Field Medical Secures $40 Million Series A Financing to Advance PFA Platform for Ventricular Tachycardia and Atrial Fibrillation

(1) Background and Time of Establishment

In the field of arrhythmia treatment, although traditional ablation techniques have improved patients' conditions to a certain extent, they still have many limitations, such as damage to surrounding tissues and limited treatment effectiveness. With continuous advancements in technology and in-depth research into cardiovascular diseases, pulsed field ablation (PFA) technology has emerged, bringing new hope for the treatment of arrhythmias. In 2022, Field Medical, Inc. was officially established in California. This company focuses on the research, development, and innovation of pulsed field ablation (PFA) technology and is committed to providing more effective and safer treatment options for patients with arrhythmias. Its emergence is like a rising star, quickly gaining prominence in the cardiovascular healthcare field.

(II) Core Figures and Achievements

Field Medical has gained significant attention, largely due to its core figure — Dr. Steven Mickelsen. He is a board-certified clinical cardiac electrophysiologist and an experienced business leader with an outstanding reputation in the cardiac care industry, earning him the title of "Father of PFA."

Dr. Mickelsen's exploration and innovation in the PFA field have never ceased. As early as 2012, he founded FARAPULSE Inc., becoming the developer of the first-generation PFA technology. Under his leadership, FARAPULSE achieved tremendous success, with its PFA technology bringing revolutionary changes to the treatment of arrhythmias. Eventually, FARAPULSE was acquired by Boston Scientific for over $460 million, which was not only a high recognition of FARAPULSE's technology but also an affirmation of Dr. Mickelsen's contributions to the PFA field.

However, Dr. Mickelsen was not content with his existing achievements. He was well aware that PFA technology still had tremendous potential for development, particularly in the treatment of ventricular arrhythmias, where many unmet clinical needs remained. Thus, in 2022, he decisively founded Field Medical, a company focused on developing advanced PFA technologies. Under his leadership, Field Medical developed the FieldForce catheter and FieldForce generator, incorporating the patented FieldBending technology. This technology significantly enhances the efficacy and safety of PFA in treating arrhythmias, especially complex ventricular arrhythmias, by optimizing electrode configurations, bringing new hope to countless patients.

(1) System Composition and Principle

The FieldForce Ablation System is the core product of Field Medical and one of the highlights of the Heart Rhythm 2025 conference. The system mainly consists of a high-pressure focal PFA catheter and an energy generator, aiming to use pulsed field ablation technology to deliver pulses within a fraction of a second for the precise treatment of various arrhythmias.

Pulsed Field Ablation (PFA) is an entirely new ablation technology, with a working principle that is completely different from traditional radiofrequency ablation and cryoablation. It applies multiple short-duration, high-voltage electrical pulses to cardiac tissue, creating irreversible nanoscale pores in the cell membrane, leading to an imbalance in the exchange of substances inside and outside the cell, ultimately causing cell death. This achieves the goal of ablating diseased tissue and treating arrhythmias. Compared with traditional ablation technologies, PFA has significant advantages such as non-thermal ablation, high tissue selectivity, and minimal damage to surrounding tissues, bringing new hope for the treatment of arrhythmias.

(II) Technical Advantages and Unique Features

The FieldForce Ablation System has gained significant attention not only because it utilizes advanced pulsed field ablation (PFA) technology, but also due to its unique design and innovative techniques. The system incorporates the patented FieldBending technology, which optimizes electrode configuration, greatly enhancing the effectiveness and safety of PFA in treating arrhythmias, especially complex ventricular arrhythmias.

Specifically, FieldBending technology incorporates unique built-in electrodes within the fluid lumen of the catheter. By transmitting voltage between external and internal electrodes, the desired electric field characteristics are generated. This design effectively enhances the tolerance of PFA, reduces the interference of far-field effects on treatment outcomes, allowing energy to be more concentrated on the target tissue, thereby improving the precision and effectiveness of the treatment. Meanwhile, the contact force between the catheter and tissue plays a crucial role in PFA treatment efficacy. An increase in contact force can lead to greater lesion depth, and effective lesion formation requires electrode-tissue contact.

