Questions and Answers

Questions and Answers

Common questions from patients and clinicians

Is this just another version of shockwave or acoustic therapy?

Absolutely notI We were among the very first urologists in the United States to begin using shockwave therapy for treating ED, importing our first LESW devise directly from Romania. We initially included LISW therapy as a part of our treatment protocol but later discovered it added no value to Peyronie's improvement.

LISW (not Acoustic wave treatments which have not been sufficiently studied) s an important and powerful tool for treating select aspects of erectile dysfunction. It will sometimes produce a false-positive with reduction of fibrous tissue plaques because of its powerful anti-inflammatory attributes. However, aside from helping cause firmer erections for patients suffering from select types of venous leakage, it has no value with treating Peyronie's Disease based upon our research.


I still don't get it. How exactly does ExoSurge's Inter-fibrinous gas and drug injections remove the plaque masses associated with Peyronies?

It starts with our understanding of the exact epidemiology behind Peyronie's. We not only know its cause and how it happens but also what makes a benign inactive case suddenly flare up into a problematic issue. The first step is to identify and manage any of these "Peyronie's Accelerators" so that treatment can be optimized. Otherwise, removal can take forever.

Aside from managing, the epidemiology of each case, how do our treatments remove fibrous tissue plaques?

Simply put, our inter-fibrinous gas injections are a novel and unique method of drug delivery. They have been shown to transform long-known generic intralesional Peyronie's medications into "super drugs" that generate curative outcomes in which Peyronie's fibrosis is broken up and dissolved into the body, just as it is expected to happen when the body initiates a fibrotic reaction because of injury.


I've lost a lot of size of my erect penis from my Peyronie's. Will ExoSurge restore my original length and girth?

Lost penis size is a byproduct of the mathematical rules of displacement.

We've discovered that patients who maintain penile traction therapy during therapy regain most if not all or their original erect penis size after the Peyronie's plaques are removed.

We discovered our treatment technology requires a modified approach to help regain penile thickness on patients who've acquired "indentions" from Peyronie's Displacement.



I lost significant length in my penis from Peyronie’s. Will ExoSurge® restore my original length?

Peyronie’s patients often notice a loss of penile length. The reasons behind this reduction are mostly rooted in displacement. Do you recall that lesson from Archimedes?

There’s a finite amount of space in every man’s penis. When an erection is triggered by arousal and blood flows in to pack the sponge-like corpora penis for an erection, the fibrosis limits the amount of blood allowed into the organ. In this case, something has to give, which is often reduced penile length.

When we break up and remove the fibrosis associated with Peyronie’s disease we’ve observed that patients usually recover about half of the loss of their pre-Peyronie’s length. Patients who are diligent with our off-site stretching protocol have better results with length restoration.

Loss of penis size from Peyronie’s disease is why we got into cosmetic penis enlargement, which has become a larger and larger aspect of our practice. We offer a variety of procedures proven to completely restore any lost penile length.
I now have erectile dysfunction since I acquired Peyronie’s disease. Does ExoSurge® also cure ED?

Peyronie’s disease can cause erectile dysfunction because the plaque can block necessary blood flow to achieve and maintain a good erection. Our ExoSurge technology breaks up the penile plaque associated with Peyronie’s Disease and if that’s why your erections are failing, it will repair that.

The testing we performs to evaluate your Peyronie’s case also reveal any issues with ED and their exact root cause. We will discuss any issues we discover with erectile dysfunction at the same time we review your Peyronie’s case.


My urologist suggested verapamil injections, penile traction, PDE-5 Inhibitors, Xiaflex injections, or finally Peyronie's surgery? Should I do that first?

Peyronie's Disease treatments to date have followed the path of all diseases where a curative outcome is no place to be found: proposed solutions only address illness symptoms, like the common cold

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How is Peyronie's Disease similar to a common cold?

The common cold and Peyronie's Disease share many similarities.

Both have been around for centuries, both cause unpleasant symptoms, both have only received treatment for their symptoms, and neither has a cure, which has perplexed healthcare for millennia.

