A medical cure for Peyronie's Disease
Let’s begin with an excerpt from our institute’s story that occurred during our long journey developing our cure for Peyronie’s
After a fellow urologist from California visited our clinic in 2015 and saw our results treating Peyronie’s at the time, our development team went through a transformative experience.
“We needed to publish ASAP, this is game-changing,” this urologist exclaimed. We knew our technology was already superior to established therapies at the time, but we hadn’t yet isolated all of the variables within the disease’s epidemiology, so we still encountered cases we couldn’t improve.
It was tempting to jump into the forefront of Peyronie’s care because we also had a firm offering us a monetization path.
“Did we all sign-on for this maddening project because we wanted to provide another treatment for Peyronie’s, or did we commit to developing a cure for Peyronie’s?” asked one of our junior associates, reminding us about our mission statement.
She was correct.
None of us agreed to work this hard just to develop another treatment. We were determined to find a cure.
Since then, we haven’t looked back.
Is Peyronie's curable?
Is Peyronie’s curable?
Yes, Peyronie’s is now curable with ExoSurge among compliant patients. However, this cure is not yet universally available.
Schedule a Review of your case
Is Peyronie’s curable?
Yes, Peyronie’s is now curable with ExoSurge among compliant patients. However, this cure is not yet universally available.
How is Peyronie's cured?
There are important facts you need to first learn and understand in these regards.
- Peyronie’s symptoms vs. Peyronie’s Disease: Peyronie’s disease is not curvature when erect or flaccid, diminished length, hourglass shape, pain during erections, or trouble maintaining a strong erection. All of those conditions are merely symptoms of what happens when fibrous plaques are in the penile organ.
- Peyronie’s disease is defined as the accumulation of fibrous plaques in the soft tissue of the organ and/or a thicker tunica albuginea. These conditions are caused by various types of penile injuries, most frequently by a lifetime of ongoing micro traumas.
- Most men have small amounts of penile fibrosis within their corpora from a wide variety of lifelong penile micro-trauma’s caused by incidents ranging from minor athletic injuries to rigorous sexual activity. However, such cases will remain asymptomatic until one or more of at least six health conditions known as “Peyronie’s Accelerators” kicks cause the fibrous plaques to begin to grow and cause one or more of the Peyronie’s symptoms shared above. Significant penile fibrosis can also occur immediately following any actuate penile injury. According to our research, roughly 60% of all new Peyronie’s cases are derived fibrotic plaques caused by lifelong perpetual micro trauma that subsequently coincide with one or more Peyronie’s Accelerators.
- Once a life-long case born from years of micro trauma becomes symptomatic, the symptoms tend to worsen as the body is triggered to respond with even more fibrotic growth in an effort to heal the condition. In actuality, the increased number of fibrous plaques cause more glaring symptoms and make the case progressively worse.
- In younger, healthy men, cases of acute penile trauma will sometimes remain asymptomatic for decades. This is why some physicians still recommend patients “do nothing” following a notable penile injury since it might “go away” on its own. We learned that even in those rare cases following acute injury where symptoms don’t occur or delineate, the fibrosis is still present in the penis and will eventually become a problem in years ahead when the patients evolves to having one or more “Peyronie’s Accelerator” conditions.
What's the Treatment Pathway for Curing Peyronie's?
Taking into account what was just learned above, our present pathway to completely cure Peyronie’s is as follows:
- Test for Health Diagnostics: A patient must be thoroughly tested and evaluated for health paradigms related to Peyronie’s Disease. If the patient is less than optimized in regards to any of the six known Peyronie’s Accelerators discussed previously, those deficiencies must be treated so that subsequent removal of fibrosis is optimized and sustainable.
- Test for Peyronie’s Plaques and Scar: A duplex Doppler penile ultrasound is performed to identify the exact size, location and density of fibrous plaques within the soft tissue of the penis organ. These plaques need to be physically mapped based upon size and location for subsequent treatment and dissolution.
- Clinical Evaluation: Algorithm and Metrics for Treatment Plan: After assimilation of the patient health diagnostics, a physical exam and interview, and results from the penile ultrasound are gathered, the combined data set is entered into our Peyronie’s Patient Treatment algorithm. This algorithm is based upon retrospective patient data from histories of over 1,000 patients, and helps us to provide an estimate on the number of ExoSurge treatments that will be necessary to resolve this Peyronie’s case. e have discovered key elements to this priority plan based upon our experience treating many patients.
- Optional: Calcified Plaques Pathway: If the penile ultrasound testing exhibits calcified plaques within the penis, we’ve developed an amended treatment pathway to remove the calcified elements which sit atop the fibrous plaques. We’ve even found cases where calcified plaques are discovered within fibrous plaques, further illuminating the progressive nature of Peyronie’s plaque build-up.
