On the basis of two recent disease prevalence studies involving over 19,000 American US men, the current US (ATM) total addressable market exceeds $147 billion, of which a $29 billion segment is identified as the targeted (ASM) serviceable available market segment for our breakthrough technology.
We believe the curative nature ExoSurge offers the potential for EXO to dominate this $29 billion marketplace.
Market Analysis
An estimated 20-30% of men (globally) will suffer from Peyronie’s disease within the next twenty years. One-third of those will be unable to perform without treatment.
Peyronie's Prevalence: Why we believe it's much higher than sometimes estimated
We utilized evidence from the 2016 Perlacky, et al. study of 7,711 American men and the 2011 Di Benedetti, et al. study of 11,420 American respondents. Both were web based which removed the embarrassing element of testimony, both reached very similar conclusions regarding the prevalence of Peyronie's disease, and they both included demographic information that was not found in other studies.
Traditional prevalence estimates for Peyronie's disease have been all over the map, ranging from 0.39% to greater than 20%, with the majority estimating prevalence at approximately 3%.
There was always a "acknowledgement" in these studies that the actual incidence of this disease in the population may be higher due to patients' reluctance to seek treatment and diagnosis for this humiliating condition. The medical community's limited comprehension of PD may also contribute to underdiagnosis.
Because of the "Smith Study" in 1969, which was conducted before the sexual revolution (increased incidence of acute injury) and the advent of new health factors we discovered when unlocking Peyronie's epidemiology, all studies cite a prevalence of up to 20%. B.H. Smith was a US Navy captain working for the Armed Forces Institute of Pathology (AFIP) who had the brilliant notion to examine the prevalence of Peyronie's disease by performing 200 penile cadaver autopsies. He discovered penile fibrosis in nearly 21 percent of the deceased. A future study of European cadavers revealed comparable instances.
We believe that the fact that most urologists diagnose Peyronie's disease through physical examination as opposed to ultrasound imaging is a significant factor in why underreporting has remained so widespread. Inter fibrous plaques have never been effectively treated in urology. Therefore, if a patient reports moderate symptoms, the majority of urologists will ask, "How bothersome is the issue?"
Our investigation into the epidemiology of Peyronie's disease reveals that Peyronie's fibrosis is a progressive condition that never "heals itself." Rather, we encountered instances in which the patient became asymptomatic while the lesions persisted. In the future, when these patients encounter Peyronie's Accelerators, they will experience the symptoms of Peyronie's.
We anticipate that the curative nature of ExoSurge technology and its capacity to treat and heal asymptomatic early-stage cases of penile fibrosis will eventually reveal a prevalence as high as Smith's study (20%), or even higher given the changes in general health and sexual activity since 1969.
Traditional prevalence estimates for Peyronie's disease have been all over the map, ranging from 0.39% to greater than 20%, with the majority estimating prevalence at approximately 3%.
There was always a "acknowledgement" in these studies that the actual incidence of this disease in the population may be higher due to patients' reluctance to seek treatment and diagnosis for this humiliating condition. The medical community's limited comprehension of PD may also contribute to underdiagnosis.
Because of the "Smith Study" in 1969, which was conducted before the sexual revolution (increased incidence of acute injury) and the advent of new health factors we discovered when unlocking Peyronie's epidemiology, all studies cite a prevalence of up to 20%. B.H. Smith was a US Navy captain working for the Armed Forces Institute of Pathology (AFIP) who had the brilliant notion to examine the prevalence of Peyronie's disease by performing 200 penile cadaver autopsies. He discovered penile fibrosis in nearly 21 percent of the deceased. A future study of European cadavers revealed comparable instances.
We believe that the fact that most urologists diagnose Peyronie's disease through physical examination as opposed to ultrasound imaging is a significant factor in why underreporting has remained so widespread. Inter fibrous plaques have never been effectively treated in urology. Therefore, if a patient reports moderate symptoms, the majority of urologists will ask, "How bothersome is the issue?"
Our investigation into the epidemiology of Peyronie's disease reveals that Peyronie's fibrosis is a progressive condition that never "heals itself." Rather, we encountered instances in which the patient became asymptomatic while the lesions persisted. In the future, when these patients encounter Peyronie's Accelerators, they will experience the symptoms of Peyronie's.
We anticipate that the curative nature of ExoSurge technology and its capacity to treat and heal asymptomatic early-stage cases of penile fibrosis will eventually reveal a prevalence as high as Smith's study (20%), or even higher given the changes in general health and sexual activity since 1969.
