- BTC Health (BTC) investee BioImpact has won exclusive rights to distribute the NEOLA device in Australia, New Zealand and Singapore
- NEOLA is a non-invasive medical device to measure volume changes and oxygen concentration in the lungs of preterm infants
- BioImpact secured the rights from GPX Medical AB, which expects to obtain CE approval for NEOLA in 2023
- Pending CE approval, BTC Health will begin the registration process allowing NEOLA to commercially launch in Australia and New Zealand
- BTC Health spiked over 100 per cent earlier today but is now up just 11.25 per cent to trade at 8.9 cents per share
BTC Health (BTC) investee BioImpact has won exclusive rights to distribute the NEOLA device in Australia, New Zealand and Singapore.
NEOLA is non-invasive medical device, which continuously measures organ volume changes and oxygen gas concentration in the lungs of infants born preterm. This allows health care professionals to instantly detect complications and provide the required treatment.
In exchange for the exclusive distribution rights, BTC Health will invest in product evaluation and pre-market trials, which will allow neonatologists to assess and trial the NEOLA device in a clinical setting.
BioImpact secured the distribution rights from GPX Medical AB, a medical device company listed on the Nasdaq First North Growth Market. GPX Medical expects to obtain Conformité Européene (CE) approval in 2023, which will allow NEOLA to be marketed and sold in Europe.
Once CE approval is obtained, BTC Health will apply to Australia’s Therapeutic Goods Association (TGA) and New Zealand’s Medsafe for product registration. This will begin the registration process required to allow NEOLA to commercially launch in Australia and New Zealand.
BTC Health’s Executive Chairman, Dr Richard Treagus, commented that the company is executing on its strategy of making life-changing medical devices available in its region.
“Every year, approximately 3 per cent or 10,651 babies are born preterm in Australia and New Zealand, over 97 per cent require respiratory support and monitoring,” he said.
“Parents can be assured that BTC will work with government authorities to register NEOLA to ensure best possible patient care can be provided to vulnerable preterm infants,” he added.
BTC expects that NEOLA will be approved and available for sale in Australia within 12 months of GPX Medical obtaining CE approval.
Earlier this morning, the company’s share price spiked as high as 111.765 per cent, before settling down as the day progressed.
BTC Health is now up just 11.25 per cent, trading at 8.9 cents per share at 12:37 pm AEDT.