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Acutus Medical

Aug 06
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Acutus Medical Announces Pricing of Initial Public Offering

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

August 6, 2020

CARLSBAD, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (NASDAQ: AFIB) today announced the pricing of its initial public offering of 8,823,529 shares of its common stock at a price to the public of $18.00 per share. All of the shares are being offered by Acutus. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Acutus, are expected to be approximately $158.8 million. The shares are expected to begin trading on The Nasdaq Global Select Market on August 6, 2020, under the symbol “AFIB.” The offering is expected to close on August 10, 2020, subject to the satisfaction of customary closing conditions. In addition, Acutus has granted the underwriters a 30-day option to purchase up to an additional 1,323,529 shares of Acutus’ common stock at the initial public offering price, less the underwriting discounts and commissions.

J.P. Morgan and BofA Securities are acting as joint book-running managers. William Blair is also acting as book-running manager. Canaccord Genuity and BTIG are acting as co-managers.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on August 5, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

About Acutus Medical, Inc.
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

Investor Contact:
Caroline Corner
Westwicke ICR
D: 415-314-1725
Caroline.corner@westwicke.com

Holly Windler
M: 619-929-1275
media@acutusmedical.com

Caution Regarding Forward-Looking Statements
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. These forward-looking statements include, without limitation, references to Acutus’ expectations regarding the commencement of trading on The Nasdaq Global Select Market and the completion, timing and size of the public offering. 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, risks and uncertainties related to completion of the public offering and the satisfaction of customary closing conditions related to the public offering. Additional factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, 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 policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors, timing of regulatory approvals, the impact of the recent coronavirus (COVID-19) pandemic and our response to it, 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

Apr 26
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Acutus Medical’s New Contact Mapping Software Receives CE Mark

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

FDA Clears Robust Second Generation AcQMap Platform

CARLSBAD, Calif. and MANNHEIM, Germany, April 26, 2019 – Acutus Medical today announced CE mark approval for AcQMap contact mapping software, offering expanded functionality that provides physicians with more options to inform individualized patient therapy. The company also announced FDA clearance of its second generation AcQMap platform. All AcQMap systems retain the unique ability to quickly reconstruct atrial anatomy using ultrasound and map electrical patterns using non-contact, charge density technology, creating ultra-high-resolution 3D images in real time.
AcQMap enables physicians to uncover the electrical activation pattern of the heart with real-time visualization during electrophysiology procedures.

“The contact mapping speed with the new Acutus system was extremely fast, which made it very easy to use,”

said Dr. Christian Meyer, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

“Clinically, having this capability available on one system that also does non-contact mapping allows me to do exactly what makes sense case-by-case. For routine cases, my treatment strategy can be confirmed using conventional mapping catheters. In more complex cases, such as atrial fibrillation, I can gather more comprehensive data about each patient’s anatomy and arrhythmia in real time with the non-contact charge density catheter, making AcQMap the complete atrial mapping solution.”

Cardiac ablation treatment can improve quality of life for patients with atrial arrhythmias such as atrial fibrillation (AF). AF affects more than 33 million people globally and increases the risk of stroke and heart failure.1,2 AcQMap enables physicians to uncover the electrical activation pattern of the heart with real-time visualization during electrophysiology procedures. With non-contact mapping, physicians see full-chamber, continuous beat-by-beat arrhythmia conduction and can locate arrhythmias outside the pulmonary veins to inform their treatment strategy, enabling an iterative map-ablate-remap approach.

“With the introduction of contact mapping software in Europe, AcQMap is unquestionably the most agile and comprehensive cardiac imaging and mapping system available, offering full spectrum arrhythmia visualization in under three minutes. No other technology offers the suite of solutions incorporated into AcQMap,”

said Acutus Medical CEO Vince Burgess.

“Our second generation system is engineered to be the cornerstone platform for electrophysiology labs for many years to come. We worked alongside physician partners to understand complex challenges and simple needs to improve the efficiency and safety of electrophysiology procedures. This next-gen AcQMap system has the capability to exponentially improve the day-to-day clinical utility of cardiac mapping and deliver long-term value by offering health systems a comprehensive solution for electrophysiologists and their patients.”

