Our mission is to deliver a cure for patients living with Peyronie’s Disease.
What is ExoSurge® curative Peyronie's technology?
Peyronie’s is a wickedly challenging disease to completely resolve and requires a three pronged approach for success, including:
- ExoSurge is a curative therapeutic treatment that includes a novel drug delivery Medtech device and intralesional drugs
- ExoSurge is a detailed protocol customized based upon the wide variety of variations in patient disease factors and personal health dynamics
- ExoSurge requires patient management and patient responsibility managing discovered metrics we call “Peyronie’s Accelerators”
The ExoSurge® Breakthrough
To appreciate how and why ExoSurge succeeds it’s helpful to understand a bit of history regarding Peyronie’s disease, its wide variety of symptoms, and the methods used to treat it.
Other Peyronie's questions?
Peyronie's symptoms vs. Peyronie's Disease
The never ending source of patient confusion
A lot of patients (and even some doctors) confuse the difference between Peyronie’s Disease symptoms versus the underlying disease. To date, everything developed to treat Peyronie’s Disease (including surgery) only addresses its many symptoms, not resolving the underlying disease, resulting in less than ideal outcomes and the likelihood of symptoms returning later.
When a disease remains incurable for centuries, its symptoms become the definition of the disease. Similarly, the efficacy of the treatments employed to treat the disease is measured by how well they alleviate its symptoms.
This human phenomenon is exemplified by the common cold. Coughing, sneezing, and congestion some of the most common symptoms of a cold, and people frequently assume we have a cold if we display these symptoms. Nobody inquiries about the type of virus we are fighting, such as rhinovirus, coronavirus, adenovirus, or enterovirus.
Since Peyronie’s Disease has remained similarly incurable, it has likewise become only known for its symptoms, even among many physicians, with erect curvature being the most notable definition.
Most common Peyronie's symptoms
“Peyronie’s Disease” received its name in 1743 after King Louis XV’s personal physician, Francois Gigot de la Peyronie (the doctor himself; “Peyronie” had the disease) published a paper describing it. However, the condition is mentioned in medical journals from the middle ages where it was wrongly categorized as a form of venereal disease.
Francois Peyronie first described the condition as a disorder marked by induration of the corpora cavernosa of the penis, which urologists refer to today as penile curvature in the shaft in which scar tissue (or plaque) has formed. This focus on erect penile curvature from the onset has caused lots of confusion among both patients and doctors assuming Peyronie’s is defined by penile curvature.
Many people, including lots of doctors would answer this question by saying: “reduce erect penile curvature”. But Peyronie’s disease is not defined by a curve. In fact, over 30% of patients with a Peyronie’s diagnosis have little or no curvature, but they still suffer from the build-up of penile fibrosis and plaques in the soft tissue of the penis and the many negative side effects associated with that condition.
7 Common Signs or Symptoms
- Penile curvature
- Reduced penile length (shortening)
- Loss of penile width which can resemble an hourglass shape
- Presence of scar tissue or plaque
- Pain during erections or otherwise
- Difficulty maintaining erections
- Pain during intercourse
Why do Peyronie's symptoms occur?
Based upon our years of focused research, we’ve accurately redefined Peyronie’s Disease as the build up of fibrous plaques within the soft tissue of the penis and or a thickened (damaged) tunica.
The fibrous plaques most commonly accumulate along the tunic albuginea (the thick sheath separating inner portions of the erect organ tissues). Thus, if plaque accumulates most heavily along the left side of the tunica, the penis will curve to the left when packed full of blood (erect+, and vice-versa with a curvature to the right.
Every man’s penis has a finite amount of space. The larger the fibrous mass, the more severe the visible symptoms once blood is forced into the penis during arousal and encounters these fibrotic obstacles. It’s a matter of displacement, if you recall the mathematical rule established by a naked Archimdes running through Rome yelling “Eureka”.
“Something” must give in every such circumstance. What gives is lost length, indentions, curvature and lost length. Depending upon the exact location and size of penile plaques within the finite amount of penile space, they’ll trigger a wide variety of potential visible symptoms such as lost length, hour glassing, indentions, curvature, even erectile dysfunction. pulls on the surrounding tissue and causes the penis to curve, often during an erection.
The pain some men experience with Peyronie’s is tied to the exact location of the fibrous plaques. A penis has a lot of nerve endings. If the plaques are pressing against one or more of those nerve endings, the patient will experience pain when erect (most common) or even when flaccid.
