Caution – Investigational Device. Limited by Federal Law to Investigational Use. CorVista™ is not available for commercial distribution.
Human body emits all kinds of signals that, if analyzed with the proper sensors and computers, can help us develop completely new diagnostic and therapeutic modalities. Most medical technology advancements are improvements of existing devices, but some people try for bigger leaps.
Analytics 4 Life is a company based in Toronto, Canada, that is developing a new technology called Phase Space Tomography, which doesn’t require any radiation and is easy on the doctor and patient to administer. The company hopes that one day its technology may become a standard part of cardiac workup. We had a chance to ask Don Crawford, CEO of Analytics 4 Life, a few questions about how the technology works and what it could mean for the practice of medicine.
Medgadget: To start us off, please give us a summary of the technology Analytics 4 Life has developed and how it’s to be used in clinical care.
Don Crawford, Analytics 4 Life: Analytics 4 Life is pioneering digital health using artificial intelligence to develop a completely new form of medical imaging. By combining advancements in artificial intelligence, cloud computing, and digital technologies with a novel approach to cardiac imaging based on advanced disciplines of mathematics and physics, we are developing CorVista, a non-invasive, physician-directed diagnostic test that aims to assist physicians in identifying the presence of coronary artery disease (CAD) without radiation, cardiac stress, contrast agents, or patient fasting.
A CorVista procedure can be broken down into four simple steps:
- First, the patient undergoes a CorVista scan where signals naturally emitted by the heart are collected while the patient is at rest.
- After the scan, the patient’s phase signal data is automatically transferred to our cloud-based repository for…
- Cloud-based analysis. There, advanced methods of mathematics and machine-learned algorithms transform and analyze the data to produce clinically meaningful results.
- These results are available on a secure, web portal for physician interpretation and physician-patient consultation, which in combination with a patient’s medical history, risk factors, and symptoms, could be used by the interpreting physician to recommend further treatment.
The current diagnosis paradigm for significant CAD entails an escalating pathway of risk, time, and cost in exchange for better accuracy. Typically, a CAD diagnosis starts with a patient going to their doctor complaining of chest pain. The doctor will perform a physical examination and consider other factors like a patient’s medical history. From there, oftentimes a resting—meaning no cardiac stress—EKG is performed on patients considered ‘at-risk’. Under the physician’s discretion, a patient could then be sent for further testing using one or more tests, including nuclear stress testing, stress echocardiography, stress EKG, and CT angiography, before ultimately heading off to cardiac catheterization (coronary angiography or “cath lab”) for definitive diagnosis and treatment. We aim for CorVista to be a new, pre-cath lab cardiac imaging diagnostic with comparable accuracy to other functional tests, but without the radiation exposure, heart rate acceleration, and injections of contrast agents.
CorVista is an investigational device limited by federal law to investigational use. CorVista is not available for commercial distribution. It is currently undergoing a two-stage clinical study at 13 sites in the U.S. to support algorithm development and regulatory filings. The ongoing study, with more than 2,000 patients enrolled so far, will develop and measure the performance of a machine-learned algorithm for CAD detection to gold-standard cardiac catheterization results.
Medgadget: What hardware does your system rely on? What biosignals do you measure?
Don: We have developed a proprietary, hand-held digital device that we call the “Phase Signal Recorder (PSR) device”. This device scans a patient’s phase signals emitted from the chest cavity over 3.5 minutes while the patient is lying down using 7 sensors attached to the patient’s chest and back.
We capture an unfiltered phase signal that contains approximately 10 million data points. Specifically, the PSR device scans the unfiltered voltage gradient at a rate of 8,000Hz at each of six observation points on the patient for 210 seconds, time-synced to 10 quadrillionths of a second (10 femtoseconds), effectively capturing all sources of energy originating from the thorax (from intrinsic physiologic processes such as, but not limited to, electrical conduction, myocyte mechano-electric transduction feedback, responses to the autonomic nervous system, and peripheral resistance).
Beyond our proprietary PSR device, CorVista relies on an Internet-connected device (e.g., computer, phone, tablet, etc.), where a physician can access patient results on our secure, web portal.
