRADIAN, DECEMBER 3, 2013

The once U.S.-centric medical device industry is maturing into a more globally connected industry as a greater number of U.S. medtech manufacturers are seeking to expand into emerging markets like China, India and Israel through investments in startups or partnering... more

UK Moves to Ban Metal-on-Metal Hip Implants in NHS Hospitals BY ANDREW VAHRADIAN, NOVEMBER 20, 2013

Due to high failure rates and toxicity concerns, the United Kingdom has decided to ban metal-on-metal (MoM) hip implants in hip replacement surgeries performed at publicly funded National Health Service (NHS) hospitals. This announcement came after the National Institute for... more

Musculoskeletal News Roundup 19-Jul-12 BY LAUREN UZDIENSKI, JULY 19, 2012

Biomet, JNJ, Stryker announce earnings ... Mindray closes Dragonbio acquisition ... K2m debuts Rail 4D Technology ... Globus files amended S-1 ... MTF receives patent covering NovaBone Putty ... Expanding Orthopedics announces data presentation ... SpineGuard reports 6-month data ... Cardinal Health launches Orthopedic Solutions offering more

Musculoskeletal News Roundup 21-Jun-12 BY LAUREN UZDIENSKI, JUNE 21, 2012

Biomet pre-announces ... BONESUPPORT raises $10M ... Biomet announces initial closing of DePuy trauma transaction ... FDA clears KFx Medical's 5mm AppianFx Tissue Fixation Anchor ... Integra launches IPP-ON PIP Fusion System more

Musculoskeletal News Roundup 14-Jun-12 BY LAUREN UZDIENSKI, JUNE 14, 2012

J&J/Synthes transaction closes ... ConforMIS raises $73M ... Mazor announces Korean regulatory approval for Renaissance ... FDA clears TransCorp's SpinePort Spinal Access System ... SANUWAVE announces preclinical osteoarthritis results ... Internal Fixation System launches GoDirect sales program ... Premier awards spine contracts more

Musculoskeletal News Roundup 7-June-12 BY LAUREN UZDIENSKI, JUNE 7, 2012

J&J/Synthes deal may close next week ... Mindray to acquire controlling interest in Chinese orthopedic manufacturer ... FDA clear's Medicrea's LigaPASS ... K2M launches MESA Small Suture implant ... SNN voluntarily withdraws the optional metal liner component of its R3 Acetabular System ... ISTO receives U.S. patent ... SYK close to settling DOJ investigation into OtisKnee ... SANUWAVE comments on preclinical data more

E.U. Approves J&J's Acquisition of Synthes BY LAUREN UZDIENSKI, APRIL 19, 2012

J&J's offer to divest its trauma business (with Biomet lined up to purchase the assets) has clearly allayed E.U. anti-trust concerns, as it was announced this morning that regulators have approved Johnson & Johnson's $21.3 billion purchase of Synthes. J&J estimates that the deal will close in 2Q:12, and it will mark the largest acquisition in orthopedics history. more

Musculoskeletal News Roundup 19-Apr-12 BY LAUREN UZDIENSKI, APRIL 19, 2012

JNJ, Stryker announce earnings ... EU approves JNJ's acquisition of Synthes ... DePuy launches VIPER F2 Transfacet Pedicular System ... IART introduces Vu aPOD Prime IBD ... Mesoblast reaches 50% enrollment on phase II study ... OREF announces $3.1 million in grants more

Biomet Offers to Buy DePuy's Trauma Business BY LAUREN UZDIENSKI, APRIL 3, 2012

Biomet announced this morning that the company has made a binding offer to acquire DePuy's worldwide trauma business for $280 million in cash. The deal comes on the heels of reports that the EU will approve J&J's $21B acquisition of Synthes and speculation that J&J offered concessions to mitigate anti-competitive concerns. more

Reuters: EU to Approve J&J/Synthes Acquisition BY LAUREN UZDIENSKI, MARCH 19, 2012

Reuters reports that the EU, which has been reviewing J&J's proposed acquisition of Synthes for anti-trust concerns, is close to approving the sale. This update follows an announcement last month that J&J had offered concessions, presumably involving its spine and trauma businesses, to help facilitate the deal. The EU regulatory panel has until April 26th to approve the acquisition, but a decision could come sooner. more

