Yoren Heart's Next-Gen Miniature Long-Term Artificial Heart EVA-Pulsar™ Gains NMPA Approval and Files for IPO

Feb 20, 2024 12:22 CST Updated 12:22

EVAHEART

Cardiovascular Medical Device Developer

Source of the article:EVAHEARTCome;Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart of the Future

Recently,EVAHEART(Abbreviation:EVAHEART's new generation artificial heart productEVA-Pulsar™ Left Ventricular Assist DeviceOfficially Obtained NMPA Medical Device Registration Certificate，Becoming the fifth artificial heart to be marketed in China.

This product, following the EVAHEART一代 (from EVAHEART), is currentlyThe Second Approved Product in China forLong-term ImplantationArtificial Heart,Marks EVAHEART's completion of product iteration,Holding the only two long-term artificial heart blood pumps in China。

AsThe only company in China with long-term artificial heart technology, EVAHEART has brought new hope to patients with severe heart failure by improving its product line.

Currently, EVA-Pulsar™ has also beenApproved for marketing by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and conducting the COMPETENCE clinical trial with the U.S. FDA., in a head-to-head comparison with HeartMate III.

Early results from the COMPETENCE trial show that EVA-Pulsar™ and HeartMate IIINo significant difference in survival rate and heart failure recovery effect, but itsThe 90-day stroke-free survival rate (100%) was significantly higher than that of HeartMate III (62.5%).。

▲Image SourceFrom the company's official WeChat

#EVA-Pulsar™ Left Ventricular Assist Device

EVA-Pulsar™ integratesLong-term implantation, ultra-small volume, pulsatile blood flow, high-flow assistance, bionic coating...and other advantages, providing a safer and more efficient treatment option for patients with severe heart failure.

Compared with the third-generation artificial heart,New Generation Ultra-Compact EVA-Pulsar™ Blood PumpImprovements and upgrades have been made in the system and design.While retaining the advantages of ultra-high flow and pulsatile blood flow, the volume has been significantly reduced.`, and brought revolutionary new features.`

▲Left:EVAHEART，Right: EVA-Pulsar

EVA-Pulsar™Product features are as follows:

(1) Ultra-small volume, ultra-large flow

Thanks to the optimized drive system and flow channel design of EVA-Pulsar™,EVA-Pulsar™ is reduced to 64% of the size of EVAHEART,Weight: 260g,And maintain a high flow rate of 20L/min, which is almost the highest flow rate in the industry.。Thanks to the open impeller and full main channel design,EVA-Pulsar'sWork efficiency has greatly improved. In daily use, a flow of approximately 5L can be easily generated at a speed of around 1700RPM.

In contrast, the 3500RPM speed commonly used by other third-generation blood pumps can only provide a flow rate of 2-3 liters, requiring over 5000RPM to achieve the 5-liter blood flow assistance of Pulsar. However,High-speed rotating impellers are extremely likely to cause blood damage., resulting in irreversible damage to blood cells, clotting factors, etc. in the blood, leading to hemoglobin and lactate dehydrogenase being exposed in the blood.

(II) Long-term implantation, long-lasting use

EVA-Pulsar™ is the same as the EVAHEART blood pump,Approved for Two Indications: Short-term Adjuvant and Long-term Treatment。EVA-PulsarAdopting MPC Bionic Coating to Enhance Blood Compatibility. This coating mimics the surface structure of cell membranes, reducing protein adsorption and blood flow resistance. Moreover, the MPC coating exhibits high stability, showing no degradation under hydrolysis and enzymatic reactions, and remains stable even under sterilization conditions.This also provides strong support for the long-term use of EVAHEART.。

(III)Pulsatile Blood Flow, Comprehensive Organ Protection

The blood flow of the third-generation artificial heart is continuous, and this mechanical blood flow lacks normal pulsatility. After long-term assistance, it can easily lead to various problems such as vascular malformation, right heart failure, aortic valve insufficiency, aortic dilation, insufficient organ perfusion, and stroke. ThereforeIn the research and development of a new generation of ventricular assist devices, blood pulsatility has always been a key breakthrough direction.。

EVA-Pulsar AdoptedFull main channel design, no secondary channel, with a minimum channel width of 16mm., its adaptive impeller and wide flow channel design bring a gentler HQ curve, allowing the user's blood flow to generate a pulse pressure difference of 20-30mmHg.Maintain Blood Pulsatility, Reduce Various Complications。

(4) New Generation Hydraulic Suspension, Full Mainstream Design

EVA-Pulsar™ adoptsThe new generation of open impeller technology achieves a full main channel design, eliminating secondary channels, with the narrowest part of the channel being 16mm wide., compared with the 1mm flow channel of HM3,A 16-fold increase; Compared with the secondary flow channels of other domestically produced products,Achieved a 60-400 fold improvement. This innovation not only enhances blood compatibility but also reaches new heights in safety.

