Autonomix Signs Key Clinical Agreements in Preparation to Begin March 2024 Human Clinical Trial
01 March 2024 - 12:30AM
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 it has
entered into a clinical site agreement with “АКFА MEDLINE" Ltd.,
for its PoC human clinical trial evaluating the use of
transvascular RF ablation for the treatment of pancreatic cancer
pain.
Additionally, Autonomix announced the selection
of Clinical Accelerator and Qmed, full service Clinical Research
Organizations (CROs) specializing in medical devices to support the
PoC human clinical trial. Clinical Accelerator will be responsible
for managing the clinical operations in country, including
recruiting patients, SIV work, and patient treatment records and
Qmed will be responsible for managing protocol and trial reporting,
as well as managing patient data.
Lori Bisson, Chief Executive Officer of
Autonomix commented, “We are pleased to execute these important
agreements and final steps towards commencing patient enrollment in
our first PoC human clinical trial. We believe each of these firms
bring valuable components to our overall clinical advancement and
we look forward to working with them closely to bring this trial
across the finish line.”
The primary objective of the PoC human clinical
trial 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
for the trial. 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 trial
objectives. Enrollment is expected to be completed before the end
of 2024.
Expected Upcoming
Milestones
- Q1 CY2024: Commence enrollment in
PoC human clinical trial evaluating proprietary ablation technology
for treatment of pancreatic cancer pain
- 2024: Complete ablation device
design intended for clinical use
- 2025: Complete development of
ablation system and catheter in preparation for human pivotal
trial
- 2025: Launch combined sensing /
ablation clinical trial
- 2026: De novo submission
- 2027: Seek FDA clearance
The Company’s catheter-based 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.
The Company is initially developing its
technology to address pancreatic cancer-related pain. Current
approaches, primarily relying on opioids or invasive ethanol
injections, can provide only limited relief and may lead to risky
side effects. 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. Forward-looking statements in this press release
include, without limitation, the timing of the completion of
patient enrollment in the trial and the Company’s ability to
successfully meet the milestones set forth in this press release on
a timely basis, if at all. 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.’
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 offering circular 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 Thomas
833-475-8247autonomix@jtcir.com
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