To Appease EU Regulators, J&J Offers Concessions in Synthes Deal BY LAUREN UZDIENSKI, FEBRUARY 23, 2012

The European Commission, the antitrust authority currently reviewing J&J's planned acquisition of Synthes, announced this week that their deadline for approving the transaction has been extended by 12 days to April 26th. Regulators will use the extension to review concessions offered by J&J to facilitate the deal, which are widely believed to include spine or trauma product line divestitures. more

Musculoskeletal News Roundup 9-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 9, 2012

Product launches from AAOS ... Nobel Biocare announces 4Q ... Hospitals settle Medicare fraud claims over kyphoplasty billing ... Updates on the American Joint Replacement Registry ... Stryker announces inventory management system rollout more

Musculoskeletal News Roundup 26-Jan-12 BY LAUREN UZDIENSKI, JANUARY 26, 2012

DJO, JNJ, SYK, ZMH report 4Q sales ... FDA clears Interventional Spine's Opticage Expandable device ... Medtronic receives FDA clearance for newest Aquamantys device ... KFx Medical receives new patent ... Judge dismisses motions in MDT/NUVA case ... Pioneer Surgical announces grand opening of new N.C. manufacturing facility more

Musculoskeletal News Roundup 19-Jan-12 BY LAUREN UZDIENSKI, JANUARY 19, 2012

ZMH acquires Synvasive Technology ... Carticept, DiFusion announce funding rounds ... KFx announces ACL study results ... MedShape launches ExoShape Soft Tissue Fastener ... VG Innovations releases VerteLoc v2.5 ... Stryker settles OP-1 charges ... Zyga Technology appoints president and CEO more

FDA Warns DePuy Over Custom Devices BY LAUREN UZDIENSKI, JANUARY 18, 2012

An FDA warning letter sent to DePuy in December alleges that the company has been manufacturing custom hip and knee components in violation of FDA regulations. Custom devices are intended to be manufactured for one patient, and such devices are generally exempt from market clearance. more

Musculoskeletal News Roundup 29-12-11 BY LAUREN UZDIENSKI, DECEMBER 29, 2011

KSpine raises $2.5M . . . ICOR provides international device registry update . . . Synthes sues Stryker . . . DePuy to distribute Anika's MONOVISC in the U.S. more

Musculoskeletal News Roundup 15-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 15, 2011

Baxter to acquire Synovis . . . FDA approves DePuy's AOX Antioxidant Polyethylene . . . EXAC launches Gibralt spinal system . . . CMS proposes industry relationships disclosure . . . Spinal Kinetics wins patent suit . . . Amp Orthopedics initiates two new studies . . . Vertiflex completes IDE enrollment . . . K2M names SVP Sales in the Americas more

Symmetry Medical to Acquire JNJ's Instrument Business BY LAUREN UZDIENSKI, DECEMBER 12, 2011

Symmetry Medical announced this morning plans to buy the surgical instrument portfolio and associated assets from J&J's Codman business. Symmetry will pay $165 million in cash for the line, which will report about $60 million in sales this year in a $1 billion worldwide market. more

Musculoskeletal News Roundup 8-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 7, 2011

Mazor reports earnings . . . HealthpointCapital acquires Blue Belt Technologies . . . DFINE receives regulatory clearance in Canada and Mexico . . . LDR approved to market ROC-C cervical cage, ROI-A ALIF cage in China . . . Ranier receives CE mark for Cadisc-C . . . DePuy launches Expedium Neuromuscular System . . . Exactech extends DPA . . . CA sobpoenas MDT over Infuse . . . IART opens China office . . . JNJ names Michel Orsinger worldwide chairman of its Global Orthopedics Group more

EU Begins "In-Depth" Antitrust Review for JNJ, Synthes BY LAUREN UZDIENSKI, NOVEMBER 8, 2011

The European Commission announced on Friday that they would begin an "in-depth" antitrust review of JNJ's proposed acquisition of Synthes. Regulators will determine if the $21B transaction reduces competition in the EU. A particular concern is spine, since the combined companies would have about 30% of the market, just behind Medtronic. more

Musculoskeletal News Roundup 20-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 20, 2011

