Clamart, France – June 23, 2026 – MicroPort CardioFlow Medtech Corporation (02160.HK, “MicroPort CardioFlow”) today announced the enrollment of the first patients worldwide in the STARLIGHT clinical study (ClinicalTrials.gov Identifier: NCT07342608), a prospective, multicenter European investigation designed to evaluate the safety and performance of the LINEA^™ cardiac pacing lead, specifically designed for implantation in the interventricular septum for Left Bundle Branch Area Pacing (LBBAP) procedures.

The first patients were enrolled by Dr. Óscar Cano, Coordinating Investigator of the STARLIGHT study, at Hospital Universitari i Politècnic La Fe in Valencia, Spain. Dr. Cano and his team successfully completed the first three study procedures on the same day, demonstrating efficient implementation of the study protocol and the seamless use of the LINEA^™ lead in combination with MicroPort CardioFlow's dedicated LBBAP implantation systems.

LBBAP, which leverages the heart's natural conduction system, is increasingly recognized as a preferred approach to physiological pacing.^¹ The STARLIGHT study has been designed to generate robust clinical evidence supporting the use of LINEA^™, MicroPort CardioFlow's dedicated pacing lead for interventricular septal implantation. LINEA^™ is a 4.6F stylet-driven lead featuring a fixed-screw design engineered to support lead placement during LBBAP procedures. The study will evaluate the safety and performance of the LINEA^™ lead in patients indicated for cardiac pacing.

Dr. Óscar Cano, Coordinating Investigator of the STARLIGHT study at Hospital Universitari i Politècnic La Fe, Valencia, Spain added:

"LBBAP has emerged as an increasingly adopted pacing strategy that more closely reproduces the heart's natural electrical activation. The STARLIGHT study will provide important data on a dedicated lead developed specifically for interventricular septal implantation. We are pleased to have enrolled the first patients and look forward to evaluating the performance of the LINEA^™ lead in a broad European patient population."

Jason Zhang, Chief Executive Officer of MicroPort CardioFlow, commented:

"STARLIGHT represents an important milestone in our commitment to advancing physiological pacing through clinical evidence. We look forward to demonstrating the safety and performance of LINEA^™ through this study and, ultimately, bringing this dedicated LBBAP pacing lead to physicians worldwide. Together with the LBBAP-labeled ALIZEA^™ and ENO^™ pacemaker ranges and the FLEXIGO^™ 3D Delivery System, LINEA^™ will further strengthen our comprehensive LBBAP portfolio, support the adoption of conduction system pacing, and reinforce MicroPort CardioFlow's position in the global cardiac rhythm management market."

The launch of STARLIGHT follows the successful completion of patient enrollment in the POLARIS clinical study, which evaluated the FLEXIGO^™ 3D delivery system for lead implantation at the interventricular septum.

The POLARIS study completed enrollment, with the last patient enrolled on April 29, 2026. Conducted across 17 European centers and also coordinated by Dr. Cano, the study enrolled 216 patients to assess the safety and performance of the FLEXIGO^™ 3D delivery catheter in LBBAP procedures. The system was designed to facilitate precise navigation and targeted lead placement, enabling consistent access to the interventricular septum across a wide range of patient anatomies.

Building on the initial phase that supported CE marking, the expanded POLARIS study included additional centers, operators and a dedicated cardiac resynchronization therapy (CRT) patient population, further validating the clinical utility of the FLEXIGO^™ system.

Together, the STARLIGHT and POLARIS clinical studies underscore MicroPort CardioFlow's commitment to advancing a comprehensive portfolio of innovative solutions for conduction system pacing, supporting physicians with dedicated technologies for both lead delivery and lead implantation while advancing the adoption of physiological pacing worldwide.

About the STARLIGHT Study

STARLIGHT (LLAI01) is a prospective, multicenter European clinical study evaluating the safety and performance of the LINEA^™ cardiac pacing lead, developed by MicroPort CardioFlow and optimized for interventricular septal implantation during Left Bundle Branch Area Pacing (LBBAP) procedures. The study aims to enroll 450 patients across Spain, Italy, Portugal, France, Belgium, and Switzerland, assessing implantation success, pacing and sensing performance, lead-related complications, and long-term clinical outcomes.

ClinicalTrials.gov Identifier: NCT07342608.

About MicroPort CardioFlow:

MicroPort CardioFlow Medtech Corporation (02160.HK) develops innovative technologies for structural heart disease and cardiac rhythm management. With roots in the development of therapies for structural heart disease, the company holds a leading position in China's TAVI market and has built one of the broadest portfolios in the segment.

CardioFlow now combines its structural heart business with MicroPort CRM’s more than 60 years of rhythm management expertise, including 12 core development programs and a global portfolio of over 40 marketed products across pacemakers and implantable cardioverter defibrillators (ICDs). Together these form an integrated platform spanning structural heart intervention and cardiac rhythm management with a unique synergy to address heart failure.

By providing physicians and patients with innovative, full-cycle cardiac health management, the company is dedicated to building a leading enterprise of emerging technologies in cardiac diagnosis and therapy.

More information is available at: https://cf.microport.com/  

References:

1. Glikson M, Burri H, Abdin A, et al. ESC Clinical Consensus Statement on indications for conduction system pacing, with special contribution of the European Heart Rhythm Association of the ESC and endorsed by APHRS, CHRS, HRS, and LAHRS. EP Europace. 2025;27(4): euaf050

LINEA^™ pacing lead is currently under clinical investigation, CE mark pending