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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - FasNaGel (NOVEL THERAPEUTIC NANOHYDROGEL FOR ACUTE AND CHRONIC PAIN TREATMENT TARGETED TO THE NERVES FASCIA)

Teaser

Summary

i+Medâ€™s team has been working since 2014 in the development of FasNaGel: a new medical solution unique in Europe for the improvement of acute pain relief, which also prevents its chronification. FasNaGel is a new nanomedicinal product that consists of a biocompatible and biodegradable injectable carrier, made of porous nanostructured hyaluronic acid hydrogel that will contain local anaesthetic drugs like L-bupivacaine or ropivacaine, that acts as protective barrier of the nerves. Nerves, arteries and veins are contained inside an envelope of connective tissue rich in hyaluronic acid named â€œfasciaâ€. Current methods that use peripheral anaesthesia try to approach the nerves by getting drugs directly into the fascia, but they are not completely efficient and have side effects due to the difficulty of the procedure that leads to unintentional injection by the surgeon in the arteries or veins that are located in the same fascia, which happens in about 0,5 million surgeries in the World. FasNaGel presents significant advantages over conventional injected pharmacological treatments that: i)efficiently provides a 100% of functional recovery in one third of the time (24h), ii) does not cause addiction as opioids iii) is easy-to-use by medical staff as it is applied as a single injection in the surgery iii) and the most important: reduces pain chronification up to an 80% leading to much lower expense and contributing to the reduction of indirect costs (productivity lost, disability payment, lost work days, medical and mental comorbidities, etc.) (up to 45% reduction) in the long-term, than currently used direct local anaesthesia injections.

Work performed

OBJECTIVES
Development of a technical and economic feasibility study of FasNaGel. It will also contain a detailed business plan with the envisaged exploitation means for the further commercialisation of the product, marketing and communication strategies, analysis of the regulatory standards.
DESCRIPTION OF WORK

Commercial feasibility assessment will be carried out in order to analyse the best commercial strategy in every market: analysing the market, and existing solutions, customers, competitors as well as the overall economic, political, cultural and technical environment. i+Med will contact relevant stakeholders (such as hospitals, health insurance companies, public agencies) and survey potential customers, analyse their preferences and assess their willingness to buy FasNaGel. In case it is not possible to reach the agreement with the players targeted, other companies operating in the same market segment will be contacted. Furthermore, the inclusion of FasNaGel in other markets will be analysed.
A financial feasibility assessment based on the commercial exploitation of FasNaGel in five different scenarios has been proposed:
1. i+Med is the only manufacturer and distributor of the product
2. i+Med manufactures the product and i+Med and a partner distribute the product: the brand is licenced to a partner who also can distribute and sell FasNaGel
3. i+Med licenses for the manufacturing, sales and distribution of the product to a third party
4. i+Med manufactures FasNaGel and sells its product via a worldwide distributor network.
5. i+Med sells the whole project
It has

After reviewing the different scenarios, i+Med has concluded that the scenarios that most adapt to the reality and the business strategy of I + Med would be the licensing of FasNaGel for the manufacturing, sales and distribution of the product to a third party.

A market study has been carried out

A Detailed analysis of the regulatory standards to be met by the new medicinal product, has been identified

A Risk analysis and Contingency plan to study the main bottlenecks and possible solutions for the commercialisation of the product have been identified .

A feasibility report including a five-year Business and Exploitation Plan has been done

Final results

i+Med will start to generate profit by 2022, being the net-margin around â‚¬2.5million that year and reaching the breakâ€even point that same year. Since this moment, the accumulated cash-flow will be positive, increasing progressively during the following years. The investment has a positive net present value; the projected future cash inflows cover the future costs of starting and running the project, so it adds value to the company and benefit company shareholders. On the other hand, the investment\'s IRR is 74.17%, very high so it seems a good investment.