Medgadget: Can you give us an understanding of what Phase Space Tomography is and how it’s used in your product?
Don: Phase space analysis is a well-known, advanced field of mathematics and physics used to model dynamic systems (such as the heart). We are pioneering phase space analysis in healthcare, using our proprietary approach to the field, Phase Space Tomography, a novel form of medical imaging.
Phase space analysis is currently used by the military for applications such as missile navigation and defense. In fact, our founder was working on phase-space-based technologies for the Royal Military College of Canada when he was inspired by its potential application in healthcare and more specifically, heart disease. He was utilizing a synchronous array of sensors to collect energy being emitted by missiles from radars to plot their trajectory. Just as militaries use phase space analysis to map out a missile’s course, we use Phase Space Tomography to measure and model cardiac signals with a synchronous array of sensors attached to the chest cavity.
After scanning a patient’s phase signals, the signal package is instantaneously transmitted to the cloud, where it is analyzed by a machine-learned algorithm to generate a unique Phase Space Tomographic image and a heart model indicating areas of potential heart disease (ischemia) associated with the presence of CAD. The results of the test are displayed on a secure, physician web portal that, in combination with a patient’s medical history, risk factors, and symptoms, can be used by the interpreting physician to recommend further treatment.
Medgadget: Your technology is designed for cardiac diagnostic applications. Do you expect that it can be applied to other fields of medicine as well?
Don: Yes, we believe that there are a number of diseases where organs are emitting energy that Phase Space Tomography and our AI platform could be applied, within cardiology (e.g., heart failure, etc.) and beyond. In fact, the brain emits even more energy than the heart! However, right now, we are 100% committed to bringing CorVista, our potentially game-changing cardiac imaging technology, to physicians and patients in need of better ways of assessing coronary artery disease (CAD), because it is the #1 cause of death worldwide.
Medgadget: Please tell us about the clinical study that is currently being conducted to evaluate your company’s technology.
Don: CorVista is currently undergoing a two-stage clinical study at 13 sites in the U.S. to support algorithm development and regulatory filings. The ongoing Coronary Artery Disease Learning and Algorithm Development (CADLAD) study already has more than 2,000 patients enrolled and will be used to develop and measure the performance of a machine-learned algorithm for CAD detection to gold-standard cardiac catheterization results. At TCT 2017, we will be presenting preliminary results from a 606-patient cohort as well as data on some of the most difficult-to-diagnose subpopulations: females (vs. males), obese, and elderly patients. In fact, these subpopulations were specifically highlighted in the FDA’s response to our pre-submission package earlier this year.
Medgadget: Given positive outcomes of this study, what are your next steps before seeking a marketing green light from the FDA?
Don: As auspicious as the preliminary CADLAD data that our principal investigator, Dr. Thomas Stuckey, presented at TCT 2017, we remain focused on completing enrollment in the study in November of this year and submitting our application to the FDA in the first half of 2018.
Medgadget: Would you tell us a bit about your background and how you came to be the President and CEO of Analytics 4 Life?
Don: I have over 25 years of medical device sales and marketing experience with positions of increasing responsibility at Medtronic, Guidant Corporation (now Boston Scientific), Ventritex, and Intermedics, including an international sales director role in Japan, where I was charge of a $100 million cardiovascular business. In 2008, I founded Sapheon Inc., a cardiovascular-focused medical device company, and led it to a $238 million acquisition by Covidien in 2014.
Interestingly, my appointment as President and CEO of Analytics 4 Life can ultimately be traced back to our capital raising strategy at Sapheon (and now at Analytics 4 Life). Sapheon was founded at the worst possible time—right in the depths of the Great Recession. It was very difficult for medtech startups to raise money from institutional investors, so we had to get creative, and that’s how we came upon targeting accredited investors. It worked splendidly, and investors were pleased. And coincidentally, that’s how I wound up at Analytics 4 Life; one of Sapheon’s investors was an early investor in Analytics 4 Life. After the Sapheon exit, he connected me with the team and the rest is history!
