Spine Stabilization Technologies Chooses bioaccess™ for the Commercial Launch of its CE Mark-Approved PerQdisc™ Nucleus Replacement System in Latin America
[ORLANDO, FL, DECEMBER 31, 2021] – Spine Stabilization Technologies, LLC (SST), a Texas company with a CE Mark-approved spine disc nucleus replacement technology designed to replace the physical space of the nucleus, has decided to engage bioaccess™ as its market access consulting firm in Latin America to launch its innovative and less invasive treatment for degenerative disc disease: The PerQdisc™ Nucleus Replacement System. bioaccess™ will help SST obtain marketing authorization in select countries in Latin America that recognize CE Mark approval and engage key opinion leaders in the region to lead post-marketing clinical follow-up (PMCF) studies to gather long-term clinical data on the PerQdisc™ Nucleus Replacement System.
As the body ages, the support structure, better known as the spine, also breaks down or degenerates. The same occurs with intervertebral discs which can result in degenerative disc disease (DDD) in some people. This deterioration of the discs happens in part because of our slowing cellular metabolism and also because of the loss of fluid from the nucleus, which can cause severe pain. SST is developing a lumbar implant that can replace the nucleus of a deteriorating spinal disc.
SST aims to replace the nucleus with silicon and off-the-shelf device it calls the PerQdisc™ Nucleus Replacement System through a surgical procedure. Many other technologies have been used to treat the condition, such as therapeutics, spinal fusion, and other experimental treatments. SST believes its device’s ability to replace the nucleus in a minimally invasive way, among other factors, differentiates it from other companies trying to treat DDD.
The patented PerQdisc™ device replaces the physical space of the nucleus (jelly-like material inside the disc) and restores motion and weight-bearing capabilities in an anatomical fashion. The PerQdisc™ Disc Nucleus Replacement System is intended to replace the nucleus pulposus in skeletally mature patients at least 22 years of age with symptomatic single-level degenerative disc disease (DDD) at levels L1/2, L2/3, L3/4, L4/5, or L5/S1.
The PerQdisc™ implant consists of a shaped membrane as an outer chamber with an additional internal chamber. Each chamber is independently inflatable. Once the device is placed inside of the prepared disc space, the inner chamber is filled with radiopaque contrast media to verify the position of the implant, the outer chamber of the implant is then filled with a polymer. The liquid polymer cures in situ within 10 minutes at body temperature. Once cured the delivery system is withdrawn.
About Spine Stabilization Technologies, LLC
Spinal Stabilization Technologies, LLC is committed to the design, development, and manufacturing of spinal medical devices that meet or exceed the expectations of our patients, customers, and regulatory agencies; and to maintaining and improving the effectiveness of its quality management system. More information at www.sstspine.com.
About bioaccess.™
bioaccess™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research and market access clients with support services to ensure their first-in-human trials and commercial launches are a success in Latin America. More information at www.bioaccessla.com.
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bioaccess™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210
Email: jmclark@bioaccessla.com