KNSY, JNJ, Medicrea, SYK, SYST announce 3Q . . . BMTI receives Australian approval for Augment . . . FDA clears Medtronic's Aquamantys3 System . . . K2M launches RAVINE Lateral Access System . . . Medicrea highlights six products at Eurospine . . . Globus to fund MIS spine outcomes registry . . . Zimmer to distribute Benvenue's Kiva . . . Lanx creates Surgeon Advisory Board more

Grim Metal-on-Metal Data from U.K. Registry BY LAUREN UZDIENSKI, SEPTEMBER 19, 2011

The bad news keeps piling up for DePuy and their ASR metal-on-metal hip, with a new batch of registry data indicating that almost a third of implanted devices failed after just six years. The company is already anticipating more than $1 billion in litigation and other expenses associated with their metal-on-metal portfolio, including medical costs for affected ASR patients, and those costs could continue to climb as the extent of the product failures are realized. more

Musculoskeletal News Roundup 25-Aug-11 BY LAUREN UZDIENSKI, AUGUST 25, 2011

Corin, Medtronic announce earnings . . . FDA clears DePuy's TRUMATCH Solutions . . . Ellipse Technologies receives 510(k) clearance . . . FDA expands Zyga's indications for the SImmetry Sacroiliac Joint Fusion System . . . Mesoblast announces first phase II procedure evaluating MPCs for the treatment of low back pain . . . VG Innovations launches modified VerteLoc system . . . Sanuwave and Spinal Restoration receive U.S. patents . . . Zyga Technologies enrolls first EU patients in GLYDER study more

Metal-on-Metal Hip Complaints Surging: NYT Analysis BY SANDER DUNCAN, AUGUST 23, 2011

The FDA received more complaints about metal-on-metal hip implants this year to date than in the preceding four years combined, according to a New York Times analysis of FDA data. more

WSJ: JNJ Facing $1+ Billion in ASR Costs BY LAUREN UZDIENSKI, JULY 11, 2011

A Wall Street Journal article on Friday highlighted three companies facing "mass litigation": Toyota for unintended acceleration, BP for last year's massive oil spill and, now, DePuy and the ASR XL hip. more

Musculoskeletal News Roundup 16-Jun-11 BY LAUREN UZDIENSKI, JUNE 16, 2011

Altor to acquire Orchid Orthopedic Solutions . . .Spinal Modulation closes $30M in funding . . . FDA approves DePuy's ceramic-on-metal hip . . . TSON announces 10,000th U.S. AxiaLIF implantation . . . Cayenne Medical partners with allograft supplier Parametrics more

DePuy Orthopaedics Appoints New President BY LAUREN UZDIENSKI, JUNE 13, 2011

DePuy Orthopaedics announced today that Andrew Ekdahl has been promoted to the position of president, filling the role left vacant by the resignation of David Floyd in March. Mr. Ekdahl previously served as franchise vice president of DePuy Europe, Middle East and Africa. more

Musculoskeletal News Roundup 28-Apr-11 BY LAUREN UZDIENSKI, APRIL 28, 2011

CNMD, IART, SYST, ZMH and more report earnings . . . FDA clears Biomet's Active Articulation E1 Dual Mobility Hip System . . . ORTHOCON receives EU, Canadian clearance to market HEMASORB . . . SI-BONE receives modification to its labeling . . . DJO Global introduces e-plus total knee replacement insert . . . Wright Medical launches FUSIONFLEX Demineralized Moldable Scaffold . . . Kuros regains certain technology rights from Baxter . . . Genzyme files two new HA infringement suits more

Musculoskeletal News Roundup 21-Apr-11 BY LAUREN UZDIENSKI, APRIL 20, 2011

JNJ, SYK report 1Q:11 . . . Benvenue raises $36M . . . FDA clears StelKast's Xp Acetabular Liners . . . Medtronic launches MARROWMAX Bone Marrow Aspiration Needle Kit . . . Genzyme sues Seikagaku for HA patent infringement . . . RTI to supply allograft to Alphatec more

J&J in Talks with Synthes Over Possible Acquisition BY LAUREN UZDIENSKI, APRIL 18, 2011

Synthes has confirmed rumors that the company is in talks to be acquired by J&J, reportedly for around $20 billion. more

