ExoBiomedical: Business Development Summary
EXO intends to license its breakthrough Peyronie's technology to an appropriate pharmaceutical company partner during 20224
EXO Development Miliestones: 2023-2024
ExoSurge® Technology Sale / License
In 2024, EXO intends to begin the process of identifying the optimal pharmaceutical partner to license its technology to, in order to help drive its Peyronie's innovation through the FDA and make it available to patients.
In 2024, EXO intends to begin the process of identifying the optimal pharmaceutical partner to license its technology to, in order to help drive its Peyronie's innovation through the FDA and make it available to patients.
We anticipate that the remainder of 2023 and a portion of 2024 will be dominated by the creation of retrospective studies of results from our experiences treating Peyronie's disease patients with ExoSurge, as well as the testing of optional new pathways that can result in faster and better outcomes.
Some of the currently planned studies we plan to organize and publish include:
Some of the currently planned studies we plan to organize and publish include:
ExoSurge® 2023 Retrospective Study Expansion: Validation for Prospective Clinical Trials
We anticipate doubling the scale of our 2021 retrospective study comparing baseline and follow-up sonographic evidence of elimination of fibrous tissue plaques as well as changes in Peyronie's symptoms such as erect penile curvature.
Notably, we did not use PTT (penile traction therapy) with our first study group, so we are eager to observe the effect of PTT on the improvement of erect curvature associated with Peyronie's disease in this second group of patients.
We believe that these results demonstrate the need for prospective clinical trials.
ExoSurge® Xiaflex® / CCH "Repairs" Case Studies
Patients who have previously "tried and failed" intralesional CCH injections have been seen in our clinic. ExoSurge® has allowed us to treat these patients and repair their Peyronie's disease.
We have also encountered patients whose CCH injections were previously successful, but whose Peyronie's symptoms returned, typically with unusually morphed erectile morphologies, such as a "S" curve. Additionally, we have been able to resolve these cases.
Treatment following intralesional CCH injections must be modified in comparison to untreated cases. In this study, we aim to identify these protocols for future clinical partners.
ExoSurge® Calcified Plaque Accelerator Study
We've invented a new device that substantially accelerates the recovery of patients with large, densely calcified Peyronie's plaque.
We intend to produce a study detailing the success of this novel technology in treating select patients.
ExoSurge® Complementary Surgical Intervention Study
EXO Chief Medical Officer Kenneth J. Carney, MD PHARM came up with an idea of combining a revised form of Peyronie's surgery with ExoSurge technology to radically speed up healing on select cases.
Which Peyronies cases are best suitable for this new CurveFree® treatment?
How do the results of CurveFree compare to those of traditional ExoSurge?
What are the potential ExoSurge® CurveFree side effects?
These are merely a few of the hypotheses we expect to test with this analysis.
ExoSurge® Active / Acute Phase Treatment Retrospective Study
During routine patient care at our Atlanta clinic, we observed that ExoSurge treatments appeared optimal for treating cases of Peyronie's disease in the active phase.
Specifically, the treatments prevented the formation of the characteristic post-acute penile injury fibrotic masses. In addition, patients reported that post-injury penile discomfort disappeared after only two or three ExoSurge treatments.
This study aims to refine protocols for treating patients in the active phase of Peyronie's disease and enhance outcomes.
ExoSurge® with select Non-Traditional Intralesional Injections Studies
The majority of the shared insights from other non-traditional intralesional injection therapies used worldwide to treat Peyronie's disease have been observed and tested. However, we have not yet formalized this analysis to determine what role any may play in enhancing EXoSurge technology's performance.
This study will attempt to close this disparity.
The majority of the shared insights from other non-traditional intralesional injection therapies used worldwide to treat Peyronie's disease have been observed and tested. However, we have not yet formalized this analysis to determine what role any may play in enhancing EXoSurge technology's performance.
This study will attempt to close this disparity.
EXO Strategy: Valuation Drivers
ExoSurge® Use of Generic Drugs
EXO leverages generic drugs with a new form of delivery within its intellectual property.
The IP around both of or drug patents revolved around the management of the detailed etiology of Peyronie’s Disease and knowledge of when and how to leverage select drugs to achieve optimal patient outcomes.
Injectable Verapamil and Phenoxathiine have been used for decades by urologist treating Peyronie’s for decades. When combined with our gas injection technology the outcome is curative with permanent removal of the penile plaques and fibrosis that cause Peyronie’s. However, our approach requires provider management of a proprietary list of patient health paradigms in order to efficiently achieve these results.
EXO leverages generic drugs with a new form of delivery within its intellectual property.
The IP around both of or drug patents revolved around the management of the detailed etiology of Peyronie’s Disease and knowledge of when and how to leverage select drugs to achieve optimal patient outcomes.
Injectable Verapamil and Phenoxathiine have been used for decades by urologist treating Peyronie’s for decades. When combined with our gas injection technology the outcome is curative with permanent removal of the penile plaques and fibrosis that cause Peyronie’s. However, our approach requires provider management of a proprietary list of patient health paradigms in order to efficiently achieve these results.
ExoSurge® Drug Pricing
A big part of market size dollar estimates is based upon the estimated cost of the drug therapies.
