TRiCares Submits IPO Prospectus Following $50M Series D Funding for Topaz Dual-Stent Transcatheter Tricuspid Valve Replacement System

Aug 07, 2024 09:51 CST Updated 09:51

Tricares

Medical Device Developer

Source: Heart Future; Editor: Sophia

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Heart Future

Recently,TRiCares Announced that it has raised funds in the D round of financing$50 million, the company allocated funds to support itsTranscatheter Tricuspid Valve Replacement (TTVR) SystemInClinical Studies Conducted in the United States and the European Union(Including completing an Early Feasibility Study (EFS) in the United States and a pivotal trial in Europe)

In addition, the funds will also be used to optimize the Topaz TTVR System and develop the next-generation delivery system.Topaz is an advanced TTVR product,Currently, 25 cases have been successfully implanted in Europe and Canada.. And will launch in the United States and Canada in the coming monthsEarly Feasibility Study (EFS) Involving Up to 8 Centers。

It is worth noting that, in the TTVR field, apart fromEdward's EVOQUE Receives FDA Approval for Market Launch,Other participants are more or less at the same starting line, either in preclinical or clinical research. In this field, the gap between domestically produced products and overseas competitors is narrowing.LuX-Vavle by Ningbo Jianshi Technology is the world's first transcatheter tricuspid valve replacement device., using a non-radial support force anchoring method, does not affect the patient's cardiac contraction function or important anatomical structures around the tricuspid valve,Unfortunately, due to the lack of rigor in clinical researchTechnical assessment not passed during the registration technical review phase。

# Topaz TTVR System

Topaz TTVR System PassedMinimally Invasive Femoral Delivery to Replace Native Tricuspid Heart Valve, without the need for prior surgical removal of the diseased native tricuspid valve.

The system includes the Topaz artificial heart valve and delivery system.Topaz is implanted through the patient's femoral vein.。

Artificial heart valves include outer stents and inner stents:

Left: External Stent Right: Internal Stent

External Stent:Fixed on the native tricuspid valve leaflets, adaptable to patientsDifferent shapes and sizesAnatomical structure;

Stent:Can achieve appropriate valve function and long-term performance; the tri-leaflet pericardial tissue valve is made from porcine pericardium, throughMore than 1000 stitchesSuture the porcine pericardium onto the inner stent.

Internal stent ensures valve roundness.(Avoid valve deformation due to different physiological outcomes in patients), thereby demonstrating perfect leaflet alignment.

No traumatic anchoring structure；It can be suitable for patients with an annulus of up to 45mm, and the second-generation Topaz valve prosthesis can be suitable for patients with an annulus of 55mm.

The valve is composed of a self-expanding nitinol stent with an integrated bovine pericardial valve., which is characterized by the enlargement of both atrial and ventricular portions to ensure reliable fixation at the annulus position.

Topaz Delivery SystemSpecifically designed for femoral vein access, consisting of two main parts:

Steerable Sheath:Used for non-traumatic entry into the femoral vein. Vertical landing on the tricuspid annulus can be achieved through active deflection of the steering wheel.

Delivery System:29Fr delivery system, capable of bidirectional bending;Easy to use,Helpful in promoting TopazValveDepartmentSigned onExpectedOfFinal Position.

# Successful Implantation

In December 2023, TRiCares announced its Topaz Transfemoral Tricuspid Heart Valve Replacement System (“Topaz”)Successfully implanted in a 74-year-old patient with a pacemaker at the University Medical Center of Mainz, GermanyThe patient was classified as New York Heart Association (NYHA)Grade III Heart Failure。

Surgery time is less than 30 minutes, the pacemaker lead passes through the tricuspid annulus, the valve is implanted into the target position, regurgitation is reduced to a trace amount, there is no transvalvular leakage, andThe performance of the pacemaker is not affected by the valve.. Two months later,The patient returned for a follow-up visit, confirming the good effect of the implant.。

Director of the Structural Heart Disease Intervention Center and Heart Valve Center in Mainz, GermanyProfessor Ralph Stephan von BardelebenCommented: "I am very proud to be involved in this implant surgery. The patient's condition was relatively severe and a pacemaker was installed. The innovative Topaz TTVR solution has the potential to provide a much-needed solution for patient groups lacking effective long-term treatment options."

# TTVR Product Information

Jian Shi Technology——LuX-Valve Plus

Lux-Valve adopts the self-developed technology of Jian Shi Technology,The world's first design concept of "non-radial support force dependence" and "interventricular septum fixation", effectively solving the special pathological issues of the tricuspid valveLarge structural differences, difficult fixation, and susceptibility to right heart tissue damageAnd other difficult problems.

Image Source: Company Official Website

Lux-ValveMainBy anchoring the valve to the interventricular septum with an anchoring device, while using a blocking component to restrict the movement of the valve,Form three fixed points to secure the position of the valve.。

The product features a soft woven ring designed according to the size of the patient's annulus, which conforms to the autologous leaflets and atrial wall, forming adhesions over time.It can effectively prevent paravalvular leakage without affecting the contraction of the right ventricle.; The valve stent of the product ensures an effective orifice area without supporting the annulus,Avoids the drawbacks of other similar productsHowever, the product registration was rejected by NMPA due to non-rigorous clinical research.

