Announcement

Translumina Therapeutics Private Limited announced on 12 October 2026 that the SPARX Global Randomized Controlled Trial has been officially initiated. The trial is a multinational, randomized study comparing a drug‑coated balloon‑first strategy with contemporary drug‑eluting stents in patients with complex coronary artery disease.

Trial Design and Objectives

The study will enroll 1,380 patients across ten countries and will follow participants for two years. The primary efficacy endpoint is the one‑year Device‑Oriented Composite Endpoint (DOCE). Additional safety and long‑term outcome data will be collected through the two‑year follow‑up.

Investigators and Rationale

Prof. Adnan Kastrati, Study Chairperson at the German Heart Centre, emphasized that permanent metallic implants may cause late adverse events and that drug‑coated balloons offer a “leave nothing behind” alternative. Prof. Florim Cuculi, Global Lead Principal Investigator at Luzerner Kantonsspital, Switzerland, highlighted the trial’s aim to provide head‑to‑head comparative data between two established paclitaxel‑coated balloon technologies. Dr. Praveen Chandra, Global Co‑Principal Investigator at Medanta‑The Medicity, Gurgaon, India, noted that India’s high prevalence of diabetes and diffuse complex coronary disease makes the country a critical setting for evaluating the technology.

Sponsor and Device

The trial is sponsored by Translumina Therapeutics Private Limited, India, a material subsidiary of Integris Medtech Limited (formerly Integris Health Private Limited). The investigational device is the Protégé™ Paclitaxel‑Coated Balloon, which incorporates a distinctive drug‑application method intended to preserve drug integrity during delivery.

Company Background

Translumina Therapeutics Private Limited is a global cardiovascular medical‑technology company with a portfolio that includes drug‑eluting stents, drug‑coated balloons, and balloon catheters. The company operates manufacturing facilities in India, Germany and the Netherlands and complies with EU MDR CE, EU MDD CE and EN ISO 13485 quality standards. It supports physicians in more than 65 countries.

Capital Market Disclosure

Integris Medtech Limited, the parent of Translumina, has filed a draft red‑herring prospectus (DRHP) dated 9 October 2025 with the Securities and Exchange Board of India (SEBI) and the relevant stock exchanges, indicating an intention to make an initial public offer of its equity shares, subject to regulatory approvals and market conditions. The DRHP is available on the company’s investor website and on the SEBI portal. The prospectus contains standard risk‑factor disclosures and notes that the securities are not registered under the U.S. Securities Act and will not be offered in the United States.

Disclaimer

The press release includes a disclaimer that the information is provided by Translumina and its subsidiaries, and that the securities mentioned are not registered in the United States. It also states that the material is not for distribution in the United States.