CARMEL,

NeurAxis Announces New Submission to the FDA for the Expansion of its IB-Stim Label; Provides Compliance with NYSE Guidelines on Audit Disclosure

Retrieved on: 
금요일, 6월 7, 2024
Patient, Marketing, Annual report, Neuraxis, Security (finance), FDA, Bank statement, Pharmaceutical industry

The new submission is significant as it would allow access to a larger patient population beyond 11-18 years of age and allow for marketing of 4 devices per prescription.

Key Points: 
  • The new submission is significant as it would allow access to a larger patient population beyond 11-18 years of age and allow for marketing of 4 devices per prescription.
  • These data were submitted to the FDA through a 510k application to expand the current label.
  • “We are excited about our new submission to the FDA to expand the label for IB-Stim which would include ages 8-21, and 4 devices over 4 weeks.
  • We are cautiously optimistic that the FDA will grant the request for a label expansion,” said Brian Carrico, President and Chief Executive Officer of NeurAxis.

NeurAxis Reports First Quarter 2024 Financial Results

Retrieved on: 
수요일, 5월 22, 2024
Patient, Abdominal pain, Neuraxis, API, BCBS

CARMEL, Ind., May 22, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the first quarter 2024 for the period ended March 31, 2024.

Key Points: 
  • CARMEL, Ind., May 22, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the first quarter 2024 for the period ended March 31, 2024.
  • Gross profit in the first quarter of 2024 was $571.6 thousand, a 19.4% decrease compared to $709.2 thousand in the first quarter of 2023 due to the lower sales volume.
  • Operating loss in the first quarter of 2024 was $1.8 million, an increase of 104.4% compared to $896.3 thousand in the first quarter of 2023.
  • The net loss in the first quarter of 2024 was $2.1 million, an improvement of 2.4% compared to $2.2 million in the first quarter of 2023.

NeurAxis to Participate in the Lytham Partners Spring 2024 Investor Conference on May 30, 2024

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화요일, 5월 21, 2024
Conference, Neuraxis, Webcast

CARMEL, Ind., May 21, 2024 (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 participate in a webcasted presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2024 Investor Conference, taking place virtually on Thursday, May 30, 2024.

Key Points: 
  • CARMEL, Ind., May 21, 2024 (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 participate in a webcasted presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2024 Investor Conference, taking place virtually on Thursday, May 30, 2024.
  • ET on Thursday, May 30, 2024.
  • The webcast can be accessed by visiting the conference home page at https://lythampartners.com/spring2024/ or directly at https://wsw.com/webcast/lytham11/nrxs/2139291 .
  • To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register for the event at https://lythampartners.com/spring2024invreg/ .

NeurAxis Announces New Medical Policy Coverage For Nearly Six Million Lives in Florida

Retrieved on: 
목요일, 5월 16, 2024
Abdominal pain, Neuraxis, Irritable bowel syndrome, FDA, BCBS, Ear, Policy, IBS

This BCBS licensee has nearly 6 million members, expanding IB-Stim’s policy coverage to roughly 22.5 million total lives.

Key Points: 
  • This BCBS licensee has nearly 6 million members, expanding IB-Stim’s policy coverage to roughly 22.5 million total lives.
  • NeurAxis’ PENFS technology is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old.
  • The current medical treatments, which are off-label drugs, can often have serious side effects, and most lack scientific evidence of efficacy.
  • “We continue to make progress on our commercialization strategy goals for IB-Stim by increasing payer coverage to drive market adoption of our technology.

NeurAxis to Host First Quarter 2024 Results and Business Update Call on Wednesday, May 22, 2024

Retrieved on: 
수요일, 5월 15, 2024
Neuraxis, PIN, Webcast, File

The Company has scheduled a conference call for the same day, Wednesday, May 22, 2024, at 9:00 am ET to review the results.

Key Points: 
  • The Company has scheduled a conference call for the same day, Wednesday, May 22, 2024, at 9:00 am ET to review the results.
  • Following today’s filing of a Form 12b-25 with the SEC, the Company expects to file its Form 10-Q on Monday, May 20, 2024.
  • For participants listening through the webcast, questions can be sent in through the portal using the “Ask a Question” link or by emailing questions to [email protected] .
  • Call-in Information: Interested parties can also access the live conference call by initially registering at the following link .

