ExoSurge® Technology
ExoSurge® Inter-fibrinous Pulsated Gas and Drug Technology (IPG)
Five issued patents, 12 patents and provisionals filed both nationally and internationally
The ExoSurge® Inter-fibrinous Pulsated Gaseous Technology (IPG) uses a sequenced three-step pulsated gas injection followed by injection of an interlesional medicine within every 20-minute ExoSurge treatment. This combination has been proven to cause measurable and permanent reduction of penile fibrosis plaques. Our new pulsated gas and drug treatment technology has resulted in 15 patent filed or granted applications from our team of medical professionals and engineers.
Our Inter-fibrinous Pulsated Gas Technology (IPG) delivers a treatment that is well tolerated, generates no heat or collateral tissue damage, requires no patient downtime or anesthesia, and works without regard to patient skin color.
IPG technology is a novel and distinctive method of drug administration. It has been clinically proven to transform long-known generic intralesional Peyronie's medications into "super drugs" that produce curative results in which Peyronie's fibrosis is broken up and dissolved into the body, just as is expected to occur when the body initiates a fibrotic response in response to injury. The pulsated gas injections open small pathways within the dense fibrous plaques, causing injected medicines to penetrate deeper and with more effectiveness.
Dive deeper into the technology and our plans for the future from the link below.
Our New Medtech Drug Delivery Device
Our clinically proven and patented ExoSurge® technology uses injected and pulsated gases in tandem with intralesional drug injections to cause the permanent removal of fibrous tissue plaques
associated with a Peyronie's Disease diagnosis.
Our years of research and development devoted to unlocking the epidemiology of Peyronie's plays a key role in our technology's success.
We are science-driven and led by executives and medical advisors. Let us show you our plans to revolutionize the treatment of Peyronie’s disease.
Important Breakthroughs from ExoSurge® IPG Technology for Clinicians
1. ExoSurge® Inter-fibrinous Pulsated Gas and Drug Technology (IPG) delivers a treatment that is well tolerated, generates no heat or collateral tissue damage, requires no patient downtime or anesthesia, and works without regard to patient skin color.
2. The methodical IPG process of breaking down and permanently removing penile fibrosis and plaques is a game-changing new tool for Peyronie’s care.
3. ExoSurge® proved effective treating recent acute penile injury cases still in the active phase. Not only did ExoSurge therapy eliminate acute pain within about a week after starting treatments but also healed injured tissue and halted the build up of fibrosis before it became a problem in 100% of cases.
4. The technology proved effective treating diffuse plaque as discovered from duplex Doppler sonogram images (early stage Peyronie’s), completely healing the disease before it became problematic.
5. ExoSurge® paves the way for preventative care in asymptomatic patients who exhibit plaque and fibrosis during pre-screening ultrasound while being evaluated for other urologic disorders such as erectile dysfunction.
6. ExoSurge® treatments can be performed by a urologist or their support staff such as a nurse practitioner, physician’s assist or licensed medical doctor.
7. The device can conveniently be stored in the corner of an exam room between uses. It’s complete size is approximately 48 inches tall by 24 inches wide.
Existing Peyronie’s Disease Treatments
To date, therapies for treating Peyronie’s disease only vie to improve symptoms of Peyronie’s Disease patients. None heal the underlying basis for the disease. None are permanent. None are effective with every case. Thus, at best, existing treatments offer some patients a temporary reprieve from the worst symptoms of Peyronie’s Disease.
ExoSurge® is the world’s first clinically-proven treatment to conservatively and permanently remove plaques and fibrosis associated with a Peyronie’s diagnosis.
Peyronie’s Disease Redefined
We have redefined Peyronie’s disease based upon our insights from curative outcomes. As such, we define Peyronie's as the build up of fibrous tissue plaques located within the soft tissue of the penis and/or thickening of the tunica albuginea. This build-up of these non-cancerous tumorous masses can result in a myriad of negative functional and misshaping of a penis including curvature when erect, indentions to the erect shaft, lost length, loss of adequate blood flow to form an erection, hour glass shaping, etc.
