SHIP – Ship for Health Innovation Pitches: Meet the nominees biotx.ai, EarlySight, mirRdetect and RAMPmedical

Two more weeks to go until 16 healthcare start-ups from all over Europe compete for this year’s EIT Health Germany Regional Headstart Award. Please meet these four young companies: biotx.ai, EarlySight, miRdetect and RAMPmedical…

The team of biotx.ai.

What is so brilliant about your business idea?

biotx.ai has developed an AI specifically designed for the analysis of biomedical data. Biomedical data have a problematic structure: small sample sizes and very many features. biotx.ai identifies complex patterns of interactions in these data in order to predict accurately the patients’ disease status. We use existing biodata provided by academic institutions, biobanks or pharmaceutical companies more efficiently with our AI. Currently, we are helping pharmaceutical companies selecting patients for their clinical trials or identifying novel drug targets. Therefore, we know from our customers that our AI works several levels of magnitude better than existing analytics platforms.

Why do you think you deserve the Grant?

Our motivation is to bring the outcomes of our sophisticated analytics from open-source and real-world data as better diagnostics for preventive treatment to patients. Because of the dramatical decreasing genome sequencing costs more biodata and healthcare related real-world data get available. In the past, we worked with these data to improve drug development in the pharmaceutical industry. Here, we want to establish a pathway how open-source biodata can be converted into new healthcare solutions. And biotx.ai aims to be a lighthouse of the new pathway to diagnostics by using a grant of only 50k € and the publicity we can get with this grant.

What are your expectations on a possible collaboration with EIT Health?

Beside the financial support we are looking forward to discuss our strategy using real-world data with EIT Health industry experts. As we are at the forefront we want wo minimize risks by benefiting from industry leaders’ experience we can get via the EIT Health network. We are keen to learn from EIT Health’s efforts in the use of real-world data for the patients’ benefits. Our hope is to placing further novel in-vitro diagnostics for other disease areas on the market with the help of EIT Health.

Just in case you win the Headstart Grant – what are your plans with the 50k?

Our goal is to demonstrate that a certified in-vitro diagnostics (IVD) for the early detection of Polygenic Familial Hypercholesterolemia (FH) based on existing biodata can be developed with a budget of 50k € and in less than one year. Polygenic Familial Hypercholesterolemia: Approximately 1 in 250 people in the Western world suffer from this disease. However, only 1% have been diagnosed (European Heart Journal 2013, 34, 3478-3490). A fast and inexpensive tool for early detection is highly required to start prevention treatment as soon as possible. Previously, we identified 13 single nucleotide polymorphisms (SNPs) from existing genome-wide association data that enable the diagnosis of Familial Hypercholesterolemia with a prediction accuracy of >90%.

The 50k € will be used within one year for:

  • Clinical Performance Study:10k €; Month 1 – 6

We plan to use 10k € for further genome-wide data acquisition from several biobanks in Europe to validate our previous results with independent data from different resources (prospective-retrospective Clinical Performance Validation). Additionally, a patent application will be submitted.

  • Analytical Performance Study:20k €; Month 2 – 9

Further 20k € will be needed to develop a PCR-based diagnostic assay through the diagnostics lab TATAA Biocenter/LifeGenomics in Gothenburg, Sweden (including an Analytical Performance Validation).

  • Placing on the Market as a Medical Device:20k €; Month 6 – 12

The last 20k € are necessary for placing on the market as a certified in-vitro diagnostic. Our existing ISO 13485 quality management system will be expanded accordingly to the new medical device regulation (MDR) and necessary documents such as development file, medical product file, specifications will be created.

What message do you have for the EIT Health community?

We want to demonstrate that existing data can be analyzed prospective-retrospectively to bring new diagnostics and, hopefully in the future new treatments, faster and more efficiently to patients. We are at the forefront in the emerging digital biodata economy. And we are happy to share our experiences with the EIT Health community in hope to enable more and better healthcare solutions for patients based on real-world data.

