Breakthrough Non-Surgical Peyronie's Disease Solution

Are you tired of dealing with the symptoms of Peyronie's Disease?

Welcome to the only institute with a proven solution for Peyronie's Disease

Curative Treatments vs. Symptom Therapies

Peyronie’s is a disease, not a bent or malformed penis. Patients will have to deal with the same terrible symptoms repeatedly in the future as this progressive disease recurs if they simply receive therapy for Peyronie’s symptoms and not the root cause.

Rejuvall’s new ExoSurge® technology stands apart from previous treatments for Peyronie’s disease. ExoSurge® technology treats and cures the underlying condition of Peyronie’s, not just its symptoms. It is the most advanced Peyronie’s treatment technology to date.

Rejuvall’s ExoSurge® is the world’s first clinically validated treatment for the conservative and permanent removal of plaques and fibrosis associated with Peyronie’s Disease.

Peyronie's Disease Breakthrough

Exciting Peyronie's Disease Discovery

Our clinically proven ExoSurge®, medical device, drugs and patient-care protocols safely and effectively delivers intralesional injections of well-known Peyronie’s disease treatments using injected interfibrous gases.

The penile plaques and fibrosis linked to a Peyronie’s Disease diagnosis are permanently eliminated by these medication combinations when combined with our gas injections.

At our flagship facility in Atlanta, Georgia, we have successfully treated Peyronie’s Disease in over 1,000 patients with no adverse side effects other than moderate swelling and occasional bruising.

Using baseline and follow-up duplex Doppler sonography image comparisons, our retrospective clinical study of 75 patients demonstrated a 79% decrease in the plaques and fibrosis responsible for Peyronie’s disease’s adverse effects. Included in these measurements were patients with thick calcified plaque.

No individuals were excluded on the basis of any pre-existing health condition or their Peyronie’s diagnosis.

To solve a problem, you must first define what it is.

Breakthrough: We unlocked the etiology of Peyronie's Disease

“What causes Peyronie’s disease?”

Doesn’t that seem like a straightforward question?

Have you ever searched Google for causes of “Peyronie’s disease”? Despite the abundance of hypotheses, no one can explain every scenario involving a patient.

Even after 2 millennia of significant advancements in healthcare, nobody can conclusively identify the etiology of this dismal diagnosis, much less find a long-term cure?

We were “heads down” for 10 years.

It required about 10 years to develop a suitable working model for the etiology of Peyronie’s disease, and an additional 10 years to show that these hypotheses were supported by the success of treatment and the careful removal of scar tissue, fibrosis, and Peyronie’s plaques.

We knew we needed to gain a complete grasp of the underlying causes of Peyronie’s disease before we could find a cure. It sounds easier than it was to accomplish this.

We can’t share all the details of our insights since they are tied to our new drug patent. However, even while we can’t share every bit of information just yet, we can refute several myths that we’ve found to be untrue.

1. How does ExoSurge® work?

Effective and safe

ExoSurge® is completely non-surgical
At present, this technology is decreasing and eliminating penile fibrosis in compliant individuals with a 100% success rate
It’s clinically demonstrated to eliminate any fibrous plaques found with Peyronie’s disease
More than 1,000 individuals have been effectively treated.
The most frequent adverse effects include temporary redness and slight swelling.

2. ExoSurge® is proven effective

The first clinically validated treatment for non-surgically and permanently removing plaques and fibrosis associated with a diagnosis of Peyronie’s disease is ExoSurge® from Rejuvall.

Rejuvall’s novel ExoSurge® technique differs completely from all previous Peyronie’s treatments.

With ExoSurge® technology, Peyronie’s disease is treated for its underlying cause as well as its many symptoms.

2. ExoSurge® therapies are easy

Free individual case consultation over the phone (does not apply to in-office sessions).
A full range of ExoSurge® diagnostics are conducted in the office during 3 appointments, which are typically 100% insurance-reimbursed for local patients.
ExoSurge® comprehensive testing offers information to create a unique algorithm that offers specifics for managing the case of every patient.
Treatments with ExoSurge® take about 15 minutes a day.
One ExoSurge® treatment every 2 weeks is covered by the majority of commercial insurance policies, including Medicare, in addition to a $60 non-covered medical treatment payment. Therefore, 90% of the ExoSurge® therapies used by local patients are typically reimbursed by insurance.
Treatments with ExoSurge® are not very painful. There is also medical-grade laughing gas and local anesthesia available.

