FIRM WAVE®

Stronger Erections.
Real Confidence.
No Surgery Required.

The advanced, non-invasive medical service to treat Erectile Dysfunction and Peyronie's Disease — built on proprietary Focused Acoustic Pulse™ (FAP™) technology.

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Understanding Focused Acoustic Pulse Therapy

What Is Firm Wave®?

Firm Wave is a series of non-surgical treatments powered by Focused Acoustic Pulse™ (FAP™) therapy. It works at the tissue level — improving penile blood flow in men with vasculogenic erectile dysfunction and remodeling the fibrous plaque that drives the curvature, shortening, and pain of Peyronie's Disease. No anesthesia. No incisions. No downtime.

What Firm Wave® Treats

Erectile Dysfunction (ED)
Difficulty achieving or maintaining erections firm enough for satisfying sexual activity — including cases where oral medications have stopped working or produce unwanted side effects.
Peyronie's Disease
Curved, shortened, and painful erections caused by the buildup of fibrous scar tissue that is often palpable within the penile shaft.

Firm Wave® by the Numbers

6 / 12 / 18

PERSONALIZED SESSIONS

15-20

MINUTES PER SESSION

1-2

WEEKS BETWEEN SESSIONS

ZERO

DOWNTIME REQUIRED

The Firm Wave® Candidate

✓
Men 18+ years old
✓
Men experiencing mild, moderate, or severe ED
✓
Men diagnosed with or showing symptoms of Peyronie's Disease — curvature, pain, palpable plaque
✓
Men confirmed via testing to have healthy testosterone levels — naturally or achieved with testosterone replacement therapy
✓
Men whose response to oral ED medications (e.g. Viagra, Cialis) has diminished or who experience side effects
✓
Men seeking a surgery-free option that is intended to treat the root vascular cause of ED
✓
Men who want to proactively optimize erectile performance and maintain sexual health as they age
✓
Men who do NOT have any type of surgically placed penile implant / prosthesis or any other Firm Wave® absolute contraindications.
The Premise
Firm Wave® is a promising, science-backed treatment designed to address the underlying vascular causes of erectile dysfunction — not merely override them temporarily the way pills do. By stimulating your body's own regenerative processes, Firm Wave® has the potential to restore erectile function to a more youthful, responsive, and reliable state. Results vary by individual, and while the clinical evidence for wave-based therapy in ED is still being established, a growing number of men report meaningful improvements following treatment.

Ready to find out if Firm Wave® is right for you?
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The Science

How Firm Wave® Works

The mechanism behind Focused Acoustic Pulse™ technology — explained in clear, straightforward terms.
1

Concentrated Energy Delivery

The Firm Wave® device delivers Focused Acoustic Pulses (FAPs) deep into the penile tissue — reaching the corpus cavernosum, the erectile chambers responsible for rigidity during an erection. Unlike radial devices that dissipate energy across the skin's surface, Focused Acoustic Pulse technology concentrates its energy at depth, where the tissue that drives erections actually lives.
2

New Blood Vessel Growth (Neovascularization)

These FAPs trigger the body's natural healing cascade, stimulating the formation of new microblood vessels in the treatment area. More blood vessels means increased blood flow capacity — the essential foundation of stronger, more reliable erections.
3

Improved Blood Flow

Erections are fundamentally a blood-flow event. By rebuilding and expanding the vascular network within the erectile tissue, Firm Wave addresses the number-one physical cause of ED at its source — not with a temporary chemical workaround, but with actual structural improvement.
4

Cellular Repair & Tissue Remodeling

Focused Acoustic Pulse energy activates dormant stem cells and growth factors, promoting cellular regeneration and repair of damaged or aged erectile tissue. During and after a series of Firm Wave therapy sessions, the erectile chambers begin to restore themselves from within.
5

Longer-Lasting Results

Unlike oral medications that provide a temporary chemical override and wear off in hours, Firm Wave creates structural, biological improvements that build with each session. In published studies, these improvements have been shown to persist for 12 months or longer after a completed treatment course. Long-term durability varies from patient to patient and is influenced by overall vascular health.

Think of it this way

ED pills temporarily force open old, narrowing pipes. Firm Wave® builds entirely new pipes and revitalizes existing ones — restoring the vascular infrastructure your body needs to perform on its own. With or without pills, the foundation is stronger.

Peyronie's Disease

How Firm Wave® Treats Peyronie's Disease

Plaque Breakdown

Focused Acoustic Pulse technology delivers concentrated energy directly into fibrous scar tissue deposits along the tunica albuginea, initiating a biological process that gradually breaks down and remodels the plaque.

Curvature Reduction

As plaque softens, remodels, and is gradually reabsorbed, penile curvature may progressively decrease during and after a series of 6 to 12 treatments.

Pain Resolution

Many Peyronie's patients report significant reduction or complete resolution of erection-related pain, often within the first six treatment sessions.

Why Firm Wave® Can Reach What Radial Devices Can't

Focused Acoustic Pulse technology delivers concentrated therapeutic energy at depth — reaching the fibrous plaque deposits where Peyronie's Disease originates. Radial, surface-dispersed devices dissipate their energy before it ever gets there.
Have questions about the science? Your local Firm Wave® providers are happy to answer them.


