Alleviant Medical Secures $90M Funding to Advance Implant-Free Alleviant System for Heart Failure Treatment

Jan 15, 2025 22:16 CST Updated 22:16

Alleviant Medical

Heart Failure Medical Device Developer

Alleviant MedicalAnnounced the completion of a $90 million financing round led by Gilde Healthcare, with participation from Omega Funds, S3 Ventures, RiverVest Venture Partners, Vensana Capital, Longview Ventures, Gilmartin Capital, and TMC Venture Fund. The proceeds will be used for its core products.Alleviant SystemLaunch New Key Clinical Studies WorldwideALLAY HFrEF。ALLAY HFrEF will be the first prospective sham-controlled trial for heart failure and atrial shunt patients with reduced ejection fraction (HFrEF).

Investor Evaluation

"We are compelled by Alleviant's innovative technology and de-risked clinical trial program. We believe the Alleviant team is developing a category-leading product dedicated to providing relief to millions of heart failure patients."

---Geoff Pardo General Partner of Gilde Healthcare Investors

Executive Evaluation

"We are committed to developing an effective treatment for heart failure patients through our minimally invasive, implant-free approach. We are very grateful to collaborate with a consortium of top investors to advance this mission for patients while building a leading healthcare company focused on this enormous market opportunity. We welcome this strong partnership with Gilde Healthcare and Omega."

---Adam Berman CEO of Alleviant Medical

With the launch of the ALLAY HFrEF clinical study,Alleviant MedicalWill become the world's only company currently conducting a comprehensive evaluation of atrial reflux technology for the treatment of heart failure. In progressALLAY HFBefore rEF,Alleviant MedicalHas already launched its first critical trialTest (ALLAY-HF aims to evaluateAlleviant SystemThe safety and efficacy of treating patients with preserved ejection fraction (HFpEF) are expected to complete enrollment within next year). This new clinical study (ALLAY HFrEF) will expand the research scope to other patients with primary heart failure, namely those with reduced ejection fraction.

This month forAlleviant MedicalIt's a double celebration, besides completing the financing, its productAlleviant SystemIt has also been granted the "Breakthrough Device" designation by the FDA.

As atrial shunt technology continues to undergo clinical research, people's understanding of it is also deepening. Overseas companies dedicated to atrial shunt technology, such as Alleviant Medical Inc., have also gained capital favor. At the start of the year,Alleviant MedicalIt has secured 90 million in capital support, while giants such as Johnson & Johnson and Edwards have also entered the atrial shunt treatment field. Notably, Johnson & Johnson has invested $1.7 billion directly. These developments have significantly boosted the industry'sConfidence in atrial shunt technology is certainly a positive development in this field. However, what follows is the need for participants in this industry to provide convincing clinical research data.

Alleviant System

Alleviant SystemIt is a device that enters the right atrium through the femoral vein,AgainBy puncturing the atrial septum to enter the left atrium, an opening is created in the atrial septum using short-pulse radiofrequency energy, forming a channel for blood to分流 from the left atrium to the right atrium, improving the patient's hemodynamic condition, thereby alleviating heart failure symptoms, enhancing the quality of life for heart failure patients, and extending the patient's lifespan.

The biggest advantage compared to other atrial shunt devices is:No implants are left post-procedure, reducing risks associated with permanent implants, such as thrombosis on the device surface and device embolization, and also avoiding potential contraindications for subsequent interventional procedures.

In addition, during the ablation process,The atrial septal tissue removed by the Alleviant System is fully retrieved and not left behind in the atrium, thus avoiding embolism.

Alleviant System Clinical

At the SCAI conference held two years ago, Alleviant Medical announced the clinical research data of the Alleviant System. In this study, 31 patients received three months of follow-up, and 15 patients received six months of follow-up.

All surgeries were successful, with no device-related adverse events occurring.
The average shunt size was 7.1±0.9 millimeters (TEE).
The average exercise peak PCWP decreased from baseline to one month.
In the HF-1 study, a significant increase in the KCCQ total score was observed at 6 months, while in the HF-2 and HFrEF studies, a significant increase in the KCCQ total score was observed at 3 months.
Echocardiography confirmed that all diverters remained patent at 1 month, 3 months, and 6 months; no device- or surgery-related serious adverse events occurred within 6 months.
Another 10 patients completed a one-year follow-up, confirming the patency of the shunt.

Alleviant Medical

Alleviant Medical It is an innovative medical device company dedicated to developing new therapies for heart failure patients.Alleviant Medical A transcatheter technology has been developed to decompress the left atrium without the need for permanent cardiac implants. The company’s mission is to alleviate the significant clinical and economic burden of heart failure and improve the lives of millions of patients suffering from this debilitating disease.