HeraMED gets set for Aussie clinical trials with new deal
Health & Biotech
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Special Report: Maternal health tech company HeraMED is preparing for clinical trials in Australia with a new partnership.
The medical data and technology company has signed an agreement with Freeman Road to run clinical studies in Australia and promote its digital monitoring solutions in the health sector.
Pilots and clinical studies will evaluate the clinical effectiveness and acceptability of remote pregnancy monitoring using the medical-grade HeraBEAT foetal and maternal heart rate device.
The trial, once confirmed, will take place at Joondalup Health Campus in Western Australia.
Freeman Road in cooperation with PHI (Partnering in Health Innovations) represents a well-connected healthcare advisory group, founded by prominent physician and researcher associate professor Dr Paul Porter.
The group has an extensive network of global consultants with diverse expertise across several locations, including Perth, Queensland, Singapore, Boston, Oxford, Helsinki, and Israel.
Later, there will be potential opportunities for HeraMED to expand the cooperation through PHI’s international network.
HeraMED, Freeman Road and PHI Group are currently in the final stage of submitting the protocols to initiate the study at the Joondalup Health Campus.
The primary goals are to examine the usability and acceptability, accuracy and reliability of the HeraBEAT device, initially in the antenatal clinic and then at home before recommending use in routine clinical protocols.
The HeraBEAT device is one of the primary features of HeraMED’s comprehensive HeraCARE software-as-a-service (SaaS) and internet of things (IoT) platform, a holistic, digital hybrid maternity care solution.
HeraMED’s proprietary technology has already obtained TGA (Australia) and CE (Europe) approvals for over the counter home use as well as FDA 510K clearance for home use under prescription in the US.
The study will be led by an experienced clinical and research team that specialises in innovative technology focused on obstetrics and paediatrics.
Final ethics approvals are anticipated in the coming weeks and further details will be released to the market once confirmed.
The company says the agreement fits within a strategy to align itself with leading healthcare providers and medical institutions to gain medical validation and to complement and improve the care currently offered by obstetricians and healthcare providers.
“PHI has set its mission to make a lasting impact on the health of current and future generations, and I believe HeraMED shares the same mission in our maternity ecosystem,” HeraMED CEO and cofounder David Groberman said.
“This agreement follows extensive due diligence and these pilots and trials are just the start of our planned collaboration.
“I am confident that with this agreement we have created a substantial and professional infrastructure to further support HeraMED’s line of products underpinning our medical and clinical positioning. ”