Autonomix Medical, Inc. Drives Towards U.S. Pivotal Trial with Appointment of Vice President, Regulatory Affairs and Quality
19 Décembre 2024 - 2:30PM
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, LLCJenene
Thomas908.824.0775autonomix@jtcir.com
Autonomix Medical (NASDAQ:AMIX)
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