VOLTA MEDICAL raises 28 million USD to revolutionize persistent AFib ablation

Volta Medical, a pioneering French-based HealthTech startup, working on novel artificial intelligence (AI) algorithms to treat cardiac arrythmias, today announced that it has successfully raised 28 million USD. The financing round was led by Gilde Healthcare with participation of existing shareholder Pasteur Mutualité. The new capital will allow the company to establish its revolutionary FDA-cleared and CE marked VX1 AI software solution as a new standard of care, pursue further R D activities and start to roll out commercial activities across the US and Europe. Recruitment for TAILORED-AF, an international multicenter trial has already started. Volta Medical will be welcoming two new Board members. Janke Dittmer, General Partner at Gilde Healthcare, has been nominated as a board member and former medical device industry top executive, Denis Gestin, as an independent board member.

After developing the first commercially available AI software to help electrophysiologists improve management of cardiac arrythmias, Volta Medical is now preparing to transform the way ablation procedures will take place in the future. Theophile Mohr-Durdez, CEO and co-founder of Volta Medical mentioned: "We are excited to be able to complete our highly ambitious medical program with the start of TAILORED-AF, a new randomized controlled trial (RCT). This trial aims to demonstrate how our AI software can help physicians optimize both efficacy and efficiency when performing complex procedures to treat heart rhythm disturbances." Among these disturbances, atrial fibrillation (AFib) is the most common[1] and currently affects over 30 million patients worldwide. This underlines the importance of the TAILORED-AF trial which is likely to result in a breakthrough approach for tackling one of the world's greatest public health challenges in a more consistent and reproducible manner. According to Gilde Healthcare's Janke Dittmer, "We are excited to support Volta's team in bringing a unique solution to address one of the biggest unmet needs in the large and fast-growing electrophysiology market".

About atrial fibrillation (AFib or AF)

AF can be considered an "electrical storm" in the atria in which all synchronized activities have disappeared, and the necessary coordination of the contraction stops. This can lead to a number of symptoms including palpitations, shortness of breath, and in some patients, heart failure. AF is also a major risk factor for stroke, as stagnant blood in the atrium during AF may lead the formation of a clot, that can migrate to the brain.

AF affected approximately 6 million patients in the US in 2019[2] and is estimated to double by 2060[3]. 120,000-215,000 new cases are projected to occur in this part of the world each year reaching a total AF patient population level of 14-17 million[4]. A study in the UK concluded that AFib is an extremely costly public health problem[5]. Evidence suggests a higher prevalence of AFib in patients with hypertension, heart failure, coronary heart disease, obesity, diabetes. In addition, recent studies show that 20-30% of patients with ischemic stroke have had AFib before, during or after the initial event[6]. AF increases the likelihood of stroke by four to five times and AFib-induced strokes that are generally associated with more severe damage[7].

The TAILORED-AF trial

TAILORED-AF is an international, multicenter trial designed to compare the VX1 AI software ablation strategy with currently used conventional anatomical ablation approaches. According to Seth H. Goldbarg, MD, FACC, FHRS, Director of Cardiac Electrophysiology, New York Presbyterian/Queens, Assistant Professor, Weill Cornell Medical College, Flushing, NY, USA and principal investigator of the trial in the US, "the complexities associated with identification, localization and treatment of the pathological zones that cause and perpetuate an abnormal heart rhythm, have historically represented a major challenge relative to clinical intervention for patients with AFib. The various attempts to standardize and simplify our approach to identifying these regions have often led to disappointing results. We are therefore placing great hope in the TAILORED-AF trial, as the VOLTA system continues to show promise in its ability to significantly enhance operator performance levels." The results of the Ev-AIAFIB proof of concept study carried out with VX1 in 8 different centers will soon be published. They will provide data on why and how this new approach has the potential to provide electrophysiologists with a guidance tool that will optimize treatment of patients with AF in a lasting manner.

Localization and ablation of drivers perpetuating AF have been at the forefront of cardiovascular disease research but have not led to any radical changes to-date. Volta's system is intuitive, user-friendly and shows promise to potentially reduce inter-operator variability in the analysis of procedural data without lengthening either the diagnostic or therapeutic procedures. "We are eager to help new centers access and use our revolutionary tool during ablation procedures. This cutting-edge medical innovation enhances the efficiency and precision of the practitioners who are analyzing real-time data in the operating room. Its robustness will help physicians adopt a more efficient workflow and take the right decisions" – claimed physician co-founder, Jerome Kalifa.

About Volta Medical

Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a HealthTech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta's overarching goal is to drastically improve cardiac arrythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data with the highest standards of data protection. Its first product, VX1, assists cardiologists for the real-time identification of specific abnormal electrograms, known as dispersed electrograms.

For more information, visit the company's website at www.volta-medical.com.

About the VX1 AI software

VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and technologies currently used in operating rooms or electrophysiology labs. The VX1 software analyzes the patient's electrograms in real-time to identify specific electrograms known as dispersed electrograms. It also provides a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters.

The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

VX1 is a medical device which is FDA cleared and has a CE mark.

About Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor managing over $1.5 billion across two fund strategies: venture growth capital and private equity. Gilde Healthcare's venture growth capital fund invests in fast growing companies active in digital health, MedTech and therapeutics. The venture growth companies are based in Europe and North America. For more information, visit the company's website at www.gildehealthcare.com.

Media Contacts

BCW agency

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References

[1] https://globalheartjournal.com/articles/abstract/10.1016/j.gheart.2014.01.004/

[2] Marco V. Perez, M.D., Kenneth W. Mahaffey, M.D., Haley Hedlin, Ph.D., John S. Rumsfeld, M.D., Ph.D., Ariadna Garcia, M.S., Todd Ferris, M.D., Vidhya Balasubramanian, M.S., Andrea M. Russo, M.D., Amol Rajmane, M.D., Lauren Cheung, M.D., Grace Hung, M.S., Justin Lee, M.P.H., et al., Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation, N Engl J Med 2019; 381:1909-1917

[3] Krijthe, Bouwe P., et al. "Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060." European heart journal 34.35 (2013): 2746-2751.

[4] 2017 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. 2016;37:2893–2962.doi:10.1093/eurheartj/ehw210

[5] https://pubmed.ncbi.nlm.nih.gov/14966048/

[6] Authors/Task Force Members:, et al. "2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS." EP Europace 18.11 (2016): 1609-1678.

[7] https://www.ahajournals.org/doi/10.1161/strokeaha.115.012004

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SOURCE Volta Medical