Medical data and technology developer HeraMED (ASX: HMD) has been granted key regulatory approval for its foetal ultrasonic heart rate monitor in the US after undergoing a premarket review process for the past six months.
The US Food and Drug Administration (FDA) granted HerdMED with 510(k) clearance for its HeraBEAT device thereby enabling direct market entry into the US and opening the door for imminent sales across the country – assuming HeraMED can leverage its existing commercial relationships including marketing and distribution.
Accompanying the FDA’s approval, HeraMED declared that it intends to progress the device’s entry into the US market “as quickly as practicable” with the company “confident that the HeraBEAT device will be well-received”.
Currently, the US represents a large addressable market for HeraMED with its device being launched as a direct attempt to court over four million women in the country that undergo pregnancies every year.
In a statement to the market, HeraMED declared that it is “revolutionising the pregnancy experience” by empowering personalised, continuous and proactive home monitoring, to deliver better care at a lower cost.
The rationale behind the HeraBEAT device and the company as a whole is to keep pregnant mothers engaged, informed and well-supported by providing a range of utilities that reassure both the mother and medical professionals who manage the pregnancy.
Via real-time monitoring, stress and anxiety levels can be significantly reduced while enabling early detection of potential risks to the foetus and the mother.
“The device development and testing, providing substantial evidence of the safety and effectiveness of the device, has passed a challenging and rigorous period of review by FDA and is now ready for distribution throughout the United States in the coming months,” said HeraMED’s co-founder and chief executive officer David Groberman.
Mr Groberman also confirmed that HeraMED now plans to liaise with its in-country partners to ensure distribution is as streamlined as possible.
Going to market
In a bid to shorten the time to market, HeraMED said it will liaise with Mayo Clinic, the company’s current clinical, research and development collaborator but will also engage with other medical institutions, hospitals and medical professionals to drive growth and product uptake.
The company’s heart rate monitor was designed to assist pregnant mothers by enabling precise real-time monitoring of foetal heartbeats while integrating relayed information with smartphones and other devices.
The device is able to detect foetal heartbeats, display foetal heart rate and play foetal heart sounds on demand.
The device is a step above existing non-medical solutions that have undergone rigorous testing which makes HeraBEAT a premium level offering for pregnant mothers with a foetus older than 12 weeks.
According to HeraMED, its device is a hand-held, battery-powered audio Doppler device integrated with a 2MHz probe, used for detecting and displaying foetal heart rates.
Moreover, the device uses an optical sensor to distinguish between foetal heart rates and the maternal heart rate, thereby eliminating what’s known as “crosstalk” and ensuring information is always accurate.
Furthermore, HeraMED is also progressing a suite of other software applications and hardware devices as part of a holistic effort to improve prenatal care.
The company says it is actively utilising the digital health ecosystem including clinical home monitoring devices, cloud computing, artificial intelligence, big data and digital social networking to “reshape the doctor-patient relationship”.