Autonomix Medical, Inc. Receives Ethics Committee Authorization for Proof-of-Concept Human Clinical Study Evaluating Proprietary Ablation Technology for Treatment of Pancreatic Cancer Pain
February 06 2024 - 8:50AM
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 that it has
received authorization from the Uzbekistan Ethics Committee to open
the clinical trial site for its proof-of-concept human clinical
study evaluating the use of transvascular ablation for the
treatment of pancreatic cancer pain. The Company is on track to
commence enrollment in the first quarter of 2024.
“Our team remains focused on the successful
execution of our clinical path forward for this potentially
groundbreaking technology. We believe that our technology has the
potential to address the significant unmet need for patients with
severe, chronic debilitating pain from pancreatic cancer,
contributing to an exceptionally difficult quality of life, that
currently is not well-treated by pharmacologic approaches. This
first-in-man study to treat pancreatic cancer pain will be the very
first time that transvascular ablation to reduce the pain
associated with this disease has been studied and it is a very
important step in validating our clinical and regulatory plans for
our technology. We are making solid progress with the study and
expect to initiate enrollment imminently,” commented Lori Bisson,
Chief Executive Officer of Autonomix.
The primary objective of the proof-of-concept
study is to successfully ablate relevant somatic nerves and
mitigate pain in patients with pancreatic cancer pain utilizing RF
ablation in a transvascular approach to the nerves in the region.
Twenty (20) subjects will be enrolled at one clinical trial site in
Uzbekistan for the study. Confirmation of suitability will be
affirmed by the primary oncology service caring for the patients.
Up to 5 additional patients will be included and treated according
to protocol to ensure the physician's familiarity with the
procedure. However, they will not be included in the analysis of
the study objectives. Enrollment is expected to be completed before
year-end.
The Company’s catheter-based sensing technology
is being developed to do two things: sense neural signals
associated with pain or disease and precisely target those nerves
for treatment. Autonomix believes this technology is a better
alternative to the current approaches commonly used today, where
doctors either rely on systemic drugs like opioids that lose
effectiveness and have unwanted side effects or treat suspected
areas blindly in hopes of hitting the right nerves, an approach
that is often inaccurate and can miss the target and even cause
collateral damage to surrounding parts of the body.
For more information about the Company’s
technology, please visit autonomix.com.
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 technology platform includes a
catheter-based microchip sensing array that has 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 our technology for
pancreatic cancer pain, a condition that can cause debilitating
pain and needs an effective solution. However, our technology
constitutes a platform with the potential to address dozens of
indications, including in cardiology, renal denervation and chronic
pain management across a wide disease spectrum.
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. Such forward-looking statements can be identified by
the use of words such as ‘’should,‘’ ‘’may,‘’ ‘’intends,‘’
‘’anticipates,‘’ ‘’believes,‘’ ‘’estimates,‘’ ‘’projects,‘’
‘’forecasts,‘’ ‘’expects,‘’ ‘’plans,‘’ and ‘’proposes.‘’
Forward-looking statements in this release include, without
limitation, the commencement of enrollment in the study in the
first quarter of 2024 and the ability of Autonomix to complete
enrollment before year-end.
Although Autonomix Medical, Inc. (or 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 final offering
statement filed with the U.S. Securities and Exchange Commission
(“SEC”) on January 26, 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
Thomas833-475-8247autonomix@jtcir.com
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