Heart Future

June 17, 2025, Leader in Atrial Shunt DevicesCorvia MedicalAnnounced that it has successfully completed a round$55 million(approximatelyRMB 396 million) to advance ongoingRESPONDER-HF Clinical Trial.

This round of financing was jointly participated by existing investors Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, and two strategic investors.

Despite significant advances in medical and device therapies over the past few decades,But the incidence and mortality of left heart failure remain high.. In patients with chronic heart failure,Elevated left atrial pressure leads to pulmonary congestionIs a common mechanism leading to symptom exacerbation and acute decompensation.Atrial shunt can achieve shunt decompression, alleviate excessive left atrial volume, and improve symptoms caused by heart failure., improve the quality of life of patients, is an emerging minimally invasive interventional treatment.

CorviaAtrial Shunt Device is aOnly coin-sizedMinimally invasive cardiac implants, specifically designed forPatients with heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF) patientsDesign.

It isThe World's FirstFor treatmentHFpEFPatient's Atrial Septal Diversion Device, alsoThe World's FirstObtainCECertified Atrial Shunt, once at2016Year obtained in EuropeCECertification, and on2019Year obtained in the United StatesFDA"Breakthrough Medical Device" Designation.

However,2022YearCorvia MedicalPublicationCorviaClinical Data for Atrial Shunt Device in Heart Failure Treatment Shows Poor Results (CorviaThe treatment did not reduce the incidence of heart failure or improve health status, and the results were no different from those in the sham surgery group.。

This incident led to a downturn for the entire atrial shunt device industry. However, with subsequent developments...Corvia Medical、V-WaveSubsequent clinical data from mainstream players such as Corvia proved effective in treating some heart failure patients, and the market began to recover.

Until last year,Johnson & Johnson6Acquisition at a price of hundreds of millions of dollarsV-Wave, making the atrial shunt a hot topic in the cardiovascular field once again., Capital Restores Confidence in Atrial Shunt Devices.

Subsequently, many foreign atrial shunt innovator companies have successively obtained new financing (for exampleAdona MedicalCompleted3350"Million USD Financing,"Alleviant MedicalCompleted9000Million USD in financing, etc.).

As the original inventor of the atrial shunt,Corvia MedicalAlso from2022Walking out of the setbacks over the years and embarking onCorvia Atrial ShuntNew Clinical Research (RESPONDER-HF), now regaining capital favor.

2022To date,Corvia MedicalTotal Completion1.09Billion-dollar financing(Including2022Yearly5400Million USD and Today5500Million USD).

# Executive Evaluation

Corvia MedicalChief Executive OfficerGeorge FazioSaid: "We are very grateful for the steadfast support of our long-term investors, which has enabled us to continuously advance.CorviaAtrial Shunt DeviceFDAFiling Process. Their commitment strengthens our mission to bring this transformative heart failure treatment to millions of patients worldwide."

# ProductionProduct Introduction

CorviaAtrial ShuntAimed to create a tiny channel in the atrial septum, allowing the heart to "on-demand" direct blood from the higher-pressure left atrium to the right atrium, achieving dynamic decompression and reducing left atrial pressure (LAP）. For ejection fraction (EF) Greater than or equal to40% Patients with heart failure,Corvia The shunt offers the most advanced treatment option.

Corvia byImplantAndPush SystemComposition.

The implant is similar to a self-expanding metal cage structure, featuring a dual-disc design with an opening in the middle. It also has X-ray visibility and ultrasound feedback capabilities, allowing for real-time guidance and monitoring through imaging during the implantation process.

The implant has 9 legs on each side, whereThe end of each leg on the left atrium (LA) side is designed with a radiopaque marker for easy positioning.The disc on the LA side has a flat structure, allowing the legs to closely adhere to the atrial wall, minimizing the profile volume within the left atrium. On the right atrial side, it is designed with a curved structure to accommodate variations in septal thickness, with only the leg tips contacting the right atrial wall.

In the fully expanded state, the implantOuter diameter: 19.4 mm, Inner diameter: 8 mm。

CorviaThe atrial分流器 is currently the most extensively researched device for heart failure using interatrial shunting. Globally, there have been over675patients received the implantation of this shunt, with more than250The patient has been carrying the device for more than5Year.

RESPONDER-HFClinical Trial

RESPONDER-HFLinBed TestTest is aA double-blind, randomized, placebo-controlled confirmatory study aimed at evaluatingCorviaThe Safety and Effectiveness of Atrial Shunt Devices Have Been Demonstrated Across Three ContinentsOver 65Home medical institutions unfold.