The FieldForce system utilizes proprietary FieldBending technology to deliver targeted, transient, high-intensity electric fields through a single-point contact PFA catheter, predictably focusing energy around the catheter while reducing unnecessary far-field effects, further enhancing treatment efficacy.

In addition, the FieldForce ablation system boasts advantages such as ease of operation and short treatment duration. Its design fully considers the operational needs of clinicians, making the surgical process smoother, reducing operation time and patient discomfort. When treating scar-related ventricular tachycardia (VT), the system can quickly and accurately locate the lesion site, enabling efficient treatment and providing patients with a better therapeutic experience.

(III) Research and Development Progress and Current Status

Currently, although the FieldForce ablation system has not yet been approved by the U.S. Food and Drug Administration (FDA), it has achieved a series of significant R&D advancements. Since May 2024, Field Medical, Inc. has initiated the first-in-human study of the FieldForce pulsed field ablation (PFA) system, known as the Ventricular Catheter Ablation Study (VCAS). The VCAS study commenced at Na Homolce Hospital in Prague, Czech Republic, with plans to enroll up to 60 patients across a maximum of five sites globally. It aims to demonstrate the safety and performance of its PFA system, particularly addressing the limitations of existing PFA and radiofrequency (RF) ablation systems, offering a more time-efficient treatment option for ventricular arrhythmias.

From the preliminary data, FieldForce has already shown great promise in the early stages of the trial, with the potential to revolutionize traditional catheter ablation for complex ventricular arrhythmias, possibly surpassing current standards of care. This positive outcome undoubtedly provides strong momentum for the further development and promotion of the FieldForce ablation system, and raises high expectations for its future clinical applications. At the upcoming Heart Rhythm 2025 conference, renowned electrophysiologist Dr. Vivek Reddy from the Mount Sinai Health System in New York City will present new clinical trial data and share first-in-human results, offering crucial insights into the safety and efficacy of the FieldForce ablation system.

(1) Multiple Demonstrations for Comprehensive Display

At the Heart Rhythm 2025 Annual Meeting, Field Medical is pulling out all the stops, presenting the outstanding performance and innovative technology of its FieldForce ablation system through up to eight demonstrations in various formats.

Starting from the Innovation Focus session on April 23, company founder Dr. Steven Mickelsen will be the first to appear at the Stanford Biodesign New Arrhythmia Technologies Symposium, sharing his innovative ideas and cutting-edge thoughts in the field of arrhythmia treatment, kicking off the conference with a brilliant start. Following this, from April 24-26, a series of fascinating live case demonstrations and poster presentations will take place.

At the PFA Live Case Summit, renowned electrophysiologists Dr. Vivek Reddy and Dr. Petr Neužil will personally perform two exciting live case demonstrations. One is "VT with Focal Force-Sensing PFA" scheduled for April 24 from 11:20 AM to 12:50 PM, and the other is "PVI with FieldForce™ (Focal PFA)" taking place in the afternoon from 3:20 PM to 4:50 PM. Through these live demonstrations, attendees will have the opportunity to witness the operational process and treatment effectiveness of the FieldForce ablation system during actual procedures, experiencing its precision and efficiency.

During the poster presentation session, experts and scholars from various fields engaged in in-depth discussions around the FieldForce ablation system. On the morning of April 25 from 10:30 to 12:30, Dr. Cory Tschabrunn will present "Treatment of Refractory VT with Investigational PFA System," sharing experiences and outcomes using this system to treat refractory ventricular tachycardia (VT); on the morning of April 26 from 9:30 to 11:30, Dr. Vivek Reddy will present "Transmural Lesions with Focal PFA," delving into transmural lesions created by focal pulsed field ablation (PFA); in the same afternoon from 12:00 to 2:00, Dr. Colin Blumenthal will present "Scar Modulation via MRI Post-PFA," examining scar modulation observed via MRI after PFA procedures. These poster presentations not only provide attendees with a platform for communication and learning but will also further advance the application and development of the FieldForce ablation system in the field of arrhythmia treatment.

