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Classified in: Health, Science and technology
Subject: FDA

NeuraLace Announces FDA 510(k) Clearance and U.S. Launch of Axon Therapy® Peripheral Nerve Stimulation System For Chronic Pain Relief


SAN DIEGO, June 17, 2021 /PRNewswire/ -- NeuraLace Medical, Inc., a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, announced today that it has received FDA 510(k) clearance for Axon Therapy® to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. 

"After 10 years of R&D, we are pleased to have received FDA 510(k) clearance for Axon Therapy and we're incredibly excited to bring to market a non-opioid treatment option that provides meaningful relief for patients suffering from chronic pain," said Shiv Shukla, Founder and CEO of NeuraLace Medical. "We believe Axon Therapy is a significant step forward on the care continuum that is accessible to patients today and we look forward to bringing sustainable pain relief to patients by launching Axon Therapy in the United States."

"Existing options to treat chronic nerve pain can be ineffective, addictive and invasive." Said Executive Chairman, Sean Edwards. "We're excited to offer patients a method of relief that is non-addictive and non-invasive."

ABOUT AXON THERAPY
Axon Therapy delivers focused magnetic pulses which activate the damaged peripheral nerve axons that are required to provide relief from chronic nerve pain. The Axon Therapy coil, connected to a compact stimulation module, produces strong magnetic pulses near the injured nerve during the course of the treatment. NeuraLace's patented low frequency waveform leverages the principles of electromagnetic induction to create a voltage differential that elicits neuronal stimulation in the axon of the damaged nerve resulting in pain relief. Current forms of neuromodulation focus on masking the transmission of pain signals, whereas Axon Therapy seeks to suppress the pain signal by re-activating the body's natural modulatory mechanism, which is dormant after traumatic injury to the nerve.

ABOUT NEURALACE MEDICAL, INC.
Privately held NeuraLace Medical, Inc., headquartered in San Diego, Calif., is committed to leading the charge in non-invasive chronic pain management and sustainable relief.  Our mission to end chronic pain inspired us to develop Axon Therapy, with the goal of being the first non-invasive, non-addictive way to effectively treat chronic nerve pain.  

Axon Therapy® and the NeuraLace logo are trademarks of NeuraLace Medical, Inc.

Inquiries: hello@neuralacemedical.com or 858-232-0779.

Follow NeuraLace on LinkedIn and Twitter at @Neuralace.
www.neuralacemedical.com

SOURCE Neuralace Medical, Inc.


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News published on 17 june 2021 at 10:37 and distributed by: