Advanced Oncotherapy PLC (LSE:AVO, OTC:AONCF) said it was making significant progress with the rolling provision of data to the US regulator as it updated on the timeline for having its next-generation proton beam therapy system fully operational.
AVO is making what’s called a Q-submission to Food & Drug Administration with the aim of securing approval for its LIGHT technology for cancer treatment.
It is doing this under the FDA’s 510(k) protocol that ensures any device is safe and effective and substantially equivalent to its currently marketed equivalent.
“As LIGHT modules are assembled and tested in situ, the company and its clinical partners, in close coordination with regulatory agencies, are continuing to perform technical verification and validation to fully map the input and output parameters of the proton beam for required treatment protocols,” the company said.
“This necessary exercise has now resulted in the request to generate and submit to the regulatory agencies additional specific beam measurement data to document and confirm that performance can be maintained within the required tolerances for particular clinical applications.”
As a result, the AVO said expects now to have its LIGHT system fully operational during this summer.