Printable Weekly
We'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 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 PEEK, at AAOS this week. The company also announced that they are pursuing phrase 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.
With healthcare reform projected to cost $950 billion, the pharma, device and hospital industries have generally consented to help fund the changes - in the device industry's case, to the tune of $20 billion over the next decade, which will be realized through an excise tax proposed to be implemented in 2011.
Now AdvaMed is pushing on behalf of the industry to lock in that $20 billion as a cap, reports Reuters.
"We understand we're obligated for our $20 billion, but no more than that," said James Mazzo, who was recently appointed AdvaMed's Chairman. Mazzo appears to be taking a strong stance against negotiations on the agreed-upon tax, which may be more meaningful as the scope of healthcare reform appears to be shrinking; the fees were initially justified by the benefit companies would receive from additional insured patients. AdvaMed is also lobbying for reform legislation to include tax exemptions for small companies, who could be heavily burdened by the tax.
While AdvaMed holds its ground, this week the Obama administration is working hard to revive its floundering healthcare package. The president has made three healthcare speeches this week, and Congressional leaders are working to finalize some changes to the legislation, including subsidies to help Americans buy insurance and federal aid to state-based Medicare programs. The CBO is in the process of scoring these changes as Democratic leaders attempt to collect enough votes to pass a bill. Right now, it is expected that the House will attempt to pass the Senate's version of the bill from last year, with a companion bill to immediately follow that will make certain changes to the Senate bill. The companion bill will have to pass with a simple majority in both chambers.
Wear debris and surgical technique are at the center of a New York Times article on metal-on-metal total hip components, with the paper suggesting that metal-on-metal correlates to poorer outcomes and higher revision rates.
Metal-on-metal components are used in about a third of the 250,000 hip replacement procedures in the U.S. each year, and the procedures utilizing these components are a mix of traditional THA and resurfacing cases. Wear debris, which is created when contact between the ball and cup sheds metal ions, may occur at higher rates with metal-on-metal components than metal-on-poly and ceramic-on-ceramic (another surface to which the Times has voiced its objection). This can lead to inflammation and tissue death and necessitate a revision as soon as one to two years after an initial procedure.
The article cites a metal-on-metal revision rate of 1-3%, with women affected more frequently than men. A surgeon at Rush University who was quoted by the Times says he revises metal-on-metal hips at a rate of about "one a month." The failure rate is largely attributed to surgeon technique, such as how implant components are aligned. This connection is not entirely new, particularly in terms of resurfacing; it has been well-documented that resurfacing is a complex procedure with a steep learning curve.
While the Times may be among the first to bring major media attention to metal-on-metal, questions about wear debris and device failure have been circulating in the scientific and clinical community for some time. Suggestions that the revision rate is higher for resurfacing than a conventional THA have been corroborated in a recent review by the AAOS, which noted that data from three joint registries showed an increased revision rate for resurfacing. However, younger male OA patients may have a lower revision rate with resurfacing than a THA. Additionally, a poster presented at the AAOS annual meeting last year identified higher blood cobalt and chromium levels in patients with unexplained failure of metal-on-metal hips.
Earnings
Corin reported full-year 2009 revenue of GBP 40.6 million ($64.7 million), down 10% over the year-ago period. Among segments, OUS hip increased 2%; U.S. hip decreased 83%; and knee increased by 1%. All growth rates exclude the effects of currency. Group operating profit before exceptional items was GBP 1.8 million ($2.9 million), down from GBP 3.4 million ($4.9 million) in 2008. Corin attributed the decline to lower sales to Stryker, which the company added were partially offset by manufacturing efficiencies.
Integra LifeSciences reported 4Q:09 sales of $183.5 million, up 5% over the year-ago period and beating estimates by $1.2 million. Orthopedic sales increased 9% to $68.5. Adjusted net income for 4Q:09 was $17.8 million, or $0.60 per diluted share, up from $15.5 million, or $0.53 per diluted share, in 4Q:08. Analysts had forecast EPS of $0.58.
Osteotech reported 4Q:09 revenue of $26.3 million, up 7% over the year-ago period and in line with a pre-announcement. New products, including MagniFuse Bone Graft and Plexur M, contributed $1.0 million in revenue during the quarter. Net income for quarter was $0.9 million, or $0.05 per diluted share, improved from a net loss of $0.4 million, or $0.02 per share, in 4Q:08. Analysts had forecast EPS of $0.06.
M&A
Baxter announced plans to acquire ApaTech for up to $330.0 million, with $240.0 million in cash up front (a 4x revenue multiple) and additional milestone payments of up to $90.0 million. ApaTech manufactures ActiFuse, a silicated calcium phosphate bone graft substitute. The transaction is expected to close in 1Q:10.
Funding
Intrinsic Therapeutics closed on $18.0 million of a $20.0 million round consisting of equity, warrants and options. Returning investors included New Enterprise Associates, Spray Ventures and New Leaf Venture Partners. Last year, the company received CE mark clearance for the Barricaid, an anulus replacement implanted during discectomies.
Regulatory
Exactech received 510(k) clearance for the Equinoxe Platform Fracture Stem, which is designed to treat fractures of the proximal humerus or a deficient, irreparable rotator cuff. The company says the device is compatible with the Equinoxe Reverse shoulder components, "giving orthopaedic surgeons the intra-operative flexibility to decide whether to perform a hemiarthroplasty or a reverse total shoulder."
MiMedx Group received CE mark clearance for the HydroFix Spine Shield, a PVA membrane intended for use during anterior spinal surgeries as an adhesion-inhibiting barrier. The device is sutured into place to provide a "plane of dissection" during a revision surgery.
OrthoDynamix received 510(k) clearance for the ArthroSteer 3.5mm Ablator, an electrosurgical device designed for the resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in a number of orthopedic procedures.
The FDA has scheduled a Orthopaedic and Rehabilitation Devices Panel meeting for March 23, where the panel will discuss the re-evaluation of ReGen Biologics' Menaflex. The product was first cleared in December 2008, though concerns from FDA scientists about the rigor of ReGen's review quickly surfaced. A subsequent FDA investigation described the ReGen case as "deterioration" of the 510(k) process.
Product Introduction and Update
OrthoView will launch the latest version of their procedure-planning software at AAOS next week. The company says the new SmartHip automatic templating feature allows a surgeon to "plan a total hip procedure in less than 60 seconds."
Stryker Interventional Spine launched VertaPlex HV, a high-viscosity bone cement for use in treating vertebral compression fractures.
Stryker launched the ADM X3 Mobile Bearing Acetabular System, a "next-generation technology for hip replacement" that the company says reduces volumetric wear by 97% when compared to conventional polyethylene.
Intellectual Property
Amedica received U.S. Patent No. 7,666,229, which covers its ceramic-on-ceramic bearings for articulating joints. This technology will be used in "ultra-low-wear bearing components for motion-preserving implants" for large joints and the spine.
Reimbursement
Aetna and United Healthcare reversed prior policies and announced that they will cover NuVasive's XLIF, allowing the procedure to shed its "investigational" status.
Congress passed a bill to delay a 21% Medicare pay cut scheduled for March 1. The cut will now take effect April 1 if no other legislation is passed.
Clinical
ProChon Biotech is nearing the halfway point in patient enrollment for the company’s Phase II study of the BioCart Autologous Cartilage System. Enrollment in the randomized, double-arm, open-label, multicenter study should be completed within three months. The study will compare the safety and efficacy of the BioCart System to microfracture for the treatment of symptomatic cartilage defects.
Distribution
Spineology will distribute Captiva's capLOX Pedicle Screw System on a non-exclusive basis in the U.S.
