Pi-Cardia Overview
Pi-Cardia is a medical device company developing a low-profile catheter for treating aortic stenosis. The company's proprietary technology is based on delivering mechanical impact to create fractures in valve calcifications without injuring the surrounding soft tissue. This treatment, which takes only seconds, is intended to increase the valve's effective orifice area, eliminating the need to replace the valve.
Cumulative Funding Raised Over Time ($)
$27.0MApr 2020
$27.0MDec 2011
$37.0MJan 2016
$37.0MNov 2024
$37.0MSep 2015
Latest News
growth-positive
Pi-Cardia Successfully Performs Mitral Valve Splitting With ShortCut(TM) | BioSpace
Pi-Cardia Ltd. has announced the successful First-In-Human treatment of the mitral valve with its ShortCut™ Mitral device in Europe. The device is designed to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after Transcatheter Aortic Valve Replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after Transcatheter Mitral Valve Replacement (TMVR). The company aims to treat more patients with mitral valve disease who have no other option. The TMVR market is growing exponentially and is predicted to reach several billion dollars in the next decade. Pi-Cardias product portfolio also includes the ShortCut™ Aortic and Leaflex™ devices, which are currently undergoing clinical trials in Europe.
CustomersExpand
growth-positive
Pi-Cardia Receives FDA IDE Approval for Pivotal Study with ShortCut(TM) Device
Pi-Cardia Ltd. has received FDA approval to commence the ShortCut™ Pivotal Study for its dedicated leaflet splitting device designed to prevent coronary obstruction during Transcatheter Aortic Valve Replacement (TAVR). The TAVR market is projected to double over the next five years, and the ShortCut™ device aims to enhance the safety of valve-in-valve procedures and expand the market. The companys CEO, Erez Golan, believes that ShortCut™ can be the first dedicated leaflet splitting device in the US, coming to market as early as 2024. Pi-Cardia is also making progress in demonstrating the feasibility of its leaflet modification technologies, including the Leaflex™ device, which mechanically scores valve calcification to improve valve hemodynamics. The company sees significant additional market opportunities in treating bicuspid and mitral valves.
CustomersExpand
growth-positive
Innovative non-surgical solutions for aortic valve stenosis
Pi-Cardia, a medical device company based in Rehovot, Israel, is developing innovative solutions for aortic valve stenosis. Their first product, Leaflex, aims to repair the aortic valve without replacing it with a prosthetic valve by breaking up calcification. The device is currently in human clinical trials in Europe and has received $27 million in funding led by Sofinnova Partners. Pi-Cardia has also signed a deal with Chinas Venus Medtech to test its products for the Chinese market. Their second product, ShortCut, is designed to split the leaflets of a previous prosthetic valve to ensure safer placement of a new one. Although not yet approved, ShortCut has already been used successfully in compassionate use cases. Pi-Cardia believes that both Leaflex and ShortCut could offer important new treatment options for aortic stenosis patients.
Customers
Pi-Cardia Successfully Treats First Patients with ShortCut™ Device
growth-positive
Heart valve co Pi-Cardia teams with China's Venus Medtech
Israeli company Pi-Cardia Ltd. has collaborated with Venus Medtech to bring its Leaflex catheter-based solutions for treating heart valve calcification to China. The collaboration is expected to have a positive impact on Pi-Cardias growth. Pi-Cardias Leaflex catheter performs mechanical scoring of valve calcification, providing a cost-effective and durable standalone treatment. The catheter can be used for patients not planning to undergo transcatheter aortic valve replacement and can also be a preparatory step for improving the outcome of TAVR in heavily-calcified and bicuspid aortic valves. Pi-Cardia aims to establish the long-term safety and efficacy of Leaflex as a standalone treatment for patients with aortic stenosis.