- Review of Findings and Treatment Plan:
- ExoSurge Therapy: We begin to safely and effectively remove and dissolve the fibrous plaques within the organ following the priority plan previously articulated through ExoSurge injections. We must adjust and modify the exact drug injection protocol based upon treatment outcomes.
- Off-Site Traction Therapy: We’ve discovered Restorex traction therapy helps speed results as the scar tissue and fibrotic masses begin to break up. It also helps restore any lost penile size as Peyronie’s plaque is dissolved.
- Optional Xiaflex Injections: In cases with excessive amounts of penile fibrosis, we sometimes employ collagenase injections to help speed improvement. This is only done after the state of the fibrosis has first been sufficiently “softened” through ExoSurge treatments. ExoSurge treatments must follow the injection of Xiaflex to ensure the dispersal of plaques and help with healing. Since Xiaflex is expensive and only insurance-covered if a patient has a curve in excess of thirty degrees, we’re testing with comparable enzymatics to create comparable “speed up” opportunities for men with little or no penile curvature.
- Follow Up Penile Ultrasound: Either the patient or one of our providers might request a follow up ultrasound during ExoSurge treatments in oder to objectively evaluate improvement with the removal of Peyronie’s fibrotic plaques.
- Post Curative Care: Once a patient’s Peyronie’s case is completely devoid of penile fibrosis, it’s essential to educate the patient in regards to their ongoing healthcare as it relates to their scores with Peyronie’s Accelerators. This is particularly important for patent’s who don’t “complete” therapy because of time and costs. Many of our patients have come from out of state, and treatment can become overwhelming. As an example, if they started with siginifant fibrosis and a 70 degree curvature when erect, and now have only a small amount of fibrous plaques, quality erections, and a less than twenty degree curvature, some patients will opt out of additional treatments for completely curative care. It’s essential such patients maintain our targeted optimization of metrics to ensure any growth of plaques don’t accelerate in the future.
Common questions and answers related to our cure for Peyronie's Disease
ExoSurge is a new non-surgical, patented medical technology that uses a custom blend of injected gases to dramatically boost the efficacy of two generic intralesionally injected Peyronie’s drugs14.
It is the world’s only clinically-proven technology to permanently remove penile fibrosis and plaques (79% reduction in most recent study).
You should understand that all of the penile conditions you hear about with Peyronie’s —including curvature when erect, diminished length, hourglass shaping, indentions, erectile dysfunction, and painful erections—are merely symptoms resulting from the precise size, density, and position of fibrous plaques within your penile organ.
Everything that’s presently offered to treat Peyronie’s Disease only treats symptoms ( most commonly the Peyronie’s-based erect curvature), including Peyronie’s surgeries and Xiaflex injections. Even if one of those therapies results in a significant improvement in Peyronie’s symptoms, there is still a good chance that the symptoms will eventually return because of the continued presence of the penile fibrous plaques.
ExoSurge is the only technology available that’s clinically proven to remove fibrous plaques that cause Peyronie’s symptoms.
A pair of off-label therapies most commonly prescribed by “men’s clinics” sometimes claim to remove Peyronie’s plaques through variations of PRP injections and/or acoustic wave / low intensity shockwave therapy.
Neither of these are successful removing Peyronie’s plaque. We’ll discuss each of these therapies separately because they fail for different reasons, even though we’ve heard from patients many clinics claim “combining” them creates some sort of magical effect.
PRP Injections
There are tons of variants on these penile injections. Studies clearly show neither of these treatments are successful in removing Peyronie’s fibrosis.
Please know this, our urology institute is not a “men’s health clinic”, with commissioned sales staff or pre-pay cash-only packages for treatment.
Sadly, they are just scams preying on vulnerable men.
Unfortunately, getting FDA approval for our gas and medicine injection technique turned into a $50 million obstacle. The curative inputs we developed for ExoSurge have never been integrated by any healthcare medtech or biomedical before us. The FDA classified ExoSurge as requiring a PMA as opposed to the far easier (and less expensive) 510(k) process for FDA authorization. That is incredibly costly and time-consuming. In order to attract a qualified pharmaceutical partner, we have had to make changes to the drug-related components of our intellectual property.
We expect to have formed a partnership with a much larger pharmaceutical company by the end of 2024, which means we’ll probably start prospective clinical trials in 2025 and then file for FDA approval; the device and drugs are not yet available for purchase or use by other urologists.
We hope to collaborate with clinicians to bring this groundbreaking technology to those seeking a permanent conservative Peyronie’s solution once we are approved by the FDA. We are also hopeful that this therapy will be fully covered by insurance at that time.
