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?
Yes, Peyronie’s is now curable with ExoSurge among compliant patients. However, this cure is not yet universally available.
How is Peyronie's cured?
In these regards, there are some key truths you should learn and grasp first.
- 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.
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What's the Treatment Pathway for Curing a Peyronie's case?
Taking into account what was just learned above, our present pathway for curative outcomes with 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:After all of the case data has been assimilated, it’s time for your provider to communicate information about your specific case, such as the size and position of fibrous plaques, their estimated density and nature, your Peyronie’s Accelerator score, and other crucial metrics from our new therapy algorithm. Following that, a member of the treatment team will go over your alternatives and timeline, taking into account your individual situation.
- 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 curative outcomes for Peyronie's Disease
ExoSurge is a new non-surgical, patented medical technology that uses a custom blend of pulsated injected gases to dramatically boost the efficacy of two generic intralesionally injected Peyronie’s drugs14. The pulsated gas injections are able to penetrate the Peyronie’s fibrosis, which allows the injected drugs to eventually penetrate the fibrotic plaques and eventually dissolve them.
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.
Acoustic Wave Therapy
Acoustic wave and LISW therapy theoretically should remove fibrous plaques from Peyronie’s. That’s one reason we employed LISW treatments as a part of our Peyronie’s care early on. Later, we discovered they played no role in the removal of Peyronie’s fibrosis. LISW (not the cheaper devices known as acoustic wave) have an important role in treating aspects of erectile dysfunction but are not effective treating Peyronie’s disease.
We employ Xiaflex (collagenase) injections on patients with more large and deense fibrous plaques but only after the density state of the fibrosis is soft and pliable. Collagenease injections do not remove plaques associated with Peyronie’s. They only sometimes soften the fibrosis to a point where a urologists can manually straighten out your penis. We must follow each collagenase injection with ExoSurge treatments to completely dissolve the soften plaques.
Recently, we’ve begun to see an increase in patients who previously saw improvement with Xiaflex injections, only to have symptoms to return in a varied often “S-shaped” erection design.
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.
