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Avvio Medical
Med device · Clinical-stage, investigational device

A clinical-stage device company breaking kidney stones with sound and microbubbles instead of a scope and a laser.

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What they do

The Avvio Microbubble SonoLithotripsy system uses low-intensity ultrasound to actuate patented microbubbles that accumulate near the stone. Activated, the microbubbles cavitate and break the stone into particles small enough to pass naturally. This is an investigational device, not yet FDA-cleared.

Source: avviomedical.com

Key facts

•Regulatory status: investigational device, not FDA-cleared.
•FDA Breakthrough Device Designation, October 2025.
•AMA published a new CPT code for the procedure, July 2025.

What makes them different

Avvio is not a better version of ureteroscopy. It is a different setting: an outpatient procedure with no routine stent and no general anesthesia, which the company says can compress stone care from weeks to days.

Why KMAK invested

Two things convinced us. First, a CPT code existed before the device was cleared, which means the reimbursement path was being built in parallel with the technology rather than after it. Breakthrough Device Designation points the same direction. Second, urinary stone disease is high-volume, recurrent, and expensive to treat, and the current pathway frustrates patients and urologists alike. A therapy that moves a case out of the OR and into the clinic doesn’t need to be marginally better to win. It changes where the procedure happens, and that is where the value is.