Acutus Medical’s contact mapping software is compatible with both first and second generation AcQMap platforms and will be installed on all European systems in Q3. The second generation AcQMap system is built to support future software innovations and will be available in the U.S. in Q3.

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.

References
1 Staerk L, Sherer JA, Ko D, et al. Atrial Fibrillation. Circ Res 2017;120:1501-17. DOI: 10.1161/CIRCRESAHA.117.309732.
2 Chugh, S.S., Havmoeller, R., Narayanan, K. et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circ Feb 25. 2014; 129: 837–847. DOI: 10.1161/CIRCULATIONAHA.113.005119.

Indications for Use
In the U.S., the AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either dipole density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. And, when used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

In the EU, the AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used in the right and/or left atria to visualize the selected chamber and display atrial electrical impulses. And, when used with patient electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. Or, when used with conventional electrophysiology catheters, the AcQMap System provides information about electrical activity of the heart and about catheter location during the procedure.

U.S. Media Contacts
Holly Winder
Head of Marketing & Communications
Acutus Medical
(503) 805-3683
holly.windler@acutus.com

Mackenzie Mohr / Jessica Stebing
Levitate
(260) 408-5383
acutus@levitatenow.com

Oct 24
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Acutus Medical® Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

FDA clearance of the AcQMap® High Resolution Imaging and Mapping System and AcQMap® 3D Imaging and Mapping Catheter is a major milestone for Acutus Medical

Clearance allows the AcQMap System to be used with commercially available cardiac ablation platforms

CARLSBAD, CA — October 24, 2017 – Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed. The Company plans to introduce initial commercial systems to U.S. customers in early 2018.

“This clearance will allow electrophysiologists (EP’s) in the United States access to a new technology that uses ultrasound to visualize cardiac anatomy and dipole density to map the pathway of every heartbeat. The System can also be used with existing commercially available cardiac ablation platforms,”

said Steven McQuillan, Senior Vice President, Regulatory and Clinical Affairs, for Acutus Medical.

“The AcQMap System was designed in close collaboration with some of the most respected names in the field to provide practitioners with a suite of tools that enables them to rapidly map and re-map to visualize changes throughout the ablation procedure. We firmly believe that by working together with EP practitioners and scientists, we will continue to uncover breakthrough innovations to improve and advance cardiac care.”

European Experience
The AcQMap System has been used in Europe over the past two years in a number of clinical trials and commercial settings. Clinical safety results from the DDRAMATIC-SVT trial were used to support the company’s 510(k) clearance.

“We are extremely excited to have participated in the early clinical work and are now using the technology as part of a patient-specific strategy to assess and treat complex arrhythmias,”

said Dr. Tom Wong, from the Royal Brompton Hospital in London, England.

“The AcQMap System is able to provide global dipole density mapping of irregular and chaotic activation in the atrial chambers, whereas conventional sequential mapping may struggle to provide us with the information that is required. In the cases we have performed thus far, real-time mapping of complex arrhythmias has allowed us to focus on areas of interest and terminate the arrhythmia using ablation therapy. We can now offer individualized, tailored therapy, and are one step closer to identifying the mechanisms of complex arrhythmias.”

About the AcQMap High Resolution Imaging and Mapping System
The AcQMap High Resolution Imaging and Mapping System detects and displays both standard voltage-based and higher resolution dipole density (charge-source) maps. The AcQMap System uniquely combines ultrasound anatomy construction with an ability to map the electrical-conduction of each heartbeat to identify complex arrhythmias across the entire atrial chamber. Following each ablation treatment, the heart can be re-mapped in seconds to continually visualize any changes from the prior mapping.

“Our company is dedicated to developing advanced intracardiac mapping tools that we hope will enable more precise diagnoses and less invasive and more targeted therapies, particularly in patients suffering from complex arrhythmias. The AcQMap System clearance represents a major step not seen since the inception of 3D mapping systems 20 years ago,”

said Graydon Beatty PhD, Chief Technology Officer, for Acutus Medical.