Musculoskeletal News Roundup 7-Apr-11 BY LAUREN UZDIENSKI, APRIL 7, 2011

aap, Medicrea report 1Q sales . . . Orthopaedic Synergy to raise $9.5M . . . FDA clears ATEC's Solus . . . Titan Spine receives CE mark for Endoskeleton lumbar devices . . . Emerge Medical introduces trauma line . . . Life Spine holds surgeon training . . . Mazor announces 2,000th procedure . . . CareFusion's COO resigns more

Ortho President David Floyd Resigning from DePuy BY LAUREN UZDIENSKI, MARCH 8, 2011

Bloomberg reported on Friday that David Floyd plans to step down from his role as worldwide president of DePuy Orthopaedics at the end of this month. Mr. Floyd, who has been in the role since 2007, intends to "pursue interests outside the company." more

Musculoskeletal News Roundup 17-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 17, 2011

ARTC, DJO, GENZ, OFIX and Synthes report earnings . . . Sonoma raises $22 million . . . Anika provides FDA update . . . AAOS product launches . . . Medtronic announces kyphoplasty data more

Musculoskeletal News Roundup 27-Jan-11 BY LAUREN UZDIENSKI, JANUARY 27, 2011

DJO, JNJ, SYK, ZMH report 4Q;10 . . . Arthrex acquires Cardo Medical's total joint assets . . . Flex Biomedical, OrthoSensor raise funding . . . LDR submits PMA for Mobi-C . . . Medtronic launches CD HORIZON SOLERA . . . Kuros releases one-year data from KUR-111 study . . . Gary Fischetti named group chairman for DePuy subsidiaries more

Smith & Nephew Rebuffs JNJ Bid BY LAUREN UZDIENSKI, JANUARY 10, 2011

Smith & Nephew has rejected a $10.9 billion bid from Johnson & Johnson to acquire the company, according to reports out late this weekend. Smith & Nephew turned down the offer before Christmas, saying it undervalued the company. The stock price has increased about 19% over the past three months, driven by takeover rumors. more

Musculoskeletal News Roundup 2-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 2, 2010

Synovis reports F4Q:10 . . . MiMedx receives $0.2 million in grant funding . . . Ortho Kinematics raises $1.0 million . . . Medtronic's CD HORIZON pedicle screw system cleared for adolescent idiopathic scoliosis . . . Smith & Nephew receives expanded CE mark clearance for DUROLANE . . . DePuy Spine launches the MOUNTAINEER Laminoplasty System . . . Spine publishes SCOLISCORE AIS data . . . Australian large joint registry data shows 98% success rate for ceramicized metal technology more

Musculoskeletal News Roundup 21-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 21, 2010

EXAC, GENZ, JNJ, VITA, SYK, SYST announce 3Q . . . Biostructures receives FDA warning letter . . . curasan receives CE mark for bone graft substitute . . . Salient Surgical announces first human cases with AQUAMANTYS 3 in Europe . . . Mesoblast announces interim clinical results . . . Merlot OrthopediX and ATEC to collaborate on bone anchorage technology . . . Symmetry division to distribute Cannuflow arthroscopy products more

Musculoskeletal News Roundup 26-Aug-10 BY LAUREN UZDIENSKI, AUGUST 26, 2010

Corin, Medtronic, TiGenix report . . . DePuy warned over TruMatch Personalized Solutions System and Corail Hip System . . . FDA clears Medyssey's Zenius Thoracolumbar Spinal System . . . Binder Biomedical launches NEWTON Intervertebral Body Spacer System . . . CareFusion launches AVAmax Vertebral Balloon . . . DePuy recalls ASR system . . . Benvenue Medical enrolls first patient in VCF study . . . MAKO Surgical appoints Director more

Musculoskeletal News Roundup 27-May-10 BY LAUREN UZDIENSKI, MAY 27, 2010

Medtronic announces FQ4 . . . Exactech acquires Brighton Partners, supplier of Optetrak knee material . . . VentureMD closes funding round . . . KFx cleared to market AppianFx knee products . . . X-spine receives FDA clearance for Fixcet Spinal Facet Screw System . . . Applied Spine awarded patents . . . DFine, Vertos release clinical data . . . curasan collaborates with Matricel on bone graft substitute . . . SpineGuard appoints Alan Olsen Chairman of the Board more

