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Acutus Medical Receives CE Mark for the AcQMap™ 3D High Resolution Imaging and Mapping System

May 4, 2016
  • Company to initiate commercial activities for next-generation imaging and mapping system in the European Union.
  • Leading Physicians to offer clinical data and demonstrations at Heart Rhythm Society Conference.

CARLSBAD, CA—May 4, 2016—Acutus Medical, an electrophysiology company committed to transforming how electrophysiologists (EPs) image, diagnose and treat complex arrhythmias, today announced CE Mark approval for its AcQMap™ High Resolution Imaging and Mapping System and AcQMap™ Catheter, enabling the company to initiate commercial activities.

“The CE Mark approval of our AcQMap System marks a significant milestone for the company and for the EP community. AcQMap will provide for the first time, the ability to unlock the mysteries of cardiac activation by truly mapping complex arrhythmias in real-time, enabling clear identification of mechanisms, and providing an accurate guide for ablation therapy,” said Randy Werneth, President and Chief Executive Officer of Acutus. “This approval comes on the heels of our $75 million Series C financing, which will be instrumental in building out our commercial operations in the European community and beyond.”

About AcQMap High Resolution Imaging and Mapping System

The AcQMap High Resolution Imaging and Mapping System is the first and only system to detect and display both standard voltage-based and higher resolution charge-source (dipole density) maps. The system is also able to generate real-time, 3D images of the heart chamber using ultrasound with quality comparable to a CT or MRI in a matter of minutes. Dipole, non-contact mapping creates a highly accurate, instantaneous global view that captures the activation pattern of every heartbeat making it uniquely capable of mapping and displaying both stable and unstable cardiac arrhythmias.

“During a recent AcQMap procedure, we were able to systematically map atrial fibrillation (AF) and eliminate the identified sites of interest, ultimately restoring the patient to their native rhythm,” said Andrew Grace, M.D., Ph.D., from Cambridgeshire, UK-based Papworth Hospital. “The ability to map and quickly remap after each set of ablations makes it possible to truly visualize AF and to achieve sinus rhythm.”

The AcQMap High Resolution Imaging and Mapping System is not available for sale in the U.S.

Heart Rhythm Society Meeting

AcQMap will be the subject of two poster presentations at the Heart Rhythm Society Meeting in San Francisco, May 4-7. Presentations are both scheduled for May 5th as follows:

Date: Thursday, May 5, 2016 from 2:00 – 5:00 p.m.
Title: Noncontact Dipole Density Mapping of Complex Atypical Flutters Using an Ultrasound-Electrode Array Catheter: Comparison to Conventional ContactMapping - PO03 – 103.
Presenter: Vivek Reddy, M.D., Homolka Hospital, Prague, Czech Republic
Location: EPicenter, Hall D

Date: Thursday, May 5, 2016 from 2:00 – 5:00 p.m.
Title: Novel Ultrasound-based Imaging and Global Dipole Density Mapping: Feasibility in Persistent Atrial Fibrillation – PO03 – 106.
Presenter: Julia Moser, M.D., Department of Electrophysciology, University Heart Center, University Hospital Eppendorf, Hamburg
Location: EPicenter, Hall D

Acutus will also be offering live demonstrations of the AcQMap System and featuring case studies at Booth #1639. In addition, Andrew Grace, M.D., Ph.D., Stephen Willems, M.D., Ph.D., and Atul Verma, M.D., will be presenting interesting AcQMap case studies in the booth on May 5th and 6th.

About Acutus Medical

Acutus Medical is a global heart rhythm technology company transforming the way electrophysiologists (EPs) diagnose and treat cardiac arrhythmias. Acutus Medical is a privately held company located in Carlsbad, CA. To learn more, visit https://www.acutusmedical.com.

Forward Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development, and clinical and regulatory milestones. We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Acutus Medical expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.