First-in-Human Study

Study Design and Methodology 

The ELS I study was a first-in-human, multicenter clinical trial conducted in Australia to evaluate the safety and efficacy of Avvio Medical’s Enhanced Lithotripsy System (ELS).

Subjects

33

patients enrolled under the pivotal protocol, 
plus additional feasibility subjects.

Stone Characteristics

Mean stone size:
~6.3 mm (range 5–10 mm)

Stone location
~41% proximal stones
~59% distal stones

Imaging Modalities

  • 28 subjects were evaluated via CT imaging at 30 days.
  • Additional feasibility subjects were evaluated via KUB only imaging. 

Technology & Procedure Settings

  • Peak negative pressure of ~1.4 MPa.
  • 80 insonation cycles delivered per treatment.
  • Most performed under general anesthesia.

Study Efficacy Outcome

With up to 78% stone-free rates (SFR) and low adverse event rates, Avvio is positioned to transform kidney stone treatment with a safer, simpler, and more scalable alternative.
Stone-Free Rate (CT)72%Stone-Free Rate in patients evaluated 
by CT imaging at 30 days (n=25). Stone-Free Rate (CT/KUB)78%Stone-Free Rate when including additional feasibility subjects evaluated by KUB imaging. : Absence of stones or residual fragments ≤3 mm. Stone-Free DefinitionSubject Accountability33Patient enrolled5excluded 
no imaging28Patients imaged25 CT onlyStone-free72% 18Pass7Fail28 CT + KUBStone-free78% 21Pass6Fail1Inconclusive** n= 1 additional subject was moved from “Fail” to “Inconclusive” as the subject had a fragment on CT at day 14, but a subsequent Day 30 KUB was stone free (stone in bladder)Stone-Free Rate (CT)72%Stone-Free Rate in patients evaluated 
by CT imaging at 30 days (n=25). Stone-Free Rate (CT/KUB)78%Stone-Free Rate when including additional feasibility subjects evaluated by KUB imaging. : Absence of stones or residual fragments ≤3 mm. Stone-Free DefinitionSubject Accountability33Patient enrolled5excluded 
no imaging28Patients imaged25 CT onlyStone-free72% 18Pass7Fail28 CT + KUBStone-free78% 21Pass6Fail1Inconclusive** n= 1 additional subject was moved from “Fail” to “Inconclusive” as the subject had a fragment on CT at day 14, but a subsequent Day 30 KUB was stone free (stone in bladder)Stone-Free Rate (CT)72%Stone-Free Rate in patients evaluated 
by CT imaging at 30 days (n=25). Stone-Free Rate (CT/KUB)78%Stone-Free Rate when including additional feasibility subjects evaluated by KUB imaging. : Absence of stones or residual fragments ≤3 mm. Stone-Free DefinitionSubject Accountability33Patient enrolled5excluded 
no imaging28Patients imaged25 CT onlyStone-free72% 18Pass7Fail28 CT + KUBStone-free78% 21Pass6Fail1Inconclusive** n= 1 additional subject was moved from “Fail” to “Inconclusive” as the subject had a fragment on CT at day 14, but a subsequent Day 30 KUB was stone free (stone in bladder)

Adverse Event Significantly Lower than Cysto/Stent (15%)

Cystoscopy with stent placement is associated with ~15% AE rates, while URS-LL 
and SWL have reported AE rates up to 38%. In contrast, the ELS trial reported 0% device-related AEs, supporting its potential to reduce risk in ureteral stone care. 
Early data suggests that the ELS system may offer a safer, less invasive alternative to conventional treatments.

21 Patients Successfully Treated

In the Australia FIH study, 21 patients were successfully treated with the ELS system, demonstrating strong early efficacy and reliable stone clearance. These results support the system’s potential to offer a simpler, less invasive alternative to traditional ureteral stone treatments.

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. Avvio Medical, Inc. does not currently offer medical devices for sale or distribution and the company’s technology has not received market clearance status by the U.S. FDA or any other country’s regulatory authority.
MKT-006 Rev P July 2025.