EVOLVING
INNOVATION

ZETA Transcatheter Aortic Valve System

The only Balloon-Expandable valve solution designed for Aortic Regurgitation + Aortic Stenosis

Not an approved device, for investigational use only

Solving Today's Unmet Needs

AORTIC REGURGITATION

Patient Risks:

There are no approved devices in the US, patients are currently treated with Medication, Surgery, or Off-Label devices:

Medication– Only for mild AR, severe AR is not treated

Surgery– Open heart, not all patients are surgical candidates, extended hospital/recovery

 Off-Label TAVR– Current devices require elevated calcification in the annulus or risk embolization; paravalvular leak risk; improper sizing causes leaks – all issues lead to heart failure

Advanced Heart Valve Replacement Technology

Combines Balloon-Expandable and Self-Expandable technologies to achieve superior heart valve performance to meet patient and physician needs.

ZETA Balloon Expandable Aortic Valve

A state-of-the-art valve design that combines the proven benefits of balloon-expandable valve systems for stenosis with the addition of self-expanding valve features to treat aortic regurgitation, and is capable of treating stenosis. Designed using industry-proven materials, the Zeta Aortic Valve is designed to be simple, reliable, with accurate deployment, and includes an easy-to-use delivery system.

Benefits:

Clinical Updates

Zeta Aortic Valve – 6 Successful Clinical Cases Completed

CLINICAL CASEDATE COMPLETEDFOLLOWUPSTATUS
1September 202360dZETA Complete Resolution
2December 2023 30dZETA Complete Resolution
 3 December 2023 30dZETA Complete Resolution
 4 December 2023 30dZETA Complete Resolution
 5 December 2023 30dZETA Complete Resolution
 6 December 2023 30dZETA Complete Resolution

Patient #1 FIM, Sep 27, 2023 - ZETA Valve Deployment

Not an approved device, for investigational use only

TAVR and Aortic Regurgitation Market

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Patients with Aortic Regurgitation

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TAVR Market in 2023

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Aortic Regurgitation market in in 2023

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Annual Growth through 2027

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