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The Comparison

Firm Wave® vs. Radial Shockwave Therapy

Not all wave-based therapies are created equal. See how Focused Acoustic Pulse technology compares to the older, legacy approach.
Factor
FIRM WAVE®  
SHOCKWAVE
TECHNOLOGY TYPE
✓ Focused Acoustic Pulse™ — latest generation
✗ Radial pulse — older, legacy technology
ENERGY DELIVERY
✓ Concentrates at depth within the treatment area
✗ Disperses from the skin's surface; energy scatters
DEPTH OF PENETRATION
✓ Deep — reaches the corpus cavernosum directly
✗ Shallow — energy dissipates before reaching deep structures
EFFECTIVENESS FOR ED
✓ Stimulates new blood vessel growth in the erectile chambers
✗ Limited penetration may reduce vascular response
PEYRONIE'S DISEASE
✓ Delivers concentrated energy at depth, where the fibrous plaque forms
✗ Surface dispersion limits the ability to reach deep plaque
NEW BLOOD VESSEL GROWTH
✓ Focused energy stimulates the angiogenic response
✗ Scattered energy may produce a less robust response
TREATMENT COMFORT
✓ Well-tolerated; most patients report mild or no discomfort
✗ Can be uncomfortable; surface percussion may cause more pain
SESSION DURATION
✓ 15–20 minutes
15–30 minutes
TYPICAL COURSE
✓ 6, 12, or 18 sessions (evidence-based)
✗ Highly variable — often more sessions required
TECHNOLOGY GENERATION
✓ Newer / state-of-the-art
✗ Older / legacy
CLINICAL PRECISION
✓ Tailored to each patient by a trained provider
✗ Often one-size-fits-all settings
Based on Focused Acoustic Pulse™ technology, Firm Wave® represents a promising leap forward in regenerative treatment for ED and Peyronie's Disease. While radial shockwave therapy disperses energy across the surface, Firm Wave® concentrates it — delivering therapeutic energy to the tissues that create meaningful erections. The difference isn't cosmetic. It's a fundamentally different approach.

Patient Experiences

Real Men. Real Firm Wave® Stories.

Every man's experience with ED or Peyronie's Disease is personal — and so is his recovery. These are real patients sharing, in their own words, how treatment changed their confidence, their relationships, and their lives.
Patient stories can be encouraging, yet they are examples, not promises. The experiences and results shown or discussed may not occur for all patients. Simply put, individual results vary.
Incentivized Participant: One or more participants may have been compensated for taking the time to produce the content and share their experience. Any compensation provided was not contingent on expressing a positive or a particular viewpoint. All opinions expressed are their own, honest, and uninfluenced.
See what Firm Wave® can do for you.
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The Complete Protocol

Amplified Restoration: The Vigor Synergy Protocol

Multiple treatment modalities. Diverse therapeutic mechanisms. Related services that work together to restore sexual function and confidence.

Calibrated TRT®

Fortify Your Hormonal Foundation

Testosterone replacement therapy individually calibrated to your lab work, symptoms, and health profile. Testosterone is the hormonal fuel that drives libido, arousal, energy, and erectile signaling. Think of it as an essential ingredient that powers sexual activity.

Learn more about Calibrated TRT →

Vigor Shot™

Support Tissue Regeneration

A platelet-rich plasma (PRP) injection therapy that harnesses your body's own concentrated growth factors and delivers them into penile tissue. Vigor Shot is designed to support the regenerative process, restore tissue responsiveness, and enhance penile sensitivity. Think of it as supercharging the revitalizing potential within your own blood.

Firm Wave®

Fortify Your Hormonal Foundation

Designed to rebuild the blood vessel network and revitalize erectile tissue through Focused Acoustic Pulse™ therapy. Firm Wave addresses the vascular infrastructure that erections depend on — and acts on the fibrous plaque associated with Peyronie's Disease, supporting its gradual breakdown. Think of it as rebuilding the engine.

Synthesis. Each therapy addresses a different layer of the problem. Calibrated TRT strengthens the hormonal signals that drive desire and performance. Vigor Shot supports tissue regeneration. Firm Wave rebuilds the vascular foundation. Individually, each is powerful. Together, they form a comprehensive approach that addresses ED with multiple therapeutic mechanisms.
Ask About the Vigor Synergy Protocol
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Choose your Course

Your Treatment Course: 6, 12, or 18 Sessions

Firm Wave® treatment courses are offered in three evidence-based intensities: 6 sessions, 12 sessions, or 18 total sessions. Each course corresponds to a published clinical protocol, and the right course for you depends on the severity of your condition, your treatment goals, and your provider's clinical recommendation following your consultation.

The published clinical evidence shows a clear dose-response relationship. In a randomized clinical trial directly comparing these protocols, meaningful improvement in erectile function was achieved in approximately 62% of patients after 6 sessions, 74% after 12 sessions, and 83% after a total of 18 sessions. More sessions tend to produce greater improvement — but 6-session courses still produce meaningful results for many patients, particularly those with milder erectile dysfunction.

Each course is anchored to a specific patient profile in the published literature:

  • 6 sessions — typically appropriate for mild vasculogenic erectile dysfunction, often in combination with daily low-dose tadalafil. This is the foundational protocol used in the original landmark clinical trials.
  • 12 sessions — typically appropriate for moderate to severe vasculogenic erectile dysfunction. This is the most extensively studied protocol and is supported by multiple randomized controlled trials.
  • 18 total sessions — for patients seeking maximum benefit, including those with severe ED or partial responders to other therapies. Important: The 18-session course is structured as 12 initial sessions followed by 6 maintenance sessions delivered approximately 6 months later, not as 18 consecutive sessions. This staged structure matches the published clinical protocol that produced the highest response rates in the literature, and it gives the regenerative biology from your initial 12 sessions time to fully develop before the maintenance phase begins.

