#South Korea #Seoul #DeepQure #HyperQure #HERO-HTN

DeepQure Unveils Exciting Results from the HERO-HTN Clinical Trial

On May 20, 2026, DeepQure, a pioneering clinical-stage medical device company, made headlines at EuroPCR 2026 by revealing robust three-month clinical data from its groundbreaking HERO-HTN-FIH study. This important clinical trial examines the efficacy and safety of the HyperQure™ extravascular renal denervation (RDN) system designed for patients suffering from uncontrolled hypertension.

Key Findings of HERO-HTN Study

The HERO-HTN-FIH study was carried out across multiple leading academic medical centers in Korea, and its preliminary results indicate that the HyperQure™ system is a highly effective and safe therapeutic solution. At the three-month mark, participants treated with the HyperQure™ witnessed an impressive median reduction in their 24-hour ambulatory systolic blood pressure (24-h ASBP) of 25.0 mmHg, alongside a median reduction of 39.5 mmHg in office systolic blood pressure (SBP). These results are statistically significant (p=0.008 and p=0.002 respectively). Notably, 70% of subjects reached their target blood pressure of less than 140 mmHg.

In addition to lowering blood pressure, the study has also shown a marked decrease in the burden of antihypertensive medications. The average number of medications each patient was on fell from six to 4.5 within three months, with about 40% of patients benefiting from a protocol-guided reduction in their medications due to the effectiveness of the HyperQure™ system.

Furthermore, throughout the study period, no major adverse events related to the device were reported, reinforcing the safety and tolerability of this innovative laparoscopic/robotic procedure.

Confidence in Future Studies

Chanho Park, Chairman of the Board at DeepQure, expressed optimism regarding the clinical outcomes, stating, "The highly encouraging clinical results from Korea have given us immense confidence in the results currently being generated in our ongoing U.S. study at prestigious institutions such as Stanford University and Mayo Clinic." To date, 15 successful procedures have been conducted, and the company is diligently preparing for the next pivotal milestone—the Global Pivotal Study. Active discussions with the FDA are also underway, aimed at bringing this transformative technology to market sooner.

DeepQure's progress is bolstered by a distinguished international advisory network, which includes renowned authorities such as Drs. David Kandzari, Herbert Aronow, and Raymond Townsend. This coalition ensures that the highest standards of clinical integrity are maintained as the company advances towards its global pivotal trials.

Understanding Uncontrolled Hypertension and RDN

Uncontrolled hypertension is a significant global health concern, impacting around 30% of individuals diagnosed with hypertension. This condition increases the risk of severe health events such as stroke and heart failure and is defined as having a systolic blood pressure exceeding 140mmHg despite medical treatment. Renal denervation (RDN) provides an interventional approach targeting the sympathetic nerves surrounding the renal arteries, aiming to reduce blood pressure effectively.

The Innovator: HyperQure™

DeepQure's leading innovation, the HyperQure™, is a next-generation RDN system crafted to deliver circumferential ablation of renal nerves from outside the vessel. The device has earned Breakthrough Device Designation from the Korean Ministry of Food and Drug Safety (MFDS) and maintains ISO 13485 certification, which underscores its commitment to quality and patient safety.

In summary, the recent findings from DeepQure's HERO-HTN study not only highlight the potential of the HyperQure™ device to manage hypertension but also emphasize its safety and applicability, potentially transforming the therapeutic landscape for millions around the world suffering from this condition.