4C Medical Technologies Announces $175 Million Series D Financing Led by Boston Scientific to Advance AltaValve™ Transcatheter Mitral Valve Replacement System

Mar 06, 2025 12:19 CST Updated 12:19

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On March 5, 2025, 4C Medical Technologies, Inc. (hereinafter referred to as "4C Medical") announced the completion of a total amount$175 million(Contract 1.26 billion RMB)The D-round financing. This round of financing was led byBoston Scientific(Boston Scientific, NYSE: BSX) andHHF Fuyuan InvestmentCo-led the investment, with existing shareholders also continuing to increase their investment. This round of financing will accelerate 4C Medical's technology development, clinical progress, and market expansion in the field of heart valve disease treatment.

# Financing Details

Due to the complex anatomy of the mitral valve and the frequent presence of comorbidities in patients, current treatment options for MR are limited. AltaValve is expected to enter the market currently dominated by Abbott's MitraClip transcatheter mitral valve repair system.

4C Medical Plans to use the funds to accelerate the clinical development and commercialization of its AltaValve system. AltaValve is 4C Medical Technologies, Inc.The next-generation transcatheter mitral valve replacement (TMVR) technology developed by 4C Medical Technologies is designed to treat mitral regurgitation (MR). If left untreated, MR may lead to heart failure or death.

In addition, the company also plans to use the funds to support the ongoing ATLAS global pivotal trial. The trial aims to evaluate the safety and effectiveness of AltaValve in patients with moderate-to-severe or severe MR who are not suitable for surgical treatment or transcatheter edge-to-edge repair (TEER).

# AltaValve System

The AltaValve™ system is currently knownThe world's onlyFully Recoverable Transseptal Low-Profile Valve System with Retrieval Function After Complete Deployment, allowing the surgeon to achieve more precise positioning and deployment during the procedure.

As a "Transfemoral-Transseptal Approach"Transcatheter mitral valve replacement product, AltaValve™, adopts a uniqueAnnular Valve Device and Atrial Fixation Design。System for Two Treatment Indications: Treatment of moderate to severe or severe mitral regurgitation (MR); treatment of moderate to severe or severe MR with moderate/severe mitral annular calcification (MAC).

Source of the image: Official WeChat account of the company

System Advantages:

Expand the treatable patient population, including patients with high-risk primary and secondary mitral regurgitation undergoing open-heart surgery;
Only atrial fixation is located above the native mitral valve., ensuring that critical cardiac structures remain within the left ventricle;
Minimize complications sometimes found with other TMVR technologies, such as device embolization, left ventricular outflow tract (LVOT) obstruction, left ventricular dysfunction (e.g., chordae tendineae rupture), etc.;
Even after full deployment, AltaValveReassemblable；It can fully function within seconds after deployment, ensuring the hemodynamic stability of the patient;
Including three different valve sizes, specifically 40mm, 46mm, and 54mm, to accommodate patients with varying annulus diameters;The TS delivery system offers controlled operability and adaptability to various anatomical structures.

The system is highly user-friendly, allowing the operator to complete the AltaValve™ implantation in just four simple steps.Significantly shortened the operation duration。

Femoral vein access established, atrial septal puncture performed, and guidewire advanced to the left atrium;
Advance the valve delivery system along the guidewire to the left atrium and precisely position it at the mitral valve annulus;
Position the AltaValve™ valve at the mitral annulus; release the valve through the delivery system.The membrane, if necessary, retrieve the valve to readjust its position for precise release, and finally withdraw the delivery system and guidewire.

The single-center clinical experience with the AltaValve™ system shows:Patient Acceptance Rate 100%, Two consecutive patients received humanitarian assistance and completed a 30-day follow-up.The 30-day postoperative follow-up results showed that the degree of mitral regurgitation in the two patients remained atNo reflux and mild reflux, no device/surgery-related events, the patient continued to improve.。

May 2024,4C Medical Technologies, Inc. AnnouncesAltaValve™ System Receives FDA Breakthrough Device Designation；Treatment of moderate to severe or severe mitral regurgitation (MR), as well as treatment of moderate to severe or severe mitral regurgitation with moderate/severe mitral annular calcification (MAC).

