French Medtech Electroducer Files IPO Prospectus Highlighting 12% Cost Reduction in PCI Procedures with Novel Leadless Pacing Technology

During the heart's average lifespan of 70 years, it will beat approximately 2.5 billion times.

But it is not always in a regular, rhythmic beat. In many cardiovascular interventional surgeries, arrhythmia or bradycardia may pose serious complication risks or even death threats to patients.

In order to address this issue with innovative therapies, Benjamin FAURIE, an interventional cardiologist at the Grenoble Cardiovascular Institute, embarked on an exploration lasting over a decade.

It all started with a surgical experience of Benjamin FAURIE in 2011.

During the first transcatheter aortic valve replacement (TAVR) procedure, Benjamin identified numerous life-threatening complications for the patient. These complications were not related to the artificial valve itself but rather to the auxiliary devices or implantation techniques. Among them, the use of a temporary pacemaker catheter during valve implantation to paralyze or revive the heart was a significant cause of severe complications.

To change this dilemma, he created a technique that directly stimulates the heart through a TAVR guidewire — Direct Wire Pacing (DWP) technology. This technique can largely avoid complications caused by the insertion of pacing catheters.

The cardiology community did not highly recognize this innovation, and Benjamin faced setbacks multiple times. However, Professor Alain Cribier, the inventor of the percutaneous aortic valve replacement technology, once defended Benjamin at a conference, which strengthened Benjamin's determination to advance the DWP technology. In 2018, Benjamin founded Electroducer, a company focused on the development of DWP technology.

To promote this technology, Benjamin also sought the help of Professor Jacques Seguin from the Cardiac Surgery Department at the University of Paris. In 2020, Professor Jacques Seguin joined Electroducer's Strategic Committee as a member, working together on the research, development, and application of the core product, Electroducer Sleeve. With the support of like-minded partners, DWP technology has become a breakthrough in interventional cardiology and has been partially adopted by the cardiology community, bringing a "bright future ahead."

In some cardiovascular interventional procedures, patients may experience arrhythmia or bradycardia due to reasons such as heart valve or coronary artery stenosis, requiring temporary electrical stimulation of a certain frequency and intensity to maintain a normal heartbeat. The traditional method involves delivering a pacing catheter into the heart through a venous access, followed by transmitting electrical signals via an external pacemaker. However, this method carries certain risks, including potential damage to blood vessels or heart tissue, as well as increased surgical duration and radiation exposure.

The emergence of DWP technology has provided a new opportunity to resolve this dilemma.

It is a novel stimulation therapy used for temporary cardiac stimulation during percutaneous cardiovascular interventional procedures (such as PCI, TAVR). This technology directly utilizes the interventional guidewire used during the surgery as a pacing electrode, connecting it to a skin anode and an external pacemaker. The pacemaker’s electrical signals are transmitted to the heart through the guidewire, thereby avoiding the additional step and risks associated with inserting a pacing catheter.

In 2019, a multicenter randomized controlled trial (EASY TAVI) recruited 302 subjects and compared the DWP technology with the standard right ventricular stimulation technology (temporary pacemaker catheter). The results showed that the DWP technology was more advantageous.

DWP technology does not require additional puncture to establish a venous access, nor does it need to place and adjust a temporary pacemaker catheter in the right ventricle. The omission of these steps reduces operation time and fluoroscopy usage, thereby optimizing the surgical procedure, shortening intervention time, and reducing radiation exposure for both patients and operators. Meanwhile, DWP reduces the invasiveness of the surgery by avoiding the implantation of additional catheters, which helps minimize intraoperative and postoperative trauma for patients.

Moreover, DWP technology offers higher safety by avoiding complications associated with catheter implantation in high-risk areas while providing the same stimulation effects as pacing probes. This is because the use of DWP technology eliminates the need to place a temporary pacemaker catheter in the right ventricle, thus avoiding complications such as catheter displacement, arrhythmias, and infections. Additionally, DWP technology allows direct cardiac stimulation via a guidewire, which is closer to the myocardial tissue compared to traditional pacemakers, making it more effective than conventional right ventricular stimulation in certain cases.

DWP technology does not require the use of materials traditionally needed for pacing, such as temporary pacemaker catheters and electrode pads, reducing the usage and consumption of other medical devices. At the same time, its advantages of shortening operation time and hospital stay, reducing the risk of complications, and lowering treatment costs also reduce economic burdens for hospitals and patients.

