• First randomized controlled clinical trial to evaluate VX1-guided ablation compared to conventional anatomical ablation approaches to treat persistent atrial fibrillation
• International, multi-center trial involving 26 sites, 374 patients is expected to report results in 2024

Marseille (France), February 2, 2023 – Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologist physicians in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced the completion of patient enrollment in the randomized controlled clinical trial, TAILORED-AF, evaluating VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach.
 
The company’s lead product, VX1, is the first commercially available AI decision-support software to help guide physicians with identification and real-time annotation of unique abnormalities (so called “dispersed electrograms“) on 3D anatomical and electrical maps of the heart. This technology ultimately may lead to optimized catheter-ablation procedures for complex arrhythmias, including persistent AF.

“Atrial fibrillation is the most common heart rhythm disturbance in adults and the need for more precise therapies is significant,” said Professor Isabel Deisenhofer, MD, of German Heart Center in Munich, Germany and primary investigator for the trial. “While catheter ablation is well-established as an important treatment for AF, a more consistent standard of care is needed for its more progressed disease state, known as persistent AF. VX-1 has the potential to meet that need by assisting electrophysiologists in delivering successful outcomes with each patient ablation.”

The TAILORED-AF clinical trial is an international, multicenter, randomized controlled study designed to confirm the clinical significance of VX1 and lay the groundwork for establishing VX1 as a new standard of care for persistent AF ablation. The primary endpoint is freedom from documented AF episodes lasting longer than 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety.

“We are committed to helping physicians use EGM-assessment software to guide ablation and providing another clinical tool to support the best possible outcomes for patients,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder. “We are excited to complete patient enrollment in this 26-site controlled trial and continue studying our VX1 platform, and look forward to reporting the results in 2024 to provide electrophysiologists more essential, life-changing care options to patients.”
 

About the TAILORED-AF Trial
TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy targeting PVI alone for the treatment of persistent AF. The primary endpoint of the study is the absence of documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety. Volta Medical expects results from the TAILORED-AF trial in 2024.

About Volta Medical
Volta Medical is a health technology company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, Volta’s overarching goal is to improve cardiac arrhythmia 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. The company’s first product, VX1, is a digital AI companion device and algorithm to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs), known as dispersed EGMs. For more information, visit the company’s website at www.volta-medical.com.

Media Contact
Jeff Martin, VP of Global Marketing
Volta Medical
jeffrey.martin@volta-medical.com

U.S. Media Contact
Glenn Silver
Finn Partners
glenn.silver@finnpartners.com

•  New round of financing led by Vensana Capital will support technology platform expansion and further validating VX1, Volta’s Artificial Intelligence (AI) Decision-Support Software in improving catheter ablation for complex cardiac arrhythmias
• Medical device executive John Slump joins as Chief Financial Officer

Marseille (France), January 5, 2023 – Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologist physicians in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced €36 million in new Series B funding, bringing the total capital raised to over €70 million.

The funding round was led by U.S.-based Vensana Capital with co-investment from Lightstone Ventures and existing investor Gilde Healthcare. The funding will help accelerate new product development, support additional clinical trials, prepare for full-scale US commercialization, and pursue further regulatory approvals. The company’s lead product, VOLTA VX1, is the first commercially available AI decision-support software to help guide physicians with identification and real-time annotation of unique abnormalities (so called “dispersed electrograms“) on 3D anatomical and electrical maps of the heart.  This technology ultimately may lead to optimized catheter-ablation procedures for complex arrhythmias, including persistent AF.

“There is a critical need to improve precision and consistency in cardiac ablation procedures for patients with persistent AF.” said Theophile Mohr Durdez, Volta Medical CEO and co-founder. “With half of these patients requiring repeat treatments, clinicians need tools that enable them to better understand the disease and drastically improve patient outcomes. We believe VOLTA’s VX1 has the potential to do just that in a consistent, reproducible way. We are most grateful to the teams at Vensana, Lightstone, and Gilde for their support and confidence as we partner to further validate our products and expand access to it globally.”

“Volta Medical’s technology is designed to redefine how electrophysiologists make real-time decisions in pinpointing areas relevant to atrial fibrillation persistence,” said Justin Klein, MD, JD, co-founder and managing partner of Vensana Capital. “We applaud the team’s commitment to validating their products with an investment in multiple high quality clinical trials. We are confident that Volta’s innovative AI software will transform the effectiveness and efficiency of these challenging procedures.”

Volta Medical also is pleased to announce the appointment of experienced medical device executive, John Slump, as CFO of Volta Medical. A seasoned operator in the industry, John has a proven track record as a founder and CFO, leading multiple MedTech companies from concept through regulatory approvals, commercial growth, and strategic acquisitions. Most recently, he served as CFO of Surgical Innovation Associates, a rapidly growing medical device company in the reconstructive and plastic surgery market that was acquired by Integra LifeSciences. Prior to that, John co-founded FARAPULSE, a medical device company in electrophysiology pioneering novel pulsed field ablation technology that was acquired in 2021 by Boston Scientific. Previously, John served as CFO of Attune Medical, an emerging growth medical device company commercializing proprietary esophageal temperature management devices in electrophysiology and other surgical markets.

