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THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ:AMIX) announced Thursday it has completed the final design review of its proprietary sensing catheter in preparation for human clinical trials. The medical device company, currently valued at $3.1 million, maintains a strong liquidity position with a current ratio of 5.63, according to InvestingPro data.
The company’s intravascular device is engineered to detect and differentiate nerve signals in real time from inside blood vessels using a microchip-based sensing antenna array. According to the press release, current technologies require physicians to treat nerves without direct visualization, which can result in incomplete treatment or overtreatment. While the company’s stock has experienced significant volatility, trading near its 52-week low of $1.09, InvestingPro analysis suggests the stock may be undervalued at current levels.
"What sets Autonomix’s approach apart is the potential of our device to sense and process neural signals directly at the source, enabled by our proprietary microchip array," said Brad Hauser, CEO of Autonomix.
The company is working toward submitting an Investigational Device Exemption (IDE) to the FDA, which if approved, would allow clinical trials to begin. Autonomix plans to initially seek FDA clearance for its sensing and RF ablation system as a treatment for pancreatic cancer pain.
The technology platform could potentially address multiple therapeutic areas including cardiology, resistant hypertension, interventional pain management, and pulmonary and gastrointestinal disorders, the company stated.
Autonomix’s catheter is designed to offer physicians the ability to detect nerve activity, guide energy delivery, optimize ablation patterns, and confirm treatment efficacy during procedures.
The medical device company’s technology is currently investigational and has not yet received FDA clearance for marketing in the United States, according to the press release statement.
In other recent news, Autonomix Medical has raised approximately $2.5 million through a warrant exercise deal, involving the immediate exercise of outstanding warrants at a reduced price of $1.723 per share. The transaction involves warrants to purchase up to 1,477,596 shares of common stock, originally issued in November 2024. Additionally, Autonomix has been granted a new U.S. patent for its "Smart Torquer" technology, designed to enhance the manipulation of intravascular devices during minimally invasive procedures. The patent integrates electronic components for mechanical control and data communication, offering advancements in medical technology. Furthermore, the company received another U.S. patent for systems related to neurological evaluation and modification, which includes tools for treating cancerous tumors and associated pain. Autonomix is also set to expand its clinical trial program for cancer pain treatment, with authorization from the Ministry of Health of the Republic of Uzbekistan. This expansion follows promising results from an initial trial targeting severe pancreatic cancer pain, demonstrating significant pain reduction and improved quality of life for patients.
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