Alleviant Medical Secures $90M Funding and FDA IDE for Implant-Free Atrial Shunt to Treat Heart Failure

In January 2025, Alleviant Medical, a heart failure-focused innovative medical device company, announced the completion of a $90 million (660 million yuan) financing round. This round was led by Gilde Healthcare, with participation from Omega Funds, S3 Ventures, RiverVest Venture Partners, Vensana Capital, Broadview Ventures, Gilmartin Capital, and Texas Medical Center Venture Fund. The proceeds will support global clinical trials for its core product, the Alleviant System, in the ALLAY HFrEF study.

It is reported that Alleviant Medical is currently conducting two pivotal trials—the ALLAY-HF trial for heart failure relief and the ALLAY-HFrEF trial for heart failure with reduced ejection fraction relief—and is expected to initiate recruitment of approximately 350 randomized patients at selected global sites in early 2025.

Heart failure is a serious complication that may occur when various heart diseases progress to a certain stage. It is characterized by high readmission rates and high mortality rates, and the number of patients continues to grow, making it one of the serious global public health issues.

According to data released by Frost & Sullivan, the number of people living with heart failure worldwide reached 29.7 million in 2019 and is expected to increase to 38.7 million by 2030, with a compound annual growth rate of 2.5% from 2024 to 2030.

Left Ventricular Ejection Fraction (LVEF) is the "barometer" of heart health, referring to the proportion of blood pumped out by the left ventricle during each heartbeat. Normally, a healthy adult’s LVEF ranges between 50% and 70%, indicating normal heart pumping function.

According to the differences in LVEF and changes after treatment, heart failure can be divided into three categories:

That is, heart failure with reduced ejection fraction (HFrEF, LVEF≤40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF 41%-49%), and heart failure with preserved ejection fraction (HFpEF, LVEF≥50%). Among these, HFrEF and HFpEF have the highest prevalence rates.

The treatment methods for HFrEF and HFpEF mainly include drug therapy, interventional surgery, heart transplantation, and other approaches. However, drug therapy primarily serves to alleviate symptoms. For end-stage heart failure patients, heart transplantation remains the optimal treatment option. Despite the limitations of this surgery, such as the need for extracorporeal circulation, high invasiveness, and significant risks.

Atrial shunt is an emerging minimally invasive interventional procedure. This technique reduces the capacity pressure of the left atrium through shunting and decompression, thereby alleviating symptoms caused by heart failure. The core of atrial shunt lies in maintaining the opening of the artificial atrial septum. Therefore, atrial shunt typically involves implanting an atrial shunt device within the atrial septum to achieve the purpose of atrial shunting.

However, the vast majority of traditional atrial shunt devices are made of metal. After implantation, they become an integral part with the blood vessels and will permanently remain in the body, which can easily lead to blood clots and also hinder CT angiography examinations.

Patients need to take antiplatelet drugs for a long time after surgery, which may increase the risk of bleeding and cause other side effects.

Achieving implant-free treatment for heart failure remains an unmet clinical need. The Alleviant System product specifically addresses this challenge, as it leaves no implants post-procedure, reduces risks associated with permanent implants, and does not interfere with subsequent imaging examinations.

Compared with similar atrial shunt devices, the biggest advantage of the Alleviant System is its non-implantable design.This design significantly reduces the risk of complications such as thrombosis and embolism on the device surface.

(Alleviant System, Image Source: Alleviant Medical Official Website)

According to the Alleviant Medical Inc. official website, during the procedure, the catheter with a blade at its distal end can be advanced through the femoral vein approach to the atrial septum, where the atrial septal tissue is resected under ultrasound guidance to create a shunt. During the ablation process, all atrial septal tissues resected by the Alleviant system are collected and do not remain inside the atrium.

In May 2021, Alleviant Medical's official website disclosed clinical data: In this study, 10 patients were followed up after one month and three months. The results showed that no device-related adverse events occurred in all patients within three months. Specifically:

In terms of motor function measurement, PCWP decreased by 5.4 mmHg.In this trial, the peak exercise pulmonary capillary wedge pressure (PCWP, a surrogate measure of left atrial pressure) was significantly reduced by 5.4 mmHg in all patients. Elevated PCWP is associated with exercise intolerance and is a hallmark feature of HFpEF. The data from this trial suggest that the Alleviant System is effective in improving patients' exercise tolerance.

6MWT increased by 37%.The 6-minute walk test (6MWT), as a simple and feasible submaximal functional capacity testing method, can also be used to evaluate a patient's aerobic capacity and endurance. Test results showed that after six months, 66.7% of patients increased their six-minute walking distance by 37% (101 meters).

In terms of quality of life, the KCCQ questionnaire showed an 83% improvement.The Kansas City Cardiomyopathy Questionnaire (KCCQ) is designed to independently measure a patient's perception of their health status, including heart failure symptoms, the impact on physical and social functioning, and how heart failure affects their quality of life over a 2-week recall period. After 6 months, the subjects showed an 83% improvement in the KCCQ questionnaire.

In terms of safety and feasibility, follow-up data confirmed no reports of cardiovascular death or major cardiovascular-related adverse events, thromboembolic stroke, systemic or pulmonary embolism, or any device-related or access site complications.

After thorough validation through clinical trials and continuous improvements, Alleviant Medical announced in January 2025 that its atrial shunt device received FDA Investigational Device Exemption (IDE) and Breakthrough Device Designation.

Similar to the Alleviant System, PAS-C is also a non-implantable product that can achieve left and right atrial shunting during surgery without leaving any foreign objects behind. However, the difference lies in the method: PAS-C uses mechanical cutting, while the Alleviant System removes tissue through mechanical compression and short-pulse radiofrequency energy.

PAS-C is the core product of Intershant, a startup medical device company. Early feasibility clinical study data (EASE-HF) confirmed the safety and feasibility of the PAS-C procedure.

From the perspective of product commercialization, four products abroad—Corvia Medical, IASD, V-Wave, and AFR—have received CE certification. In addition to Alleviant System, China's D-shant atrial shunt has also obtained FDA Breakthrough Device Designation, becoming the first domestically produced atrial shunt product in China to receive this designation.

In recent years, international cardiovascular giants have been entering the heart failure treatment market, indicating a large number of unmet patient needs in this field. In 2019, Edwards acquired Corvia Medical for $35 million; in August 2024, Johnson & Johnson acquired V-Wave for $1.7 billion, signaling continued investment in atrial shunt technology by major companies.

Impact of Aging Population: The Burden of Heart Failure in China Remains Heavy

Driven by market demand, Chinese companies have started to focus on atrial shunt technology. Companies such as Lepu Medical, Nuosheng Medical, Weike Medical, and Qichen Medical are all involved.

In the field of non-implantable atrial shunt technology, NoYA RF Atrial Shunt System, independently developed by China's Nuosheng Medical, ushers in a no-implant era for catheter-based treatment of heart diseases. The NoYA system is an adjustable atrial shunt device that utilizes electrodes to ablate interatrial septum tissue and employs adjustment lines during surgery to regulate the diameter within a range of 4 to 12 mm. After the procedure, the shunt device is removed, effectively creating an atrial septal fenestration without leaving any implants behind.

In addition, LEPU Medical also has products involving non-implant technologies. Its products under research include the first-generation, second-generation, and third-generation atrial shunt devices. Among them, the second-generation product is characterized by biodegradable materials, leaving no residue after implantation; the third-generation product features radiofrequency energy ablation of the atrial septum, achieving no implant in the body.