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NeurAxis, Inc. commercializes neuromodulation therapies for chronic and debilitating conditions in children and adults. The company’s proprietary IB-Stim product uses Percutaneous Electrical Nerve Field Stimulation, or PENFS, and is FDA cleared for functional abdominal pain associated with irritable bowel syndrome, functional dyspepsia, and FD-related nausea symptoms in patients 8 years and older.
Recurring NeurAxis news includes FDA clearance updates, reimbursement and coding developments, medical policy coverage decisions, commercial access through payer and government channels, and adoption of PENFS in clinical practice. Company updates also cover quarterly financial results, business update calls, preferred stock dividends, equity and balance-sheet activity, and changes involving licensed neuromodulation assets.
NeurAxis (NYSE: NRXS) reported preliminary Q4 2024 results showing significant growth. Q4 revenues reached approximately $800,000, marking a 50% increase compared to Q4 2023, accelerating from 40% growth in Q3. Full-year 2024 revenues were approximately $2.7 million, up 11% year-over-year.
The company's IB-Stim technology, supported by 16 peer-reviewed studies from leading U.S. children's hospitals, has expanded insurance coverage to approximately 45 million lives, up from 4 million a year ago. The company ended 2024 with a cash balance of $3.7 million.
Recent developments include FDA 510(k) clearance expanding IB-Stim's indication to patients aged 8-21 years (previously 11-18 years), new Category I CPT code for PENFS procedures, and upcoming commercialization of the FDA-approved Rectal Expulsion Device in Q1 2025.
NeurAxis Inc (NYSE American: NRXS), a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in children and adults, has announced its participation in the upcoming Lytham Partners 2025 Investor Healthcare Summit.
CEO Brian Carrico will deliver a company presentation on Monday, January 13, 2025, at 2:30 PM Eastern time. The virtual event will be accessible via webcast through the conference homepage or directly through a dedicated link. A replay option will be available following the presentation.
Interested investors can request one-on-one meetings after the event by contacting the provided email address.
NeurAxis Inc. (NYSE: NRXS) received FDA 510(k) clearance for RED (Rectal Expulsion Device), a self-inflating balloon designed to test and evaluate patients with chronic constipation due to pelvic floor dyssynergia. The device duplicates traditional balloon expulsion test performance without requiring electronics or software.
The company plans a soft launch in Q1 2025 followed by a full launch in Q2 2025. The total addressable market is estimated at $1.5 billion, with existing Category I CPT code coverage from Medicare and most commercial insurance companies. RED can also be used to test for rectal hypersensitivity, helping identify patients with exaggerated urge to defecate.
NeurAxis (NYSE: NRXS) reported strong Q3 2024 results with revenues increasing 40% to $667,000 compared to Q3 2023. Operating loss improved by 45% to $1.7 million. The company expanded total covered lives to approximately 35 million from 4.5 million last year. Key developments include receiving a new CPT Category I code for PENFS procedures, FDA clearance expanding IB-Stim's age range to 8-21 years, and securing a $5.0 million capital investment. Unit sales grew 50% in Q3, though gross margin slightly declined due to financial assistance program discounts. The company's cash position was $261,000 as of September 30, 2024.
NeurAxis (NYSE American: NRXS), a medical technology company focused on neuromodulation therapies for chronic conditions, has scheduled its Q3 2024 earnings call for Tuesday, November 12, 2024, at 9:00 AM ET. The company will release its financial results for the quarter ended September 30, 2024, before the market opens.
Stakeholders can participate through a live webcast available on the company's investor relations website, with options to submit questions through the portal or via email. A conference call option is also available for participants who register in advance, and a replay will be accessible on the company's website.
NeurAxis (NYSE American: NRXS) has received a new FDA 510(k) clearance for IB-Stim™, expanding its addressable market by approximately 75%. The clearance extends the age range for use from 11-18 to 8-21 years old and increases the treatment protocol from 3 devices over 4 weeks to 1 device per week for 4 weeks. IB-Stim, a non-surgical neuromodulation device, treats functional abdominal pain associated with IBS by sending gentle electrical impulses to cranial nerve bundles in the ear. The company expects increased revenue and margin growth due to expanded payer coverage and a new CPT Category I code effective January 2026.
NeurAxis (NYSE: NRXS) announced medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS) by Capital Blue Cross, effective October 1, 2024. The coverage applies to Capital Blue Cross Medical Members in a 21-county region in Central Pennsylvania and the Lehigh Valley. IB-Stim, NeurAxis' PENFS technology, is FDA-cleared for treating functional abdominal pain associated with IBS in adolescents aged 11-18. The non-surgical device delivers gentle electrical impulses to cranial nerve bundles in the ear. The company also highlighted the upcoming implementation of a new CPT Category I code for their technology, effective January 1, 2026.
NeurAxis, Inc. (NYSE American: NRXS) has announced that the American Medical Association (AMA) has established a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures, effective January 1, 2026. This development is significant for NeurAxis' PENFS technology, IB-Stim, which is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18 years.
IB-Stim is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. This advancement is particularly important as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction. The new Category I code recognizes the strong clinical evidence and utilization of PENFS procedures, led by IB-Stim, and is expected to drive patient awareness and access to this FDA-cleared treatment option for IBS.
NeurAxis (NYSE American: NRXS), a medical technology company specializing in neuromodulation therapies for chronic conditions in children and adults, is set to participate in the Lytham Partners Fall 2024 Investor Conference on October 1, 2024. The event will be held virtually, featuring a webcasted presentation at 12:30 p.m. ET and one-on-one meetings with investors.
Investors can access the webcast through the conference homepage or a direct link, with replay available after the event. To schedule meetings with NeurAxis management, interested parties can contact Lytham Partners or register for the event online. This conference provides an opportunity for NeurAxis to showcase its innovative medical technologies and engage with potential investors.
NeurAxis (NYSE American: NRXS) has announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology by Geisinger Health Plan, effective September 15, 2024. This coverage will bring the national total for PENFS to approximately 24 million insured lives. NeurAxis' FDA-cleared IB-Stim™ device is designed for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. The company aims to achieve medical policy coverage for at least 50 million lives by the end of 2024, setting the stage for significant revenue and margin growth in late 2024 and 2025.