HeraMED announces TGA regulatory classification upgrade for HeraBEAT

HeraMED Limited (ASX:HMD) has received an update from the Therapeutic Goods Administration (TGA) regarding the regulatory classification of its HeraBEAT device. Following a two-year post market review, the TGA has decided to cancel all home-use foetal dopplers supplied in Australia, including HeraBEAT, and require its reclassification to a higher class of regulatory classification. HeraMED is actively working on the reclassification in consultation with the TGA and is scheduled to meet with them in October to finalize the reapproval pathway.

HeraMED CEO's perspective on TGA's decision

HeraMED CEO Anoushka Gungadin expressed full support for the TGA's decision to remove consumer foetal dopplers without clinical oversight from the market. Gungadin highlighted the exciting commercial opportunity for HeraBEAT and emphasized the company's commitment to working closely with the TGA to complete the regulatory process as quickly as possible. She also reassured that the FDA and CE regulatory approvals for HeraBEAT in the US and European markets remain unaffected.

HeraBEAT's unique market position and outlook

The TGA's decision to reclassify HeraBEAT presents a significant commercial opportunity for HeraMED, positioning HeraBEAT as the likely only foetal heart rate monitor for home use available in Australia. This unique market position is expected to provide strategic value for HeraMED's data base and offers the company a chance to continue building its foetal heart rate measurements as part of its vital maternity database. HeraMED will continue to provide updates as the regulatory pathway for HeraBEAT progresses, and the company remains optimistic about the device's outlook in the market.