NeurAxis, Inc., a medical company specializing in neuromodulation treatments for persistent and challenging conditions affecting both children and adults, has revealed that the US Food and Drug Administration (FDA) has provided 510(k) clearance for their RED (Rectal Expulsion Device). This clearance enables NeurAxis to commercially offer the device for the assessment and diagnosis of patients with chronic constipation linked to pelvic floor dyssynergia who do not respond well to increased laxative use.
NeurAxis is planning to commence commercial distribution of RED, aiming for a preliminary launch in the first quarter of 2025, with a full-scale release anticipated in the second quarter. Management is optimistic that healthcare providers can swiftly adopt this clinically advantageous technology, considering its medical necessity and an approximately $1.5 billion market potential. The procedure associated with RED is currently recognized under a Category I CPT code and enjoys coverage by Medicare along with most private insurance firms.
RED features a unique, self-inflating balloon designed to assess a patient’s capability to expel contents from the rectum. “In many instances of chronic constipation, standard laxative treatments fall short as the root issue is not about colon movement, but rather the neuromuscular function of the pelvic floor,” explained Dr. Adrian Miranda, NeurAxis’ chief medical officer. “Without precise testing, patients could remain undiagnosed and suffer from ineffective treatments.” Additionally, RED can be employed as a qualitative test to assess rectal hypersensitivity, aiding in identifying patients who experience an amplified urge to defecate, influencing the treatment plan for constipation sufferers.
“The approval of RED under the 510(k) standards marks a significant milestone as we progressively expand our gastroenterology offerings, driving robust revenue growth towards achieving cash flow neutrality,” expressed Brian Carrico, NeurAxis’ president and CEO. “I am enthusiastic about the numerous opportunities for revenue and profitability expansion, spurred by enhanced insurance coverage and age indications of our IB-Stim product for pediatric functional abdominal pain/IBS, combined with our RED commercial roll-out. We are also eager to explore additional FDA indications leveraging our PENFS technology, including both adult and pediatric Functional Dyspepsia,” Carrico summed.
NeurAxis, Inc. is dedicated to developing pioneering medical solutions through neuromodulation interventions that combat prevalent, chronic conditions affecting both pediatric and adult populations. The company is committed to propelling scientific progress and employing evidence-based practices to promote the broader use of its IB-Stim therapy, renowned for its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, within medical, scientific, and patient sectors.