# Clinical Research

Launch U.S. Clinical Research

In October 2024, 4C Medical Technologies, Inc. announced that its innovative mitral valve product, AltaValve, has beenEuropeAndUnited StatesLaunched a pivotal clinical study named ATLAS.

The core objective of this study is to comprehensively evaluate the safety and efficacy of AltaValve in treating patients with moderate to severe or severe mitral regurgitation (MR) who are not suitable for surgery or transcatheter edge-to-edge repair.The ATLAS trial includes two independent non-randomized cohorts, respectively:a) Moderate/Severe Mitral Annulus Calcification Cohort;b) Main cohort without MAC or with mild MAC.

Latest Data Sharing

On February 7-9, 2025, during the PCR Tokyo Valves conference, Professor Tsuyoshi Kaneko from Washington University in St. Louis announcedAltaValve™ Early Feasibility Study 6-Month Follow-Up Results, providing preliminary confirmation of the safety and efficacy of the new generation AltaValve™ Transcatheter Mitral Valve Replacement System in treating high-risk surgical patients with symptomatic severe mitral regurgitation (MR).

Research Data

At 30 days post-operation, the all-cause mortality rate was 10%, the cardiac-related mortality rate was 7%, with a cardiac-related mortality rate of 0% via the trans-septal approach, and a thrombosis incidence rate of 3%.
In terms of valvular hemodynamics, the patient's MR severity was significantly reduced, with mean mitral valve and LVOT gradients of 4.1 mmHg and 2.0 mmHg, respectively. The mean LVEF was 52%.
At 6 months post-operation, the all-cause mortality rate was 14%, the cardiac-related mortality rate was 7%, with a cardiac-related mortality rate of 0% via the trans-septal approach. The thrombosis incidence rate was 3%.
In terms of valvular hemodynamics, the patient's MR severity was significantly reduced, with mean mitral valve and LVOT gradients of 3.8 mmHg and 2.0 mmHg, respectively. The mean LVEF was 53%.

# Investment Analysis

Boston Scientific has been very active in its strategic layout in the medical device field, especially with frequent moves in the cardiovascular segment.Through a series of acquisitions and investments, Boston Scientific has rapidly entered multiple cardiovascular细分领域 with high growth potential:

PFA (Pulsed Field Ablation):Has achieved significant market success, and Boston Scientific has gained a technological advantage and market recognition in this field.
IVL (Intravascular Lithotripsy): The acquisition of Bolt Medical marks an entry into the IVL field, with the potential to address complex vascular calcification issues and unlock significant market potential.
RDN (Renal Denervation): Acquire SoniVie to enter the RDN field for the treatment of hypertension, with broad market prospects.
TMVR (Transcatheter Mitral Valve Replacement): By investing in 4C Medical Technologies, Inc. to enter the TMVR field, although facing competition from Edwards and Medtronic, Boston Scientific's technical accumulation and market channels are expected to help its rapid development.

Boston Scientific's strategic layout in the cardiovascular field demonstrates its keen insight into high-growth niche markets and strong resource integration capabilities.

# About 4C Medical

4C Medical is aFocus on the Development of Transcatheter Mitral Valve Replacement (TMVR) TechnologyAn innovative medical device company dedicated to addressing the challenges faced in the clinical treatment of mitral regurgitation. Its flagship product, the AltaValve™ system, is the world's only fully retrievable low-profile TMVR system, utilizing a unique atrial fixation design that effectively reduces impact on mitral valve anatomy and decreases the incidence of postoperative left ventricular outflow tract obstruction. Currently, 4C Medical has initiated global pivotal clinical trials in the United States and Europe to further validate the safety and efficacy of this system.

4C Medical Technologies, Inc. has established a deep cooperative relationship with MicroPort.MicroPort Medical has made multiple rounds of investments in 4C Medical Technologies, Inc. through its subsidiary MicroPort CardioFlow, becoming one of its significant shareholders. In the Series C financing round of 2024, MicroPort CardioFlow led the investment with $35.4 million, further solidifying its shareholder position in 4C Medical. Additionally, MicroPort CardioFlow holds exclusive commercial rights to the AltaValve product in mainland China, Hong Kong, Macao, and Taiwan, and is collaborating with 4C Medical to advance the global pivotal trial ATLAS for AltaValve, aiming to support its CE Mark and FDA approval.