We're fully prepared to treat patients from other states and countries

Currently, 90% of our Peyronie’s patients come from other states or foreign nations.

It takes about 45 minutes to get to Atlanta Hartsfield-Jackson International Airport from our facility. Conveniently located just off Interstate 75 in Buckhead, our office is just north of Atlanta’s downtown.

Patients from out of state are required to pay for 1 office visit, which typically costs around $175 due to the 2-week delay for ultrasound readings, as per insurance restrictions.

Patients from outside the state who come for treatments 1 week out of the month have insurance cover the first treatment (plus the $60 non-covered expense). The remaining treatments during the visit must be paid for out of pocket, at a cost of around $370 per treatment.

We’ve put together a few pages with travel information and discounted hotel rates to help our out-of-town patients make planning their trip to Atlanta easier.

ExoSurge® gives men their lives back.

A shorter penis
Curvature that makes penetration challenging
Shaft indentions
Hour glass shaping
Nodules along penile shaft
Erectile dysfunction

These are among the most common symptoms of a Peyronie’s diagnosis.

All of them can result in decreased pleasure during intimacy, strained relationships, a reduction in self confidence, and a negative self image.

Peyronie’s is a disease. It’s not just these symptoms.

Rejuvall treats the disease, its many symptoms, and the man – to help you get your life back.

The 2 Most Common Peyronie's Myths

Peyronie’s Myth #1: “Peyronie's disease heals on its own in about 13% of cases”

This myth appears to originate from a commonly cited 2002 study¹. That study also plays a role in urologists failing to offer care during the initial “acute” phase of the disease.

We discovered 6 different Peyronie’s Accelerators (health issues that cause a long-standing benign case to become active).

Through patient interviews, we discovered a number of instances in which a patient reported sustaining a traumatic penile injury in the past, which was followed by a noteworthy change in erection shape that afterwards faded. Subsequently, these normally healthy patients developed spontaneous symptoms later in life.

This outcome is the result of an important discovery that we call what Peyronie’s Accelerators.

If multiple accelerators occur about at the same time, Peyronie’s disease symptoms progress rapidly. Some of them are associated with aging, although they can occur at any moment to any patient.

We discovered significant variations in the plaque structures beneath the initial layers when we treated these patients, indicating that the initial trauma was still present but that their bodies were able to fight off the symptoms until one or more of the Peyronie’s accelerators hampered that ongoing ability.

We also discovered that a Peyronie’s diagnosis is comprised of ten distinct plaque structures. For each, a slightly different approach is required for successful removal.

A large part of this technology’s success can be attributed to our personalized diagnosis of each patient and adaptation of therapies to deficits and plaque deposits.

^[1] Kadioglu A, Tefekli A, Erol B, et al. A retrospective review of 307 men with Peyronie’s disease. J Urol 2002; 168: 1075–1079.

Peyronie’s Myth #2: “Cases with small plaques, minimal penile curvature, no pain, and satisfactory sexual function do not need treatment”

We have discovered Peyronie’s is a progressive condition. The fibrosis that occurs following severe or mild injury does not “go away”. Rather, the body can often keep negative consequences in check as long as the patient is without any Peyronie’s accelerators.

Among the 10 unique plaque design aspects we discovered while treating Peyronie’s were those we attributed to the body sending additional fibrotic material to the previously injured area in an effort to heal the condition.

It gets worse. The masses get bigger. And when one or more of the accelerators kick in, it becomes a nightmare diagnosis.

Peyronie’s FACT: “There has never been, and will never be, a simple and quick cure for Peyronie's Disease.”

Finally, understand there’s not and never will be a quick and easy solution to cure Peyronie’s Disease.

Peyronie’s symptoms have been documented in medical journals since the 1400s. It was named after the personal physician to Louis XV in France in 1743, who was the first to describe it clinically and added his name to it.

Beyond treating some of its symptoms, there has never been a curative Peyronie’s treatment. There’s not even agreement on what is causing it.

How many diseases have been identified that long with such little success with treatment? To understand the complexities of this disease, you must respect those failures.

We’ve spent 20 years focused on this disease. It took 10 years just to develop a working theory model on the etiology alone.

We discovered 6 Peyronie’s Accelerators that cause a long benign case to go south, as well as 10 distinct plaque structures that must be identified in order to successfully remove them.

