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.
Once the system is documented and proven safe to use on a patient, the following is planned to be performed:
Define optimal approach to inject the nanoparticles in humans
The goal is to determine the nanoparticle dose and optimal time between the injection of the nanoparticle and the execution of the examination.
”Proof of Concept” on the patient
The goal is to prove that the examination method is safe and works on patients, as well as to produce educational materials, and instructions for how the diagnosing doctor should interpret the images.
Create clinical evidence for official registration
The goal is to prove that NanoEcho's diagnostic method is safe and provide clinical evidence. 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.
Clinical development studies in progress
Two investigator-led clinical development studies on resected rectal cancer tissue are ongoing, one at Sahlgrenska University Hospital in Gothenburg, under the direction of Professor Eva Angenete, and one at Skåne University Hospital in Malmö, under the direction of Professor Henrik Thorlacius. Feedback from these studies has provided NanoEcho with continuous guidance for development and use of the product, as well as for continued clinical evaluation of the diagnostic method.
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)