However, that is all about to change in the case of Peyronie's Disease with ExoSurge.

Is ExoSurge® therapy covered by health insurance?

Yes.

Most commercial insurance companies including Medicare cover about 80% of the cost of ExoSurge® treatments allowing for a therapeutic once every two weeks. As part of our effort to make the technology available to as many men as possible, we don’t presently charge for the medical device or patented technology. We only charge for the administration of the approved drug we use to help destabilize the plaque during therapy

Unfortunately, patients traveling from out of town must pay out of pocket for all but their first therapeutic since it’s not economical to travel to Atlanta for a singular treatment every two weeks.

If a patient is diagnosed with inadequate arterial blood flow coming into the penis (20% of patients usually fall into that category), we employ external counter pulsation (ECP) therapy to remedy that situation and that’s not covered by insurance.

Low testosterone is treated with bioidentical pellet therapy which is also cash-pay although most insurance companies cover the cost of labs and office visits associated with such care.


I just injured my penis during sex. Should I get ExoSurge® now or wait?

At present, standard AUA guidelines for the treatment and care of an acute penile injury case recommend a “hands off” approach for at least six months following the dissemination of pain from the penile injury.

ExoSurge technology completely changes that approach. We strongly recommend patients come into our office for care within seven days of penile trauma. ExoSurge® therapeutics reduce the pain from the injury and most importantly, stop the scar tissue and fibrosis from forming that will trigger a subsequent Peyronie’s diagnosis.

Can ExoSurge® technology cure Peyronie’s Disease?

The word “cure” has a very specific meaning for diseases in the healthcare space.

Our mission with ExoSurge technology is to provide for permanent removal of the fibrosis and penile plaques associated with a Peyronie’s diagnosis. However, if you’re one of the unfortunates who are heavily predisposed to acquire Peyronie’s (i.e., patients with select connective tissue disorders) you’ll have to remain extra to not even slightly injure your penis after the plaques are removed as your prone for that to happen. If it does, you’ll face another round of ExoSurge treatments to remove the newly formed fibrosis.


Can my local Urologist provide ExoSurge® Peyronie’s Treatment Technology?

ExoSurge is a new, patented technology that employs a combination of gas injections that have been clinically proven to enhance the efficacy of generic intralesional Peyronie’s disease medications and eliminate penile plaques, scar tissue, and fibrosis permanently.

We have spent twenty years and a substantial amount of money creating it. In the years to come, we plan to license and expand this new healing platform globally once we have completed a comprehensive clinical analysis demonstrating the positive patient outcomes we are now observing.

Several patients have recently traveled to Atlanta for ExoSurge treatments and then returned home to their preferred urologist for Xiaflex injections: this can be an ideal approach for certain individuals. We are delighted to collaborate with your preferred vendors and within your comfort zone to maximize your success.

Is ExoSurge® technology available anywhere else besides Atlanta, GA?

Not yet.

Our technology is both patented, proprietary, and still under development. It’s available exclusively in Atlanta, GA at present.

We plan to partner with a pharmaceutical company and begin our journey for FDA-approval starting in 2025. We will be posting updates in this regard as well as announcing the locations for prospective clinical trials in that process.

Following FDA-approval, we expect ExoSurge® to be available globally and hopefully covered by traditional health insurance.
What can I do for my Peyronie’s disease if I can’t afford travel to Atlanta for ExoSurge® therapy?

As we mentioned earlier, we now strongly recommend buying a Restorex penile stretching device if you can’t yet get ExoSurge treatments. At the very least, it will help insure you don’t lose as much additional penile length.

Traction (or stretch) therapy uses a device to stretch the penis and sometimes even bend the penis in the opposite direction of the curvature. This encourages the scar tissue to be recycled into more normal tissue and can improve curvature, restore length lost due to Peyronie’s disease, and even improve the hardness of erections.

