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Acutus Medical, Inc. (AFIB)

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12.80-0.68 (-5.01%)
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Previous Close13.47
Open13.65
Bid12.81 x 1200
Ask12.93 x 800
Day's Range12.42 - 13.65
52 Week Range12.32 - 38.99
Volume118,442
Avg. Volume361,060
Market Cap359.476M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateMar 18, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est21.67
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    • Acutus Medical Announces FDA Clearance of AcQCross™, a Full Suite of Universal Transseptal Crossing Devices
      GlobeNewswire

      Acutus Medical Announces FDA Clearance of AcQCross™, a Full Suite of Universal Transseptal Crossing Devices

      Product Family Targets Over 300,000 Annual US Electrophysiology and Structural Heart Procedures AcQCross Transseptal Crossing Device Versatility to be utilized with top sheaths currently used in left atrium electrophysiology and structural heart procedures CARLSBAD, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the FDA clearance of the AcQCross™ family of universal transseptal crossing devices. This is the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers. In the United States, there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices1,2,3. The company will initiate its full US commercial launch of AcQCross in the coming weeks. Crossing the septum to gain access to the left atrium of the heart is a critical and required step in any atrial fibrillation or left sided tachycardia ablation procedures as well as in many left sided structural heart procedures (such as left atrial appendage closure device implants or percutaneous mitral valve repair). Achieving the proper crossing angle and location of septal crossing can significantly impact the efficiency of the entire procedure. The new and expanded family of AcQCross catheters include versions that are length-, diameter- and tip-matched and designed to lock into the hub of sheaths now used in the vast majority of left heart procedures, including those provided by Acutus and by other vendors. This unique compatibility allows physicians to utilize AcQCross with their sheath of choice during virtually any left heart procedure. AcQCross enables mechanical septal crossing with a spring-loaded needle that can also be enhanced with concurrent delivery of radiofrequency (RF) energy. AcQCross further streamlines procedural workflow by eliminating the need for wire and needle exchanges, as it incorporates a retained .032 guidewire within the hollow crossing needle. “The elimination of guidewire and needle exchanges is an important step in facilitating transseptal crossing procedures,” said Dr Peter Weiss MD, MSC, Director of Ventricular Arrythmia Management and Robotics, Assistant Professor of Medicine, Banner University of Arizona Medical Center Phoenix. “The optimal septal crossing location and angle differs depending on the procedure – be it Cryoablation, RF ablation, non-contact mapping or left atrial appendage implant – so the unique ability to easily reposition without cumbersome catheter withdrawals and exchanges are benefits that cannot be overstated. As physicians, we rely on meaningful device innovation that fits into our existing procedural workflow and provides improvement. Acutus is delivering that with AcQCross.” “This product is absolutely unique in the industry. We are giving physicians an immensely adaptable and versatile product family developed to provide an enhanced and more precise transseptal approach – and still allow them to continue to use their sheath of choice for the remainder of the procedure,” said Vince Burgess, President and CEO of Acutus Medical. “We expect that this product will be quickly and widely adopted by electrophysiologists and interventional cardiologists.” AcQCross is now commercially available in the United States. For more information, visit www.acutusmedical.com/us/. References12019 Millennium Research Group: Electrophysiology Mapping and Ablation Devices | Market Analysis |US | 20192American College of Cardiology – The NCDR Left Atrial Appendage Occlusion Registry3Transcatheter Cardiology Therapeutics (TCTMD), American Heart Association Database About Acutus MedicalAcutus 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. Follow Acutus Medical on: Twitter: @AcutusMedicalLinkedIn: www.linkedin.com/company/acutus-medical-inc-/Facebook: @AcutusMedical US Media ContactsHolly Windler(619) 929-1275holly.windler@acutus.com Levitate(260) 408-5383 acutus@levitatenow.com Investor ContactCaroline Corner 415-202-5678caroline.corner@westwicke.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/34afae1d-86f9-41a4-a8d4-50411cc4787c

    • ACCESSWIRE

      SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Acutus Medical, Inc. - AFIB

      NEW YORK, NY / ACCESSWIRE / April 8, 2021 / Pomerantz LLP is investigating claims on behalf of investors of Acutus Medical, Inc. ("Acutus" or the "Company") (NASDAQ:AFIB).

