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Acutus Medical, Inc. (Nasdaq: AFIB) is a pioneering company in the field of arrhythmia management, focused on improving the way cardiac arrhythmias are diagnosed and treated. Based in Carlsbad, California, and founded in 2011, Acutus is dedicated to advancing electrophysiology with innovative products and technologies that enable more efficient and effective treatments for complex arrhythmias.
Acutus Medical has attracted some of the most respected experts in electrophysiology and cardiac device manufacturing, creating a strong network of global collaborative partners. Their mission is to provide electrophysiologists with the highest quality suite of tools and exceptional clinical support to better understand and treat complex arrhythmias. This mission is driven by the need for advanced technology in the high-growth electrophysiology market, addressing unmet needs for evidence-based approaches to treating atrial fibrillation, ventricular tachycardia, and other complex arrhythmias.
The company's product portfolio includes the AcQMap® Mapping System, the AcQMap 3D Mapping Catheter, the AcQBlate® Force-Sensing Ablation Catheter, and the AcGuide™ Max 2.0 Steerable Sheath. These products are designed to provide a complete solution for catheter-based treatment of cardiac arrhythmias.
Recently, Acutus announced a strategic realignment to focus exclusively on the production and distribution of left-heart access products for Medtronic, Inc. This shift aims to optimize financial performance and maximize cash flow. As part of this restructuring, Acutus will wind down its electrophysiology mapping and ablation business, significantly reducing its workforce and operational expenses.
Financially, Acutus reported significant growth in revenue from its continuing operations, driven by its partnership with Medtronic. For example, first quarter 2024 revenue was $3.6 million, a 192% increase compared to the same period in 2023. The company has also seen improvements in gross margins and reductions in operating expenses, highlighting the benefits of its strategic focus.
Despite challenges, including the need to manage expenses and cash burn rates, Acutus remains committed to its mission and continues to innovate and support the medical community with advanced solutions for cardiac arrhythmia management.
Acutus Medical (Nasdaq: AFIB) announced the acceptance of its AcQForce Flutter abstract for presentation at the AF Symposium in Boston on February 3, 2023. The abstract details the clinical results of the AcQForce Flutter trial, which utilizes the AcQBlate Force Sensing Ablation Catheter. This catheter features a gold tip electrode with four times the thermal conductivity of platinum, enabling efficient energy delivery at lower temperatures. This marks Acutus' first PMA submission and first presentation at a Late-Breaking Clinical Trials session.
Acutus Medical, Inc. (Nasdaq: AFIB) announced it achieved a significant milestone in its agreement with Medtronic, submitting the left-heart access portfolio for CE Mark under EU MDR, resulting in a $17 million earnout. This marks the second milestone after a $50 million initial payment for the portfolio. The CE Mark submission is expected to accelerate adoption in Europe, enhancing Acutus's financial stability and allowing further focus on their mapping and therapy platform.
Acutus Medical has launched AcQMap 8.5, enhancing its ultrasound capabilities for cardiac arrhythmia management. The new software improves accuracy and workflow in non-contact anatomical reconstruction. It features advanced algorithms for better visualizations, particularly of critical atrial structures. This release is positioned as a key growth driver for 2023, allowing for more efficient, personalized treatments for patients with arrhythmias. AcQMap's non-contact technology aims to provide a holistic view, optimizing treatment strategies for challenging cases.
Acutus Medical has announced that its flagship AcQMap 3D Imaging and Mapping Catheter has received a CE Mark under new European Medical Device Regulations. This certification, which ensures compliance by May 2024, allows physicians in Europe continued access to Acutus's unique mapping technology for diagnosing and treating complex arrhythmias. The CE Mark signifies adherence to enhanced standards for public health and patient safety, positioning Acutus for growth in European markets. Additionally, the company received certification for its quality management system.
Acutus Medical, Inc. (Nasdaq: AFIB) granted 12,000 restricted stock units (RSUs) to three new employees as a material inducement for employment, approved by its Compensation Committee on December 1, 2022. These RSUs will vest annually over four years, contingent on continued employment. Acutus focuses on enhancing the diagnosis and treatment of cardiac arrhythmias through innovative products and technologies. The company emphasizes its commitment to evolving electrophysiology while facing various market risks and uncertainties.
Acutus Medical reported third quarter 2022 revenue of $3.6 million, down from $4.6 million year-over-year. The decrease was attributed to a drop in capital revenue. Despite this, global mapping procedure volumes grew by 17%. Operating expenses decreased to $17.2 million from $23.2 million, driven by cost-saving measures. The net loss for the quarter was $20.4 million, an improvement from $28.5 million last year. The company anticipates revenue between $15.5-$16.0 million for Q4 2022 due to foreign exchange and supply chain challenges.
Acutus Medical has reached a significant milestone in its asset purchase agreement with Medtronic, triggering a $20 million earnout payment. This deal allows Acutus to become an original equipment manufacturer (OEM) for Medtronic, which will facilitate the transition of Acutus's left-heart access portfolio to commercial distribution. Previously, Medtronic paid $50 million for this portfolio, including various medical devices. Acutus also remains eligible for further milestone payments and revenue-based earnouts over the next four years, enhancing its financial position.
Acutus Medical, based in Carlsbad, California, announced the grant of 17,500 restricted stock units (RSUs) to three individuals as a material inducement for employment. This action was approved by the Board’s Compensation Committee on November 1, 2022, following Nasdaq Listing Rule 5635(c)(4). The RSUs will vest in four equal installments annually, contingent on the employees' continued employment. Acutus focuses on enhancing arrhythmia diagnosis and treatment through innovative electrophysiology products and technologies.
Acutus Medical, Inc. (AFIB), based in Carlsbad, California, announced the release of its third quarter 2022 financial results on November 10, 2022. The company focuses on enhancing arrhythmia diagnosis and treatment and will host a conference call at 1:30 p.m. PT to discuss these results and recent highlights. Investors can access the call via telephone by registering in advance. The company aims to improve treatment efficiency through innovative products and global partnerships in electrophysiology.
Acutus Medical, Inc. (Nasdaq: AFIB) announced the submission of pivotal clinical data from the AcQForce Flutter trial to the FDA for its AcQBlate Force Sensing Ablation Catheter and System. This submission is a major milestone as catheter ablation for right atrial flutter constitutes about 30% of ablations in the U.S., projected to reach 200,000 by 2025. The trial showed successful acute procedural success with no serious adverse events reported. The full data will be presented at the AF Symposium in February 2023, reinforcing Acutus's growth strategy.
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