Recently, Field Medical announced that its core product, the FieldForce™ Ablation System, has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) pilot and has receivedBreakthrough DeviceTitle.

01

The world's first and only

Field Medical was established in 2022 and is aFocusing on the Field of Pulsed Electric Field Catheter AblationAn innovative company founded by Steven Mickelsen, the father of PFA, is currently developing a patented technology called FieldBending, which aims to concentrate therapeutic effects and reduce the harmful far-field effects associated with the first generation of PFA technology.

Dr. Steven Mickelsen is called the Father of PFA because he is a pioneer in introducing pulsed field ablation technology for patient treatment.First established FARAPULSE, Inc., the company was the developer of the first-generation PFA technology. Although FARAPULSE was eventually acquired by Boston Scientific for over $460 million, Dr. Mickelsen's work in the PFA field laid the foundation for the development and clinical application of this technology.

Subsequently, Dr. Mickelsen founded Field Medical, Inc.Focus on Developing Improved PFA Technology, such as FieldForce catheters and FieldForce generators,And introduced the patented FieldBending technology, this technology has significantly improved the efficacy and safety of PFA in treating arrhythmias, especially complex ventricular arrhythmias.

Currently, Field Medical plans to expand the indications for pulsed field ablation (PFA) beyond atrial fibrillation treatment by addressing more challenging ventricular arrhythmias and common procedures such as supraventricular tachycardia (SVT) that require minimal sedation. The company completed its seed funding round in September 2023, raising $14 million.

The product that received the Breakthrough Device Designation this time — FieldForce™ — is the core product of Field Medical and is suitable forTreatment of Persistent Monomorphic Scar-Related Ventricular Tachycardia (VT)FieldForce™ is an innovative pulsed field ablation (PFA) technology that aims to provide a safer and more efficient treatment solution by using a pressure-contact PFA catheter specifically designed for the ventricles.

FieldForce™ includesCatheters and Energy Generators, and has multiple technical advantages:

• Catheter TipAdopted the innovative FieldBending technology, which features a unique built-in electrode integrated into the fluid lumen as shown in the cross-sectional view. By transmitting voltage between the external and internal electrodes, the desired electric field characteristics are generated.

• Tolerance of PFAIt is a fundamental challenge, as remote stimulation of excitable tissues may cause discomfort and/or involuntary movements, which can interfere with work efficiency. FieldBending features electrodes placed within the saline flush lumen of the catheter, with a non-conductive distal tip and external electrodes. The current flows from a 3 mm outer ring located 4 mm from the distal tip to the internal electrode. This new bipolar pulse electrode configuration significantly enhances the tolerability of PFA.

• Contact Force Between Catheter and TissuePlays an important role in the efficacy of PFA treatment. An increase in contact force can lead to an increase in lesion depth, and effective lesion formation requires electrode-tissue contact.

In addition, the FieldForce™ system also utilizes proprietary FieldBending™ technology to deliver via a single-point contact force PFA catheter.Targeted, brief, high-intensity electric fieldsFieldBending technology can predictably concentrate energy around the catheter, reducing unwanted far-field effects. This technology allows power to be applied more accurately and focused on the target tissue, enhancing the precision of treatment.

Currently, Field Medical has already initiated the first human study of its FieldForce™ Ablation System in May 2024. Preliminary data shows that the product has demonstrated significant promise in the early stages of the trial.Has the potential to completely revolutionize traditional catheter ablation for complex ventricular arrhythmias, which may exceed the current standard of care.

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PFA "Battle" on the Verge of Eruption

According to Industry and Wall StreetTest, with the unique technical advantages of PFA, PFA will soon become the mainstream ablation technology for treating atrial fibrillation. By 2028, the global atrial fibrillation ablation market will double to reach 11 billion yuan. Among this, the market share of PFA in the atrial fibrillation ablation market will also increase from less than 5%.Increase to over 60%Relevant analysts also speculate that, in the third year after the initial official launch of PFA, it will gradually become the primary procedure in the ablation market. Traditional ablation methods will account for about half of the market share (42% radiofrequency ablation, 10% cryoablation), while PFA will occupy the remaining half.

Moreover, according to Frost & Sullivan's forecast, the market size of PFA in China is also continuously increasing, and will reach 1.3 billion yuan in 2025, maintaining rapid growth.Expected to reach 16.3 billion yuan by 2032, with a CAGR of 43.73% during the period; the share of the PFA market size in the overall electrophysiology device market size is also expected to continuously increase, reaching 8.18% by 2025.Increase to 38.87% by 2032。

Based on this, major giants are also accelerating their layout in the PFA field, with this "sense of urgency" being reflected in mid-2024.

As of now, the NMPA has approved the registration applications for innovative cardiac pulsed field ablation products from five companies: Jinjiang Electronics' PulsedFA, Denovo Electrophysiology's CardioPulse, Medtronic's Pulseselect, Boston Scientific's FARAPULSE, and HT Medical's Pulstamper.

The FDA has also approved five PFA products, including two from Boston Scientific – FARAPULSE and FARAWAVE NAV, two from Medtronic – PulsesSelect and Sphere-9 & Affera, and one from Johnson & Johnson – VARIPULSE.

Moreover, following the FDA approval of Johnson & Johnson's VARIPULSE on November 7, the tripartite competition in the PFA market has officially taken shape, with a "major battle" imminent. Major companies are also intensifying their R&D efforts, focusing on innovation, expanding product indications, and acquiring businesses to address their weaknesses.

At the same time, the strength of Chinese production is also gradually rising. Although there are still few companies in China that can comprehensively research and develop ablation catheters, mapping catheters, and 3D mapping systems, an increasing number of domestic companies have started to enter the PFA field. According to incomplete statistics, more than 20 companies in China, including AccuPulse Medical, XuanYu Medical, and Northcore Medical, have already begun to lay out their presence in the PFA track.

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Conclusion

This time, the father of PFA has taken a different approach, targeting the field of persistent monomorphic scar-related ventricular tachycardia, and FieldForce™ has also become the current...The First and Only PFA System Specifically Designed for Ventricular Arrhythmia Ablation, once again leading the market.

References:

1. "Breakthrough Device! The Father of PFA Embarks on a New Venture in a New Track" Heart Future