Many of these conditions worsen with time. The body often sends additional fibrosis to the affected area in an attempt to help heal the condition.
Furthermore, any calcification in the bloodstream eventually accumulates on top of pre-existing fibrotic masses, resulting in a much more dense and problematic case known as "calcified plaque".
Current FDA-Cleared Peyronie’s Disease Treatments
Approvals and clearances by the FDA for Peyronie’s treatments to date have only evaluated changes in potential symptoms that can be caused by the build of plaques and fibrosis within the penis, such as the degree of erect curvature. Significant erect curvature is a common symptom of a Peyronie’s diagnosis affecting about 70% of patients. Based upon our research, the degree of erect curvature is tied to the exact size and location of the fibrous tissue plaques.
All of the negative side effects of Peyronie’s Disease are tied to the build up of penile plaques, in the soft tissue of penis, which is the true definition of Peyronie’s disease.
ExoSurge® is the world’s first clinically-proven therapeutic to measurably and permanently remove fibrous tissue plaques from the penis.
Collagenase clostridium histolyticum injections
Known under the brand name Xiaflex®, collagenase clostridium histolyticum is an enzyme that purports to breaks down the collagen scar tissue found in the plaques that cause PD. Xiaflex® is the only injectable drug approved by the U.S. Food and Drug Administration for the treatment of PD, and is administered directly into the plaques on the penis, via injection, following local anesthesia.
Collagenase clostridium histolyticum is very expensive, but it’s covered by most health insurance plans, and Endo Pharmaceuticals sometimes provides a co-pay assistance.
Treatment typically starts with two injections, given 1 to 3 days apart, followed by 6 weeks of penile stretching (see below). This cycle is repeated three more times for a total of eight injections.
Though sometimes effective, CCH injections won’t completely resolve penis curvature from PD, and they won’t restore lost length or girth. In addition, in rare instances, injectable treatments can cause rupture of the penile tissues that will require surgical repair.
Verapamil
Verapamil is a generic antihypertensive drug and calcium channel blocker, which is most commonly used for treating high blood pressure. Research suggests that calcium channel blockers increase the activity of collagenase, an enzyme that helps breaks down the excess collagen that makes up PD plaques.
Verapamil injections are usually covered by health insurance plans if performed by a urologist. It’s administered as an injection every two weeks for 12 weeks, for a total of six injections. Injections are administered directly into the affected area of the penis, under local anesthesia.
Improvement from Verapamil injections is historically minimal.
Restorex® Penile Traction Therapy (PTT)
There are countless penile traction devices on the market, However Retorex® is the only version that's FDA-cleared.
We love Restorex® and we now recommend it to most of our patients getting ExoSurge® treatment. It's an exceptionally well-engineered device compared to prior iterations for penile traction. That advanced design and components are reflected in its $500 price but it's money well spent.
The most frequently encountered adverse side effects of penile traction are mild pain, skin irritation, bruising and skin discoloration, and itching.
During ExoSurge's first retrospective study, where our patients with erect curvature saw a 60% improvement, Restorex® was not used.
We believe our reported curvature results would have been significantly better if patients had used Restorex penile traction device at that time.
Peyronie’s Surgery
Surgery remains the gold standard for Peyronie’s care according to the AUA's standards of care and it comes in two basic pathways: "incision and graft" and "plication".
Incision and graft is usually only indicated for the most severe cases. However, the incidence of recurrence and erectile dysfunction is significant, and some individuals may experience irreversible loss of penile sensation.
A retrospective study published by Florian Wimpissinger, MD, of the department of urology at Rudolfstiftung Hospital in Vienna, Austria in 2012[2] regarding the long-term outcomes associated with PD surgery showed a notable recurrence of Peyronie’s symptoms over time.
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.
Plication surgery has the most reliable outcome and the least chance of ED, but it is unacceptable for many patients due to the "loss" of penile length. The post-surgical penile length is usually around where the erect curvature begins along the penis shaft. Very few men are comfortable losing 1-3 inches of erect length regardless of circumstances.
Non-Traditional Peyronie’s Disease Treatments
We always explore and stay abreast of new ideas and innovations for Peyronie's care.
