FastWave’s IVL Technology Delivers Promising Early Results

FastWave: The Next Generation of Intravascular Lithotripsy (IVL)

Our peripheral IVL platform achieved 100% procedural success with a 93% reduction in mean residual diameter stenosis, while our pre-clinical coronary IVL data demonstrates significant potential. Upcoming studies will further validate our differentiated calcium modification technologies.

Peripheral FIH

Coronary Pre-Clinical

Future Studies

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

Subject 01

68-year-old male, BMI of 30.3, RCC 6, and ABI of 0.70

Lesion Locations: Fem-Pop

Target Lesions: 3

IVL Pulses Delivered: 300

Total Lesion Length: 60mm

Results: <10% RDS

Subject 04

84-year-old female, BMI of 28.6, RCC 4, and ABI of 0.54

Lesion Locations: Popliteal

Target Lesions: 1

IVL Pulses Delivered: 120

Total Lesion Length: 40mm

Results: 0% RDS

Subject 05

89-year-old male, BMI of 22.2, RCC 4, and ABI of 1.96

Lesion Locations: Femoral

Target Lesions: 2

IVL Pulses Delivered: 90

Total Lesion Length: 160mm

Results: <10% RDS

Subject 08

71-year-old male, BMI of 27.4, RCC 3, and ABI of 0.6

Lesion Locations: Fem-Pop

Target Lesions: 2

IVL Pulses Delivered: 300

Total Lesion Length: 40mm

Results: <10% RDS

Coronary Pre-Clinical Evidence

Deep Calcium Fissures

Our novel coronary system has demonstrated impressive efficacy in cadaveric artery disease models, leading to compelling luminal gain through comprehensive calcium fracturing.

Omni-Directional Calcium Cracking

FastWave’s next-gen coronary platform delivers consistent and powerful 360-degree energy, resulting in multi-directional fractures for optimal vessel expansion.

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 ATK and BTK peripheral arterial disease.

Submit Your Site

Coronary IDE Trial

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

Submit Your Site

See How You Can Invest in FastWave

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

Learn More

IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.

Dr. Puneet Khanna

Interventional Cardiologist & Medtech Investor

See How You Can Invest in FastWave

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

Learn More

IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.

Dr. Puneet Khanna

Interventional Cardiologist & Medtech Investor

See How You Can Invest in FastWave

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

Learn More

IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.

Dr. Puneet Khanna

Interventional Cardiologist & Medtech Investor

Mailing Address:

FastWave Medical
400 S 4th St, Ste 410
PMB 21892
Minneapolis, MN 55415

Phone:

(833) 888-9283

Email:

team@fastwavemedical.com

Follow FastWave’s Journey

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

Mailing Address:

FastWave Medical
400 S 4th St, Ste 410
PMB 21892
Minneapolis, MN 55415

Phone:

(833) 888-9283

Email:

team@fastwavemedical.com

Follow FastWave’s Journey

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

Mailing Address:

FastWave Medical
400 S 4th St, Ste 410
PMB 21892
Minneapolis, MN 55415

Phone:

(833) 888-9283

Email:

team@fastwavemedical.com

Follow FastWave’s Journey

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

FastWave’s IVL Technology Delivers Promising Early Results

FastWave: The Next Generation of Intravascular Lithotripsy (IVL)

FastWave: The Next Generation of Intravascular Lithotripsy (IVL)

Peripheral First-in-Human (FIH) Results

Peripheral First-in-Human (FIH) Results

Peripheral First-in-Human (FIH) Results

9 successfully treated limbs.

9 successfully treated limbs.

16 target femoral-popliteallesions.

16 target femoral-popliteallesions.

99% moderate to severe calcification.

99% moderate to severe calcification.

100% lesions crossed, including 3 CTOs.

100% lesions crossed, including 3 CTOs.

5.9% mean residual diameter stenosis.

5.9% mean residual diameter stenosis.

0% major adverse events with no balloon ruptures.

0% major adverse events with no balloon ruptures.

Selected FIH Case Studies

Selected FIH Case Studies

Selected FIH Case Studies

Subject 01

Subject 01

Subject 01

Subject 04

Subject 04

Subject 04

Subject 05

Subject 05

Subject 05

Subject 08

Subject 08

Subject 08

Coronary Pre-Clinical Evidence

Coronary Pre-Clinical Evidence

Coronary Pre-Clinical Evidence

Deep Calcium Fissures

Deep Calcium Fissures

Deep Calcium Fissures

Omni-Directional Calcium Cracking

Omni-Directional Calcium Cracking

Omni-Directional Calcium Cracking

Future Studies

Future Studies

Future Studies

Peripheral Pivotal IDE Trial

Peripheral Pivotal IDE Trial

Coronary IDE Trial

Coronary IDE Trial

See How You Can Invest in FastWave

IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.

Dr. Puneet Khanna

Interventional Cardiologist & Medtech Investor

See How You Can Invest in FastWave

IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.

Dr. Puneet Khanna

Interventional Cardiologist & Medtech Investor

See How You Can Invest in FastWave

IVL is an impressive therapy with an attractive market and I’m very excited about FastWave’s prospects.

Dr. Puneet Khanna

Interventional Cardiologist & Medtech Investor

Mailing Address:

FastWave Medical400 S 4th St, Ste 410PMB 21892Minneapolis, MN 55415

Phone:

(833) 888-9283

Email:

team@fastwavemedical.com

Follow FastWave’s Journey

Mailing Address:

FastWave Medical400 S 4th St, Ste 410PMB 21892Minneapolis, MN 55415

Phone:

(833) 888-9283

Email:

team@fastwavemedical.com

Follow FastWave’s Journey

Mailing Address:

FastWave Medical400 S 4th St, Ste 410PMB 21892Minneapolis, MN 55415

Phone:

(833) 888-9283

Email:

9
successfully treated limbs.

9
successfully treated limbs.

16
target femoral-popliteal
lesions.

16
target femoral-popliteal
lesions.

99%
moderate to severe calcification.

99%
moderate to severe calcification.

100%
lesions crossed, including 3 CTOs.

100%
lesions crossed, including 3 CTOs.

5.9%
mean residual diameter stenosis.

5.9%
mean residual diameter stenosis.

0%
major adverse events with no balloon ruptures.

0%
major adverse events with no balloon ruptures.

FastWave Medical
400 S 4th St, Ste 410
PMB 21892
Minneapolis, MN 55415

FastWave Medical
400 S 4th St, Ste 410
PMB 21892
Minneapolis, MN 55415

FastWave Medical
400 S 4th St, Ste 410
PMB 21892
Minneapolis, MN 55415