Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., announced results from two clinical studies presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference: data from the Global Paradise System (GPS) Registry demonstrated a 19.6 mmHg reduction in office systolic blood pressure at six months with the Paradise™ Ultrasound Renal Denervation (uRDN) system; and the pooled analysis of data from the RADIANCE global clinical trial program showed a sustained reduction of 15.7 mmHg in office systolic blood pressure at 24 months. The Paradise uRDN system is a device-based adjunctive therapy for patients with uncontrolled and resistant hypertension whose blood pressure cannot be properly managed with lifestyle changes and medication.

The GPS Registry is a real world, all comers, prospective and retrospective registry being conducted in nine countries outside of the United States, designed to assess the long-term safety and effectiveness of the Paradise uRDN system when used according to its labelling. Presented by Dr. Karl Fengler, Heart Centre, Leipzig, the results included the first prospective analysis of data from 212 patients. Office systolic blood pressure at 6 months post-procedure was reduced by 19.6 mmHg and home systolic blood pressure was reduced by 14.4 mmHg compared to baseline (all p<0.0001). Procedure times, contrast volume, and fluoroscopy time were all reduced compared to the previous RADIANCE trials. This cohort of patients represents a higher risk profile and higher baseline blood pressures than previous RADIANCE studies. No safety concerns were observed.

The RADIANCE Pooled Analysis includes data collected through 24 months of follow-up from 243 patients randomised in the three studies from Recor's RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. Presented by Ajay J. Kirtane, MD, Professor of Medicine at Columbia University, Irving Medical Centre, data from a pooled cohort of patients from the RADIANCE trials showed a reduction of 15.7 mmHg in office systolic blood pressure at 24 months, demonstrating that the blood pressure reductions are sustained at the two-year follow-up. No safety concerns were observed.

"The growing body of real-world evidence continues to demonstrate the power of the Paradise uRDN system to meaningfully lower blood pressure in patients with uncontrolled and resistant hypertension," said Lara Barghout, President and CEO of Recor Medical. "These results further strengthen the case for the Paradise uRDN system as a safe, durable, and effective treatment option and underscore the important and real impact this therapy can have on patients' lives."