“Despite decades of procedural and technical advancement in the electrophysiology field, only about 50% of patients with persistent complex atrial arrhythmias treated with ablation therapy can expect to remain arrhythmia free at 12 months. At Acutus, we think better mapping and the ability to re-map during the initial therapeutic procedure has the potential to lead to better outcomes and quality of life.”

About Acutus Medical
Acutus Medical is a global heart rhythm technology company transforming the way electrophysiologists diagnose and treat cardiac arrhythmias. Acutus Medical is a privately held company located in Carlsbad, CA. To learn more, visit http://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.

Media Contact
Amy Covino
201-774-3111
Amy.covino@tmstrat.com

Mar 22
Love0

Acutus Medical Completes $75 Million Series C Financing

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

  • Expands Existing Blue Chip Syndicate with Institutional and Strategic Investors.
  • Financing Will Support Quest to Transform EP Market by Expanding Clinical Studies and Upcoming European and U.S. Launches of AcQMap™ High Resolution Imaging and Mapping System.

CARLSBAD, CA—March 22, 2016—Acutus Medical, an electrophysiology company committed to transforming how electrophysiologists (EPs) image, diagnose and treat complex arrhythmias, today announced that the company has closed a $75 million Series C financing. The all-equity financing round included new investors Deerfield Management Company, Xeraya Capital and an undisclosed strategic investor. Also participating in the round were existing Acutus Medical investors Advent Life Sciences, which has been an investor in the company since its inception along with OrbiMed and GE Ventures, which joined in the B-series.

“The Acutus Medical AcQMap™ technology has the potential to play an important role in the detection and treatment of atrial fibrillation (AFIB),”

said Steve Hochberg, partner at Deerfield.

“Presently, EPs are only able to map the inside of the heart chamber by actually touching the heart wall with a catheter one location at a time. This limitation prevents the EP from truly seeing the AFIB in a complete, full chamber, high-resolution view, leading them to treat the patient via an empirically-based approach versus an evidence-based approach. AcQMap allows EPs, for the first time, to see a three dimensional, high-definition view of the heart chamber and its electrical activity in real-time, helping them to make critical treatment decisions based on clear evidence of the abnormality causing the arrhythmia.”

 

The key differentiator of the AcQMap High Resolution Imaging and Mapping System is its ability to truly map AFIB and other complex arrhythmias, identify the mechanism of those arrhythmias, and provide a guide for ablation therapy. In addition, AcQMap can show the EP the effectiveness of the therapy in real-time. After the ablation has been delivered and upon the next heartbeat, a new complete map is rendered to confirm how the therapy changed the electrical pattern inside the heart. This real-time feedback loop can continue until the EP is satisfied that the therapy and the procedure have been successful.

Proceeds from the Series C financing will allow Acutus to continue to develop the entire suite of AcQMap products necessary to perform any catheter-based procedure, expand its clinical programs worldwide and continue developing a U.S. and European sales force in preparation for commercialization in both geographies.

“The rapid pace of progress in the past few years has brought Acutus from an early stage start-up to a company on the verge of a commercial launch,”

said Randy Werneth, president and chief executive officer of Acutus Medical.

“That progress has energized our existing syndicate of top-tier investors and financial partners, while attracting the participation of new, world-class investors to participate in the next critical stages of the company. Their support and shared vision for the company are essential for us to complete our regulatory and clinical milestones in preparation for commercialization.”

About Acutus Medical

Acutus Medical is a global heart rhythm technology company transforming the way electrophysiologists (EPs) diagnose and treat cardiac arrhythmias. The company is currently pursuing CE mark approval in Europe for the full suite of AcQMap™ System products. Acutus Medical is a privately held company located in Carlsbad, CA. To learn more, visit http://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.

 

 

Media Contact

 

Julia Baron

Pure Communications, Inc.

(858) 692-2001

Julia@purecommunicationsinc.com

 

Investor Contact

 

Matt Clawson

Pure Communications, Inc.

(949) 370-8500

Matt@purecommunicationsinc.com