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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