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European
EXAC, KNSY, RTIX, SNN announce 4Q:11 ... CartiHeal raises $5M ... ConforMIS raises $89M ... FDA clears Eden Spine's GIZA device ... NLT announces 510(k) clearance for the PROW FUSION TLIF device ... ThermoGenesis announces "encouraging" study results more
We're in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging). Industry presence is much lighter than is typical at these events, with commercial exhibits limited to single tables from the handful of sponsoring companies. The focus is instead clinical - surgical technique, treatment modalities and optimizing outcomes. more
MAKO, NUVA, OFIX, SYK, TRNX pre-announce ... FDA clears Biomet's E1 humeral bearing and Comprehensive Segmental Revision System ... Ortho Kinematics receives 510(k) clearance ... Lanx announces 100th implantation of Durango ... Mazor receives EU patent ... SNN announces VISIONAIRE study ... Arthrex to market ThermoGenesis PRP, bone marrow concentrate product ... Pioneer Surgical promotes Daniel Webber to CEO more
IART pre-announces . . . China Kanghui subsidiary receives FDA clearance for hip and knee systems . . . first procedure performed with Ellipse Technologies device . . . Pioneer Surgical announces first clinical use of nanOss Bioactive 3D . . . Wright Medical launches ORTHOLOC 3Di Ankle Fracture System and the QUICKDRAW Knotless Soft Tissue Fixation System . . . Globus appoints SVP and CFO . . . Vexim appoints CEO more
Biomet pre-announces . . . Oregon judge throws out SNN suture anchor ruling . . . Exactech initiates cartilage repair study . . . Spine Wave and MB Innovations announce partnership more
ATEC, ARTC, EXAC, IART, WMGI and more announce 3Q . . . FDA clears LDR's ROI-A Oblique ALIF cage . . . ATEC, Custom Spine, Globus, K2M, Medtronic and others debut new products at NASS . . . Relievant MedSystems starts enrolling SMART trial . . . Spine Wave starts EU NuCore study more
This week we attended Eurospine in Milan, and we came away noticing a couple of trends. One, VCF technologies are continuing to generate a lot of interest, despite the damper the NEJM studies may have placed on these products in the U.S. Also notable was the increasing prominence of companies based in Asia, who may be playing more of a role in the EU market as cost containment and austerity measures affect hospital budgets. Finally, we observed U.S. companies using Eurospine as an opportunity to highlight their increasing international reach. more
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
aap Implantate pre-announces 3Q:11 ... ISTO receives CE mark for InQu ... Biomet celebrates 35th anniversary of the Oxford partial knee ... TiGenix announces Finnish distribution for ChondroCelect more
In comments to the Financial Times, Medtronic CEO Omar Ishrak criticized the FDA for a slow regulatory process that limits patient access to care. In the EU, "the response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers are less stringent," Mr Ishrak told the FT. He also spoke in favor of adopting a regulatory process more like the Europe's, adding, "It will certainly put products on the market more quickly, so from a very selfish device manufacturer perspective, absolutely." more
MedShape Solutions receives SBIR grant . . . Ascendx Spine receives CE mark . . . Pioneer Surgical receives Canadian clearance for the Sternal Cable System . . . SNN launches new DYONICS PLATINUM Series Shaver Blades . . . SpineSource launches WAVE-O Expandable Lumbar Interbody Fusion Cage . . . Gary Henley appointed Executive Chairman of the Board at TransCorp Spine more
Biomedical Structures acquires Concordia Medical . . . Neue Magnetodyn IP to go up for auction . . . Wright Medical closes tender offer for convertible senior notes . . . K2M receives CE mark for RAVINE Lateral Access and ALEUTIAN Lateral Interbody Systems . . . Smith & Nephew files suit against former employees . . . OrthAlign comments on new clinical data . . . Misonix, Aesculap sign new distribution agreement . . . Shukla Medical licenses Kytogenics' biopolymer technology . . . Inion resumes operations . . . DePuy Spine appoints worldwide president more
Align announces 4Q:10 . . . The Carlyle Group acquires Integrated Dental Holdings . . . Glidewell Laboratories' Inclusive Custom abutments now compatible with Astra Tech's implant system . . . Periodontal bacteria linked to respiratory infections . . . Align, Cadent to develop software for Invisalign . . . Dentsply makes donation to NYU more
