NEURAXIS, INC.


Associated tags: Abdominal pain, IBS, Evidence-based medicine, Irritable bowel syndrome, FDA, Science, Neuraxis, NYSE, Patient, Policy

Locations: CARMEL,, IN, US, FLORIDA

NeurAxis Announces Publication of Prospective Study Showing IB-Stim™ Improves Quality of Life of Adolescents with IBS

Retrieved on: 
Tuesday, September 12, 2023

The publication , led by investigators from Children’s Hospital of Orange County, investigated changes in gastrointestinal symptoms and quality of life in 31 adolescent patients aged 11 – 18 years with functional abdominal pain disorders (FAPDs) before and after treatment with IB-Stim.

Key Points: 
  • The publication , led by investigators from Children’s Hospital of Orange County, investigated changes in gastrointestinal symptoms and quality of life in 31 adolescent patients aged 11 – 18 years with functional abdominal pain disorders (FAPDs) before and after treatment with IB-Stim.
  • The patients were treated for 4 weeks and data were collected prospectively from both the patient and the parents using validated questionnaires.
  • The global health scores also significantly improved based on both patient and parent reports (p
  • Dr. Adrian Miranda, Chief Medical Officer of NeurAxis said, “We are pleased that outcomes post IB-Stim treatment continue to be replicated at centers of excellence across the country.

NeurAxis Highlights Pediatric Post-Concussion Clinical Study

Retrieved on: 
Tuesday, August 29, 2023

Brian Carrico, President and Chief Executive Officer of NeurAxis, said, “We are thrilled to support this research because if the data is positive and the FDA gives clearance, this would be a groundbreaking therapeutic option for post-concussion syndrome.

Key Points: 
  • Brian Carrico, President and Chief Executive Officer of NeurAxis, said, “We are thrilled to support this research because if the data is positive and the FDA gives clearance, this would be a groundbreaking therapeutic option for post-concussion syndrome.
  • According to literature, the majority of concussions occur in children, mainly due to sports and unstructured play with or without helmets.
  • While symptoms generally resolve in a few weeks, others persist, including ongoing headaches, nausea, and dizziness, as well as mood and behavioral disorders.
  • Currently enrolling up to 100 patients, the clinical trial’s primary endpoint is improvements in validated measures, including the Immediate Post-Concussion Assessment, Post-Concussion Symptom Scale, and Balance Error Scoring Symptom compared to placebo.

NeurAxis Highlights Strength of its Board of Directors

Retrieved on: 
Thursday, August 24, 2023

CARMEL, Ind., Aug. 24, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS), (“NeurAxis,” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today highlighted the strength of its board of directors.

Key Points: 
  • CARMEL, Ind., Aug. 24, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS), (“NeurAxis,” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today highlighted the strength of its board of directors.
  • “We are fortunate to have a board with a depth of experience in relevant areas to NeurAxis, including medical device commercialization, commercial insurance, and finance.
  • “We are excited to have this strength at the board level as we continue to develop and drive adoption of our IB Stim Therapy™,” concluded Mr. Carrico.
  • The Company’s Board of Directors includes:
    Ms. Keyser has more than 20 years of experience in executive roles in population health.

NeurAxis Highlights Two Independent Studies Showing Benefits of IB-Stim in Adolescents Involving the Gut Microbiome

Retrieved on: 
Tuesday, August 22, 2023

Bacterial species in the Clostridiaceae family were more abundant in IBS patients compared to healthy control group.

Key Points: 
  • Bacterial species in the Clostridiaceae family were more abundant in IBS patients compared to healthy control group.
  • After treatment with IB-Stim, there were notable decreases in the clostridial species which have previously been implicated in gastrointestinal pro-inflammatory states.
  • Also, noted after treatment was a decrease in bacterial pathways of long-chain fatty acid synthesis, suggesting modulation of the microbiome and perhaps related inflammation.
  • According to the authors, “this suggests that patients with a specific microbial signature have a more favorable response to therapy.”2

NeurAxis Announces Over $8 Million in IB-Stim™ Revenue

Retrieved on: 
Thursday, August 17, 2023

Sales began after NeurAxis received FDA clearance for IB-Stim™ in the pediatric treatment of functional abdominal pain and irritable bowel syndrome.