A good quality VED (Vacuum Erection Device) will help maintain good blood flow within the penis. It’s not going to trigger any plaque reduction but as we discussed with stretching, it will help keep things from getting worse.

Verapamil injections are a worthy intralesional treatment that we employ with ExoSurge and our intralesional gas injections cause the drug’s effects to become amplified. If you’re also young and healthy and not facing effects from Peyronie’s accelerators, we believe they’ll help keep fibrotic growth in check.

Exercising and keeping your vascular system healthy is a key ingredient to keep things in check. If you are presently diagnosed with Type II diabetes, you need to stay focused on keeping our A1C below 7. The vascular constricture that occurs when your A1C reaches double digits will almost invariably trigger fibrotic growth in the penis.

Regarding supplements, we recommend a combination of Omega-3 fatty acid (fish oil) and Curcumin to help slow down the process of arteriosclerosis (fat deposition on the blood vessel walls). Neither of these will reverse existing fibrosis, but it will help limit more growth.

ExoSurge is the only therapeutic in the world that measurably treats and removes Peyronie’s disease plaque. Anything else claiming to do so is a sham.

Work to keep your Peyronie’s case in check using the tools we just described. We plan to have our technology in the hands of every Peyronie’s urologist in the world soon.

What are the negative aspects of ExoSurge® treatments for Peyronie’s disease?

There have been no negative side effects associated with our ExoSurge® technology treatments aside from mild swelling and tenderness following care. Those outcomes are temporary are minimal for most patients.

The biggest problems associated with the ExoSurge® treatment platform are time, investment, and patient compliance.

Time Investment

Depending upon the size, nature, density, and location of plaque within your penis and the number and severity of Peyronie’s accelerators we must modulate, treatments can take anywhere between four and fifty-two weeks to completely remove the plaque and fibrosis.

A thorough analysis of your individual case will allow us to offer a realistic estimate of the time that will be required to heal your penis. The good news is that ongoing results are measurable: this isn’t a “wait until the end” guessing game.

We are willing to customize your approach based upon your personal circumstances.

Peyronie’s Treatment Costs

Depending upon all the related underlying diagnosis and your exact type of health insurance, some parts of your treatment are often covered by insurance. However, the breakthrough technology itself will not be covered until the technology is approved by the FDA. We only charge $60 per treatment for that aspect of care at this juncture in order to make this technology to as many men as possible.

At this point the drug injections are only insurance covered once every 14 days since that’s what’s recommended under the old method of just using Verapamil injections. (That will all change after FDA approval). For local patients, this works out fine. However, for patients coming from of town, traveling to Atlanta doesn’t make economic sense for a singular, insurance covered therapies. Additional treatments cost $370 per visit and patients can only get one session per day for safety’s sake.

Compliance: Peyronie’s Treatment Time Requirement

Because of the cost and time investments associated with our treatment process, some patients are unable to complete the process. Additionally, a few have attempted to start self-adjusting their prescribed protocol with things like P-shots which only hinders progress.

We are able and willing to create a custom regimen to support whatever specific circumstances whenever possible. The optimal and fastest result includes whatever complete process is prescribed, but we understand not everyone is in a position to achieve that situation.

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. Unfortunately, in such cases – the most notable reduction to curvature often occurs happens in the final phases because of the spider web nature of most plaque designs. We first must eliminate the largest plaques that are triggering the symptoms. 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.

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.
Common questions from patients and clinicians

What is Peyronie's Displacement?

"Peyronie's Displacement"

A patient's most hated enemy from a Peyronie's diagnosis

The symptoms of Peyronie's Disease are caused by "displacement". Thus, they are a byproduct of the condition, not a definition for the disease itself.


Curvature when erect, lost length, indentions, transformed shapes, and erectile dysfunction are not the "definition" of Peyronie's disease any more than coughing, sneezing, and congestion are the "clinical definitions" for the common cold virus. Peyronie's Disease is the accumulation of fibrous tissue plaques within the penis's soft tissue.