What's required to actually cure Peyronie's?
A curative Peyronie’s Disease treatment is one that measurably and permanently removes Peyronie’s fibrous tissue plaques and reduces the size of an enlarged tunica (if applicable).
Thickening of the tunica albiquea is common with well- established Peyronies cases. Thickening can be defined both in terms of increased size from a form of swelling plus more pronounced tunica density. It’s also a source of confusion for some urologists since a damaged Tunica can cause Peyronie’s symptoms by itself, without any visible fibrotic plaques from ultrasonic testing.
Removal of Peyronie’s fibrosis is complex since the size and nature of established plaques as well as existing patient health dynamics all play important roles with the exact protocol to permanently remove the penile fibrous tissue plaques.
At the onset, the plaques, fibrosis, and scar tissue that cause all Peyronie’s symptoms can be precisely measured. Improvement can also be precisely quantified.
Uniquely compared to conditions like erectile dysfunction, the locations and sizes of Peyronie’s fibrosis and penile plaques can be quantifiably measured, in mm3, by dynamic penile color Doppler sonography (readily available at most urology clinics) after administration of intracavernosal alprostadil 10 mcg. To calculate the volume of the penile plaque, plaques are measured in three dimensions and using an ellipsoid formula: V =_ _length × _width × _thickness × _0:52 which is typically used in the evaluation other urogenital diseases.
Thus, 99% of existing Peyronie’s plaques, fibrosis and scar tissue can be fully quantified at the onset before any treatments begin and subsequently be reevaluated for signs of improvement through follow up sonography compared to the baseline to accurately determine if any therapeutic is eliminating Peyronie’s plaque.
Because there has never been a unified standard for defining a successful Peyronie’s treatment, existing Peyronie’s treatment devices and drug treatment approved by the FDA refer to clinical trials that measured success by the degree of change in erect curvature, which is only a potential symptom of Peyronie’s disease and proves nothing about healing the underlying cause of the curvature. Additionally, none followed the status of the six Peyronie’s Accelerators within each patient, making comparative outcomes completely skewed.
With all of this in mind, we believe it is critical to be as clear as we can about our use of statistics and to help clinicians and patients build appropriate expectations. Thus, we believe the revised gold standard for measuring improvement in regard to any Peyronie’s treatment technology should include an initial duplex ultrasonography that both measures the size of any and all penile plaques and records their location within the soft tissue of the penis.
In our soon to be published clinical study of Peyronie’s patients who completely treatment with ExoSurge IPG we saw a 79% reduction in fibrous tissue plaques (including cases with calcification) and a 60% reduction in measurable erect curvature (if applicable). Since this study was performed, we’ve continued to make innovations that cause even better and faster outcomes.
A potential Peyronie's pandemic is looming
Our research indicates up to 50% of all men in America presently have Peyronie’s fibrosis in the soft tissues of their penis, but the large majority remain asymptomatic for the time being.
A pair of recent studies6 which both garnered patients from the general populous and reduced the embarrassment associated with the indication showed a much larger prevalence of men with palpable plaque in the penis at about 13 % of the US male population7 or 14 million men.
Much higher indications for Peyronie’s are not without precedent. A 100-patient postmortem study8 by BH Smith in 1969 that examined the prevalence of fibrosis among cadavers disclosed a fibrosis incident rate of 23%. Additionally, a 1980 study from data derived from phalloarteriography by Michel9, et al found Peyronie’s deformity of 20%. Notably, most of the men where deformity was observed were aware they had any sort of problem. It’s also worth nothing Smith’s study occurred long before the sexual revolution, the proliferation of PGE injections to treat erectile dysfunction and other societal aspects that have increased the likelihood of penile injury.
Mathematical extrapolation of these studies combined with our newfound insight into Peyronie’s Accelerators, paints a pandemic-level number of debilitating Peyronie’s cases within the next 15-20 years.
[6] Dana Britt DiBenedetti, Dat Nguyen, Laurie Zografos, Ryan Ziemiecki, and Xiaolei Zhou, (2011) A Population-Based Study of Peyronie’s Disease: Pevalance and Treatment Patterns in the United States
[7] Stuntz M, Perlaky A, des Vignes F, Kyriakides T, Glass D (2016) The Prevalence of Peyronie’s Disease in the United States: A Population-Based Study. PLoS ONE 11(2): e0150157. doi:10.1371/journal.pone.0150157
[8] Smith BH. Subclinical Peyronie’s disease. Am J Pathol. 1969;52:385–90.
