Acutus Medical

human heart
Randy Werneth
CEO: Randy Werneth
Based: San Diego
Founded: 2011
Company website

The scoop 

Atrial fibrillation describes an irregular heartbeat that can lead to blood clots, stroke, heart failure and other complications. It is treated with catheter ablation, which creates small scars in heart tissue so that it can no longer conduct or sustain the arrhythmia. While several effective ablation tools are on the market, the key problem holding the success rate of these procedures around the 50% mark, said Acutus CEO Randy Werneth, is we don’t know where to ablate.

Acutus is trying to fix that.

Electrophysiologists currently use voltage-based mapping to determine where to ablate. The physician creates a low-resolution map of the heart ahead of the ablation procedure by touching the heart tissue in several places with a catheter, one location at a time. Acutus’ CE-marked AcQMap system tracks a patient’s arrhythmia in real time, generating a high-resolution, three-dimensional view of the heart chamber and its electrical activity. The company hopes to bring the 50% ablation success rate up to 100%.

What makes Acutus fierce

AcQMap uses a mapping algorithm based on dipole density, or the actual, localized source of heart activity. Voltage measurements are not as precise because they not only include localized charge sources in an area of tissue but also blend in the sum of the charge sources surrounding the area in question. This makes it difficult to discern the actual charge source using voltage.

With AcQMap, electrophysiologists may, for the first time, see a complete picture of the heart and atrial fibrillation in real time. As ablation continues, the map updates itself with each heartbeat. AcQMap identifies how each application of ablation affects the heart rhythm, and, based on this feedback, the physician may adjust and continue delivering ablation until the procedure is considered successful. This evidence-based approach takes the guesswork out of an empirical-based strategy and allows ablation to be individualized to each patient.

In March last year, the company raised $75 million in a Series C and counts GE Ventures, Advent Life Sciences and OrbiMed among its backers. "The rapid pace of progress in the past few years has brought Acutus from an early stage startup to a company on the verge of a commercial launch," Werneth said at the time.

The system snagged a CE mark in May and is currently in a study, dubbed UNCOVER-AF, to assess its safety, effectiveness and efficacy at guiding ablation in patients with persistent AFib. The study, which is taking place at 15 sites in Canada and Europe, involves “untreatable” AFib patients; that is, patients who are not eligible for ablation based on current technology and outcomes.

What to look for

With a CE mark in the bag, Acutus is anticipating FDA clearance by the end of 2017. The company will be spending the year focusing on clinical validation and preparing for regulatory approval.

“We need to prove beyond a shadow of a doubt, with irrefutable evidence that what we say is validated and verified across centers and studies,” Werneth said. “2018 is when we will get started commercially.”

While Acutus doesn’t plan to branch out from AFib anytime soon, it is considering expanding the AcQMap system for use in treating other complex arrhythmias, such as ventricular tachycardias and left ventricular flutter, Werneth said. The system may also have applications in drug studies: Because AcQMap images at the cellular level, researchers could potentially use the technology to show in real time if a drug does or does not work for a particular patient. — Amirah Al Idrus, @FierceBiotech

Acutus Medical