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SoftWave TRT Frequently Asked Questions

SoftWave Technology & Mechanism

What is Extracorporeal Shockwave Therapy (ESWT)?

Extracorporeal Shockwave Therapy is a non-invasive treatment that delivers shockwaves into soft tissue and bone. These waves stimulate biological responses such as angiogenesis, inflammation modulation, and activation of dormant cells, supporting natural healing and regeneration.

What is SoftWave TRT?

SoftWave® Therapy is a specialized form of Extracorporeal Shockwave Therapy (ESWT) that uses a uniquely engineered parabolic and ellipsoidal reflector to generate broad-focused shockwaves. Unlike other devices that concentrate energy in a single point, SoftWave distributes energy across both deep and superficial tissues, creating a therapeutic zone that can reach up to 12 cm deep without causing microtrauma.

This broad energy field triggers a process called mechanotransduction — where the physical force of shockwaves is converted into biochemical signals at the cellular level. These signals activate stem cells, promote new blood vessel formation, reduce inflammation, and stimulate the body’s natural healing response.

Because of this design and mechanism, SoftWave Therapy is both powerful and gentle: it can treat a wide area of tissue effectively, supporting recovery, pain relief, and tissue regeneration.

How does the parabolic reflector improve outcomes?

SoftWave’s parabolic reflector and ellipsoidal design spreads shockwaves into a broad-focused disbursement, rather than a single painful point. This allows energy to reach 7 cm wide and up to 12 cm deep and cover a wider area, stimulating both superficial and deep tissues at once. The patented distribution avoids microtrauma while effectively triggering mechanotransduction — the cellular process that reduces inflammation, grows new blood vessels, and activates stem cells for natural healing.

How is SoftWave different from other shockwave devices?

Not all technologies marketed as “shockwave” are the same:

  • Focused shockwaves concentrate energy into a very small point, treating only limited tissue.

  • Radial devices don’t produce true shockwaves — they generate pressure waves that disperse lower energy near the surface.

  • SoftWave® Therapy uniquely delivers broad-focused true shockwaves that reach both deep and wide tissue zones. This broader therapeutic field activates more biological responses, supports natural healing, and typically requires fewer retreatments.

Clinical Indications and Use Cases

What conditions is SoftWave cleared to treat?

SoftWave is FDA 510(k) cleared for:

  • Relief of minor muscle aches and pains
  • Temporary increase in local blood circulation
  • Activation of connective tissue
  • Treatment of chronic diabetic foot ulcers
  • Treatment of superficial partial-thickness second-degree burns

SoftWave also holds Health Canada licensure for:

  • Musculoskeletal conditions (tendinopathies, plantar fasciitis, stress fractures)
  • Acute and chronic wounds
  • Pathologic scarring
  • Urological and pelvic health indications

View the full FDA and Health Canada clearance details

What patient populations benefit most?

SoftWave is especially beneficial for patients with:

  • Musculoskeletal injuries
  • Sports-related injuries
  • Chronic wounds or ulcers
  • Early-stage degenerative conditions
  • Post-surgical stiffness or scar tissue
  • Men’s and women’s pelvic pain and conditions

Can SoftWave Therapy help athletes recover?

Yes. Providers frequently use SoftWave for tendon and ligament injuries, sprains, and overuse conditions. Athletes often experience faster recovery timelines and reduced recurrence rates.

Can SoftWave be used after surgery?

Yes. Providers often apply SoftWave to post-operative patients who have adhesions, stiffness, or scar tissue that has not responded to traditional rehabilitation.

Is shockwave therapy new?

Shockwave therapy originated in the 1950s for lithotripsy. In Europe, it has long been a standard option for musculoskeletal injuries. In the U.S., SoftWave has been in business since 2004.

Evidence, Outcomes, and Patient Experience

What clinical research supports SoftWave?

SoftWave is supported by peer-reviewed studies, real-world registries, and adoption at major U.S. medical centers such as Mayo Clinic, UCSF, Thomas Jefferson University, and more. Clinical evidence highlights its effects on angiogenesis, inflammation modulation, pain reduction, and wound healing.

Explore SoftWave Research

How soon do patients notice results?

