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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 26-Sept-13 BY LAUREN UZDIENSKI, SEPTEMBER 26, 2013

M&A
Stryker will acquire orthopedic robotics company MAKO Surgical Corp. for $30.00 per share in cash, valuing the transaction at approximately $1.65 billion overall. The purchase price represents an 86% premium to the close on September 24th and approximately 13.0x estimated 2013 revenues of $126.5 million.

Regulatory
Crosstrees Medical received FDA 510(k) clearance for the Crosstrees PVA Pod System for Percutaneous Vertebral Augmentation (PVA). The 510(k) was supported by a prospective, single-arm IDE study that enrolled 135 patients in the United States, China, Venezuela and Belgium. Patient outcomes for the Crosstrees procedure were compared to a literature control, which included vertebroplasty and kyphoplasty outcomes. The IDE study met its primary endpoints of a significant reduction in pain scores and PMMA bone cement extravasation over a follow-up period of 12 months. Additionally, the Crosstrees procedure demonstrated a significant reduction in new fracture rates often found with vertebroplasty and kyphoplasty procedures.

Last week, the FDA issued a final rule on unique device identifiers (UDIs), which will require a label on all medical devices to contain product lot number, expiration date and date of manufacture. Class III devices will be the first to be required to carry UDIs, with manufacturers having one year to implement the new labeling rules. Class II and Class I devices will have three and five years, respectively, to adopt the UDI practice. The system is designed to provide more robust post-market surveillance, allowing the FDA to "identify product problems more quickly, better target recalls and improve patient safety." Information will be collected in the Global Unique Device Identification Database (GUDID), a publicly-searchable database that can be used as a reference for every device with an identifier.

Product Introduction & Update
ICAP Patent Brokerage announced that Allogeneic Bone Gel, a "low-inflammatory" demineralized bone material from PlusLife, is available for sale.

Integra LifeSciences announced the first U.S. implantation of its Integra Titan Reverse Shoulder System. The system is used in shoulder replacement surgery.

RTI Surgical announced the first implantation of the company's map3 Cellular Allogeneic Bone Graft implant in a foot and ankle procedure. Map3 cellular allogeneic bone graft is an alternative to autograft that incorporates multipotent adult progenitor cell-based (MAPC-based) technology with stem cells isolated from the same donor as the other bone material.

Solana Surgical launched the FuseFORCE SuperElastic Fixation System, indicated for use in fusion procedures of the small joints in the foot and ankle and hand and wrist. The company received 510(k) clearance for the product in mid-July.

Offerings
Mazor Robotics filed a draft prospectus with the SEC to raise up to $46.0 million in an offering of American Depository Shares on Nasdaq. The company said that proceeds from the offering would be used to expand the company's U.S. sales and marketing organization.

Distribution
Mazor Robotics received an order from its Russian distribution partner, Neuroproject Ltd., for one of the company's Renaissance robotic spinal systems. Mazor will have a total of six surgical guided systems installed in Russia, primarily in Moscow.

Appointments
MiMedx Group appointed Dr. Gary Stanziano Vice President of Medical Affairs. Dr. Stanziano, who previously served as the Vice President of Medical Affairs at Matria Healthcare, will focus primarily on interfacing with health plans to facilitate broader reimbursement for MiMedx products.

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