Should I start with a one-on-one case consultation or in-office evaluation?
Please know this, our urology institute is not a “men’s health clinic”, with commissioned sales staff or pre-pay cash-only packages for treatment.
How do I get started with ExoSurge therapy?
We provide unique pathways to help you get started which vary depending upon if you’re local, coming from out of state, or visiting from another country
Local patient pathway
- You can start by scheduling your in-office medical tests and diagnostics, or you can begin your journey with ExoSurge with a free “one on one” phone case consultation.
Without comprehensive testing, it is impossible to diagnose each individual Peyronie’s condition with accuracy. When compared to your age, health, and the size, density, and location of your penile fibrosis, your “degree of erect curvature or lost penile size” usually has far less of an effect on the number of treatments needed to dissolve your fibrotic plaques.
Generally speaking, more treatments are needed to dissolve your penile fibrosis the longer it has been present (more dense plaques).
2. The next steps involve office-based tests such as an examination, a penile Duplex Doppler ultrasonography, and a Peyronie’s blood panel draw. We next input all of your vital information into our ExoSurge patient therapy algorithm, including the location, density, and size of your fibrous plaques, along with vital information gleaned from your blood work and diagnostic testing.
3. Following that, we can present you a comprehensive plan that includes an estimate of how many ExoSurge treatments will be required to end your case and the actions you’ll need to take to heal your Peyronie’s. The precise size, density, and location of your fibrous plaques, as well as any additional potential inadequacies found during testing, all affect this figure.
Better still? The majority of insurance policies pay for all of these exams as well as documentation of your success plan.
We invented a life-changing technology to free patients from the horrors of the symptoms from Peyronie’s disease
[14] Warwick, David, et al, “Collagenase Clostridium His¬tolyticum: emerging practice patterns and treatment advances” Journal of Plastic Surgery and Hand Surgery, 2016 Sep 2; 50(5): 251–261
What’s involved with ExoSurge Therapeutics?
Most patients are best suited receiving a single ExoSurge® treatment once daily, and each treatment takes about 20 minutes from start to finish. The total number of ExoSurge® treatments required for each patient is determined by the size and density of the treated penile plaque areas (the longer the plaque has been in place, the denser it typically becomes). We must also evaluate and manage the status of any Peyronie’s accelerators in each patient, existing health paradigms, and which of the ten various plaque structures is predominant. Failure to optimize these latter aspects dramatically slows improvement with plaque reduction.
Reported side effects from ExoSurge® have included penile bruising, swelling, and mild pain at the injection site.
ExoSurge® Patient Sciences
While our device and intralesional injections technology are poised to change the game with Peyronie’s Disease care from treating symptoms to curing the disease, urologic clinicians must also perform extensive analysis and planning to successfully cure each Peyronie’s case.
We have discovered that there are six distinct “Peyronie’s Accelerators” (health paradigms that induce a long-standing benign case to become active) and ten unique plaque and fibrosis design variations. Thus, a significant portion of this technology’s success is tied to our individualized diagnosis of each patient and assimilation of therapies to resolve any health deficits, plaque size, and type.
No two cases of Peyronie’s disease are identical. Every Peyronie’s case is unique based upon the exact size and location of the penile plaques, the amount of time the fibrosis has been established within the corpora (density), and the status of a select set of patient health indicators we determined notably affect Peyronie’s outcomes.
Much of this information is derived from data and images from duplex Doppler sonography testing, detailed blood panels and patient examination and interview.
We now have a functioning prototype for the ExoSurge Peyronie’s patient algorithm that assimilates all of this data and provides the curative pathway and the expected number of treatments to achieve that outcome, using retrospective data from previous patients.
This algorithm will be essential to ensure optimal results when ExoSurge becomes available to urologists around the globe.
[15] Levine LA, Newell M, Taylor FL. Penile traction therapy for treatment of Peyronie’s disease: a single-center pilot study. J Sex Med 2008; 5: 1468–1473. [16] Martinez-Salamanca JI, Egui A, Moncada I, et al. Acute phase Peyronie’s disease management with traction device: a non-randomized prospective controlled trial with ultrasound correlation. J Sex Med 2014; 11: 506–515
ExoSurge Supporting Therapeutics
The patients in our published retrospective study where we permanently removed approximate 80% of Peyronie’s place and fibrosis did not employ these supporting therapeutics.
However, we now prescribe some of them to patients with select cases to help speed their healing time horizon.
These include:
Penile Traction Therapy (PTT)
Penile traction has long been proposed and utilized to treat PD to reduce erect curvature15, prevent the progression of scar growth, regain sexual function16, and help recoup lost penile length and thickness.
