Industry News

Spinal Kinetics Marks Disc Implant Milestone

Spinal Kinetics has completed its 10,000th implant of the M6 Artificial Spinal Disc, which treats patients suffering from degenerative disc disease. The M6 disc, introduced internationally in 2007, offers an alternative to spinal fusion and is designed to preserve motion and reduce the chances of subsequent degeneration of

adjacent discs.

“We are very excited about reaching the 10,000th implant mark so soon after introducing the M6 discs internationally,” said Tom Afzal, president and CEO. “The enthusiastic reception from both the spinal surgeon community and patients who received the M6 disc has been extremely gratifying for the entire organization.”

The M6 disc replicates the anatomic structure and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus. According to the Sunnyvale, Calif.-based company, the M6 is the only artificial disc with such a mechanism. Spinal Kinetics has completed a U.S. Food and Drug Administration investigational device exemption (IDE) pilot study of the M6-C disc in patients with both single and two-level disease. The company has been given approval to initiate an IDE pivotal study as well.

China Kanghui Gears Up for Domestic, International Expansion

China Kanghui Holdings is expanding its presence both at home and internationally through the purchase of a 60 percent stake in fellow Chinese implant maker Beijing Wei Rui Li Medical Device Co. Ltd.

“[This] is a key component of our plan to launch a full line of reconstruction products in China and in international markets over the next three years,” Libo Yang, CEO of China Kanghui, said.

The company expects to launch its first collaborative implant product in the Chinese market by early next year.

“[With this acquisition we are] putting the pieces in place to address this compelling and under-served market,” said Chen Yu, chief business officer at China Kanghui.

Shares of China Kanghui went public in August 2010 for $12.10 per share. Cost per share rose to $22.79 in December before settling at approximately $17. The company earned just under $37 million in 2010, a 32 percent increase compared with 2009. The increase boosted net income to $15.1 million, a 33 percent increase compared with 2009. China Kanghui is headquartered in Changzhou, China.

Bacterin International Acquires Assets of CMF Distribution Firm

Bacterin International Holdings Inc. is acquiring Robinson MedSurg LLC, a medical device distribution company focused primarily on maxillofacial and craniofacial surgery devices.

Under the proposed deal, Belgrade, Mont.-based Bacterin will exchange common stock valued at $1 million for all of Lone Tree, Colo.-based Robinson MedSurg’s assets, including approximately $500,000 in inventory, existing commercial agreements and intellectual property. The agreement also provides an incentive for Robinson MedSurg to reach certain revenue goals over the next two years: Upon achieving those goals, Robinson MedSurg would be entitled to an additional infusion of $1 million in Bacterin common stock.

Bacterin Chairman and CEO Guy Cook said the acquisition will enable his company to enter the craniomaxillofacial market, valued at roughly $277 million annually.

“This proposed acquisition will be margin enhancing and importantly leverages our sales force, which will now have additional product to sell into the same call points,” Cook said. “It is our plan to expand the RMS distribution through our company sales reps and independent reps, as well as further enhance the [Robinson MedSurg] product line with our antimicrobial coatings. A number of months ago, we began the 510(k) process to add our coatings to the RMS product line. We believe this will add an additional and important differentiating IP protection to the product line and hope to receive approval in early 2012.”

Bacterin reported revenues of $6 million for the first quarter 2011, more than double the $2.7 million in revenue the company reported in the first quarter of 2010 and an increase of 13.5 percent compared with revenues of $5.3 million in the fourth quarter of 2010.

Robinson MedSurg founder Randolph C. Robinson said the deal will enable him to improve his surgical technique. “I have been able to achieve remarkable results in reconstruction surgery with using Bacterin’s Osteosponge product line. This [has] enabled me to achieve results that I would never have been able to reach with any other product in the market.”

Bacterin develops, manufactures and markets biologics products to domestic and international markets. The firm’s Medical Device division develops antimicrobial coatings designed to inhibit biofilm formation and microbial contamination.

ArthroCare Transfers R&D Operations to Headquarters

ArthroCare Corp. is moving its primary research and development operations from Sunnyvale, Calif., to a new location near the company headquarters in Austin, Texas, before the end of this year. ArthroCare’s headquarters followed the same path in 2004.

Like other large employers in various industries, ArthroCare is relocating to an area with lower costs and a strong talent pool.

In a quarterly financial filing, ArthroCare estimated the move would cost between $10 million and $10.5 million, including employee severance, lease termination and relocation expenses. The company employs 459 people throughout the United States, including workers in Austin, Sunnyvale and Irvine, Calif. The latter location is not affected by the move.

Once it settles in its new home, ArthroCare will occupy a total of 136,000 square feet in two buildings, both of which have been vacant for two years. The space offers three times the square footage ArthroCare utilizes in Sunnyvale. ArthroCare is leasing the buildings from CarrAmerica Lantana LP for an initial period of 130 months.