Peyronie's disease "symptoms" are caused by
displacement, a principle discovered by the ancient mathematician Archimedes around 210 BC. While plunging into a bath, Archimedes discovered that the volume of the overflowing water was equal to that of the submerged portion of his body.

The same effect is produced by a penis organ inappropriately embedded with plaques, scar tissue, fibrosis or thickened tunica. When the brain sends a signal for the body to pump blood into the penile organ for an erection,
something must give in accordance with the laws of displacement. Thus, what gives are the subsequent dimensions and shape of the penis after it is packed full of blood.

Therefore, the key to curing Peyronie's disease is to verifiably reduce the fibrous tissue plaques that are the root cause of these dreadful symptoms.

The good news?

The fibrous tissue plaques of Peyronie's disease are the first cousins of a benign tumor. Both are noncancerous and can be detected and measured using ultrasound sonographic imaging prior to the initiation of treatment. Progress should be measured by the diminution or eradication of the fibrous tissue plaques that are responsible for many of the negative effects of "Peyronie's Displacement".


Symptoms of displacement from fibrous tissue plaques

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I have a bunch of questions and need to get them answered by the doctor before I consider scheduling a visit to your clinic

We have an ExoSurge®-certified patient support expert available to answer questions regarding what we do and how we do it. However, until we perform our comprehensive diagnostics to evaluate your case, everything we discuss is just conjecture. We’re just starting the process for FDA-clearance for much of our technology. Hopefully, it will be available nationally by 2025.

I just injured my penis during sex. Should I get ExoSurge® now or wait?

At present, standard AUA guidelines for the treatment and care of an acute penile injury case recommend a “hands off” approach for at least six months following the dissemination of pain from the penile injury.

ExoSurge technology completely changes that approach. We strongly recommend patients come into our office for care within seven days of penile trauma. ExoSurge® therapeutics reduce the pain from the injury and most importantly, stop the scar tissue and fibrosis from forming that will trigger a subsequent Peyronie’s diagnosis.

Can you combine Xiaflex® and ExoSurge®?

One of the most frequently asked questions we receive is whether we use Xiaflex (CCH intralesional injections) or whether ExoSurge® is compatible with Xiaflex®. ExoSurge® and Xiaflex® are generally perfect complements and we’ve even had cases where patients who had received CCH injections from another urologist before arriving at our clinic have also been successfully treated and repaired. In the coming year, we plan to publish a five-patient study of men who previously failed with Xiaflex injections but succeeded with ExoSurge®.

CCH (Xiaflex®) consists of C. histolyticum-derived enzymes that have been purified. The inventors believed Collagen types I and III targeted by CCH are the most abundant fibers found in Peyronie’s plaques. Thus, the treatment concept was that when CCH is administered intralesionally, “it would synergistically cleave type I and type III collagens”

Unfortunately, we discovered that although Peyronie’s fibrosis frequently begins as collagen types I and III, it quickly becomes more dense with time, to the point where collagen formed more than 18 months prior to CCH injections is typically too dense for CCH to soften in any manner where the penis can be manually straightened afterwards.

Moreover, even in cases where CCH dissolved a portion of the Peyronie’s plaque, it almost always left enough of it that the body’s healing mechanism signals the body to send more fibrotics over time, resulting in a solution that is at best temporary.

We sometimes use CCH collagenase clostridium histolyticum (Xiaflex®) in the treatment of penile fibrosis, but only after reducing the amount of penile fibrosis to a predetermined level.

The US Food and Drug Administration (FDA) approved only CCH in 2013 for the treatment of Peyronie’s Disease (PD) in men with dorsal or lateral penile curvature greater than 30 degrees. Notably, in the initial clinical trials for FDA approval of CCH, patients with calcified plaque (other than tiny, loose “stipple” calcified plaque) were excluded from all studies, and Xiaflex was not recommended for patients with detectable calcified plaques at the time. Following the 2015 hostile takeover of Auxilium by Endo Pharmaceuticals, this advisory was removed from the drug’s prescribing protocols. Nonetheless, a 2018 study24 confirms that CCH is unable to effectively penetrate calcified PD penile plaque.

