The company’s catheter-based technology includes microchip sensing array that is designed to sense pain-related neural signals or disease and precisely target those nerves for treatment
Autonomix Medical completes site initiation for RF ablation technology trial. (Credit: valelopardo from Pixabay)
Autonomix Medical has started the proof-of-concept (PoC) human clinical study of its transvascular radiofrequency (RF) ablation device for the treatment of pancreatic cancer pain.
The US-based company’s catheter-based technology includes a microchip sensing array that is designed to sense pain-related neural signals or disease and precisely target those nerves for treatment.
Autonomix Medical said that it has completed the site initiation for its clinical study.
The primary objective of the trial is to effectively ablate relevant somatic nerves and reduce pain in pancreatic cancer patients by using radiofrequency ablation in a transvascular approach to the nearby nerves.
The study will involve the enrolment of 20 patients at one clinical trial site.
According to the medical device company, the confirmation of suitability will be verified by the primary oncology service that is taking care of the patients.
To make sure the doctor is familiar with the procedure, up to five more patients will be added and treated as per protocol. They will not be considered when analysing the study’s goals, Autonomix Medical said.
It is anticipated that enrolment will be finished by the end of 2024.
The company expects making De novo submission in 2026 and secure the US Food and Drug Administration (FDA) clearance in 2027. These will be after completing ablation device design for the purpose of clinical use.
Autonomix Medical CEO Lori Bisson said: “We continue to make solid progress with our PoC human clinical study. This study is a very important step in validating our clinical and regulatory plans for our technology and as such our team is dedicated to its successful execution.
“With the site initiation now complete, we are working to identify and train Principal Investigators for the study and remain on track to commence patient enrolment this quarter.”
Autonomix Medical said that its technology is a superior option to the methods currently in use, wherein medical professionals treat suspected areas blindly, relying on chance to target the correct nerves.
Initially, the company is developing the technology to treat pain associated with pancreatic cancer.