11:41 AM EDT, 06/07/2024 (MT Newswires) -- NeurAxis said Friday it is seeking approval from the US Food and Drug Administration to expand its IB-Stim label to allow access to a patient population beyond 11 to 18 years of age and also allow for marketing of four devices per prescription.

The company said a systematic literature review showed that "many patients as young as 8 years and up to 21 years, which is outside of the current indication age range, have been successfully treated with IB-Stim."

A systematic literature review also showed that "at least 9 published studies that used the IB-Stim technology in children with chronic abdominal pain used a total of four devices over 4 consecutive weeks," the company said.

The data were filed to the regulator via a 510k application to expand the label, NeurAxis said.

The company also said it continues to strengthen its balance sheet and liquidity position last month after it closed on an additional $3.0 million in convertible notes with a healthcare focused fund.

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