Periodic Reporting for period 1 - NIMBLE WOMENTECHEU (A novel non-invasive and non-ionizing medical device for monitoring patients with implanted stents)
Période du rapport: 2023-06-01 au 2024-05-31
Susana Amorós is the CTO and co-founder of NIMBLE Diagnostics, a MedTech company developing a first in class microwave-based medical device for the continuos, non-invasive, non-ionizing monitoring of patients with implanted stents. Stents are one of the most implanted devices worldwide and are used to restore the correct flow of blood or other fluids. They are especially useful to prevent heart attacks or to treat their lasting symptoms, but once implanted can become blocked or damaged, which occur in 30% of the cases. The symptoms only appear after a stent is already 90% dysfunctional, which increases the incidence of serious complications, including strokes, heart attacks or sudden death. The standard-of-care is still symptom-driven and is based on an invasive procedure called catheter angiography, involving anesthesia, X-ray exposure and 24h hospitalization recovery. This complex procedure is not standardized for recurrent monitoring, not allowing clinicians to act upon the problem until it has already manifested.
The NIMBLE System can read the electromagnetic signature of the stent non-invasively, providing information on stent satus and malfunction that can be correlated with relevant clinical outcomes. Thus, NIMBLE enables early treatments to prevent negative outcomes and personalization of pharmacological therapy, shifting from reactive to proactive care. Our technology is currently at TRL5 with an MVP that has shown and excellent results in on-going validations. However, before we can offer our solution to cardiologists and primary care clinicians, we must complete key activities in our action plan. WomenTechEU will help us to better understand pricing and reimbursement strategies for the NIMBLE System in European markets, gain visibility with investors and collaborators, and support and mentoring from being one of the growing numbers of female entrepreneurs. Susana expects that this program supports her in bringing NIMBLE System to the market.
The NIMBLE System can read the electromagnetic signature of the stent non-invasively, providing information on stent satus and malfunction that can be correlated with relevant clinical outcomes. Thus, NIMBLE enables early treatments to prevent negative outcomes and personalization of pharmacological therapy, shifting from reactive to proactive care. Our technology is currently at TRL5 with an MVP that has shown and excellent results in on-going validations. However, before we can offer our solution to cardiologists and primary care clinicians, we must complete key activities in our action plan. WomenTechEU will help us to better understand pricing and reimbursement strategies for the NIMBLE System in European markets, gain visibility with investors and collaborators, and support and mentoring from being one of the growing numbers of female entrepreneurs. Susana expects that this program supports her in bringing NIMBLE System to the market.
Key outcomes of the project and main achievements are:
1) Established pricing strategy for the NIMBLE System in the European target regions, including Spain, Germany, France, Italy, and Great Britain. The study performed shows that the average price of the device would be around €50,000, maintaining a consistent distribution across the diverse countries included. It is important to highlight that, in Germany, the average price might be slightly higher.
2) Established reimbursement process in Spain and Germany.
3) Corporate materials prepared for the Series A funding round: 1) pitch for presenting to investors; 2) executive summary; and 3) project brochure.
4) A new corporate website launched: HOME - Nimble Diagnostic (dxnimble.com)
5) A consolidated Advisory Board established: Joan O’Callaghan, PhD (Technical Advisor); Prof. Javier Tejada, PhD (Technical Advisor); Prof. Antoni Bayés Genís, MD, PhD (Medical Advisor); Sievert Horst, MD, PhD (Medical Advisor); Prof. Peter Fitzgerald, MD, PhD (Business Advisor); Yolanda Casas (Business Advisor).
1) Established pricing strategy for the NIMBLE System in the European target regions, including Spain, Germany, France, Italy, and Great Britain. The study performed shows that the average price of the device would be around €50,000, maintaining a consistent distribution across the diverse countries included. It is important to highlight that, in Germany, the average price might be slightly higher.
2) Established reimbursement process in Spain and Germany.
3) Corporate materials prepared for the Series A funding round: 1) pitch for presenting to investors; 2) executive summary; and 3) project brochure.
4) A new corporate website launched: HOME - Nimble Diagnostic (dxnimble.com)
5) A consolidated Advisory Board established: Joan O’Callaghan, PhD (Technical Advisor); Prof. Javier Tejada, PhD (Technical Advisor); Prof. Antoni Bayés Genís, MD, PhD (Medical Advisor); Sievert Horst, MD, PhD (Medical Advisor); Prof. Peter Fitzgerald, MD, PhD (Business Advisor); Yolanda Casas (Business Advisor).
Our technology is the first opportunity to obtain data on metallic implant’s status (a growing trend in many medical fields) and their biological environment. This will assist primary care clinicians and cardiologists in decisionmaking, prevent life-threatening situations, lowering healthcare costs, and through understanding the biological process that are driving pathological restenosis (calcification, endothelization, etc.), be able to tailor each patient's pharmacological treatment (precision medicine) and drive new R&D (drugs, treatments). We are a company with the international projection of introducing a new standard of care in the management of patients with implanted stents, addressing an unmet clinical need and creating the new stent monitoring and management market.
Our company's main objective is the health and well-being of the population, addressing United Nations Sustainable Development Goal (SDG) 3 (Good Health and Well-being). It is targeted at the monitoring and
diagnosis of implanted stents, where malfunctions pose a risk to patients' lives. NIMBLE allows for the identification of problems before symptoms appear, enabling preventive care and improving the quality/quantity of patients' lives, and consequently, their health and well-being.
NEEDS TO ENSURE FURTHER UPTAKE AND SUCCESS: Our next steps will be focused on bringing NIMBLE’s technology to the market by completing the technological development and clinically validating our product. Clinical trials will initiate the regulatory process and market access.
Our company's main objective is the health and well-being of the population, addressing United Nations Sustainable Development Goal (SDG) 3 (Good Health and Well-being). It is targeted at the monitoring and
diagnosis of implanted stents, where malfunctions pose a risk to patients' lives. NIMBLE allows for the identification of problems before symptoms appear, enabling preventive care and improving the quality/quantity of patients' lives, and consequently, their health and well-being.
NEEDS TO ENSURE FURTHER UPTAKE AND SUCCESS: Our next steps will be focused on bringing NIMBLE’s technology to the market by completing the technological development and clinically validating our product. Clinical trials will initiate the regulatory process and market access.