Develop simple tissue regeneration technologies for the benefits of humanity by leveraging the biomimetic properties and the mechanical advantages of a new silk manufacturing nanotechnology.

Project Information

SilkByPass

Grant agreement ID: 684079

DOI

10.3030/684079

Project closed

EC signature date 15 June 2015

Start date 1 July 2015

End date 31 December 2015

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

KLISBIO SRL
Italy

Periodic Reporting for period 1 - SilkByPass (Develop simple tissue regeneration technologies for the benefits of humanity by leveraging the biomimetic properties and the mechanical advantages of a new silk manufacturing nanotechnology.)

Reporting period: 2015-07-01 to 2015-12-31

Summary of the context and overall objectives of the project

Within the challenges of topic NMP-25-2015-1, which is focusing on “accelerating the uptake of nanotechnologies, advanced materials or advanced manufacturing and processing technologies by SMEs”, Silk Biomaterials intends to bring its silk-based tissue engineering nanotechnology to the market. The company will develop SilkByPass, an advanced tissue engineering scaffold for small blood vessel repair and regeneration, that is a vascular bypass. This first application will help solve an urgent unmet clinical need in the area of peripheral artery diseases, particularly in relation to critical limb ischemia, where there is a lack of economically viable and clinically long term solutions for revascularization procedures. The exploitation of the research results obtained for the development of SilkByPass and the related technology platform is expected to create value for the biomedical sector and bring innovation to the more traditional textile sector by widening the market opportunities towards advanced biomedical applications.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

An extensive market assessment has been performed on the vascular market, including a validation of both cardiac and peripheral medical needs with expert clinicians. The evaluation of the clinical gold standard, the competitive landscape and the proposed technical innovation allowed Silk Biomaterials to realign its SilkByPass project on grafting solutions for optimal open revascularization of peripheral small blood vessels versus the riskier coronary artery bypass graft surgery.We received a very positive search report on our Italian patent from the European Patent Office, which allowed us to file a Patent Cooperation Treaty (PCT) ameliorated application on October 27th, 2015. We also got a detailed freedom to operate analysis, which showed “the risks of interference shall be considered low, if not fully inexistent, at least with reference to the main markets”. Finally, we better understood the details and timing of our potential regulatory path and found some European partners to conduct preclinical and clinical studies.
A detailed business plan and the technical feasibility of the project has been drafted during Phase 1: they are both reported in the final report. In addition to that, Silk Biomaterials has already identified a list of possible partners and suppliers that will be able - thanks to their network of agents - to contribute to the initial promotion of SilkByPass. This will allow Silk Biomaterials to reach the main vascular surgeons in the national territories.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Thanks to the work conducted in Phase 1, partly financed by the SME instrument, Silk Biomaterials was able to obtain € 485’000 in seed funding from some angels investors and sign a € 7’000’000 Series A term sheet (with the investment to be completed in 1Q16) from an Italian life science venture capital fund.
Therefore, the current project will continue and further expand its strategic vision. In particular, thanks to the development conducted in the last six months on the technology platform itself, we’ve been able to assess and confirm many other uses and applications: scaffolds for peripheral nerves' and anterior cruciate ligaments' injuries reconstruction, carriers for targeted drug delivery and programmed release for oncologic treatments, etc.
The SME instrument in Phase 1 allowed us to focus much more on the exact first application for the SilkByPass medical device (i.e.: from coronary artery bypass grafting to peripheral artery bypass) and on the clinical needs related to a specific indication (i.e.: critical limb ischemia). The objective of the technological development and manufacturing scale-up has been confirmed: in particular, with the same nanotechnology Silk Biomaterials will be able to develop other specific clinical applications.
Given the high capital intensity of our technological area - due to the several preclinical and clinical tests we need to perform in the coming years before accessing the market - Silk Biomaterials will require continuous support from clinical partners (on top of those already identified) and regulatory and manufacturing consultants (who we already engaged in the last six months). Thanks to our specialized venture capital investor, Silk Biomaterials will be able to access the financial resources needed to support a further expansion of the technology platform. The European Union contribution through the SME instrument is a valuable set of resources (including coaching activities) that already demonstrated its ability to speed up our project and will allow for a sustainable development of our SilkByPass application.

Another example of silk's nanofibers

The first prototype implanted in a rat's abdominal aorta: see the full regeneration

A tubular vascular scaffold designed with silk's nanofibers

An histological section of our scaffold, where the internal darker area shows regeneration

The scaffold is functionally regenerated, with vasa vasorum (D,E) and elastic lamina (B,C)

An example of silk's nanofibers