Then there’s the exact plaque size, location, and density, which are determined by high-level sonograms.

That doesn’t even take into account the fact that all of the masses are attached just above the penile neuro network, making surgical removal of the plaque impossible.

Peyronie’s Treatments: Don’t Get Scammed

Peyronie’s is a devastating diagnosis. Its affects sexual health, relationship intimacy, and men’s personal well-being.

It’s not uncommon for men with Peyronie’s to experience thoughts of suicide.

To make matters even worse? There’s a number of completely bogus therapies on the market marketed as effective for treating Peyronie’s.

Please don’t fall for any of these well-marketed “quick fixes” that promise to make everything better. It’s heartbreaking every time we encounter such patients.

Some of these sham treatments include:

No form of Shockwave or Acoustic Wave Therapy heals Peyronie’s Disease

We were the country’s first private practice urologist to utilize low intensity shockwave (LiSW) therapy devices to treat erectile dysfunction, importing the technology direct from eastern Europe.

After that, as the technology improved, we tested LiSW on Peyronie’s plaque. We discovered that it had no effect on plaque removal, using a comparative baseline duplex doppler imaginary of Peyronie’s fibrosis.

Based on our years of experience, we believe LiSW is an effective treatment for one of the four primary causes of erectile dysfunction. It is useless for treating Peyronie’s disease beyond the ability to improve erections in select cases and sometimes reduce pain.

No form of PRP injection is effective treating Peyronie’s disease

Similarly, no version of PRP injections is successful treating Peyronie’s disease.

Before publishing a valuable study on the success of shockwave therapy in treating aspects of Erectile Dysfunction², renowned erectile dysfunction and Peyronie’s disease researcher Tom Lue, MD, spent 2 years attempting to leverage every variation of P-shots to heal the penis.

It never worked. Importantly, he figured out why that pathway was fraught with failure: nocturnal erections.

Every man has 6 or 7 nocturnal erections every night during REM sleep. Within 48 hours of injection, 99% of implanted cells are gone.

Because of the massive rush of penile blood flow during sleep, they never have a chance to heal anything within the penis.

There are no magic Peyronie’s pills or creams

Finally, there is no pill, supplement, or cream that can cure the disease.

When each was properly tested against a placebo³, none showed any measurable improvement.

^[2] Pakpahan, et al: Low-energy Shock Wave Therapy Ameliorates Erectile Dysfunction in a Pelvic Neurovascular Injuries Rat Model, World Journal of Stem Cells, Volume 13, 10, October 26, 2021.
^[3] Oral therapy for Peyronie’s: does it work? Brittani Barret-Harlow, Run Wang, Vol. 5, No. 3, June 1, 2016, Translational Andrology and Urology

Retrospective Study Results

Outcomes of Non-Surgical Treatment for Peyronie’s Disease: Retrospective, single clinic, observational cohort study

By:

Steven L. Morganstern, MD

Kenneth J. Carney, MD, PharmD, FACS

Angela Bates, APRN

Abstract

Objectives: The goal of this study is to evaluate the outcomes of a non-surgical treatment for Peyronie’s Disease.

Peyronie’s Disease (PD) is recognized as a difficult disease to treat within the medical community. The basis for difficulty may stem from the controversy in agreement on the etiology of PD (Nehra, et al., 2015). Most treatments to date are centered around treating the symptoms caused by the disease or for discouraging the initiation of fibrosis (Fallo & Sarnacchiaro, 2019) (Gonzalez-Cadavid & Rajfer, 2010). At this time there is only one treatment approved by the FDA (U.S. Food and Drug Administration) for non-surgical intervention of PD, clostridium collagenase histolyticum (CCH). This treatment can be effective however due to stringent qualifications for use, many patients suffering with PD are excluded from this treatment (Nehra, et al., 2015). Recommendations for treatment from the American Urological Association (AUA) include several options for medication usage with varying degrees of expected success, other than CCH. The evidence listed for these medications is rated as Grade C. This level of reliability in the research shows an expectation toward change in the confidence level with further research (Nehra, et al., 2015).

Materials and Methods: Of the 101 subjects reviewed, 31 patients were excluded due to a lack of continuity in record keeping leaving 70 patients who were actively in treatment between the dates of January 1, 2018 and March 6, 2020. Peyronie’s treatment using Exosurge follows current guidelines provided by the AUA for Peyronie’s Disease (Nehra, et al., 2015). No patients were excluded for past medical history, fibrotic condition of calcification, degree of initial curve or previous treatments.

