September 24, 2018
NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, announces the momentous start of the MATRIXX Trial – marking the first ever clinical evaluation of novel 3D-printed lumbar interbody fusion devices relative to PEEK.
The Nexxt Matrixx® System is a collection of porous titanium spinal fusion implants that interweave highly differentiated surface texturing technology with novel 3D-printed cellular scaffolding. With the sponsorship of this trial, Nexxt Spine hopes to prove that their technology can accelerate bony ingrowth and improve clinical outcomes.
“Since we launched last October, over 1400 Nexxt Matrixx® devices have been implanted and the response from our surgeon leaders has been phenomenal,” stated Nexxt Spine President, Andy Elsbury. “While our early adopters have witnessed improved clinical outcomes first-hand, we are excited to take the industry lead and quantify the clinical merits of Nexxt Matrixx® scientifically.”
The MATRIXX Trial is a prospective randomized controlled trial that will evaluate the clinical and radiographic outcomes of the Nexxt Matrixx® System following lumbar interbody fusion. Patients will be randomized to receive either a Nexxt Matrixx® 3D-printed porous titanium cage or a traditional plastic PEEK cage routinely recognized as the current ‘gold standard.’ Data will be collected at 3, 6, 12, and 24 months in order to quantify the speed and quality of fusion relative to the two implant materials.
“Although often used in spinal surgery, plastic PEEK cages are limited as they function more like static shims holding expensive biologics as opposed to active scaffolds that enable endplate to endplate healing,” explains Alaedeen Abu-Mulaweh, Director of Engineering.
While other manufacturers have used 3D-printing to develop devices that mimic bone’s trabecular geometry, Nexxt Spine chose to ignore the marketing allure and focus instead on the core science.
“Titanium is physically incapable of biological remodeling, so using 3D-printing to directly mimic the structural randomness of bone doesn’t make a whole lot of sense,” explains Abu-Mulaweh. “Rather than simply looking like bone, Nexxt Matrixx® was designed with the vision of actively facilitating the body’s natural power of cellular healing.”
The initiation of the MATRIXX Trial is “a milestone moment for Nexxt Spine and the medical community as a whole,” says Elsbury. “We believe that our Nexxt Matrixx® technology has the potential to revolutionize the landscape of spinal fusion and are excited for the opportunity to prove it.”
About Nexxt Spine
Nexxt Spine, LLC is a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions. The Nexxt Matrixx® family currently consists of implants available for cervical, TLIF Oblique, and TLIF procedures. Stand-Alone Cervical, Stand-Alone ALIF, and Corpectomy devices incorporating Nexxt Matrixx® technology are actively in development & testing.
Nexxt Spine LLC
Alaedeen Abu-Mulaweh, 317-678-8424