BioMAdvanced Diagnostics

🧬 **June 22nd, Organ Donation and Transplantation Awareness Day!** 🧬   "Organ donation is one of the very rare opportunities we have to save up to 7 lives (or even more with tissue donation) with just a word, a conversation with your loved ones, on June 22nd and every other day of the year!" explains Marine Jeantet, General Manager of l’Agence de la Biomédecine.   In France, ✔80% of people are in favor of organ donation, yet in 2023, the opposition rate stood at 36%. ✔73% of people support donation to save lives, yet 50% haven't discussed their wishes with family.   Misconceptions still linger, and it’s vital to break these barriers.     For more information : https://lnkd.in/dNqcwiHz   #dondorganes #TousDonneursTousReceveurs  

👏Please join us to congratulate Sophie Brouard, co-founder of BioMAdvanced Diagnostics, CNRS Research Director and head of an immunology team at the CR2TI, an INSERM lab located at the University Hospital of Nantes, as we are extremely proud to announce that she has just been appointed corresponding member of the French Academy of Medicine! About her research focused on kidney transplantation, Sophie Brouard states : "Our goal is to discover new biomarkers for graft survival, particularly subclinical rejection. Current monitoring relies on functional parameters like creatinine and proteinuria levels in transplant patients' blood. However, these changes indicate existing histological alterations. We aim to anticipate these changes by identifying molecular gene biomarkers in recipients to enable early therapeutic intervention. Our subclinical rejection score, based on two genes and some clinical parameters, allows us to diagnose subclinical rejection early. This score has been validated across multiple European cohorts and platforms" For memory, about 10% to 30% of kidney transplant patients experience subclinical rejection. 🎬In this video, Sophie discusses the pioneering research that led to the creation of our company.   🔬BioMAdvanced Diagnostics is about to bring this score directly to the patients and their clinicians, significantly improving early detection and intervention for transplant patients.   #Atlanpole #AtlanpoleBiotherapies #LaFrenchCare #medtech #kidneytransplant

🏆 Last week, our CEO Frédéric Pette proudly received a trophy from BPIFrance, marking BioMAdvanced Diagnostics' selection to join the prestigious Club Excellence. Reflecting on this achievement, Frédéric Pette shared, " Just a couple of years ago, joining this prestigious Club was beyond our imagination. We are honored to be part of this influential community and look forward to the opportunities for growth and collaboration ahead." This new accolade joins our previous recognitions: - 🏆 2021: Prix de la Région Pays de la Loire at Start West.   - 🏆 2022: Award for job creation at Startups & Innovation Day Each award reminds us of all the progress we've made since our launch in 2021. #Atlanpole #AtlanpoleBiotherapies #LaFrenchCare #medtech

📌Always one step ahead. 🧪 Our IVD platform is based on q-PCR technology. However, our lab team just got trained on d-PCR technology (Digital PCR). ✔D-PCR is still mainly used in Research, but we are evaluating the opportunity to prepare future products on this technology and therefore wanted to make sure that our lab team completely masters it. 📌Q-PCR TECHNOLOGY STILL MASSIVELY USED BY HOSPITAL Our IVD platform combines gene expression identification/quantification and algorithms and is materialized by products destined to hospitals which today are massively using q-PCR technology. This is the reason why we have adopted this technology so that there would be no barrier to entry or adoption of our product in the form of capital investment. 📌D-PCR IS EMERGING Mainly used in research, digital PCR (d-PCR) is emerging as a complementary technology to real-time PCR for precise quantification of nucleic acids. It can offer a high level of sensitivity and robust performance against inhibitors. Digital PCR is used in a variety of research applications, providing unparalleled confidence in the quantification of rare targets, copy number variation (CNV), gene expression and much more. We thank our local representative from Qiagen for having organized and driven this training. #Atlanpole #AtlanpoleBiotherapies #LaFrenchCare #medtech

Exciting Milestone for BioMAdvanced Diagnostics! We're thrilled to unveil the commercial name for our project formerly known as "SRDK0921" ✨BioMAdvanced Kidney SCR Score 🚀Along with its new name, we're also introducing its dedicated logo, aligning closely with our established corporate identity now protected and registered across the EU, USA, and Japan.   Why this name ? ✔We will have other applications following this one, it was therefore mandatory to precise both the target organ and condition in the name.   ✔The "SCR" in the name stands for Sub-Clinical Rejection, pinpointing the test's unique focus and specialization. 🧪BioMAdvanced Kidney SCR Score is one of the few tests completely specific and dedicated to detecting early the absence of SCR of a kidney transplant, providing specific insights that are critical for early intervention and a true personalized medicine approach. 📅As we move into the final clinical phase with results anticipated by year-end, our focus shifts towards achieving a CE mark by end of 2025. Next on our launch roadmap, we are now actively seeking a commercial partner to prepare for a successful European market launch. #Atlanpole #AtlanpoleBiotherapies #LaFrenchCare #medtech #KidneyHealth

