NEWS & EVENTS

Today, August 14, 2025, we announce that IntraLink, an injectable device technology created to treat symptomatic disc degradation, has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)—a major milestone that accelerates regulatory review and may also provide reimbursement pathways to bring this novel technology to market.

IntraLink utilizes plant-derived compounds that self-polymerize and attach to collagen fibrils throughout the spinal disc. This process mechanically supports the disc to inhibit excessive motion and stabilize the spinal joint.

The FDA’s Breakthrough Device program is designed to speed patient access to innovative technologies that offer the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. Through this designation, IntraLink will benefit from priority FDA review and streamlined, collaborative communication on development and clinical trial protocols throughout the premarket review process.

The company has previously published clinical results on 20 patients treated in Malaysia and Australia (Journal of Pain Research).  Clinically meaningful improvements in both VAS pain and ODI disability scores were achieved in 80% or more of the treated patients at all timepoints from 2 weeks post-treatment to 2 years. The procedures were well-tolerated by the patients with no intraoperative serious adverse events, and patients typically progressed to sitting, standing, or walking in less than an hour after the implantation.

“Breakthrough status validates both the innovation and the urgency of our mission,” said Tom Hedman, PhD, inventor of IntraLink. “We’re eager to work with the FDA to bring this technology to patients as quickly as possible.”

“For interventional pain physicians, halting the degenerative cascade of the disc at its earlier stages has always been the goal,” said Dr. Timothy Deer, President & CEO at The Spine and Nerve Center of the Virginias.  “The FDA’s Breakthrough Device Designation for IntraLink recognizes a technology that could allow us to help patients with degenerative disc disease earlier in life – before the cascade of events leads to more severe disc failure and decades of disabling pain.”

“This is more than a regulatory win—it’s a springboard for rapid market entry and strong reimbursement support,” said Todd Moseley, CEO of Spinal Simplicity. “It moves us one giant leap forward in redefining what the standard of care will be and gets us that much closer to a life-changing solution for patients worldwide, ultimately helping patients get their freedom back.”

For more information, contact:

Media:
Parker Snedden
Vice President of Marketing
psnedden@spinalsimplicity.com

Investor Relations:
Jonathan Hess
Vice President of Finance & Investor Relations
jhess@spinalsimplicity.com