Partners
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $37M |
| Last funding | Undisclosed |
| Stage | C |
| Rounds | 5 |
| Investors | 9 |
Team Members
2
Employees: 51-200
Web & Social Links
| Website | www.pi-cardia.net |
Locations
David Fikes St 5, Rehovot, Israel
Photos & Videos
1 item(s)
Pi-Cardia Business
Business models
B2B
Product stage
Clinical Trial
Employees
51-200
Sector
Health Tech & Life SciencesMedical DevicesMedical Treatment & TherapeuticsTarget Customer
Healthcare & Life SciencesHealthcareProvidersCore Technology
—Tags (9)
medical-devicescardiovascularsurgerycardiologycathetersvalvessurgeonsmedical-productstreatmentsGeographic Markets
ChinaPi-Cardia Financials
$37M
Total funding
Undisclosed
Capital raised
Undisclosed
Last funding
C
Funding stage
5
Total rounds
9
Investors
Cumulative Funding Raised Over Time ($)
$27.0MApr 2020
$27.0MDec 2011
$37.0MJan 2016
$37.0MNov 2024
$37.0MSep 2015
Private Equity Funding
Undisclosed Round
Nov 2024
Undisclosed
Minogue Consulting (Lead)
C Round
Apr 2020
$27M
Sofinnova Partners (Lead)
,
Jacques Sguin , Clal Biotechnology Industries (CBI)
C Round
Jan 2016
$10M
Innogest Capital, Clal Biotechnology Industries (CBI), Atlante Ventures, Viventures, Anatomy Medical Technology Fund
B Round
Sep 2015
Undisclosed
Accelmed, Clal Biotechnology Industries (CBI)
A Round
Dec 2011
Undisclosed
Pi-Cardia Lifecycle
Cumulative Funding Raised Over Time
$27.0MApr 2020
$27.0MDec 2011
$37.0MJan 2016
$37.0MNov 2024
$37.0MSep 2015
All Events
Undisclosed Round
Nov 2024
Undisclosed
Minogue Consulting (Lead)
C Round
Apr 2020
$27M
Sofinnova Partners (Lead)
,
Jacques Sguin , Clal Biotechnology Industries (CBI)
C Round
Jan 2016
$10M
Innogest Capital, Clal Biotechnology Industries (CBI), Atlante Ventures, Viventures, Anatomy Medical Technology Fund
B Round
Sep 2015
Undisclosed
Accelmed, Clal Biotechnology Industries (CBI)
A Round
Dec 2011
Undisclosed
Pi-Cardia News
11 articles
growth-positive
Pi-Cardia Successfully Performs Mitral Valve Splitting With ShortCut(TM) | BioSpace
Pi-Cardia Ltd. has announced the successful First-In-Human treatment of the mitral valve with its ShortCut™ Mitral device in Europe. The device is designed to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after Transcatheter Aortic Valve Replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after Transcatheter Mitral Valve Replacement (TMVR). The company aims to treat more patients with mitral valve disease who have no other option. The TMVR market is growing exponentially and is predicted to reach several billion dollars in the next decade. Pi-Cardias product portfolio also includes the ShortCut™ Aortic and Leaflex™ devices, which are currently undergoing clinical trials in Europe.
CustomersExpand
growth-positive
Pi-Cardia Receives FDA IDE Approval for Pivotal Study with ShortCut(TM) Device
Pi-Cardia Ltd. has received FDA approval to commence the ShortCut™ Pivotal Study for its dedicated leaflet splitting device designed to prevent coronary obstruction during Transcatheter Aortic Valve Replacement (TAVR). The TAVR market is projected to double over the next five years, and the ShortCut™ device aims to enhance the safety of valve-in-valve procedures and expand the market. The companys CEO, Erez Golan, believes that ShortCut™ can be the first dedicated leaflet splitting device in the US, coming to market as early as 2024. Pi-Cardia is also making progress in demonstrating the feasibility of its leaflet modification technologies, including the Leaflex™ device, which mechanically scores valve calcification to improve valve hemodynamics. The company sees significant additional market opportunities in treating bicuspid and mitral valves.
CustomersExpand
growth-positive
Innovative non-surgical solutions for aortic valve stenosis
Pi-Cardia, a medical device company based in Rehovot, Israel, is developing innovative solutions for aortic valve stenosis. Their first product, Leaflex, aims to repair the aortic valve without replacing it with a prosthetic valve by breaking up calcification. The device is currently in human clinical trials in Europe and has received $27 million in funding led by Sofinnova Partners. Pi-Cardia has also signed a deal with Chinas Venus Medtech to test its products for the Chinese market. Their second product, ShortCut, is designed to split the leaflets of a previous prosthetic valve to ensure safer placement of a new one. Although not yet approved, ShortCut has already been used successfully in compassionate use cases. Pi-Cardia believes that both Leaflex and ShortCut could offer important new treatment options for aortic stenosis patients.
