Plan to demonstrate clinical benefit
NanoEcho works systematically together with the healthcare to produce clinical evidence for a new diagnostic method. The goal of the clinical path forward is to create a basis for market approval of the imaging system that includes both the equipment and the nanoparticles (NanoEcho Particle-1). The system is documented and proven safe to use on patients, and the following step are now planned to be carried out:
1. Dose confirmation study (ongoing)
The goal is to determine the nanoparticle dose and optimal time between the injection of the nanoparticle and the execution of the examination on healthy study participants. The study is currently ongoing at one of CTC's (Clinical Trial Consultants) clinics in Uppsala and is planned to include a total of 12 participants.
2. Proof of Concept-study (preparatory)
The goal is to confirm the selected dose of the nanoparticle, and the timing of examinations on patients with rectal cancer, as well as producing educational materials and instructions for how the diagnosing physician should interpret the images.
3. Create clinical evidence for official registration (design)
The goal is to prove a basis for market approval, which includes both NanoEcho's diagnostic equipment and NanoEcho Particle-1. The patients are examined in a controlled study based on a defined dose and time between injection and examination. Diagnosing doctors interpret the images based on the educational materials.
Continuous information
Signed agreements
Authority approval
An image of magnetic nanoparticles in human tissue, which was created with NanoEcho’s prototype system, published in a peer-reviewed scientific journal.
Jansson T, Jansson L, Mousavi A, Persson L, Angenete E, Detection of magnetomotive ultrasound signals from human tissue, Nanomedicine : NBM (2023)