Edwards Lifesciences —— EVOQUE

In February 2024, Edwards' tricuspid product EVOQUE received FDA approval for market release. This isThe first transcatheter tricuspid valve replacement product approved by the FDA。

EVOQUE is aSelf-expanding Tricuspid Valve, composed of a self-expanding nitinol stent, bovine pericardial leaflets, a fabric skirt, and a leaflet clamping device, featuring a unique anchoring mechanism that utilizes the valve annulus, leaflets, and chordae tendineae.Stable implantation through 9 ventricular anchors。

The EVOQUE Transcatheter Tricuspid Valve Replacement System is designed to replace the patient's native tricuspid valve., without the need for open-heart surgery. The valve is implanted using a minimally invasive delivery system, where the doctor threads a thin tube through a vein in the patient's leg to reach the heart and perform the valve replacement procedure.

U.S. Navigate Corporation——Gate

Gate is a product developed by NaviGate, an American company.Transcatheter Tricuspid Self-Expanding Bioprosthesis via Right Atrial Approach. Composed of an atrioventricular valve stent and delivery system.

The Gate-type self-expanding tricuspid atrioventricular valve stent is a nitinol tapered stent with three pericardial leaflets, low height (21 mm), and annular fins for fixation of the tricuspid annulus and tricuspid valve. It relies on radial support force and barbs for fixation.

Cardiovalve & Qiming Medical

Cardiovalve is a product developed by the Israeli company Cardiovalve.Innovative Transcatheter Valve Replacement System for Treating Both Mitral Regurgitation and Tricuspid RegurgitationCardiovalve was acquired by Qiming Medical in 2022.

Currently,In the treatment of tricuspid regurgitation indications，Cardiovalve has been granted the "Breakthrough Device Designation" by the US FDA and has entered the Early Feasibility Study (EFS) phase in the United States.

In addition, for the treatment of mitral regurgitation, Cardiovalve has entered the clinical research stage in Europe and the early feasibility study (EFS) stage in the United States.

Its Cardiovalve TARGET CE pivotal clinical study for tricuspid regurgitation officially launched at the end of 2022. The enrollment for the pivotal clinical study is proceeding smoothly. To date, it has covered more than twenty well-known cardiovascular centers in Europe and North America.

Medtronic —— Intrepid

The Intrepid valve, initially developed by Medtronic for transcatheter mitral valve replacement, is now applied in tricuspid valve interventions.

▲Intrepid Transcatheter Mitral Valve Replacement System (Image SourceOfficial CompanyNet)

Intrepid Valve AdoptedDouble-layer Stent DesignThe outer stent is soft and contains barbs, which can pierce into the mitral valve leaflets to secure the entire device in place; the inner stent serves as the functional stent, with three bovine pericardial leaflets sutured inside.

Both stents are cylindrical in shape,The peripheral stent can deform with cardiac contraction.To reduce left ventricular outflow tract obstruction and protect the contractile function of the cardiac base;Internal stents can also avoid interference from external stents., thereby better enhancing the function of the valve.

The design of the peripheral stent also allows for a smaller artificial valve diameter.Reduce the stress on the valve leaflets, thereby extending the life of the valve.(The lifespan of bioprosthetic valves is related to both the height of the leaflet suspension and the orifice area).

P+F Company —— TricValve® System

TricValve® Transcatheter Bicuspid System for the treatment of patients with hemodynamically relevant tricuspid insufficiency and inferior vena cava reflux.It is a heterotopic system composed of two valves.：One is implanted in the superior vena cava (SVC), and the other is implanted in the inferior vena cava (IVC).

The implantation of the valve prevents reflux in the venous system, reduces hepatic congestion, increases the right ventricular ejection volume into the pulmonary artery system, and improves cardiac output.Without interfering with the native tricuspid valve anatomy, especially suitable for patients with extremely high surgical risks or those unsuitable for surgery due to inability to undergo open surgical treatment.

TricValve System Obtains CE Mark in May 2021, allowing further treatment of the tricuspid valve through edge-to-edge repair or valve-in-valve replacement.。

Looking at China,Cardiovalve, the Mitral and Tricuspid Valve Replacement Products of Qiming MedicalHas entered pivotal clinical trials, with over 40 patients enrolled in Canada, Europe, and other regions as of mid-2023; progress is at the forefront.Tricares' Tricuspid Valve ReplacementProduct MonarQCompleted the first human implantation in the United States, expected to initiate clinical enrollment;Nuvalve Medical's Tricuspid Valve Replacement Product Prizvalve-THas entered the design phase;Hanyu Medical's Tricuspid Valve Replacement System ValveNeo-TPrototype iteration is in progress.

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