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Argá Medtech

Feb 28
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Pulsed Field Ablation Innovator Argá Medtech Announces €54 Million Oversubscribed Series B Capital Raise

By Argá Medtech, Press Release, Private Companies
Press Release.

 

Pulsed Field Ablation Innovator Argá Medtech Announces €54 Million Oversubscribed Series B Capital Raise

– Funding will advance US and EU clinical studies of innovative pulsed field ablation system for treating atrial fibrillation  – 

Lausanne, Switzerland and San Diego, CA, USA — February 27, 2024 — Argá Medtech, a private company developing Coherent Sine-Burst Electroporation™ (CSE™), a next-generation cardiac ablation system for treating cardiac arrhythmias, including atrial fibrillation (AF), today announced the closure of a €54M oversubscribed Series B funding. The round was led by the existing investors, Advent Life Sciences (UK) and Earlybird Health (Germany), as well as new investor Gilde Healthcare (the Netherlands) and an undisclosed strategic investor. The financing enables Argá Medtech to advance the development of its innovative CSE™ Pulsed Field Ablation (PFA) system for treating AF through the execution of an IDE study in the US and a CE Mark study in the EU. With the funding, the company will also expand its US offices in San Diego, CA, in anticipation of its US clinical activities.

“We are pleased to secure the support of such marquee investors who believe that Argá Medtech will revolutionize the atrial fibrillation ablation field,” said David Neale, CEO of Argá Medtech. “This financing enables us to advance toward our goal of validating the CSE™ PFA system in Europe and the US as we work to deliver a safe, fast, and effective treatment to millions of people affected by cardiac rhythm disorders and atrial fibrillation. We are proud of our accomplishments to date, including conducting a 48-patient first-in-human study in Europe, which demonstrated the high performance of our platform in treatingatrial fibrillation.”

Argá Medtech’s CSE™ ablation system enables electrophysiologists to treat any region in the heart safely and efficiently using a single, multi-configurable catheter while titrating lesion depths according to the location within the heart.

The company’s CSE™ PFA platform combines its proprietary CSE™ PFAgenerator with a multi-configurable catheter to provide unmatched flexibility in AF treatment. Argá Medtech’s CSE™ system uses a sinusoidal/sine wave, while other PFA platforms are typically powered by square wave energy sources. This approach offers several advantages, such as allowing physicians to configure the energy delivery and titrate the depth to the location in the heart. Additionally, the waveform is delivered through a versatile, all-in-one catheter that can be shaped to create circular, linear, or focal ablation lesions, eliminating the need to perform catheter exchanges to achieve the desired lesion set. Thus, the procedure is simplified, reducing the risk of introducing air bubbles as one catheter is removed and another is reinserted, as well as reducing costs.

AF is the most common heart arrhythmia, affecting about 38 million patients worldwide1, rendering them five times more likely to have a stroke.2 While ablation using thermal energy has proven effective in alleviating AF symptoms, higher risks are associated with its use.3In contrast, PFA energy delivery offers a tissue-selective, precise ablation of the intended heart tissue while preserving nearby tissues and minimizing the risks of thermal injury, such as those to the esophagus or the phrenic nerve.

About Argá Medtech SA

Argá Medtech SA is developing a Coherent Sine-Burst Electroporation™ (CSE™), Pulsed Field Ablation (PFA) system to treat patients with cardiac arrhythmias. Argá Medtech is setting the standard for the next-generation PFA systems with its versatile catheter design able to create circular, linear, and focal lesions, coupled with a unique CSE™ PFA waveform that allows energy titration based on tissue depth to achieve durable lesions. The company was co-founded in June 2020 by veteran medical device executive David Neale, CEO, and serial entrepreneur Randy Werneth, CTO, and has offices in Lausanne, Switzerland and San Diego, CA, USA. With over 50 years of combined experience in creating and commercializing cardiac and arrhythmia management products, the leadership team is well connected in electrophysiology and understands the current challenges faced by physicians and patients.

To learn more, visit https://argamedtech.com.