As artificialCore Technology of the HeartPart, Flow ChannelThe design depth of the impeller significantly impacts the long-term safety of the blood pump.Previously, Medtronic's HVAD artificial heart was withdrawn due to its secondary flow channel being too narrow, resulting in a high risk of thrombosis and ultimately leading to an excessively high stroke rate.City.Magnetic suspension, magnetic liquid suspension and other closed cylindrical rotors inevitably introduce secondary flow paths. Some products, such asHM3 widened the secondary flow channel to 1mm, but the fundamental problem remained unresolved.

(5) No vascular insertion, non-invasive assistance

The inflow cannula design of artificial hearts is mostly a metal tube that extends into the left ventricle. While this design is stable, it also brings risks such as wedge thrombosis, arrhythmia, and ventricular suction.EVAHEART's pioneering Bioflow blood vessels have fundamentally resolved these issues.。

Bioflow vascular implant is flush with the endocardium after placement,The metal ends of the third-generation blood vessels that extend into the heart have been removed, avoiding the possibility of wedge-shaped thrombus formation around the metal tube.. At the same time, Bioflow adopts a double suture design, which everts the myocardial section, therebyEliminates the risk of tissue crawling into blood vessels. The design without insertion avoids the risks of arrhythmia and myocardial injury that may be caused by long-term contact between blood vessels and the endocardium, not only providing patients with a safer and more comfortable treatment experience, but alsoDoes not interfere with the internal fluid dynamics of the heart, truly achieving imperceptible assistance.。

# Heart Failure Treatment Market

Heart failure, the end-stage of heart disease progression, has a five-year mortality rate as high as 30-70%, and is widely recognized as "the final battlefield in the field of cardiovascular diseases."According to public data, there are nearly 30 million heart failure patients globally.China has approximately 10.67 million heart failure patients.. It is expected that with the extension of survival period for heart disease patients and the deepening of aging,The Number of Heart Failure Patients Will Continue to Grow。

Data released by market research firm ReportLinker shows:The global heart failure treatment device market is expected to reach 14 billion US dollars by 2025.The Market Size of Heart Failure Management in China Will Exceed 10 Billion。

In China, the population suffering from heart failure accounts for 1.3% of the total population, with approximately 13.7 million heart failure patients. Among these patients, 5% progress to advanced heart failure each year, or 685,000 individuals. For advanced heart failure, the commonly used treatment methods currently include medication, heart transplantation, and mechanical circulatory support, but...The effect of drug treatment is poor, and patients with severe heart failure undergo drug treatment.The 6-month mortality rate is as high as 60% to 80%, and the 1-year survival rate is only 25%.。

At the same time,Heart TransplantAs an effective treatment for end-stage heart failure currentlyConstrained by factors such as the number of donors, donor matching conditions, and the high difficulty of surgery., The current annual average volume of transplant surgeries in ChinaOnly about 600 cases(564 units in 2020).The implantable ventricular assist system mainly refers to an auxiliary device that partially or completely replaces the natural blood supply of the human body through mechanical or biomechanical means, thereby treating end-stage heart failure.

As of now,Only Four Chinese-Made Implantable Artificial Hearts Approved for Marketing, respectively, for EVAHEARTEVAHEART, Core Medical, Suzhou CH Biomedical, Aerospace TAIHEART Technology，Among themOnly EVAHEART's artificial heart (EVAHEART) can be used for long-term assistance.。Academician Shengshou Hu, President of Fuwai Hospital, Chinese Academy of Medical Sciences, pointed out: Currently, 70 hospitals across China have carried out artificial heart implantation, with 177 patients receiving implant treatment in 2022 alone, showing rapid growth.

According to data from the U.S. Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs),More than 80% of artificial hearts in the United States are used for long-term assistance.Long-term assistance means that after the artificial heart is implanted, the patient can use it for a lifetime without undergoing another surgery for a heart transplant.Therefore, for end-stage heart failure patients in China,Long-term assistive artificial hearts are currently the best solution for treating heart failure.。

Details of 4 Chinese-Made Implantable Artificial Hearts Approved:

August 2019,EVAHEART Implantable Left Ventricular Assist System by EVAHEART MedicalApproved for marketing. The product isFirst Official LaunchChina-Made Implantable Left Ventricular Assist System, using a centrifugal mechanical bearing structure.