UK Identifies Higher-than-Anticipated Revision Rate for DePuy's ASR BY LAUREN UZDIENSKI, MAY 26, 2010

ASR.pngCiting registry data, the UK released a medical device alert noting that DePuy's ASR acetabular cups have a higher-than-expected revision rate. While regulators anticipated a revision rate of about 3%, the actual rate has been closer to 4-5%. In addition to the registry data, two of the UK clinical sites that implant the device have echoed the higher failure rate. DePuy has been marketing the device in the UK since 2003. more

Musculoskeletal News Roundup 20-May-10 BY LAUREN UZDIENSKI, MAY 20, 2010

ANIK, SYK resolve FDA warning letters . . . FDA clears Mesoblast Phase II study . . . DePuy Mitek to launch Bristow-Latarjet Instability Shoulder System . . . OrthoX developing new bone cement . . . DOJ recovers $20 million in allegedly fraudulent kyphoplasty billings . . . SpineGuard signs European distributor . . . B1 collaborating with Invibio more

Musculoskeletal News Roundup 22-Apr-10 BY LAUREN UZDIENSKI, APRIL 22, 2010

GENZ, DePuy, NUVA, VITA, SYK, ZMH report 1Q:10 . . . Internal Fixation Systems, Soft Tissue Regeneration announce funding rounds . . . Smith & Nephew wins 510(k) clearance for additional VERILAST claims . . . First commercial use of Interventional Spine's RENEW interspinous process device . . . NUVA files legal dispute against OFIX over Osteocel IP . . . LDR completes follow-up on two-level Mobi-C study more

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI, MARCH 11, 2010

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 28-Jan-10 BY LAUREN UZDIENSKI, JANUARY 29, 2010

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

Industry Reaches Out to Help Haiti BY LAUREN UZDIENSKI, JANUARY 20, 2010

A week after a catastrophic earthquake in Haiti, the orthopedic industry is mobilizing to help. Alphatec Spine, DePuy, Medtronic, Smith & Nephew and Synthes are among the companies contributing money and surgical supplies in the wake of the crisis. Synthes... more

Musculoskeletal News Roundup 10-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 10, 2009

M&A The Yorkshire Post reported that DePuy Orthopaedics acquired Finsbury Orthopaedics. Finsbury has a range of hip, knee and small joint replacement products, including a hip resurfacing device. No details of the transaction were disclosed. Funding BioMedFlex raised $0.25 million... more

Musculoskeletal News Roundup 3-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 3, 2009

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

Musculoskeletal News Roundup 12-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 12, 2009

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, OCTOBER 15, 2009

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, OCTOBER 8, 2009

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 10-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 10, 2009

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 20-Aug-09 BY LAUREN UZDIENSKI, AUGUST 20, 2009

Earnings aap Implantate reported 1H:09 sales of EUR 14.7 million ($20.7 million), representing a 10% decreased from 1H:08. Adjusting for one-time income, sales were down 3%, and in the second half of 2009, the company "anticipates a recovery in demand... more

FDA Panel Recommends DePuy's Ceramic-on-Metal Hip for Approval BY LAUREN UZDIENSKI, AUGUST 18, 2009

An FDA panel unanimously determined on Tuesday that DePuy's ceramic-on-metal hip, the Pinnacle CoMplete, is safe and effective, essentially recommending it for market approval. The panel also recommended modifying the labeling and undertaking a post-market study as conditions for approval.... more

Musculoskeletal News Roundup 13-Aug-09 BY LAUREN UZDIENSKI, AUGUST 13, 2009

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

Musculoskeletal News Roundup 6-Aug-09 BY LAUREN UZDIENSKI, AUGUST 6, 2009

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

Muscloskeletal News Roundup 16-Jul-09 BY LAUREN UZDIENSKI, JULY 16, 2009

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

Musculoskeletal News Roundup 2-Jul-09 BY LAUREN UZDIENSKI, JULY 2, 2009

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

Musculoskeletal News Roundup 4-Jun-2009 BY LAUREN UZDIENSKI, JUNE 4, 2009

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

A Look at the Medical Device Industry Today BY ARIELLA P. GOLOMB, MD, JUNE 3, 2009

