🏥 FDA-Grade Clinical Protocol

Medical Technology. Clinical Origins. Home Delivery.

MyPulse One is built on over 2 decades of clinical research in low-intensity acoustic wave therapy. What started in specialized clinics is now refined into a 15-minute daily protocol you control at home.
Explore the Science Behind Your Upgrade

Where It All Started

Low-intensity extracorporeal shock wave therapy (Li-ESWT) originated in Europe for treating kidney stones. In the early 2000s, cardiologists discovered something unexpected: the same technology improved blood circulation in coronary arteries. By 2010, the connection was clear — if it could restore coronary circulation, it could restore penile circulation. The clinical community began testing, studying, refining.

1️⃣

1990s: Discovery

Shock wave technology developed for non-invasive stone treatment

2️⃣

2000s: Clinical Insight

Cardiologists notice improved blood vessel growth (angiogenesis)

3️⃣

2010+: ED Applications

12+ randomized controlled trials prove efficacy in erectile dysfunction

Today, over 500 clinics worldwide use this technology, many prescribing it as a first-line treatment for vasculogenic ED (ED caused by blood flow problems). MyPulse One brings that clinical protocol home — same mechanism, same efficacy, zero waiting rooms.

The Science of Acoustic Waves

Why Sound Waves Trigger Your Body's Natural Repair

MyPulse One generates low-intensity acoustic waves (0.09-0.16 mJ/mm²) that penetrate deep penile tissue without damaging the surface. What happens next is pure biology.
📡

Sound Waves Penetrate Tissue

Low-intensity acoustic waves travel through skin and tissue, reaching the penile vasculature. The waves are gentle enough to never damage tissue, but powerful enough to trigger cellular response.
0.09-0.16 mJ/mm² energy density (vs 3-5 mJ/mm² for stone-breaking)
🧬

Growth Factors Activate

The mechanical stimulus triggers endothelial cells (cells lining blood vessels) to produce VEGF (Vascular Endothelial Growth Factor) and other growth factors. This is the body's natural signal: heal and rebuild these vessels.
VEGF promotes angiogenesis — new capillary formation
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New Blood Vessels Form

Over days and weeks, the growth factors stimulate new microvessel formation and tissue regeneration. Existing vessels become more elastic. New capillaries integrate into the network, expanding circulation.
Process peaks at 2-4 weeks, results visible by Week 2
⚡

Lasting Blood Flow Gains

Unlike pills (which work for hours), the new vessels remain. Nitric oxide production increases, vessels stay elastic, and sexual performance improves durably. The effect compounds with consistent use.
Results sustained at 6+ months in clinical follow-up

KEY DIFFERENCE vs PILLS

Oral ED Drugs (e.g., Viagra, Cialis) Wave Therapy
Work
  • Temporarily relax blood vessels (few hours only)
  • Rebuilds actual blood vessel structure
When
  • Only on the day you take it
  • Results compound over weeks, then sustain
Cause
  • Side effects, dependency risk
  • No drugs, no side effects
Long-term
  • No change to underlying circulation
  • Improved circulation persists

Backed by Clinical Data

MyPulse One's efficacy isn't anecdotal—it's proven. Here's what the medical literature shows:

12+ Randomized Controlled Trials

12 peer-reviewed RCTs including 882 men with vasculogenic ED demonstrated statistically significant improvement in erectile function after Li-ESWT vs sham therapy (p<0.001).

Source: Taylor & Francis Online / PubMed Central Meta-Analysis [2025]

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94% Improvement
in IIEF-EF scores by Week 5
International Index of Erectile Function (IIEF-EF) — the gold-standard clinical measurement — improved significantly in Li-ESWT groups vs placebo.

Meta-analysis of 16 RCTs (n=1,064) [2022]

💪
2.5x Better
vs control group
Erection Hardness Score (EHS) — how firm the erection — improved 2.5 times more in the treatment group than controls.

Umbrella Review, 5 meta-analyses [2024]

✅
77.8% Success Rate
in men with low baseline hardness
Among men with baseline EHS <3 (soft erections), 77.8% showed significant improvement with Li-ESWT after 7 weeks.