[9] Michal V, Posipichal J, Blazkova J . Arteriography of the internal pudendal arteries and passive erection In: Zorgniotti AW, Rossi G, eds Vasculogenic impotence Charles Thomas: Springfield Illinois 1980 pp 169–179
Patient responsibilities with curative outcomes
There’s a reason Peyronie’s has been around for 600 years without a curative pathway. The disease’s complexity rivals autoimmune disorders and requires a lot of work to completely heal each case.
Eighty percent of Peyronie’s cases are born over a lifetime of minor penile trauma’s and patient health paradigms that make the disease (and symptoms) worse. Curative outcomes can likewise require a lot of treatments to disperse the long established fibrotic plaques, changes to lifestyle habits, adherence to protocols, and following off-site therapeutics to most quickly cure a case.
1. Health Adjustments
Contrary to established medical opinions, our research discovered a patient’s good health plays a key role in a Peyronie’s case. A patient’s health scoring never causes Peyronie’s fibrotic plaques, but it often plays a key role in cases getting worse more quickly. There are also a few lifestyle choices which need to be managed to targeted numbers.
Patients diagnosed with connective tissue healing disorders like Dupuytren’s or Marfan’s Disease are naturally susceptible to end up with Peyronie’s disease. Neither of these diagnosis causes Peyronie’s by itself, it just makes the patient much more likely to acquire. Thus, such patients need to approach intimacy less rigorously.
2. Adhearance to off-site therapeutics
Supporting off-site therapeutics are essential to success in cases, particularly with helping the speed of improvement and regaining lost penile size after the fibrotic plaques are non-surgically dissolved.
Patients who adhere to prescribed therapeutics achieve faster and better results, however these regimens are essential to patients who lost penile size from Peyronie’s. When we didn’t include them in the past, most patients only recovered about half of their original size after the fibrosis was removed. This outcome is what players a key role in our developing a line of cosmetic urology procedures. Later we discovered that patients who adhered to off-site therapeutics regained 99% of their original penile length and width.
3. Patience
One frustrating aspect of healing we’ve discovered from our patients with severe, long-established Peyronie’s conditions is that the curvature is all they’re fixated upon. In long established Peyronie’s cases with large, dense plaques, the degree of curvature is sometimes slow to occur even after measurable plaque is dissolved. Our research points to the plaques spider-web designs in such cases.
Additionally, we sometimes have to enhance aspects of your underlying health or progress becomes much slower. These circumstances in cases with lots of dense plaque make resolution especially challenging when a patient refuses to be compliant. Severe Peyronie’s plaque almost always didn’t occur in one day. We can’t safely remove quick, either.
4. Following Prescribed Protocols
Patients who are intermittent with treatments and non-compliant with prescribed changes in lifestyle and health are in for a snail-like pace when it comes to Peyronie’s symptom improvement.
Our philosophy
Our clinic is focused on finding a cure for Peyronie’s Disease. After more than two decades of research and development, we’ve achieved many major milestones in pursuit of our purpose, including:
- We identified the underlying epidemiology of Peyronie’s.
- Our research identified six Peyronie’s Accelerators that need to be regulated and optimized to treat the disease.
- Our patented therapeutic uses pulsated gas injections to penetrate Peyronie’s fibrous plaques, allowing medications to breakdown fibrosis without surgery.
- Our new therapy algorithm takes into account all variables of a Peyronie’s case, such as plaque size, density, and position, as well as health factor rating and the state of each Peyronie’s Accelerator. This will assist future clinicians in treating cases.
Earlier in our Peyronie’s technology development, we were unable to restore the original size of the penis following the removal of Peyronie’s plaques, therefore we developed unique approaches for cosmetic urology (penis augmentation). Since then, we’ve learned ways to restore lost size from Peyronie’s during therapeutic treatments, but our cosmetic urology platform, led by renowned reconstructive urologist Kenneth J. Carney, MD, PHARM, FACS, has been highly successful. Our cosmetic platform has provided the principal funding for our Peyronie’s research.
We are now developing technology to accelerate the progression of obstinate Peyronie’s cases using enhanced techniques and innovative medications. We have initiated negotiations to partner with a multinational pharmaceutical platform to fund our FDA approvals and help ensure the ExoSurge breakthrough is available internationally in the coming years.
