Neuralace Medical has announced the upcoming clinical study presentation of the SEAT randomised controlled trial (RCT), which is assessing the safety and efficacy of its Axon therapy, at the American Society of Pain and Neuroscience (ASPN) conference (13–16 July, Miami, USA).
Leonardo Kapural (Carolinas Pain Institute, Winston-Salem, USA), principal investigator for the SEAT study, will be presenting three-month patient follow-up data comparing conventional medical management (CMM) to Axon therapy combined with CMM.
“As the principal investigator for this study, I have become very familiar with Axon therapy and have seen encouraging results from a wide cross-section of patients,” Kapural said. “For many patients, prescription drugs have adverse side-effects, and surgical options are daunting and may have complications. Axon therapy is a non-invasive approach to bring the benefits of neuromodulation to many more patients.”
As part of the same announcement, Neuralace reports that it has initiated a multicentre, double-blind RCT to evaluate the clinical efficacy of its magnetic peripheral nerve stimulation (mPNS) technology in the treatment of painful diabetic neuropathy. Enrolment in this study—AT-PDN—will be completed in June 2023, with subsequent submission to the US Food and Drug Administration (FDA) targeting regulatory clearance by the close of this year, as per a company press release.
“I am especially proud of our team of investigators led by Dr Lora Brown in St Petersburg [USA] and also the Neuralace clinical team on the ground supporting the AT-PDN study,” said Neuralace COO Joe Milkovits. “Enrolment has moved quite quickly due to the excitement from patients and our clinical investigators. We look forward to our submission to FDA and to the prospect of bringing relief to the many patients suffering from diabetes-related chronic neuropathic pain.”
In keeping with Neuralace’s strategy of Axon therapy treatment expansion for additional patient types, the company will also be conducting a pilot study focused on chemotherapy-induced chronic neuropathic pain, led by principal investigator Carrie Johnson (Carolinas Pain Institute, Winston-Salem, USA).
“Currently, options are limited for patients struggling with chemotherapy-induced peripheral neuropathy,” Johnson noted. “This condition can be chronic, life-changing, and too often prevents patients from being able to complete their recommended anti-cancer therapy.”
These clinical milestones follow Neuralace’s announcement in late-May that Peter Staats (National Spine and Pain Centers, Frederick, USA) would be joining the company’s medical advisory board as chief medical officer. Neuralace also recently announced the first close of US$3.1 million in seed funding targeting a total raise of US$5–7 million.