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Peyronie's Disease

An estimated 20-30% of men (globally) will suffer from Peyronie’s disease within the next twenty years. One-third of those will be unable to perform without treatment.

Peyronie's Disease: A Growing Challenge

The number of men, from all walks of life, facing consequences from palpable and non-palpable penile fibrosis and Peyronie’s plaques has grown dramatically. However, many have been dealing with the condition for decades, unable to find a successful therapy.

Peyronie's Disease: U.S. Men Under Age 45

Whereas the historical percentage of younger men under the age of 45 years with palpable Peyronie’s fibrosis stayed relatively constant at around 3% for decades, that average has now jumped to 12% – a whopping 300% increase – among US men in that age group. For men under the age of twenty-five, prevalence increased an astounding 900% in the US. The long term trend line among the under-45 crowd is concerning: the incidence rate is increasing 20% every five years.

Peyronie's Disease: US Men Age 45 And Over

The historical percentage of men aged 45 years and over old with a Peyronie’s indication also climbed, from 9% to 13%, a 44% increase.

Our medical research will provide perspective on this phenomenon and how clinicians can better help these patients.

A Global Peyronie’s Challenge

Let’s do the math:

If the current increase in the number of Peyronie's indications among younger men just maintains its current level continues at its current rate (ignoring the fact it's been increasing at a rate of 20% per year over the last decade)
And we add the historical nominal average (3%) for new PD diagnosis triggered by accidents and acute penile injury during sex

The result indicates 20-30% of adult US males could be facing consequences of penile fibrosis and plaques within the next 20 years.

A 2011 population-based study published in Advanced Urology regarding Peyronie’s prevalence by Dibenedetti DB, Nguyen D, Zografos L, et al., indicated about one-third of cases will have a notable impact upon sexual function and a resulting significant impact on relationships, lifestyle, and self-image.

That tally means 9.1% of adult males, or 5.7 million US men will be needing effective treatment in the near future.

Peyronie's Prevalence: Studies Indicate its Prevalance is Much Higher than Estimated

We utilized evidence from the 2016 Perlacky, et al. study of 7,711 American men and the 2011 Di Benedetti, et al. study of 11,420 American respondents. Both were web based which removed the embarrassing element of testimony, both reached very similar conclusions regarding the prevalence of Peyronie's disease, and they both included demographic information that was not found in other studies.

Traditional prevalence estimates for Peyronie's disease have been all over the map, ranging from 0.39% to greater than 20%, with the majority estimating prevalence at approximately 3%.

There was always a "acknowledgement" in these studies that the actual incidence of this disease in the population may be higher due to patients' reluctance to seek treatment and diagnosis for this humiliating condition. The medical community's limited comprehension of PD may also contribute to underdiagnosis.

Because of the "Smith Study" in 1969, which was conducted before the sexual revolution (increased incidence of acute injury) and the advent of new health factors we discovered when unlocking Peyronie's epidemiology, all studies cite a prevalence of up to 20%. B.H. Smith was a US Navy captain working for the Armed Forces Institute of Pathology (AFIP) who had the brilliant notion to examine the prevalence of Peyronie's disease by performing 200 penile cadaver autopsies. He discovered penile fibrosis in nearly 21 percent of the deceased. A future study of European cadavers revealed comparable instances.

We believe that the fact that most urologists diagnose Peyronie's disease through physical examination as opposed to ultrasound imaging is a significant factor in why underreporting has remained so widespread. Inter fibrous plaques have never been effectively treated in urology. Therefore, if a patient reports moderate symptoms, the majority of urologists will ask, "How bothersome is the issue?"

Our investigation into the epidemiology of Peyronie's disease reveals that Peyronie's fibrosis is a progressive condition that never "heals itself." Rather, we encountered instances in which the patient became asymptomatic while the lesions persisted. In the future, when these patients encounter Peyronie's Accelerators, they will experience the symptoms of Peyronie's.

We anticipate that the curative nature of ExoSurge technology and its capacity to treat and heal asymptomatic early-stage cases of penile fibrosis will eventually reveal a prevalence as high as Smith's study (20%), or even higher given the changes in general health and sexual activity since 1969.

We expect the permanent removal
of the fibrosis and plaques
associated with a Peyronie's diagnosis
to become a global challenge
for the medical industry in the years ahead.

Over 10 million American men are presently indicated as having Peyronie’s fibrosis and plaques…and cases only get worse with time

Sadly, among the vast majority of patients with a Peyronie’s diagnosis, current methods for treatment are of little or no value. The gold standard of Peyronie’s care remains surgery but is only indicated for select cases and a 2012 10-year retrospective study shows Peyronie’s surgery results in high recurrence rate for erectile dysfunction, Peyronie’s fibrosis and erect curvature.

To date, therapies for treating Peyronie’s disease only vie to treat the various symptoms of the condition: erect curvature, lost length, disfigured shaping, etc. None address the challenge of actually healing the underlying basis for the disease. None are permanent. None effectively treat and heal all cases. Thus, at best, existing treatments offer some patients a temporary reprieve from some of the worst symptoms of Peyronie’s Disease.

ExoSurge® is the world’s first clinically-proven treatment to conservatively and permanently remove plaques and fibrosis associated with a Peyronie’s diagnosis.

ExoSurge®

Technology:

Refinements and Observations

Between the period of the invention of our first successful Peyronie's treatment technology that achieved measurable improvement with plaque reduction confirmed through our Proof of Study Observations in 2014 to the completion of our 2021 Retrospective Study, we treated hundreds of patients suffering from Peyronie's disease at our clinic in Atlanta with our evolving therapeutic and began to make important observations regarding what the underlying cause and epidemiology of Peyronie's Disease.

When this key pillar was finalized, we became focused upon refinement and improvement of our technology, including:

• Refining our "working-model-theory" regarding the underlying etiology of Peyronie's
• Further study in the nature of penile plaques and fibrosis within varied disease cases
• Patient health factors as a part of a Peyronie's case and diagnosis
• Variations in the most effective means to treat the wide variety of Peyronie's plaques
• Developing weighted scoring for patient's existing health dynamics and their impact on a Peyronie's diagnosis and permanent plaque removal

Continued refinements from case observations to each of these pillars resulted in continued improvement of treatment outcomes. We were late evolving to the use of baseline and followup Duplex Doppler ultrasonography as our measuring stick for patient improvement. We now embrace this "before and after" comparison as the gold standard for the evaluation of Peyronie's treatment

Following is a summation of our most important Breakthrough Observations with Peyronie's Disease made between 2014 and 2021.

The Peyronie's Disease Breakthrough

Peyronie's Disease

Peyronie's Prevalence: Studies Indicate its Prevalance is Much Higher than Estimated

ExoSurge®

Refinements and Observations