Neuralace Medical has announced the commencement of and first patient enrolments in its AT-PDN (Axon therapy and painful diabetic neuropathy) study.
The multicentre AT-PDN study has a targeted enrolment of 80 patients and will be led by Lora Brown (TruWell Health, St Petersburg, USA) as study principal investigator. It is set to include a total of three clinical investigators and five clinical sites—primarily in the southeast of the USA—according to a Neuralace press release.
“We are very excited to be part of the AT-PDN study as non-invasive, opioid-sparing therapies are an important part of the care continuum, especially for PDN patients that have an elevated risk of infection but for whom peripheral neuromodulation may be a useful clinical strategy,” said Brown.
Alongside the company’s ongoing SEAT (Safety and efficacy of Axon therapy) clinical study, which is nearing completion of enrolment, the newly launched AT-PDN study will lead Neuralace’s entry into a large, fast-growing segment of patients with diabetic neuropathy for which there are no effective, non-invasive solutions available alongside or following prescription drugs, the release adds.
Neuralace says it plans to continue to build a robust body of clinical evidence to support US Food and Drug Administration (FDA) labelling, and therapy adoption, as well as important evidence in the company’s pursuit of Medicare and private payer reimbursement.
“We are pleased to have a thought-leading team of investigators participating in this very important clinical trial,” said Joe Milkovits, COO of Neuralace. “Assuming a successful completion of the trial and subsequent expansion of the FDA label to include treatment of PDN, Neuralace Medical will be able to provide a non-invasive, peripheral neuromodulation option for the millions of patients suffering from this debilitating condition.”
This month, Neuralace also announced the signing of a US$1.4 million, five-year contract with the Department of Veterans Affairs in Augusta, USA. The company will be providing the Axon device and consumables needed to treat chronic pain patients with individual 13-minute Axon therapy treatments, as performed by the Augusta VA Pain Medicine Service, across a range of conditions causing chronic neuropathic pain.