ST. LOUIS and CARLSBAD, Calif., March 15, 2019 — Stereotaxis (OTCQX: STXS) and Acutus Medical today announced the first patients have been successfully treated utilizing integrated Stereotaxis Robotic Magnetic Navigation and Acutus AcQMap systems. The integrated technologies are cleared for use in Europe with additional regulatory clearances expected in the coming months.
The therapeutic approach used in these first patients combines high-resolution real-time cardiac imaging and mapping from Acutus’ AcQMap system with the unprecedented precision and stability of the Stereotaxis Robotic Magnetic Navigation system. The integration of these advanced technologies enables physicians to clearly see a patient’s arrhythmia pattern and then reach those targets to deliver therapy with the accuracy of robotic navigation. The first integrated procedures were conducted by Dr. Tamas Szili-Torok of Erasmus Medical Center in Rotterdam, The Netherlands.
“When you combine an advanced mapping technology that shows you the potential locations to treat the patient with a robotic technology that gets you there more rapidly, precisely and safely, you improve patient care and the physician experience simultaneously. Physicians are safer, patients are safer, procedure time may be shortened with a potential for a reduced likelihood of additional procedures,” said Dr. Tamas Szili-Torok. “Integration of the technologies worked smoothly and provided an enhanced workflow. The procedures went very well, with successful treatment of patients with atrial arrhythmias in a safe and efficient fashion.”
AcQMap uses high-resolution ultrasound imaging and charge density mapping to create a clear visual display of the patient’s cardiac anatomy and arrhythmia conduction pattern in real time, informing ablation strategy beyond the pulmonary vein. Physicians can then use Stereotaxis Robotic Magnetic Navigation to steer the catheter according to their treatment strategy, allowing for precise guidance in areas of the heart that can be challenging to access. Physicians remain in a control room during the procedure, reducing radiation exposure that can lead to cancer and other debilitating health issues.
“Precision is critical when treating cardiac arrhythmias. Understanding a patient’s specific arrhythmia conduction pattern allows a physician to intuitively navigate an ablation catheter and treat the most challenging patients,” said Vince Burgess, Chairman, President and CEO of Acutus Medical. “We’ve created an integrated treatment option that prioritizes physician safety and leads to quality outcomes that improve lives. The ability to iteratively re-map in less than two minutes following each ablation step further enhances the appeal of this adaptive therapeutic approach. It’s a winning solution that every hospital should provide.”
“The successful integration of the Stereotaxis and AcQMap systems allows physicians and patients to seamlessly receive the benefits of both world class technologies,” said David Fischel, Chairman and CEO of Stereotaxis. “Using Stereotaxis’ robotic technology, electrophysiologists are able to enjoy the benefits of unparalleled patient and physician safety and exceptional catheter stability, all while seated away from the x-ray source in the control room. Our collaboration is premised on a shared vision that open ecosystems – stimulating collaboration and increasing choice – are positive for patients, physicians, providers, and medical progress.”
About Acutus Medical
Acutus Medical is a dynamic arrhythmia care company focused on developing distinct, innovative technologies that provide physicians and patients with improved results. At Acutus, we know that seeing is better than believing. Diagnosing and treating patients with atrial arrhythmias requires eliminating the unknown. Acutus’ advanced cardiac imaging and mapping system provides real-time arrhythmia visualization displaying the heart’s true activation pattern, turning the chaos of an atrial arrhythmia into a clear vision for electrophysiologists. Founded in 2011, Acutus is based in Carlsbad, California.
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Over 100 issued patents support the Stereotaxis platform. The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Japan, Canada, China, and elsewhere.
This press release includes statements that may constitute “forward-looking” statements by Stereotaxis (the Company), usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness, or to obtain additional financing, in either case on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
SOURCE Acutus Medical; Stereotaxis