MAKO, NUVA, SYK pre-announce . . . Globus acquires Facet Solutions' assets . . . Doctors Research Group raises $7.7M . . . Wright Medical launches DARCO system in Japan . . . Zimmer introduces NexGen LPS-Flex Mobile Bearing Knee with Prolong Highly Crosslinked Polyethylene . . . FDA approves Wright Medical's IDE for the INBONE Total Ankle Replacement with Calcaneal Stem . . . China Kanghui Holdings and Consensus Orthopedics announce manufacturing and marketing agreement more
Theken Spine wins Ohio grant . . . Ellipse Technologies receives CE mark for the PRECICE limb lengthening device . . . Memometal Technologies launches MemoDerm Acellular Dermal Matrix and Smart Toe II Hammertoe Fixation System . . . Zimmer receives reimbursement premium from Japan for the Trabecular Metal Modular Cup . . . Stryker files patent infringement suit against Zimmer . . . Lanx appoints CEO more
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
MDT reports F2Q:11 . . . Bacterin, Sonoma Orthopedics announce financing rounds . . . curasan AG receives Health Canada approval for Cerasorb M ORTHO . . . Medtronic launches SOVEREIGN Spinal System in Europe . . . Blue Cross Blue Shield of North Carolina releases new lumbar spinal fusion guidelines . . . Stryker supports South Carolina medtech development consortium more
A new medtech survey found that compared to the U.S. regulatory process, European approvals were faster, and EU regulatory authorities received substantially higher ratings in the area of "predictability," "reasonableness" and "transparency." As for "overall experience," 75% of respondents rated their regulatory experience in the EU excellent or very good, compared to 16% for the FDA. more
ATEC, ANIK, KH and TSON announce 3Q . . . SYST acquires surgical power tools . . . MAKO closes public offering . . . ConforMIS launches next-generation iDuo G2 . . . SYK's Triathlon knee has lowest three-year revision rate compared to competitive systems, according to U.K. data . . . SYK receives subpoenas related to OtisKnee and PainPump . . . Arthrex to distribute KNSY's Cartilage Repair Device in Europe more
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
Biomet announces FQ1:11 . . . Core Essence Orthopaedics raises $1.5M . . . Medical Tracking Solutions launches iTraycer . . . 1,000th Zimmer Natural Nail Cephalomedullary Nail implanted . . . Vertiflex enrolls 200 patients in its Superion IDE study . . . Pioneer Surgical to manufacture and distribute SpineSmith's Cequence anterior cervical plate . . . Cardo Medical seeks capital . . . Pioneer Surgical to open manufacturing and distribution facility in Scotland more
InVivo Therapeutics planning a reverse merger . . . MiMedx to raise $5.0 million . . . FDA clears ArthroCare's Parallax device to treat VCFs . . . Osseon Therapeutics announces 1,000-patient milestone . . . AAOS releases clinical guidelines for vertebroplasty and kyphoplasty . . . ProChon reports BioCart Autologous Cartilage System outcomes . . . RepRegen releases in vivo StronBone data more
NUVA lowers guidance . . . HydroCision acquired by three VC firms; new President and CEO appointed . . . TiGenix closes seed financing round for new pharma spinoff . . . Creaspine, Ranier Technology receive CE mark clearances . . . Medtronic introduces Kyphon Cement Delivery System in Europe . . . SpineAlign Medical introduces European Observational Registry for the VerteLift System . . . Medtronic wins certain rulings in ongoing patent infringement suit brought by Synthes . . . Synthes sues Biomet, former sales rep more
Amedica raises $30M . . . BioMimetic affirms Augment PMA timeline . . . Aesculap, K2M announce 510(k) clearances . . . BMTI and Eden Spine announce U.S. and EU patents . . . Tornier announces early clinical results more
Medtronic to acquire Osteotech . . . Stryker may buy Boston Scientific's neuromodulation unit . . . SI-Bone raises $11M . . . Aesculap received 510(k) clearance for the A-Fix Spinal System . . . Biomet responds to FDA warning letter . . . Benvenue Medical announces first U.S. use of the Blazer system for treating VCFs . . . Cytori receives patent for stem cell use in musculoskeletal applications . . . NuOrtho Surgical announces pre-clinical results . . . RTI Biologics reports "no change" to Medtronic supply agreement more
CNMD, IART, NUVA, OFIX, Synthes report 2Q:10 sales . . . Axiomed raises $14.5M . . . China Kanghui Holdings to go public . . . FDA panel votes in favor of Medtronic's Amplify . . . FDA approves Orthovita's new collagen processing facility . . . curasan seeking distribution partners for ATR . . . TranS1 launches next-gen AxiaLIF 2L+ system . . . Ortho Kinematics enrolling study more