In comparison to a drug therapy that only treats a symptom of Peyronie’s (erect curvature), our financial model includes notably lower drug pricing for a curative outcome. Historically, new technologies with curative outcomes are priced notably than current drug prices. In this regard, we will defer to our Pharma partner’s expert knowledge. Higher drug prices, on the other hand, would cause the estimated market size to grow proportionally.
Costs
• Verapamil cost: $13 / per ML
• Pentox cost: $10 / per ML
A big part of market size dollar estimates is based upon the estimated cost of the drug therapies.
In comparison to a drug therapy that only treats a symptom of Peyronie’s (erect curvature), our financial model includes notably lower drug pricing for a curative outcome. Historically, new technologies with curative outcomes are priced notably than current drug prices. In this regard, we will defer to our Pharma partner’s expert knowledge. Higher drug prices, on the other hand, would cause the estimated market size to grow proportionally.
Costs
• Verapamil cost: $13 / per ML
• Pentox cost: $10 / per ML
ExoSurge® Orphan Status Potential
When Auxilium Pharmaceuticals (wholly acquired by Endo Pharmaceuticals in 2015) first gained FDA clearance for Xiaflex in XXXX, the drug was granted Orphan status which caused it to be faster and easier to get approval.
While the recent prevalence studies for Peyronie’s might indicate a market considered too large for Orphan designation, the fact most cases remain undiagnosed by a urologist and
When Auxilium Pharmaceuticals (wholly acquired by Endo Pharmaceuticals in 2015) first gained FDA clearance for Xiaflex in XXXX, the drug was granted Orphan status which caused it to be faster and easier to get approval.
While the recent prevalence studies for Peyronie’s might indicate a market considered too large for Orphan designation, the fact most cases remain undiagnosed by a urologist and
ExoSurge® FDA Approval Path
In regard to achieving FDA approval, we believe there’s three aspects of our technology that will help make this approval more likely.
1. We have treated over 1,000 patients without a single negative reportable incidents.
2. The drugs used in our therapeutics are all a generic format and thus would theoretically face a less challenging hurdle achieving FDA approval.
3. Partnering with a well heeled and experienced Pharma partner to help better navigate the process.
ExoSurge® UK, Canada, Australia, Europe: Xiplax
2019 saw the discontinuation of “Xiapex” by public health systems in Europe, Canada and Australia due to efficaciousness vs. cost-effectiveness issues. At present, there’s no viable non-surgical options available in these markets.
In regard to achieving FDA approval, we believe there’s three aspects of our technology that will help make this approval more likely.
1. We have treated over 1,000 patients without a single negative reportable incidents.
2. The drugs used in our therapeutics are all a generic format and thus would theoretically face a less challenging hurdle achieving FDA approval.
3. Partnering with a well heeled and experienced Pharma partner to help better navigate the process.
ExoSurge® UK, Canada, Australia, Europe: Xiplax
2019 saw the discontinuation of “Xiapex” by public health systems in Europe, Canada and Australia due to efficaciousness vs. cost-effectiveness issues. At present, there’s no viable non-surgical options available in these markets.
ExoSurge® Urologists as a part of Team
EXO: Urologists as Partners
While urologists welcomed the exciting news around the promises of Xiaflex when it first launched, it’s been a bit of a failure because of its poor success rate. It only succeeds because there’s nothing else available.
EXO: Urologists as Partners
While urologists welcomed the exciting news around the promises of Xiaflex when it first launched, it’s been a bit of a failure because of its poor success rate. It only succeeds because there’s nothing else available.
ExoSurge® 1,000 Patients Treated
We’ve treated over 1,000 patients with EXO technology at our flagship facility in Atlanta without a single negative patient incident.
ExoSurge® Patient Treatment Algorithm
EXO: Proof from Studies
EXO has to date completed a singular retrospective study that included 75 patients. The close-out date for this study was determined by an upcoming corporate financing event (from study / date). All results can be verified by individuals skilled in the arts.
We’ve treated over 1,000 patients with EXO technology at our flagship facility in Atlanta without a single negative patient incident.
ExoSurge® Patient Treatment Algorithm
EXO: Proof from Studies
EXO has to date completed a singular retrospective study that included 75 patients. The close-out date for this study was determined by an upcoming corporate financing event (from study / date). All results can be verified by individuals skilled in the arts.
ExoSurge® World Market Opportunity
2019 saw the discontinuation of “Xiapex” (Euro brand name for Xiaflex) by the public health systems in Europe, Canada and Australia due to efficaciousness vs. cost-effectiveness issues.
At present, there’s no viable non-surgical options available in these world markets.
2019 saw the discontinuation of “Xiapex” (Euro brand name for Xiaflex) by the public health systems in Europe, Canada and Australia due to efficaciousness vs. cost-effectiveness issues.
At present, there’s no viable non-surgical options available in these world markets.
EXO: Long Term Vision
Healing is our opportunity
We invested twenty-million dollars and over two decades developing our breakthrough Peyronie's technology.
When we distill our Peyronie's technology to "the essence of the invention" and combine those insights with our experiences developing a curative solution for the disease, we see new opportunities that are exciting.
Our core team is composed of life science veterans, with more than 150 years of life science experience, multiple device clearances, and national company launches.
When we distill our Peyronie's technology to "the essence of the invention" and combine those insights with our experiences developing a curative solution for the disease, we see new opportunities that are exciting.
Our core team is composed of life science veterans, with more than 150 years of life science experience, multiple device clearances, and national company launches.