Many patients begin with a 6 or 12-session course and have the option to extend treatment with the maintenance phase if their provider recommends it after evaluating their initial response. Your provider will help you choose a course that balances clinical evidence, treatment goals, and practical considerations including cost.

‍

After Each Session

Aftercare

Firm Wave® is non-invasive and requires no downtime — but it's important to know what's normal, what isn't, and when to seek help.

Firm Wave® is non-invasive and requires no downtime. You can resume all of your normal daily activities — including work, exercise, and sexual activity — immediately after each session. Most patients experience no significant side effects. Some may notice mild, short-lived effects at the treatment area, such as slight bruising, mild soreness, or minor redness. These typically resolve on their own within a day or two.

In the rare event that you experience anything beyond mild, short-lived effects, the guidance below explains what to do.

Tier 1 — Normal post-treatment effects (manage at home)

Mild bruising, slight soreness or tenderness, or minor redness at the treatment area that resolves on its own within 1–2 days. These are normal and do not require any action.

Tier 2 — When to contact your Firm Wave® provider

Reach out to your provider if you experience any of the following:

  • Discomfort, soreness, or bruising that lasts longer than 2–3 days or is worsening rather than improving
  • Persistent or unusual swelling at or near the treatment area
  • Any change in the treatment area that concerns you
  • Any question about whether what you're experiencing is normal

When in doubt, reach out. Your Firm Wave® provider is your first point of contact for any post-treatment concerns that aren't an emergency.

When to seek emergency care (call 911 or go to the nearest emergency room)

Do not wait to call your Firm Wave® provider first. Go directly to emergency care if you experience any of the following:

  • Significant or uncontrolled bleeding from the treatment area
  • Signs of a serious infection — fever above 101°F (38.3°C), spreading redness, pus, or severe worsening pain
  • Signs of an allergic reaction — difficulty breathing, swelling of the face, lips, or tongue, or hives spreading across the body
  • Severe sudden pain that you cannot manage
  • Any symptom that feels like a medical emergency

Emergency care is for genuine emergencies. Most Firm Wave® patients will never need it — but if you do, do not delay.

The Science

Expected Results & Timeline: Erectile Dysfunction

Firm Wave® works through biological processes — angiogenesis, tissue regeneration, and vascular remodeling — that unfold gradually. Most patients don't see immediate dramatic changes after their first session. In fact, one of the most encouraging findings in the published research is that the most meaningful improvements often appear after the treatment course is complete, as the regenerative biology continues to develop in the weeks and months that follow.

During Your Treatment Course

In the early weeks of treatment, most patients don't notice meaningful changes in erectile function. Some report subtle improvements — better morning erections, increased spontaneous arousal, or improved sensation — but these early signs are inconsistent and not yet predictive of final results. As treatment progresses through the middle and later sessions, many patients begin to notice gradual improvements: better erection quality, increased spontaneity, and a return of confidence. The pattern is one of cumulative, gradual improvement that builds session by session rather than appearing as a sudden change.

1 to 3 Months After Your Final Session

This is often when patients start to notice the most meaningful changes. Published research consistently shows that improvements in erectile function continue to develop in the months following a completed treatment course. The biological processes set in motion during your sessions — new blood vessel formation, tissue repair, and improved vascular response — continue to mature and produce results long after your last appointment. For many patients, the difference between how they feel at the end of treatment and how they feel three months later is striking.

6 to 12 Months After Your Final Session: Peak Benefit

This is the phase that surprises many patients: improvements typically continue to build throughout the first year following treatment, with peak benefit generally occurring around 12 months after the completed course. In one published clinical study, the proportion of patients achieving meaningful improvement rose from approximately 57% at 1 month post-treatment, to 63% at 6 months, to 75% at 12 months. The treatment doesn't stop working when the sessions end — the regenerative biology it triggers continues to unfold over the year that follows. This is one of the most distinctive features of Firm Wave® compared to medication-based approaches: the results are not just maintained after treatment ends, they often grow.
Individual results vary, and not every patient responds in the same way or to the same degree. The clinical evidence base for wave-based therapy in erectile dysfunction is still being established, and Firm Wave® is not a guarantee of specific outcomes for any individual patient. Response is influenced by many factors, including the severity and duration of your ED, your overall vascular health, your testosterone levels, and any underlying conditions affecting blood flow.
The Science

Expected Results & Timeline: Peyronie's Disease

Treatment for Peyronie's Disease addresses three distinct aspects of the condition — pain, plaque, and curvature — each of which has its own timeline for improvement. Outcomes for Peyronie's are generally more variable than outcomes for ED in the published literature, and response depends significantly on the phase of your condition (acute or chronic), the size and location of your plaque, and how long you've had the condition.

Pain Reduction (often the first improvement)

Pain is the most consistently reported improvement in the published literature on wave-based therapy for Peyronie's Disease. Many patients report meaningful reduction or complete resolution of erection-related pain during the treatment course or in the weeks immediately following it. In one 10-year follow-up study of patients treated for acute-phase Peyronie's, mean pain scores dropped substantially at 3 months post-treatment and continued to improve through 12 months and beyond. Because pain is often the most immediately distressing symptom of Peyronie's, early pain relief can be meaningful even before structural changes appear.

