Welcome to our dedicated page for Neuraxis news (Ticker: NRXS), a resource for investors and traders seeking the latest updates and insights on Neuraxis stock.
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 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.
NeurAxis, Inc. (NYSE American: NRXS) has announced medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS) by Blue Cross Blue Shield (BCBS) of Vermont, effective October 1, 2024. This coverage brings the national total for PENFS to approximately 23 million, with more decisions from major payers pending. NeurAxis' IB-Stim™ device, which uses PENFS technology, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18 years.
The company's CEO, Brian Carrico, expressed excitement about the coverage expansion in Vermont and stated that NeurAxis is on track to achieve its goal of having medical policy coverage for at least 50 million lives by the end of 2024. This expansion is expected to drive market adoption of their technology and set the stage for significant revenue growth in late 2024 and into 2025.
NeurAxis Inc (NYSE American: NRXS) reported Q2 2024 financial results. Key highlights include:
- Expanded covered lives to 22.5 million, up from 4.5 million in May 2023
- Submitted FDA applications for RED device and IB-Stim label expansion
- Q2 revenue of $611.5K, down 5.3% YoY
- Gross profit of $538K, down 6.9% YoY
- Operating loss increased 97.5% to $2.2M
- Net loss increased 30.5% to $2.9M
- Cash on hand: $1.8M
The company expects to double covered lives to 50 million in H2 2024, potentially accelerating growth in late 2024 and 2025. FDA clearance for RED device is anticipated in Q4 2024.
FAQ
What is the current stock price of Neuraxis (NRXS)?
What is the market cap of Neuraxis (NRXS)?
What is Neuraxis, Inc.?
What is PENFS technology?
What recent achievements has Neuraxis made?
What are Neuraxis' plans for 2024?
How has Neuraxis' financial condition changed recently?
How can I stay updated on Neuraxis' latest news?
What is the significance of Neuraxis' research publications?
What markets does Neuraxis serve?
How can I contact Neuraxis' Investor Relations?
When is Neuraxis' next financial results conference call?
