Autonomix Medical Hires Regulatory Affairs and Quality VP

Autonomix Medical Inc. has appointed Julie Manchester as vice president, Regulatory Affairs and Quality. She is a biotech/medical device executive with more than 15 years of quality and regulatory experience within the medical device, cosmetics, pharmaceutical, and product testing industries.

The company has completed its animal testing and design lock for its RF technology and is building the required team and infrastructure to support its clinical and regulatory initiatives necessary for the U.S. Food and Drug Administration (FDA) approval process. The company remains on track with its projected timelines and expects to submit an IDE (Investigational Device Exemption) and begin its pivotal clinical trial this year to support a De Novo application for FDA approval.

“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,” Autonomix Medical CEO Brad Hauser said. “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. We look forward to leveraging Julie’s experience and continue taking the necessary steps toward commencing a pivotal clinical trial, planned in 2025, and beyond to potential De Novo clearance.”

Over the course of her career, Manchester has built, led, and executed quality management and regulatory programs, product launches, and new product development. She has managed operations across 10 different locations including other countries, ensuring consistent adherence to quality standards and regulatory compliance, including building and leading teams.

“I am pleased to join the Autonomix organization and work closely with the team to bring this technology to patients in need,” Manchester said. “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.”

Autonomix Medical is a medical device company focused on advancing innovative technologies to change the way in which 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 be able to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. This will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

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