VISTA, Calif., Aug. 10, 2015 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of its Ventura™ NanoMetalene® transforaminal intervertebral body fusion device.
Ventura NanoMetalene, which is commercially available and has been successfully implanted, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD). It is the latest device to leverage SeaSpine's proprietary NanoMetalene technology, building on the surgical success of the company's Hollywood™ NanoMetalene interbody device.
NanoMetalene is an ultra-thin layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® implant. It is applied in a proprietary high-energy, low-temperature surface process and encompasses the entire implant, including the center graft window. This creates a 62 percent increase in surface area for potential titanium and bone interaction compared to the same implant with coated endplates only1.
NanoMetalene offers the uncompromised benefits associated with traditional PEEK-OPTIMA devices such as a modulus of elasticity similar to bone2 and does not impair postoperative imaging, allowing surgeons to view the operative area and determine the extent of fusion of the vertebral bodies3. The ultra-thin layer of NanoMetalene upholds the similar mechanical profile of its PEEK-OPTIMA core2.
"We collaborated with our surgeon partners to create an implant that utilizes existing instrumentation and addresses today's increasingly complex spinal surgery requirements," said Keith Valentine, CEO of SeaSpine. "NanoMetalene technology is a great bridge product in our portfolio because it offers the benefits of hardware with biologic-driven features that support bone growth. Its success to-date supports our plan to develop additional implants leveraging NanoMetalene technology in the future."
With convex surfaces and multiple footprints, surgeons can create a secure anatomical fit, and Ventura NanoMetalene's large graft aperture for autogenous bone graft assists in fusion. Ventura NanoMetalene is optimal for either open or minimally transforaminal lumbar intervertebral fusion (TLIF) procedures.
SeaSpine has received FDA 510(k) clearance for a number of other NanoMetalene coated PEEK interbody devices in its current portfolio and expects to launch these additional products in future periods.
|1 Results of imaging study. Data on file.|
|2 Data on file.|
|3 Area percentages are calculated comparing the implant endplates vs. entire implant of the smallest Ventura implant.|
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.