Venture capital companies believe the dynamics and fundamentals and the medical technology industry haven't changed, even though the economic crisis is causing a revaluing of assets. Many VC-backed companies are expecting down rounds, particularly as midstage assets are revalued. These... more

Musculoskeletal News Roundup 28-May-09 BY LAUREN UZDIENSKI, MAY 28, 2009

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, MAY 21, 2009

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

Musculoskeletal News Roundup 30-Apr-09 BY LAUREN UZDIENSKI, APRIL 30, 2009

Earnings aap Implantate reported 2008 revenues of EUR 31.9 million ($45.0 million), a 14% increase over 2007 sales. Sales in the Trauma & Orthopedics division grew by 35%. Biomaterials sales increased by 4%, with the company attributing slower growth to... more

Musculoskeletal News Roundup 16-Apr-09 BY LAUREN UZDIENSKI, APRIL 16, 2009

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

Early Earnings Reports Show Growth Despite Economy BY LAUREN UZDIENSKI, APRIL 16, 2009

DePuy and Biomet have kicked off 1Q earnings season on a positive note, offering a view of industry growth that may be outpacing expectations. These two companies, which together comprise more than a third of the ortho market, reported 7%... more

Four of Big Five Settle with DOJ; Compliance Monitors Leave BY DAVID KRESSEL, MARCH 31, 2009

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

NASS Announces More Stringent Disclosure Policy BY LAUREN UZDIENSKI, JANUARY 26, 2009

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 22-Jan-08 BY LAUREN UZDIENSKI, JANUARY 22, 2009

Earnings aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners"... more

The New Rules for Public Company Acquisitions BY DAVID KRESSEL, DECEMBER 18, 2008

With stock values down so much, particularly over the past few months, we took a look at the mergers & acquisition environment. We pulled information on M&A premiums on the NASDAQ and NYSE in the recent past, given the recent... more

Musculoskeletal News Roundup 11-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 12, 2008

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 20-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 20, 2008

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 16-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 16, 2008

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 25-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 25, 2008

Funding Anulex Technologies, Inc. secured a $7.0 million growth capital term loan from Silicon Valley Bank. The company plans to use the proceeds to further their R&D efforts, complete their clinical study and expand their sales force. Anulex markets the... more

Musculoskeletal News Roundup 18-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2008

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

Musculoskeletal News Roundup 17-July-08 BY LAUREN UZDIENSKI, JULY 17, 2008

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

Musculoskeletal News Roundup 5-June-08 BY ARMELLE WIART, JUNE 6, 2008

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

Musculoskeletal News Roundup 22-May-08 BY LAUREN UZDIENSKI, MAY 22, 2008

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 24-Apr-08 BY LAUREN UZDIENSKI, APRIL 24, 2008

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

Musculoskeletal News Roundup 17-Apr-08 BY LAUREN UZDIENSKI, APRIL 17, 2008

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 Dives on FDA Communication to J&J BY DAVID KRESSEL, APRIL 2, 2008

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

Musculoskeletal News Roundup 13-Mar-2008 BY LAUREN UZDIENSKI, MARCH 13, 2008

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 6-Mar-08 BY LAUREN UZDIENSKI, MARCH 6, 2008

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

Musculoskeletal News Roundup 25-January-08 BY LAUREN UZDIENSKI, JANUARY 24, 2008

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, JANUARY 17, 2008

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 20-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 20, 2007

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

Musculoskeletal News Roundup 15-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 15, 2007

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

Highlights from DePuy's Third Quarter BY ARIELLA P. GOLOMB, MD, OCTOBER 18, 2007

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

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

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, SEPTEMBER 28, 2007

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 6-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 6, 2007

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

Musculoskeletal News Roundup 30-Aug-07 BY LAUREN UZDIENSKI, AUGUST 30, 2007

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

Musculoskeletal News Roundup 26-July-07 BY LAUREN UZDIENSKI, JULY 26, 2007

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 12-July-07 BY LAUREN UZDIENSKI, JULY 12, 2007

