Test di laboratorio e su pazienti, soldi e tempo: lanciareun nuovo farmaco o dispositivo medico può essere un’odissea e, in […]
- € 150.000
- Min. investment
- € 500
- Company type
- PMI Innovativa
- Quota type
- B (€ 50.000), C
Every new drug or medical device placed on the market must be thoroughly tested through in vitro, pre-clinical and clinical studies. These tests are costly and time consuming: the launch of a new drug on average requires up to 12 years and more than $ 2B.
For years universities, research centers, and specialized companies have been developing mathematical models and simulations to support the development of new medical products. Their work was supported by increasingly advanced technologies, capable of refining and reducing animal and human trials.
Today the use of these models is not widespread due to lack of proper dissemination. Thus, models and simulations are not made available to a broad spectrum of potential users.
This happens because there is no publicly available platform that facilitates the use of these models and simulations while managing the intellectual property of the models’ creators and the payments related to their use.
Or rather, there was not – until now.
In analogy with the automotive and aerospace sectors, where in-silico evaluation and validation are regularly performed, InSilicoTrials.com brings the same type of evolution in the medical field.
InSilicoTrials.com is the web platform that allows companies and institutions to accelerate the research and development processes specific to the medical devices and pharmaceutical sectors and reducing costs and time by using models and simulations. These are developed with advanced technologies by researchers at the highest scientific level.
Through modeling and simulation, InSilicoTrials.com accelerates the evolution of science by exploiting the experience and know-how of specialists in the field, by preventing the repetition of studies already performed, and by spreading the knowledge through the web.
Additionally, InSilicoTrials.com provides companies with own private software environment with high security standards. In this environment, for example the performance of new prototypes can be tested, or new prosthesis designs can be investigated, or the concentration data of a new drug candidate can be explored.
The models and the data available on the platform are provided by the Scientific Partners, under a commercial contract with InSilicoTrials. Specifically, the Scientific Partners are research groups and internationally known companies, and their models and simulations are the results of extensive researches that have given rise to scientific publications, European or international projects, patents, etc.
The strong innovative component of the project led the U.S. Food and Drug Administration (FDA) to propose a five-year collaboration agreement that was signed on the July 22nd, 2017.
We have already filed the application for two patents and we are working with Jacobacci&Partners – an important patent and intellectual property firm – for the filing of two additional patents related to the blockchain platform.
In January 2018 we acquired CONSEL to support the market demand for the test on 3D printed medical devices, and to complete the engineering tests for traditional medical devices. CONSELF is a leading company in the sector and has served over 3,000 users from all over the world in the last 3 years.
The competitive advantages of InSilicoTrials.com are:
- First mover on international scale
- Easy access to medical devices and pharmaceutical models and simulation tools in a virtual environment which is validated and compliant to the regulatory requirements
- Simplicity of usage with respect to the currently available solutions that are designed for expert bioengineers or researchers in the medical devices pharmaceutical sectors, respectively
- Proven experience in the management of Clinical Trials
- Established collaboration with hospitals and biobanks at European level to generate virtual patients
- Collaboration with the Center for Devices and Radiological Health within the U.S. Food and Drug Administration (FDA-CDRH), with a five-year Research Collaboration Agreement
- Collaboration with the European Medicines Agency (EMA), within the Consultative Cloud Security Group
- Established network of research institutions and university hospitals in Europe and the United States
- Filed two patents applications
The company has started the process to become an innovative SME and will therefore give the possibility to benefit a 30% deduction of the invested amount from the income tax (IRPEF).
By becoming shareholder of InSilicoTrials you will: i) financially support further development of the platform, ii) boost the existing business development opportunities, iii) help to increase the number of models and simulations on the platform.
All this will be possible within a timeframe of six months also because we have performed the full acquisition of CONSELF technologies and know-how.
Furthermore, the company is currently discussing several Proof of Concept project proposals with potential customers, activity which will lead to the closure of extremely interesting contracts at international level in the near future.