Customers
Pi-Cardia Successfully Treats First Patients with ShortCut™ Device
growth-positive
Heart valve co Pi-Cardia teams with China's Venus Medtech
Israeli company Pi-Cardia Ltd. has collaborated with Venus Medtech to bring its Leaflex catheter-based solutions for treating heart valve calcification to China. The collaboration is expected to have a positive impact on Pi-Cardias growth. Pi-Cardias Leaflex catheter performs mechanical scoring of valve calcification, providing a cost-effective and durable standalone treatment. The catheter can be used for patients not planning to undergo transcatheter aortic valve replacement and can also be a preparatory step for improving the outcome of TAVR in heavily-calcified and bicuspid aortic valves. Pi-Cardia aims to establish the long-term safety and efficacy of Leaflex as a standalone treatment for patients with aortic stenosis.
Partners
growth-positive
Pi-Cardia Closes a $27 Million Financing led by Sofinnova Partners to Continue Clinical Trials With Its Leaflex™ Aortic Valve Technology
Pi-Cardia Ltd. has closed a $27 million round of financing led by Sofinnova Partners and joined by Professor Jacques Séguin. The funding will enable the company to conduct clinical trials in the United States and Europe to demonstrate the therapeutic effect of aortic valve scoring over time. Pi-Cardias Leaflex catheter is a non-implant catheter-based solution for treating heart valve calcification. It can be used as a standalone treatment or as a preparatory step for valve implantation in heavily calcified and bicuspid aortic valves. The company aims to provide patients with an alternative to valve replacement and contribute to the treatment of structural heart disease.
Investment
Pi-Cardia Appoints Prof. Jacques Séguin As Chairman " Cardiology2.0
growth-positive
Pi-Cardia First-in-Human Study Shows Significant Improvement in Aortic Valve Function Following Treatment With its Novel Non-Implant Based Leaflex™ Catheter
Pi-Cardia Ltd. has successfully completed its First-in-Human study, demonstrating substantial improvement in valve function with its Leaflex Performer catheter. The catheter uses unique mechanical structures to score valve calcification and improve valve hemodynamics. The study showed safety, feasibility, and significant hemodynamic improvement. Pi-Cardia is a global leader in non-implant-based solutions for treating valve calcification. The companys Leaflex catheter is a cost-effective standalone treatment or preparatory step for valve implantation. The next set of trials will focus on demonstrating the long-term durability of the treatment.
CustomersPartners
growth-positive
Pi-Cardia Initiates First-in-Human Study With Novel Non-Implant Based Treatment of Aortic Stenosis
Pi-Cardia Ltd. has started its First-in-Human study with its Leaflex Performer catheter system, which aims to treat valve calcification. The catheter uses unique mechanical structures to score valve calcification and improve valve hemodynamics. Initial trial results have shown safety, feasibility, and superior hemodynamic improvement compared to balloon valvuloplasty. The Leaflex Performer is designed to be a cost-effective standalone treatment or a preparatory step for valve implantation. Pi-Cardia aims to expand treatment options in the market dominated by surgical or trans-catheter aortic valve replacement. The company plans to present the catheter system and clinical results at the EuroPCR meeting in May 2018.
Expand
growth-positive
Pi-Cardia Completes $10M Financing
Pi-Cardia Ltd. has completed a $10 million financing round, including participation from a new strategic investor. The company has developed the Leaflex Catheter System, a non-implant based technology for treating patients with aortic valve stenosis. The system creates fractures in valve calcification to improve valve hemodynamics without the need for a new valve implant. Pi-Cardia aims to expand treatment options in the growing market dominated by surgical or trans-catheter aortic valve replacement. The funds raised will be used to develop a second generation device and continue clinical studies for CE-Mark approval.
Investment
growth-positive
Clal Biotech to invest in heart valve co Pi R Squared
Clal Biotechnology Industries Ltd. is set to make its first investment through a medical devices investment fund. The investment will be in Pi R Squared Ltd., a company developing a treatment for calcification of coronary valves. The investment is expected to be several million dollars.
Investment
Pi-Cardia Team
Erez Golan
Co-founder & CEO
Founder
Employee Info
| Employees (range) | 51-200 |
| Exact count | 68 |
| Team members | 3 |
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Pi-Cardia Internal
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Admin Info
| Confidence | 90/100 |
| Missing | markets, not claimed |
| BI Verification | Yanina Wainscheinker |
| Registrar ID | 514181379 |
| Crunchbase | pi-cardia |
| Phone | +97289484800 |
| Creator | Raz Zohar |
| Creator email | raz@platterz.ca |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2022-11-01T00:00:00.000Z |
| Created | 2014-09-10T00:00:00.000Z |