Based on patients who presented to our clinic after failing multiple rounds of CCH injections at other clinics, our research indicates that CCH is also unsuitable for dense, noncalcified, long-standing plaques. In addition, 56% of Peyronie’s cases are caused by chronic micro trauma, indicating that their plaque fits the definition of long-standing dense fibrosis.

We believe that these are two of the primary reasons why Xiaflex has received such negative reviews on the two most prominent online drug review sites: Drugs.com and WebMD.com.

On Drugs.com, 69% of patients rated the drug as “1” on a scale from 1 to 10.
According to WebMD.com, 73% of patients rated the drug as “1” on a scale from 1 to 10. (25% of 34 total reviews)
Before considering administration of CCH, we advise all new patients to thoroughly review these public data.

[24] Wymer, Kevin et al, Plaque Calcification: An Important Predictor of Collagenase Clostridium Histolyticum Treatment Outcomes for Men With Peyronie’s Disease, Journal of Urology, 2018 September, 119; 119-114

Patient reviews at WebMD.com for Xiaflex in treating Peyronie’s Disease
How does ExoSurge® work with Xiaflex®?

Yes – Xiaflex can be an ideal complement to ExoSurge, if indicated for the patient’s condition.

The reason these two therapies complement each other so well is due to the underlying effect of each: Xiaflex (CCH) is a potent enzymatic (Collagenase Clostridium Histolyticum) that has been demonstrated to be effective in softening Peyronie’s fibrosis to the point where the penis can be manually “straightened” in what are known as “shaping sessions” with a treating urologist.

In almost every instance, however, the plaque and fibrosis that serve as the basis for the diagnosis remain within the penis. CCH is not inherently curative. Sometimes, it softens plaque to the point where it can be manually reshaped. CCH is a recognized treatment for one of the most common symptoms of Peyronie’s disease (erect curvature) and is covered by insurance when erect curvature is at least 30 degrees. Having adequate health insurance is crucial when using Xiaflex, as the total cost of the protocol is approximately $23,000.

ExoSurge, on the other hand, breaks up and permanently removes Peyronie’s plaque and fibrosis, but improvement in erect curvature takes longer because we cannot initially determine which specific plaque characteristics are most influential in erect curvature. ExoSurge technology is curative, as it permanently eliminates the disease’s cause as opposed to treating its symptoms.

After sufficient plaque and fibrosis have been removed to expedite a case, we’ve discovered that CCH injections are an excellent option. In addition, we have developed a protocol to optimize these outcomes that is significantly superior to what Xiaflex recommends. To maximize success with our new tandem, ExoSurge-Xiaflex patients must be willing to ignore repeated reminders from Xiaflex support that “it’s time for your next treatment.”

I lost thickness in my penile shaft, and I have a couple of “indentions” from Peyronie’s. Will ExoSurge® fix those issues?

Peyronie’s patients with significant plaque often observe some form of disfigurement in their penis. Lost length, narrowing, unexplained indentions are common observations.

The reasons behind this reduction are mostly rooted in displacement. Do you recall that lesson from Archimedes?

There’s a finite amount of space in every man’s penis. When an erection is triggered by arousal and blood flows in to pack the sponge-like corpora penis for an erection, the fibrosis limits the amount of blood allowed into the organ. In this case, something must give, which is manifested by narrowing, lost length or shaft unevenness depending upon the exact size and location of the plaque triggering a displacement reaction.

When we break up and remove the fibrosis associated with Peyronie’s disease we’ve observed that patients usually recover about half of the loss of their pre-Peyronie’s length. Patients who remain vigilant with our recommended off-site treatments using Restorex® and VED’s have been found to regain more of their lost size than those who skimped on such care.

We have been testing with a modified ExoSurge treatment technique that helps specifically resolve shaft disfigurement, but those new approaches are not yet part of our standard protocol.

