Periodic Reporting for period 1 - MECADISTEM (A new and innovative method to extract adipose Stromal Vascular Fraction: Application in post-prostatectomy erectile dysfunction)
Período documentado: 2019-05-01 hasta 2019-08-31
Prostate cancer is the most common cancer in men with a total of 1,276,106 cases reported worldwide in 2016. Radical prostatectomy, which consists in surgically removing the prostate, is considered the first line choice for the treatment of localised prostate cancer. Despite the technical progress that have been achieved these last years, a majority of patients who undergo this surgery inherit erectile dysfunction as a consequence of this surgical act. This frequent complication strongly impairs the quality of life of men and their sexual partners and is therefore the main reason that discourages the patients to benefit from this intervention.
Post-prostatectomy erectile dysfunction represents a significant unmet medical need as there is no efficient treatment to repair the nervous and muscular lesions caused by the surgery. In this context, regenerative medicine, and more particularly the stromal vascular fraction (SVF) derived from the adipose tissue (more commonly referred as fat), represents a strong candidate for the treatment of this condition. However, currently the extraction step is a technical challenge and requires the use of enzymes (collagenase). We have developed a new medical device to mechanically extract adipose SVF (containing stem cells) named Mecadistem. This device comes in the form of a single-use kit that includes all the tools to simply and rapidly (less than 30 minutes) extract SVF cells.
The feasibility study confirms the feasibility of the project in all technical, commercial and financial aspects. The main activities to be carried out include the conduct of clinical studies and product industrialisation.
Post-prostatectomy erectile dysfunction represents a significant unmet medical need as there is no efficient treatment to repair the nervous and muscular lesions caused by the surgery. In this context, regenerative medicine, and more particularly the stromal vascular fraction (SVF) derived from the adipose tissue (more commonly referred as fat), represents a strong candidate for the treatment of this condition. However, currently the extraction step is a technical challenge and requires the use of enzymes (collagenase). We have developed a new medical device to mechanically extract adipose SVF (containing stem cells) named Mecadistem. This device comes in the form of a single-use kit that includes all the tools to simply and rapidly (less than 30 minutes) extract SVF cells.
The feasibility study confirms the feasibility of the project in all technical, commercial and financial aspects. The main activities to be carried out include the conduct of clinical studies and product industrialisation.
TECHNICAL FEASIBILITY:
To reduce the manufacturing costs of our medical system, we re-designed some components. Subsequently, the protocol for the extraction of the SVF was optimised and validated for the new design, and we characterised the composition of the SVF obtained. The characterisation of the SVF cell composition isolating using Mecadistem resulted in the draft of a composition patent. An industrialisation plan has also been drafted which included the identification of potential suppliers. Furthermore, we have written the protocol of two clinical studies that will be carried out during Accelerator Phase project to validate the safety and efficacy of intra-cavernosal injection of SVF using our innovative solution.
COMMERCIAL FEASIBILITY:
The commercial feasibility of the project has also been carefully assessed. The assessment confirmed the freedom to operate of our project, the great prospects of the post-prostatectomy erectile dysfunction market and the scarcity of efficient treatments, what highlights this largely unmet clinical need and the opportunity behind it. Our commercial strategy involves both direct and indirect sales as a way to reach all the geographical target regions, and a gradual penetration first in Europe and Australia, and then in the USA and in Asia.
FINANCIAL FEASIBILITY:
We conducted a financial analysis based on revenue stream, commercialisation plan and prostate cancer epidemiology. In our financial model (5-years business projections), we considered two sales scenarios: one conservative and one optimistic. Even in the conservative scenario, we will generate a big turnover, profit and new job positions.
We also estimated our funding needs at €1.88 million, with €1.31 million, from the Accelerator Pilot SME Instrument funds.
The Feasibility Study confirms the technical feasibility and commercial profitability of our project. Moreover, it shows the novelty of our innovation and the great benefits that would bring to patients and the health sector.
To reduce the manufacturing costs of our medical system, we re-designed some components. Subsequently, the protocol for the extraction of the SVF was optimised and validated for the new design, and we characterised the composition of the SVF obtained. The characterisation of the SVF cell composition isolating using Mecadistem resulted in the draft of a composition patent. An industrialisation plan has also been drafted which included the identification of potential suppliers. Furthermore, we have written the protocol of two clinical studies that will be carried out during Accelerator Phase project to validate the safety and efficacy of intra-cavernosal injection of SVF using our innovative solution.
COMMERCIAL FEASIBILITY:
The commercial feasibility of the project has also been carefully assessed. The assessment confirmed the freedom to operate of our project, the great prospects of the post-prostatectomy erectile dysfunction market and the scarcity of efficient treatments, what highlights this largely unmet clinical need and the opportunity behind it. Our commercial strategy involves both direct and indirect sales as a way to reach all the geographical target regions, and a gradual penetration first in Europe and Australia, and then in the USA and in Asia.
FINANCIAL FEASIBILITY:
We conducted a financial analysis based on revenue stream, commercialisation plan and prostate cancer epidemiology. In our financial model (5-years business projections), we considered two sales scenarios: one conservative and one optimistic. Even in the conservative scenario, we will generate a big turnover, profit and new job positions.
We also estimated our funding needs at €1.88 million, with €1.31 million, from the Accelerator Pilot SME Instrument funds.
The Feasibility Study confirms the technical feasibility and commercial profitability of our project. Moreover, it shows the novelty of our innovation and the great benefits that would bring to patients and the health sector.
Currently there are no effective treatments for post-prostatectomy erectile dysfunction nor an easy method to extract the SVF cells from adipose tissue. Our innovative solution, Mecadistem, does not require the use of enzymes, avoiding the problems and constraints imposed by the use of an enzymatic digestion (current reference method) and offering substantial time of money savings. It will have a big impact on 1) patients and their relatives´ quality of life, 2) urologists, providing an effective tool, 3) health systems and insurance companies, reducing the high associated costs and 4) our company's growth.