Startup Tales | How M2TEST revolutionises osteoporosis prevention and diagnosis

The company co-founded by Professor Francesca Cosmi and Dr. Alessandra Nicolosi, with the innovative BES TEST, evaluates the quality of the internal structure of bones, predicting the risk of fractures and osteoporosis.

An innovative patented "Made in Italy" methodology that not only diagnoses osteoporosis but also identifies individuals at risk of fractures due to bone fragility and calibrates therapies accordingly. This is the BES TEST (acronym for Bone Elastic Structure Test), the first solution of its kind in the world created by the startup M2TEST co-founded by Professor Francesca Cosmi and Dr. Alessandra Nicolosi.

A female-led startup active in the STEM field with another peculiarity: Professor Cosmi - graduated in Mechanical Engineering from the Politecnico di Milano and a professor of Engineering at the University of Trieste with prestigious collaborations in her career including MITI Tsukuba (Japan), NASA JPL-CalTech, and the University of California at Berkeley (USA) - is the mother of Alessandra Nicolosi, who graduated in Pharmacy and Herbal Techniques from the University of Trieste and is also the CEO of M2TEST.

"M2TEST was founded in 2016 thanks to Innovation Factory, an accelerator present in the Science Park area: one of the most important scientific consortia in Italy based in Trieste. After winning a call for proposals, we had the opportunity to establish the company," says Alessandra Nicolosi.

They participated in the call with the BES TEST, the result of 20 years of work by Professor Cosmi: a research project developed within the Department of Engineering and Architecture at the University of Trieste, from which the startup was born as an academic spin-off.

What is the BES TEST and how does it work?

Currently, the gold standard for diagnosing osteoporosis is bone densitometry (MOC). "MOC is known to have limitations," explains Dr. Nicolosi, "in fact, it may not correctly assess the fracture risk of those who undergo it, up to 50% of cases." The problem arises from a physical issue on which bone densitometry is based, which identifies how much mineral is present in the bones but is not able to capture the internal structure.

"The Genoa bridge was made of concrete, therefore high density, and a hole was enough to make it collapse. In Japan, bridges are made with low-density but elastic bamboo canes," explains M2TEST's CEO with a concrete example, "positioned in such a way as to withstand loads so that the bridge does not collapse despite earthquakes."

"The BES TEST," highlights Dr. Nicolosi, "is exactly this: while densitometry only reads the density of the bone, our solution looks at how it is structured internally and assesses fragility and resistance even before problems arise."

An innovation complementary to MOC, which covers the aforementioned gap while offering other advantages: firstly, the possibility of undergoing it at any age, and secondly, the fact that the test can be repeated every 4-6 months as opposed to the 2 years of bone densitometry.

The operation of the BES TEST - delivered in Software as a Service mode - is as simple as it is revolutionary: "A software capable of performing an engineering analysis starting from an X-ray of the patient. Our clients," adds Alessandra Nicolosi, "are private doctors, clinics, and hospital.”. Moreover, the results are available in very short times thanks to the proprietary algorithm that virtually analyzes the elastic response of the patient's bone through simulations, created and written by Professor Cosmi, who clarifies: "As an engineer, I don't want things to fracture, whether they are bones or mechanical parts. How do we engineers usually determine resistance? Either we take the material under study and subject it to a load test until it fractures, or we create computer simulations, as with the BES TEST."

M2TEST: the origins of a startup born "in the family"

When the call for proposals was published in 2016, "I was graduating in Pharmacy. My mother called me into her office saying: 'a call for proposals from Innovation Factory has been released, if you want, we can do it together.' I immediately replied let's try, without thinking it would change my life," recalls Alessandra Nicolosi.

After winning the call and establishing the startup, Professor Cosmi "mainly took care of the scientific part as the creator of the BES TEST, while I had to manage the company and, honestly, I didn't really know how to do it," admits the CEO of M2TEST. The startup's first steps were consequently "slow," both due to gaps in management and the patenting of the innovative technology, to be tackled step by step.

