Things are moving fast for Aortyx. How do you value the milestones achieved so far?

I want to point out that we have achieved Caixaimpulse’s support as an IQS research group and the Retos grant has also been achieved with IQS’s collaboration. But at the end of the day we have had high successful rates in extremely competitive calls, public and private. That shows that we are not the only ones that believe in our project. Experts in Catalonia, Spain and Europe believe in the strength of our science and the feasibility of our project.

What is the added value of your device regarding the existing products in the market to treat aortic dissection?

Aortic dissection is a potentially mortal operation in which a tear in the aorta is conducted. Current treatments are no optimal because they are either very invasive or they present many side effects.Technologically speaking, Aortyx’s approach is a change of paradigm in the treatment of the condition, as it provides a definitive regeneration instead of a temporary repair. Our disruptive solution has an enormous potential as it will be able to overcome the gold-standard treatments, reducing mortality and intervention ratios of treatments.

How does your Aortyx behaves inside the human body?

Aortyx’s solution is based on an adhesive patch done with a bio-resorbable material that imitates the mechanical properties of the artery and it promotes its regeneration. The patch is administered in the sick vase using a minimally invasive endovascular catheter that navigates to the dissection and it delivers the patch. We have presented a patent application for the solution and we will present another one for the delivery system. The initial plan is to initiate the proceedings to file the patent for the delivery and implementation system once we have finalised developing the prototype (2020 in the context of NEOTEC-CDTI program).

Thanks to the good results in animal models you are planning to request the FDA approval of your device. What would represent this approval for the company?

The approval of the FDA and of the other regulatory agencies (Europe, Japan, China) is the main goal of our company right now. It will be the door to reach market and the best way to value Aortyx. All our energies go on this direction.

Which are the next steps?

First, we must complete the pre-clinical studies: our lab tests and studies in animals and are showing that our device is safe, viable and effective. Next step will be to start studies in humans. Phase 1 will be done with a small sample of patients, probably in Spain with Dr. Vicenç Riambau. If we are successful, we will go to next phase, in which we will organise an international multicentre trial.

Nanotechnologies and new materials are revolutionizing many sectors, specially medicine. Do you think we will see great innovations soon?

The easy answer would be “yes”, but the reality is that is not that simple. Science has moved rapidly in the last 20 years, especially regarding nanotechnologies, biotechnology, and medicine. However, bringing an innovative product to market is a journey full of barriers. The main one is that regulatory agencies are extremely reluctant to the entry of new technologies. They are nervous and very demanding with the tests before authorising the commercialisation of new products. That involves heavy investments which scare investors. However, once in the market the margins that you can achieve with an innovative device are big and the profits totally compensate the investment.

The other barrier is that the market is dominated by a handful of multinationals that are pushing so their products -usually obsolete-, survive in the market (they are the so-called cash cows). These companies will eventually buy the license of innovative products but as they have a dominant position in the market, they don’t always have the incentive to incorporate them to their portfolio.

How can these barriers be overcome?

We are confident that the situation is going to change. We are seeing an increase of innovative products authorisations in the US and new licenses and acquisitions are growing; There is more competition… The Covid-19 vaccines that are being developed are an example that regulations and M&A can be accelerated. We are confident that these principles are extended to other areas, especially to cardiovascular health and medical devices.

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