The company stated that in a study titled "Left Ventricular Rapid Pacing Through the Valve Wire During Transcatheter Aortic Valve Replacement," DWP significantly reduced perioperative and postoperative trauma by shortening procedure duration and invasiveness, and decreased the total procedural cost by approximately 12%. This study was published in the *Journal of the American College of Cardiology* in 2019 by Dr. Faurie et al.

Based on DWP technology, Electroducer has invented its core product, the Electroducer Sleeve. This is a conductive device made from highly innovative materials, capable of safely transmitting electrical signals from an external pacemaker to a patient's heart via a guidewire. The Electroducer Sleeve is compatible with any guidewire and pacemaker and is suitable for various cardiac interventional procedures requiring temporary pacing, such as transcatheter aortic valve implantation (TAVI), transcatheter mitral valve repair (TMVR), transcatheter tricuspid valve repair (TTVR), and percutaneous coronary intervention (PCI).

Electroducer Sleeve utilizes multiple patented technologies to integrate DWP technology in a way that maximizes effectiveness, enhances the repeatability of the procedure, reduces patient discomfort, and maintains an acceptable threshold. Additionally, this device connects with traditional percutaneous cardiac surgical equipment without altering the physician’s operational habits, offering a low learning curve and enabling rapid adoption.

Before performing percutaneous cardiac interventional surgery, the doctor needs to place the Electroducer Sleeve over the guidewire used for the procedure and insert the guidewire into the blood vessel. After advancing the guidewire to the target position in the heart, the doctor connects the Electroducer Sleeve to an external pacemaker and controls the stimulation frequency and intensity of the guidewire on the heart by adjusting the parameters of the external pacemaker, thereby achieving direct guidewire pacing. After completing the surgery, disconnect the Electroducer Sleeve from the external pacemaker and remove the guidewire along with the Electroducer Sleeve.

On December 15, 2022, Electroducer announced that the positive results of its pilot study had been published in the medical journal EuroIntervention, the globally recognized and most prestigious European publication focused on interventional cardiology. The study is titled "A Direct Wire Pacing System for Transcatheter Heart Valve and Coronary Interventions: The First-in-Human, Multicenter Study of the Electroducer Sleeve." A total of 60 patients were recruited from four French medical centers for this trial.

Trial research results show that the Electroducer Sleeve is safe and effective in the treatment of heart valve disease and complex coronary artery interventions. Notably, the Electroducer Sleeve improves patient tolerance, causing no pain during stimulation, which also allows doctors to reuse it multiple times during the procedure.

Dr. Benjamin Faurie, CEO and founder of Electroducer, stated, "The publication of the Electroducer Sleeve study in such a prestigious medical journal demonstrates the potential of Electroducer's clinical approach to become the preferred surgical method." Electroducer plans to launch the Electroducer Sleeve in the market within the next year, making the device accessible to as many patients and cardiologists as possible.

In 2019, Electroducer became one of the winners of the i-Lab 2019 Innovation Competition. i-Lab is the largest deep-tech innovation contest in France and serves as a growth accelerator for innovative companies, establishing itself as a benchmark in the field of innovation. This award signifies that Electroducer's cardiac pacing therapy will not remain just a simple idea or invention but is expected to evolve into an innovative solution addressing significant clinical needs.

In January 2021, Electroducer Sleeve obtained ISO 13485 certification, the internationally recognized quality management system standard for the medical device industry. This certification indicates that Electroducer Sleeve has met international standards and regulatory requirements, ensuring the quality and safety effectiveness of its products. It will help the company enhance risk management and defect prevention, reducing the risk of quality incidents or adverse events in its products. Additionally, this lays the foundation for Electroducer Sleeve to eliminate trade barriers and enter the international market in the future.

On May 10, 2022, the 7th Medical Device Innovation and Entrepreneurship Day was held at the City of Science and Industry in Paris to recognize companies in the medical device industry for their innovation and excellence. Electroducer won the "2022 Jury Award" at this event and was named "Startup of the Year" by the French National Union of Medical Technology Industries (SNITEM). The Electroducer Sleeve is planned to enter the U.S. market by the end of 2023, followed by the European market in 2024, obtaining FDA clearance and CE marking respectively. Additionally, Electroducer will continue to expand the application scope of its core product, applying it to mitral and tricuspid valve surgeries.