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Orthopedic and Dental Industry News Complete Archive »

Orthopedics News Roundup 15-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 15, 2007

Earnings
Tutogen announced results for first fiscal quarter ending December 31, 2006. Total revenues increased 43% to $11.5 million, compared to $8.0 million in the comparable quarter of fiscal year 2006. U.S. revenues increased 50%, and international revenues increased 27% over the comparable quarter. Net income for the first quarter of fiscal year 2007 was $.36 million or $0.02 per share, compared to a net loss of $.08 million or negative $0.01 per share, in the first quarter of fiscal year 2006.

DJ Orthopedics reported 4Q:06 net revenues of $110.8 million, an increase of 47.8 percent over 4Q:05. The Company's Domestic Rehabilitation, Regeneration and International business segments grew by 36%, 12% percent and 185% percent, respectively.

Wright Medical Group Inc. reported revenues of $86.6 million for 4Q:06, an 8% increase compared to revenue of $80.3 million in 4Q:05. Earnings for the quarter were $5.7 million, or $.16 per diluted share, a 185% increase compared to earnings of $2.0 million, or $.06 a share in 4Q:05. President and CEO Gary Henley attributed the growth to Wright's domestic hip business, increased sales in international markets.

ArthroCare Corp. announced 4Q:06 revenues of $69.8 million, an 18% increase over 4Q:05. The Company's spine business grew 46% over 4Q:05, and the press release attributes the growth to "improved penetration, acceptance by the surgical community and increased reimbursement."

IsoTis reported preliminary unaudited revenues for 4Q:06 of approximately $10 million (unaudited), a 16% increase over 4Q:05. President and CEO Pieter Wolters attributes the growth to the "Accell line of products, especially in the US markets, and the healthy growth in our International markets and increase in revenue from our Private Label agreements." Complete financial results will be released on February 26, 2007.

M&A
Last Friday, Zimmer announced an agreement to acquire Endius, Inc., a Massachusetts-based spine company. Endius has developed a minimally invasive instrument kit, Atavi, and associated implants for spinal fusion. Zimmer indicated that this system could be used in conjunction with its Dynesys dynamic stabilization system. The acquisition is expected to close in the second quarter of 2007.

Tornier has signed a definitive agreement to acquire Nexa Orthopedics, a privately held, California-based company that develops, manufactures and markets medical devices for orthopedic and podiatric surgeons. Under the terms of the agreement, Tornier will acquire 100% of the fully diluted equity of Nexa. Tornier's agreement with Nexa is subject to governmental regulatory review and other customary closing conditions. Until receipt of regulatory approval, the acquisition will not be able to close, although Tornier presently anticipates that closing may occur in the first quarter of 2007.

Service Agreements
Wright Medical signed an agreement with Regeneration Technologies to develop advanced xenograft implants for use in foot and ankle surgeries. Wright Medical will design and distribute the implants until its CANCELLO-PURE™ brand, while RTI will develop, manufacture and supply Wright's designs. The contract will be effective immediately.

Funding
Cayenne Medical, Inc. announced the closing of a $12.7 million Series B preferred equity financing led by Split Rock Partners. Other participating investors include MB Ventures and a group of accredited private individuals. Cayenne recently received market clearance from the FDA for its platform AperFix™ System for ACL reconstruction.

Regulatory
Osteotech received 510(k) approval for Plexur™ P, an osteoconductive, bone/polymer biocomposite that can be used to fill bony voids of the pelvis and extremities. Plexur P will initially be available as granules and cylindrical plugs, but will be expanded to other forms including blocks, wedges and sheets.

N Spine received 510(k) clearance for its NFix™ II dynamic pedicle screw and rod system for stabilization of the lumbar spine as an adjunct to fusion. Additionally, outside the U.S., the Company is conducting a prospective, randomized study evaluating NFlex™ Controlled Motion System in comparison to Zimmer's Dynesys® device. NFlex is CE marked for non-fusion indications.

Scient'x USA has received 510(k) clearance for their Isobar LP® Low Profile Pedicle Screw System. This system works in conjunction with the other components in the Isobar TTL system, including the EASYS Crosslink and Dynamic TTL-Rod which provides controlled micro-motion in compression, distraction, flexion, extension and rotation.

PLUS Orthopedics USA has received 510(k) clearance for the next-generation PiGalileo™ computer-assisted surgery system for knee replacement procedures. The system is designed to reduce concerns about misalignment and stability with a minimally invasive procedure targeted at reducing recovery time. The previous generation of the PiGalileo system has been in use since 1999.

Applied Spine Technologies received the CE Mark for its new Stabilimax NZ Dynamic Spine Stabilization System as well as its Stabilimax BAR, which received 510(k) clearance last July. In January 2007, Applied Spine announced that it had received permission to begin an IDE clinical study in the US of the Stablimax NZ, which the Company will begin enrolling this month.

Public Offering
Due to regulatory issues with the FDA, IsoTis Inc. will not proceed with plans for a public offering of its common stock. The concern is over whether IsoTis' Accell bone graft products can be classified as medical devices; the Company says that human cells, tissues and cellular and tissue-based products do not need clearance under medical device regulations, but if the FDA determines that the Accell products are a device, IsoTis will seek Class II medical device status.

