PR89719

Spinal Stabilization Technologies Ltd Earns CE Mark, FDA "Breakthrough Designation" For PerQdisc Nucleus Replacement System For Degenerative Disc Disease

KILKENNY, Ireland, May 25, 2021 /PRNewswire=KYODO JBN/ --

Spinal Stabilization Technologies, Ltd. (SST), Kilkenny, Ireland announced

today that it has earned the CE Mark and the FDA's "breakthrough designation"

for its PerQdisc(TM) Nucleus Replacement System.

PerQdisc is the only commercially available lumbar nucleus replacement system

in the world. The PerQdisc device replaces the nucleus pulposus of the

intervertebral disc in the L1 - S1 spinal region in patients with single-level

discogenic pain. The patient may have single or multi-level degenerative disc

disease (DDD) but the discogenic pain must be limited to a single level.

The PerQdisc procedure has delivered impressive pain relief when used as

indicated in patients with severe, debilitating back pain. Patients with mild

to moderate degenerative disc disease with severe back pain have been offered

surgical treatment with spinal fusion or total disc replacement.  These

procedures have inherent limitations and can be associated with complications

that can be difficult to manage. "Nucleus replacement with the PerQdisc is a

better option for these patients," said Michael Hess MD, Coordinating

Investigator.

Many companies have tried to develop nucleus replacement devices but never

fully commercialized their devices globally. "Our technology, combined with new

surgical and imaging techniques, allowed SST to solve the complex challenge of

lumbar spine nucleus replacement," said Mark Novotny, SST's CEO.

This novel procedure is a minimally invasive surgery compared to spinal fusion

or a total disc replacement procedure. Our procedure is done with a small

incision that minimizes the risk of blood loss and results in a custom implant

that fills the patient's disc space. Patients are usually in the hospital

overnight and can go home the following day. "When used as indicated, the

results are impressive and patients can have significant reductions in pain

immediately after the surgery," commented Jeff Golan, MD, SST's Medical

Director.

The PerQdisc device and the surgical procedure are not yet FDA approved. "SST

is working with the FDA to develop a comprehensive clinical trial program,"

adds Novotny. "As part of that process, the FDA recently designated the

PerQdisc as 'breakthrough technology.' In the meantime, with the CE Mark

approval, SST has plans to launch sales of its device in Europe, the Middle

East, and Asia including China."

About Spinal Stabilization Technologies, Ltd

Spinal Stabilization Technologies, Ltd (SST) is an Irish limited company,

headquartered in Kilkenny, Ireland. Its US headquarters are located in

Westminster, Colorado. SST develops novel technologies for treating patients

with lumbar discogenic back pain. The company has an extensive worldwide

intellectual property. The products and techniques SST develops are based on

the philosophy that less invasive surgery may be associated with better

clinical outcomes. These products and techniques could improve the lives of

many patients that have limited options for treating their back pain. The

company is focused on evidence-based medicine and plans to conduct numerous

clinical trials.

For more information, physicians may visit https://www.sstspine.com/home

SOURCE Spinal Stabilization Technologies

CONTACT: Paul Maccabee, 612-366-5287