We are publishing a new report soon to explore non-traditional therapies and their possible role in Peyronie's care for the future.
ExoSurge® Inter-fibrinous Pulsated Gas and Drug Technology (IPG)
The ExoSurge® Inter-fibrinous Pulsated Gas and Drug Technology (IPG) uses a sequenced five-step, single visit, 20-minute treatment process that results in measurable permanent reduction of penile fibrosis with repeated applications.
Our inter-fibrinous gaseous injections are a novel and distinctive method of drug administration as they're able to penetrate plaques and open pathways to medicines. They have been clinically prove to transform long-known generic intralesional Peyronie's medications into "super drugs" that produce curative results in which Peyronie's fibrosis is broken up and dissolved into the body, just as is expected to occur when the body initiates a fibrotic response in response to injury.
The combination of new pulsated gas technology and intralesional drugshas resulted in 15 patent filed or granted applications from our team of medical professionals and engineers.
Our accomplishments in studying the epidemiology of Peyronie's disease are critical to our success.
ExoSurge® researchers have identified six "Peyronie's Accelerators" that not only speed up the onset of Peyronie's symptoms in otherwise healthy patients, but also impair treatment efficacy if left unmanaged during care.
Calcified Plaque: Before & After Sonogram Images
Following are examples of "before and after" duplex sonogram images of ExoSurge® Peyronie's patients with calcified plaques. The reduction of calcified plaques is readily apparent, even to an inexperienced layperson. As far as we are aware, these photos are the first sonographic evidence of a visible reduction in calcified Peyronie's plaque from conservative therapy in the history of urology.
Before and After Peyronie's Treatment Photos
Have you ever Googled "before and after Peyronie's treatment photos"? The only images you'll find are gut wrenching photos taken midway through plication or "incision & graft" Peyronie's surgery.
Following are baseline and follow up images of Peyronie's patients following treatments with ExoSurge®. We hope to share many more soon. Unfortunately, patients must grant us permission to release these photographs, and few are willing to do that.
ExoSurge® is the world's first clinically-proven treatment to conservatively and permanently remove plaques and fibrosis associated with a Peyronie's diagnosis.
ExoSurge® Technology: Refinements and Observations
Between the period of the invention of our first successful Peyronie's treatment technology that achieved measurable improvement with plaque reduction confirmed through our Proof of Study Observations in 2014 to the completion of our 2021 Retrospective Study, we treated hundreds of patients suffering from Peyronie's disease at our clinic in Atlanta with our evolving therapeutic and began to make important observations regarding what the underlying cause and epidemiology of Peyronie's Disease.
When this key pillar was finalized, we became focused upon refinement and improvement of our technology, including:
• Refining our "working-model-theory" regarding the underlying etiology of Peyronie's
• Further study in the nature of penile plaques and fibrosis within varied disease cases
• Patient health factors as a part of a Peyronie's case and diagnosis
• Variations in the most effective means to treat the wide variety of Peyronie's plaques
• Developing weighted scoring for patient's existing health dynamics and their impact on a Peyronie's diagnosis and permanent plaque removal
Continued refinements from case observations to each of these pillars resulted in continued improvement of treatment outcomes. We were late evolving to the use of baseline and followup Duplex Doppler ultrasonography as our measuring stick for patient improvement. We now embrace this "before and after" comparison as the gold standard for the evaluation of Peyronie's treatment
Following is a summation of our most important Breakthrough Observations with Peyronie's Disease made between 2014 and 2021.
To learn more about our diagnostics and Peyronie's treatments with ExoSurge technology right away, please visit our clinical website and schedule a "one on one" phone consultation or a visit to our clinic in the Buckhead area of Atlanta, Georgia.
Stay Up To Date
If you are a Peyronie's patient who has interest in participating in one of our upcoming clinical trials around the United States, please click here
If you are a urologic clinician who has a potential interest with being involved in our upcoming prospective clinical trials, please click here
If you would like to stay abreast of our progress during clinical trials and in the future, please click here:
Sign up to follow our story and to watch us grow!