NeurAxis Announces New Medical Policy Coverage in North Dakota

Retrieved on: 
화요일, 4월 23, 2024
Irritable bowel syndrome, FDA, BCBS, Neuraxis, Ear, Abdominal pain, IBS, Health insurance

CARMEL, Ind., April 23, 2024 (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, today announced the publication of medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), effective 05/06/2024, with a Blue Cross Blue Shield (BCBS) licensee in North Dakota.

Key Points: 
  • CARMEL, Ind., April 23, 2024 (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, today announced the publication of medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), effective 05/06/2024, with a Blue Cross Blue Shield (BCBS) licensee in North Dakota.
  • The BCBS licensee is the largest provider of health care coverage in North Dakota, insuring and/or administering claims for over 310,000 people, effective May 6, 2024.
  • Neuraxis’ PENFS technology is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old.
  • “We are pleased to announce a new medical coverage policy, expanding our total covered lives for IB-Stim™ to approximately 16.5 million individuals, which speaks to the strength of the clinical data,” said Brian Carrico, President and Chief Executive Officer of NeurAxis.

NeurAxis Reports Fourth Quarter and Fiscal Year 2023 Financial Results

Retrieved on: 
화요일, 4월 9, 2024
Neuraxis, BCBS, Abdominal pain, Patient, API, Health insurance

Gross profit margin in the fourth quarter of 2023 was 86.4%, compared to 87.7% for the same period in 2022.

Key Points: 
  • Gross profit margin in the fourth quarter of 2023 was 86.4%, compared to 87.7% for the same period in 2022.
  • Selling expenses for fiscal year 2023 were $323.6 thousand, a decrease of 21.3% compared to $410.9 thousand for fiscal year 2022.
  • Selling expenses for the fourth quarter of 2023 were $72.6 thousand, an increase of 10.1% compared to $66.0 thousand for the fourth quarter of 2022.
  • G&A costs for the fourth quarter of 2023 were $2.0 million, an increase of 46.1%, compared to $1.4 million for the fourth quarter of 2022.

NeurAxis to Host Fourth Quarter and Full Year 2023 Results and Business Update Call on Tuesday, April 9, 2024

Retrieved on: 
월요일, 4월 1, 2024
Neuraxis, Form, PIN, Webcast, Calendar, Form 10-K, IPO

The Company has scheduled a conference call for the same day, Tuesday, April 9, 2024, at 4:30 pm ET to review the results.

Key Points: 
  • The Company has scheduled a conference call for the same day, Tuesday, April 9, 2024, at 4:30 pm ET to review the results.
  • Call-in Information: Interested parties can also access the live conference call by initially registering at the following link .
  • As indicated in this press release, the Company expects to have filed its Form 10-K on April 9, 2024.
  • The Company is unable to file timely due primarily to the unique circumstances associated with the Company’s IPO last year.

NeurAxis Announces IB-Stim Results from a Large, Pediatric, Multi-Center Registry

Retrieved on: 
수요일, 3월 27, 2024
Neuraxis, Abdominal pain, Patient, API, Pain

IB-Stim is NeurAxis’ proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology therapy.

Key Points: 
  • IB-Stim is NeurAxis’ proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology therapy.
  • The large and comprehensive study concluded efficacy of IB-Stim for gastrointestinal symptoms and functionality for pediatric disorders of gut-brain interaction (DGBI).
  • Dr. Adrian Miranda, Chief Medical Officer of NeurAxis stated, “To my knowledge, this is the largest, prospective, multicenter registry for any drug or device in pediatric patients with pain associated DGBIs.
  • The results significantly highlight the durability of response after just 4 weeks of treatment, which is a commonly asked question.

NeurAxis Announces Highmark BCBS Policy Coverage

Retrieved on: 
월요일, 3월 11, 2024
Neuraxis, Highmark, Policy

CARMEL, Ind., March 11, 2024 (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, today announced receipt of Highmark Blue Cross Blue Shield (“Highmark BCBS”) policy coverage for approximately seven million lives effective April 8, 2024.

Key Points: 
  • CARMEL, Ind., March 11, 2024 (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, today announced receipt of Highmark Blue Cross Blue Shield (“Highmark BCBS”) policy coverage for approximately seven million lives effective April 8, 2024.
  • Highmark BCBS provides coverage in the mid-Atlantic, covering Pennsylvania, Delaware, New York, and West Virginia.
  • “We are thrilled to announce new policy coverage from Highmark BCBS, expanding our total covered lives to now approximately 16.25 million individuals,” said Brian Carrico, President and Chief Executive Officer of NeurAxis.
  • We look forward to receiving positive responses from payers on a national level as we aim to expand the coverage of IB-Stim.”