NIMBLE Diagnostics

Medicine is rapidly moving towards implanting increasingly more devices into the human body, including stents, valves, prostheses, sensors and others (i.e recently first patient Neuralink). However, there are no companies focused on creating new technologies for the correct monitoring of such devices to ensure they work properly and do not cause additional harm in the long-term, as they are usually implanted for the rest of the patient's life. 

At NIMBLE Diagnostics we have developed a first-in-class, microwave-based medical device for the non-invasive, easy and rapid monitoring of metallic implants. We are currently focused on developing the technology to aid patients with implanted stents (small metallic mesh tubes used to re-open blocked vessels and restore the correct flow of blood to the tissue). Stents are mainly used to treat cardiovascular diseases, and >50M patients currently have a cardiac stent (>4M stents implanted each year), but can become blocked or damaged in up to 30% of the cases in the first 2 years after implantation (>80% affected after 10 years). Currently, the only way to know if an implanted stent is working properly is through a very complex (anesthesia, x-rays, 2-3h, 3-5 people), expensive (12-15K euros/procedure) and invasive (catheter based, >72h hospitalization, 1-week at-home rest), called catheter angiography, that cannot be used to screen asymptomatic patients that may be at risk, which increases the incidence of serious complications (heart attack, stroke, sudden death...). The NIMBLE technology would allow for the correct monitoring of the stent from implantation (to ensure the procedure has gone well and the patient can be discharged safely) to a continuous follow-up (to identify risks early on and adopt the right treatment at the right time, decreasing complications, hospitalization rates and mortality). 

This coronary market alone is valued at 8 Billion euros TAM, and we plan to capture through DTC/Leasing to hospitals, primary care facilities, private clinics and CROs/research Biotechs/MedTechs. 

•  
• We have raised aprox. 5.5M€ (Non-dilutive: 2.3M€ EIC Accelerator + 1.2M€ RETOS + 900K research grants; Dilutive: 1.03M seed round) .
•  
• We have validated our technology in pre-clinical models (swine): 100% sensitivity and 90% specificity values vs clinical guidelines (St Dev - 4%) and 0.98 R correlation with catheter-based state-of-the-art imaging techniques (OCT) 
•  
• We have started our FiH pilot study (120 patients) tha will end April 2025. 
•  
• Team: We are a team of 11 people (clinical, technological, regulatory and commercialization). 
•  
• Cap table: 9 founders (70% shares, including CEO, CTO, CSO, CMO and technological lead + 3 universities), 2 seed funds (Grow Venture Partners and Namarel Ventures + BA network (30% shares) 
•  
• Pre-marketing activities: Finished early Health Technology Assessment in EU (savings of 2.000 euros/patient; mortality decrease 38%) and early Health Economics in the US (savings of 65M$/year), Finished Regulatory Roadmap (Class IIa CE/Class II FDA), Finished prototype for human testing (IDNEO) 
• LOIs from 16 hospitals across EU to participate in clinical trials, follow-up from several key companies (Abbott, Medtronik, Boston Scientific etc.) 
•  

We are now raising Series A 12M€ to 1) include US hospitals in our pivotal trial (2025) to get FDA in parallel with CE mark; 2) Scale-up manufacturing; 3) Start EU commercialization (2026-2027); 4) start R&D into other clinical applications (Other stents - neurovascular, peripheral; Prostheses - infection; Valves-calcification; Sensors- encapsulation). We are looking for 1 lead investor (ticket 3-5M€) to close the round (50% Series committed by the EIB [matching Lead investor term sheet; no board seat]; 3 small funds committed with tickets aprox 1M euros)