Marseille, 7 January 2020 – 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 23 million Euros. 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.” Atrial fibrillation (AF) 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 (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 increases the likelihood of stroke by four to five times and AFib-induced strokes that are generally associated with more severe damage.

AF is an extremely costly public health problem. It affected approximately 6 million patients in the US in 2019 and 11 million patients in Europe in 2018 and prevalence is estimated to double by 2060. In Europe 120,000-215,000 new cases are projected to occur each year reaching a total AF patient population prevalence of 14-17 million by 2030. Evidence suggests a higher prevalence of AF 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 AF before, during or after the initial event.

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 Dr Tom De Potter, Head of Electrophysiology, OLV Hospital, Aalst, Belgium and one of the TAILORED-AF trial investigators, “treatment of the more severe forms of drug-resistant persistent AF remains a major challenge in our field, both due to the large number of patients affected and lack of therapeutic strategies that can offer predictable efficacy. Thanks to the software’s ability to identify signals that are relevant, from those that are less relevant, one of its greatest and most unique benefits is to allow for a more easily reproducible approach to ablation.” 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.

Conventional ablation methods, while useful for treating patients, who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, have so far been less precise than desired. Their results, even if significant in certain cases, remain sub-optimal. 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 based 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 €1.4 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
Linda Pavy – Tel: +33 (0)6 07 59 43 95 – Email: linda.pavy@bcw-global.com
Maëly Daviles – Tel: +33 (0)6 13 20 51 02 – Email: maely.daviles@bcw-global.com
Pauline Coudert – Tel +33 (0)6 88 38 46 58 – Email: pauline.coudert@bcw

References
1.https://globalheartjournal.com/articles/abstract/10.1016/j.gheart.2014.01.004/
2.https://www.ahajournals.org/doi/10.1161/strokeaha.115.012004
3.https://pubmed.ncbi.nlm.nih.gov/14966048/
4.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
5.https://www.jnjmedicaldevices.com/sites/default/files/2020-07/Burden%20of%20Disease%20Full%20report.pdf
6.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.
7.2017 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
8.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.

Marseille, December 10, 2020 –Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software. This is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during atrial fibrillation (AFib) or atrial tachycardia. These annotations help physicians locate heart regions harboring a specific electrogram abnormality, known as spatiotemporal dispersion. This innovative detection and patient-specific localization of abnormal regions may eventually help physicians better decide where they need to intervene to either burn (radiofrequency) or freeze (cryotherapy) faulty electrical pathways.

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, “AFib represents a major challenge in cardiology due to the complexities associated with identification, localization and treatment of the pathological zones that cause and perpetuate this abnormal heart rhythm. The current standard of care does not provide us with a uniform, easy to follow and predictable approach to identify these regions. This has led to heterogenous approaches to treating these patients, with very mixed and often disappointing results. We are excited to be part of the further studies taking place with this AI software, as the VOLTA system may provide a major step forward in the effective approach to ablation of persistent AFib.”

Conventional ablation methods, while useful for treating patients, who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, have so far been less precise in persistent AFib patients than desired. Their results, even if significant in certain cases, remain sub-optimal. Localization and ablation of drivers perpetuating AFib has been at the forefront of cardiovascular disease research but has not led to any radical changes to-date. The Volta mapping 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.

The VX1 system holds enormous promise for offering an easier, faster, more accurate and reliable way to identify zones of interest in patients who suffer from chaotic heart muscle contractions. Developed jointly by top experts in the fields of electrophysiology and digital technologies, VX1 is simple to use. It bears the potential to provide a permanent solution to a chronic health burden with a one-time breakthrough procedure and has the potential to become the gold standard AI solution, for efficient and affordable cardiac ablation procedures. For Jérôme Kalifa, MD and cofounder of Volta Medical “our ultimate goal is to offer an alternative to a lifetime of medication that can have problematic side effects in some patients, while bringing a better quality of life to those who suffer from bothersome daily disease symptoms. This is what is generating increasing enthusiasm around the potential of our solution. The recently obtained FDA clearance is an important milestone for our company and ultimately for patients who suffer from difficult to treat forms of AFib”.

