Argá Medtech Secures €54M Series B Financing to Advance CSE PFA System for Atrial Fibrillation Treatment

Mar 04, 2024 10:08 CST Updated 10:08

Argá Medtech

Medical Device Developer

Gilde Healthcare

Healthcare Investment Company

Advent Life Sciences

Investment Institutions Focused on the Life Sciences Sector

Earlybird

Venture Capital Firms

Source of the article:Heart NotCome;Editor:Bai Xiaofei

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Heart Future

Recently,Pulse Field Ablation (PFA) Electrophysiology Device Developer ArgáMedtechAnnouncement Completed€54 million (approximately 420 million RMB) oversubscribed Series B financing roundThis round of financing was led by existing investors Advent Life Sciences and Earlybird Health, with new investors Gilde Healthcare and an unnamed strategic investor following.

This financing enables Argá Medtech toConducting IDE Studies in the United States and CE Mark Studies in the European Union，Advance the development of its innovative CSE (Coherent Sine Wave Pulse Ablation) system for treating atrial fibrillation.With this funding, the company will also expand its U.S. office located in San Diego, California, to carry out clinical activities in the United States.

David Neale, CEO of Argá MedtechStated: "We are delighted to have the support of these renowned investors who believe that Argá Medtech will revolutionize the field of atrial fibrillation ablation. This funding allows us to progress towards validating the CSE PFA system in Europe and the United States, and we will striveProviding safe, fast, and effective treatment for millions of patients with arrhythmia and atrial fibrillation. We are proud of the achievements we have made so far, among whichIncluding those conducted in EuropeFirst 48-Patient Human Study, which demonstrates the high performance of our platform in treating atrial fibrillation.。”

# PFA Market Competition

FMIData shows,From 2021 to 2022, the global pulsed field ablation market experienced a compound annual growth rate of 48.6%, reachingThe market size reached 1.3 million US dollars in 2023。Based on historical data, the market has been steadily growing with the adoption of modern technologies such as robot-assisted surgery and the reduction of invasive surgical techniques.

Technological advancements will continue to enhance the efficacy, safety, and minimally invasive nature of this procedure, and the market is expected to maintain an upward trend in the coming years.Boston Scientific previously estimatedPFA Will Dominate the Atrial Fibrillation Treatment Market in the Next Five Years, which has been laid out early on in this area.

On January 30, 2021, Farapulse, a subsidiary of Boston Scientific, announced itsFARAPULSE Pulsed Field Ablation (PFA) ProductReceived CE approval for marketing, becomingThe World's First PFA Technology to Receive CE Approval, used for ablation in the field of atrial fibrillation, can be said to be the big brother in the PFA field.

Until November 2023, Medtronic announced that its PFA product, PulseSelect, had received CE approval for market release.

It was thought that Boston Scientific only had to wait steadily for FDA approval, but unexpectedly, in less than a month,MedtronicAnnounced again through an announcement, stating itsPulseSelect Pulsed Field Ablation SystemReceived FDA approval for marketing, becomingThe World's First PFA Product to Receive FDA Approval。

Medtronic's approval announcement even preceded the FDA's official database, which means it has gained an edge over Boston Scientific in this FDA approval race. By now, Medtronic has launched two PFA products in the atrial fibrillation field.

A key factor in Medtronic's ability to stand out among many competitors and launch the world's first PFA product approved by the FDA is itsIDE Research Data Shows Excellent Performance, far exceeding expectations.According to the IDE study data published by Medtronic at the beginning of the year,PulseSelect has exceeded expectations in terms of both safety and efficacy (the rate of safety events for patients with paroxysmal and persistent AF was 0.7%).Clinical success rate was 80%）。

On January 8, 2024, the third major player in the PFA fieldJohnson & JohnsonAlso unwilling to lag behind, it announced itsFirst PFA Product---VARIPULSEApproved for marketing by Japan's Ministry of Health, Labour and Welfare (MHLW), applicable for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation. This isJapan's First Approved PFA Product.

Compared with Medtronic and Boston Scientific,Johnson & Johnson'sStepAdjustAlthoughSlower, but looking at this piecePFA Market Worth $9 Billion with Only About 5% Penetration, Still Growing at a Double-Digit RateStill thrilled by nature.

Until January 31, 2024,Boston ScientificThe company has just announced itsFARAPULSE Pulsed Field Ablation System Receives FDA Approval for Market Launch, used for the treatment of refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

Argá Medtech, a company with unique PFA and catheter technologies, gains capital favor。But its technology still needs to be validated for safety and efficacy through clinical research., and there is not much time left for Argá Medtech. Once a large number of PFA products enter the market, it remains to be seen whether its core product, CSE, can seize market share from the giants.

What the future holds for the PFA market remains unknown as numerous strong competitors vie for this highly coveted opportunity. Ultimately, however, we look forward to manufacturers both in China and overseas showcasing their unique strengths through healthy competition, driving innovation to empower better treatment and care experiences for patients!

# CSE Coherent Sine Wave Pulse Ablation Catheter

The Sinusoidal CSE System consists of a configurable (circular, linear, and focal) ablation catheter and a pulse ablation generator. Compared with all other PFA waveforms,CSE AdoptionUnique Sine WaveRather than a square wave。Therefore,CSE was also hailed by Argá Medtech as the next-generation PFA technology.。

CSE aims toMinimize muscle stimulation, reduce bubble formation, and increase targeted energy delivery., to create transmural lesions in tissues of any thickness. CSECan provide bipolar, monopolar, or a combination of both waveforms., allowing users to adjust the width and depth of the ablation lesion.

▲CSE Ablation System and Ablation Catheter Combination (Image SourceOfficial CompanyNetwork)

▲Schematic diagram of CSE waveform (Image SourceOfficial CompanyNet)

Argá Medtech announced in October 2022 the start of itsFirst-in-Human Clinical Trial"Atrial Fibrillation Patient Coherent Sinusoidal Pulse Electroporation (CSE) System"Pilot Study（BURST-AF）。

At the 2023 HRS conference, a presentation was given on a preclinical study of lesion depth and safety using the CSE multi-channel ablation system. The study involved epicardial ablation in five dogs with open-chest procedures and endocardial ablation in three pigs (standard & high energy), confirming...The phased sine wave can adjust the bipolar-unipolar ratio to control the depth of injury, injury filling, and muscle excitation.. The sine wave pulse generator uses a transformer circuit to provide better electrical isolation; moreover, the bipolar/unipolar phase control method can operate along 2, 4, and 8 charged electrodes in linear and circular configurations.Non-thermal continuous lesions with an average ablation depth of 6mm and 7.5mm。

AboutArgá Medtech

Argá Medtech was co-founded in June 2020 by seasoned medical device executive David Neale (CEO) and serial entrepreneur Randy Werneth (CTO), with offices in Lausanne, Switzerland, and San Diego, California, USA. The leadership team hasDevelopment and Commercialization of Cardiac and Arrhythmia Management ProductsWith over 50 years of comprehensive experience in the field, extensive connections in electrophysiology, and a deep understanding of the challenges currently faced by doctors and patients.

Argá Medtech isDeveloping the Next Generation of Non-Thermal Cardiac Ablation Systems, itsUnique Pulse Field Ablation (PFA) Generator and Its Proprietary CatheterWhen used together, they provide strong flexibility. The company has set the standard for the next-generation PFA system, with a versatile catheter design capable of creating circular, linear, and focal lesions. It also offers the practicality of a single-injection device without losing its ability to generate linear and focal lesions, thereby eliminating the need to change catheters during the procedure.The unique CSE PFA waveform allows for energy titration according to tissue depth to achieve durable lesions.。

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