Plaque Remodeling (gradual, throughout and after treatment)

The fibrous plaque that drives Peyronie's Disease is gradually softened and remodeled by the biological processes that Focused Acoustic Pulse™ therapy stimulates. Patients can't directly observe plaque remodeling, but you may notice over the course of treatment that palpable plaque deposits feel softer or smaller than they did at the start. Published research has shown measurable reductions in plaque size in some patient populations — though, as with curvature, results vary considerably. The remodeling process continues to unfold for weeks and months after the completed treatment course.

Curvature Reduction (variable, slower to develop)

Curvature reduction is the most variable Peyronie's outcome in the published literature. Some studies have reported meaningful curvature improvement in a substantial proportion of patients, while others have shown more modest results. When curvature reduction occurs, it typically develops slowly — often in the months following the completed treatment course rather than during it. Patients in the acute (inflammatory) phase of Peyronie's tend to respond more favorably than those in the chronic (stable) phase, and patients with smaller, non-calcified plaques and shorter disease duration generally have better outcomes than those with larger, calcified plaques or longer-standing disease. Patients who measure their progress in weeks may feel discouraged. Patients who think in terms of months are typically more satisfied with what they observe.
Peyronie's Disease is a complex, individualized condition, and outcomes from wave-based therapy are more variable than for erectile dysfunction in the published literature. While the evidence consistently supports pain reduction as a meaningful benefit, the evidence for curvature reduction is mixed and depends heavily on individual disease characteristics. Your provider will discuss realistic expectations based on your specific phase of disease, plaque characteristics, and overall clinical picture.
Long-Term Outlook

How Long Do Results Last?

Unlike oral ED medications that produce a temporary chemical effect lasting hours, Firm Wave® creates structural and biological changes — new blood vessels, regenerated tissue, remodeled plaque — that persist after the treatment course is complete.

Published research has shown that the benefits of wave-based therapy can persist for 12 months or longer following a completed treatment course. The most robust improvements typically appear and reach their peak in the months after treatment ends, generally within the first year. Long-term durability beyond 12 months is variable in the published literature — some studies have shown sustained improvement extending two years or more in certain patient populations, while others have shown more variable long-term outcomes. Individual durability varies considerably, and your provider cannot predict in advance how long your specific response will last.

It's important to understand that the underlying causes of erectile dysfunction — vascular disease, a

ging, diabetes, cardiovascular conditions — continue to progress over time. Firm Wave® can produce meaningful biological improvements, but it cannot halt the natural progression of these underlying conditions. The most durable results tend to be seen in patients who maintain good overall vascular health, address modifiable risk factors, and consider periodic maintenance sessions as part of their long-term plan.

Sustaining Your Results

Maintenance Sessions

Some patients choose to extend their benefits through periodic maintenance sessions. The published evidence on retreatment is encouraging: in one randomized study, repeating treatment after 6 months produced additional improvement in erectile function without side effects, with cumulative benefit continuing to build through a total of 18 sessions.

Maintenance schedules are individualized — your provider will recommend an approach based on how you responded to your initial treatment course, your current condition, and your goals. A typical maintenance approach might involve a small number of sessions (often 3–6) at intervals of 6 to 12 months. Some patients prefer more frequent maintenance, others less.

Maintenance is an option to discuss with your provider, not a hard requirement — many patients see lasting benefit from their initial treatment course alone.

Your Safety Comes First

Firm Wave® Is Not for Everyone

Firm Wave is a powerful treatment — and we take your safety seriously. Not every patient is an appropriate candidate, and that's exactly why every Firm Wave patient receives a thorough medical evaluation before treatment begins. The following conditions may affect your eligibility.

Absolute Contraindications

Firm Wave® cannot be administered if you have any of the following:
✗
Penile prosthesis or implant of any type, including inflatable penile implants, malleable or semi-rigid penile implants, or any surgically implanted device in the penis.
‍
Why this matters: Firm Wave® cannot be safely delivered to penile tissue containing an implant. The acoustic energy may damage the device, and the mechanical solution an implant provides has different treatment considerations than the vascular approach Firm Wave® uses.
✗
Active penile or urogenital infection, such as urinary tract infections, sexually transmitted infections (including active herpes outbreaks, chlamydia, or gonorrhea), prostatitis, or balanitis.
‍
Why this matters: Acoustic energy applied to infected tissue can spread the infection more deeply and interfere with the body's natural healing response. Treatment must wait until any active infection has fully resolved.
✗
Active or suspected penile or urogenital malignancy, such as penile cancer, prostate cancer, bladder cancer, testicular cancer, or any cancer currently being evaluated or treated in the pelvic region.
‍
Why this matters: Focused acoustic energy has not been studied in tissue affected by cancer, and its effects on malignant cells are unknown. Patients with active or suspected cancer should focus on oncology evaluation and treatment before considering elective procedures.
✗
Untreated or unstable coagulation or bleeding disorder, such as uncontrolled hemophilia, von Willebrand disease, severe thrombocytopenia, or any condition that significantly impairs blood clotting.
‍
Why this matters: Firm Wave® can cause minor bruising at the treatment site as a normal side effect. In patients with untreated or unstable bleeding disorders, this could become a serious bleeding event.
✗
Current anticoagulant therapy without physician clearance, ncluding warfarin (Coumadin), apixaban (Eliquis), rivaroxaban (Xarelto), dabigatran (Pradaxa), heparin, or other prescription blood thinners.
‍
Why this matters: Anticoagulant medications substantially reduce your blood's ability to stop bleeding. Without specific clearance from your prescribing physician, treatment cannot be safely delivered.
✗
Open wounds, lesions, or active skin conditions at or near the treatment area, such as cuts, abrasions, active dermatitis, psoriasis lesions, herpes outbreaks, or surgical incisions that haven't fully healed.
‍
Why this matters: Focused acoustic energy applied to disrupted or inflamed skin can worsen the condition and interfere with healing. The treatment area must be free of active wounds or skin conditions before treatment can proceed.

