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

CARLSBAD, Calif.–(BUSINESS WIRE)–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 re-map 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 5^th 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 Contact
Mapping – 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 5^th
and 6^th.
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
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to many risks and uncertainties. Forward-looking statements include
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ongoing and planned product development, and clinical and regulatory
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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.