Autonomix Medical, Inc $AMIX: The Chronic Pain Solution!

Benzinga

Lori Bisson, CEO of Autonomix Medical, Inc., was recently interviewed by Benzinga.  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 it says has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies.   Ms. Bisson spoke about the exciting opportunities that her company’s innovative technology presents.

Transcript

00:00All right, today we're going to be talking to a very exciting company.

00:05I'm lucky enough to be joined by the CEO and director of Autonomics.

00:10We've got Lori Bisson hanging out with us.

00:12Lori, how are you doing today?

00:13Doing great, Aaron.

00:14How are you?

00:15I am good.

00:16Great to be chatting with you again.

00:18So I'm familiar with the company by now because we've spoke before, but some of our audience

00:22may not be.

00:23Do you mind giving us an overview of your company?

00:25No, absolutely.

00:27So our goal at Autonomics is to create sensing technology that could revolutionize our understanding

00:33of the human nervous system and how it interacts with the body.

00:36So the nervous system is responsible for, or at least involved in, almost every function

00:42of the human body.

00:43And today, we have no way to view it.

00:45And this leaves physicians without the tools to sense or to see target treatment areas

00:51in the nervous system.

00:52We believe that enhanced visibility that our technology is designed to provide is going

00:58to greatly advance our ability to diagnose and to treat a wide range of disorders from

01:04pain to hypertension.

01:06The potential applications for our nerve sensing technology places Autonomics at the core of

01:11an estimated $100 billion market opportunity.

01:15Wow.

01:16And how does this technology work, Lori?

01:19Our technology is catheter-based sensing technology that's able to travel within the

01:25arteries and veins of the human body and detect the very faint signals that our nerves send,

01:31electronic signals.

01:32It is comprised of an array of sensors that pick up the signals and a proprietary microchip,

01:39which is located right by the sensing antenna.

01:42And that chip amplifies, converts, and geolocates the signal right there on the catheter in

01:49extremely close proximity to the nerve.

01:52And all of this results in a sensing technology that is 3,000 times more sensitive than what's

01:58available today, and for the first time, is capable of detecting nerve activity.

02:04Wow.

02:05I mean, that sounds like some high tech you guys got there.

02:08What indications are you targeting first?

02:10What could that lead to in other indications and total addressable market?

02:14Sure.

02:15So our first target is the treatment of pain associated with pancreatic cancer.

02:21So 90% of pancreatic cancer patients experience pain with their tumors.

02:26In fact, it's usually why they get diagnosed, right, that pain that they don't understand.

02:32And today, treatment options available to these patients are really limited and ineffective

02:37for most of them.

02:39And because this indication represents a significant unmet need in patients that are unfortunately

02:46usually terminal, the regulatory hurdles are lower and clinical trial sizes are smaller.

02:52And so we think that equates to a faster and cheaper path to approval for our technology.

02:59We believe if we can successfully gain clearance for the pancreatic cancer pain indication,

03:04this could serve as the basis for clearing and then commercializing our technology for

03:08other future targets.

03:10For example, it's a very directly from pancreatic cancer pain to the treatment of pancreatitis.

03:16The mechanism of action or the ablating of targeted nerves that we're using to treat

03:22pancreatic cancer pain will be very similarly applied in a broader pain management market

03:28as well as in the treatment of nerves in the renal artery to impact high blood pressure.

03:33Whether we anticipate that we could see improvement in COPD via denervation of bronchial nerves

03:39or nerves in the lungs, the connecting factor is that in all of these targets, we have the

03:46potential to replace systemic drugs with a singular procedure.

03:49But take it as a whole that this first indication can start to open the door to a market opportunity

03:56that exceeds $100 billion.

03:57Wow.

03:58Yeah.

03:59And I mean, I was just going to say, that's amazing.

04:00I'm rooting for any company that's out there trying to help manage the pain of cancer patients

04:05and as well as patients with COPD and other diseases like that.

04:09Lori, I know you guys recently completed an animal study.

04:13What were the results of that study?

04:14So we recently did announce an animal study where we conducted testing of our sensing

04:20technology.

04:21We placed our sensing catheter in the renal artery and treated target nerves with ethanol,

04:26which is a known nerve irritant, which is known to destroy nerve tissue.

04:30While we were ablating with ethanol, we were able to locate the nerves, treat with that

04:36ethanol and watch on the screen as the nerve activity slowed down and then recovered after

04:41five to 10 minutes.

04:42And so it gives us a lot of confidence that we may be able to improve renal denervation

04:47procedures, which is a more recent and significant focus in the electrophysiology space in the

04:54industry today.

04:56These procedures right now are being done blind by physicians today and we expect visibility

05:02of that target nerve to make procedures safer, faster and more effective.

05:07And then Lori, what major inflection points can investors expect to see out of the company

05:12in the next six to 12 months?

05:14Well, our first in man proof of concept study that's underway right now in pancreatic cancer

05:20pain would be the first inflection point that investors should keep their eyes on.

05:24If we can demonstrate that our approach to mitigating pancreatic cancer pain is effective,

05:29then we're going to have validated our plan and significantly de-risked it.

05:35We can start to get early data from first patients over the coming weeks that we'll

05:39be able to share publicly.

05:40And if the results from this study, in fact, do demonstrate a new and effective way to

05:46combat the pain from pancreatic cancer, I would expect it to be meaningful to the market.

05:51We'll use the results from this clinical study and previously executed animal studies

05:56to apply for breakthrough designation with the FDA.

05:58If we're successful in that application and we receive breakthrough designation, that's

06:03going to further de-risk our regulatory path and could be impactful to perceived company

06:08value.

06:09We'll also be sharing some additional animal study work and getting very close to kicking

06:15off our pivotal study in pancreatic cancer pain within that 12 month period that you're

06:21asking about.

06:22So there are a lot of exciting developments to be watching for over the balance of the

06:26year and moving into 2025.

06:28Yeah, well, we're excited to cover those developments here at Benzinga.

06:31We'll be watching closely.

06:33Again, we've been talking to the CEO and director of Autonomics, Lori Bassan.

06:37Lori, thank you again for joining us today.

06:39And I know you're really busy, so I'll let you get back to work.

06:41Thanks, Aaron.

06:42Have a good day.

06:43You do the same.

06:51Thank you.

06:52Thank you.

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