Results: Changes in presentation after treatment resulted in 84% of patients with improvement. Of these patients, there was a 58% average reduction in curvature. Fourteen percent showed no change and only one patient worsened after treatments began.

The average plaque reduction was found to be 79%. Patients who had an initial curve showed an average plaque reduction of 88%. An incidental finding revealed that only 24% of patients with a curve greater than or equal to 30 degrees measured an acceptable erection grade of 3.5 or 4.0 at baseline. After treatments, this number increased to 42%.

Conclusion: Not only do these results show an impressive reduction in plaque size and consistency, but a notable difference was seen in the degree of curve and erectile function. This author feels there is enough evidence presented within this review to proceed to clinical trials for the use of ExoSurge as a foundational, non-surgical treatment for Peyronie’s Disease.

Key Points:

· 84% of patients showed improvement in their curve.

· 58% average reduction in curve.

· 79% overall reduction in plaque.

· 55% of patients with an initial curve greater than 30 degrees achieved an erection grade of at least 3.5 after treatment. This is an increase of 31%.

Outcome of Non-Surgical Treatment for Peyronie’s Disease:

Retrospective, single clinic, observational cohort study

Introduction

Peyronie’s Disease (PD) has been defined as a disease of the tunica albuginea in which fibrosis and plaque formation alter the physiology of the corpus cavernosum. The presentation of this plaque may cause a singular or a combination of changes such as erectile dysfunction, pain, curvature, reduction in girth and length as well as a “wasting effect” of the penis (Hussein, Alwaal, & Lue, 2015). During a systematic review performed by the AUA (Nehra, et al., 2015), a definition of PD was constructed as an abnormality characterized by fibrosis. Further, it was reported that PD may include pain, erectile dysfunction, or a deformity. Although symptoms are included in the definition of PD, it should be recognized that the base definition of PD is fibrosis.

Treatment for PD is controversial as most treatment modalities have minimal success and few show a continued progress toward resolution. Many known treatments only address the symptoms that present with PD and do not look to the cause. The AUA recommends that clinicians should only offer treatment if the clinician is experienced to treat the condition (Nehra, et al., 2015). The purpose of this study was to review the outcomes of PD patients undergoing the non-surgical treatment, ExoSurge at a single clinic, Morganstern Urology Clinic (The Clinic) between the dates of January 1, 2018, and March 6, 2020. No patients were excluded based on past medical history or type of treatment received in the clinic.

2 Method

2.1 Eligibility criteria for participants

A database search using The Clinic’s Electronic Health Records (EHR) system was completed extrapolating patient medical charts with the diagnosis of PD and undergoing treatment between the dates of January 1, 2018, and March 6, 2020. Patient charts were included when they were found to have identifiable and measurable plaque with no less than two duplex doppler ultrasound diagnostic tests within that timeframe providing a pre-treatment ultrasound and a post or intra-treatment ultrasound for comparison. Of these patients, 101 were found to be consistent in receiving treatments during this timeframe. Those excluded were patients who had not been seen in the clinic within three months or more prior to the post or intra-treatment ultrasound tests and considered inconsistent with treatment.

Upon further review it was determined that within this patient sampling of 101, some pre-treatment recordings of the duplex doppler ultrasound diagnostic test was not complete and/or not comparable in recording to the post and/or intra-treatment ultrasound and therefor were not considered a good comparison. These patient charts were removed from the study leaving a total of 70 patient charts for comparison. All duplex doppler ultrasound diagnostic testing during the listed dates was completed by an independent, outside source on site at The Clinic.

2.2 Past Medical History

Past medical history (PMH) for each patient was recorded only. No participants were excluded based on PMH. Past medical history was broken down into these categories: Cardiac, Diabetes Mellitus (DM), Cancer (CA), Cerebrovascular Accident (CVA) and Low Testosterone (Low T). The heading of cardiac included patients with diagnosis and having been medically treated for hypertension (HTN), hypercholesterolemia, arrhythmia, congestive heart failure (CHF) or had a history of myocardial infarction (MI). Patients were included in the diabetes category if they were found to have a history of being treated medically or were currently being treated for diabetes mellitus (DM).

