Pi-Cardia

Non-implant-based Valve Treatment

Health Tech & Life Sciences
Private

Company Overview

Snapshot

Founded in January 2009 by Erez Golan and Eyal Kolka, Pi-Cardia operates with 51–200 employees. The company has raised $37 million across 5 funding rounds from 9 investors. In July 2022, Pi-Cardia received FDA IDE approval for a pivotal study of its ShortCut™ device.

Business overview

Pi-Cardia is a medical device company focused on developing a low-profile catheter for the treatment of aortic stenosis. Its proprietary technology utilizes mechanical impact to fracture valve calcifications without harming surrounding soft tissue. This rapid treatment aims to increase the valve's effective orifice area, providing an alternative to valve replacement. The company operates within the Health Tech & Life Sciences sector, specifically targeting the medical devices and cardiovascular markets with its non-implant-based solutions.

Strategic signal

In July 2022, Pi-Cardia received FDA IDE approval for a pivotal study of its ShortCut™ device. This regulatory milestone is a significant validation of the company's technology and signals a critical step towards commercialization and broader market access for its innovative non-implant-based treatment for aortic stenosis.

Company Intelligence Q&A

What is Pi-Cardia's core technology?
Pi-Cardia develops a low-profile catheter that uses mechanical impact to fracture valve calcifications in aortic stenosis patients, aiming to increase the valve's effective orifice area without requiring valve replacement.
When did Pi-Cardia receive FDA IDE approval for its ShortCut™ device?
In July 2022, Pi-Cardia received FDA IDE approval for a pivotal study of its ShortCut™ device, marking a significant regulatory milestone for the company.
Which investors participated in Pi-Cardia's April 2020 financing round?
In April 2020, Pi-Cardia closed a financing round led by Sofinnova Partners, with participation from.
What was a key clinical development for Pi-Cardia in 2019?
In May 2019, a first-in-human study demonstrated significant improvement in aortic valve function following treatment with Pi-Cardia's novel non-implant-based Leaflex™ Catheter.
What strategic partnership did Pi-Cardia form in 2020?
In July 2020, Pi-Cardia partnered with China's Venus Medtech to advance its heart valve technology.

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