Product Introduction and Update
Orthofix debuted three products this week: the VeroNail® Trochanteric System, a minimally-invasive screw and nail design intended to reduce surgical trauma and allow the patient to ambulate sooner after surgery; the Centronail® System for the treatment of long bone fractures in the extremities, including those in the humerus, femur and tibia; and enhancement to BREG's FUSION OA line of knee braces.

Medtronic launched its SYNERGY™ EXPERIENCE STEALTHSTATION® System, designed to shorten operating room set-up and procedure time by using software that stores surgeon preferences for each procedure. The system combines Navigational Procedural Solutions with Minimal Access Spinal Technologies (MAST™) and is designed to enable less invasive procedures, smaller incisions and less exposure to radiation.

CONMED's Linvatec unit launched its Hip Arthroplasty Kit, which includes two 120mm disposable operative cannulas, a 17g Hip Distention Needle, 40cc Syringe, Guidewires, Switching Stick, Extended Length Banana Knife, and Skin Marker/Ruler. The Company is also launching the IM4000 TrueHD™ High Definition Camera System for use in endoscopic surgery including arthroscopy, laparoscopy, urology and OB/GYN and the 24K Irrigation System, a fluid management system that provides fluid to the joint space for irrigation, distention and hemostasis during arthroscopic procedures.

Integra LifeSciences launched the TenoGlide™ Tendon Protector Sheet. Cleared under a 510(k), the TenoGlide Tendon Protector Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The Company also launched the Integra Mozaik Osteoconductive Scaffold, a bone void filler, and new Mid and Hind Foot Plating Systems.

Advanced Bio-Surfaces announced that over 125 OrthoGlide Medial Knee devices have been successfully implanted in the U.S.

Clinical
Zimmer and ISTO Technologies have initiated a clinical trial for Neocartilage, a living tissue-engineered graft under investigation for the restoration of cartilage defects, reestablishment of joint function and relief of pain in the knee. The study is being conducted under an IND (Investigational New Drug) application. Zimmer plans to market the product as DeNovo® ET Engineered Tissue Graft.

Osiris Therapeutics, Inc. released interim results in its evaluation of CHONDROGEN™ for the regeneration of meniscus in the knee. A total of 55 patients were treated in the Phase I/II, double-blind study evaluating the safety and exploratory effectiveness of CHONDROGEN, a preparation of adult stem cells formulated for direct injection into the knee. At the six month time point, CHONDROGEN met its primary endpoint, demonstrating product safety. So far, CHONDROGEN has not been shown to have a statistically significant increase in the volume of meniscus as compared to placebo; however, an improvement in baseline cartilage and joint condition was noted in patients treated with the stem cell drug that was not seen in patients that received placebo.

Aesculap Implant Systems announced the first implants of its Activ-L Artificial Disc. Under an IDE, the Activ-L Artificial Disc is being investigated for the treatment of single-level degenerative disc disease of the lumbar spine that has been unresponsive to prior conservative treatment of at least six months duration. It is a prospective, randomized, single-masked, controlled, multi-center clinical trial consisting of an estimated 387 subjects. In the study, the Activ-L Artificial Disc is being compared with the Synthes Spine ProDisc®-L Total Disc Replacement and the DePuy Spine Charite® Artificial Disc. Between 15 and 20 investigational sites will participate in the investigation. The Activ-L Artificial Disc received the European CE Mark in 2005 and is currently in use in Europe and Canada.

Aastrom released interim data from its U.S. Phase I/II multi-center clinical trial evaluating the use of Tissue Repair Cells (TRCs) in the treatment of severe long bone fractures. 90% of the patients who completed 12 months of post-treatment follow-up had multiple bone bridges, evidence of bone regeneration. Post-surgical evaluations of the patients using standard clinical and radiographic evaluations of the healing fracture site will continue through June 2007.

Appointment
Stryker Corporation announced that Merrill Lynch Analyst Katherine A. Owen will join the Company in the newly-created position of Vice President, Strategy and Investor Relations. Ms. Owen will be responsible for leading Stryker's strategic planning process, overseeing the Business Development function and driving strong alignment between the Company's mid- and long-term strategies and its external business development plans. Additionally, she will have responsibility for day-to-day Investor Relations activities.

Alphatec Holdings, Inc. named J. Patrick Johnson, M.D., M.S., to its Scientific Advisory Board. Dr. Johnson is Director of the Cedars-Sinai Institute for Spinal Disorders in Los Angeles and Co-Director of Cedars-Sinai's Hyperhidrosis Center. Dr. Johnson also serves as Consultant Neurosurgeon at Fort Harrison VA Medical center in Helena, Montana; and is an Attending Neurosurgeon at Cedars-Sinai Medical Center, Santa Monica-UCLA Medical Center, St. John's Hospital in Santa Monica, West Los Angeles VA Medical Center, and Harbor/UCLA Medical Center in Torrance.

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