“I’m excited to join the Volta Medical team and am pleased with our ability to attract significant equity investment from both new and existing investors in an increasingly challenging fundraising climate,” John said. “VOLTA VX1 has the potential to make a major difference in the lives of millions of people with AF, and this Series B Financing will help to accelerate its development and adoption nationally and across the globe.”

About Volta Medical
Volta Medical is a health technology company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, Volta’s overarching goal is to improve cardiac arrhythmia 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. The company’s first product, VX1, is a digital AI companion device and algorithm to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs), known as dispersed EGMs. For more information, visit the company’s website at www.volta-medical.com.

About Vensana Capital

Vensana Capital is a venture capital and growth equity investment firm dedicated to partnering with entrepreneurs who seek to transform healthcare with breakthrough innovations in medical technology. Launched in 2019, Vensana manages $550M in capital and is actively investing in development and commercial stage companies across the MedTech sector, including medical devices, diagnostics and data science, life science tools, digital health, and tech-enabled services. Vensana’s investment team has a history of successfully partnering with management teams behind industry-leading companies including Cameron Health, CardiAQ, Cartiva, CV Ingenuity, Epix Therapeutics, Inari Medical, Intact Vascular, Lutonix, Neuwave Medical, Personal Genome Diagnostics, Sequent Medical, Topera, Ulthera, Veran Medical Technologies, Vertiflex, and Vesper Medical. Learn more at www.vensanacap.com.

About Lightstone Ventures

Lightstone Ventures is a global venture capital firm investing in biotech and MedTech companies pioneering big ideas poised to transform patient outcomes. Lightstone Ventures was founded in 2012 to empower visionary entrepreneurs with the resources and operational guidance necessary to bring their innovative therapeutics and technologies to the patients who need them most. Lightstone Ventures’ investment team has led deals resulting in 19 acquisitions and 20 initial public offerings over the last two decades. The firm has offices in Boston, Mass., Menlo Park, Calif., Dublin, Ireland and Singapore. For more information, visit www.lightstonevc.com.

About Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor with two fund strategies: Venture&Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States). Gilde Healthcare Venture&Growth invests in fast growing, innovative companies active in (bio)pharmaceuticals, healthtech and medtech that are based in Europe and North America. For more information, please visit www.gildehealthcare.com.

Media Contact
Jeff Martin, VP of Global Marketing
Volta Medical
jeffrey.martin@volta-medical.com

U.S. Media Contact
Glenn Silver
Finn Partners
glenn.silver@finnpartners.com

Europe Media Contact
Julia Bittner
MC Services AG
julia.bittner@mc-services.eu

France Media Contact
Caroline Carmagnol
Alize RP
caroline@alizerp.com

• Volta VX1 decision support software reproduces expert-physician electrogram(EGM) analysis that can assist physicians in the real-time identification of specific abnormal electrograms in a persistent atrial fibrillation (AF) population
• After a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively
• VX1 allowed for robust center-to-center standardization of identification of abnormal electrograms, confirming reproducibility of results across 8 centers and 17 operators
• The Ev-AIFib study was an open-label single-arm uncontrolled study comparing the acute and long-term outcomes of 85 patients in persistent AF after ablation in regions exhibiting VX1-highlighted abnormal electrograms
• The ongoing Tailored-AF randomized controlled trial is designed to demonstrate clinical significance and compare the outcomes of VX1-guided ablation versus standard ablation

Marseille (France), 31 August 2022 – Volta Medical, a pioneering health tech company developing artificial intelligence (AI) software solutions to assist electrophysiologists to treat cardiac arrhythmias, today announced that the Journal of Cardiovascular Electrophysiology (JCE) has published peer-reviewed results from the Company’s successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution to assist operators in the real-time identification of specific abnormal electrograms (EGM) during atrial fibrillation (AF) procedures. The article titled “Artificial Intelligence Software Standardizes Electrogram-based Ablation Outcome for Persistent Atrial Fibrillation” is available at https://onlinelibrary.wiley.com/doi/abs/10.1111/jce.15657.

The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram (EGM) analysis and assists operators in the real-time identification of specific abnormal EGMs, known as dispersed EGMs, during ablation procedures in a persistent AF population. Results demonstrated that VX1 allowed for the building of standardized “Volta VX1 maps”, used as a reference for operators to conduct EGM-guided ablation. The standardization of the detection of abnormal EGMs facilitated a robust patient-to-patient and center-to-center uniformity in EGM-based ablation. No major differences between operator’s visual analysis and VX1 EGM maps were recorded, and there were no statistically significant differences between outcomes across the 8 study centers and 17 operators. Furthermore, after a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively. Also, notably there was acute AF termination of 88% for subjects in all centers.

