Denis Dufrane, NOVADIP Biosciences - Stem Cell-Based Tissue Regeneration Therapies | LSI USA '24

Denis Dufrane  0:05  
Thank you. I will note that it was founded in 2013 to develop to a new class of bone product in view to restore the aboon physiology. And now we are a clinically advanced company with realizing five clinical trials since the start of the company. We have two class of product large bone reconstructions to avoid amputations. And based on the knowledge that we acquired with the autologous bone program, we developed an allogenic cell the hive project as a first line of treatment to restore bone physiology in patients with bone nonunions. Since the bone on unions is increasing dramatically now, due to comorbidities, factors such as steroids, obesity, and also aging, because we are losing 50% of our potential to treat and to restore bone continuity after 50 years old. In this context, we developed a unique platform called three and 343 dimensional scaffold three approach derived from adipose stem cells for the autologous bone program the origins of our platform is a small adipose tissue collections two to three CC that we use to isolate stem cells, we are producing a three dimensional to three dimensional mature product, which we can transplant directly into the body to restore the bone contiguity after a big trauma on congenital disease for young patients, in parallel and based on the key growth factors and micro RNA is involved in the process of the bone healing, we develop an allogenic approach which is not to sell based but to sell the hive because we are using only the metrics to VI kill the growth factors in the micro RNA as a first line of treatment, we develop an off the shelf bioactive matrix. I demonstrate you that we are in clinical stage company with already demonstrated in severe trauma in adult populations of patients after a very infections and trauma that you can restore the bone healing physiology, but most of the important things and really the target of our company that's to treat these recovered indications in pediatric populations called the congenital to that so these of the tibia you can see these young kids aged three years old with a full description of the tibia eligible unfortunately for amputations, and now you can see the two years after you saw he can walk we restore the length of the limb and restore normal quality of life. Currently, we are conducting a phase one B to A trials in US and in EU and all the patients were recruited and we implanted the first patients in us in last November. For the off the shelf and base of what we learned for the from the autologous bone product we develop this bio active powder as a first line of treatment for old patient for example, in that case, with a registered Roma a classical fracture in old patients, the product can be formulated very easily during operating room just with blood, you can directly implant into the body and you can see at discharge that we have already the the bone defect field by the matrix, but most important thing after three months is that exactly the timing that we saw for the the allogenic one will restore the complete bone continuity. We restore by the stimulations of the OST recipient cells, the new formations of the bone by the product called here allergenic one and VD X free. We are not only in trauma, and we know that spine is a big market and also is now associated to higher rates of bone unions, especially due to obesity and smoking. It's why we are performing in parallel of our trauma study or preclinical models in large animal models in sheep for example, a model of spine fusions and we perform a post the whole article up so we perform a posterior lateral spine fusions here that we demonstrated that the three months we have a complete full bridging in comparisons with the autologous bone graft use currently as the gold standard. In parallel of our preclinical large animal models we are conducting now also in EU a spine fusion trials in do to demonstrate that the safety and also the feasibility of our product, the most interesting thing currently we are the first and the first one off the shelf, allergenic cells, the highest product stored at room temperature, and also without any hesitations of immune reactions. humoral and cellular it's free only tolerated by the OST, not only in allogenic, but also in case of xenios any context because here that was human materials implanted into the sheep recipient. With this platform, we are the only ones to cover 95 Nine 5% of the clinical indications in the orthopedic field, because her autologous cell based product can cover all the adult and pediatric populations for her large defect, covering a market size of one billions of US dollar, incorporating all the orphan indications that you can find in enlarge bone indications. And in the opposite the off the shelf cell derived product. It's really a new paradigm to restore the bone healing physiology for patients currently affected by this bone unions and the comorbidities factors leading to this non healing of the boat for a significant border market seven billions of US dollar mainly driven by toma and spine and also mainly driven by the US market. I have mentioned you we are a clinical stage company because we already completed the first trials in bone nonunions large bone defect for the adult populations, we recruited all the patients and all the patients are treated with the autologous project for the pediatric indications. And in parallel, we you can see that the toma trials is fully recruited for the off the shelf product. While we have already recruited for patients with for the spine indications all goal and we are already prepared now is to be able to start the old for us trials that you can see here in q1 2020 fi because all the regulatory to see all the interactions ind submissions at type C meeting for the FDA respectively, are already done into to start or trials in q1 2025 and to be on the market end of 2026. With the autologous bone program and starting phase, phase two slash phase three with the off the shelf, the objective end of 2026. With the autologous bone program, we have access to a priority review voucher because we are dedicated to a new cadre of pediatric indications leading to this access to this peer review estimated in terms of transactions up to one and read millions of US dollar in terms of revenue. And now we are seeking this 50 millions of US dollar in view to really plan all what is needed to be achieved between early 2025 up to end 2026 to lead all in parallel this activity and I'm relatively proud by the teams that we have because all the patients transplanted currently, both in US and in EU have were treated with product produced in Belgium's with the same teams now and with a really great expertise and challenge by purely mainly us cables from the HSS from the Langley and from also the Boston Children's Hospitals. And I think I'm on time. Thank you so much