Titan Spine has expanded its commercial launch of the nanoLOCK surface technology across the US.
The full US launch follows the company's alpha introduction of the technology in several market areas.
Recently, the company signed contracts to supply the new technology to 14 hospitals across 8 states and is in the process of signing furthermore contracts with several other hospitals.
Titan Spine claims that the nanoLOCK technology is manufactured using subtractive process and has received two differentiated government agency designations highlighting the uniqueness of the product.
In 2014, the interbody fusion device maker received clearance from US Food and Drug Administration (FDA) clearance for its ‘nano-textured surface’ to the product’s initial 510 (K) clearance.
The US Centers for Medicare & Medicaid Services (CMS) had recently given the product a status of new technology with its own category and code, known as “ICD-10pcs New Technology Section X Code”.
The company expects strong sales with full scale introduction of this product. Titan Spine saw a growth in sales of 51% in 2015, compared to 2014. The strong demand for the product has been growing challenge to the company to keep up with the sales.
The product will showcased at the North American Spine Society (NASS) Annual meeting in Boston to be held between October 26 and 29.
Kevin Gemas, President of Titan Spine, commented, “The full U.S. launch of our nanoLOCK surface technology comes at an optimal time as the interbody market is rapidly shifting toward titanium surface-enhanced implants.
“It represents a major milestone for Titan Spine and is the culmination of years of preparation through scientific study, manufacturing validation, IP protection, and unique regulatory clearances through collaboration with the FDA and CMS.
“This effort resulted in nanoLOCK being the only nano-cleared interbody device on the market and is the only interbody device that has access to the recently-created new technology ICD-10 code for a nanotextured surface on an interbody fusion device.
Image: A human stem cell proliferating on the nanoLOCK surface. Photo: Courtesy of Business Wire.