Nimble Diagnostics

THE PROBLEM

Atherosclerosis is the main cause of most cardiovascular diseases, as it causes a restriction of oxygen and nutrient-rich blood flow to the tissues. Stents are small, metallic tubes implanted in the location of the obstruction to re-open these arteries and restore the correct flow of blood or other fluids. It is estimated that >50 million people have implanted cardiac stents, and an additional 4 million are implanted each year. However, after implantation, the stent can become blocked or damaged, putting the patient’s life at risk, which happens in up to 30% of the patients. Currently, the only way to know if a stent is working properly is through a very invasive and expensive procedure called catheter angiography, which requires hospitalization, X-ray radiation and sedation. Thus, this procedure is not available for the routine screening of patients, and clinicians cannot act upon the problem until it has already manifested, which dramatically increases their risk of heart attack, stroke, and sudden death.

THE TECHNOLOGY

We have developed the NIMBLE System, a novel non-invasive and non-ionizing medical device for monitoring symptomatic and asymptomatic patients with implanted stents irrespective of stent type and location. Our technology is based on Microwave Spectrometry (MWS), a frequency scanning procedure that allows to obtain information on two main parameters: 1) The stent environment; and 2) The stent geometry. This information makes it possible to accurately measure and quantify stent malfunction in less than 5 seconds, allowing for easy patient monitoring and follow up over time. The NIMBLE System has demonstrated exceptional sensitivity (100%) and specificity (90%) in real-time detection of stent-related malfunction in large animal models (swine). These results have been compared to histological findings and clinical guideline thresholds (correlation of R=0.91 and 92% accuracy), further confirming the system's accuracy and reliability. This positions the technology at TRL5 as it is ready for clinical validation (undergoing). Our system would allow for early diagnosis of stent related problems to improve clinical management, optimize pharmacological treatment, and guide re-interventions, thus preventing serious complications and significantly improving patients’ quality of life while decreasing healthcare costs.

THE MARKET

Our initial target market (stent market) is large, growing and unserved. Based on our estimations, the TAM for NIMBLE is projected to reach almost 8B€ in 2028 (second year of commercialization) with a CAGR over 5%. This number is derived from approximately 11.9M implanted stents (coronary, neurovascular, and peripheral), which would require 156M patient visits and considering a 10% reduction accounting for patient mortality and a 5% of new stents implanted. However, the NIMBLE system has many other applications, including: 1) Monitoring other metallic implants (valves, sensors, mechanical transplants or prostheses); 2) Industrial applications as quality control during manufacturing; 3) Veterinary applications, as pets and farming animals also have metallic implants; and 4) NIMBLE home device enabling patients to independently monitor the condition of the stent implanted in their body. Considering all these markets the TAM of NIMBLE would be close to 90B€ by 2040.