Saluda Medical Enters The Market With FDA Approval

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EvokeEarlier this month Saluda Medical, a global medical device company developing in the field of neuromodulation, announced $125M in equity funding.

Throughout the last decade, Saluda has evolved innovations designed to read, record, and respond to the nervous system during stimulation. The technology is able to provide dosing that can be titrated at the microsecond level to maintain and optimize consistent therapy for patients. Net proceeds from financing are said to be used for operationalizing and scaling commercialization of the Evoke® Spinal Cord Stimulation System (SCS) for chronic pain. 

Furthermore, results of several studies of the closed-loop Evoke® system have shown promise, and the FDA has recently opted to approve the technology for chronic pain treatment.

According to Saluda Medical, this is the first time the agency has provided premarket approval to a spinal cord stimulation system based on the results of a randomized controlled trial. 

With the given approval, Saluda will begin a rollout of its system among several of its clinical trial sites. A full commercial launch is projected to launch in 2023.

“The FDA approval of the Evoke® System marks a seminal moment in the field of spinal cord stimulation,” said Timothy Deer, M.D., an investigator for the device’s clinical trial and president and CEO of the Spine and Nerve Center of The Virginias. “For the last 50 years, our field has relied on subjective feedback from the patient to optimize therapy, with results in published literature demonstrating good clinical outcomes, but also highlighting challenges with predictable long-term durability.”

Treatment for back pain (with spinal interventions) is transitioning away from fixation, utilizing motion-preserving techniques in the cervical spine or non-instrumented decompression for cervical/thoracolumbar, or pain management through other means, such as spinal cord stimulations, as discussed in iData’s Spinal Implants Report Suite.

For further insights, iData’s market monitoring can assist you with tracking the competitive entrance of Saluda Medical. 

kamranSaluda Medical Enters The Market With FDA Approval