Company Overview
Snapshot
Founded in January 2009 by Erez Golan and Eyal Kolka, Pi-Cardia operates with 51–200 employees. The company has raised $37M across 5 funding rounds from 9 investors.
Business overview
Pi-Cardia is a medical device company focused on developing a low-profile catheter for treating aortic stenosis. Its proprietary technology delivers mechanical impact to fracture valve calcifications without harming surrounding soft tissue. This treatment aims to increase the valve's effective orifice area, thereby eliminating the need for valve replacement. The company operates within the Health Tech & Life Sciences sector, specifically targeting the cardiovascular and medical devices markets.
Strategic signal
In July 2022, Pi-Cardia received FDA IDE approval for a pivotal study involving its ShortCut™ device. This approval is a significant regulatory milestone, indicating the potential for the device to advance through clinical trials and ultimately reach the market, signaling strong progress in the company's product development and regulatory strategy within the medical device industry.
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- What is Pi-Cardia's core technology?
- Pi-Cardia develops a proprietary low-profile catheter system designed to treat aortic stenosis by delivering mechanical impact to fracture valve calcifications without injuring the surrounding soft tissue, aiming to increase the valve's effective orifice area.
- 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 with its ShortCut™ device, marking a key regulatory advancement for the company.
- When did Pi-Cardia initiate its first-in-human study for aortic stenosis treatment?
- In May 2018, Pi-Cardia initiated its first-in-human study for the novel non-implant-based treatment of aortic stenosis.
- Has Pi-Cardia formed any strategic partnerships?
- In July 2020, Pi-Cardia teamed with China's Venus Medtech, indicating a strategic collaboration in the heart valve market.