KOKACLIP® – World’s First Full-Size, Full-Leaflet Self-Locking Transcatheter Mitral Valve Clip Receives NMPA Approval and Files IPO Prospectus

KOKACLIP^®Transcatheter Mitral Valve Repair SystemForOne of the first transcatheter valve repair products in China to enter the NMPA Innovative Medical Device Special Review Process.。

As KokaiLife SciencesTheFirst Class III Medical Device Registration Certificate, the product's launch will further break the monopoly of imported products in this field, providing a safer and more effective clinical solution for patients with mitral regurgitation.

# Overview of the Mitral Regurgitation Market

Mitral Regurgitation (MR)It is the most common heart valve disease in an aging society. If patients with severe mitral regurgitation do not receive effective treatment, the 5-year mortality rate can reach 50%.

The global number of transcatheter mitral valve repair procedures increased from 15,300 in 2017 to 27,700 in 2021, with a compound annual growth rate of 16.0% from 2017 to 2021.

Expected toBy 2027, the global volume of transcatheter mitral valve repair procedures will reach104,300 units，The compound annual growth rate from 2021 to 2027 is 24.7%.

China Mitral Regurgitation Market Size

In China, the prevalence of moderate to severe mitral regurgitation in the population aged 35 and above increased from 1.31% in 2017 to 1.37% in 2021, and is projected to...By 2027, the prevalence will increase to1.42%。

The number of patients with moderate to severe mitral regurgitation in China increased from 10 million in 2017 to 11.1 million in 2021, with a compound annual growth rate of 2.6% from 2017 to 2021.

This patient population figure will further expand,It is expected to reach by 202712.6 million people, with a compound annual growth rate of 2.1% from 2021 to 2027.

In 2021, the number of transcatheter mitral valve repair surgeries in China was approximately 200 cases, and it is expected thatWill reach by 202720,000 units, with a compound annual growth rate of 117.3% from 2021 to 2027.

# Product Introduction

KOKACLIP^®ByClamper and Delivery System, Catheter Sheath AssemblyComposition. The clip and delivery system consists of a clip, an implant catheter, and a controllable sheath. The catheter sheath assembly consists of a catheter sheath and a dilator. The catheter sheath includes a deflectable sheath and a handle.

TheThe product adopts percutaneous interventional technology, breaking through the limitations of traditional open-heart surgery to provide high-risk patients with safer and more precise minimally invasive treatment. Its clip device, featuring an elastic self-locking function utilizing the superelastic properties of nickel-titanium alloy, achieves autonomous locking and dynamic adjustment. While reducing leaflet tension, it simplifies the surgical procedure, demonstrating excellent clinical reliability and operational convenience.

AsChina's First Batch of One-Piece Mitral Valve Clips, which can also avoid the problem of tendon entanglement to the greatest extent. With the unique small-radius bending function of the product, it can also significantly reduce the requirements for puncture height. Through the above design, the product can achieve safer and more effective clamping, adapt to a wider range of patients, make the overall operation more intuitive and convenient, and the treatment effect is remarkable.

Relevant Clinical Data

KOKACLIP^®Clinical data shows that the system has good long-term safety and effectiveness.:

1、30Survival rate as high as99.15%, CompoundMAERate of13.7%；

2、Significant and sustainedMRDecrease:Postoperative12MonthsMR≤2+As high as97.8%；

3、Significant improvement in mitral regurgitation symptoms and quality of life;Persistent low pressure difference after surgery remained below5mmHg。

# Overview of the Mitral Valve Intervention Market

As of now, globally there are13PaymentMitral Valve Intervention Device Approved.

Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) FieldIncluding:

• AbbottMitraClip is the only one that has obtainedFDA/CE/NMPAThird-party certifiedTMVRProduct.

• EdwardPASCAL Respectively on2019Year and2022Year obtainedCEAndFDACertification.

• 2023Year9Month and12Month,Hanyu MedicalValveClamp、Dejin MedicalDragonFly 2 Chinese-madeTEERObtainNMPAApproved for marketing, breaking the situation of China's market being monopolized by foreign capital. By 2025,Zhenyi Medical NeoNova、Kokai Life Sciences KOKACLIPThese 2 Chinese-madeTEER also followed suit, successfullyObtainNMPAApproved for marketing.

Relative toTEER，The development of related instruments for annuloplasty and chordae tendineae repair is relatively slow, and there is also less evidence from evidence-based medicine.

AndMitral Valve Replacement FieldIncluding the femoral vein approachEdward SAPIEN M3Transcatheter Mitral Valve Replacement SystemAnd the transapical approachAbbottTendyneTranscatheter Mitral Valve Replacement System、Baren MedicalRenatoTranscatheter Valve-in-Valve SystemThis3Products have been approved, including AbbottTendyneIt is the world's first approved and marketed transcatheter mitral valve replacement system.

▲Global Approved Mitral Valve Repair and Replacement Products

Due to the complexity of the mitral valve structure and high technical barriers, the development of transcatheter mitral valve replacement is quite challenging. Currently, the vast majority are in the exploratory or early clinical exploration stage, AbbottTendyneIn2020Received at the beginning of the yearCEAfter gaining approval for market release, Medtronic, Edwards, and others quickly followed suit in pursuit of breakthroughs.

Domestic MarketTMVRAmong the challengers,TAVRThe Big ThreeVenus Medtech, Heartflow Medical, Peijia MedicalMainly relying on strategic cooperation for layout, introducing foreign technologies through purchasing, agency, and other methods can quickly achieve track layout in a short time, but it is difficult to fully master the core key technologies, and subsequent re-innovation capabilities may be insufficient.

Currently, in the field of mitral valve replacement in China, only Benn Medical is available.RenatoTranscatheter Valve-in-Valve System Approved, in addition to forming a three-legged tripodNymphea Medical, Yixin Medical, and Zhenyi Medical，3Respective Enterprises3IndividualTMVRProduct:Mi-thos、MitraFix AndTruDelta, currently3All products have entered the registered clinical stage, with promising prospects.

# Company Introduction

Kokai Life SciencesFounded in2018Year9Kokai Life Sciences is a high-end biopharmaceutical technology enterprise that integrates the research and development, production, and sales of medical devices in the field of structural heart disease, developing systematic solutions for valve diseases targeting different populations, needs, and scenarios.

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