I had repeated treatments of Xiaflex® with no success. Will ExoSurge® work for me?

We usually have good news and bad news for patients who already had one or more Xiaflex® injections with no success.

The good news?

Yes – we can still use our technology to repair your Peyronie’s Disease indication.

The bad news?

It usually takes 25%-35% longer to resolve a case that already started with Xiaflex® injections than one that did not.


Why is that?

The active ingredient in Xiaflex® is collagenase, a powerful enzyme that’s akin to an acid, but that is safe for human tissue. The concept behind this solution is that the robust enzyme will essentially dissolve the plaque and heal the condition. Unfortunately, it appears to remove the curvature in less than half the cases. Amongst those where it was perceived to have succeeded, we’re now seeing cases where Xiaflex® was administered 4-5 years ago and the condition returned, albeit with novel “corkscrew” shaped erections. To put it another way, it doesn’t appear to always “dissolve” the plaque, but rather sometimes just soften it enough to where a urologist can manually straighten the curve; only to return later with a new situation.
When plaque has been melted in any manner by collagenase injections, those treated areas become denser than they were before such treatments.

The stronger the density of the plaque, the longer it takes to break it up.


I have a 45-degree curvature during erection. Can ExoSurge® fix me?

We understand the degree of curvature is what most patients are obsessed over. It triggers penile length reduction and can cause sexual intercourse to become impossible.

Illustration

However, the degree of any penile curvature is just a potential symptom based upon the size and location of the fibrosis within your penis. If the mass is located on the underside of the penis, an erection will point downward. If the fibrosis is on the top of the penis, the erection will curve upward. If it’s positioned along the side of the penis, the penis will point sideways during erection. As the curve triggering fibrotic mass gets larger over time, the curve becomes more severe.

When we treat and break up the plaque, the curve is reduced / removed accordingly. Thirty percent of Peyronie’s cases we treat have little or no curvature but face other debilitating symptoms such as severe erectile dysfunction or a disfigured penis.

Please note that not all men with a curved penis have Peyronie’s disease. Approximately 35% of the patient’s we’ve treated to date had minimal or no curvature when erect, but significant fibrosis in the soft tissue of the penis and / or a thickened tunica.

Most every penis has some degree of slight curve during erection, regardless of a Peyronie’s diagnosis. Additionally, some men were born with a significant “congenital curve” that’s not remotely associated with plaque or fibrosis. If you’ve had significant penile curvature during erections for as long as you can recall since childhood, you most likely have a congenital curve or chordee. If you have a congenital curve, you’ll want to be mindful of be careful steering clear of partner on top



I’m skeptical, where’s the published studies?

Our lawyers have not yet allowed us to share any details of our studies because the information contained therein includes details for upcoming patents. This is a frustrating to us as it is to many of our patients and future clinical partners.

Our most recent retrospective study showed a 79% reduction in the penile plaque and fibrosis that cause Peyronie’s (confirmed through verifiable changes in imagery from duplex Doppler sonographic imagery). More recent results appear to be even better.

We can now share some imagery you won’t find anywhere else in the world.

First, are a handful of “before and after” ultrasonic images of reduction in calcified plaque from ExoSurge technology. Fibrotic plaque appears in “movie” type images that require motion to measure, making them impossible to compare frame to frame.

What’s the biggest challenge facing our new ExoSurge® Technology?

Any new Peyronies treatment or technology is met with skepticism. This disease has been medically identified since the middle ages. The best any existing technology has achieved is to improve symptoms f the disease in a select number of patients. Acknowledging ExoSurge is a curative pathway, only broadens doubt.

That’s only fair. We understand that this cynicism will take time to overcome. Our patent legal issues further complicate matters. We can’t even share a tenth of what we’ve discovered yet. We have nearly two decades of effort and a lot of money invested in the development of this technology.

Right now, our hands are tied. Much of this, we’re told, will change by the end of 2023 or in 2024.

We can’t wait to tell everyone about our discoveries.