IntraLink® Enrolled in FDA’s Total Product Life Cycle Advisory Program (TAP)
Today, September 24, 2025, we announced that our IntraLink technology has been enrolled in the Total Product Life Cycle Advisory Program (TAP). TAP is administered by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
IntraLink was recently designated as a Breakthrough Device, recognizing its potential to provide more effective treatment for patients with serious conditions. The invitation into the TAP program marks another significant step in advancing IntraLink toward clinical adoption.
The TAP program is designed to foster early, frequent, and strategic engagement between device developers, FDA, and non-FDA stakeholders. TAP advisors provide:
- Expertise across multiple fields—including regulatory, technical, and clinical perspectives.
- Proactive identification of key challenges that could impact U.S. marketing authorization.
- Facilitation of discussions with external parties to address potential barriers to market adoption, clinical use, and patient access.
With TAP, FDA aims to play a more active role in supporting patient access to innovative, safe, and effective devices.
“Enrollment in TAP is an important milestone for IntraLink and for Spinal Simplicity,” said Adam Rogers, Senior Vice President of Regulatory Affairs at Spinal Simplicity. “We are grateful for the opportunity to be included in the TAP program, where we will benefit from enhanced collaboration with FDA experts and external advisors. This collaboration will help us anticipate challenges earlier, refine our regulatory and market access strategy, and ultimately bring IntraLink to patients and practitioners faster.”
Spinal Simplicity remains committed to advancing safe and effective technologies that address unmet clinical needs in spine care. Enrollment in TAP underscores both FDA’s recognition of IntraLink’s potential and the company’s dedication to accelerating patient access to innovative treatment options.
Media:
Parker Snedden
Vice President of Marketing
psnedden@spinalsimplicity.com
Investor Relations:
Jonathan Hess
Vice President of Finance & Investor Relations
jhess@spinalsimplicity.com