Brian Carrico, Chief Executive Officer of NeurAxis, commented, “We are excited about another strong quarter of continued execution, bringing us much closer to having the complete foundation in place to scale revenues. Our commercialization strategy for IB-Stim(TM), based on strong data publication leading to insurance coverage, is beginning to bear fruit. We now have 22.5 million lives under insurance coverage with many pending decisions, a significant increase from 4.5 million a year ago. While revenues in 2Q24 declined 5.3% on a year-over-year basis, this is a significant improvement compared to year-over-year declines of 19.7% and 13.3% in 1Q24 and 4Q23, respectively. Most importantly, the revenue we lost in the previous quarters is not due to lost accounts but rather accounts receiving “no-authorization required” responses from payers, which means the claim will likely not be paid. These accounts are set up and ready to begin treating again once the larger payers have a policy in place. The fact that we are alleviating the losses without these accounts shows we are adding accounts, and current accounts are treating more and more children as their insurance coverage increases. The demand for our product is at record levels and continues to increase. In the second half of 2024, we expect to roughly double our lives under insurance coverage to 50 million, setting the stage for growth acceleration in late 2024 and into 2025. In recent weeks, we received a commitment from our largest payer to date with over 12 million covered lives, with launch expected on October 1st. Further contributing to our growth acceleration in 2H24 will be the commercialization of RED, our licensed innovative rectal expulsion device, a self-inflating balloon expulsion test that allows for point-of-care testing to effectively identify patients with an evacuation disorder, such as pelvic floor dysfunction. We have made the submission to the FDA and expect the device to receive FDA clearance late in the fourth quarter of 2024 We remain committed to further commercializing our lead pediatric indication for functional abdominal pain associated with IBS in children. We have recently made an FDA submission to expand our label beyond the current 11-18 year old patient population to the 8-21 year old patient population and four devices. In addition, we are advancing our development pipeline for a number of new indications leveraging our unique neuromodulation therapy, including Functional Dyspepsia, Cyclic Vomiting Syndrome, and more. As a result of recent financings with long-term investors in the healthcare space, our balance sheet is well positioned to execute our business plans for the foreseeable future.”
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