Addressible US Market Size Metrics
US Serviceable Available Market (ASM) Size Calculation: $29 Billion
US Total Available Market (ATM) Size Calculation: $147 Billion
Worldwide Total Available Market (ATM) Size Calculation: $350 Billion
EXO: Competition
EXO Strategy: Complementary Disruptor
Existing FDA-Approved Treatments
As mentioned previously, both existing FDA-approved therapies only treat symptoms (erect curvature) of Peyronie's. Neither addresses or resolves the underlying epidemiology of the disease. Long term success rates are anemic.
Strategically-speaking, EXO's technology is what's classified as a "complementary disruptor". While EXO's breakthrough technology is most certainly market disruptive because of its curative outcomes, it doesn't directly compete with any of the established FDA-approved therapies.
Rather, each of these existing treatments often make EXO's technology work faster and better for certain patients. Thus, EXO's success does nothing but make both FDA-approved treatment paths much more successful.
We expect these symbiotic relationships to be a powerful component of our rapid success in the years ahead.
Strategically-speaking, EXO's technology is what's classified as a "complementary disruptor". While EXO's breakthrough technology is most certainly market disruptive because of its curative outcomes, it doesn't directly compete with any of the established FDA-approved therapies.
Rather, each of these existing treatments often make EXO's technology work faster and better for certain patients. Thus, EXO's success does nothing but make both FDA-approved treatment paths much more successful.
We expect these symbiotic relationships to be a powerful component of our rapid success in the years ahead.
Peyronie's Surgey
Peyronie's surgery is presently recognized as the "gold standard" for Peyronie's care by the American Urological Association (AUA). It only addresses select cases with erect curvature, does not remove or cure the underlying basis for the disease (the fibrous tissue plaques) and doesn't have a history of good outcomes.
Surgery for Peyronie’s Disease is currently only indicated in the most severe cases with a degree of curvature that does not allow for sexual intercourse and/or causes pain.
According to a recent retrospective study published by Florian Wimpissinger, MD, of the department of urology at Rudolfstiftung Hospital in Vienna, Austria in 2012 regarding the long term outcomes associated with PD surgery – results are anything but ideal.
After a mean of 9.3 years, the recurrence of postoperative curvature had increased from 0% after a mean of 38 months (18–73 months) to 23.7%, post-op erectile dysfunction increased from 3.0% to 39.5%, penile shortening from 0.0% to 65.8%, and impairment of penile sensitivity from 3% to 31.4%.
"We saw that results tend to worsen with time," said Dr. Wimpissinger, who presented the study results at the 2011 European Association of Urology annual congress in Vienna.
The bottom line?
Long-term results from Peyronie’s surgery indicate the condition usually returns – and remains equally debilitating and painful.
Surgery for Peyronie’s Disease is currently only indicated in the most severe cases with a degree of curvature that does not allow for sexual intercourse and/or causes pain.
According to a recent retrospective study published by Florian Wimpissinger, MD, of the department of urology at Rudolfstiftung Hospital in Vienna, Austria in 2012 regarding the long term outcomes associated with PD surgery – results are anything but ideal.
After a mean of 9.3 years, the recurrence of postoperative curvature had increased from 0% after a mean of 38 months (18–73 months) to 23.7%, post-op erectile dysfunction increased from 3.0% to 39.5%, penile shortening from 0.0% to 65.8%, and impairment of penile sensitivity from 3% to 31.4%.
"We saw that results tend to worsen with time," said Dr. Wimpissinger, who presented the study results at the 2011 European Association of Urology annual congress in Vienna.
The bottom line?
Long-term results from Peyronie’s surgery indicate the condition usually returns – and remains equally debilitating and painful.
There are two generally recognized Peyronie's surgery pathways
1. Peyronie's Incision and Graft Surgery
During the penile grafting procedure, surgeons remove the plaque or swelling that has created a tough covering of the erectile portion of the penis. They replace this tough covering with a graft of synthetic or biological material. This procedure should correct the curve of your penis.
During the penile grafting procedure, surgeons remove the plaque or swelling that has created a tough covering of the erectile portion of the penis. They replace this tough covering with a graft of synthetic or biological material. This procedure should correct the curve of your penis.
2. Peyronie's Plication Surgery: Plication surgery has the least negative side effects when it comes to post-surgical complications.
During plication of the penis, a saltwater solution or specified medications are injected to induce an artificial erection. The penis's outermost skin is drawn back. The penis is straightened, and the excess tissue on what had been the outer side of the curve is constrained with a series of sutures or "tucks." The ultimate length of the penile will depend on the length of the shorter side, the side with Peyronie's disease scarring.
That last sentence is the big challenge with plication surgery. Most men end up with erect penile length where their curve now begins. Losing up to three inches of erect length is not uncommon.
