Revolutionary vascular repair patch to treat aortic dissections

Project Information

AORTYX

Grant agreement ID: 876061

DOI

10.3030/876061

Project closed

EC signature date 2 August 2019

Start date 1 September 2019

End date 29 February 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

AORTYX SL
Spain

Periodic Reporting for period 1 - AORTYX (Revolutionary vascular repair patch to treat aortic dissections)

Reporting period: 2019-09-01 to 2020-02-29

Summary of the context and overall objectives of the project

Aortic Dissection (AD) is a major disease that occurs when a tear opens in the wall of the aorta, the major artery carrying blood out of the heart. With symptoms hard to diagnose and solutions not specifically developed for the problem, today’s treatments have a high tendency to fail. Aortyx wants to change that.

We have developed a vascular graft, a “patch” that is inserted via a minimally invasive procedure. It adheres to the tear, stops the pathological blood flowing between the wall layers, and then promotes natural repair. Complicated, life-threatening open-heart surgery is avoided, as well as post-operation failures. Current endovascular approaches use rigid grafted stents, which will be replaced by our viscoelastic biomimetic patch.

Specifically developed for Aortic Dissection, but with possibilities to pivot towards other conditions such as Aortic Aneurysms, we are able to deliver a result that bypasses most drawbacks generated by the existing solutions.

The patch itself is at an advanced stage of patent application, pre-clinical trials are underway and the business plan seeks to use the contacts and traction of existing solution providers in the sector.

With this feasibility study, we have investigated and revised various aspects of our product development and commercial planning. The end result is that we have predicted that, by 2030, we will be operating in a comfortable position with a viable, functioning business. Our conclusion is that Aortyx, as a business proposition is feasible and we are further energised to continue our work and developmental path.

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

At AORTYX we have used the six months of this Feasibility study to advance the planning for the industrialisation of our product, to increase our understanding of key stakeholders and to improve our Business Planning.

For example, we delivered a summary of the GMP plan that we have developed. This includes all the needed providers with dates and a timeline until a final GMP product is delivered ready for clinical trials. We also created an overview of our clinical trials plan, including our quality procedure for obtaining ISO 13485. Our IPR status and plan was revised and delivered.

We also conducted interviews of the medical and pharma sectors. All medical experts showed willingness to know more about Aortyx and our product, indicating that its usage could be beneficial for their work and their patients. Further, representatives from the Industrial, distribution and sales sector showed good engagement with them wanting to be further informed of our product and progress.

Our product roadmap was revised, with high level steps towards our goals. The needed resources (human, suppliers, facilities and financial) were detailed. Market sizes for our treatment lines were calculated along with product development and organisational costs. Strategies for market entry and ramp were developed linking to potential market barriers. Finally, overall Profit and Loss predictions were calculated.

The final result of this project shows that by 2030 we predict that Aortyx will be a functioning organisation with strong order books and revenues supporting our structure. The exploitation result of this six month feasibility study will be assistance with this business success.

This project has been disseminated through the presentation of information and our results to various medical centres and to the medical device distribution industry.

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)

Aortyx is proposing a less-invasive definitive Aortic repair solution. A solution that promotes regeneration of the body’s own tissue and is inserted through key-hole surgery. Current solutions rely on highly invasive open repair and the insertion of an external, non-natural full support, or graft.
As such, Aortyx is past the current commercial state of the art, with disruptive innovation placing it in a unique position.
This phase 1 feasibility study has calculated that we will be providing 12,860 patches by 2030 (5,717 for AD and 7,143 for AA). This means that by 2030 at least 12,860 patients per year will be treated with Aortyx patches (both AX-P01 and AX-P02). Our results indicate that these patients will suffer less mortality and a much higher quality of life compared to current invasive treatments. The end result is that this project will generate an important socio-economic impact.

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