🚀 [Q1 2024 – recap] Our first 3 months of 2024 have already been marked by several key milestones, enabling us to stay confident about our current scheduled roadmap and to prepare for a global launch.   📢 New License Agreement: this exciting license opens a market of 25 million patients worldwide suffering from cancer or kidney failure and at risk for an irreversible muscular atrophy.   ✨ Bpifrance CLUB EXCELLENCE Selection. Among the 200,000 companies supported by Bpifrance, only 2,000 companies, including startups, small and medium-size companies (PME), and intermediary size companies (ETI), have been chosen.   📈 ISO 13485 - we successfully completed the audit for ISO 13485 certification of our quality system and we are officially certified. This is a big deal as companies involved in the development and manufacturing of Medical Devices are REQUIRED to have a Certified Quality System in accordance with the ISO 13485 standard.   🧪 RNA Export Authorization: we are now authorized to export RNA extracted from human blood to partner laboratories in Europe as part of the development of our first in vitro diagnostics test (targeting patients with a kidney transplant).     🌍 « BioMadvanced Diagnostics » and its logo successfully registered as Trademarks in the USA.  Another step in our journey towards delivering great diagnostics solutions to transplanted patients and their clinicians around the world.   🛠 Usability Testing: Crucial to our product : its ease of use and its safety. We conducted a series of tests and were able to conclude that our current product (kit and software components) met all of our expectations.   Stay tune for other upcoming milestones   #medtech #nantes #LaFrenchCare #innovation    

🚀In the dynamic realm of healthcare technology, some MedTech products such as ours can often reach the market faster than others or than their Biotech counterparts, a fact that can be intriguing to some investors and healthcare professionals alike. THE ABILITY TO ADOPT AN AGILE DEVELOPMENT PROCESS ✔BioMAdvanced Diagnostics has applied the principles of “Agile” development resulting in a remarkably fast yet extremely qualitative product development. ✔We seized the opportunity for early feedback from end-users before getting into the Regulated phase of the development which accelerates refinement, making the path from concept to commercialization more efficient and ultimately faster. A MORE STREAMLINED REGULATORY APPROVAL PROCESS & THE USE OF BIO-COLLECTIONS ✔Biotech involves complex biological processes requiring extensive clinical trials which are split in phases (I, II and III with subsets such as IIa, IIb, etc.) to ensure safety and efficacy, thus extending development time. ✔MedTech products also need to be clinically trialed, but these studies can take less time. This is the case for BioMAdvanced Diagnostics which develops non interventional products and therefore can leverage the benefits of using bio-collections (cf. our previous communication https://lnkd.in/dpZJqzJa ). 📌This distinction underscores the importance of some MedTech’s, such as BioMAdvanced Diagnostics’, potential swifter innovation cycle in addressing urgent healthcare needs and driving progress in medical technology. #MedTech #HealthcareInnovation

🧪BioMAdvanced Diagnostics Receives Authorization for RNA Export. 📌From March 15, 2024, and for a period of 5 years, BioMAdvanced Diagnostics is authorized to export RNA extracted from human blood to some partner laboratories in Europe as part of the development of its first in vitro diagnostics test (targeting patients with a kidney transplant). For memory, this first product aims at assessing with a very high degree of confidence the absence of subclinical rejection in kidney transplant patients. ✨AN AUTHORIZATION ESSENTIAL TO OUR DEVELOPMENT Our product development process includes extensive testing involving selected partner laboratories located in Norway, Spain, Italy, and the Netherlands. We are planning to send RNA samples alongside our kits to those laboratories so that they can test our product. The results of these analyses will aim at validating the reproducibility and suitability for use in very different settings by independent teams. 🔎A LITTLE BIT OF BACKGROUND Concerning elements from the human body (organs, tissues, cells, components, and derivatives), French legislation provides for cross-border movement restrictions between France and another member state of the European Union. The import and/or export of elements from the human body is only possible for specific purposes, including scientific purposes, and subject to authorization from the French minister responsible for research. Among other things, the legislation ensures that the consent of donors, free donation, and anonymity are preserved. #MedTech #LaFrenchCare

Wondering how we're able to process our clinical trials at such a rapid pace? The secret lies in Bio-collections (or Biobanks). These collections of samples (blood, biopsies, etc.) and clinical data, gathered from patients recruited without bias, enable us to expedite processes and tap into a vast pool of patients. 🚀SPEED AND SAVINGS Bio-collections enable BioMAdvanced Diagnostics to shorten the recruitment and the observation time, tap on large pool of patients and simplifies the administrative burden as most of it was already incurred to constitute the Bio-collection itself. These combined effects also cut significantly the costs of the needed studies. How did it translate for us ? ✔ In just few months in 2023 à our subclinical kidney rejection test validated on a 1st multicentric clinical study on 421 patients. ✔Finished within less than a year à a second prospective multicentric international clinical study ✔Our chronic lung rejection test 1st multicentric international study expected to be performed in a few months as well 🧪ABOUT OUR BIO-COLLECTIONS The Nantes CHU (*) has provided us with access to valuable bio-collections of samples from patients who have undergone kidney and lung transplantation. (*) as a reminder BioMAdvanced Diagnostics is a spinoff from the CR2TI (Centre de Recherche Translationnelle en Transplantation et Immunologie, UMR 1064, INSERM – Nantes University) and from the University Hospital (CHU) of Nantes. ❓Why isn’t every company needing clinical studies doing the same? Because this approach only works for non-interventional products like in vitro diagnostics (IVD). 📢So stay tune for clinical studies news towards the end of 2024!

“BioMAdvanced Diagnostics” and its logo have been successfully registered as Trademarks in the United States of America. Another step in our journey towards delivering great diagnostics solutions to transplanted patients and their clinicians around the world! “This paves the way to the protection of future product names under the umbrella “BioMAdvanced” in these geography in the field of in vitro medical devices commercialization.” Frédéric Pette, CEO BioMAdvanced Diagnostics “BioMAdvanced Diagnostics” and its logo are now fully registered in : ✔The European Union ✔Japan ✔The United Kingdom ✔The USA #medtech #trademarks #nantes