2.3 Study Design

This was a single clinic, descriptive study conducted in review of clinical treatments by Morganstern Urology Clinic including patients undergoing treatment for Peyronie’s Disease between January 1, 2018, and March 6, 2020. Patient identification information was removed to maintain HIPAA Compliance.

Data retrieved from each duplex doppler ultrasound included degree of curve, identification of venous leak, identification of arterial insufficiency, erection grade, size of plaque, and consistency of plaque as either calcified or non-calcified.

2.4 Treatment Description

ExoSurge treatment includes a gas combined with an intralesional injection of no less than 1 mL of the calcium channel blocker verapamil. Other supportive treatments were used based on each patient’s individual presentation, but ExoSurge and Verapamil were administered to every patient in this study. Supportive treatments may have included straight stretching devices, vacuum devices, oral medications, intralesional medications and/or over the counter supplements.

2.5 Data Review & Analysis

A beginning baseline duplex doppler ultrasound analysis that included up to three measurable pieces of plaque was compared to a follow up duplex doppler ultrasound for measurable changes. Data retrieved from both the initial and final duplex doppler ultrasounds included findings of plaque. Plaque size was recorded in a 3-dimensional format in millimeters. Consistency of plaque was recorded as calcified or non-calcified. Penile curvature was identified in degree of curvature, which was then divided into two classes: curvature greater than or equal to 30 degrees and a curvature less than 30 degrees.

Vascular integrity was recorded by review of arterial flow and/or venous leak. A simple A to B Ratio was used to determine level of integrity. The average value of Peak Systolic Velocity (PSV) was recorded per sides left and right. The average value of End-Diastolic Velocity (EDV) was also recorded by sides left and right. These results were then divided into Healthy, Moderate or Severe and noted as left and right. An A/B ratio greater than 20 was labeled as healthy, between 7 and 19 as moderate and less than 7 as severe. For final review only results shown to have Moderate or Healthy in both the left and right side were recorded as “unhealthy”.

Erection grade was recorded on a scale of 1 to 4 with increments of 0.5 based on the Erection Hardness Score (EHS).

Figure 1 EHS (Goldstein, et al., 2008)

2.6 Statistical Analysis

Of the total 70 patients reviewed, 50 were found to have a curve not considered as natural and developing later in life. All 50 patients were evaluated with color duplex doppler ultrasound for the following variables: penile plaque volume, calcified vs. non-calcified plaque, degree of penile curvature, and aspects of erectile function. Existing health conditions were noted but have not been used to score or further rate any changes in the level of disease for this review.

Plaque volume was measured, in mm3. To calculate the volume of the penile plaque, we measured three dimensions of each piece to determine the volume; V = length ×width × depth. Up to three separate pieces of plaque were recorded when present.
Degree of penile curvature was recorded during the initial and follow up duplex doppler ultrasound by use of a protractor. In many cases, but not all, pictures were provided with protractor showing measurement of current curve. Value of curve was accepted with or without confirmation picture.

Each duplex doppler ultrasound included an intra-cavernosal injection of 10 mcg alprostadil (Nehra, et al., 2015) administered prior to any measurements (Cavallini, Scroppo, & Zucchi, 2016). PSV was recorded every five minutes for a total of thirty minutes on both the left and right sides. For purposes of evaluation, PSV readings less than 30 were considered deficient (Gomez Varela, Mateos Yeguas, Rodriguez, & Duran Vila, 2020) and recorded as “arterial insufficiency”. EDV was also recorded in the same increments. It is commonly recognized that the EDV must be low to offer an effective veno-occlusive mechanism (Cavallini, Scroppo, & Zucchi, 2016). For evaluation, we considered readings >4 cm/sec as insufficient and this is labeled as “venous leak”. A simple ratio calculation of PSV / EDV provided the ratio between the two ratings.

3 Results

3.1 ExoSurge treatment changes in Plaque size

3.1A Plaque Area One Condition:

For the baseline duplex Doppler ultrasonography, the total number of pieces counted were 66. Of these, 52 were non-calcified and 14 were calcified. On the follow up duplex Doppler ultrasonography, the total number was 58. Of these, 48 were non-calcified and 10 were calcified. The reduction in the number of calcified plaque pieces was 28.6%.

3.1B Plaque Area One Measurement:

The total plaque size measured with the baseline duplex Doppler ultrasonography in Area One was 302.9 mm3 and the follow up duplex Doppler tally in Area One was 55.7 mm3, representing an 81.5% reduction in penile plaque for the 70 patients.

