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DeepQure's Novel Extravascular RDN Device Shows Promise in Global Hypertension Trials

• DeepQure's innovative HyperQure™ device demonstrates successful blood pressure reduction in initial trials across South Korea and the United States, with no reported complications.

• The company is expanding clinical trials to six leading U.S. universities, including Mayo Clinic and Stanford, aiming to enroll 15 patients in H1 2025 before initiating a pivotal study.

• DeepQure is broadening its technology application to treat atrial fibrillation, potentially offering an improved solution to reduce the 30-50% recurrence rates seen with current PVI treatments.

DeepQure Inc. has achieved significant milestones in its global clinical trials for HyperQure™, an innovative extravascular renal denervation (RDN) device designed to treat resistant hypertension through a laparoscopic approach. The technology represents a departure from traditional catheter-based RDN systems, offering more precise sympathetic nerve ablation.

Clinical Progress in South Korea and the United States

Seven patients in South Korea have undergone the HyperQure™ procedure, demonstrating meaningful blood pressure reductions without adverse events. The company expects to complete enrollment for its Korean trial by the end of Q1 2025.
In a significant development, DeepQure successfully conducted its first U.S. clinical case at the University of California, Irvine on January 17, 2025. Dr. Pengbo Jiang performed the procedure, which resulted in substantial blood pressure reductions after one month, with no complications reported. The next patient treatment is scheduled for March 2025.

Expanding Clinical Trial Network

The company has secured Institutional Review Board (IRB) approvals from several prestigious U.S. medical institutions, including Mayo Clinic and Stanford University. DeepQure's clinical trial network now encompasses six leading university hospitals across the United States. The company aims to enroll 15 patients during the first half of 2025, laying the groundwork for a pivotal study planned to commence by year-end.

Novel Application in Atrial Fibrillation Treatment

DeepQure is extending its RDN technology beyond hypertension to address atrial fibrillation (Afib), a common cardiac arrhythmia. The company has submitted an application to South Korea's Ministry of Food and Drug Safety (MFDS) to begin clinical trials for this indication.
Current Afib treatment primarily relies on Pulmonary Vein Isolation (PVI), which faces challenges with high recurrence rates of 30-50%. DeepQure's RDN technology could potentially enhance PVI effectiveness by reducing these recurrence rates, offering a promising alternative where traditional drug therapies have shown limited efficacy.

Market Impact and Future Outlook

The global RDN market is projected to expand from $1.3 billion in 2024 to $10.3 billion by 2031, with a compound annual growth rate of 34.4%. DeepQure's innovative approach positions the company to capitalize on this growth while potentially transforming the treatment landscape for both hypertension and cardiac arrhythmias.
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