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Orthopedic and Dental Industry News Complete Archive »

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

OR.jpgWe're live from AAOS this week. See below for a summary of the latest product launches and clinical news, and check back next week for our complete AAOS wrap-up.

Earnings
MAKO Surgical reported 4Q:09 revenue of $8.9 million, up 790% from $1.0 million in the year-ago period and beating estimates by $1.3 million. During the quarter, seven new RIO systems were installed, bringing the total number to 36 installed systems. During the fourth quarter, 561 MAKOplasty procedures were performed, up 34% from 3Q:09 and 181% from 4Q:08. Net loss was $9.3 million, or $0.28 per share, improved from a net loss of $10.8 million, or $0.48, in 4Q:08. EPS missed estimates by a penny.

Orthovita reported 4Q:09 revenues of $24.4 million, up 17% over the year-ago period and in line with estimates. Cortoss contributed $0.7 million in revenues. Net loss narrowed to $0.3 million, or $0.01 per share, from $1.2 million, or $0.02 per share, in 4Q:08. EPS was in line with estimates.

M&A
Healthcare of Today, Inc. signed a letter of intent for DyfucaMed, which manufactures the DyfucaMed Ratio Applicator for delivering an autologous platelet gel.

Orthopaedic Synergy signed a letter of intent and entered into period of exclusivity to acquire Praxim. Praxim manufactures navigation systems for large-joint surgery.

Regulatory
Axis Surgical Technologies received 510(k) clearance for their C-MOR Visualization Device, a portable system is designed for use in arthroscopic and endoscopic procedures.

biospace med received 510(k) clearance for their "ultra-low-dose" imaging system, the EOS 2D/3D workstation, for pediatric use in spine applications.

ETEX received 510(k) clearance for their CarriGen Porous Bone Substitute Material, a calcium phosphate technology that the company calls the "first highly-porous bone graft substitute that sets hard upon implantation."

Israel-based N.M.B. Medical Applications received FDA clearance for the Endolign-based QUANTUM Humeral Composite Nailing System. Endolign consists of carbon fibers in a PEEK-OPTIMA polymer matrix.

Replication Medical received CE mark clearance for its GelFix interspinous spacer, which is made from HPAN, a biocompatible hydrogel.

Product Introduction and Update
Ascension Orthopedics launched the PyroTITAN Humeral Resurfacing Arthroplasty System, which the company says is the first commercially-available shoulder arthroplasty prosthesis made of PyroCarbon.

Bacterin launched OsteoSelect DBM putty, a moldable product that consists of allograft material suspended in a polymer matrix. It is designed to withstand irrigation.

CONMED launched five new products this week from its sports medicine and capital products lines: the Presto Bioabsorbable Suture Anchor, the Ergo Shaver Handpiece, the Liberator Plus Shaver Blade, the PRO6350M Mpower 2 Battery Powered Oscillating Saw and the VP1600 HD Still Capture System.

According to a report in the New York Times, DePuy Orthopaedics sent a letter about the ASR hip resurfacing device to surgeons, saying that Australian registry data showed that the device "had been failing early at a significantly higher rate than some competitors' devices." The letter comes several months after an announcement that DePuy would phase out the ASR due to slow sales.

depuy_shoulder1.jpgDePuy launched several new products at AAOS: the XTEND Reverse Shoulder System (shown at left), the Global CAP CTA for shoulder resurfacing, the Elbow Plating System and the Proximal Tibia System. The latter two products were introduced into the company's Anatomic Locked Plating Systems (A.L.P.S.) portfolio.

Integra Lifesciences debuted a new spine orthobiologics suite that includes OsteoSparx and OsteoSurge, both DBMs, and the OsteoStrux Osteoconductive Scaffold, a collagen ceramic matrix. Additionally, the company launched Mozaik Moldable Morsels, a bone void filler that will be sold in four sizes, and the Total Wrist Fusion System, a fixation system designed to decrease soft tissue irritation.

MedShape Solutions launched their MORPHIX Shape Memory Suture Anchor, which is made from a proprietary, shape-memory PEEK Altera, at AAOS this week. The company also announced that they are pursuing phase III SBIR grants and achieved "preferred vendor" status at the Veterans Health Administration and other federally-funded hospitals.

Medtronic launched the VERTEX SELECT Posterior Cervical System.

Pioneer Surgical Technology announced the full launch of the Contact Anterior Lumbar Plate, which the company says "provides a one-step locking mechanism along with back-out protection and controlled screw toggle."

RTI Biologics launched two products at AAOS: BTB Select, an allograft that provides "precision-sized" tendons for ACL reconstruction, and BioCAP Select, a composite allograft plug for filling bone voids.

Smith & Nephew announced the launch of a number of new products at AAOS. Their orthopedics division released the VLP FOOT Variable-angle Locked Plating System, which offers a wide range of screw types and plate designs, and the TRIGEN SURESHOT Distal Targeting System, a portable, 3-D imaging system that may reduce radiation exposure for surgeons. The endoscopy group launched the BIORAPTOR Knotless Suture Anchor for the repair of torn labrum in the hip and shoulder, the FAST-FIX 360 system for meniscal repair and the TWINFIX Ultra PK Suture Anchor for rotator cuff repair.

TiGenix launched ChondroCelect in an initial roll-out in Germany, Belgium, the U.K. and the Netherlands. The company notes that "negotiations on pricing and reimbursement with local health insurance authorities and payers are ongoing," and they expect feedback on their reimbursement efforts in the second half of 2010.

Investigations
The SEC dropped an investigation into Wright Medical Group's foreign sales practices, and no further action is expected, according to a regulatory filing.

Clinical
BioMimetic Therapeutics announced results from three pre-clinical studies this week: two showed that when combined with tissue-specific matrix materials, rhPDGF-BB "promotes healing in tendon-tendon and tendon-bone injuries." A third in vitro study demonstrated rhPDGF-BB's "ability to stimulate tenocytes."

Two new studies on bisphosphonates (such as Boniva and Fosamax) suggest that long-term use for the prevention of osteoporosis may actually correlate to fractures. In data presented at AAOS, one in 50 women who got fractures and were on the drugs for more than five years suffered atypical hip fractures of the femur.

Stryker announced results from their IDE study comparing their mobile-bearing and traditional fixed-bearing knees. The study found "no statistical difference" in clinical outcomes between the devices, and as a result, the company said that they would not bring a mobile-bearing knee to the U.S. market.

Licensing and Distribution
Oldelft Benelux will market biospace med's EOS 2D/3D imaging workstation in Belgium, the Netherlands and Luxembourg.

OMNIlife science entered into an exclusive agreement to distribute Societe d'Etudes Recherches Fabrication-Dedienne Sante's NOVAE Dual Mobility Acetabular Cup System in the U.S. OMNI plans to launch the device once they receive FDA clearance.

X-spine entered into an exclusive license agreement with Gamma Spine to develop a fixation spinal device that aims for "minimal tissue disruption."

Collaborations
NeoStem entered into a one-year sponsored research agreement with the University of Michigan to evaluate bone defect repairs using the company's VSEL Technology, which is based on "very small embryonic-like stem cells." NeoStem will have the first option to license any discoveries from the project.

TrueVision Systems and Weigao signed a letter of intent to form WEGO-TrueVision, a joint venture to build and distribute TrueVision products in China. TrueVision is described as a real-time, 3-D, high-definition visualization and guidance system for MIS procedures, including orthopedic and spine.

Appointments
MiMedx hired Karl-Matthias Moehlmann to "lead the establishment of key distribution partners in Europe" for the sale of the HydroFix Spine Shield product, which received the CE mark last week.

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