Our clinician partners and patients rely on us to stand by our technology, and undergo thorough testing to the highest standards. This is why we describe our protocols, use controls whenever possible, showcase our complete results, and explain who conducts our trial.  This is the standard we feel all science should be held to, and at Soliton, we lead by example.

Our journey searching for an effective conservative treatment for Peyronie's disease spanned over twenty years ago. We explored and tested over 50 different approaches to plaque removal in that span.

It was in 2014 that we administered our first successful Proof-of-Concept (POC) Trial involving a study of seven patients with moderate to severe Peyronie's, each treated with an earlier version of the ExoSurge® IPG device.

In a single 20-minute treatment, the (IPG) device was applied under the shaft skin and directly to the surface of the patients’ plaques and fibrosis, following an interlesional injection of 1 ML of verapamil. The treatments required no anesthesia, caused no bruising, incurred minimal swelling or bleeding, and were evaluated as relatively painless by the trial participants. We performed 15 more IPG treatments to the affected areas, once weekly.

Follow-up assessments were performed at 3 months.

At the end of the 12-week POC Trial, 67% of patients reported noticing a change in the amount of palpable plaque and 31% observed a change in erect curvature (when applicable).

This early study served as the basis for our initial patent applications for the technology.

Between 2014 and 2021, we treated hundreds of Peyronie's patients at our urology clinic in Atlanta, Georgia. We sought to improve and refine our approach to treating Peyronie's Disease. We also developed breakthrough observations and the development of new working theory for the evaluation of Peyronie's cases that helped speed progress.

We were late maintaining comparative baseline and follow up duplex Doppler ultrasonography of our patient's fibrous tissue plaques as the basis for evaluating success with permanent removal of Peyronie's plaques with our treatment technology. Even within our 2021 Peyronie's Retrospective Study, a large percentage of patients (40%) were only about "half done" with therapeutics when we closed the study on October 31, 2020. The closing date for the retrospective study was driven by needs from our corporate finance operations at that time.

We feel results shared in our 2021 retrospective study provided strong evidence for the administration of prospective clinical trials for ExoSurge®.

ExoSurge® Prospective Clinical Trials

Without a doubt, the most exciting study on our horizon will be our the prospective clinical trials for ExoSurge® technology. This is essential for our vision of gaining FDA approval for our technology which is essential to achieve insurance reimbursement where this breakthrough can be used to heal all men suffering from Peyronie's.

By early 2025, we plan to have recruited and selected our clinical trials director, finalized protocols and parameters for comparative management within our study with an independent review board and recruited our first study partner clinics around the USA. We are planning for our prospective trails to be administered in double blind placebo format

If you are a urologic clinician with potential interest with participating in our upcoming prospective clinical trials, please submit your contact information via the following form.

If you are a Peyronie's patient and would like to potentially participate in our upcoming prospective national clinical trials, please submit your contact information via the following form.