Musculosketal News Roundup 25-Oct-07
BY LAUREN UZDIENSKI, OCTOBER 25, 2007
Earnings
ArthroCare Corp. reported 3Q:07 total revenues of $78.5 million, an increase of 21% over the comparable quarter. Revenues missed estimates by $0.11 million. The company reported net income of $11.1 million, or $0.39 per share, up 28% over 3Q:06 and beating estimates by $0.03. Arthrocare reported revenue growth in each of the company's business units, including a 95% increase in spine sales; sports medicine sales, from which 62% of total revenues were derived, increased 11%. The company attributed the sales growth to the "positive impact of new products, the move of key new products from launch stage into high volume manufacturing, as well as the benefits from multi-year investments in sales and marketing."
Alphatec Holdings, Inc. announced financial results and record revenue for the third quarter ended September 30, 2007. Third Quarter 2007 results highlights include: consolidated revenues grew 17.1% to a quarterly record of $20.3 million from Q3 2006 to Q3 2007; U.S. revenues grew 20.0% to $16.8 million from Q3 2006 to Q3 2007; Asia revenue grew 4.6% to $3.5 million from Q3 2006 to Q3 2007; non-GAAP net loss per share for the quarter was $(0.04), from a non-GAAP net loss of $(0.13) during Q3 2006; consolidated adjusted EBITDA grew to $1.5 million in Q3 2007 from negative adjusted EBITDA of $2.4 million in Q3 2006; and the company completed a follow-on equity offering with net proceeds of $32.2 million during the quarter.
NuVasive reported 3Q:07 revenues of $38.5 million, beating estimates by $2.1 million and demonstrating a 52.9% increase over 3Q:06. On a non-GAAP basis, the company reported net income of $1.5 million, or $0.04 per share, beating estimates of ($0.09.) CEO Alex Lukianov attributed the revenue growth to "success in product penetration with existing accounts while expanding with new customers," as well as the first full quarter of revenues from the SpheRx® II pedicle screw system, XLP™ Lateral Plate and Formagraft® products.
Zimmer reported 3Q:07 net revenues of $903.0 million, an increase of 10% (8% constant currency) over 3Q:06. The company missed consensus estimates by $5.1 million. President and CEO David Dvorak attributed the revenue growth to demand for the Gender Solutions™ Knee. Diluted earnings per share for 3Q:07 were $0.91 adjusted, an increase of 18% over 3Q:06 and in line with estimates. Among individual product divisions, knees contributed $378.0 million in revenue, up 10% in the Americas and 12% worldwide (9% cc). Hips reported revenues of $299.0 million, up 7% in the Americas, 8% worldwide (5% cc). Extremities reported 36% growth worldwide (33% cc); Dental was up 19% (17% cc); Trauma was up 2% (0% cc); and Spine sales increased 9% (7% cc).
Regeneration Technologies announced 3Q:07 revenues of $23.8 million, beating estimates by $0.6 million and representing an increase of 31% over 3Q:06. The company reported net income of $0.18 million, or $0.01 per diluted share, in line with estimates. In 3Q:06, there was a net loss of $1.5 million and a net loss per diluted share of $0.05. According to the press release, third quarter highlights included the first shipments of spinal allograft to Stryker; spinal allograft distribution contributed $10.8 million to revenues for the quarter. Additionally, the most siginificant revenue growth among divisions was seen with the distribution of sports medicine implants, which brought in $6.8 million for the quarter, a 90% increase over 3Q:06.
LifeCell reported 3Q:07 product revenues of $47.5 million, beating estimates by $1.2 million and representing a 35% increase over the comparable quarter. The company attributed sales growth to demand for AlloDerm® Regenerative Tissue Matrix, which increased 41% over 3Q:06. Net income for 3Q:07 was $7.3 million, or $0.21 per diluted share, beating estimates by a penny and up from $5.1 million, or $0.15 per diluted share in 3Q:06.
CONMED Corp. reported 3Q:07 revenues of $164.4 million, representing a 6.1% increase over the comparable quarter and missing estimates by $0.67 million. Net income was $8.34 million, or $0.29 per share, in line with estimates. The company's arthroscopy division reported $58.8 million in revenues, up 7.3% over the comparable quarter, which the company attributed largely to imaging sales.
Genzyme reported that 3Q:07 sales of Synvisc™ increased 9% over the year-ago quater, to $61.2 million. Genzyme added that they expect a U.S. and European regulatory decision this year on marketing applications for the single-injection regimen Synvisc-One™. Total revenues for the company were up 19%, to $960.2 million, beating estimates by $5.5 million. Genzyme's earnings of $241.3 million, or $0.90 per diluted share, beat estimates by $0.03.
Kensey Nash reported total revenues of $17.6 million FQ1:08, up 8% from the comparable quarter and in line with estimates. Sales of orthopedic products were up 40% to $6.1 million, which the company attributed to its acquisition of Macropore Biosurgery. Additionally, revenues from the spine business and sports medicine business increased 42% and 16%, respectively.The company reported adjusted earnings per share of $0.16, beating estimates by $0.03.
M&A
Wright Medical Group acquired certain assets from Metasurg, including the BIO-ARCH™ subtalar implant for surgical treatment of flatfoot deformity. The purchase consists of an initial cash payment of $2.5 million and potential future performance-based cash payments.
Orthovita Inc. announced plans to acquire raw bovine collagen material, equipment and a technology license from Allergan Inc. for the continuing production of Orthovita's Vitagel surgical hemostat. Terms included a $6.6 million payment to Allergan on or around Oct. 31, 2008. A term sheet provides for a definitive agreement to be signed on or before Nov. 1, 2007.
