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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 14-Jan-10 BY LAUREN UZDIENSKI, JANUARY 14, 2010

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 cost and corporate structure" by selling its dental division, closing a site, focusing R&D on its ortho, trauma and spine businesses and selling its Analytics division.

Genzyme reported preliminary 4Q:09 revenues of $1.08 billion, in line with estimates and down 8% from the year-ago period. Synvisc sales were $96.0 million in 4Q:09, a 40% increase over the year ago-period. The company named Synvisc-One as a driver of overall revenue growth, with sales of the Synvisc products increasing 25% from 2008 to 2009.

Osteotech pre-announced 4Q:09 revenues of $26.3 million, up 7% over the year-ago period and beating estimates by $3.5 million. The company attributed $1.0 million in sales to new products in limited-launch phases, including the MagniFuse and Plexur M bone graft substitutes, and $3.3 million in one-time revenue from a licensing agreement.

RSB Spine reported that 2009 sales were up 38% over 2008, with 4Q:09 sales increasing 42% over 4Q:08. The company attributed the sales growth to a distribution agreement signed with Paradigm BioDevices in October 2009.

Stryker reported preliminary 4Q:09 revenues of $1.8 billion, up 3% over the year-ago period and beating estimates by $35.0 million. Orthopedic implant sales were $1.1 billion, up 5% over 4Q:08. Growth rates exclude the effects of currency.

Funding
According to reports, BioPoly raised more than $2.0 million from unnamed investors in its first round of equity financing. Proceeds will be used complete product development and launch of the first of its products, which are made from a synthetic biomaterial. Applications in development include the use of the BioPoly material as a synthetic cartilage in partial knee resurfacing.

Salient Surgical Technologies, formerly TissueLink Medical, raised $15 million from unnamed investors, though prior rounds included Piper Jaffray, Medtronic, Arnerich Massena & Associates and RiverVest Venture Partners. The company's Transcollation technology uses radio-frequency energy and saline to seal soft tissue, vessels and bone.

Stryker filed a $1.0 billion debt financing. Funds will be used for "working capital and other general corporate purposes, including acquisitions, stock repurchases and other business opportunities."

Regulatory
SOTA Orthopaedics received CE mark clearance for its O-Jig, which is designed to aid in placing pins in the treatment of olecranon fractures. Lynch Medical Supplies will distribute the product in Ireland and the U.K.

Product Introduction and Update
Biocomposites launched geneX ds, a dual-syringe mixing and delivery system containing geneX. geneX is a synthetic, fully-resorbable bone graft material processed to create a negative surface charge, which the company says "stimulates bone cell activity."

Integra Spine announced that the first surgery using its Paramount Pedicle Screw System has been completed in Oklahoma City. The product, which was purchased from IST, features a rod that is already attached to the polyaxial head. The company says this helps to streamline the fusion procedure and reduce the steps in the procedure.

MAKO Surgical reported that during 4Q:09, seven RIO systems were installed and customer accepted, with 19 new RIO systems installed in total in 2009. As of year-end, there were 36 commercial MAKOplasty sites. MAKOplasty procedures performed in 4Q:09 increased 34% over 3Q:09 and 180% over 4Q:08.

VertiFlex announced the first human implantation of the Shockwave Dynamic Stabilization System in Munich. The company says the Shockwave dynamic rod is designed to "allow patients a normal range of motion while providing hard stops that limit excessive motion and thereby relieve symptoms." The device is not available in the U.S.

Intellectual Property
Applied Spine Technologies was awarded U.S. Patent No. 7,635,379. This covers "Pedicle Screw Assembly with Bearing Surfaces," which allows for the "intraoperative assembly of a sphere onto a pedicle screw to enable dynamic angulation of a dynamic stabilization device."

Distribution
Alphatec Holdings, Inc. has entered into an exclusive distribution agreement with Parcell Spine, LLC, pursuant to which Parcell will license and supply Alphatec Spine with Parcell's proprietary adult stem cells for the treatment of spinal disorders. The stem cell, which Parcell commercially calls the ELA stem cell, is a unique adult stem cell that possesses self-renewal and bone regenerative capabilities.

SpineAlign Medical entered into an agreement with Italy-based ab medica for the OUS distribution of the SpineAlign Vertebral Body Replacement, which offers a "transpedicular, minimally-invasive approach to vertebral body reconstruction and anterior spinal column support."

Partnerships
Nobel Biocare signed a preferred partnership agreement with Ivoclar Vivadent, a provider of "high-performance" ceramic and acrylic prosthetic materials used in a variety of restorative and prosthetic dental products. This partnership will involve the development of new materials, joint educational and training programs and commercial activities.

Appointments
RTI Biologics appointed Christie Blakely and Michael LaPrade vice presidents of the company. Ms. Blakely joins the company from Zimmer as vice president of sports medicine marketing. Mr. LaPrade will serve as vice president of surgical specialties and joins RTI after two years as vice president of Americas marketing for Gambro's intensive care division.

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