SOFTWAVE TRT

We choose Softwave TRT as our first company to vet. Many of the original horror stories we heard from the shockwave community came directly from this company. And since they are probably the biggest company with the largest foot print, we thought it fair to give them their due respect!

Several weeks were spent compiling this information, hours of calls, state and federal record searches, court filings, fda records, ftc records, the works! Remember we pull no punches but we also will not overinflate or exaggerate claims either.

First, the history of Softwave TRT...

SoftWave Tissue Regeneration Technologies (SoftWave TRT) was founded in 2004 by John Warlick and Mark Gronowski, neither of whom hold formal medical degrees or clinical training. Their backgrounds are primarily in business, entrepreneurship, and previous ventures in medical sales, rather than in medicine, engineering, or biophysics.


From the outset, their only significant innovation appears to have been branding—creating the name “SoftWave TRT” and positioning themselves as thought leaders in shockwave therapy. The core technology they sell—the OrthoGold® shockwave device—was designed, developed, and manufactured entirely by MTS Medical in Germany. SoftWave TRT had no involvement in its invention, engineering, or manufacturing processes.


The company’s rise to prominence hinges on becoming the exclusive U.S. distributor for MTS Medical, rather than any technical or scientific contribution. They now sell and market a device they neither created nor fully understand. And then they received their 510K from the FDA based off of Storz, which is an electromagnetic unit, and softwave is electrohydraulic. Some would say there were some fishy things going on their when they filed that.


Further illustrating their lack of technical understanding, the company changed its public terminology from “focused shockwave” to “unfocused shockwave”—not to clarify or reflect a scientific distinction, but as a marketing strategy to make their device appear differentiated and innovative in a competitive market where focused shockwave devices are widely available. The underlying technology remains largely unchanged, nearly 40 years old, while the company leverages branding and marketing to maintain relevance.


In essence, SoftWave TRT and its leadership:

Did not invent or develop the technology they sell.

Have no direct medical or technical expertise in shockwave therapy.

Built their business primarily through exclusive distribution rights.

Rebranded technical terminology for marketing purposes rather than scientific accuracy.

The company’s success appears to be marketing-driven, rather than grounded in research, innovation, or mastery of the technology itself.

Here's a timeline:


SoftWave TRT: Visual Timeline of Overreach and Marketing Spin


2004 – Founding

Founded by John Warlick and Mark Gronowski.

Neither has medical or technical credentials.

Innovation: branding the company as SoftWave TRT.

2004–2006 – Early Operations

Focused on business setup and distribution.

Began positioning themselves in the U.S. market for shockwave therapy.

Technology they sold: fully developed by MTS Medical (Germany).


2008–2012 – Exclusive Distribution Secured


Became exclusive U.S. distributor for MTS Medical’s OrthoGold® devices.


Core business: marketing and selling a machine they did not invent that is over priced and uses an excessive amount of consumables.


2012–2019 – Marketing Spin & Terminology Change


Changed device description from “focused shockwave” to “unfocused shockwave”.

Goal: differentiate in a crowded market, not scientific clarity.

Technology largely unchanged for ~40 years. This change in terminology is a huge red flag and shows that the company leadership know they are quickly becoming obsolete and out paced by newer technologies. It had nothing to do with anything else.


2019–2025 – This company spends the majority of its time and money now trying to sling mud and poo poo their competition, still claiming they are the "only true shockwave device." Which is hilariously untrue...


CLAIMS MADE

They claim to be the only "true shockwave" device.

THIS CLAIM IS ABSOLUTELY FALSE.

After extremely thorough research and actually talking to physics professionals, engineers, and people who actually make their own machines (which softwave does not), we have been able to determine that the vast majority of the units available do indeed produce a true shockwave. Not all of them get below the less than 10 nanosecond rise time, but many of them do which means that this claim is 100% false. Yet they perpetuate it and keep telling this lie.

They claim to be great innovators in the shockwave field.

THIS CLAIM IS ABSOLUTELY FALSE.

Other than conducting research, which they do, they have no control over the engineering or manufacturing of their device. Rather they have "bought" their own legitimacy funding countless research studies, filing dozens of irrelevant patents, and going on an absolute marketing bonanza!

Let dive in further...

In order to file their first FDA registration, they filed the unit as an electric massager....

Then once they began to make money they upgraded their FDA registrations and applied for a Class II Medical Device under 510K using the preexisting Storz filings. This is weird because in order to get a 510K you need to be going off of a very similar device, which the Storz device is electromagnetic and the Softwave is electrohydraulic...

Sounds like there could be some misleading information turned in to the FDA... Also their FDA paperwork that reports the power output of their machine doesn't match what they tell providers.... hmmmmmmm, something fishy is definitely going on here. Also they have the most adverse incident reports of any other company on file with the FDA.

Later they then launched a marketing campaign claiming that all other shockwave companies were registered as electric massagers, claiming that was bad, somehow, yet they themselves were originally registered under that same classification. Those is glass houses....

LONG STORY SHORT

Softwave was founded by two door to door medical device salesmen who really did nothing other than come up with a brand and are selling someone else's technology. They purchase their units from MTS Medical in Germany for mid $20k and resell it for $80,000... All the while not caring that this technology is incredibly outdated and unchanged since the 1970's...

Incredibly over priced.

Outdated.

Has one of the highest consumables costs in the industry.

Frequently lie about their technology claiming to be the highlander of focused shockwave.

Demean and Slander competitors on the regular.

COMPLETELY OPEN SOURCE. FREE INFORMATION FOR ALL.