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| CADence device--Courtesy of Aum Cardio |
A startup that's aiming to make the diagnosis of obstructive coronary artery disease part of a physician office visit has raised $5 million as it heads into a European launch of its CADence device. The company, Aum Cardiovascular--named after a Sanskrit syllable that means "to make a continuous low humming sound"--gained a CE mark for the device earlier this year.
The startup is headed by industry heavyweights from the Stanford Biodesign program and the upper echelons of Medtronic ($MDT) management. The CADence device is already in a 729-patient, U.S. pivotal trial that's slated to report final data in October, according to a recently updated description in clinicaltrials.gov.
Currently, a diagnosis of obstructive coronary artery disease can be determined by a number of methods including electrocardiogram (ECG) via a Holter monitor, echocardiogram, stress test, angiogram, computed tomography and magnetic resonance angiography. But these methods all have in common that they primarily rely upon in hospital or in clinic diagnostic testing, although smartphone-based ECGs are already available from startup AliveCor.
The CADence device relies upon the detection of sounds that are associated with turbulent blood flow through partially blocked or restricted arteries. The approach is somewhat similar to that used in blood pressure measurement. Also, like those in the coronary arteries, blockages in the carotid arteries can be detected by the sounds they produce.
The tiny startup has quite a distinctive team. Its CEO is Dr. Marie Johnson, who trained in the Stanford Biodesign program and launched the University of Minnesota Medical Devices Innovation Fellowship program.
Also part of the executive team is Dr. Susan Alpert, who was previously SVP and Chief Regulatory Officer at Medtronic. In that position, she was responsible for all of its regulatory efforts. She's also been VP of Regulatory Sciences for C.R. Bard ($BCR) and worked in the FDA as the Director of the Office of Device Evaluation.
- here is the SEC filing
- and the U.S. pivotal trial description