French MedTech Startup FineHeart Submits Prospectus for IPO of Icoms Flowmaker, Backed by €48M EU Funding

Severe heart failure is the second leading cause of death globally after cancer. As a degenerative disease, it may lead to the heart's inability to pump blood properly.

For patients with severe heart failure, there are currently almost only two treatment options available: heart transplantation and the implantation of ventricular assist devices. However, neither of these methods can solve the problem at its root.

Due to the lack of donors, the number of heart donation surgeries performed each year is extremely low, failing to meet the transplantation needs of patients with heart failure; after the implantation of left ventricular assist devices (LVAD), complications such as infection, gastrointestinal bleeding, and thrombosis occur frequently, further increasing the physical burden on patients with heart failure.

This is also a daily challenge for Stephane Garrigue, a cardiologist specializing in heart failure. "Due to the lack of effective therapies, untreated severe heart failure patients face an annual mortality rate of up to 50%. I know the only solution is to find a disruptive and innovative approach."

And the inspiration for this solution came from his youngest son.

One day, while Stephane Garrigue was reviewing a manuscript about CRT for a scientific magazine, his son was playing with a model boat equipped with a propeller nearby. Watching his son focus intently on the propeller, Stephane Garrigue had a sudden flash of inspiration: "Could we place a 'propeller' inside the heart to enhance blood flow and treat heart failure?" With that idea in mind, their multidisciplinary team of experts began developing a new type of flowmaker system—FineHeart's Icoms Flowmaker. This is a fully implantable cardiac output management system designed to meet the unmet treatment needs of patients with severe heart failure.

FineHeart is a preclinical medical device company headquartered in Bordeaux, France. Its core product, Icoms Flowmaker, is a wirelessly powered implantable rotary blood pump that can monitor and adjust heart function non-invasively. The device includes a miniature pump, only 18 millimeters in diameter and 10 centimeters in length, which automatically adjusts the pump's flow rate and speed according to the body's physiological needs.

In traditional therapies, LVAD implantation brings about a "honeymoon period" of approximately two years, during which the patient's symptoms are temporarily improved. Afterward, complications such as catheter infections, gastrointestinal bleeding, and stroke may occur, significantly impacting their prognosis. However, the Icoms Flowmaker avoids the use of catheters, which is key to reducing all complications.

Due to the low power consumption of Icoms Flowmaker, transcutaneous energy transmission is easily achieved. The device's battery weighs only 70 grams and is charged through the skin using a wireless transcutaneous energy transmission system (TET), without the need for external drive lines, thus eliminating the source of frequent and severe infections.

At the same time, Icoms Flowmaker can be directly implanted into the left ventricle without the need for aortic bypass surgery, artificial blood vessels, or connectors, which helps reduce the risk of thrombosis. The inlet and outlet of the device’s micropump are both located within the ventricle, with no pressure gradient between them, thereby minimizing pump-induced damage to the heart. Due to its low torque, the Icoms Flowmaker has relatively low power consumption, which extends battery life and reduces the frequency of charging. Additionally, its battery can operate independently for several hours, freeing patients from reliance on external devices and enabling them to perform normal daily activities such as exercising and bathing.

Icoms Flowmaker is implanted through minimally invasive beating-heart surgery, typically performed by cardiac surgeons, with an average procedure time of 90 minutes. The surgery only requires a small incision in the left chest, avoiding full sternotomy and the use of cardiopulmonary bypass. Additionally, the procedure involves reduced use of inotropes and is associated with a lower risk of postoperative ventricular dysfunction.

Icoms Flowmaker's Micro Pump Image Source: FineHeart Official Website

Arnaud Mascarell, CEO and co-founder of FineHeart, stated: "After decades of development, existing treatment technologies allow patients to regain some freedom of movement, but they still have many limitations and constraints. The Icoms Flowmaker, however, has the potential to enable patients with severe heart failure to return to a normal life."

Based on a comprehensive understanding of the intraventricular fluid mechanics caused by cardiac contraction, the Icoms Flowmaker can sense and support cardiac hemodynamics, maintaining the patient's regular heartbeat and normal blood flow during the seven-day follow-up period.

Icoms Flowmaker can synchronize with the opening of the aortic valve, adjust blood flow according to the heart's own contractions, and allow the blood flow generated by the micropump to pass through the aortic valve into the aorta along with the native blood flow, thereby increasing cardiac output and improving blood circulation in patients with severe heart failure. This enables Icoms Flowmaker to align with the heart’s natural rhythm without interfering with or damaging heart function, optimizing treatment outcomes and aiding in cardiac recovery.

It is worth noting that the Icoms Flowmaker is also referred to as a "hybrid of pacemakers and cardiac assist devices." So, what characteristics does this device share with pacemakers? What advantages does it have over other cardiac assist devices? The answer lies in the algorithms it employs.

The algorithm used by Icoms Flowmaker is the true intelligence of the device. It utilizes an algorithm similar to that used in pacemakers, capable of recognizing the patient's level of physical activity, detecting arrhythmias, and adjusting the level of assistance in real time. This pump can also adjust its operating mode based on the patient’s physical condition and heart rhythm to achieve optimal therapeutic effects. Moreover, the device can provide temporary or permanent cardiac assistance according to the patient's needs.

Core Advantages of the Icoms Flowmaker System (Source: FineHeart Official Website)

Dr. Stephane Garrigue, Chief Scientific Officer of FineHeart and co-designer of the Icoms Flowmaker, stated: "The Icoms Flowmaker is a physician-programmable intelligent micro heart device that operates independently of the patient’s cardiac characteristics and rhythm, generating blood flow strictly according to the patient's cardiac physiology. It promotes cardiac recovery in each implanted patient in a personalized manner, offering a new option for patients with heart failure who previously only had heart transplantation as a treatment." This increases the chances of natural cardiac rehabilitation while avoiding lifelong dependency on cardiac assist devices, addressing a major drawback common to all current cardiac assist devices.

On September 5, 2022, FineHeart announced that it had obtained ISO 13485:2016 certification and passed the audit by the British Standards Institution (BSI). This demonstrates that FineHeart's quality management system complies with the regulatory requirements of the medical device industry and is capable of producing and providing high-quality complex medical devices and related services that meet safety and relevant regulatory requirements.

On October 19, 2022, FineHeart received a €2.5 million grant from the European Commission (EC) under the EIC Accelerator program. Following this grant, the EIC Fund may potentially make an equity investment of up to €15 million (approximately 110 million RMB) in the company’s next round of Series C financing. These funds will support the commercialization and clinical trials of the Icoms Flowmaker.

Just over a month later, on December 8, FineHeart announced again that it had received €1.5 million in funding support from the European ERDF/ESF program. It was also named one of the "Top 15" by FierceMedTech and considered one of the most promising private medical technology companies in the industry.

On April 25, 2023, the company announced that it had obtained its first two patents from the China National Intellectual Property Administration (CNIPA). These new patents complement the company's international patent portfolio, which includes 20 series and over 78 patents, covering aspects such as the concept, design, production, and surgical implantation of the Icoms Flowmaker.

This patent certification brings FineHeart one step closer to its strategic goal of providing a minimally invasive, effective, and durable implantable solution for the largest number of severe heart failure patients. In an economic and regulatory environment favorable to medical device innovation both in China and abroad, along with attractive reimbursement opportunities, the Icoms Flowmaker meets the treatment needs of severe heart failure patients in line with aging trends and has significant potential to meet the demands of China's mechanical ventricular assist device market. This also lays the foundation for the company to enter China's vast and rapidly expanding heart failure medical device market.