Additionally, InSilicoTrials can rely upon a strong network of Scientific and Business Partners in the hospital sector (e.g. San Raffaele Hospital (IT), CRO Aviano Oncological Reference Center (IT), IRCCS Galeazzi Orthopedic Institute (IT), Erasmus Medical Center Rotterdam (NL)); in the academic sector (e.g. Emory University (US), University of North Carolina at Chapel Hill (US), Université Libre de Bruxelles (BE), University of Bath (UK), University of Pavia (IT), Universitat de Valencia (ES) and in the technology sector (e.g. ANSYS, Microsoft, Siemens, CompBioMed).
COLLABORATIONS WITH REGULATORY INSTITUTIONS
The Center for Devices and Radiological Health within the U.S. Food and Drug Administration (FDA-CDRH) has proposed to InSilicoTrials a five-year Research Collaboration Agreement (RCA), which was signed on July 22nd, 2017
The RCA was signed for the development of a web-based computational framework to perform simulations aimed to test the safety in MRI (magnetic resonance imaging) of implantable medical devices like stents, orthopedic prostheses and neurostimulation implants. The collaboration with the FDA strengthens the project and emphasizes the support of regulatory bodies to the use of modeling and simulation in the development and evaluation of novel medical devices and therapeutics.
The first model available on the platform is the result of this important collaboration. The model allows to evaluate the overheating of vascular stents when a patient undergoes an MRI examination. The model’s electromagnetic compatibility testing is currently being expanded to a broad range of implantable medical devices, including both active (pacemakers, defibrillators, deep brain stimulators, etc.) and passive (stents, screws, plates, etc.) devices as part of the regulatory process.
In addition, Luca Emili, CEO of the company, has joined in 2017 the Cybersecurity Consultative Group created by EMA, the European Medicines Agency.PATENTS
InSilicoTrials has filed two patents’ applications and is working with the Jacobacci&Partners firm – an important patent and intellectual property specialist – to file two additional patents related to the platform.
- Patent submission “platform for medical devices development”: number: IT 102018000004044 – filing date: 28/03/2018
- Patent submission “platform for drug development”: number: IT 102018000004045 – filing date: 28/03/2018
PLATFORM STATE OF THE ART
The development of the InSilicoTrials platform was started in 2017 after an intense and complex market analysis on the use of models and simulations within the medical devices and pharmaceutical sectors.
The first product available on the platform is the InSilicoMRI tool for the safety evaluation of implantable medical devices undergoing an MRI scan. This product is unique because it is the first tool of this kind accessible via web, and because it is the result of the collaboration with the FDA-CDRH and ANSYS, world leader in engineering simulation software.
The tool can be used in free and pay-per-use version. The free version enables you to perform a limited range of simulations; the pay-per-use version enables you to perform a wide range of simulations based on advanced functions. Furthermore, the pay-per-use version enables you to download the results of the simulations in an automatically created report formatted as by FDA guidelines. This feature saves considerable time and facilitates the review and evaluation of submission packages by regulatory bodies.
Two regional tenders were won (Friuli Venezia Giulia, the Italian region where InSilicoTrials is based) with the Image Mining and Farmaprice projects for a total contribution of about € 500,000.
InSilicoTrials is already generating revenues by working with companies in the pharmaceutical and medical devices sectors. Prognosed revenues in 2018 are expected to exceed a budget of € 500,000.
Use of proceeds
The objective of the equity crowdfunding campaign is to:
i) financially support further development of the platform,
ii) boost the existing business development opportunities and sales activities,
iii) help to increase the number of models and simulations on the platform.
The collected capital will feed the company’s activities together with the revenues that the company is already generating, and the grants for the research and development activities that the company has received.
Depending upon the amount of proceeds received, two investment scenarios have been foreseen.
If the minimum quota of € 150,000 is reached, activities will primarily focus on the integration of a minimum of 5 models and simulations made available by Scientific Partners and on the development of the platform. Whereas, if the maximum quota of € 450,000 is reached, activities for integration of a minimum of 15 models and simulations will be performed in parallel with a more advanced development of the platform.
The information on the offer is not subject to approval by Consob. The bidder is solely responsible for the completeness and truthfulness of the data and information provided by the same. The investor's attention is also drawn to the fact that the investment, including through OICR or companies that mainly invest in financial instruments issued by small and medium-sized companies, is illiquid and characterized by a very high risk.