(II) The Most Anticipated Speech

Among numerous presentations, the most anticipated one was delivered by renowned electrophysiologist Vivek Reddy, M.D., from the Mount Sinai Health System in New York City, on April 27 from 11:15 to 11:25 a.m. In this highly awaited speech, Dr. Reddy shared first-in-human data, providing a detailed overview of the safety and efficacy of the FieldForce ablation system in patients with scar-related ventricular tachycardia (VT).

Scar-related ventricular tachycardia is an extremely complex and difficult-to-treat arrhythmia, characterized by dense fibrotic substrates and a high recurrence rate, often posing challenges even for the most skilled electrophysiologists. The emergence of the FieldForce ablation system, however, has brought new hope to patients suffering from this condition.

The announcement of this first-in-human data will provide crucial evidence for the application of the system in clinical treatment, helping to evaluate its potential and advantages in treating VT related to scar tissue. This data will address a series of key questions, such as: Can the FieldForce ablation system effectively eliminate scar tissue and reduce the frequency of arrhythmia episodes? How safe is it, and could it lead to severe complications? What impact will it have on patients' quality of life and long-term prognosis?

By answering these questions, the first-in-human data will provide doctors and patients with more comprehensive and accurate information, helping them make more informed treatment decisions. At the same time, this will also guide the further development and improvement of the FieldForce ablation system, promoting its continuous advancement and refinement in the field of arrhythmia treatment. It is believed that at the Heart Rhythm 2025 conference, this speech by Dr. Vivek Reddy will become the highlight of the event, sparking widespread attention and in-depth discussions among experts and scholars in the cardiovascular field.

(1) Financing News Release

Just as the Heart Rhythm 2025 conference was in full swing, an exciting piece of news broke: Field Medical, Inc. had just successfully completed a $40 million Series A financing round. This news hit like a bombshell, causing a stir in the cardiovascular medical field and capturing the attention of numerous industry professionals.

It is reported that this round of financing has attracted the active participation of many investors, including industry strategic investors, venture capital firms, and more. Notably, several seed-round investors have once again chosen to invest in Field Medical, which undoubtedly reflects a high level of recognition and strong confidence in the company’s technical strength and development prospects. The completion of this financing not only injects robust capital momentum into Field Medical but also further enhances the company’s reputation and influence within the industry.

(II) Use of Funds and Strategic Significance

For this hard - earned funding, Field Medical has clear and well - defined plans. First, the funds will be mainly used to support the completion of two important preliminary studies. One is the VCAS study for ventricular tachycardia (VT), which aims to further verify the safety and efficacy of the FieldForce ablation system in treating VT, providing a stronger scientific basis for its wide application in clinical treatment. The other is the Field PULSE study for atrial fibrillation (AF), a common type of arrhythmia that seriously affects patients' quality of life and health. By conducting this study, Field Medical hopes to explore more effective treatment methods and offer more treatment options for AF patients.

In addition, the funds will continue to advance the development of Field Medical's commercial pulsed field ablation (PFA) system. Despite a series of significant R&D advancements achieved by the FieldForce ablation system, the company is not content and hopes to further optimize the system’s performance and functionality through continuous investment and innovation, improving treatment outcomes and reducing treatment risks. At the same time, the company also plans to use this funding to expand its operational scale, strengthen team building, and enhance the overall strength and competitiveness of the company. This will fully prepare the company for its upcoming pivotal VT-focused trial, VERITAS, ensuring the trial proceeds smoothly and achieves the desired results.

From a strategic perspective, the $40 million Series A financing round is undoubtedly an important milestone for Field Medical. It not only provides strong financial support for the company’s technology development and product innovation but also lays a solid foundation for its future commercial growth. By completing two pilot studies and continuing to develop the FieldForce ablation system, the company aims to further enhance its technological edge and market competitiveness in the field of arrhythmia treatment, bringing more efficient and safer treatment solutions to the market for the benefit of patients. At the same time, this will also help drive the advancement and application of pulsed field ablation technology, leading innovative transformation in the cardiovascular healthcare sector.

