NELA BioDynamics | Jose Exposito-Ollero

(Transcription)

Jose Exposito-Ollero  0:02  

Good morning. My name is Jose Exposito. I'm the CEO and co founder of NELA BioDynamics. NELA BioDynamics is a spinoff of the Polytechnic University of Valencia and Clinical Hospital Valencia based  in Spain. I started in the sector 15 years ago, which allowed me to identify the critical points in to improve in the joint replacement. In NELA we are development the new generation of joint replacement for intermediate is the new generation of inflammatory stem for Gene replacement. Due to subpopulation H graveley. We are almost at attained to encounter a familiar friend that needing from joint replacement. This is the current way to perform a new replacement. This is a very traumatic and imprecise method that imparts ruts in the bone to mechanize the hole to come place the implant also like how many these had several problems that I've had mainly to senarios to patients and healthcare systems and we try to solve. With our implant we eliminate the necessity to impact rats or using bone cement, inserted the implant with clearance into the bone and then prestress it achieving the right instruction, fixing the implant to the bone with a wind plan on tools with development and a new Surgical Clinic more easier, faster and precise. View to be increased in longevity and active lifestyle. There are an increase in injuries and disease that affects a wide range of population today is more common to see a younger people that need a joint replacement. Or started right this is one of the main the Unity disease, the produce very impediment that the which translates into more than 2 million hip implant procedures per year while the surgery is the most effective intervention, but it's very dramatic and require a lot of vacation per year. Currently, there are two types of implants press fit on Simon's both types are inserted by harmony and have problems to to produce a high inFile rate among these problems are the loosening of the implant or fracture of the bone due mainly to the high rigidity of the implant. If the implant fails, the only solution is remove it, but it's very very difficult. In the 50% of the cases the bond must be dissected to construct it. This is a very traumatic and long experience especially taking into account that the patient that the most of the patient of seniors and staff undergo surgery or hip surgery. Our implant is composed by an alternative series of polymeric bolt and cylinder coating with Itani and united by a Central School when the implant is prestressing the the implant is achieved rather than expansion fixing the implant to the bone, the implant combined polymeric and metallic materials to achieve reality so closer to the bone to maintain the physiological boundary modulation process. We develop very faster easier and precise technique. First we make any state the bone with strike and conical bars very similar to the carbon revision surgery. And then we use a very precise reamer auto mechanic save the final call us our new patron tool we can mechanics say the femoral neck geometry with all rasp then the implant is introduced with screws ran into the bone and use and different Dinamo metric toward rent we can control the amount of the Royal expansion and the fourth fixation applying to the bone. The type of customization is unique in the sector. And we call densitometric adaptation. We perform the initial in vivo test to to prove the concept in real environment. What this is a comparative study between our implant and our press with implant and the historical results. So better tolerability introducing Ronaldo city roseum reducing the fibrosis number of colored it's facing an inflammatory reaction to our PA To avoid the hammering these results, so, in superior to the current implants and maintain in maintaining in the main study, our implant will be proved superior to the current implants. We also perform mechanical tests to determinate the capacity of rotation of the implant and to find the maximum fixation force also we are we are performed and mechanical resistances to the terminate the durability of the implant. As our patent protects a wide range of applications, both in joint replacement on trauma we expect to impact in more or less 52% of the market. This market is dominated by big four companies that represent the 68% of the company of the of the market. And basically in the study of acquired Big, small innovative companies. Our exit strategy is by set in to be acquired by one of these large companies to to improve their portfolio. Today, we raised more than $1 million between grant public grants CDROM three f c grown pulley loans and academic grants. Just now we are funding to a new procedure around of 2 million to complete the preclinical test validation product P validations. Expand the team and facilities employ our ability and quality control to increase our activity markets marketing activities and establish our presence in the USA. Today at update we performed all the preliminary preliminary tests both B and mechanical tests obtaining a very good results. And just now we are become a member of Mayo Clinic innovation and check program. This year we have planned to complete all the preclinical testing to kind of start with that multicenter clinical trials in 2023. And Ken to put the plan into the market in 2025. With the FDA approval and see market. With a very conservative forecast market penetration, we can achieve a positive return in 2020 with an appraised implant price very similar to the current mid high in implant prices in the market. We have three patents in our portfolio. The main patent is the intermediate die implant issue in USA and Europe. This implant protects all the application for joint replacement but also for naval fracture and exporter it says yeah, this is a new a new topic a new application. In visa in the last application the implant can be combined with a percutaneous Kohler to reduce the stomach infections. And just now we are presenting or I think baiting to protect the tool for mechanized that femoral neck the company's leading by me I'm Hindustan engineering and biomedical engineering and just now I'm finishing my PhD. My sorry, my PhD cell technology. I'm past the last eight years working in the concert with the Dr. Antonio Sylvester, head of the orthopedic surgery of the clinical hospital road Valencia and Dr. Rochelle Vela, senior professor of engineering of Hindustan engineering of the Polytechnic University. Then the last team is completed with six o clock later have more than eight years of experience in the development of medical device with the cannabis, half of our CFO, Andreas Aveda of our CTO, all of these ways our greatest pension in the medical device sector. And with the with the wrong we expect to expand our team. Thank you very much and I expect to see you in the one to one meeting.