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

Orthopedic News Roundup 28-June-07 BY LAUREN UZDIENSKI, JUNE 28, 2007

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

J&J Seeking a Bigger Hold on Device Industry BY LAUREN UZDIENSKI, JUNE 12, 2007

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

Star-Ledger: DOJ Settlement Could Come this Summer BY LAUREN UZDIENSKI, MAY 24, 2007

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

Orthopedics News Roundup 24-May-07 BY LAUREN UZDIENSKI, MAY 24, 2007

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

Society for Biomaterials a Product Pipeline Crystal Ball BY DAVID KRESSEL, APRIL 24, 2007

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 19-Apr-07 BY LAUREN UZDIENSKI, APRIL 19, 2007

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

Orthopedic News Roundup 5-Apr-07 BY LAUREN UZDIENSKI, APRIL 4, 2007

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

Congress, Industry Aim to Broaden Pediatric Device Research BY LAUREN UZDIENSKI, APRIL 4, 2007

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

Orthopedic News Roundup 29-Mar-07 BY LAUREN UZDIENSKI, MARCH 29, 2007

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

J&J Bets on Prognostic Tests in Ortho BY ARIELLA P. GOLOMB, MD, MARCH 28, 2007

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, MARCH 22, 2007

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 8-Mar-07 BY LAUREN UZDIENSKI, MARCH 8, 2007

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

Orthopedics News Roundup 25-Jan-07 BY LAUREN UZDIENSKI, JANUARY 25, 2007

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

H.R.D.I. Settles Conflict Case BY LAUREN UZDIENSKI, JANUARY 25, 2007

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

DePuy Reports 4Q:06 Financials BY JOHN CHOPACK, JANUARY 24, 2007

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

SNN Issued a Statement Re: BMET Acquisition Rumors BY HUYEN NGUYEN, NOVEMBER 2, 2006

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, OCTOBER 19, 2006

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

Orthopedic News Roundup 21-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 21, 2006

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

Orthopedic News Roundup 17-Aug-06 BY HUYEN NGUYEN, AUGUST 17, 2006

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

DePuy (JNJ) Reports 2Q:06 Earnings BY ARIELLA P. GOLOMB, MD, JULY 18, 2006

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

Controversy over Potential Kickbacks to Hospital Execs BY TODD BARTELS, JULY 18, 2006

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 Receives DOJ Subpoena BY ARIELLA P. GOLOMB, MD, JUNE 30, 2006

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, JUNE 29, 2006

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, MAY 25, 2006

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

CMS Changes its Charite Decision BY DAVID KRESSEL, MAY 17, 2006

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

1Q:06 Preliminary Earnings Summary BY HUYEN NGUYEN, APRIL 27, 2006

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, APRIL 20, 2006

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

Surgeon Choice and Pricing BY LAING RIKKERS, JANUARY 27, 2006

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, JANUARY 27, 2006

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

Another Acquisition in 2006: DePuy Acquires Hand Innovations BY JOHN CHOPACK, JANUARY 19, 2006

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

Update on Surgeons' Subpoenas (DOJ Investigations) BY SUSAN BERSON, NOVEMBER 9, 2005

[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

Blue Shield of California Denies Lumbar Artificial Disc Coverage BY JOHN MCCORMICK, OCTOBER 31, 2005

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

Lumbar Artificial Discs: A Class Action Lawsuit? BY JOHN MCCORMICK, OCTOBER 20, 2005

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

Orthopedic News Roundup 20-Oct-05 BY HUYEN NGUYEN, OCTOBER 20, 2005

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

Call to Action: Local Non-Coverage Draft Policy for Artificial Discs BY KELLI HALLAS, OCTOBER 3, 2005

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

Novel Products to Rejuvenate Hip Market Growth BY JOHN CHOPACK, SEPTEMBER 21, 2005

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

CMS (Medicare) opens a National Coverage Determination (NCD) request to review coverage of the lumbar artificial disc BY BARB PETERSON, SEPTEMBER 14, 2005

[Update: We're moving this entry to the top of the blog since it is sparking a lot of interest from our readers.] more

