Zynex Obtains FDA clearance for new Pain Management Device

ENGLEWOOD, Colo., Sept. 3, 2024 /PRNewswire/ — Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and rehabilitation, today announced FDA clearance of its new TensWave device.

The TensWave device, by prescription only, builds on Zynex’s strong legacy of innovation in pain management. It offers a user-friendly, portable design that can be easily integrated into patients’ daily routines. The device aims to provide effective pain relief through TENS (Transcutaneous Electrical Nerve Stimulation) therapy, which has been clinically proven to reduce chronic and acute pain without needing medication.

“The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions,” said Thomas Sandgaard, CEO of Zynex Medical. “We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand. It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients.”

It is important to note that the TensWave device is not intended to replace our market-leading NexWave electrotherapy device, which remains the top choice for patients seeking a comprehensive electrotherapy solution but in certain instances, can provide flexibility in dealing with patients’ insurance coverage. The TensWave is a complementary product designed for those whose insurance plans exclusively cover TENS therapy.

The TensWave is poised to become an essential tool for patients suffering from chronic pain conditions, offering them a safe, effective, and drug-free alternative to pain management. It complements our offerings of electrotherapy products, cervical traction, braces, cold/hot therapy and compression devices.

This new product clearance by the FDA marks another milestone in Zynex’s ongoing mission to improve patient outcomes through innovative medical technology.

About Zynex Inc. 

Founded in 1996, Zynex develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation, as well as non-invasive monitoring systems for use in hospitals. For more information, please visit: www.zynex.com.

Safe Harbor Statement 

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements reflect our current beliefs and expectations but are subject to various risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause such differences include, but are not limited to, the acceptance of our products by insurance providers and patients, the continued availability of reimbursement for TENS therapy, and our ability to maintain and expand our market presence. For more detailed information on the risks and uncertainties associated with our business, please refer to the filings we have made with the Securities and Exchange Commission.

Investor Relations Contact:
Quinn Callanan, CFA or Brian Prenoveau, CFA
MZ Group – MZ North America
ZYXI@mzgroup.us
+949 694 9594

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SOURCE Zynex