Healthcare Industry News: cervical spine
News Release - October 16, 2015
SeaSpine Launches Cambria(TM) NanoMetalene(R) Interbody DeviceCompany's Proprietary NanoMetalene Technology Now Available for Anterior Cervical Discectomy and Fusion Procedures
VISTA, Calif., Oct. 16, 2015 -- (Healthcare Sales & Marketing Network) -- SeaSpine Holdings Corporation (SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of its Cambria(TM) NanoMetalene(R) cervical interbody body fusion device.
Cambria NanoMetalene is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) and accompanies SeaSpine(R)'s growing portfolio of devices offering this proprietary technology.
NanoMetalene is an ultra-thin layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA(R) implant. It is applied in a proprietary high-energy, low-temperature surface process and encompasses the entire implant, including the center graft aperture.
In a presentation during NASS, Dr. James Bruffey, orthopedic spine surgeon in San Diego, commented on the topic of bond strength of NanoMetalene and indicated that destructive testing as well as insertion and push-out testing demonstrated no delamination of our atomic deposition titanium surface.
Cambria NanoMetalene offers the benefits associated with traditional PEEK-OPTIMA devices such as a modulus of elasticity similar to bone1 and radiolucency for postoperative imaging, which allows surgeons to view the operative area and determine the extent of fusion of the vertebral bodies2. With a molecularly bonded titanium surface on an uncompromised PEEK-OPTIMA implant2,3, SeaSpine provides customers an interbody solution offering the best of both materials.
"SeaSpine is committed to leveraging this unique technology and delivering interbodies that provide an optimal environment for fusion," said Keith Valentine, CEO of SeaSpine. "We are excited to now add Cambria NanoMetalene to the portfolio for cervical procedures."
SeaSpine has received FDA 510(k) clearance for other NanoMetalene-coated PEEK interbody devices in its current portfolio and expects to continue launching additional products with this technology throughout the next year.
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal fusion hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. The SeaSpine spinal fusion hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products through a network of independent sales agents in the United States and through stocking distributors in over 30 countries worldwide. Read more about SeaSpine at the company's website, www.seaspine.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and reflects the Company's judgment as of the date of this release. Such forward-looking statements include expected benefits of the NanoMetalene coated interbody devices and future new product launches. Actual results may differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited to: actions by governmental and regulatory authorities; delays, costs and difficulties related to the spin-off and the operation as a separate, publicly traded company following the spin-off; general economic and political conditions globally and in the markets in which SeaSpine does business; and other factors identified under the heading "Risk Factors" of SeaSpine's Form 10 Registration Statement, as amended, filed with the Securities and Exchange Commission. These forward-looking statements are made only as the date thereof, and, except as required by law, SeaSpine undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
NanoMetalene and SeaSpine are registered trademarks of SeaSpine Orthopedics Corporation or its subsidiaries in the United States and/or other countries. Ventura, Hollywood and the SeaSpine logo are trademarks of SeaSpine Orthopedics Corporation or its subsidiaries. PEEK-OPTIMA is a registered trademark of Invibio and is used by SeaSpine under license.
1 Invibio, PO-ENG-SUR-01 09/07.01
2 Results of Imaging study. Data on file.
3 Results of mechanical testing. Data on file.
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