Relative Contraindications

The following conditions may affect your eligibility for Firm Wave® treatment and require careful evaluation by your physician.
⚠
Controlled or treated bleeding disorder, such as well-managed hemophilia under hematologist care, controlled von Willebrand disease, treated thrombocytopenia, or any bleeding disorder currently under medical management.
‍
Why this matters: Firm Wave® can cause minor bruising at the treatment site as a normal side effect. Patients with bleeding disorders may experience more pronounced bruising or slower resolution, so you should coordinate with your hematologist to confirm treatment is safe for you.
⚠
Use of antiplatelet medications, including daily aspirin (even low-dose 81mg "baby aspirin" for cardiovascular protection), clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), or dual antiplatelet therapy.
‍
Why this matters: Antiplatelet medications reduce your blood's ability to clot at the treatment site, which can lead to more visible bruising. Stopping these medications is often not safe, so you must consult with your prescribing physician (typically not your Firm Wave® provider) to decide whether treatment can proceed and whether any adjustments are needed.
⚠
Severe or uncontrolled cardiovascular disease, or a recent cardiac event within the past 6 months, such as heart attack, coronary stent placement or bypass surgery, uncontrolled hypertension, severe heart failure, unstable angina, or any active cardiac condition that limits your exercise tolerance.
‍
Why this matters: Sexual activity places real demands on the heart, and patients with severe or recent cardiac conditions need cardiology clearance before resuming it. Treatment that restores erectile function is only appropriate when your cardiologist believes your cardiovascular health can safely support sexual activity.
⚠
Penile anatomical variations not related to Peyronie's Disease, such as hypospadias, epispadias, severe curvature from causes other than Peyronie's, history of penile fracture, prior urethral surgery, or any congenital or acquired anatomical features your physician should know about before treatment.
‍
Why this matters: Firm Wave® is designed for standard penile anatomy. Congenital or acquired anatomical variations may affect how treatment is delivered and how your body responds, so your physician will evaluate whether Firm Wave® is appropriate for your specific situation.
⚠
Active use of nitrate medications for chest pain or heart conditions, such as nitroglycerin (in any form — sublingual tablets, sprays, patches, or ointments), isosorbide dinitrate (Isordil), or isosorbide mononitrate (Imdur).
‍
Why this matters: Nitrate medications usually indicate active cardiovascular disease that needs to be evaluated by a cardiologist before any ED treatment. Nitrates also cannot be safely combined with oral ED medications like Viagra or Cialis, which limits your post-treatment options — your cardiologist should discuss these considerations with you.
⚠
History of pelvic or penile surgery, such as prostatectomy, bladder surgery, hernia repair in the inguinal or pelvic region, pelvic radiation therapy, prior penile surgery, or any surgical procedure in the pelvic or genital region.
‍
Why this matters: Prior surgery in the pelvic or penile region can alter your anatomy and affect how Firm Wave® is delivered or how your body responds. The evaluation depends on the specific surgery you had, when it was performed, and your current condition.
Note: The examples above are illustrative, not comprehensive — other conditions may also apply.
If you're unsure whether you qualify, that's what your consultation is for. Our providers will review your complete health history and determine whether Firm Wave is the right — and safe — choice for you.
COMMON QUESTIONS

Frequently Asked Questions

What does a Firm Wave session feel like?
How soon will I see results?
How long do results last?
Is Firm Wave painful?
Is Firm Wave FDA-approved?
How is Firm Wave different from other "shockwave" treatments I've seen advertised?
Can I combine Firm Wave with oral ED medications?
What is Peyronie's Disease, and how do I know if I have it?
How much does Firm Wave cost? Is it covered by insurance?
Are the results permanent?
Who administers the treatment?
Is there any downtime after a session?
What if Firm Wave doesn't work for me?
Full Disclosure

Important Safety Information — Firm Wave®, Focused Acoustic Pulse™ ED Therapy, & Wave-based ED Therapy

Purpose & Potential Benefits

Firm Wave is a non-invasive, Focused Acoustic Pulse therapy designed to improve erectile function, enhance erection firmness and reliability, and reduce penile curvature and pain associated with Peyronie's Disease. Potential benefits include improved ability to achieve and maintain an erection, increased erectile rigidity, enhanced blood flow to penile tissue, reduction of Peyronie's-related plaque and curvature, decreased erection-related pain, and reduced dependence on oral ED medications. Individual results vary; benefits are not guaranteed for every patient.