"Today, the technology transfer has been completed, and the company has also grown, with a turning point in 2019 when we won the selection for the famous Skydeck acceleration program at Berkeley University," emphasizes Dr. Nicolosi. "We participated in the GIP Program, and I spent six months in the United States, in the heart of innovation, returning with a mental shift: I had become a true entrepreneur."

The growth of M2TEST, between unforeseen events and new opportunities

After completing the acceleration program, "in 2019, the goal was to go to America, also because there were already interested investors who, however, only invest in startups based in the USA," clarifies Dr. Nicolosi. "The idea was to return overseas with the BES TEST approval process at the FDA (Food & Drug Administration) already underway for two reasons: contacts with investors and the 'strength' of MedTech in the United States.".

With the Covid-19 pandemic, plans changed, but "instead of stopping, we decided to focus on entering the ministerial guidelines, also because since 2019, Professor Cosmi had come into contact with the leading medical experts in bone metabolism diseases, immediately very interested in the BES TEST," explains Alessandra Nicolosi.

The technology - covered by 3 patents in addition to the CE mark as a medical device registered with the Ministry of Health and various certifications - with entry into the ministerial guidelines will become a service also provided by public structures, moving out of the private sector.

Entry has not yet occurred due to an already long process that suffers further delays caused by the pandemic. Despite the unforeseen events, "in 2021, we had our first fundraising," recalls Alessandra Nicolosi. "In the meantime, the patient base has increased, and to date, we have reached 12,000 people of both sexes who have undergone the BES TEST. We have 16 multi-specialty centers that perform the BES TEST monthly, highly requested from all over Italy. Now we are again in fundraising with the goal of raising one and a half million euros," adds the CEO of M2TEST.

From B-Heroes to Up2Stars to the ELITE Lounge: the journey with Intesa Sanpaolo and Intesa Sanpaolo Innovation Center of M2TEST

M2TEST, selected among the 16 finalists of the fourth edition of B-Heroes (a business talent dedicated to innovation realized in collaboration with Intesa Sanpaolo and Intesa Sanpaolo Innovation Center), participated in Up2Stars in the MedTech/Healthcare category.

"I am always very attentive to new opportunities," clarifies the CEO of M2TEST, "and when an interesting call for proposals comes out, I participate, and I also aim to introduce the BES TEST into corporate welfare." "First of all, what I liked about Up2Stars was the fact that at the presentation there were people active in this field, with a consequently more sectoral program," emphasizes Alessandra Nicolosi.

"Moreover, Up2Stars - born from the collaboration between Intesa Sanpaolo and Intesa Sanpaolo Innovation Center - is supported by Gellify, an innovation platform that is highly regarded," emphasizes the CEO of M2TEST.

"One of our problems," adds Dr. Nicolosi, "has always been attacking the market without losing resources, and thanks to the program, we found a solution. The demand for the BES TEST is enormous, so we created waiting lists by organizing screening days in medical centers. A solution that works and has given a significant boost to the business."

After the Demo Day pitch, "we were contacted by several companies for the distribution of our innovation. In the past, we had negative experiences with pharmaceutical informants," explains Alessandra Nicolosi, "but thanks to Up2Stars, we reached an agreement with Croma Gio.Batta SrL, which will distribute the BES TEST from September 2023."

Entering the ELITE Lounge of Intesa Sanpaolo organized in collaboration with ELITE - an Euronext ecosystem that aims to identify Italian entrepreneurial realities and prepare them to face growth challenges with a set of services to support the business - M2TEST has completed the first part of the journey that will resume after the summer break. A useful experience to work on the managerial aspects of a startup born as a family business with associated difficulties, which "is offering us tools to build the company structure and understand how to work best given the entry of external personnel and investors into the company," points out the CEO of M2TEST.

Looking to the future, one of the startup's goals is to include the BES TEST in the corporate welfare of the Intesa Sanpaolo Group, as well as to target the American and European markets. In order to ensure wide dissemination of the BES TEST, the intention is to finalize the exit as "we are aware that a solution that can change so much must be brought to the market by an already developed company," concludes Dr. Nicolosi.

Photo credit: M2Test