Autonomix Medical, Inc. Drives Towards U.S. Pivotal Trial with Appointment of Vice President, Regulatory Affairs and Quality

Rhea-AI Summary

Autonomix Medical (NASDAQ: AMIX) has appointed Julie Manchester as Vice President of Regulatory Affairs and Quality, strengthening its team ahead of planned FDA approval initiatives. The company, which recently completed animal testing and design lock for its RF technology, remains on track to submit an Investigational Device Exemption (IDE) and commence a pivotal clinical trial in 2025 to support a De Novo FDA application.

Manchester brings over 15 years of quality and regulatory experience in medical devices and related industries. The company granted her an inducement stock option to purchase 19,500 shares, vesting over four years. Autonomix continues to make progress in its proof-of-concept clinical trial for treating pancreatic cancer pain, reporting positive patient outcomes.

Positive

• Successfully completed animal testing and design lock for RF technology
• On track for IDE submission and pivotal clinical trial in 2025
• Reporting positive outcomes in ongoing proof-of-concept trial for pancreatic cancer pain

Negative

• None.

Continued efforts to build team and infrastructure required to support clinical and regulatory initiatives in anticipation of the FDA approval process for first-in-class catheter-based sensing technology

Company remains on track to submit an Investigational Device Exemption (“IDE”), and if approved, will commence a pivotal clinical trial in 2025 to support a De Novo application for FDA approval

THE WOODLANDS, TX , Dec. 19, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the appointment of Julie Manchester as Vice President, Regulatory Affairs and Quality. As recently announced, the Company successfully completed its animal testing and design lock for its RF technology and is executing on its efforts of building the required team and infrastructure to support its clinical and regulatory initiatives in anticipation of the FDA approval process. The Company remains on track with its projected timelines and expects to submit an IDE and commence its pivotal clinical trial in 2025 to support a De Novo application for FDA approval.

Ms. Manchester is a Biotech/Med Device executive with over 15 years of quality and regulatory experience within the medical device, cosmetics, pharmaceutical, and product testing industries. Over the course of her career, she has built, led, and executed quality management and regulatory programs, product launches, and new product development. She has managed operations across ten different locations including other countries, ensuring consistent adherence to quality standards and regulatory compliance including building and leading teams from the ground up.

“Over this past year, we have continued to make steady progress in our ongoing proof-of-concept clinical trial for treating pancreatic cancer pain with extraordinary outcomes for our patients. We are pleased with the progress made and believe the year ahead holds catalytic milestones that we believe have the potential to truly transform the Company. As we prepare for upcoming milestones and position ourselves for success, key hires remain a focus. With that, we are pleased to welcome Julie to our team and believe her leadership and expertise will be incredibly valuable as we work to meet the regulatory needs to advance our technology forward,” commented Brad Hauser, CEO of Autonomix. “We look forward to leveraging Julie’s impressive experience and continue taking the necessary steps toward commencing a pivotal clinical trial, planned in 2025, and beyond to potential De Novo clearance.”

Ms. Manchester added, “I am pleased to join the Autonomix organization and work closely with the team to bring this innovative technology to patients in need. Based on the preclinical and initial proof of concept data seen to date, I believe Autonomix has the potential to provide a much-needed breakthrough technology for the treatment of a number of high value indications where there remains unmet need. I believe we are poised for an exciting 2025, and I look forward to playing a key role on the regulatory front.”

Inducement Grant

In connection with Ms. Manchester joining Autonomix, the Compensation Committee of Autonomix’s Board of Directors approved the grant of an inducement stock option on December 17, 2024 to purchase 19,500 shares of the Company’s common stock. The option award was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of the individual’s employment compensation and was granted as an inducement material to her acceptance of employment with Autonomix.

The option has an exercise price equal to the closing price of Autonomix’s common stock as reported by the Nasdaq Capital Market on December 17, 2024. The options have a ten-year term and vest in four equal annual installments, subject to Ms. Manchester’s continued service with Autonomix through the applicable vesting dates.

About Autonomix Medical, Inc.

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.

For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.

Forward Looking Statements

Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer, to submit and receive approval of an IDE, and to file a De Novo application. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”

Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.

Investor and Media Contact

JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com

Attachment

• Autonomix Medical, Inc.

FAQ

When will Autonomix Medical (AMIX) begin its pivotal clinical trial for its nerve sensing technology?

Autonomix Medical plans to commence its pivotal clinical trial in 2025, following the anticipated approval of their Investigational Device Exemption (IDE) application.

What is the status of Autonomix Medical's (AMIX) RF technology development?

The company has successfully completed animal testing and design lock for its RF technology and is now preparing for the FDA approval process.

What are the terms of Julie Manchester's stock option grant at Autonomix Medical (AMIX)?

Julie Manchester received an inducement stock option to purchase 19,500 shares, with a ten-year term and vesting in four equal annual installments, at an exercise price equal to the closing price on December 17, 2024.

What progress has Autonomix Medical (AMIX) made in its pancreatic cancer pain treatment trials?

The company reports making steady progress in their proof-of-concept clinical trial for treating pancreatic cancer pain, with extraordinary outcomes for patients.