“Catheter ablation is well-established as an important treatment for AF and is by far the most common cardiac ablation procedure performed worldwide. Due to the complexity of persistent AF, however, there is no uniform standard of care resulting in heterogenous approaches that yield mixed and often disappointing results associated with high recurrence rates”, said Jean-Paul Albenque, MD, Cardiac Electrophysiologist at the Clinique Pasteur, Toulouse, France, and co-author of the study. “Strategies using EGM assessment to guide ablation visually, rely heavily on the individual experience of the treating electrophysiologist to identify relevant areas making outcomes highly operatordependent.”

With VX1, Volta has developed the first commercially available companion AI decision support software to assist operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial abnormal EGMs during atrial fibrillation or atrial tachycardia. The cutting-edge software solution uses machine learning including deep learning algorithms to detect abnormal signals and thus highlights potential regions of interest during AF ablation procedures. The system works in real time and identifies specific abnormal EGMs, known as dispersed EGMs. Théophile Mohr Durdez, CEO and Co-Founder of Volta Medical, added: “The publication of these peer-reviewed trial results provides further validation of our approach – to leverage AI with cutting-edge software solutions and assist operators during cardiac ablation procedures. Over 1000 procedures have so far been supported in the EU and US by VX1 and based on clinician’s feedback and clinical results, we are confident that this approach will ultimately contribute to make ablation outcomes significantly more reliable.”

Based on these encouraging results, Volta Medical has initiated the TAILORED-AF trial, the first randomized controlled clinical trial to evaluate VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach. The aim of the study is to confirm the clinical significance of Volta Medical’s technology and lay the ground for establishing VX1 as a new standard of care for persistent AF ablation.

“The results of the Ev-AIFib trial show that Volta’s AI enhanced VX1 software is finally able to provide reliability and reproducibility in an EGM based approach – the holy grail of EGM based ablation approaches. The technology has shown a high potential to assist in treating the complex persistent AF patients,” said Prof. Dr. Isabel Deisenhofer, MD, head of electrophysiology at German Heart Centre Munich, and principial investigator of the international, multicenter TAILORED-AF trial. She continues: “In my experience, VX1 has been an extremely helpful tool, and I look forward to further explore and confirm the technology’s potential in the ongoing TAILORED-AF trial.”

About Ev-AIFib Trial
The EV-AIFib trial, a prospective, multicenter, non-randomized, study was designed to determine the feasibility and relevance of constructing standardized dispersion maps, so called ‘Volta VX1 maps’, to be used as a reference to operators conducting EGM-guided ablation of patients in persistent atrial fibrillation (AF), as well as the use of the VX1 technology for center-to-center standardization of dispersion mapping. In the trial physicians were provided with VX1 adjudications in real time and used their discretion to ablate where it was the most clinically relevant. Carried out in 8 different centers with 17 participating operators, the study compared the acute and long-term outcomes of 85 patients after ablation in regions exhibiting dispersion between a primary and satellite centers. At the primary center, operators were the most experienced at dispersion-based ablation, while satellite centers corresponded to hospitals where physicians had little experience at performing dispersion-based ablation. The results were also compared to a control group in which dispersion-guided ablation was performed visually by trained operators.

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 affects approximately 33 million patients worldwide – a figure expected to double by 2030 driven by an aging population.1 Evidence suggests a higher prevalence of AF 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 AF before, during or after the initial event. AF is also a major risk factor for stroke, increasing the likelihood of stroke by four to five times, as stagnant blood in the atrium during AF may lead to the formation of a clot, which can migrate to the brain. In addition, AF-induced strokes are associated with more severe damage.

Common treatment for AF includes medication that regulates or slows the heart rate.2 For patients who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, ablation is the current standard of care.2 Ablation uses heat or cold energy to create tiny scars in the heart to block abnormal electrical signals and restore a normal heartbeat.1 However, the efficacy of this approach depends to a large degree on the experience and intuition of the ablating physician.

About the Volta VX1 AI decision support software
VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and mapping technologies currently used in operating rooms or electrophysiology labs. VX1 is a medical device which is FDA cleared and has a CE mark. The FDA label reads “The VX1 assists operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial EGMs exhibiting specific abnormal EGM, known as dispersion, during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial EGMs exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.”

About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a health tech company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures. Volta’s overarching goal is to drastically improve cardiac arrhythmia 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, a digital AI companion device and algorithm assists cardiologists for the real-time identification of specific abnormal EGMs, known as dispersed EGMs.
For more information, visit the company’s website at www.volta-medical.com.

Media Contacts

Volta Medical
Jeff Martin, VP of Global Marketing
jeffrey.martin@volta-medical.com

U.S. Media Contact
FinnPartners
Glenn Silver
glenn.silver@finnpartners.com

Europe Media Contact
MC Services AG
Julia Bittner
julia.bittner@mc-services.eu

France Media Contact
Alize RP
Caroline Carmagnol
caroline@alizerp.com

References
1 Chugh SS, Havmoeller R, Narayannan K, et al. Worldwide epidemiology of atrial fibrillation: A global burden of
disease 2010 study. Circulation 2014; 129:837–8472
2 Mayo Clinic, Patient Care & Health Information, Tests & Procedures, Cardiac Ablation:
https://www.mayoclinic.org/tests-procedures/cardiac-ablation/about/pac-20384993