Many patients report improvement after the first session. Standard protocols involve weekly treatments for 3–5 weeks, with progressive pain relief and improved function. Please note SoftWave is a true tissue regeneration technology, and there is a researched timeline for regeneration. For example, weeks 0-1 represent the priming phase, weeks 2-4 focus on molecular acceleration, weeks 5-8 involve neovascularization and early remodeling, and weeks 9-12 mark the stages of regeneration and continued remodeling.

How long do results last?

Many patients experience noticeable relief after just 1–3 sessions, and improvements often continue to build over several weeks as the body’s healing processes are activated. Because SoftWave® Therapy stimulates long-term biological changes like new blood vessel growth, stem cell activation, and reduced inflammation, results are designed to be lasting rather than temporary.

While the exact duration depends on the condition being treated, many providers report that patients maintain benefits for months to years — often with fewer retreatments compared to other therapies.

What side effects are associated with SoftWave?

SoftWave® Therapy is generally very well tolerated. Unlike other shockwave devices, it does not cause microtrauma to tissues. The most common side effects are mild and temporary, such as slight redness, swelling, or soreness in the treated area. These usually resolve within a few hours.

Because SoftWave stimulates the body’s natural healing processes without drugs, injections, or surgery, it avoids the risks associated with more invasive treatments.

Is SoftWave painful?

SoftWave® Therapy is generally well tolerated. Because the technology uses a broad-focused energy field instead of a pinpoint, it feels gentler than many other devices. Some patients may notice brief sensitivity in areas of injury or inflammation, but this does not cause tissue damage.

Importantly, treatments are interactive — patients give feedback during the session, and the provider can adjust the energy level, placement, and treatment area to match each patient’s tolerance. This ensures the therapy is both effective and comfortable. Sessions typically last only 5–10 minutes.

Implementation, Training, and Workflow

Who can perform SoftWave Therapy?

Licensed providers and trained staff can administer SoftWave Therapy after completing certification offered by SoftWave TRT.

How long does a SoftWave session take?

A typical SoftWave® Therapy session lasts only 5–10 minutes. The exact time depends on the condition being treated and the size of the treatment area. Because the therapy covers both deep and wide tissue zones in a single session, it is efficient while still producing powerful biological responses.

What training is required for providers?

SoftWave® Therapy is designed to be safe and easy to integrate into clinical practice. Providers receive comprehensive onboarding and clinical training that covers:

  • Device setup and operation
  • Patient positioning and comfort
  • Energy level selection and adjustment
  • Treatment protocols for different conditions
  • Safety guidelines and best practices

Training ensures providers can confidently tailor treatments to each patient’s needs.

How does SoftWave impact clinic workflow?

SoftWave® Therapy is designed to fit seamlessly into a busy clinic. Sessions take only 5–10 minutes, require no anesthesia or downtime, and can often be performed by trained staff under provider supervision.

Because treatments are quick, efficient, and well tolerated by patients, clinics can:

  • See more patients in less time
  • Reduce reliance on provider-only interventions
  • Generate new revenue streams without adding significant scheduling burden
  • Improve patient satisfaction with a therapy that doesn’t interrupt daily activities

This combination makes SoftWave easy to incorporate into existing workflows while expanding both treatment capabilities and practice growth.

What protocols exist for different conditions?

Condition-specific treatment protocols are available for musculoskeletal pain, wounds, burns, and sports injuries. These protocols standardize dosing parameters and improve outcomes.

Product and Brand-Specific Information

What does SoftWave TRT stand for?

SoftWave TRT is SoftWave Tissue Regeneration Technologies, the company that developed the patented broad-focused shockwave device.

What is the difference between SoftWave and Sofwave?

SoftWave is a medical therapy for pain relief, wounds, and tissue regeneration. Sofwave is a cosmetic device used for skin tightening and aesthetics. They are unrelated technologies. 

Read more: SoftWave vs Sofwave

Is SoftWave FDA approved?

SoftWave is FDA 510(k) cleared for specific indications, including diabetic foot ulcers, burns, connective tissue activation, temporary pain relief, and improved blood supply. “Cleared” means the device is authorized for these labeled uses. Providers may also use it in broader real-world clinical settings.

Explore use in podiatry, urology, pelvic health, orthopedics, sports medicine, physical therapy, and more.

