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
preliminary positive results from the first five “lead-in” patients
in the Company’s ongoing proof-of-concept (PoC) human clinical
trial evaluating the safety and effectiveness of delivering
transvascular energy to ablate relevant problematic nerves and
mitigate pain in patients with pancreatic cancer pain. The goal of
this trial is to assess pain reduction via radiofrequency (RF)
ablation. The Company’s catheter-based microchip sensing array used
to detect and differentiate neural signaling was not used in this
trial and will be evaluated in future studies. As previously
announced, management will host a webcast presentation to discuss
the preliminary results today, Tuesday, June 18, 2024, at 8:30 a.m.
ET (details below).
The first five patients were enrolled and
treated according to protocol in the beginning of the trial to
familiarize the Principal Investigator (PI) with the procedure and
will not be included in the analysis of the trial objectives. These
first five “lead-in” patients successfully completed the procedure
per protocol with no immediate procedural-related complications or
significant adverse events.
“We are very pleased with these initial positive
results, which confirm our ability to treat this historically
difficult-to-treat cancer pain with catheter-based transvascular RF
ablation. While preliminary, we are highly encouraged with the
level of pain reduction and quality-of-life improvement these
patients gained and we hope continue throughout the remainder of
the trial. While these data will not be included in the final
analysis, they provided our clinical team valuable insight into
optimizing the procedure, particularly the catheter entry point,
where 3 of the 5 patients who saw a pain response had femoral
access of the catheter and the 2 that did not respond had brachial
access. We believe access factors played a role in the ability to
ablate the appropriate nerves to see mindful pain reduction in the
brachial access patients, as the bias of the catheter appears less
optimal in ablating the target nerves from this approach to the
target anatomy,” commented Dr. Robert Schwartz, Co-Founder and
Chief Medical Officer of Autonomix.
The primary objective of the PoC human clinical
trial is to assess the success rate of ablating relevant nerves to
mitigate pain in patients with pancreatic cancer pain utilizing RF
ablation in a transvascular approach to the nerves in the region.
Secondary objectives include assessing the incidence of device- and
procedure-related adverse events up to 4-6 weeks post-procedure;
estimating the change in pain levels from pre- to post-procedure;
and estimating the change in quality of life from pre- to
post-procedure. All subjects who have had a successful procedure
were evaluated at 7 days, 4–6 weeks, and at 3 months
post-procedure. All patients entered the study with severe
abdominal pain from unresectable pancreatic cancer and a life
expectancy of 3 months or less. Following the successful completion
of the procedure, two subjects have since succumbed to their
disease. Both events were expected outcomes and not related to the
trial procedure.
“We are very encouraged by the results from the
first five lead-in patients from our ongoing first-in-human trial
and while they appear to support our ability to have a meaningful
impact on pain via RF ablation when we successfully ablate targeted
nerves, it is only part of the story. We believe that in future
studies and with our catheter-based microchip sensing array, which
we expect to be able to detect and target overactive nerves causing
pain and confirm nerve death after ablation, we may be able to
improve on the level of responders. We are extraordinarily pleased
with the positive outcome this procedure is having on responding
patients and the relief they are experiencing from the difficulty
of end-stage pancreatic cancer,” Lori Bisson, Executive Vice
Chairman of Autonomix added.
Click here to watch patient testimonials from
some of the trial participants and treating physician.
Summary of Topline Results 7 Days
Post-Procedure
- 24 hours post-procedure showed an
overall mean VAS Pain Score of 2.3 after treating each of the five
subjects.
- Three patients were treated with
femoral access and two were treated with brachial access. Patients
treated with brachial access showed no improvement in their pain
scores (or worsened) while all patients treated with femoral access
positively responded to treatment. The results presented in the
charts above are for the three patients in the responder
group.
- 60% of subjects responded with a
mean 6.33 reduction of pain on the VAS pain scale (from baseline of
8.0 to 1.67) at 7 days post-procedure.
- Pain relief was experienced as
quick as 1-day post-procedure for the three patients in the
responder group.
- Reduction of pain score occurred
simultaneously as the subject’s underlying disease (pancreatic
cancer tumor) continued to grow. This is beneficial for patients
who are considered end of life given their advanced stage of
disease.
- Responder patients reported a mean
78% improvement in quality of health at 7 days.
- Responder patients reported a mean
45% improvement in quality of life at 7 days.
When evaluating the total treated population,
including non-responders, the mean reduction in the VAS pain score
was a 2.9 point reduction, or 43%, in pain scores reported
pre-procedure to day 7.
As previously announced, Autonomix has amended
the trial protocol to include the gathering of additional
information on tumor encroachment on the vessels as well as other
key bio-measurements that may correlate with effective nerve
ablation. Additionally, the Company has further defined severe pain
for inclusion criteria as a 7 or above on the VAS scale as
indicated by the patient rather than physician determination. A
total of twenty (20) additional subjects will be enrolled in the
trial that will be formally included in the trial data results and
analysis of trial objectives. Suitability is determined by the
primary oncologist caring for the patients with the treating
Principal Investigator confirming eligibility for the trial.
Autonomix commenced patient screening under the amended protocol in
May 2024 and remains on track to complete enrollment in the PoC
human clinical trial by year-end.
The Company’s catheter-based technology is being
developed to do two things: sense neural signals associated with
pain or disease and deliver targeted ablation to 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, with plans
for follow-on indications pending the results of the initial data.
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.
Webcast Presentation
Details
As previously announced, Autonomix management
will host a webcast presentation for investors, analysts, and other
interested parties today, Tuesday, June 18, 2024 at 8:30 a.m. ET to
discuss the preliminary results. Interested participants may
register for the event here. The live webcast will be accessible on
the Events page of the Investors section of the Autonomix website,
autonomix.com, and will be archived for 90 days.
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 technology for the
treatment of pain, with initial trials focused on pancreatic
cancer, a condition that causes debilitating pain and is without an
effective solution. Our technology constitutes a platform to
address dozens of 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 US.
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 pain associated with pancreatic cancer, to successfully
enroll patients within the specific timeframe, and to complete its
clinical study in pancreatic cancer pain. 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 ContactJTC Team, LLCJenene
Thomas833-475-8247autonomix@jtcir.com
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