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Neuraxis, Inc. (symbol: NRXS) is a growth-stage company pioneering in the development of neuromodulation therapies aimed at treating chronic and debilitating conditions in children. With a steadfast focus on disorders of gut-brain interaction (DGBIs), the company is committed to improving the lives of pediatric and adolescent populations. Neuraxis leverages its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology to deliver targeted therapies that are both innovative and effective.
In recent months, Neuraxis has made significant strides. Following its IPO, the company has successfully built a robust portfolio of research publications, which has enabled it to secure broad insurance policy coverage sooner than anticipated. This has led to increased revenues in regions such as Massachusetts and Wisconsin, where written policy coverage is in place.
As the company moves into 2024, it continues to focus on expanding insurance policy coverage, with 10 major meetings scheduled in the first quarter alone. Additionally, Neuraxis is preparing for the FDA clearance of a new pediatric IB-Stim indication by the end of 2024 and the introduction of a new RED product aimed at the adult gastrointestinal market, both expected to generate substantial revenue growth.
Financially, Neuraxis recently filed a restatement of its third-quarter 2023 financial results, resulting in a $3.7 million increase to the company's net loss and additional paid-in capital. However, this restatement is unrelated to revenues or cash expenses, and the company's cash position remains unchanged.
Looking ahead, Neuraxis is well-positioned for continued success. The company's dedicated team remains focused on advancing policy coverage, expanding its product pipeline, and preparing markets and children’s hospitals for effective treatments once coverage is in place.
For more detailed updates and to stay informed on the latest developments, shareholders and interested parties are encouraged to participate in the company’s upcoming first-quarter 2024 financial results conference call. Details for accessing the live webcast and replay are available on the company's Investor Relations website.
NeurAxis (NYSE: NRXS) has secured medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology with a major insurer, extending coverage to approximately 5.1 million members across 13 states, including MI, IL, NY, and TX.
The company's IB-Stim device, which is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in patients aged 8-21 years, delivers gentle electrical impulses to cranial nerve bundles in the ear. This non-surgical treatment is particularly significant as there are currently no FDA-approved drug therapies for children with abdominal pain-related gut-brain interaction disorders.
NeurAxis has expanded its insurance coverage from 4 million to 51 million lives over the past year, positioning the company to serve approximately 600,000 individuals suffering from IBS.
NeurAxis (NYSE: NRXS) has announced medical policy coverage with Molina Healthcare for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim. The coverage extends to Molina's approximately 5.1 million members across 13 states, including Michigan, Illinois, New York, and Texas.
IB-Stim is an FDA-cleared, non-surgical device that treats functional abdominal pain associated with irritable bowel syndrome (IBS) in patients aged 8-21 years through gentle electrical impulses to cranial nerve bundles in the ear. This treatment is particularly significant as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction.
The company has notably expanded its insurance coverage from 4 million to 51 million lives over the past year, with potential to treat approximately 600,000 individuals suffering from IBS.
NeurAxis has issued a letter to shareholders, highlighting significant achievements in 2024 and plans for 2025. The company focuses on commercializing IB-Stim for pediatric IBS and advancing the RED device for chronic constipation. In 2024, IB-Stim, supported by PENFS technology, treated about 1,000 patients and expanded insurance coverage from 4 million to 51 million lives, significantly boosting revenues. The FDA recently expanded IB-Stim's indication to ages 8-21, increasing its market by 75%. A new CPT Category I code for PENFS will take effect in 2026, enhancing patient access. Additionally, the FDA cleared the RED device for US commercialization, with initial revenues expected in Q1 2025. NeurAxis aims to achieve cash flow breakeven by 2026, supported by strong sales growth, disciplined cost management, and recent investments from healthcare funds.
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.
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