During plication of the penis, a saltwater solution or specified medications are injected to induce an artificial erection. The penis's outermost skin is drawn back. The penis is straightened, and the excess tissue on what had been the outer side of the curve is constrained with a series of sutures or "tucks." The ultimate length of the penile will depend on the length of the shorter side, the side with Peyronie's disease scarring.
That last sentence is the big challenge with plication surgery. Most men end up with erect penile length where their curve now begins. Losing up to three inches of erect length is not uncommon.
ExoSurge and Peyronie's Surgery
As with the existing FDA-approved therapies for Peyronie's, ExoSurge functions as a disruptive complement to Peyronie's surgery, or more specifically, Peyronie's plication surgery.
We believe that the reason plication surgery results in a shorter penis after surgery is due to the density of fibrous tissue plaques prior to surgery and healthcare's lack of knowledge regarding Peyronie's accelerators.
We hypothesized that if a Peyronie's disease patient's case was effectively managed, the plaque would become suitable for plication without the size loss side effects.
One such operation was performed by the EXO Chief Medical Officer, and the results were exceptional, with no size reduction. The precise protocols for this pathway require additional work, but we believe it will be well received by urologists with experience in Peyronie's plication surgery.
We believe that the reason plication surgery results in a shorter penis after surgery is due to the density of fibrous tissue plaques prior to surgery and healthcare's lack of knowledge regarding Peyronie's accelerators.
We hypothesized that if a Peyronie's disease patient's case was effectively managed, the plaque would become suitable for plication without the size loss side effects.
One such operation was performed by the EXO Chief Medical Officer, and the results were exceptional, with no size reduction. The precise protocols for this pathway require additional work, but we believe it will be well received by urologists with experience in Peyronie's plication surgery.
Peyronie's Care Reimagined
ExoSurge introduces an entirely new treatment paradigm for Peyronie's for urologists.
- Prevention: Testing that identifies susceptible patients in advance of fibrosis and prescribed treatment
- Early Stage Detection and treatment:
- Active Stage Resolution and Repair:
- Established Cases: Both Calcified and Non-calcified cases
- Established Cases: Asymptomatic Case Solution
Peyronie's Prevention Care
ExoSurge researchers have identified a blood test that has proved to be nearly 100 percent accurate in predicting Peyronie's cases that are about to become problematic for patients. Urologists can now regulate the prevention of Peyronie's disease.
ExoSurge researchers have identified a blood test that has proved to be nearly 100 percent accurate in predicting Peyronie's cases that are about to become problematic for patients. Urologists can now regulate the prevention of Peyronie's disease.
Early State Peyronie's Detection and Treatment
Urologists will be able to detect and treat mild forms of penile fibrosis before they become a problem by using duplex Doppler sonographic testing and other tests that disclose a patient's status with Peyronie's accelerators.
Urologists will be able to detect and treat mild forms of penile fibrosis before they become a problem by using duplex Doppler sonographic testing and other tests that disclose a patient's status with Peyronie's accelerators.
Active Stage Peyronie's Resolution and Repair
Current AUA guidelines for the treatment of Peyronie's disease caused by a specific incident of penile trauma recommend no treatment during the "acute phase" immediately following the incident, some conservative therapies during the "active phase," and case-specific pathways once the condition has stabilized.
ExoSurge completely alters the situation.
If ExoSurge is applied promptly during the acute phase, post-trauma pain is reduced to a few days, and subsequent treatments prevent the formation of fibrous plaques in the tissue.
Current AUA guidelines for the treatment of Peyronie's disease caused by a specific incident of penile trauma recommend no treatment during the "acute phase" immediately following the incident, some conservative therapies during the "active phase," and case-specific pathways once the condition has stabilized.
ExoSurge completely alters the situation.
If ExoSurge is applied promptly during the acute phase, post-trauma pain is reduced to a few days, and subsequent treatments prevent the formation of fibrous plaques in the tissue.
Established Cases: Calcified and Non-Calcified
During the first five years of integration, EXO will prioritize effectively treating the large inventory of existing Peyronie's disease cases. ExoSurge is efficacious regardless of preexisting conditions in all cases.
Cases of Exiting Asymptomatic Peyronie's Disease
Existing Peyronie's disease patients with only palpable plaque and minimal or no curve are left with few treatment options under the current urologic care paradigm. Frequently, they are queried, "How bothersome is it?"
ExoSurge provides these patients with a safe and effective solution.
Existing Peyronie's disease patients with only palpable plaque and minimal or no curve are left with few treatment options under the current urologic care paradigm. Frequently, they are queried, "How bothersome is it?"
ExoSurge provides these patients with a safe and effective solution.