The StudyExpected to provide critical clinical data to support the applicationFDAApproval, making this shunt a treatment for heart failure with preserved ejection fraction and mildly reduced ejection fraction (HFpEF/HFmrEF) Breakthrough Medical Device.

# Market Overview

Due to the intensifying global aging trend and the increase in the number of cardiovascular disease patients, the atrial shunt device market is developing rapidly.Global Super60 Million Heart Failure Patients, Over 40 Million Pulmonary Hypertension PatientsPropped up the market for atrial shunt devices.

Currently, although the demand for atrial shunt devices is high, the actual number of implants is relatively low, as they are still in the clinical research and market education phase.。

Globally, more than 10 products have entered clinical research,Only foreignCorvia Atrial Shunt (IASD), V-Wave, and AFR Obtain CE Certification, all are permanently implanted in the body,No atrial shunt device has yet received FDA approval.。

Main domestic companies include Weike Medical, Nuosheng Medical, Aoliu Medical, Qichen Medical, Jianshi Technology, Betterway Medical, and Lepu Xintai.Currently, none have been approved for marketing by the NMPA, and most are in the clinical trial stage.。Among themCorvia Medical, Inc.D-shant^®Atrial ShuntIt is one of the earliest atrial shunt devices in China to enter the clinical trial stage and is expected to become the first certified atrial shunt device product in China.

Weike Medical D-shant^®Atrial ShuntYesChina's first domestically developed implantable atrial shunt.The ProductThe structural design adopts an internally embedded metal stent, which is only the size of a coin and provides excellent radial support.At the same time, D-Shant can achieve secondary intervention to ensure surgical safety.

D-shant^®Atrial Shunt Device Demonstrates Excellent Efficacy in Optimizing Hemodynamic Parameters, Effectively Controlling Disease Progression, and Significantly Enhancing Cardiac Function in Heart Failure Patients.

November 2023,D-shant^®The Atrial Shunt Device has been granted "Breakthrough Device Designation" by the U.S. FDA.

▲NoYA™Adjustable Interatrial Shunt System

In summary,Chinese companies are continuously innovating in product design to fill the time gap with superior performance products.。

First, in the atrial shunt deviceImprovement in the product's own performance, such as atrial shunt size, endothelialization, radial support force, etc. Secondly, heart failure patients have different conditions and require different atrial shunt volumes. In the past, most products had a fixed shunt diameter, making it difficult to meet personalized treatment needs. Moreover, when an atrial shunt remains in the body for a long time, a certain degree of endothelialization and reduction in aperture can occur, decreasing the shunt volume.Adjustable atrial shunt diameter becomes a new direction in the development of atrial shunt devices。

Moreover,Atrial ShuntProducts must meet good safety standards.Heart failure patients undergoing atrial shunt surgery are often in their middle-aged or elderly stages. These patients may have comorbidities such as atrial fibrillation and mitral stenosis, necessitating surgical intervention. Therefore,Recyclable, biodegradable, or even non-implantable atrial shunt devices are also emerging as new directions.。

In the current global context where there is still no effective treatment for heart failure, the atrial shunt market is extremely hot, whether it's due to early technical and product accumulation or capital-driven development.

# Company Introduction 

Corvia MedicalFounded in2009Year，Headquartered in MassachusettsTewksbury，Focused on developing transcatheter atrial shunt technology, dedicated to revolutionizing structural heart devices.，For the treatment of heart failure with preserved ejection fractionExhaust (HFpEF`) and other refractory heart failure diseases.`

The company's leadership team is composed of a group of senior executives from top international medical technology companies, including its CEO.George FazioSelf2010Led the company's development since the year, driving its products into clinical and market application stages.

Its core product isAtrial Shunt Device, which is also the world's first minimally invasive shunt device used to improve atrial pressure management.

Corvia MedicalYesThe world's first transcatheter device for the treatment of heart failure approved by the EU, used for treatmentHFpEFOrHFmrEF。

2019In that year, the company was acquired by a globally renowned cardiovascular medical company.Edwards LifesciencesAcquisition, further enhancing its capabilities in product commercialization and global expansion.

As one of the pioneers in the field of minimally invasive heart failure treatment,Corvia MedicalOccupies a unique and leading position in the global medical device industry.

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