Dr. Marco Schmidt, Founder & CSO, biotx.ai GmbH
The team of EarlySight.

1.What is so brilliant about your business idea?
Monitoring retinal diseases progression is crucial to adapt the treatment and prevent vision loss. Using our innovating imaging technology we are able to quickly assess the disease state by looking at the cellular structure of the retina without waiting months for a visual acuity change or large morphological change.
2.Why do you think you deserve the Grant?
Our solution has the potential to greatly improve healthcare which is one of the main societal challenges of EIT Health’s mission. By reducing the current examination time and enabling more accurate patient follow up, it will reduce healthcare costs and improve patient quality of life.
3.What are your expectations on a possible collaboration with EIT Health?
Collaborating with EIT Health will bring us visibility and the opportunity to meet interesting partners. It will definitely help us taking our project closer to commercialisation thanks to EIT Health mentorship.
4.Just in case you win the Headstart Grant…What are your plans with the 50k?
We will use the grant to accelerate quality management system implementation to certify the company and our product. We will also use it to finish the prototyping (software) and marketing.
5.What message do you have for the EIT Health community?
Our technology is very innovative in the ophthalmologic imaging landscape and has many possible applications for various diseases. We are very open to discuss with any partner in the community that is working on eye diseases in order to explore new market segments and/or establish potential partnership.
Mathieu Kunzi, CTO, EarlySight SA
The team of miRdetect.

What is so brilliant about your business idea?

miRdetect developed a proprietary high-performance molecular diagnostics technology applicable to a wide range of liquid biopsy diagnostic tests for cancer and beyond. Proof of concept was established in clinical trials with our gold standard potential diagnostic test for testicular cancer clearly superior to existing immune assays in a market with high, unmet medical need and substantial market opportunity.

Why do you think you deserve the Grant?

The miRdetect test kit improves the sensitivity and specificity of testis cancer diagnosis significantly and also facilitates treatment monitoring. Our test produces much more reliable results than the current gold standard, thereby increasing security for the, often young, testis cancer patients. We therefore believe, that we deserve the grant, because our work helps these men to better cope with testis cancer.

What are your expectations on a possible collaboration with EIT Health?

We expect to contribute to and receive from the extensive EIT Health network customer and market contacts with the possibility to extend our marketing, partnering and financing opportunities.

Just in case you win the Headstart Grant – what are your plans with the 50k?

Our serum test kit has to be produced, and while we of course have some budget planned for the production, the Headstart Grant would help us to establish a production line faster. We would thus be able to bring the test faster to the market.

What message do you have for the EIT Health community?

With our proprietary high performance technology platform we want to set a new standard in the high growth area of liquid biopsy.

Meike Spiekermann, Managing Director, miRdetect

The team of RAMPmedical.

What is so brilliant about your business idea?

Our methodology, combined to the expertise of our team, enabled us to become the only therapy decision support tool that is accurate and adheres to treatment guidelines. Our software helps all doctors to find the best therapy for each patients, which means that not only the amount of potential clients is huge, but also the potential impact on health worldwide is massive.

Why do you think you deserve the Grant?

We made a solution that is detailed enough, transparent enough, and clear enough so that doctors can decide safely to give their patient a therapy they do not know, within the few minutes they see them. We deserve the grant because many others tried to develop products like ours but could not because they encountered many issues that we do not have thanks to our technical approach.

What are your expectations on a possible collaboration with EIT Health?

EIT Health will allow us to increase the number of partners and pilots, as well as access a network of mentors and specialists. This will bring new feedback and validation of our solution, and widen the use of our software.

Just in case you win the Headstart Grant…What are your plans with the 50k?

We plan to use it to enter into contact with hospitals, start pilot projects, and implement the feedback received during these processes. By having an existing working relationship with hospitals we can develop it towards into a client-provider relationship.

What message do you have for the EIT Health community?

We think the approach used by EIT Health is the one that makes it possible for startup to have a real impact on healthcare Europe-wide. Thank you for that.

Helene Schönewolf, CEO, RAMPmedical by Henisaja GmbH

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