Earning Calls Replay Info BY HUYEN NGUYEN, AUGUST 10, 2005

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

CMS Denies Add-On Payments for Charite BY JOHN MCCORMICK, AUGUST 2, 2005

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

Orthopedic News Roundup 22-Jul-05 BY HUYEN NGUYEN, JULY 22, 2005

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

AOSSM 2005: A Sports Medicine Trip Report BY JOHN MCCORMICK, JULY 15, 2005

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

Orthopedic News Roundup 8-Jul-05 BY HUYEN NGUYEN, JULY 8, 2005

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

Orthopedic News Roundup 24-Jun-05 BY HUYEN NGUYEN, JUNE 24, 2005

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

An Interview with Dr. Charles Rosen on Artificial Disc Clinical Trials BY JOHN MCCORMICK, MAY 23, 2005

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

1Q:05 Large Joint Review: Knees Remain Strong while Hips Weaken BY JOHN CHOPACK, MAY 9, 2005

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

CMS Holding Pattern a Blow to J&J BY JOHN MCCORMICK, MAY 2, 2005

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

SpinalMotion Receives $20 million in Funding BY HUYEN NGUYEN, MAY 2, 2005

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

AANS 2005: A Trip Report BY JOHN MCCORMICK, APRIL 25, 2005

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

Artificial Discs: A Discussion with Dr. Fred H. Geisler BY JOHN MCCORMICK, APRIL 25, 2005

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 Industry Subpoenaed: Our Perspective BY JOHN MCCORMICK, APRIL 4, 2005

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, MARCH 14, 2005

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

Johnson & Johnson (NYSE:JNJ) Reports 4Q:04 Results: We Examine DePuy's Charite BY JOHN CHOPACK, JANUARY 31, 2005

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 Takes Hold in Orthopedics | EDITORIAL | BY JOHN CHOPACK, JANUARY 24, 2005

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 FDA Approves Charite Disc Arthoplasty BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

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

The 3Q:04 Earnings Season is Half-way Completed for Large Joint Manufacturers: Any Trends? BY JOHN CHOPACK, OCTOBER 25, 2004

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

The Struggle to Reimburse Disc Arthroplasty BY ROBIN R. YOUNG CFA, AUGUST 23, 2004

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

Disc Arthroplasty's Steep Learning Curve BY ROBIN R. YOUNG CFA, JULY 12, 2004

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

DePuy, Stryker and Synthes Receive Most FDA Approvals YTDwhile Zimmer lags BY ROBIN R. YOUNG CFA, JUNE 21, 2004

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, JUNE 21, 2004

  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

Only One Clinical Trial Counts with the Charite BY ROBIN R. YOUNG CFA, JUNE 14, 2004

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

It's About Time! Mobile-Bearing Knee Is Headed for a Down Classification BY JOHN CHOPACK, JUNE 7, 2004

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

FDA Panel Decides Charite Approvable with 5 Conditions BY ROBIN R. YOUNG CFA, JUNE 2, 2004

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

CMS Sets Disc Arthroplasty Procedure Payments at Discectomy Levels - $4,200-6,300 BY ROBIN R. YOUNG CFA, MAY 24, 2004

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

Stryker Corp & DePuy Report 1Q:04 Earnings and Provide Insight into Strength of Large Joint Reconstructive Market BY JOHN CHOPACK, APRIL 19, 2004

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

Medtronic's InFuse® cutting into DePuy Spine's Sales BY ROBIN R. YOUNG CFA, APRIL 19, 2004

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

Charite Clinical Trial Data Released at AANS 25% Owestry Pain Improvement, Better Motion than a BAK Cage BY EDITOR, MARCH 29, 2004

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

A Random Walk Down the Academy's Halls BY JOHN CHOPACK, MARCH 22, 2004

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

Down Classification of Mobile Bearing Knee for Total Knee Arthroplasty Commentary BY JOHN CHOPACK, FEBRUARY 2, 2004

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

Charite Artificial Disc FDA Approval Expected Mid-2005 – according to DePuy Spine BY ROBIN R. YOUNG CFA, JANUARY 26, 2004

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 Set to Emerge from Bankruptcy with $50 Million in Cash, over $23 Million in Sales and a New DBM Product. BY EDITOR, SEPTEMBER 8, 2003

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

$325 million for disc arthroplasty, again. BY EDITOR, MAY 12, 2003

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

First Quarter's Recon Revenue Growth Rate - so far 20-24% BY EDITOR, APRIL 21, 2003

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, APRIL 14, 2003

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


Complete Archive