Pi-Cardia’s ShortCut™ becomes First Leaflet Modification Technology to receive CMS NTAP for Valve-in-Valve TAVR

Boston, Massachusetts, August 6, 2025 — Pi-Cardia Inc., a global leader in the development of leaflet modification solutions for treating heart valves, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-On Payment (NTAP) for the ShortCut™ device, effective October 1, 2025. The NTAP designation recognizes ShortCut™ as a breakthrough technology that addresses a critical unmet need in valve-in-valve transcatheter aortic valve replacement (TAVR) by enabling treatment for patients at risk of coronary obstruction.

Beginning October 1, 2025, CMS will provide eligible hospitals with up to $9,750 in additional reimbursement per case when the ShortCut™ procedure is performed. This payment is in addition to the Medicare Severity Diagnosis Related Group (MS-DRG) amount for TAVR. To receive the NTAP, hospitals must report ICD-10-PCS code X28F3VA, which specifically identifies leaflet splitting procedures performed with ShortCut™.

“We are thrilled to get CMS NTAP for the ShortCut™ device,” said Erez Golan, Pi-Cardia’s Chief Executive Officer. “We started our U.S. limited commercial launch just a few months ago at leading TAVR centers and already see significant utilization and enthusiasm with the device. The NTAP will now allow us to expand our commercial footprint, enabling more hospitals to adopt ShortCut™ with additional reimbursement support—and ultimately helping more patients at risk of coronary obstruction gain access to this important technology.”

TAVR has become the preferred treatment for aortic stenosis, recently surpassing surgery—even in patients younger than 65.1 As bioprosthetic valves degenerate over time, many of these patients will eventually require a valve-in-valve procedure. A significant portion of them who are at risk for coronary obstruction may benefit from leaflet splitting with ShortCut™.

According to models recently published in the Structural Heart Journal (2024), by 2035 more than 40,000 valve-in-valve procedures will be performed annually in the U.S., representing over 15% of all TAVR procedures. Planned future indications in native and bicuspid valves could make leaflet modification necessary in ~30% of TAVR cases, to ensure safety, reduce complications and improve patient outcomes.

The NTAP program is intended to facilitate Medicare beneficiary access to new technologies that offer substantial clinical improvement over existing technologies. It provides hospitals with supplemental payments to help offset adoption costs while enabling CMS to collect cost data that will inform future inpatient payment rates.

About Pi-Cardia

Pi-Cardia is a global leader in the development of a unique portfolio of non-implant, catheter-based, leaflet modification solutions for treating heart valves. The ShortCut™ device is a safe, simple and effective way to split valve leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction and is designed to preserve coronary access; ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. The Leaflex™ device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex™ is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The ShortCut™ Mitral and Leaflex™ are investigational devices, limited by United States law for investigational use.

For more information, please visit: www.pi-cardia.net

For further information, contact:

Pi-Cardia

reimbursement@pi-cardia.net

SOURCE: Pi-Cardia Inc.

References

1. O'Riordan, Michael. TCTMD, June 2024