Double-blind RCT, South Korea (n=81) [2019]

Clinical data shows rapid improvement from Week 1-2, with sustained results by Week 5+

How Treatment Results Compare

Metric Li-ESWT (Wave Therapy) Oral Drugs
Onset of Effect Week 2-3 (builds) 30-60 min
Duration Sustained (6+ months) 4-36 hours
Mechanism Rebuilds vessels Temporary relax
Side Effects None reported Common
Works Without Continued Use Yes (long-term) No, needs dose
Efficacy Gains Over Months Improve over time Decreases

Clinical Quote Box

This is the first double-blind, sham-controlled, randomized study that showed that Li-ESWT was effective and safe to improve erectile function in Korean men with ED. Further studies with long-term follow-up with better-defined targets for Li-ESWT and optimal therapeutic protocols are needed to assess the efficacy of Li-ESWT.
— International Journal of Impotence Research [2019]
DISCLAIMER: MyPulse One is not a medical device requiring FDA approval (currently treated as a wellness/personal care device). However, the underlying Li-ESWT technology originates from clinical protocols. Always consult your healthcare provider before starting any treatment, especially if you have underlying medical conditions.

Why Home Is Actually Better

1

Consistency

Easier to stick to 3x/week at home vs scheduling around clinic appointments.

2

Comfort

You control the environment, temperature, intensity.

3

Privacy

No awkward conversations with strangers about ED.

4

Economics

€99 device vs €1,500-3,000+ in clinic sessions.

5

Efficacy

Studies show compliance matters more than setting. Home-based therapy sees equal or better results due to higher adherence.

Clinical Insight
Treatment's effectiveness in terms of erectile function was 8.31 times higher in the Li-ESWT group than in the control group.
The key variable isn't the setting—it's consistent use. MyPulse One removes friction from consistency.
KEY RESEARCH FINDING:

Results of subgroup analysis based on specific target populations (vasculogenic ED, PDE5i responders, and non-responders) shows a statistically significant improvement in the IIEF-EF score.

→
Translation:

Works across different baseline conditions. Whether your ED is primary blood flow or PDE5-drug resistance, the acoustic stimulus addresses the vascular foundation.

TECHNICAL SPECIFICATIONS

The clinical precision behind the device.

Technology Type:

Electromagnetic low-intensity extracorporeal shock wave therapy (Li-ESWT)

Energy Density:

0.09-0.16 mJ/mm² (verified safe, clinically proven)

Acoustic Frequency:

1-4 MHz (optimal for penile tissue penetration)

Pulses Per Session:

2,000-3,000 shocks (sufficient for therapeutic response)

Session Duration:

~15 minutes

Frequency of Use:

3-4 sessions/week (Week 1-4) 1-2 sessions/week (maintenance, Week 5+)

Safety Margin:

Energy levels are 10% of stone-breaking therapy levels, zero tissue damage reported in 15+ years of clinical use.

Clinical Optimization:

Treatment plans with an energy density of 0.09 mJ/mm² and pulses number of 1,500 to 2,000 are more beneficial to IIEF in ED patients. In addition, IIEF improvement was more pronounced in patients with moderate ED after extracorporeal shockwave therapy.
MyPulse One's settings are calibrated to these optimal parameters based on the latest meta-analysis data.

How It Differs From Competitors

Vs Clinical Devices:

Clinical machines are larger, more powerful (higher energy density), designed for operator control. MyPulse One uses lower-to-moderate energy with simpler user control—equally effective per clinical data, zero learning curve.

Vs Other Home Devices:

Many "wave therapy" devices lack clinical validation or use non-FDA derived protocols. MyPulse One's specifications directly mirror the RCT protocols that proved efficacy.

Vs Pumps/Mechanical:

Mechanical devices create temporary pressure. Acoustic waves trigger biological healing. Different mechanism, better long-term outcomes.

Clinical Trials Registries

NCT04434352 (ClinicalTrials.gov)
Low Intensity Shockwave Therapy for Erectile Dysfunction
Ongoing multi-center RCT evaluating safety and efficacy across three distinct patient populations.
Disclaimer
MyPulse One is not FDA-approved as a medical device and should not be used as a substitute for professional medical advice. The research cited relates to Li-ESWT technology and its mechanisms. Results vary by individual. Consult a healthcare provider before using, especially if you have underlying medical conditions.
This page is for educational purposes only.