Experimental / Regulatory Status

Firm Wave is classified as an experimental and investigational treatment for Erectile Dysfunction and Peyronie's Disease. The Firm Wave® device is FDA-cleared for general musculoskeletal applications; however, its use for the treatment of ED and Peyronie's Disease is considered off-label and has not received specific FDA clearance or approval for these indications. While a growing body of clinical research supports the use of Focused Acoustic Pulse technology for ED and Peyronie's Disease, it has not yet completed the FDA approval process for these specific applications. Patients should understand that they are receiving a treatment that, while supported by published clinical evidence and administered by trained providers, is not yet FDA-approved for this purpose.

Potential Side Effects

Common (mild; typically resolve within 24–48 hours):

  • Mild soreness or tenderness at the treatment site
  • Temporary redness of the skin in the treated area
  • Minor bruising or petechiae at the treatment site
  • Mild tingling or temporary numbness immediately following the session
  • Temporary increase in sensitivity

Rare or Very Rare:

  • Moderate bruising that takes several days to resolve
  • Temporary worsening of erectile symptoms (typically resolves within 1–2 weeks)
  • Temporary worsening of Peyronie's-related pain (typically resolves within days)
  • Skin irritation, swelling, or hematoma at the treatment site
  • Urinary discomfort following treatment (transient)

No serious or long-term adverse effects have been commonly reported in published clinical literature for focused low-intensity acoustic pulse therapy applied to penile tissue. However, as with any medical procedure, unanticipated side effects are possible. Report any unusual or persistent symptoms to your provider immediately.

Clinical Considerations

  • Results vary by individual and are influenced by condition severity, overall health, adherence to the full protocol, and concurrent treatments
  • Firm Wave should be administered only by a trained, qualified healthcare provider
  • Not a substitute for comprehensive evaluation and diagnosis of underlying ED causes
  • Patients with cardiovascular risk factors should receive appropriate cardiac screening prior to treatment
  • Firm Wave does not protect against sexually transmitted infections
  • Discuss all current medications, supplements, and health conditions with your provider prior to treatment
Take ACTION

Take the First Step Toward Stronger,
More Confident Performance

You've done the research. You understand the science. Now it's time to find out what Firm Wave can do for you. Schedule your confidential consultation today — no obligation, no pressure, just an honest conversation about your options with a provider who specializes in exactly this.
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Evidence-Based

The Research Behind Firm Wave™

Firm Wave is grounded in a growing body of clinical research. Understanding how that research applies to Firm Wave requires understanding three related terms and how they fit together.

Low-intensity extracorporeal shockwave therapy (LI-ESWT) is the scientific name for a category of non-invasive treatments that use energy waves to stimulate the body's natural regenerative response in vascular and connective tissues, including the erectile tissue of the penis. LI-ESWT — along with closely related terms such as "low-intensity shockwave therapy" and "low-intensity extracorporeal shock wave treatment" — is the terminology used throughout the medical literature cited herein. These terms refer to the broad treatment category, not any specific device, brand, or clinical protocol.

Focused Acoustic Pulse™ (FAP™) is a proprietary form of low-intensity extracorporeal shockwave therapy (LI-ESWT). It is the treatment modality that the Firm Wave® medical service and clinical protocol is built around. Not all LI-ESWT works the same way. Older devices deliver their energy radially, spreading it across the skin's surface, where much of it dissipates before reaching the tissue that matters. Focused devices deliver their energy at depth, concentrating it where the body's regenerative response is actually triggered: in the vascular and erectile tissue below the surface. As the name implies, Focused Acoustic Pulse delivers focused energy waves — and the medical literature supports focused delivery as a more effective method. The Focused Acoustic Pulse trademark was developed by Raihan Haque M.D. and is used under license by Firm Wave providers.

Firm Wave is the non-invasive medical service that delivers Focused Acoustic Pulse therapy to patients for the treatment of erectile dysfunction and Peyronie's Disease. The service is built around a proprietary clinical protocol developed by Raihan Haque M.D., with defined session structures, energy parameters, and clinical guidelines that serve as the reference framework for qualified Firm Wave providers administering treatment. Firm Wave is a registered trademark that refers specifically to this medical service and its underlying clinical protocol — not to the broader low-intensity extracorporeal shockwave therapy (LI-ESWT) treatment category.

Firm Wave provides Focused Acoustic Pulse therapy, the form of low-intensity extracorporeal shockwave therapy (LI-ESWT) that delivers concentrated energy at depth. The medical literature on LI-ESWT — and particularly on focused rather than radial approaches — therefore forms the evidence base supporting the mechanism, efficacy, and safety profile of Firm Wave. The studies cited below were published in leading urology and medical journals and are indexed by the U.S. National Institutes of Health. They do not study Firm Wave specifically. They study the treatment category that Firm Wave is built on.

