Russ:  Hi I’m Russ Capper and this is HealthMakers.  Coming to you today from Columbus, Ohio, and my guest Peeyush Shrivastava, the Co-founder and CEO of Genetesis.  Peeyush welcome to the chow.

Peeyush:  Thanks for having me Russ.

Russ:  You bet.  Tell us about Genetesis.

Peeyush:  Genetesis is a clinical stage medical device company.  We’re based out of Mason, Ohio.  We’ve developed the Cardio Flux Magnetocardiograph; MCG for short.  It’s basically a technology that can rapidly rule out coronary artery disease in patients coming to the emergency room with chest pain.

Russ:  So it’s a technology that nobody has been using historically.  We’ve been using the same old way to diagnose for years right?

Peeyush:  Absolutely.  You start with an EKG which is pretty nonspecific, it’s wrong half the time but it’s easy to use.  And ultimately we do a lot more invasive testing like nuclear stress testing where you inject radioisotopes and shine a gamma camera on a patient to evaluate which parts of the heart aren’t taking up a radioisotope and those areas are blocked vessels.

Russ:  And this actually can take quite a long time really; you’re in pain, you’re in the emergency room, you’re probably feeling anxiety and it takes a long time for them to tell you whether or not you had a heart attack.

Peeyush:  That’s right, you have to treat every case as if it’s a potential heart attack.  Time is always pretty extensive in terms of the triage process for chest pain and there’s also a lot of cost associated with it, for example with the radioisotopes and the nuclear stress test, those are expensive.

Russ:  And your method, which is a non-invasive device, takes how long to diagnose?

Peeyush:  60 seconds for the scan and then a couple of minutes for the analysis report to be generated, so all together we’re talking a less than 7 minute process from start to finish.

Russ:  And the fact that it’s noninvasive does shorten the FDA approval process significantly right?

Peeyush:  It does.  It’s not just noninvasive, we’re not emitting any energy or even touching the skin so it’s definitely a nonsignificant risk device which makes us a Class II medical device; easier pathway.

Russ:  Sounds magic actually so tell us how it works.

Peeyush:  The same signal actually that the EKG measures – the electricity – the same moving electricity inside the heart generates a magnetic field.  So we’ve developed a technology where we can shield out the magnetic fields in the environment and only measure the field that’s generated directly from the heart.  So the sensors hang right above the chest, they’re just a single plain of sensors in a little box and we’re measuring that magnetic field and its multiple components.  And the software we’ve developed maps that magnetic field data back onto the chest, so what you’re looking at is this very data-rich movie file essentially of the moving magnetic field over time and that helps us diagnose coronary artery disease.

Russ:  What led to this discovery?

Peeyush:  I think a lot of these opportunities come by evaluating a disparity between what’s being done in the lab versus what’s being done in the clinic standard of care medicine.  So I got my start in basic science research and had seen that in the basic science world we were isolating heart cells and measuring the currents flowing through them.  And the closest thing we had to that in the clinic was doing an EKG or putting in catheters and even those type of approaches have strong limitations.  So my CO-founders and I saw ultimately an opportunity for us to translate something truly cutting-edge, something that not a lot of people had even heard of, and see it through to clinical use.

Russ:  Why haven’t other people heard of it?

Peeyush:  That magnetic field is really small.  It’s a needle in a haystack problem at its finest and so developing infrastructure around measuring that small magnetic field has typically been restricted to research use.  The only way it had been done in the past was creating huge, magnetically shielded rooms – kind of looked like the lunar module for example, that’s kind of the size that we’re talking about – and then very, very expensive liquid helium cooled sensors inside that closet-sized room and now we’re talking about a system that’s compact, patient-sized.  It took a lot of effort to get it there.  We started developing the business at a time where sensor technology, computing, all of these things that started converging at a very high technology level, so we took advantage of that fact and started building the full system.

Russ:  How many partners do you have?

Peeyush:  Four partners.

Russ:  Okay, so there’s four of you, how many employees are you at today?

Peeyush:  Including the partners twenty-three.

Russ:  Okay.  Are the other people all medical people like doctors and nurses?

Peeyush:  No.  We’re a very engineering-focused firm so we have talent from software development, artificial intelligence to electrical engineers to a full mechanical engineering team in-house.

Russ:  Wow.  So that’s to build actually the device right?

Peeyush:  Yeah, yeah we definitely didn’t start out that way.

Russ:  Oh, so how did you start out?

Peeyush:  When we had locked in that we were going to build this magnetic imaging platform we started off as a software company.  We thought we would build software for companies that are producing the device, that actual scanning part, but those didn’t exist.

Russ:  Wow, did you try to persuade some of the big medical device companies to build it?

Peeyush:  We did in the beginning.  We started with trying to convince smaller, more domain specific companies to try to build it and the technologies they were proposing were archaic.  So we thought we could do a lot better, so I hired our first mechanical engineer – when we were still a software company – and convinced him I’m bringing you on because you’re a problem-solver.  We’re not a device company today but I have a good feeling that something is going to happen where your skills will be put to the test.  And we’re a device company now.

Russ:  So interesting, but it probably made the execution of the plan more difficult too.

Peeyush:  It did, it did but also it’s a good risk mitigation tool for us to be at full systems integrator.  We have a foot in each aspect of the business development side of things.

Russ:  Well what about intellectual property along the way?  What all are you protecting?

Peeyush:  We have six patents; two issued, four pending.  Our IP spans everything from the front end device side of the technology to the software and the artificial intelligence algorithms.

Russ:  Wow, cool.  So back to the device itself, you’re still in this approval process but have you actually used it now on human beings?

Peeyush:  The device has been in investigational use in St. John Hospital in Detroit, Michigan since July.  Thus far we’ve scanned almost 200 people.  Results have been promising, we’ve submitted them and had them been accepted for presentation at a number of academic conferences leading up to our product launches at the end of the year at the American Heart Association.

Russ:  Peeyush I really appreciate you sharing your story with us, it sounds real exciting.  Keep doing what you’re doing.

Peeyush:  Thank you Russ, appreciate it.

Russ:  You bet, you bet.  And that wraps up my discussion with Peeyush Shrivastava, Co-founder and CEO of Genetesis.  And this is The HealthMakers.