3.1C Plaque Area Two Condition:

For the baseline duplex Doppler ultrasonography, the total number of pieces counted in plaque area Number Two were 42 with the follow up study showing a total of 40. Of the original 42 pieces, 28 were non-calcified and 14 were calcified. On the follow up duplex Doppler ultrasonography analysis for plaque in Area Two, 32 were non-calcified and 8 were calcified, a 43% decrease in calcified plaque.

3.1D Plaque Area Two Measurement:

The average total size as measured from the baseline duplex Doppler for area two was 209.9 mm3 and the follow up results measured 63.4 mm3, representing a 70% reduction in penile plaque.

3.1E Plaque Area Three Condition:

For the baseline duplex Doppler ultrasonography, the total number of pieces counted in plaque Area Three were 22. The follow up duplex Doppler ultrasonography showed a total of 23 plaque pieces. Of the original 22 pieces, 15 were non-calcified and 7 were calcified. Data derived from the follow up duplex Doppler ultrasonography indicated 18 plaque fragments were non-calcified and 5 were calcified, representing a 28.6% improvement in the reduction of calcified plaque.

3.1F Plaque Area Three Measurement:

The total size as measured with the baseline duplex Doppler ultrasonography study for plaque in area three was 198.45 mm3 and the follow up duplex Doppler ultrasonography was 30.59 mm3, representing an improvement in the reduction of penile plaque of 84.6%.
Figure 2 Plaque Size Reduction

3.1G Combined Areas Condition:

The initial baseline number of calcified plaque pieces derived from duplex Doppler ultrasonography among all 70 patients in this study was 35. The follow up duplex doppler study showed the total number of calcified plaque pieces after treatment was 23. This shows a 34.3% reduction in calcified plaque pieces.

The non-calcified numbers increased from an initial count of 95 to the follow up count of 98. This is an expected finding as the calcified plaque will change to non-calcified before it is no longer measurable.

3.1 H Combined Areas Measurement:

The initial baseline plaque size total derived from duplex Doppler ultrasonography among all 70 patients in this study was 711.2 mm3. The follow up duplex Doppler ultrasonography was 149.7 mm3. The combined measurable penile plaque reduction for all areas was 79.0%.

Figure 2 Penile Plaque Size Reduction

3.2 ExoSurge treatment change in curve

A comparison was made between initial duplex doppler ultrasound and final/intra-treatment ultrasound as some patients were still undergoing treatments. Of the initial 50 patients with a curve, 36 of those patients also had a venous leak. Of the 50 patients with a curve, 17 of them had a curve less than 30 degrees with 12 of those with a venous leak. Thirty-three of the 50 had a curve greater than 30 degrees, of which 24 had a venous leak. The final study review of the 50 pts who were initially found to have a curve, 8 of those patients had no curve at all. Of the original 33 with a curve greater than 30 degrees, this number decreased to only 20 patients. On the initial study only 17 patients had a curve less than 30 degrees and this increased to 22. Therefore, 8 patients completely corrected to no longer have a curve and 5 had reduced significantly, one patient’s curve increased by 8 degrees. A 58% reduction in curve was noted for the entire group who showed a decrease in the degree of curve. Fourteen percent of patients showed no improvements with the curve.

During the time reviewed, we found only 24 patients still receiving therapy at the final date for review. The individual average improvement for these patients at the end date was 60%. Of the 26 patients no longer participating in treatment, there was an individual average improvement of 55% to their curvature. This change is congruent with our observations showing the largest change in curvature realized toward the end of therapy.

Figure 3 Improvements Average Per Patient

3.3 ExoSurge treatment changes in erectile dysfunction

Figure 4 EHS Patient Improvement

This study was a Peyronie’s disease/plaque study and shows reduction in volume of plaque however, the results may be easier to see when reviewing the changes recognized in the degree of curve. Of the total 70 patients reviewed, 16 were initially found to show an erection grade of 3.5 or higher. The data reviewed is the measured erections grade found on the first and last vascular study to allow for comparison. Initially, of the total 70 patients, 13 patients were evaluated at an erection grade of 4, after treatments there was a total of 16 patients. Initially only 3 pts were graded at a 3.5 but there was a total of 20 patients on the re-evaluation. It could be that those 3 patients who were graded at a 3.5 moved up to a 4 and the 20 came from patients who initially were found with erections grades at a 3 or lower. Therefore, to begin with only 16 patients had erection grades of 3.5 or 4 out of the original 70 participants but afterward 36 patients showed a grade of 3.5 or 4.