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 atrial fibrillation (AFib or AF)
AFib 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. AFib is also a major risk factor for stroke, as stagnant blood in the atrium during AFib may lead to the formation of a clot, that can migrate to the brain. This is why AFib is such an important risk factor for heart failure and stroke and a major reason for loss of quality life.

AFib is expected to reach 12.1 million patients in the US by 2030. Prevalence of arrhythmias increases with age and total annual costs for treatment of AFib in the US were estimated already in 2001 at US$6.65 billion. Evidence suggests a higher prevalence of AFib in patients with hypertension, heart failure, coronary heart disease, obesity and diabetes. In addition, recent studies show that 20-30% of patients with ischemic stroke have had AFib before, during or after the initial event. AFib increases the likelihood of stroke by four to five times while AFib-induced strokes are generally associated with more severe damage.

Media Contacts
BCW agency
Linda Pavy – Tel: +33 (0)6 07 59 43 95 – Email: linda.pavy@bcw-global.com
Maëly Daviles – Tel: +33 (0)6 13 20 51 02 – Email: maely.daviles@bcw-global.com
Pauline Coudert – Tel +33 (0)6 88 38 46 58 – Email: pauline.coudert@bcw

References
1.https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
2.https://www.uscjournal.com/articles/epidemiology-economic-burden-af
3.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.
4.https://www.ahajournals.org/doi/10.1161/strokeaha.115.012004

Marseille (France) October 22, 2018
Volta Medical, a young French med‐tech company that has developed the first Artificial Intelligence (AI) software to guide cardiologists during heart surgeries, announces it has raised € 2.3 million euros in seed funding, including € 2 million from the Pasteur Mutualité Group. The funding round came on the heels of the first tests performed with patients in Marseille (France) and following the hiring of Denis Hansjacob, a prominent figure in the med‐tech industry, as Chief Operating Officer.

The funds raised will be used to implement a European multicentric clinical trial in order to demonstrate the performance of Volta Medical’s AI software during heart surgeries; to expand the company’s R&D team for the development of new products; and to prepare the market launch of AIFib in 2020. AIFib is the first AI software in interventional cardiology capable of guiding surgeons during their procedures, specifically for the treatment of atrial fibrillation (AF).

“Atrial fibrillation, AF, is a severe condition that decreases life expectancy and increases the risk and recurrence of strokes, as well as post‐stroke mortality. Our vision is to offer a solution to this major public health issue, and we thank the Pasteur Mutualité Group for trusting our innovative approach,” said Volta Medical’s four co‐founders, Dr. Julien Seitz, Dr. Clément Bars (Marseille), Dr. Jérôme Kalifa and engineer Théophile Mohr Durdez. “Our ambition, which is ideally aligned with the World Health Organization (WHO) program on heart diseases, is to help improve the treatment of atrial fibrillation – a condition whose prevalence increases as the world population ages – by bringing the artificial intelligence revolution to cardiologists and guiding them during their surgeries.”

“We are delighted to support Volta Medical, our very first investment in a young and promising start‐ up company. Volta Medical and its team hit all the right notes when it comes to our investment policy. They embody the core values of our Group and of the health professionals we serve, namely, the promotion of breakthrough innovation for the benefit of the greater medical community, including by significantly improving key treatments in the field of cardiology. From the company’s young, visionary founders to our mutualist Group, we are also very pleased with the positive approach taken during this operation, marked by a commitment to the evolution of the complex task of practicing medicine,” said Mr. Thierry Lorente, CEO of the Pasteur Mutualité Group.

Volta’s intelligent software, AIFib
AIFib is an AI software developed to guide doctors through the complex medical procedure intended to treat atrial fibrillation, from the detection of electrical foci, which trigger atrial fibrillation, to the surgery itself. Up until now, to identify electrical foci, cardiologists had to maneuver probes inside the heart as a way to identify electrical signals and detect them visually. Such technique is very hard to master, however, and surgeons had to analyze very complex sets of intracardiac electrical signals. Volta Medical had the idea of modeling and automating this technique to make it accessible to a large number of surgeons.