November 2021,CH-VAD Implantable Left Ventricular Assist System by Suzhou CH BiomedicalApproved for marketing. This product adopts the latest generation of magnetic levitation technology, which isFirst Official LaunchTheChinese-Made Fully Magnetically Levitated Artificial Heart, breaking Abbott's monopoly.

July 2022,HeartCon Implantable Left Ventricular Assist System by Aerospace TaixinApproved for marketing, isThe First in ChinaAdoptMagnetic Liquid Suspension TechnologyImplantable artificial heart.

June 2023,Core Medical's Corheart®6 Implantable Left Ventricular Assist SystemApproved for marketing,Is currentlyThe Smallest Volume and Lightest Weight GloballyArtificial Heart.

# Prospects for the Promotion of Artificial Hearts

In the context of heart failure treatment, in addition to issues such as the education of patients and doctors about artificial hearts, and patients' concerns about life after implantation, compared to developed countries where artificial hearts are mostly covered by commercial insurance,The Current Situation in China: Domestic Health Insurance and Commercial Insurance Have Not Yet Covered Artificial HeartsEven moreBecoming the Most Realistic Problem in the Market Promotion of Artificial Hearts。

Director of EVAHEART MedicalYan HuaHe said that during the progression of heart failure, patients will receive treatments including medication, ICD (Implantable Cardioverter Defibrillator), CRT (Cardiac Resynchronization Therapy), etc., and the financial burden on families is already heavy. "Some patients with acute heart failure may require ICU monitoring and treatment, using ECMO (Extracorporeal Membrane Oxygenation) for cardiopulmonary support, and if the support duration is relatively long,It also costs more than 200,000 yuan.. Therefore, when patients reach the late stage of heart failure, they needDuring the artificial heart implantation,Other expenses will also exceed five or six hundred thousand.. Not to mention proceeding with the next stepsFull Self-Pay Artificial Heart Implantation。”

Lack of understanding + full self-payment, making artificial hearts still in the tough uphill stage of early education in China., thereforeIt is necessary to solve patients' affordability through various forces before the widespread implementation of medical insurance., insurance is a very good way.

According to Yan Hua, EVAHEART will be introduced inHealth Insurance + Commercial Insurance + Charity, a combination of punches,Enable patients to use it before medical insurance reimbursement.，even after national medical insurance can reimburse, as a good supplement to medical insurance.

The strong clinical demand for artificial hearts goes without saying, but the market volume and scale that can support such demand are also indispensable. With leading capital flowing in first,Whether this track can open up more domestic markets in China through technological innovation may be more meaningful than which enterprise can take the lead.。

Perhaps as Yan Hua said,Only with more players joining can education be popularized and the market expanded together.Under the vision of saving lives, artificial hearts still need a better commercial answer.

# EVAHEART

EVAHEARTEstablished in June 2014, mainly engaged in the research and development, production, and sales of high-end medical devices —— the implantable left ventricular assist device EVAHEART (artificial heart).

This product is the crystallization of over 50 years of fundamental research and more than 20 years of collaborative design and development by prestigious institutions such as Waseda University, Tokyo Women's Medical University, the National Institute of Advanced Industrial Science and Technology, and Japan Sun Medical Technology Research Institute.EVAHEARTThrough the full set of technology introduction and the advancement of localization in China，Becoming the company in China currently approved for both short-term and long-term treatment dual indications artificial heart research, manufacturing, and sales.。

▲EVAHEART Left Ventricular Assist Device

As of now,EVAHEART Left Ventricular Assist Device Breaks Multiple Records in China's Industry：

● Officially Certified Earliest: The first artificial heart product approved by the China Food and Drug Administration, with a 1-year clinical trial survival rate of 100%;

● Full Range of Indications: An artificial heart approved by the FDA for both short-term and long-term treatment indications;

● The Fastest Globalization Process: Approved for marketing in Europe and Japan, and also received IDE approval from the United States. It is the only Chinese artificial heart being used overseas.

● Longest Implantation Duration: The first implant recipient has been assisted for over 11 years.

March 2023,EVAHEART CompletesNearly 100 Million USD in Series A FinancingLed by Sinovac (Beijing) Biotech Co., Ltd., with follow-up investments from Taiping (Shenzhen) Medical and Health Industry Private Equity Fund Partnership (Limited Partnership), and additional investment from existing shareholder Vivo Capital.This round of financing will enable EVAHEARTFurther Construct and Develop a Severe Heart Failure Treatment and Health Industry Platform。

As of the date of publication, the company's financing history is as follows:

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Medtronic｜J&J MedTech|Boston ScientificBoston Scientific|

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