4 Discussion

Although this study was to review the success or failure of a new, non-surgical technique for correction of Peyronie’s Disease the data obtained has value in treatments for erectile dysfunction related to venous leak and arterial insufficiency. Further review is necessary to identify the variables and obtain a more in-depth presentation toward future treatment recommendations for ED. Within the cohort information collected for this review, there is sufficient data for other conclusions related to abnormalities of the penile shaft.

Many of the tools used during the initial and subsequent duplex doppler ultrasound studies were standardized to the industry however the A/B ratio used for review of PSV to EDV was not. It appears to be sufficient to identify venous leak levels in conjunction with arterial flow for this data review, however the Resistive Index (RI) is more common practice and should be evaluated for future use. Although the A/B ratio is used in The Clinic for determining different treatment options, it does not seem to directly correlate with erection grade.

Surprisingly, there appeared to be a connection with patients who initially showed a venous leak alone or in combination with arterial insufficiency and their original erection score. This data should be reviewed for analysis of vaso-occlusive erectile dysfunction.

Based on our findings, it would be of interest to review and compare each patients PMH along with their level of treatment to see to what degree these disease processes affect the treatment of Peyronie’s Disease (Herrera, Henke, & Bitterman, 2018) (Ming, Ma, Xhang, Guo, & Yuan, 2020) and not just the disease itself.

5 Conclusion

The review of data has shown significant improvements with patients undergoing ExoSurge treatments and Verapamil. This data proves this to be a successful foundational treatment for Peyronie’s Disease in patients of all conditions and medical histories. Not only did these results show an impressive reduction in plaque size and consistency, but a notable difference was also seen in degree of curve as well as erectile function. Current guidelines from the AUA for the treatment of Peyronie’s Disease include several options for treatment and a category named “Other Treatments”. Also included are recommendations for surgical intervention if a patient presents with erectile dysfunction along with PD (Nehra, et al., 2015). The results indicate that not only is there is enough evidence presented to proceed to clinical trials for the use of ExoSurge as a, non-surgical treatment for Peyronie’s Disease but also shows that improvements can be made in PD patients who experience ED as well. We should not be going directly to surgical intervention for patients with ED. This treatment continues to follow current guidelines provided by the AUA while avoiding recommended irreversible surgical interventions such as penile prosthesis or grafting.

5 Authors Notes/Conflicts of Interest

Authors are current members of the care team at Morganstern Urology and active during treatment administration, data assimilation and extrapolation.

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Table of Figures

Figure 1 EHS (Goldstein, et al., 2008)
Figure 2 Plaque Size Reduction
Figure 3 Improvements Average Per Patient
Figure 4 EHS Patient Improvement

What’s upcoming for ExoSurge® technology?

Because it’s especially revolutionary, we’ve been told by the FDA that getting approval for our novel gas injections / drug technology will cost more than $50 million (Is that amount insane or what?).

We’ve already invested approximately $20 million over the last 2 decades in our pursuit of a cure for Peyronie’s Disease.

We’ve had to wait for key patents to be filed and issued before proceeding with any further steps. This impediment prevents us from sharing key data, publishing, or educating other urologists about the details of our breakthrough.

All of these phases are occasionally distressing for our development team, as we see and hear about so many men afflicted by this illness. Several members of our team have committed their entire careers and life savings in the development of this cure.

Our gas and intralesional medication injections for the treatment of Peyronie’s disease are not yet ready for sale; we aim to commence prospective trials for the technology in 2026 in collaboration with a new pharmaceutical partner.

Following prospective trials, we anticipate FDA approval of the device and intralesional drug injections, and then we’ll work with clinicians around the globe to deliver this revolutionary technology to patients seeking a permanent conservative Peyronie’s cure.

Similarly, we expect this technology will be fully reimbursed by health insurance.

Free Initial Consultation

Do you want to know if ExoSurge® is right for you? We provide a free initial case consultation over the phone to evaluate your current condition and determine if ExoSurge® treatment is appropriate for you in the future.

Most insurance plans (including Medicare) usually cover the costs of the extensive testing required to develop an accurate treatment plan for your Peyronie’s disease.

However, there will be out-of-pocket expenses for care, which can be costly if you travel from out of state and must include travel costs, lodging, and meals.