References: 

1. Lippi, Giuseppe et al. “Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge.” International journal of stroke: official journal of the International Stroke Society vol. 16,2 (2021): 217-221. doi:10.1177/1747493019897870. https://pubmed.ncbi.nlm.nih.gov/31955707/

2. World Stroke Organization. Stroke and Atrial Fibrillation. Accessed February 16, 2024.  https://www.world-stroke.org/world-stroke-day-campaign/prevent-stroke/stroke-and-atrial-fibrillation

3. Aldaas OM, Malladi C, Aldaas AM, Han FT, Hoffmayer KS, Krummen D, Ho G, Raissi F, Birgersdotter-Green U, Feld GK, Hsu JC. Safety and acute efficacy of catheter ablation for atrial fibrillation with pulsed field ablation vs thermal energy ablation: A meta-analysis of single proportions. Heart Rhythm O2. 2023 Sep 12;4(10):599-608. doi: 10.1016/j.hroo.2023.09.003. PMID: 37936671; PMCID: PMC10626185. https://pubmed.ncbi.nlm.nih.gov/37936671/

Media Contact: 

Finn Partners

Glenn Silver

glenn.silver@finnpartners.com

Apr 27
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Argá Medtech Shows Promise for New Cardiac Ablation Technology at 2022 Heart Rhythm Society Annual Meeting

By Argá Medtech, Press Release, Private Companies
Press Release.

 

  • Argá Medtech’s next-generation non-thermal cardiac ablation system shows promise in improving precision, speed and flexibility in treating atrial fibrillation
  • Preliminary feasibility study results demonstrate the company’s Coherent Sine-Burst Electroporation (CSE) Pulsed Field Ablation platform’s ability to titrate lesion depth using sinusoidal waveforms

Lausanne, Switzerland and San Diego, CA, USA — April 27, 2022 —Argá Medtech, a company developing Coherent Sine-Burst Electroporation (CSE), a next-generation non-thermal cardiac ablation system for treating cardiac arrhythmias, announced a featured poster presentation on preliminary findings for its innovative technology at the 2022 Annual Meeting of the Heart Rhythm Society (HRS), April 29 to May 1 in San Francisco. The company’s CSE Pulsed Field Ablation (PFA) offers unmatched flexibility in treating atrial fibrillation (AF) with its proprietary CSE generator and a multi-configurable catheter.

“AF affects 37.5 million people worldwide1, significantly raising their chances of a stroke or heart attack and greatly diminishing their quality of life,” said David Neale, CEO and co-founder of Argá Medtech. “While the cardiac ablation field has achieved major progress in treating AF, outcomes have only marginally improved in the past 15 years, and costs have increased. It is imperative to develop new tools that improve success rates while lowering procedure costs.”

Argá Medtech’s unique CSE PFA platform offers several advantages over other PFA technologies, which are powered mostly by a square wave energy source. Argá’s new CSE system allows physicians to select all bipolar, all unipolar or combinations of bipolar and unipolar energy delivery modes to titrate the lesion to the needs of the patient.

Argá Medtech’s catheter also offers unmatched flexibility in its ability to perform any lesion type necessary for the patient’s treatment of AF, eliminating the need to use additional ablation catheters. Its design enables the catheter to take different shapes allowing for the creation of circular, linear or focal lesions. These advantages offer the potential to improve precision, speed, safety and efficiency in cardiac ablation procedures while reducing procedure costs.

“Argá Medtech gives physicians an unparalleled ability to perform much more flexible, elegant ablation procedures, likely improving outcomes and reducing the need for repeat surgeries and saving costs for both hospitals and the healthcare system,” said Neale. “We are very optimistic about our technology’s promise and plan to launch our first in-human trial in 2022.”

The HRS presentation reports findings from an animal feasibility study on using multi-programmable CSE waveform to achieve a titratable range of lesion depths that address the variability of tissue thickness within the atrium and ventricle.

Presentation Information
Multi-programmable Coherent Sine Burst Electroporation Waveform for Atrial and Ventricular Catheter Ablation
Date: Friday, April 29, 2022
Time: 1:30 – 1:45 p.m. PT
Location: Abstract Pavilion Podium 11
Authors: Micah Lee BS, Ricardo Roman BS, Ale Lopez BS, Mark Zurcher MS, Deborrah Hunt BS, Randy Werneth MS, Kurt S Hoffmayer MD.

About Argá Medtech
Argá Medtech SA (Argá) is a privately held medical device company based in Switzerland founded by a seasoned team of leaders in the medical device industry. Argá is developing an innovative non-thermal energy-based cardiac ablation system for the treatment of cardiac arrhythmias. With the use of Pulsed Electrical Fields to create irreversible electroporation of cardiomyocytes, Argá is developing a safer, faster, cheaper and more effective cardiac ablation treatment for the benefit of millions of people affected by cardiac rhythm disorders and atrial fibrillation. To learn more, visit https://argamedtech.com.

Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707