    • Acutus Medical Initiates First IDE Therapy Trial with the AcQBlate® FORCE Sensing Ablation System
      GlobeNewswire

      Acutus Medical Initiates First IDE Therapy Trial with the AcQBlate® FORCE Sensing Ablation System

      AcQBlate FORCE Sensing Ablation System A complete ablation system which includes the smallest footprint of any RF Generator and is comprised of four components: Qubic RF controller, Qubic Force Module, Qubic RF Generator and Qiona Irrigation pump. AcQBlate FORCE Sensing Ablation Catheter AcQBlate FORCE: the first and only force sensing ablation catheter with a gold-tip electrode. CARLSBAD, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced initial US enrollments in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial. This trial is expected to enroll up to 150 subjects in leading centers globally and will evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of Right Atrial Typical Flutter. In the US, Right Atrial Typical Flutter ablation procedures currently account for approximately 30% of cardiac ablations and are expected to reach 200,000 annually by 20251. In contrast to the most contemporary ablation systems, AcQBlate FORCE can operate both in a stand-alone manner or in conjunction with a compatible 3D mapping system. The AcQBlate FORCE sensing ablation system is comprised of Acutus’ AcQBlate FORCE catheter and Qubic Force module that seamlessly integrates an RF generator and irrigation pump. The complete AcQBlate FORCE sensing ablation catheter and system, which received full CE Mark in late 2020, is now commercially available in Europe through our Acutus direct organization and our partner BIOTRONIK. Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate FORCE system shows physicians, in real-time, how much contact force is being applied to the heart during ablations. Studies have shown the utility of real-time contact force information in helping physicians guide safe and effective therapy, which may improve patient outcomes2. “The AcQBlate FORCE sensing ablation catheter provides stable contact force readings with low fluid irrigation requirements. It displayed both easy maneuverability and excellent stability during atrial ablation. I look forward to further evaluating this system and believe this technology has the potential to improve patient outcomes,” said Dr. Gery Tomassoni of Baptist Health Medical Group in Lexington, Ky., who performed the first case in the trial. Dr. Sean Beinart of Adventist Healthcare White Oak Medical Center in Silver Springs, Md. further commented, “the system was very easy for our lab staff to set up, and we were able to complete the case without changing our existing workflow. As the incidence of atrial arrhythmias increases, we continue to look for safe, effective and efficient treatment options for patients. The AcQBlate FORCE sensing ablation catheter incorporates a gold-tipped electrode that is designed for efficient energy delivery and effective lesion creation in less time.” “This trial represents our initial entry into the United States with a therapeutic technology for the treatment of atrial arrhythmias,” said Vince Burgess, CEO of Acutus Medical. “The gold-tipped AcQBlate FORCE catheter is a state-of-the-art ablation device that is paired with our laser-based contact force console and further integrated with the smallest and most modern RF generator and pump available. As we have experienced in our European centers during our initial market release, when used in concert with our novel AcQMap 3D mapping system we are seeing highly efficient workflow and operational efficiency. We look forward to offering the benefits of a comprehensive, force sensing ablation system to electrophysiologists and patients in the United States once we complete clinical trials and gain regulatory approval.” Enrollment for the AcQForce Flutter trial is ongoing, and the company is actively working with selected sites to initiate cases under the IDE. For more information on this trial, please see NCT04658940 on https://www.clinicaltrials.gov. AcQBlate FORCE Sensing Catheter is limited by US Federal Law to investigational use. References1. Erik J. Bracciodieta, Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0059, June 2019.2. Ariyarathna N. et al., Role of Contact Force Sensing in Catheter Ablation of Cardiac Arrhythmias: Evolution or History Repeating Itself? JACC: Clinical Electrophysiology (2018); 707-723 About Acutus Medical 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. Follow Acutus Medical on: Twitter: @AcutusMedicalLinkedIn: www.linkedin.com/company/acutus-medical-inc-/Facebook: @AcutusMedical Media ContactHolly Windler619-929-1275holly.windler@acutus.com Investor ContactCaroline Corner 415-202-5678caroline.corner@westwicke.com Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6c455e7c-6377-4f65-b55d-b51acd15a2ea https://www.globenewswire.com/NewsRoom/AttachmentNg/3f011ba9-59e5-430c-a559-b9d66b6822b8