A clinical study is ongoing at Saint Joseph Hospital, in Marseille (France), to test the feasibility of the AIFib software during actual procedures. The initial data obtained on more than 30 patients are very promising and show that doctors’ expertise is either matched or outperformed by the AIFib software. The first results of the study are expected in the spring 2019.

Previous data presented in May 2018, at the annual Heart Rhythm Society Conference, in Boston, already showed that the performance of the software surpassed that of a panel of 28 cardiologists, including that of its creators, as recorded during a conference earlier this year in Marseille.

Atrial fibrillation (AF)
AF manifests itself by an anarchic, rapid and irregular heart rate. These chaotic heartbeats prevent the heart from properly pumping blood. The root cause is an “electrical storm” in the atria disrupting all synchronized activities, so that the mechanical contraction of the atria no longer occurs. The heart loses its strength. The ventricle may momentarily compensate for this loss, but in the long run, the exhaustion of its contractile forces can lead to heart failure. Atrial fibrillation can cause a blood clot in the heart, which may migrate into the brain arteries and cause a stroke.

This is the world’s most common heart arrhythmia and its prevalence increases with age, affecting 1 in 25 adults over 60 and 1 in 10 over 80. There are 7 million patients in the U.S., 11 million in Europe and 750,000 in France (the number of patients is expected to double within the next 30 years). A 55‐ year‐old person has 1 in 4 chances of developing AF during his lifetime (24.8% of men and 22.9% of women). It is therefore a true “epidemic.” AF is a severe disease that decreases life expectancy. AF is responsible for 1 in 6 strokes. The overall prevalence of AF is 5.5% of the population aged 55 and up, and it increases with age (10% at 80 and up). This is a major public health issue whose treatment costs 3,000 euros per year and per patient in France (2.5 billion euros per year in France, with hospitalization accounting for half the costs).

About Volta Medical
Founded in 2016 in the south of France by 3 doctors and one engineer, Volta Medical is a young med‐tech company based in Marseille that develops artificial intelligence (AI) intended for interventional cardiology. The 4 co‐founders are world‐renowned experts in cardiac electrophysiology and intracardiac signal analysis. It took them 10 years to develop a new state‐of‐the‐art medical procedure capable of guiding cardiac surgeons in the treatment of atrial fibrillation. Volta Medical will automate it thanks to the artificial intelligence software AIFib which has been developed by a highly skilled team of engineers and data scientists.
For more information: https://www.volta‐medical.com

About the Pasteur Mutualité Group
As a 160‐year‐old leading mutual insurance group managed by and intended to healthcare professionals, the Pasteur Mutualité Group is committed to helping its members, from the beginning of their studies, to provide them with solutions catered to the needs of their professional and private lives. Our DNA is marked by strong values of mutual assistance, respect and fairness. The spirit of our Group and its members is also the foundation of our strong Corporate Social Responsibility (CSR) investment policy. The Group places innovation at the heart of its development project. With more than 138,000 members, the Pasteur Mutualité Group is the preferred partner of healthcare professionals.
For more information: www.gpm.fr
Follow the Pasteur Mutualité Group on Twitter: @gpm_en

Heart diseases in numbers

French figures (Sources: Inserm)
✔ In France, heart diseases are responsible for 180,000 deaths every year
✔ Coronary artery diseases (including myocardial infarctions), strokes, and heart failures (HF) account for 27%, 25%, and 23% of all cardiovascular deaths, respectively. That does not include the sequelae and handicaps caused by heart diseases.
✔ In France, 120,000 people are treated each year for a myocardial infarction, 130,000 people for a stroke and about as much for HF.

World figures (Sources: WHO)
✔ Coronary artery diseases (ischemic diseases) and strokes are the leading cause of death worldwide. They accounted for a total of 15 million deaths in 2015.
✔ They have been the leading causes of death in the world for the past 15 years.

Press contacts
ALIZE RP
Caroline Carmagnol and Najette Chaib
+33 (0)6 64 18 99 59 / voltamedical@alizerp.com