Aug 24, 2025

The Memo: Spinally Developing Intrathecal Spinal Cord Interface for Chronic Pain and Beyond

The Memo: Spinally Developing Intrathecal Spinal Cord Interface for Chronic Pain and Beyond

Pawel-Soluch-Co-Founder-and-CEO-of-Spinally

Under the direction of Co-Founder and CEO Pawel Soluch, Spinally is pioneering a new generation spinal cord interface designed for intrathecal implantation. By placing leads directly in the intrathecal space rather than the standard epidural position, the company aims to improve stimulation precision, enable clearer neural signal recording, and reduce burdens for patients living with chronic pain. Based in Spain, Spinally is advancing preclinical studies and preparing for its first-in-human trial, with an FDA pre-submission planned for early 2026.

Origin Story

Spinally began with the vision of Dr. Carles García-Vitoria, an anesthesiologist and pain specialist. “During his PhD research, and building on his years in the clinic, he developed the idea for an intrathecally implanted spinal cord lead,” Soluch explained. “He believed it could outperform current spinal cord stimulation (SCS) systems, which are placed epidurally.”

This was more than a technical concept; García-Vitoria saw firsthand how patients struggled with limited relief from existing technologies and wanted to create a solution that could truly change lives. To help advance the idea, he brought in Beatriz Llamusí, Andrés Izquierdo, and Richard Nash, who together formed the foundation of Spinally.

Originally brought in to take part in Spinally’s CEO recruitment process, Soluch was soon convinced to take on the role himself. “After reviewing the concept and meeting the team several times, I discussed it with my network and realized that it could be a game changer in classic SCS, other neuromodulation therapies, and even as a platform for a spine-computer interface,” he said.

The Current Landscape

Chronic pain is a widespread and growing issue. According to the CDC, nearly one in four U.S. adults reported experiencing chronic pain in 2023, a 4% increase from 2019. Current SCS therapies, while valuable, rely on epidural electrodes, which face a key limitation: “The electrode is separated from the spinal cord by as much as 8 millimeters, filled with tissue that interferes with current and signal transmission in both directions,” Soluch noted. As a result, only about 10% of delivered energy reaches the spinal cord.

This anatomical barrier also hinders sensing, with epidural placement producing noisy signals that are insufficient for closed-loop applications. Globally, approximately 180,000 SCS units are implanted annually, a figure that highlights both the market demand and the potential for improvement.

Inside the Innovation

Spinally is developing an intrathecal lead designed to address these shortcomings. By bypassing the epidural barrier, the device enables deeper and more precise stimulation while simultaneously unlocking the ability to record high-quality neural signals.

“Our in vivo studies, which began in May, have confirmed our assumptions,” said Soluch. “The intrathecal lead has proven to be 10 to 14 times more sensitive than epidural systems, depending on the stimulation protocol. We can record high-quality signals and extract evoked compound action potentials without the need for filters. We can capture P1 peaks that are typically lost due to artifacts. We require significantly less current to activate a neuronal response.”

In addition to these performance benefits, Spinally is developing novel lead designs and algorithms to tailor therapy to individual patients. Over time, the company envisions the technology evolving into a platform for a spine-computer interface, expanding beyond chronic pain into other neurological conditions.

Progress and Milestones

Spinally is currently in the preclinical stage, conducting both cadaver and animal trials. Acute in vivo tests are underway, and a chronic trial is set to begin in October. The company is targeting a final product for IDE submission by late 2026 or early 2027, followed by its first-in-human trial.

In the near future, Spinally plans to share its first scientific presentations and publications. “We believe our approach will be a true breakthrough in the field, starting with chronic pain as our initial focus, and expanding over time with our next-generation interface to other neurological indications,” Soluch said.

The LSI Effect

For Soluch and his team, LSI provides an important platform. “LSI brings together exactly the kind of people and ideas that help medtech projects grow,” he said. “For Spinally, it is a place to share what we are working on, learn from others in the field, and meet both investors and potential partners. We are excited to join the upcoming meeting and look forward to making LSI a regular stop on our journey.”

Join Us at LSI Europe ‘25

Soluch has been selected to present at LSI Europe ’25 (September 7–11) in front of hundreds of global medical technology companies. Join us in welcoming him to the event in London, where he will share the latest updates on Spinally’s technology and development.