Acutus Medical Inc. is working to build itself into a major competitor in cardiac electrophysiology. The latest step to do so is an FDA clearance for its second-generation cardiac mapping software known as Supermap. This works in conjunction with its next-gen Acqmap 3D Imaging and Mapping System.

The Carlsbad, Calif.-based startup, which was founded in 2011, is now marketing these in both the U.S. and Europe, where Supermap received a CE mark in October 2019. Its initial system and software were aimed specifically at the most complex arrhythmias, but the latest iterations are intended to provide electrophysiologists with tools that can be used routinely across a wide variety of arrhythmias to enhance the accuracy, efficacy and speed of the procedure.

A better tool?

“The goal of both the gen-two system and gen-two software Supermap was to evolve the system, which was a special purpose system and catheter to go after only really complex arrhythmias, and turn it into a system that has the ability to be ubiquitous and used in virtually any electrophysiology case in the atrium,” Acutus President and CEO Vince Burgess explained to BioWorld.

“It’s kind of a Swiss Army knife that can be used in any case; it has really highly differentiated capabilities in mapping some of those complex and challenging cases that physicians face on a daily basis,” he added.

The current standard of care in electrophysiology is to create a contact map of the heart based on the electrophysiologist repeatedly touching a catheter to different points in the heart. That approach relies upon the luck and skill of the practitioner to identify the relevant point in the heart that would benefit from ablation to restore a more normal heart rhythm. After the electrophysiology procedure, the heart usually is not tested to see if the goal was achieved and repeat procedures, which can result in accumulation of scar tissue, are not uncommon.

The second-gen system from Acutus is the only one to offer a trio of mapping modalities for use in electrophysiology: the standard contact mapping, non-contact mapping and non-contact hover mapping. The last is enabled by and known as Supermap. This technique enables the insertion of a catheter and creation of a whole-chamber map of the left or right atrium by simply placing it close to the patient’s anatomy, rather than requiring contact at a given point.

This enables an electrophysiologist to quickly map a heart chamber in just a few minutes, allowing the mapping and remapping of the heart throughout and after treatment as needed.

The next-gen system has been available in full in Europe for a few months--and Acutus is starting to get feedback. "In less than three minutes, the Acqmap system can map the entire chamber to clearly identify re-entrant circuits, regions of slow conduction and focal origins,” noted Tom Wong, an electrophysiologist with the Royal Brompton & Harefield NHS Foundation Trust in London. “The Automatic Beat Grouping algorithm of Supermap is helpful to map alternating or changing atrial tachycardias by categorizing and displaying multiple tachycardias occurring at the same time.”

Acutus has already shipped its first fully gen-two systems to Europe and is rolling out another eight or nine into the U.S. market. Electrophysiologists are just starting to test and present their experiences using it cases.

"We recently completed an extraordinary case with the Acutus system and Supermap. We captured three whole-chamber maps, targeted three ablation sites, and the patient left in sinus rhythm – all in the span of one hour," said Arjun Gururaj, an electrophysiologist at Nevada Heart & Vascular Center in Las Vegas.

"These are notoriously complex atrial tachycardias that the EP community knows about,” he added. “Supermap can show potential sources and likely mechanisms in those complex cases in minutes as opposed to hours with conventional systems – because we are seeing things that we couldn't see before. Now we may be able to do something about it in far less time with better acute results. It has amazing potential."

Personalized treatment

Acutus is currently in the midst of the prospective, single-arm RECOVER AF trial in 100 patients with recurrent atrial fibrillation after a failed ablation. The data is anticipated in March. The company is also initiating a registry study that will evaluate all its various mapping modes.

The long-term vision for Acutus is to have a full suite of electrophysiology products to take on the top market players, which include Abbott Laboratories, Boston Scientific Corp. and Medtronic plc, by offering technology that is novel and increasingly advanced but also accommodates a wide range of mapping and ablation approaches.

On its way, Acutus has already acquired numerous smaller companies and technologies, as well as setting up in-licensing and distribution partnerships. It’s already integrated with the EP robotic surgery platform from partner Stereotaxis Inc. and it’s also working with catheter reprocessing company Innovative Health in order to reduce supply costs.

Last June, Acutus racked up a $170 million financing that included a $100 million series D round alongside a $70 million credit facility. The cash infusion is slated to help the company to commercialize and to expand globally. Its investors include some high-profile life sciences investor names such as Orbimed, Deerfield Management Company and GE Ventures.

“We are in a large, very complicated and competitive space with a very quickly growing company of over 230 people in the U.S. and Europe,” summed up Burgess. “Our plan is to remain independent and to really bring options to a field that has for the last couple of decades only had a few players for this technology.”

“We're really focused on bringing individualized diagnosis and therapy to each and every patient that shows up on the table, rather than a cookie-cutter approach. We are focused on speeding procedures, lowering costs and improving outcomes.”