Biomet and RSB Spine announce revenues . . . Bacterin announces reverse merger, private placement . . . FDA begins review of BioMimetic's Augment . . . Cerapedics receives CE mark for iFactor bone graft . . . DFine signs distribution agreements for Italy and Morocco . . . Michael DeMane declines CEO, Chairman role at Lanx more
Orthopaedic Synergy closes acquisition of PRAXIM . . . Trauson reveals IPO details . . . HyperBranch Medical Technology receives CE mark for a spine sealant . . . TriMed and Stryker back in court over wrist fixation device . . . Bacterin signs deal with hospital purchasing group Broadlane . . . Inion files for bankruptcy . . . BONESUPPORT and TSON announce Board appointments more
Mazor announces first German GO-LIF sales . . . OrthoDynamix launches the ArthroSteer Biter . . . Osprey Biomedical introduces the Eagle Cervical Allograft Series . . . DOJ settles with Idaho orthopedists . . . Stryker and Wright Medical settle knee infringement suit . . . Amedica awarded patent . . . AOFAS releases position paper on total ankle replacement . . . Pioneer Surgical announces NuBac data . . . RepRegen reports StronBone data . . . Medtronic to report physician payments greater than $5,000, and Steve La Neve steps down from spine & biologics more
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
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
Biomet kicks off earnings seasons . . . ATEC preannounces . . . Articulinx, biospace med, Osseon close funding rounds . . . ConforMIS G2 Uni receives CE mark clearance . . . EXAC's Novation hip approved for sale in Japan . . . Stryker Interventional Spine launches iVAS for VCFs . . . Cayenne Medical announces clinical results for the AperFix System more
 ATEC closes Scient'x acquisition . . . Anulex and Carticept Medical close funding rounds . . . OrthAlign receives 510(k) clearance for its latest KneeAlign design . . . Eden Spine receive a European patent . . . Medicare cuts loom as Congress departs for Easter recess . . . ArthroCare reports data on their Plasma Disc Decompression products more
 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
Earnings DJO reported 4Q:09 revenues of $257.2 million, up 5% over 4Q:08, with domestic rehab sales up 3% and domestic surgical implant sales up 8%. The company attributed the latter largely to "strong sales of our Reverse Shoulder Prosthesis." Net... more
Earnings Nobel Biocare reported 4Q:09 revenues of EUR 156.0 million ($213.6 million), flat over the year-ago period and missing estimates by EUR 5.0 million ($6.9 million.) EPS of EUR 0.21 ($0.29) missed estimates by EUR 0.05 ($0.07). The company called... more
Earnings CONMED reported 4Q:09 sales of $190.6 million, up 3% over the year-ago period and beating estimates by $6.0 million. Arthroscopy sales rose 3% to $75.7 million. All growth rates exclude the effects of currency. 4Q:09 EPS of $0.37 beat... more
Earnings MEDICREA reported 4Q:09 sales of EUR 3.9 million ($5.6 million) and 2009 sales of EUR 13.1 million ($18.8 million), representing a 45% increase over 2008. The company said their sales development in the U.S. has been "successful" and a... more
Earnings aap Implantate reported preliminary sales of EUR 7.4 million ($10.6 million) in 4Q:09, down 4% from the year-ago period. Full year sales were up 3% to EUR 33.0 million ($47.3 million). Company highlights for the year include "optimizing its... more
Earnings Biomet reported FQ2:10 (ended November 30, 2009) revenues of $696.0 million, up 5% over the year-ago period. Recon sales increased 6% to $528.4 million, with hip up 4%, knee up 8%, dental down 8% and extremity up 27%. Additionally,... more
M&A Alphatec Holdings, Inc. announced that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France. The transaction is structured as an all-stock transaction such that 100% of outstanding Scient'x stock... more
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
Earnings aap Implantate reported nine-month revenue of EUR 25.6 million ($37.4 million), which represents a 6% increase over the year-ago period. The company said third-quarter highlights included the signing of several IP agreements that emphasize orthopedics, trauma ad spine. Artimplant... more
Earnings Anika Therapeutics reported 3Q:09 revenues of $10.1 million, representing an 18% increase over the year-ago period and missing estimates by $0.3 million. Joint Health sales, including the Orthovisc and Monovisc products, were up 31% to $6.1 million. Anika noted... more