Small Bone Innovations Cleared to Register Products in Japan

Small Bone Innovations, Inc. (SBi) has received manufacturers’ accreditation from the Japanese government for its facilities in Morrisville, Pa., and Péronnas, France. The authorization allows the company to complete product registration in Japan, which currently is the largest market for orthopedic technologies in the Asia Pacific region ($25 billion in revenue annually).

The certification was issued in the “general manufacturing” category for orthopedic products. The application included a review of SBi’s current manufacturing standards and practices, as well as the ability of its partnership with Olympus Terumo Biomaterials Corporation to deliver products throughout Japan in compliance with all relevant regulations.

“The accreditation is a major building block in the development of the partnership because it comes at a time where demand for orthopedic technologies is growing sharply in Japan,” said Hitoshi Mizuno, CEO and president of Olympus Corporation and division manager of the biotech division.

SBi is headquartered in New York, N.Y.

Lanx Talks Milestones, New Products at AANS

Lanx Inc. was quite the newsmaker at the recent American Association of Neurological Surgeons Annual Meeting in Denver, Colo. It was there the company announced that its Aspen Spinous Process Fixation Device had reached 17,000 implantations.

“As the core product in our comprehensive fusion portfolio, the success of the Aspen system is a significant accomplishment for Lanx,” CEO Dan Gladney said. “We plan to leverage its momentum and expand the platform to include enhancements that will better fit patient anatomies, further simplify the procedure and address new clinical applications.”

Two such enhancements may be the Durango Stand-Alone ALIF (anterior lumbar interbody fusion) System and the Concero Facet Screw System.

The Durango System, which received 510(k) clearance from the U.S. Food and Drug Administration in February, is used to treat degenerative disc disease at one or two levels from L2 to S1 through anterior lumbar interbody fusion. It is approved as a stand-alone implant when used with all four fixation screws, and is the first on the market to offer multiple plate options including a full plate, a zero-profile plate and the first-ever half plate, which has 15 angled screws for some of the more challenging anatomies.

One of the first surgeons to use the System, Randall Porter, M.D., a neurosurgeon at Barrow Neurological Associates Ltd. in Phoenix, Ariz., said, “The design of the Durango system, with its variety of plates and screw angles, is significant in that it allows for a unique, tailored approach to ALIF based on the affected vertebral level and patient’s anatomy.”

The Concero System is a minimally invasive fixation alternative to pedicle screws. It serves to stabilize the spine during fusion procedures at single or multiple levels from L1 to S1 through bilateral immobilization of the facet joints. The System comes in various lengths and diameters and is available in both cannulated and non-cannulated versions. This System—which can be used in conjunction with other fixation devices—also includes a toothed washer for improved bone fixation and a lag screw design for secure compression.

“Concero facet screws are intuitive and straightforward to implant,” said Glenn L. Keiper, M.D., neurosurgeon at the Spine & Brain Center of Eugene in Eugene, Ore.

Lanx is based in Broomfield, Colo.

K2M’s Spinal Disease Device Receives 510(k) Clearance

K2M Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Everest Degenerative Spinal System, a top-loading polyaxial pedicle screw system that can accommodate multiple levels of fixation rigidity to help surgeons individualize patient care. The announcement was made at the International Society for the Advancement of Spine Surgery Conference in Las Vegas, Nev.

The Everest features a locking set screw with a modified square thread, which could reduce the potential of cross-threading. In addition, the mixed material screw head minimizes splay in comparison to the titanium screw head, which improves biomechanical performance.

“In my opinion, the strength, range of motion, and stiffness of Everest provides surgeons the intraoperative flexibility to address a variety of surgical pathologies,” said John Carbone, M.D., orthopedic surgeon at Harborview Reconstructive Spine and Orthopedic Specialists in Maryland.

K2M President and CEO Eric Major called the FDA clearance for Everest an important expansion of his company’s product offering for treatment of degenerative disc disease and other complex pathologies.

K2M is a spinal device manufacturer headquartered in Leesburg, Va.

Medyssey’s LP Cage Receives 510(k) Clearance

Medyssey Co., Ltd. has announced that Medyssey Spine has received 510(k) clearance from the U.S. Food and Drug Administration for its LP Cage device. The LP Cage is used in adult patients with degenerative disc disease at one or two contiguous levels from L2 to S1. The company currently is selling the product in selected markets; executives have scheduled a full commercial launch for the last quarter of 2011.

“Given the challenging regulatory climate, we are extremely pleased to obtain clearance, and we are eager to introduce, market and sell the first of many cages of what will ultimately be a portfolio of interbody fusion systems,” Joseph Jin, Medyssey’s vice president of sales for the Americas, said.

According to growth consulting services firm Frost & Sullivan Inc., more than 30 million people suffer from back pain in the United States. The LP Cage was developed to help the 4.5 million people who still experience pain despite physical therapy and medication, and for whom spinal surgery is recommended. The device also addresses a market need for advanced spinal fusion solutions and maximum endplate-to-endplate contact; it is comprised of two footprints with three varying degrees of lordosis and substantial graft windows.

