NeurAxis, Inc. makes a medical device that uses our proprietary PENFS technology to provide stimulation and give pain relief to children suffering from IBS (irritable bowel syndrome). We have concentrated our marketing focus on 260 children’s hospitals. To date, we have sold our IB-Stim product to approximately 50 children’s hospitals within our target market.
We are a growth stage company focused on developing neuromodulation therapies to address chronic and debilitating conditions in children. We are dedicated to advancing science with our proprietary PENFS technology, which we developed. “PENFS” means Percutaneous Electrical Nerve Field Stimulation. We believe that superior science and evidence-based research are necessary for adoption by the medical and scientific community. With one FDA indication — functional abdominal pain associated with IBS in (children and) adolescents 11-18 years old — on the market, additional clinical trials of PENFS in multiple pediatric conditions are underway focused on unmet healthcare needs in children, see “—Our Pipeline” for more information.
The IB-Stim device is to be used for the indication of functional abdominal pain associated with IBS and functional nausea in children. The same underlying technology will be used for the remaining pipeline indications, but we may use a name other than “IB-Stim” for marketing and commercialization purposes.
With one FDA indication — functional abdominal pain associated with IBS in adolescents 11-18 years old — on the market, additional clinical trials of PENFS in multiple pediatric conditions are underway focused on unmet healthcare needs in children. These indications consist of chronic nausea, post-concussion syndrome, chemotherapy-induced nausea and vomiting, and cyclic vomiting syndrome.
The chart below shows our status in the FDA process for IB-Stim and each of the following pediatric indications:
1. Chronic nausea — RCT completed, and data being analyzed, see ClinicalTrials.gov Identifier: NCT03675321.
2. Post-concussion syndrome — RCT currently enrolling patients, see ClinicalTrials.gov Identifier: NCT04978571.
3. Chemotherapy-induced nausea and vomiting — RCT currently enrolling patients, see ClinicalTrials.gov Identifier: NCT05143554.
4. Cyclic vomiting syndrome — Pilot study completed, see ClinicalTrials.gov Identifier: NCT03434652; multicenter RCT is anticipated to begin enrolling patients in the first half of 2023.
*Note: Revenue and net loss figures are for the 12 months that ended Sept. 30, 2022.
(Note: NeurAxis, Inc. priced its micro-cap IPO at $6.00 – the assumed IPO price in the prospectus – on 1.1 million shares (1,098,667 shares) – slightly less than the 1.17 million shares (1,166,667 shares) in the prospectus – on Tuesday night, Aug. 8, 2023, to raise $6.59 million. The IPO raised slightly less than the estimated $7.02 million, based on the terms in the prospectus. Shares of NeurAxis are expected to start trading Wednesday, Aug. 9, 2023, on the NYSE – American Exchange, according to the company’s pricing statement.)
(Note: NeurAxis, Inc. filed an S-1/A dated July 28, 2023, disclosing that it would offer 1.17 million shares (1,166,667 shares) at $6.00 to raise $7.02 million. In that filing, NeurAxis also said that it had switched its listing to the NYSE – American Exchange from the NASDAQ. Selling stockholders also plan to offer 2.81 million shares (2,806,233 shares) for sale. The company will NOT receive any proceeds from the sale of the selling stockholders’ shares.)
(Note: NeurAxis, Inc. changed its IPO structure again to a stock-only structure from a unit structure in an S-1/A filing dated June 1, 2023, without stating the terms.)
(Background: NeurAxis, Inc. revamped its IPO to a unit structure of stock and warrants – from its previous status as a stock-only deal – in an S-1/A filing dated Feb. 13, 2023: 1.875 million units (1,875,000 units) – at an assumed IPO price of $8.00 per unit – to raise $15.0 million. The units and the warrants, however, will NOT be listed, Neuraxis says in the Feb. 13, 2023, amended prospectus. So, in effect, only the 1.875 million shares of common stock (1,875,000 shares) will be listed on the NASDAQ, the S-1/A filing (Feb. 13, 2023) says. The unit IPO will raise the same amount as under the stock-only terms, which were 1.875 million shares at a price range of $7.00 to $9.00.)
(Note: In addition, NeurAxis, Inc. disclosed in the Feb. 13, 2023, filing that selling stockholders will offer 1.12 million shares (1,119,900 shares) at $8.00; the selling stockholders’ shares, however, will not be sold as part of the IPO. Neuraxis will not receive any proceeds from the sale of the selling stockholders’ shares. Background: Neuraxis, Inc. disclosed its IPO terms – 1.88 million shares (1,875,000 shares) at $7.00 to $9.00 to raise $15.0 million – in an FWP filed on Jan. 20, 2023. Neuraxis filed an S-1 dated Jan. 10, 2023. Neuraxis submitted confidential IPO documents to the SEC on Sept. 27, 2022.)