Earnings CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.... more
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
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
TiGenix announced that ChondroCelect, its ACI treatment for cartilage regeneration, has been cleared by the European Commission for sale on the EU market. This is the first product to be approved in the EU as an advanced therapy medicinal product,... more
Earnings MEDICREA reported revenues of EUR 6.1 million ($8.6 million) in 1H:09, representing a 32% increase over 1H:08, which the company attributed to growth in sales from direct subsidiaries, primarily in the United States. Net loss was EUR 1.5 million... more
Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more
M&A Integra LifeSciences acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Last year the company recorded $2.2 million in revenues, though they ceased operations in January and went into liquidation in May. This transaction... more
Regulatory Active Implants Corporation received a CE Class III Certificate for its TriboFit Hip System. The system is made from a low-wear polycarbonate-urethane material that the company says shares some of the characteristics of human cartilage. MEDICREA received 510(k) clearance... more
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
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
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
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
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
Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more
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
Patients suffering crippling pain from metastatic cancer or even "benign" conditions like rheumatoid arthritis may find relief in a minimally-invasive treatment called osteoplasty. Similar to vertebroplasty, osteoplasty is the injection of bone cement into cancerous lesions in the skeleton, and... more
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
Yes, that ozone. The molecule that filters UV rays in the atmosphere and is a pollutant on the ground could have applications for reducing back pain, according to new studies out of Europe. Over the past five years, it is... more
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
Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more
Earnings Kensey Nash reported FQ2:09 revenues of $20.8 million, up 6% over the year-ago period and beating estimates by $0.4 million. Net income for the quarter was $5.2 million, or $0.44 per diluted share, beating estimates by $0.04 and representing... more
Earnings Exactech reported 3Q:08 revenues of $37.9 million, missing revenues by $0.9 million and representing an increase of 27% over the year-ago period. Among segments, knee revenue increased 16%; organic hip implant revenue increased 8%; biologic services revenue increased 12%;... more
M&A Life Spine, Inc. has acquired the "majority" of the intellectual property of Spinal Generations, LLC. Neither details on the acquired technology nor terms of the transaction were disclosed. Funding Harvard received a $125 million donation from Synthes Chairman Hansjorg... more
M&A Wright Medical Group, Inc. acquired the RAYHACK System for wrist reconstruction, which consists of "procedure-specific bone-cutting guides and fixation plates that allow precise shortening and repositioning of the radius and ulna." The system will be available in the U.S.... more
Earnings AOI Medical Inc. reported a 1H:08 loss of $3.5 million, widening from a loss of $1.8 million in 1H:07. The company added in the press release that they're conducting a new clinical study for their Ascendex tools for the... more
A European investigation of dental amalgam, undertaken in an effort to evaluate the safety concerns associated with the material's mercury content, found that the product was safe. The European Commission's (EC) Scientific Committee on Emerging and Newly Identified Health Risks... more
Earnings Alphatec Spine, Inc. reported consolidated revenues for 2Q:08 of $23.9 million, an increase of 27% from the $18.8 million reported in 2Q:07. U.S. revenues for 2Q:08 were $19.4 million, an increase of 20% from the $16.2 million reported in... more
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
Earnings Symmetry Medical reported 1Q:08 revenue of $101.9 million, up 57% from the year-ago period. Revenue was positively affected by the recent acquisitions of TNCO, Inc., Specialty Surgical Instrumentation Inc. and DePuy Orthopaedics, Inc.'s Massachusetts manufacturing facility. Net income for... more