Annotated Citations

1
Vardi Y, Appel B, Kilchevsky A, Gruenwald I. "Does Low Intensity Extracorporeal Shock Wave Therapy Have a Physiological Effect on Erectile Function? Short-Term Results of a Randomized, Double-Blind, Sham Controlled Study." The Journal of Urology. 2012;187(5):1769–1775. DOI: 10.1016/j.juro.2011.12.117.
This is the landmark randomized, double-blind, sham-controlled trial that established wave-based therapy as a legitimate physiological intervention for erectile function rather than an expectation-driven response. Patients receiving active treatment showed measurable improvements in both subjective erectile function scores and objective penile hemodynamic measurements (blood flow velocities on duplex ultrasound), while the sham group did not — a key methodological achievement because it separated the true treatment effect from patient expectation. The paper is frequently cited as the foundational proof-of-concept study for the entire technology class and set the stage for the expanded clinical research program that followed over the next decade.
2
Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. "Can Low-Intensity Extracorporeal Shockwave Therapy Improve Erectile Function? A 6-Month Follow-Up Pilot Study in Patients with Organic Erectile Dysfunction." European Urology. 2010;58(2):243–248. DOI: 10.1016/j.eururo.2010.04.004.
The earlier pilot study from the same research group, and the first published clinical trial to suggest that wave-based therapy could produce meaningful improvement in men with vasculogenic erectile dysfunction, with benefits sustained at six-month follow-up. The study was open-label and uncontrolled, which is why the 2012 sham-controlled trial anchors the evidence base instead.
3
Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee Y-C, Lue TF. "Low-Intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-Analysis." European Urology. 2017;71(2):223–233. DOI: 10.1016/j.eururo.2016.05.050.
A meta-analysis pooling data from multiple randomized controlled trials to produce an aggregate estimate of treatment effect across the published literature. The authors found that wave-based therapy produced statistically significant improvements in erectile function scores compared with control conditions, with the effect size clinically meaningful for the patient populations studied.
4
Sokolakis I, Hatzichristodoulou G. "Clinical Studies on Low Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Review and Meta-Analysis of Randomised Controlled Trials." International Journal of Impotence Research (Nature Publishing Group). 2019;31(3):177–194. DOI: 10.1038/s41443-019-0117-z.
A more rigorous follow-up to the Lu et al. meta-analysis that incorporated additional randomized controlled trials and applied stricter inclusion criteria. The authors confirmed the efficacy signal seen in earlier reviews while identifying the patient subgroups and treatment protocols most likely to produce benefit, and candidly acknowledged the heterogeneity of treatment protocols and the need for further standardization — an important counterweight to studies that overstate certainty.
5
Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. "Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment." The Journal of Sexual Medicine. 2018;15(3):334–345. DOI: 10.1016/j.jsxm.2018.01.003.
This is the single most important study for understanding the dose-response relationship in wave-based therapy and the published basis for the 6-, 12-, and 18-session Firm Wave® protocol framework. The authors directly compared a 6-session protocol against a 12-session protocol in a randomized head-to-head design, and then evaluated what happened when non-responders received a second round of treatment approximately six months later. The study found that 12 sessions produced meaningfully higher response rates than 6 sessions, and that repeating treatment after an interval produced additional gains without new safety concerns — the evidence basis for structuring the 18-session course as 12 initial sessions followed by 6 maintenance sessions rather than 18 consecutive sessions.
6
Fode M, Hatzichristodoulou G, Serefoglu EC, Verze P, Albersen M. "Low-Intensity Shockwave Therapy for Erectile Dysfunction: Is the Evidence Strong Enough?" Nature Reviews Urology. 2017;14(10):593–606. DOI: 10.1038/nrurol.2017.119.
A comprehensive expert review examining the scientific rationale, mechanisms of action including neovascularization and stem cell activation, and clinical evidence for Focused Acoustic Pulse technology in ED treatment.
7
Gruenwald I, Appel B, Vardi Y. "Low-Intensity Extracorporeal Shock Wave Therapy — A Novel Effective Treatment for Erectile Dysfunction in Severe ED Patients Who Respond Poorly to PDE5 Inhibitor Therapy." The Journal of Sexual Medicine. 2012;9(1):259–264. DOI: 10.1111/j.1743-6109.2011.02498.x.
This study addresses one of the most clinically important questions about wave-based therapy: can it help men who no longer respond adequately to oral PDE5 inhibitors like Viagra or Cialis? The authors treated a cohort of men with severe erectile dysfunction who had become non-responders to oral medications and found that a meaningful proportion experienced improvements significant enough to restore PDE5 responsiveness — that is, they could once again benefit from oral medications they had previously abandoned. For patients who have exhausted pharmacological options and are weighing the prospect of invasive procedures like penile implant surgery, this paper establishes the therapy's potential role as an intermediate option that may restore function without surgical intervention.
8
Palmieri A, Imbimbo C, Longo N, Fusco F, Verze P, Mangiapia F, Creta M, Mirone V. "A First Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Extracorporeal Shock Wave Therapy for the Treatment of Peyronie's Disease." European Urology. 2009;56(2):363–369. DOI: 10.1016/j.eururo.2009.05.012.
The first prospective, randomized, double-blind, placebo-controlled clinical trial of wave-based therapy for Peyronie's Disease. The study established a statistically significant reduction in penile pain compared with placebo — the most consistently replicated outcome across subsequent Peyronie's studies. Findings on curvature reduction and plaque size were more modest and variable, a pattern that has held across the broader Peyronie's literature: pain relief is the most reliable benefit, while structural improvements are meaningful but less consistent and depend heavily on disease phase and individual plaque characteristics.
9
Chung E, Wang J. "A State-of-Art Review of Low Intensity Extracorporeal Shock Wave Therapy and Lithotripter Machines for the Treatment of Erectile Dysfunction." Expert Review of Medical Devices. 2017;14(12):929–934. DOI: 10.1080/17434440.2017.1403897.
