After Basil Leaf Technologies won the Qualcomm Tricorder XPrize in 2017, founder Dr. Basil Harris needed help figuring out how to bring this almost-all-in-one diagnostic tool to market.
Basil Leaf’s mobile platform DxtER includes a group of non-invasive sensors that can wirelessly communicate with a smart device as they collect data on vital signs, body chemistry and biological functions. An artificially intelligent engine at the heart of DxtER learned to diagnose by integrating ER practices with data analysis from actual patients with a variety of medical conditions and outcomes.
A Philadelphia-area emergency room doctor with a PhD in engineering, Harris worked with his brother, network engineer George Harris, and their Final Frontier Medical Device team to invent their version of the tricorder of Star Trek fame. Armed with the $2 million XPrize, Harris started shopping DxtER around to device development companies. He chose Smithwise of Newtown Square, Pa. and Newton, Mass. to help with engineering and regulatory issues.
But DxtER had a problem. The platform had too many potential uses to become a single product.
“That’s a little bit like trying to boil the ocean in medical device,” said Eric Sugalski, Smithwise founder and president. “You need to focus in on a specific patient population and figure out what problem you’re trying to solve in that patient population.”
Harris settled on heart failure as the first use for DxtER because it would demonstrate the bulk of its sensors. Heart failure is also a major malady among of Harris’ ER patients and a leading cause of hospital readmittance. Rather than marketing DxtER as diagnostic, the first iteration is being designed to help physicians manage heart failure patients to keep them as healthy as possible and out of the hospital, Harris said. Patients would use it at home to measure their vital signs and notify their doctor if something seems amiss.
“We’re using some unique measurements to really predict whether this patient is heading toward a decompensation event, when their heart failure really gets out of control,” Harris said. “We can predict when they are headed toward this before they’re even feeling major symptoms. Then we can intervene with the same medications, but we’re catching it early enough that we can keep them out of the hospital… If the patient’s picking up the phone and calling 911, we’ve already lost the battle.”
After Harris identified the target patient population, Smithwise started designing the clinical strategy, then the regulatory and payer aspects of that population. Now the product is in the design phase. All of this had to happen before the company could launch its first clinical trial, something that Harris had hoped would have begun months ago.
Basil Leaf is like many other medtech startups whose leaders are focused on obtaining initial clinical data to prove their value proposition, Sugalski said. That especially applies to companies developing a diagnostic device such as DxtER. Other startups want to dive into manufacturing without considering some of the big questions surrounding payers and economics, Sugalski added.
DxtER’s first clinical trial is set to begin next year at Harris’ base, Lankenau Medical Center in Wynnewood, Pa., and at the University of California at San Diego. He hopes to enroll up to 150 patients, and expects the trial to last a year. DxtER has been through a few institutional review board reviews at Lankenau and will have two or three more there as well as at UCSD, according to Harris. From the FDA, he expects that the device will need 510(k) approval for basic functions and then either PMA approval for the overall device or more 510(k)s for more advanced functions. The company also needs to build trust in the AI that it demonstrated in the XPrize competition among cardiologists, according to Harris.
He has learned a lot from the development process.
“It’s been great with Eric and Smithwise because they’ve been able to really get us focused and get us on track in a very logical trajectory (and) streamlined what we were thinking of,” he said. “I was trying to go all the directions at the same time and it was really not sustainable.”