Medyssey also announced an 84 percent increase in U.S. sales in the first quarter of 2011 compared with the same period last year.

Medyssey Spine is privately owned and headquartered in Seoul, South Korea.

Toshiba Introduces Extra-Large Knee Coil

Toshiba America Medical Systems Inc. has obtained U.S. Food and Drug Administration clearance for the extra-large knee Array coil for the Vantage Titan MR (magnetic resonance) system. Toshiba claims it is the first diagnostic imaging vendor to offer an extra-large knee coil with a 22-centimeter interior diameter for magnetic resonance imaging. The Array coil can be used in both routine and advanced magnetic resonance knee studies, including assessing cartilage, fractures or knee replacement.

The Array coil accommodates most bariatric and non-bariatric patients. The coil provides bariatric patients with a more comfortable exam and improves clinicians’ accuracy, according to Toshiba. The Array coil also can be used for imaging a flexed or bent knee for patients who cannot straighten their leg due to injury or a medical condition.

“By listening to customer feedback about the changing needs of patients, we learned that it is important to design products that will provide quality images without sacrificing patient care,” Stuart Clarkson, director of Toshiba’s Magnetic Resonance Business Unit, said. Toshiba America Medical Systems is based in Tustin, Calif.

Integra LifeSciences Acquires License for Interbody Device; Firm Expands Spinal Manufacturing

Integra LifeSciences Holdings Corporation has partnered with Stout Medical Group, LP to develop and market an expandable interbody device.

“Stout Medical Group strongly believes in working with its licensing partners in the development and commercialization of its technologies,” said Tom Molz, president and CEO of Stout Medical Group.

The license allows Plainsboro, N.J.-based Integra to develop an implantable device for spinal discs using minimally invasive techniques. An expandable device would enable surgeons performing an interbody fusion to adjust the space between a patient’s discs based on his or her needs.

“This agreement leverages our expertise in business development and underscores our commitment to provide new technology to our spine distribution partners,”said Brian Larkin, Integra’s president, Global Spine and Orthobiologics, and head of strategic development.

Integra LifeSciences manufactures surgical devices and implants.

Stout Medical Group develops technologies for the medical device industry, with a particular focus on orthopedic technologies. The firm is based in Perkasie, Pa.

To respond to its increased business demands, Integra recentlyopened a new facility in Medina, Ohio, to house its expanding spinal implant business.

To support global business operations, the new facility is equipped with the latest video and communication technology, a state-of-the-art prototype shop and a medical device mechanical testing laboratory.

“The new facility will enable Integra to sustain the expected growth of its spine team and better serve our global customers,” said Brian Larkin, president of Integra’s Global Spine and Orthobiologics division and head of Strategic Development.

The new facility, which opened its doors April 21, marks the expansion of the company in Ohio. Integra’s other Ohio-based location is in the greater Cincinnati area. The older facility manufactures and distributes the company’s Mayfield cranial surgical stabilization systems and distributes extremity reconstruction products.

“Having Integra as a new corporate citizen enhances the diversity of Medina County’s business base, which has a growing medical device and healthcare industry,” said Bethany Dentler, executive director of the Medina County Economic Development Corporation.

EAG Announces Acquisition of Chemir and Affiliates

Evans Analytical Group, Inc. (EAG) has acquired Chemir Analytical Services and its affiliates, CAS-MI Laboratories and Cyanta Analytical Services. Cyanta will be renamed EAG Life Sciences to reflect its planned expansion of service. CAS-MI and Chemir will continue to operate under their current names, and all three laboratories will continue to operate at their respective facilities.

“The combination of our companies and integrated scope of services means EAG is a stronger partner for our clients,” said Harry Davoody, CEO.

EAG believes the new acquisition will allow the company to serve the industry-specific needs of a diverse client base, including device and pharmaceutical companies that require U.S. Food and Drug Administration testing beyond materials characterization and clients seeking to develop novel coating technologies beyond surface analysis investigations. The addition also gives clients greater access to analytical capabilities.

“Chemir is pleased to become part of an organization as solid as EAG,” David W. Riggs, president of Chemir said. “With EAG as our new owner we have the financial resources and stability our clients deserve.”

Riggs also is also confident that EAG’s global reach will significantly benefit Chemir’s growth.

“Until now, Chemir has been primarily focused on U.S. clients,” he said. “We believe this acquisition will greatly enhance our failure analysis and investigational capabilities due to EAG’s extensive knowledge and instrumentation related to materials characterization and surface analysis.”

EAG primarily is owned by Odyssey Investment Partners, LLC, a private equity firm that makes majority control investments mainly in established middle-market industrial manufacturing and business services companies in various industries. EAG is headquartered in Sunnyvale, Calif. Odyssey Investment Partners has offices in New York, N.Y., and Los Angeles, Calif.