Date and Time: Tuesday, August 12, 2024, at 9:00am ET Financial results to be released before market open; Conference call to be conducted at 9:00 a.m. Eastern Time CARMEL, Ind., Aug. 05, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, will report financial results for its second quarter 2025, for the period ended June 30, ...

Core Insights - NeurAxis, Inc. announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with two health insurers, impacting approximately 700,000 members in Connecticut and Massachusetts, bringing total national coverage to about 53 million [1][3] Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia in adolescents aged 8-21 [2][4] Technology and Market Position - IB-Stim is a non-surgical device that delivers gentle electrical impulses to cranial nerve bundles in the ear, addressing a significant gap as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders [2] - The technology has been incorporated into treatment guidelines by a leading pediatric academic society, which is expected to enhance policy coverage and reimbursement [3] Future Developments - The activation of a Category I CPT code for PENFS, effective January 1, 2026, is anticipated to improve reimbursement and encourage broader adoption in children's hospitals [3] - NeurAxis is currently conducting additional clinical trials for PENFS across various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - NeurAxis, Inc. has announced that its PENFS technology is now included in clinical practice guidelines for treating Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS), which is a significant milestone for the company [1][6] - The inclusion of IB-Stim in these guidelines is expected to enhance insurance coverage and drive growth, with an estimated addressable market exceeding $3 billion in the U.S. alone [2][3] - The guidelines were developed collaboratively by pediatric gastroenterology societies and emphasize evidence-based recommendations, positioning IB-Stim as a top-tier treatment option [2][6] Company Developments - NeurAxis's CEO highlighted the recognition of IB-Stim as part of the standard care for FAP in IBS, indicating a strong growth strategy and potential for substantial revenue generation [2] - The company has recently received FDA expanded clearances for IB-Stim and is set to implement a new Category I CPT code, further enhancing its market position [2] - The company aims to address the needs of over 600,000 children in the U.S. suffering from FAP, leveraging the new guidelines to expand treatment options [2][3] Market Context - The global market for abdominal pain in IBS presents a multi-billion-dollar opportunity, with IB-Stim being the only FDA-cleared pediatric treatment for FAP in IBS [3] - The guidelines recommend PENFS among other therapies, which elevates NeurAxis's profile and supports broader adoption of IB-Stim within the healthcare industry [2][6] - The rigorous GRADE approach used in developing the guidelines underscores the efficacy and safety of PENFS, enhancing its credibility as a treatment option [2][6]

Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4] - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs [4] Upcoming Events - NeurAxis will participate in the Lytham Partners Spring 2025 Investor Conference, with a webcast presentation scheduled for May 29, 2025, at 9:30 a.m. ET [1][2] - The webcast will be accessible via the conference homepage and will be available for replay after the event [2] - Management will also engage in virtual one-on-one meetings with investors during the conference [3]

Core Viewpoint - NeurAxis, Inc. has successfully closed a registered direct offering, raising approximately $5.0 million to strengthen its balance sheet and support growth initiatives, particularly for its IB-Stim therapy targeting chronic abdominal pain in pediatric patients [1][2]. Group 1: Financial Details - The offering consisted of 1,538,461 shares of common stock priced at $3.25 per share, resulting in gross proceeds of about $5.0 million before expenses [1]. - In addition to the offering, NeurAxis secured over $1 million from warrant exercises, further enhancing its financial position [2]. Group 2: Product and Market Impact - The recent FDA clearance for expanded indications of the IB-Stim treatment for Pediatric Functional Abdominal Pain (FAP) is a significant milestone for the company, addressing a critical need in pediatric care [2]. - The IB-Stim therapy is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21, with ongoing clinical trials for various pediatric and adult conditions [5]. Group 3: Future Outlook - The funds raised will be utilized to drive revenue growth for IB-Stim and prepare for the implementation of a CPT Category I code effective January 1, 2026, which is expected to enhance reimbursement and adoption of the therapy [2].

Core Viewpoint - NeurAxis, Inc. has announced a registered direct offering of 1,538,461 shares of its common stock at a price of $3.25 per share, aiming to raise approximately $5.0 million for working capital and general corporate purposes [1][2]. Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [5]. - The company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [5]. - NeurAxis is conducting additional clinical trials of its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology for various pediatric and adult conditions with significant unmet healthcare needs [5]. Offering Details - The offering is expected to close on or about May 22, 2025, pending customary closing conditions [2]. - Craig-Hallum Capital Group is serving as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering are anticipated to be around $5.0 million before deducting fees and expenses [2]. Regulatory Information - A shelf registration statement on Form S-3 was filed with the SEC on December 13, 2024, and was declared effective on February 11, 2025 [3]. - The offering will be conducted through a prospectus supplement and accompanying prospectus that are part of the shelf registration statement [3].

Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].

Core Viewpoint - NeurAxis, Inc. is set to present at the Planet MicroCap Showcase: VEGAS 2025, highlighting its focus on neuromodulation therapies for chronic conditions in both children and adults [1][2]. Company Overview - NeurAxis, Inc. specializes in medical technology aimed at neuromodulation therapies to treat chronic and debilitating conditions [3]. - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [3]. - Ongoing clinical trials are being conducted for PENFS in various pediatric and adult conditions with significant unmet healthcare needs [3]. Event Details - The presentation will take place on April 23, 2025, at 11:00 AM EST during the Planet MicroCap Showcase: VEGAS 2025 [1][2]. - Investors interested in one-on-one meetings with NeurAxis can register for the event, which will be held at the Paris Hotel & Casino in Las Vegas, NV [2].

Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [3] - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [3] Upcoming Presentation - NeurAxis will present at the Planet MicroCap Showcase: VEGAS 2025 on April 23, 2025, at 11:00 AM EST, with CEO Brian Carico hosting the presentation [1] - The presentation will be accessible via a webcast, and 1x1 investor meetings can be scheduled during the conference at the Paris Hotel & Casino in Las Vegas, NV [2] Clinical Trials and Development - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions that have significant unmet healthcare needs [3]