Key Points: 
  • Sales began after NeurAxis received FDA clearance for IB-Stim™ in the pediatric treatment of functional abdominal pain and irritable bowel syndrome.
  • NeurAxis is conducting clinical trials with IB-Stim™ for four additional pediatric indications, including chronic nausea, post-concussion syndrome, chemotherapy induced nausea and vomiting, and cyclic vomiting syndrome.
  • Approximately $2 million of the over $8 million in IB-Stim™ revenue through March 31, 2023 was generated in 2020 and 2019.
  • You should, however, consult further disclosures and risk factors we include in our filings with the Securities and Exchange Commission.

NeurAxis Announces Positive University of Michigan IB-Stim™ Cost Effectiveness Study at ANMS 2023

Retrieved on: 
Tuesday, August 15, 2023

The authors conclude that addressing abdominal pain in adolescents with IB-Stim™ would improve quality of life and reduce healthcare needs.

Key Points: 
  • The authors conclude that addressing abdominal pain in adolescents with IB-Stim™ would improve quality of life and reduce healthcare needs.
  • The study corroborates the effective treatment of adolescent IB using our proprietary IB-Stim™ therapy, while also providing favorable economic benefits to families and the healthcare system.”
    Dr. Adrian Miranda, Chief Medical Officer of NeurAxis said, “Functional abdominal pain associated with IBS drives significant healthcare costs.
  • Having a treatment with a favorable safety and efficacy profile in children is critical, but providing value is also important.
  • We look forward to leveraging our growing body of evidence to support the clinical adoption of our IB-Stim™ therapy.”

NeurAxis Highlights Current Commercial Insurance Coverage with BCBS Massachusetts, BCBS South Carolina, BCBS Nebraska, and Quartz Wisconsin

Retrieved on: 
Thursday, August 10, 2023

CARMEL, Ind., Aug. 10, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today highlighted current commercial insurance coverage policies for its IB-Stim™ therapy, with a total of 4.75 million lives covered, including:

Key Points: 
  • CARMEL, Ind., Aug. 10, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today highlighted current commercial insurance coverage policies for its IB-Stim™ therapy, with a total of 4.75 million lives covered, including:
    Blue Cross Blue Shield (“BCBS”) Massachusetts, which covers approximately 3 million lives;
    BCBS South Carolina, which covers approximately 750,000 lives;
    BCBS Nebraska, which covers approximately 700,000 lives; and
    Quartz Wisconsin, which covers approximately 300,000 lives.
  • Brian Carrico, President and Chief Executive Officer of NeurAxis, said, “Our 4.75 million lives covered today is foundational, as we seek to actively scale up our operations in states that have broad BCBS coverage of our target patients, physicians and hospitals.” Mr. Carrico continued, “To further expand coverage, we launched an internal prior authorization team in an attempt to remove barriers for certain children’s hospitals who do not have the time to do prior authorizations for patients in need of IB-Stim.
  • We are also actively leveraging publications to expand coverage with a goal to drive support of IB-Stim as the standard of care.”
    “There is a large unmet need for our target indications, with an approximately $9 billion addressable market in pediatrics and approximately $21 billion in adults.
  • We look forward to continuing to focus on growing our body of clinical evidence to accelerate the adoption of our IB-Stim therapy,” Mr. Carrico concludes.

NeurAxis Announces Pricing of Initial Public Offering

Retrieved on: 
Wednesday, August 9, 2023

CARMEL, Ind., Aug. 09, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced the pricing of its underwritten initial public offering of 1,098,667 shares of common stock at an initial public offering price of $6.00 per share.

Key Points: 
  • CARMEL, Ind., Aug. 09, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced the pricing of its underwritten initial public offering of 1,098,667 shares of common stock at an initial public offering price of $6.00 per share.
  • The gross proceeds from the offering, before underwriting discounts and commissions and estimated offering expenses payable by the Company, are expected to be approximately $6,592,000.
  • In addition, the Company has granted the underwriters a 45-day option to purchase up to 164,800 additional shares of common stock at the initial public offering price, less the underwriting discount.
  • The Company intends to use the net proceeds of the initial public offering for sales and marketing activities, research and development, certain payments to executive officers pursuant to their respective employment agreements, and general corporate purposes.