Fundraising, key product development milestones, a licence agreement strengthening our IP, big headways on the regulatory front…A new year always gives the opportunity to reflect on the previous year.
Of course paramount to our success, our ability to raise funds to finance the requested investments. Several major news on that front in 2023 :
✔In july, we confirmed our growth by raising an additionnal 1,4 million euros. Sodero Gestion and Pays de la Loire Participation (managed by Siparex) renewed their confidence in us by investing 500 K euros. The second part of this fundraising came from Bpifrance – this aid confirming our deeptech status.
✔ In december, Bpifrance granted us a 250 K euros strategic Seed Investment loan.
Earlier in 2023 :
✔Evosciences had agreed to finance most of our laboratory equipment.
✔Airbus Développement decided to support BioMAdvanced Diagnostics
2️⃣PRODUCT DEVELOPMENT | KIDNEY
✔In october : we finished successfully the processing of more than 420 samples from patients who had been transplanted with a kidney for our first clinical study with the University Hospital of Nantes.
✔In november, the positive results of this first clinical study were released. This success propels us forward, allowing us to embark on a subsequent prospective European multicentric study, last step before CE marking by the end of 2025.
As a reminder, our kidney test will be our first product and its development paves the way for the two others – enabling a subsequent accelerated development.
3️⃣PRODUCT DEVELOPMENT | LUNG
✔In may, we signed off the product Design Freeze for our lung rejection test.
✔In december, we signed an exclusive unlimited license with the SATT Ouest Valorisation for the patent titled “A blood gene score to prognose chronic lung allograft dysfunction” which completes the 2 existing patents protecting the lung transplantation test.
4️⃣ OUR SOFTWARE
✔In march, Design freeze of our software platform and start of the analytical validation phase.
✔ Our software successfully passed a 3rd wave of testing
✔In september, we copyrighted the full code and the user interface design of our software to fully protect it.
5️⃣ NEW POTENTIAL LICENCE | NEW PRODUCT OPPORTUNITY
We signed an agreement with Clermont Auvergne Innovation aiming at securing an exclusive license on a patent owned by the Université Clermont Auvergne, the CHU de Clermont-Ferrand and INRAE protecting a technology enabling the early muscular atrophy diagnosis/prognosis for patients suffering from cancer or kidney failure.
🚀for us, the opportunity to develop a test for 25 million patients worldwide suffering from cancer or kidney failure and at risk for an irreversible muscular atrophy.
6️⃣ SUPPLY CHAIN
✔ In february, Eurofins Genomics accepted to deliver to us oligonucleotides under an OEM agreement.
✔In september, our entire supply chain was up and running enabling us to ship the 1st batch of our 1st product (the IVD* test of absence of subclinical rejection for patients who received a kidney transplant)
7️⃣A GROWING TEAM
After a lot of hiring in 2022, we welcomed two additional team members in 2023.
✔In January, Lise Letellier joined us as a Laboratory Technician to complete the Molecular Biology R&D Team.
✔In October, Sonia Brinet took her role of Clinical Project Manager (Responsable Projets Cliniques).
In March, – Kidney International released online the article “Subclinical rejection-free diagnostic after kidney transplantation using blood gene expression” authored by our co-founders Sophie Brouard and Richard Danger. An article that provides bullet-proof scientific credibility to BioMAdvanced Diagnostics’ solution.
9️⃣BIG HEAD WAYS ON THE REGULATORY AFFAIRS FRONT
Launching a medical device on a global scale includes many steps.
✔In February, we underwent a Pre-Certification assessment audit of our Quality Management System with our Notified Body (companies aiming at developing, manufacturing and distributing Medical Devices need to have a Certified Quality System according to the ISO13485 standard)
✔In may, our request for company registration in EUDAMED was approved. Our unique identification number (or SRN: Single Registration Number) as a manufacturer is FR-MF-000035475.
✔In june, our Quality Management System underwent successfully its stage 1 audit for the ISO 13485 certification of our quality system. More news to come on that front.