Funding Exactech received a $40.0 million syndicated line of credit which will be used to fund future acquisitions and refinance debt, among other expenses. SunTrust Bank served as lead agent with participation by Compass Bank. M&A clickNsettle announced plans... more
M&A Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The... more
After four years of back and forth between the European Parliament, European Commission and the European Counsel, the revised Medical Device Directive (MDD) was eventually published in the Official Journal of the European Communities on September 21st, 2007. The amendments... more
Earnings JNJ reported 4Q:07 revenues of $15.96 billion, up 17% over the year-ago period and beating consensus estimates of $15.4 billion. Net income was $2.37 billion, or $0.82 per share, missing estimates by $0.04. Depuy reported 4Q:07 sales of $1.21... more
M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more
M&A Curis, Inc. entered into an agreement to sell and assign its remaining BMP-7 technologies to Stryker Corporation. Curis will receive an initial payment of $1.0 million as well as additional cash payments based on specified clinical, regulatory and sales... more
Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more
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
M&A Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix... more
Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... more
Earnings Biologics: Orthovita reported 2Q:07 revenues of $14.85 million, beating estimates of $14.13 million and reflecting a 33% increase over 2Q:06. Sales growth was attributed to increased U.S. sales of VITOSS® FOAM and VITAGEL® products. Net loss decreased to $3.17... more
Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more
Regulatory TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was... more
The European Parliament recently approved 141 amendments to the Medical Device Directive, the legal framework created in 1990 to regulate device safety throughout Europe. The approval follows a public comment period on the first draft of the Directive, which was... more
Earnings Spine Kyphon reported that worldwide revenues in 1Q:07 increased 40% to $128.1 million, which includes $18.1 million in X-STOP® Interspinous Process Decompression (IPD®) sales from the St. Francis acquisition. In the U.S., revenues increased 34% to $101.1 million, while... more
Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... more
In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... more
Earnings: Biomet reported its 1Q:07 earnings totaled $0.44 per share (excluding the adoption of the share-based payment) which was $0.01 more than what analysts were expecting. Revenues increased by 5% to $508 million (foreign currency had a $3 million favorable... more
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
Appointment: A medical imaging company ONI Medical appointed Victor Ruiz to Vice President, of the Corporate Strategy and Marketing division. Mr. Ruiz's past experience include world-famous imaging companies: GE Medical Systems and Cardinal Health Inc. Clinical Update: LDR Spine announced... more
Posted by Tim Berkowitz and Anne Villeneuve. We attended late last week the Inspiration (International Spine Research and Innovation) meeting in Cannes. More than 70 spine surgeons from twenty-three countries discussed: cervical spinal tumors canalar stenosis with degenerative scoliosis in... more
This week, we decided to post the Orthopedic News Roundup for Thursday, instead of Friday due to the upcoming holiday. Clearly the biggest headline this week is the announcement of a take-over bid by Musculoskeletal Transplant Foundation ("MTF") for Osteotech... more
At a recent shareholders' meeting IsoTis OrthoBiologics announced that it appointed James (Jim) Hart to its Board of Directors. Jim is familiar to many of you as the former CEO of Opus Medical which was sold to ArthroCare for over... more
Today Ranier Technology Limited, a UK based artificial disc manufacturer announced that it received £4 million ($7.3 million) in an institutional venture capital round. The funding was provided by FNI Venture Capital, which was a previous investor in Ranier's first... more
About six months ago I had an individual come into my office asking about an article he had recently read in a local newspaper regarding hip resurfacing. The man was approximately 40 years old and was too young for a... more
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