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Meet Artero

TM

: Advanced IVL for

Peripheral Artery Disease

Artero™ streamlines the IVL experience with an intuitive, one-click design that delivers durable, consistent therapy at twice the speed of today’s technology.

Seamless Usability

Advanced Crossing Capabilities

Efficient and Predictable Therapy

Menu

Meet Artero

TM

: Advanced IVL for

Peripheral Artery Disease

Artero™ streamlines the IVL experience with an intuitive, one-click design that delivers durable, consistent therapy at twice the speed of today’s technology.

Seamless Usability

Advanced Crossing Capabilities

Efficient and Predictable Therapy

Meet Artero

:

TM

Advanced IVL for

Peripheral Artery Disease

Artero™ streamlines the IVL experience with an intuitive, one-click design that delivers durable, consistent therapy at twice the speed of today’s technology.

Seamless Usability

Advanced Crossing Capabilities

Efficient and Predictable Therapy

Seamless Usability

One-click activation. Real-time feedback. Hands-free operation. No connector cables. Artero™ is peripheral IVL streamlined — so interventionalists can focus on patients, not clunky cables.

Advanced Crossing Capabilities

Artero™ is designed to navigate challenging anatomy with a reduced crossing profile and optimized shaft for superior pushability. Our rupture-resistant balloon delivers consistent results, even in complex vessels.

Efficient and Predictable Therapy

The novel emitter design of Artero™ delivers sonic pressure at 4 Hz — twice as fast as current IVL technologies. With more pulses per catheter, experience predictable outcomes with consistent longitudinal and circumferential energy.

Peripheral First-in-Human (FIH) Results

Peripheral First-in-Human (FIH) Results

Peripheral First-in-Human (FIH) Results

9

successfully treated limbs

16

target femoral-popliteal lesions

99%

moderate to severe calcification

100%

lesions crossed, including 3 CTOs

5.9%

mean residual diameter stenosis

0%

major adverse events with no balloon ruptures

Selected FIH Case Studies

Before
After

Subject 01

68-year-old male, BMI of 30.3, and RCC 6

Lesion Locations: Fem-Pop

Target Lesions: 3

IVL Pulses Delivered: 300

Total Lesion Length: 60mm

Results: <10% RDS

Before
After

Subject 04

84-year-old female, BMI of 28.6, and RCC 4

Lesion Locations: Popliteal

Target Lesions: 1

IVL Pulses Delivered: 120

Total Lesion Length: 40mm

Results: 0% RDS

Before
After

Subject 05

89-year-old male, BMI of 22.2, and RCC 4

Lesion Locations: Femoral

Target Lesions: 2

IVL Pulses Delivered: 90

Total Lesion Length: 160mm

Results: <10% RDS

Before
After

Subject 08

71-year-old male, BMI of 27.4, and RCC 3

Lesion Locations: Fem-Pop

Target Lesions: 2

IVL Pulses Delivered: 300

Total Lesion Length: 40mm

Results: <10% RDS

Future Studies

Peripheral Pivotal IDE Trial

We anticipate IDE approval from FDA to begin our peripheral pivotal trial in the first half of 2025. This study will evaluate the safety and efficacy of our peripheral IVL system in treating patients with severely calcified peripheral arterial disease.

Invest in the Future of IVL

We oversubscribed our last round of financing in just a few weeks, so don’t miss out on the next opportunity to invest.

$40M+ raised from corporate venture, VC, and KOLs.

100% lesions crossed in successful first-in-human study.

Only market incumbent acquired in 2024 by J&J for $13B.

Invest in the Future of IVL

We oversubscribed our last round of financing in just a few weeks, so don’t miss out on the next opportunity to invest.

$40M+ raised from corporate venture, VC, and KOLs.

100% lesions crossed in successful first-in-human study.

Only market incumbent acquired in 2024 by J&J for $13B.

Invest in the Future of IVL

We oversubscribed our last round of financing in just a few weeks, so don’t miss out on the next opportunity to invest.

$40M+ raised from corporate venture, VC, and KOLs.

100% lesions crossed in successful first-in-human study.

Only market incumbent acquired in 2024 by J&J for $13B.

Follow FastWave's Journey

Next-level intravascular lithotripsy (IVL) devices for calcific artery disease.

© 2025 FastWave Medical Inc.

FastWave Medical is developing devices limited by Federal (or United States) law to investigational use. To see FastWave’s patents, click here.

Follow FastWave's Journey

Next-level intravascular lithotripsy (IVL) devices for calcific artery disease.

© 2025 FastWave Medical Inc.

FastWave Medical is developing devices limited by Federal (or United States) law to investigational use. To see FastWave’s patents, click here.

Follow FastWave's Journey

Next-level intravascular lithotripsy (IVL) devices for calcific artery disease.

© 2025 FastWave Medical Inc.

FastWave Medical is developing devices limited by Federal (or United States) law to investigational use. To see FastWave’s patents, click here.

Follow FastWave's Journey

Next-level intravascular lithotripsy (IVL) devices for calcific artery disease.

© 2025 FastWave Medical Inc.

FastWave Medical is developing devices limited by Federal (or United States) law to investigational use. To see FastWave’s patents, click here.