Studies have revealed measurable improvement with selected deformities during the tested phase, but we found none that analyzed the therapeutics impact on reduction of the penile plaque through comparative ultrasonography imagery, nor did we find any longer-term analysis of results over time after therapeutics were halted for some period.
We now prescribe penile traction as an aspect of ExoSurge® therapeutics but for different reasons that most Peyronie’s traction therapeutic pundits or modalities which remains a trade secret at this time.
Vacuum Erection Device (VED)
Vacuum erection devices VED) were the first successful physiological treatment for erectile dysfunction and have a long history within erectile dysfunction and Peyronie’s care. When used singularly to treat PD, VED’s have been found to be only marginally effective17.
We now prescribe their use to support faster outcomes from aspects of ExoSurge therapy.
PDE-5 Inhibitor Use
PDE-5 inhibitors18 have been recognized for helping with Peyronie’s care by helping elevate cyclic guanosine monophosphate in the corpora and enhancing penile blood flow. Again, our motivation in using PDE-5 inhibitors is unique and remains proprietary at this time.
[17] Lin HC, Yang WL, Zhang JL, et al. Penile rehabilitation with a vacuum erectile device in an animal model is related to an antihypoxic mechanism: blood gas evidence. Asian J Androl 2013; 15: 387–390. [18]Valente EG, Vernet D, Ferrini MG, et al. L-arginine and phosphodiesterase (PDE) inhibitors counteract fibrosis in the Peyronie’s fibrotic plaque and related fibroblast cultures. Nitric Oxide 2003;9:229-44
Additional Therapeutics
ExoSurge® was not invented in a straight line.
Along the way, we discovered additional off-label medicines and techniques were notably suitable for overcoming obstacles in more difficult Peyronie’s cases and/or accelerating improvement in patients with longer established plaques.
Including these additional devices and technologies in our planned ExoSurge® clinical trials was not feasible.
However, they remain available at Morganstern Health, our flagship Peyronie’s treatment center in Atlanta for treating more difficult Peyronie’s cases, such as men with considerable insufficient arterial flow, extensively calcified plaque, and significant venous leakage at the outset.
Inadequate Arterial Flow Treatment
We prescribe external counterpulsation (ECP) therapy for roughly 20% of our Peyronie’s patients (98% are ECP patients are 55 years or older), based upon data derived and analyzed from penile duplex doppler ultrasonography and photography regarding penile arterial blood flow, unless it’s contraindicated by such preexisting conditions as significant arrhythmias, decompensated heart failure, uncontrolled hypertension, etc.
The most important rationale for the use of ECP is that it delivers a 144% increase in internal iliac blood flow19, which also boosts blood flow to the penis. Also, along with reduced cardiac demand, ECP20 improves endothelial function21 and vasodilation, which may result in increased levels of nitric oxide22, plus vascular endothelial and fibroblast growth factors.
Most conservative therapeutics, including ExoSurge®, are dependent upon blood flow to help repair PD penile plaque. In cases where duplex doppler ultrasonography demonstrates severely deficient arterial blood flow, we recommend ECP therapy to those patients before we begin therapeutics.
Our duplex doppler ultrasonography testing reveals readings every five minutes for a total of thirty minutes on both the left and right PSV (Peak Systolic Volume). We consider any reading where PSV is above 40 to be good enough to not recommend ECP treatment. We define a mild to moderate penile arterial flow deficiency as is a PSV reading of between 20-30. We would recommend a moderate number of ECP treatments before starting ExoSurge® therapeutics to optimize healing dynamics. A severe arterial insufficiency, which would negatively impact our speed and outcomes dissolving Peyronie’s plaque would be any PSV below a reading of 20.
[19]Syed A. Raeissdat, et al Enhanced external counterpulsation in rehabilitation of erectile dysfunction: a narrative literature review, Vascular Health Risk Management, 2018; 14: 393–399.
[20]Syed A. Raeissdat, et al Enhanced external counterpulsation in rehabilitation of erectile dysfunction: a narrative literature review, Vascular Health Risk Management, 2018; 14: 393–399.
[21]R. M. J. Palmer, D. S. Ashton, and S. Moncada, “Vascular endothelial cells synthesize nitric oxide from L-arginine,” Nature, vol. 333, no. 6174, pp. 664–666, 1988.
[22]H. H. Davila, T. R. Magee, D. Vernet, J. Rajfer, and N. F. Gonzalez-Cadavid, “Gene transfer of inducible nitric oxide synthase complementary DNA regresses the fibrotic plaque in an animal model of Peyronie’s disease,” Biology of Reproduction, vol. 71, no. 5, pp. 1568–1577, 2004