As Dr. Steven Mickelsen, CEO of Field Medical, stated: "This financing is a crucial step in redefining how electrophysiologists approach ablation therapy. We are accelerating the development of the FieldForce™ Ablation System and working to expand the applicability of next-generation pulsed field ablation (PFA) solutions in the cardiac ablation field." With the support of this funding, Field Medical is expected to make even more solid progress in the field of arrhythmia treatment, bringing more hope and benefits to patients.

(1) Potential Transformations in the Treatment of Arrhythmias

If the FieldForce ablation system is successfully launched, it will undoubtedly bring a profound transformation to the field of arrhythmia treatment. In terms of therapeutic effects, the pulsed field ablation technology it employs, particularly the unique FieldBending technology, can target diseased tissues more precisely, achieving more efficient ablation and significantly improving the success rate of treatment. For patients suffering from arrhythmias who have had poor results with traditional treatments, this is undoubtedly good news. In the past, many patients had to rely on long-term medication, enduring the side effects of drugs while often finding the treatment outcomes unsatisfactory. The emergence of the FieldForce ablation system offers them a new and more effective treatment option, with the potential to fundamentally resolve arrhythmia issues and improve patients' quality of life.

In terms of treatment safety, the FieldForce ablation system also offers significant advantages. Traditional ablation techniques, such as radiofrequency ablation, may cause damage to surrounding healthy tissues during the procedure, leading to a series of complications. However, PFA technology is characterized by non-thermal ablation and high tissue selectivity, which can reduce damage to surrounding tissues and lower the risk of complications. This means that patients not only achieve better treatment outcomes but also experience reduced surgical risks and postoperative recovery pain. For doctors, this also decreases the difficulty and risk of the procedure, allowing more patients to benefit from ablation therapy.

In terms of the convenience of the treatment process, the FieldForce ablation system’s ease of operation and short treatment duration will also greatly enhance the patient's medical experience. Traditional arrhythmia treatment surgeries often take a long time, causing significant discomfort for patients. However, the FieldForce ablation system can complete pulse treatment in a fraction of a second, significantly reducing operation time. This not only minimizes the patient’s suffering during the procedure but also improves the hospital’s operational efficiency, allowing more patients to receive timely treatment. Additionally, shorter treatment times translate to lower medical costs, which holds substantial importance for both patients and society.

(II) Competitive Situation in the PFA Market

In the highly competitive PFA market, Field Medical has demonstrated significant growth potential through its innovative technology and robust R&D capabilities. Currently, numerous companies worldwide have positioned themselves in the PFA sector, resulting in exceptionally fierce market competition. Nevertheless, Field Medical's FieldForce ablation system stands out among many competitors due to its unique technical advantages and clear market positioning.

From a technical perspective, the FieldBending technology of the FieldForce ablation system significantly enhances the effectiveness and safety of PFA in treating arrhythmias, especially complex ventricular arrhythmias, by optimizing electrode configuration. This technological innovation gives the FieldForce ablation system an edge over many competing products in terms of treatment outcomes and safety. Meanwhile, the company is continuously increasing its R&D investment to further optimize product performance and maintain its technological leadership.

In terms of market positioning, Field Medical focuses on treating complex ventricular arrhythmias, an area in the current PFA market that remains underserved. Unlike other PFA products primarily targeting atrial fibrillation treatment, the FieldForce ablation system is specifically designed for treating ventricular arrhythmias, better addressing the needs of this niche market. This precise market positioning allows the company to carve out its unique advantage in the highly competitive PFA market and quickly capture market share.

Moreover, the core team of Field Medical consists of experts with extensive experience in the PFA field. They not only possess a strong technical background but also have sharp market insight and excellent business operation capabilities. This provides the company with solid talent support and strategic guidance for its development. In the future, as the FieldForce ablation system continues to improve and is promoted in the market, the company is expected to occupy an important position in the PFA market and become an industry leader. Its successful development will also drive innovation and progress across the entire PFA market, encouraging other companies to increase R&D investment and launch more and better products, offering arrhythmia patients a wider range of treatment options.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Cloud Leaf Pavilion

Post-production: Zhang Lirong