Kona Medical — Pioneering Non-Invasive Hypertension Treatment in LATAM
Kona Medical developed Surround Sound®, a non-invasive externally focused ultrasound system for renal denervation to treat resistant hypertension. bioaccess® managed their first clinical studies in Latin America.
Study facts
- Sponsor / company: Kona Medical
- Indication / area: Cardiovascular / Hypertension
- Country: Colombia
- Study type: Early Feasibility Study (EFS)
Key metrics
- Trial Type: EFS
- Approach: Non-invasive
- Indication: Hypertension
- Outcome: Feasibility validated
The challenge
Resistant hypertension affects 10–15% of hypertensive patients globally. Kona Medical's non-invasive approach could eliminate the need for catheter-based procedures, but the company needed early human feasibility data to differentiate from catheter-based competitors and validate their ultrasound-guided approach.
bioaccess® solution
bioaccess® coordinated early feasibility studies in Colombia with hypertension specialists, managing patient screening, treatment delivery, and ambulatory blood pressure monitoring follow-up to demonstrate the feasibility and safety of the non-invasive renal denervation approach.
Results
- Early feasibility study completed with promising blood pressure reductions
- Non-invasive approach validated as safe in human subjects
- Ambulatory blood pressure data collected per protocol
- Clinical evidence supported further development investment
- Differentiated Kona from catheter-based competitors with human data
Frequently asked
- What did bioaccess® do for Kona Medical?
- bioaccess® coordinated early feasibility studies in Colombia with hypertension specialists, managing patient screening, treatment delivery, and ambulatory blood pressure monitoring follow-up to demonstrate the feasibility and safety of the non-invasive renal denervation approach.
- Where was the Kona Medical Early Feasibility Study (EFS) study run?
- The Kona Medical Early Feasibility Study (EFS) study was executed in Colombia by bioaccess® in the cardiovascular / hypertension area.
- What was the outcome of the Kona Medical study?
- Reported outcomes for Kona Medical's device: Early feasibility study completed with promising blood pressure reductions; Non-invasive approach validated as safe in human subjects; Ambulatory blood pressure data collected per protocol.
Run a similar trial: Clinical trials in Colombia
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