How long has SoftWave been available?

SoftWave technology has been in use in the U.S. since 2004, with past models known as UroGold, OrthoGold, DermaGold, and VetGold, with the current Gold Li-Series representing its latest generation.

Cost, Coverage, and Device Evaluation

What does SoftWave cost?

The investment in SoftWave® Therapy goes beyond the purchase price — it’s about long-term value for both patients and the practice. Costs vary depending on the model and setup, but key factors include:

  • Device Investment – SoftWave is a Class II FDA-cleared medical device engineered in the U.S. with patented broad-focused technology. Pricing reflects its clinical validation, safety, and durability.
  • Low Consumables – Unlike many other systems, SoftWave requires minimal disposables. Its SmartTrode® electrodes are designed for longevity, reducing per-treatment costs.
  • Efficiency & ROI – Because fewer shocks and sessions are needed compared to narrow-focused or radial devices, SoftWave is one of the most cost-effective technologies available.
  • Support Included – Training, onboarding, clinical protocols, and marketing resources are built into the program, minimizing hidden costs

While exact pricing is discussed with a SoftWave representative, most clinics find that the device pays for itself quickly through new patient demand, efficient treatments, and sustainable revenue.

How much does a SoftWave session cost?

Most clinics charge between $150 and $250 per session, though costs vary depending on location and indication.

Is SoftWave covered by insurance?

At this time, SoftWave is generally a cash-pay procedure for musculoskeletal conditions. Providers are getting reimbursement for 0864T and 0512T.

What should providers look for when selecting a shockwave device?

Not all devices marketed as “shockwave” actually produce true shockwaves, and the differences directly affect outcomes, patient comfort, and return on investment. Before choosing a device, providers should evaluate:

  1. FDA Clearance – Is it truly FDA Class II cleared for medical indications, or only “registered” as a Class I therapeutic massager?

  2. True Shockwave vs. Pressure Wave – Does it generate real electrohydraulic, electromagnetic, or piezoelectric shockwaves — or just radial/acoustic pressure waves?

  3. Treatment Zone – How broad and deep is the energy field? A broad-focused zone activates more tissue per pulse, leading to faster, more comfortable outcomes.

  4. Clinical Evidence – Is there peer-reviewed research, registry data, or inclusion in global guidelines specific to that device?

  5. Cost of Care – Beyond the purchase price, what are the consumables, maintenance, and downtime costs per treatment?

  6. Training & Support – Does the company provide on-site onboarding and ongoing education, or minimal device-only training?

  7. Service & Maintenance – Is support U.S.-based, and does the device use safe, simple systems (closed-loop water, auto-degas, self-adjusting electrodes) to reduce downtime?

  8. Track Record & Innovation – How long has the company been in business, and does it have patents or proven innovation?

  9. Patient Experience – Is the treatment comfortable, well tolerated, and able to provide real-time diagnostic feedback?

  10. Trusted Adoption – Are respected institutions, clinics, or pro sports teams using it?

These questions help cut through marketing spin and ensure providers choose a proven, evidence-based shockwave technology that delivers safe, effective, and lasting outcomes

How does SoftWave support practice growth?

SoftWave® Therapy helps practices grow by combining clinical credibility with business efficiency:

  • Proven Outcomes – With FDA clearances, published research, and registry data, SoftWave builds patient trust and strengthens your reputation.

  • Broader Treatment Capabilities – A single device supports multiple specialties (orthopedics, sports medicine, podiatry, urology, wound care), reducing referrals and expanding services.

  • Efficiency & Delegation – Sessions take only 5–10 minutes and can be delegated to trained staff, freeing provider time while increasing patient throughput.

  • Patient Demand – Comfortable, non-invasive, drug-free treatments align with what today’s patients want — leading to stronger word-of-mouth referrals.

  • Marketing Support – SoftWave partners with clinics by providing marketing resources, outcomes data through DataBiologics, and patient education tools to help attract and retain patients.

  • Financial Return – With minimal consumables and fewer sessions needed, SoftWave delivers one of the highest ROIs in regenerative medicine, supporting both cash-pay and insurance-based model.

The result is a therapy that not only improves patient outcomes but also drives sustainable growth in revenue, reputation, and efficiency.

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