Pioneer Surgical Technology announced their acquisition of Angstrom Medica Inc. for an undisclosed amount. Angstrom manufactures a nanocrystalline calcium phosphate technology called NanOss.
Funding
San Diego-based OuroBoros raised $4.0 million in a funding round for a minimally invasive spinal fusion device. No details on the company or round have been released.
Regulatory
Alphatec Holdings, Inc. received 510(k) clearance from the U.S. Food and Drug Administration to market its DYNAMO™ Rod System. "Unlike a traditional rigid fusion procedure, DYNAMO™ is designed to allow for controlled compression, distraction, flexion and extension of vertebrae adjacent to a fusion location, which should enable the patient to have an additional range of motion during the initial healing phase following fusion surgery," stated Dirk Kuyper, President and Chief Executive Officer of Alphatec.
BioMedical Enterprises announced 510(k) clearance for the company's OSSpine product for use in anterior fixation of the cervical spine. The product is made from nitinol, a biocompatible alloy that has shape memory and super-elastic properties. OSSpine joins the OSStaple, OSSplate and OSSArc products in the OSSforce Fixation System portfolio.
Inion received 510(k) clearance for its bone void filler Inion BioRestore™. The product is now indicated for use in trauma and spinal applications and was first cleared for use in dental and CMF applications in September 2007. BioRestore is a synthetic bioactive and biodegradable bone graft substitute made from bioactive glass fibers.
Synthes received an Approvable Letter from the FDA regarding the ProDisc™-C Total Disc Replacement. The FDA will issue an approval order after the manufacturing processes have been reviewed and determined to be acceptable.
Product Introduction
ArthroCare Corp. launched the MD SpineWand® for the removal of soft tissue, including disc material. According to the company, the SpineWand offers a less invasive approach to lumbar microdiscectomy and other procedures.
Collagen Matrix, Inc. launched OssiMend™ Bone Graft Matrix for orthopedic and spine applications. OssiMend is a bone graft material comprised primarily of collagen and anorganic bone mineral which, combined with autologous bone marrow, can be used as a bone void filler. According to the company, OssiMend is conformable, non-friable and has a high absorption capacity. It is available in strips, pads, or granular form.
NuVasive launched five new products at NASS this week, including core components for the XLIF® Thoracic approach; the CoRoent XLT and CoRoent Revision PEEK implants for thoracic applications, as well as instruments for thoracic spinal procedures; the SpheRx® DBR® II system, a minimally disruptive pedicle screw system; and the Helix anterior cervical plate and the Helix MiniPlate for cervical fusion.
Pioneer Surgical Technology announced the U.S. launch of its CLARITY™ Posterior Retractor System. The Clarity system is made with PEEK, which allows the retractor to be radiolucent and renders it less opaque in fluroscopy images. The enhanced visual field can help the surgeon achieve precise implant placement.
SpineVision announced the launch of its motion-preservation system FlexPLUS™ outside the U.S. and the 2.5mm-diameter PediGuard™ worldwide. The FlexPLUS offers a single, posterior lumbar pedicle screw system which the company describes as offering various degrees of stabilization: rigid, hybrid and dynamic. PediGuard is a wireless freehand drilling instrument designed to detect an inadvertent breach of the pedicle.
Spinal Elements, Inc. launched the Mercury™ Spinal System. The System is top loading and features a low-torque locking cap that eliminates the need for locking nuts. The device was cleared by the FDA earlier this month, and the company says they anticipate device will be widely adopted for minimally invasive fusion procedures.
Vertebron launched a complete PEEK product line at NASS this week, including patented stand-alone ACIF and ALIF interbody devices, anterior lumbar locking plates and a proprietary cervical motion preservation device. Additionally, a new interspinous process spacer device was presented to surgeons at a private, invitation-only event.
VertiFlex Inc., which specializes in minimally invasive and motion preservation technologies for spine disorders, announced the U.S. launch of the Silverbolt™ MIS Screw System. The Silverbolt is a platform for percutaneous and mini-open fusion procedures.
Intellectual Property
X-spine Systems, Inc. received patent US 7,282,065 to protect the company's Disk Augmentation System and Method. According to the press release, the technology "incorporates a unique adjustable elastomer which allows the surgeon to dial in the desired compliance of the system." The product, currently undergoing biomechanical testing, features a tissue-sparing implantation procedure.
Clinical
Aastrom Biosciences announced final results from a U.S. Phase I/II clinical trial designed to collect safety and efficacy data on the use of Bone Repair Cells in the treatment of severe non-union fractures. Patients with non-union tibia, humerus or femur fractures that failed to heal after one or more medical procedures showed healing in 91% (21 of 23 patients) of tibia fractures, 100% (3 of 3) of humerus fractures and 86% (6 of 7) of femur fractures.
ApaTech announced the completion of enrollment into its AIIS study, a prospective comparison of Actifuse™ and Infuse® Bone Graft. The Actifuse Infuse Interbody Study is an international trial designed to compare the clinical performance of Actifuse Synthetic Bone Graft with Infuse in interbody spinal fusion.
LDR completed enrollment for its single-level study for the Mobi-C® cervical artificial disc. According to the company, the Mobi-C is designed to provide six degrees of motion with a mobile bearing technology. The device features a “screw-less and keel-less” design intended to cause minimal disruption to the cervical spine during implantation. The company anticipates completing enrollment for the two-level cervical arthroplasty study in the next three months.
