BioAffinity Technologies

00:03Thank you for tuning in to this edition of NASDAQ amplifies Issuer Spotlight,

00:08where we feature conversations with leaders from some of

00:10the world's most innovative and growth oriented small cap companies.

00:13Today, I'm joined by Maria Zins,

00:15President and Chief Executive Officer of NASDAQ listed Bio Affinity Technologies.

00:20Maria, thank you so much for being here.

00:21Thank you for having me. I.

00:23Can you start by telling us a little bit about Bio affinity and what you're working on?

00:27Sure, Boafinity is a biotech company that has developed and

00:31now is commercializing a test for the early detection of lung cancer,

00:35which is not only our nation's largest leading cancer killer, but also the world's.

00:40Our test is non invasive,

00:42and it's used for individuals or used with individuals,

00:45most often who have had a CT scan,

00:48who have had some type of imaging that shows a pulmonary nodule.

00:52And with that, the doctor often is not sure what's next step,

00:56and that's where our test comes in.

00:58People collect their sample.

01:01They collect a sputum sample at home.

01:03The privacy of their home,

01:05and they overnight it to our laboratory where it's processed.

01:08We've had really quite impressive performance in our clinical trials,

01:13so we're very excited to bring it to market,

01:15which we're doing now. Sure.

01:17And you actually brought the side path test with you,

01:19right, for early screening.

01:21I did. Well, I brought what I brought was basically the kit that is taken home that has

01:26a small collection cup it and a Federal Express pack to send the sample back overnight.

01:32And then instructions, of course.

01:34We also provide for both physicians and their patients

01:37very simple instructions and videos as to

01:40how to collect your sputum over that three day period. How simple is it?

01:44How exactly does it work?

01:45You know, lung cancer is not simple.

01:48So I don't want to give the impression that this is a test

01:51that it certainly is easy to perform for patients,

01:55but it's quite sophisticated in its approach and how we find early lung cancer.

02:02For patients, they get that small cup.

02:05They have a patient coach if they need so.

02:07They have videos. They have instructions as to how to collect, and then they overnight.

02:12So that patient journey is relatively simple and straightforward.

02:17Once a sample gets to the lab,

02:21the lab does something called it dissociates.

02:24It takes that mucus, that is our sputum,

02:27and it makes it into a single cell suspension.

02:30We run that sample through a flow cytometer,

02:34and what the flow cytometer allows us to do is look at cell populations.

02:39This is a test that looks at the lung micro environment.

02:43It's not looking at DNA.

02:45It's actually looking at how

02:47the lung has changed because of the presence of a malignancy.

02:53What is the competitive landscape currently look like and what differentiates

02:57your product CyPath from other early detection diagnostic tests?

03:02Unfortunately, for patients and their physicians,

03:05there are not many, if any,

03:07really non invasive tests like ours where we help to move forward.

03:12So for a patient who has a lung nodule,

03:15there are several courses of action.

03:17One is just a wait and see.

03:19In other words, it's a small nodule.

03:21And most I want to emphasize most lung nodules,

03:25most pulmonary nodules are benign.

03:27So I don't want people to be overly frightened over them,

03:31but often a physician determines that they should move forward with something.

03:36Unfortunately, most of the time,

03:38it's a wait and see to see if the nodule tumor,

03:42if it is a tumor has grown or not.

03:45And so that brings some anxiety.

03:48That's where our test comes in.

03:49In addition to which, you may have

03:52more aggressive approach where there's a bronchoscopy done or there's biopsy done.

03:57But often, as I said,

03:59these nodules are benign, and so therefore,

04:02it's important to have something like our test like

04:05cypathblung that can help guide the patient and guide

04:09the physician to the proper next step where we don't have

04:13unnecessary procedures or necessary anxiety over what's next.

04:19I'd like to also point out we recently published or I should say,

04:24two physicians recently published a paper,

04:27looking at the cost savings to healthcare

04:30because if we use psypath when we use psypathine.

04:35It was two physicians,

04:36one from the VA, doctor Sheila Habib,

04:38and another from the Brook Army Medical Hospital,

04:41so a military pulmonologist, doctor Morris.

04:44What they did was they took 2022 data and they said,

04:49What if during that time,

04:51we provided our patients who had indeterminant nodules.

04:56In other words, had patients who had

04:58nodules physicians wouldn't know what to do with next,

05:01and we gave them Cypath.

05:03What would be the savings to healthcare?

05:05And they found if they assumed just a Medicare population that we

05:10would save close to $3,700 per patient in using this.

05:15And if we looked at a population and assumed that it was private payer,

05:19it would be greater than $7,000 per patient.

05:22So what that means is that using pipath in the pathway of diagnosis can

05:29not only find cancer earlier or relieve

05:32anxiety by saying that you do not have lung cancer,

05:36but it also can save our healthcare system and our individual patients money.

05:40So what does the future look like for bioaffinity?

05:43And what does success look like?

05:45Success looks like certainly nationally and internationally,

05:50selling, offering cypath lung.

05:52And for that, we have a strong patent portfolio,

05:54and we're just starting to move out into the national arena.

05:59We started this year in our own backyard, which is a big backyard.

06:03We're in San Antonio, Texas,

06:04so we started to commercialize in Texas and have seen very,

06:08very good adoption from our physicians.

06:11So this is a much needed test,

06:13and then we'll be moving into a national stage this next year.

06:17Towards that regard, we just recently heard in October that the VA had approved the test,

06:25had awarded the test, the ability to be on what's called the federal supply schedule.

06:30And that opens up sale of this test to our veterans and to our military,

06:34to others in government who can use this test.

06:37So that's a very important part.

06:39But in addition to cypath lung,

06:42ours is a platform technology.

06:44So we're also looking at and developing tests for other lung diseases such as COPD,

06:51asthma as a companion to bronchoscopy.

06:54So there's a number of different additional tests that we'll bring to market,

06:58as well as looking at CyPath to find and

07:02detect other cancers such as prostate or bladder cancer.

07:07Those are a little behind the other in the pipeline,

07:11but certainly a possibility.

07:13And we look forward to seeing that.

07:15One last question for you.

07:16Please. Obviously, we're here at NASDAQ Market side in Time Square.

07:20You're a NASDAQ listed company.

07:22So what role have the public markets played in advancing your mission?

07:25And what does NASDAQ represent to you?

07:27NASDAQ has been just a wonderful partner to us in getting not only the word out,

07:33but also having the ability to get the funds for operation.

07:39It's a tough market right now,

07:41but I have to say that being on NASDAQ has been just an excellent experience for us.

07:46Oh, we're so excited to have you be a member of

07:49the NASDAQ family and applaud you for everything you're doing.

07:52I think that's a great place to leave it.

07:54If you want to learn more about Boaffinity technologies,

07:57they trade right here on NASDAQ under the symbol BIAF Maria,

08:02thank you so much for being here.

08:03Remember, early detection saves lives. Thank you all for watching.