A device review comparing the different device types on the market — focused versus radial, piezoelectric versus electromagnetic versus electrohydraulic wave generation — and how these technological differences affect energy delivery, depth of tissue penetration, and clinical outcomes. The paper provides the published context for the comparison table on this page: the devices are not interchangeable, and the evidence base supporting focused delivery is distinct from the evidence base for radial devices.
10
Kitrey ND, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y, Gruenwald I. "Low Intensity Shock Wave Treatment for Erectile Dysfunction — How Long Does the Effect Last?" The Journal of Urology. 2018;200(1):167–170. DOI: 10.1016/j.juro.2018.02.070.
This paper directly asked the question that every patient considering the treatment wants answered: how long do the benefits last? The authors followed 156 patients who had initially responded to wave-based therapy and tracked their outcomes at 6, 12, 18, and 24 months post-treatment. The headline finding was sobering: approximately half of the initial responders still maintained their improvement at two years. However, the subgroup analysis revealed that patients who had started with milder erectile dysfunction were substantially more likely to maintain their response long-term — approximately three-quarters of the mild-ED subgroup remained improved at 24 months, compared with a much lower rate among those who had started with severe dysfunction. This paper is the empirical foundation for the page's honest framing that individual durability varies considerably and is influenced by baseline severity and overall vascular health.
11
Brunckhorst O, Wells L, Teeling F, Muir G, Muneer A, Ahmed K. "A Systematic Review of the Long-Term Efficacy of Low-Intensity Shockwave Therapy for Vasculogenic Erectile Dysfunction." International Urology and Nephrology. 2019;51(5):773–781. DOI: 10.1007/s11255-019-02127-z.
This systematic review specifically focused on long-term outcomes beyond the six-month follow-up window where most earlier trials had stopped reporting. The authors pooled data from eleven studies covering nearly 800 patients and found that the short-term benefit at six months was reasonably consistent across studies, but that the twelve-month picture was more complex: some studies showed plateau of benefit while others showed measurable deterioration between six and twelve months. Importantly, even the studies showing deterioration found that erectile function remained above baseline — meaning patients were still better off than before treatment. This nuanced finding is why the page states that long-term durability beyond twelve months is "variable in the published literature" rather than claiming uniform sustained benefit.
12
Chung E, Cartmill R. "Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study." Sexual Medicine. 2021;9(4):100384. DOI: 10.1016/j.esxm.2021.100384.
This is the longest prospective follow-up study published to date on wave-based therapy for erectile dysfunction, extending out to a minimum of five years post-treatment. The authors documented a pattern of gradual efficacy decline over time that eventually reached a plateau at approximately 40% clinical efficacy at 48–60 months — considerably lower than the peak response rates seen at 12 months, but still representing meaningful sustained benefit for a subset of patients years after their treatment course had ended. Equally important, the study reported no significant adverse events across the entire five-year follow-up period, which is one of the strongest pieces of long-term safety evidence available for the therapy. The authors explicitly cautioned that patients should be counseled about the expected decline rather than promised indefinite sustained improvement — a candid framing that this page's durability section echoes.
13
Lange M, Charles D, Kazeem A, Jones M, Sun F, Ghosal S, Krzastek S, Rapp D, Ortiz N, Smith R. "Is Low-Intensity Shockwave Therapy for Erectile Dysfunction a Durable Treatment Option? — Long-Term Outcomes of a Randomized Sham-Controlled Trial." Translational Andrology and Urology. 2024;13(10):2194–2200. DOI: 10.21037/tau-24-329.
The most recent peer-reviewed evidence on long-term durability, and one of the few prospective long-term follow-ups of patients originally enrolled in a randomized sham-controlled trial. The authors tracked outcomes at 12, 24, and 36 months post-treatment and found that improvement in erectile function reached its peak at the 12-month mark, was largely sustained at 24 months, and showed measurable decline by 36 months. The authors cautioned that the 24-month finding was based on a smaller cohort and should be interpreted with corresponding care.
These citations are provided for informational and educational purposes. The studies referenced above were conducted on low-intensity extracorporeal shockwave therapy (LI-ESWT) — the broader treatment category described above — using a range of devices, energy parameters, session protocols, and patient populations. Firm Wave® is the medical service that delivers Focused Acoustic Pulse™ therapy, a proprietary form of LI-ESWT, through a clinical protocol developed by Raihan Haque M.D. The Firm Wave trademark refers specifically to this service and its underlying protocol — not to the LI-ESWT treatment category as a whole.The terms "shockwave therapy" and "low-intensity" appear in the study titles because those are the terms the original researchers used to name the broader category. Their presence in these citations does not mean Firm Wave should be categorized or marketed as a shockwave product, and Firm Wave should not be referred to as "shockwave therapy" in any clinical, marketing, or patient communication context. The individual devices, protocols, and patient populations in the published literature may differ from those of Firm Wave, and these references do not constitute a claim that Firm Wave itself has been evaluated in the studies cited. Patients are encouraged to discuss the current state of the evidence — including its strengths, limitations, and unresolved questions — with their provider as part of making an informed treatment decision.
Firm Wave® and Focused Acoustic Pulse™ (FAP™) are proprietary trademarks of Raihan Haque M.D. and/or his organization(s). All rights reserved.

The content on this page is for informational purposes only and does not constitute medical advice. Consult with a qualified healthcare provider to determine if Firm Wave® is appropriate for you.