Analytics 4 Life has raised a total of $35m, the most recent being a $25m Series B closed in September, to carry it through US FDA clearance of its CorVista noninvasive system for diagnosing coronary artery disease based on intrinsic signals from the heart without radiation, contrast agents or cardiac stress.
The Series B financing was supported by an international syndicate of accredited investors, including physicians, health-care professionals, and medical device experts, according to the company. "We've raised about $35m all through private investment – with no institutional or venture capital funding, and we intend to stay on that pathway," Crawford said. "This gives us all the runway we need to get to FDA clearance, and then some."
By the second quarter of 2018, the company will submit to FDA data on 606 patients comparing CorVista to coronary angiogram, the gold-standard test for coronary disease. The results show the CorVista test is 92% – comparable to nuclear stress-testing or EKG testing – with a 96% negative predictive value, according to the company. The firm is seeking FDA clearance via the de novopathway.
"Ultimately, the benefit and the value of this test is that the patient doesn't have to prepare anything the day before or spend a whole day off of work. They can do it in one office visit. The device does the recording and by the time they're in to see the physician, they have a three-dimensional report in their inbox," Analytics 4 Life CEO Don Crawford told Medtech Insight.
Once FDA clears CorVista, Analytics 4 Life will support a targeted direct sales strategy to market it to "key centers," and then start another "major trial to support adoption and look at the economic metrics," Crawford said.
While most imaging modalities project energy into the body and then collect the signal that returns to construct an image, CorVista collects signals naturally created by the heart. "The heart is a pump that produces a tremendous amount of energy," he said.CorVista collects voltage gradient data produced by the heart, in three dimensions, with six standard electrodes, just like a standard EKG, and then turns the data into images with a mathematical approach called phase-space analysis. Analytics 4 Life has developed a unique microprocessor that can synchronize the leads so that each lead is precise to within ten femtoseconds. During the three-minute scan, CorVista collects 8,000 data-points a minute for a total of more than 10 million data-points.
Crawford explained that while phase-space analysis was first developed in the 19thcentury and developed for military applications for many years, only recently has the cloud-computing and sensor-synchronization technology advanced to the point where it could be applied to cardiac diagnostics.
He envisions the CorVista test becoming one of the noninvasive diagnostic options available to doctors treating patients with suspected coronary disease, which currently includes cardiac MRI, echocardiogray and computed tomography angiography. Each modality has different costs, accuracies and risks, Crawford said.
"Ours will just be one of those five or six tests, but with the key benefit that our device requires no ionizing radiation or contrast. We do not require the patient to stress themselves with pharmacologic agents. It requires minimal time for the patients," he said. "This system holds promise for value-based health care. Will [doctors] use our system versus a CT angiogram or a nuclear scan? Well, that will be answered with time and physician experience, but there are a lot of advantages that we can see to this, and many of our physicians have told us that."