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16th April 2024

Beating Heart Disease: How ConKay leads the charge against Valvular Regurgitation?

“Our purpose goes beyond technology. We’re driven by a profound commitment to changing lives.”

– Albert Yuan, Founder, President and CEO – ConKay Medical Systems 

Imagine each morning, struggling for breath as if your lungs are tightly bound by chains. Every inhale is a battle, your chest tight with the strain of a failing heart. This is the daily reality for millions with valvular regurgitation—their hearts struggling as valves fail, allowing blood to wreak havoc within. Can you imagine facing each day like this, or seeing a loved one suffer so?

ConKay Medical Systems is dedicated to changing that. 

The heart of the matter

Established in 2020 at the onset of the COVID-19 pandemic, CEO Albert Yuan founded ConKay Medical Systems driven by a profound and personal journey. Inspired by witnessing a loved one’s harrowing battle with this debilitating condition, the mission is deeply rooted in compassion and determination.

The journey humbly began within the confines of a garage where the focus was on the Tricuspid valve—an area without FDA-approved treatments. It was within those same garage walls that the innovation began and the first prototypes took shape, assembled from donated equipment and components received as samples from suppliers.

From these modest beginnings emerged the Stargazer Delivery System, a beacon of hope for those confronting the daunting prospect of invasive surgeries or ineffective treatments.

“Fueled by a desire to confront the limitations of current medical solutions,” explained Yuan with deep enthusiasm, “the journey began to revolutionise treatment options.”

ConKay’s device mimics traditional open-heart procedures, long considered the gold standard for treating heart valve disease. However, isolated open-heart surgery for the Tricuspid valve carries a high mortality risk, ranging from 8-10% or higher according to research. 

To mitigate this risk, ConKay’s technology employs a similar implant concept but delivers it percutaneously from the femoral vein, eliminating the need for opening the chest cavity and reducing the risk of mortality for patients.

The effectiveness of the initial studies is evident in their ability to attract significant attention, as demonstrated by a successful fundraising round that concluded in March, securing an impressive $1.8 million in seed funding.

Speaking on behalf of the company, Yuan expressed profound gratitude for the unwavering support and confidence shown by investors, acknowledging the pivotal role this capital infusion plays in advancing the landscape of valvular regurgitation treatment.

“This capital infusion marks a pivotal step in our mission to revolutionise valvular regurgitation treatment. Its profound impact empowers us to undertake critical initiatives, driving us closer to our ultimate goal of First-in-Human testing.”

Focusing on simplicity and efficiency

So how does the device tackle the core challenges of valvular regurgitation?

Firstly, it expands treatment options by accommodating larger valves, thus surpassing existing limitations. Additionally, it addresses the issue of pacemaker leads, enhancing both patient safety and procedural efficacy. 

With a dedicated lumen for advanced imaging capabilities, this provides physicians with additional tools needed for clarity and real-time visualisation during procedures, thereby improving overall safety. Furthermore, its minimally invasive approach mirrors open-heart procedures without requiring invasive chest cavity access, offering patients the benefits of proven efficacy with reduced procedural risks and faster recovery times.

Notably, the device also leaves behind an annular ring, paving the way for potential future treatments and ensuring adaptability to evolving patient needs over time. Lastly, its one-size-fits-all design streamlines procedural logistics, enhancing efficiency for physicians.

As he described the technology, Yuan addressed a common misconception regarding the Tricuspid and Mitral valves, emphasising their distinct characteristics. 

“Unlike the Mitral valve, the Tricuspid valve can grow significantly larger, reaching up to 80 mm in diameter in severe cases. Patients with Tricuspid valve issues often face additional challenges, such as the presence of pacemaker leads passing through the valve due to heart failure.”  

Moreover, imaging limitations, particularly with Transesophageal Echocardiography, further complicate treatment planning. ConKay’s technology addresses these limitations comprehensively, capable of treating larger valves, avoiding pacemaker leads, and providing clearer imaging through a dedicated lumen for IntraCardiac Echocardiography (ICE). 

With its one-size-fits-all percutaneous device, ConKay aims to offer hope to millions worldwide, including those currently lacking viable treatment options due to valve size constraints.

“At ConKay Medical Systems, our unwavering commitment to pave a path of hope and healing, will allow patients to reclaim their lives and cherish moments with loved ones. While we couldn’t assist my family, I’m determined that our device will extend life for countless others.”

First-In-Human testing means hope for patients

Looking forward, last month’s investment positions ConKay Medical Systems for significant growth and expansion. With this added capital, the company foresees opportunities for team expansion, faster development, and the establishment of a new R&D facility, fostering further innovation.

ConKay will conduct First-In-Human testing in 2025, planning a 10-person study outside the US to demonstrate safety and efficacy. With determination, Yuan shared how the ultimate goal is to address the needs of millions worldwide suffering from Tricuspid Regurgitation, including those currently without viable medical options due to valve size constraints or large coaptation gaps.

“This milestone will mark a crucial step forward in addressing the unmet needs of this patient population and bringing hope to those currently left without treatment options.”

Do you find ConKay’s journey heartening?

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