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 (completed)
The primary objectives have been achieved, meaning that the study has determined an appropriate dose of the nanoparticle NEP-1 (ferumoxtran) as well as the time interval for subsequent imaging examination with NanoEchos' diagnostic system on healthy study participants. The study was conducted at one of CTC's (Clinical Trial Consultants) clinics in Uppsala and included 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.
For more information
read press releases related to the clinical study (in Swedish)
Continuous information
2025-02-24: All study participants have completed NanoEcho’s dose confirmation study
2024-12-20: NanoEcho reports interim results from ongoing dose confirmation study
2024-12-09: Half of the study participants have completed NanoEcho’s ongoing clinical studies
2024-11-05: The first study participant has participated in the dose confirmation study
2024-10-16: Recruitment of study participants is now starting in the dose confirmation study
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)
