A Cure for Peyronie’s Disease
When we began our odyssey some twenty years ago, our mission was never to innovate a new and better way to treat Peyronie’s or enhance its many negative symptoms. Rather, our mission was and remains to develop the cure for Peyronie’s disease.
While we’re not able to state we’ve invented the cure for Peyronie’s Disease just yet, we’re proud to share that we’re very, very close to that achievement.
ExoSurge: Core Treatment Technology
What is ExoSurge® Technology?
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) that trigger morphed penile appearance issues such as erect curvature, indentions, shortened length, and hourglass shaping.
[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
Request information about Peyronie’s treatments
Unfortunately, we’re headed directly toward a new $50 million obstacle: obtaining FDA approval for our gas and drug injection technology. We expect to have formed a partnership with a much larger pharmaceutical company by the end of 2023, which means we’ll be able to start prospective clinical trials in 2024 and then file for FDA approval; the device and drugs are not yet available for purchase 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.
What’s involved with each ExoSurge Treatment?
We discovered that 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’re still refining a new therapy algorithm to assist in guiding and managing the complexities of this process and hope to have it integrated within the interface of the device and a supporting application for future partner urologic clinicians.
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 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.
[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
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
Unique Therapies
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
