HeraMED Seeks Approval for HeraBEAT- Submitted 510K Application To FDA

  • Apr 29, 2019 AEST
  • Team Kalkine
HeraMED Seeks Approval for HeraBEAT- Submitted 510K Application To FDA
HeraMED Limited (ASX: HMD) is a medical technology company. The company offers smart pregnancy monitoring solutions for professional and home use. HeraMED provides peace of mind to expecting parents by solving problems associated with the reliability of the prenatal analysis, as well as the cost and shortage in fundamental services through end-to-end medical grade solutions utilising monitoring devices, cloud-based platforms and AI capabilities. The company has announced today, on 29th April 2019, that it has submitted a 510K application to the US Food and Drug Administration (FDA) to seek FDA approval for its medical grade, foetal heart rate monitor, the HeraBEAT. The US Food and Drug Administration is an association which evaluates and approves a wide range of items for medical use, including drugs and medical appliances. A 510K approval would mean that the FDA considers HeraBEAT device safe and effective for its intended use in the United States. The United States represents a large potential addressable market for HeraMED, boasting up to circa 4 million births annually. The company expects to enter the United States market in the first half of 2020, following the receipt of the FDA regulatory approvals. Once the FDA approval has been granted, the company will collaborate with current R&D collaborator the Mayo Clinic, as well as other medical institutions, hospitals and doctors to drive device uptake. The CEO and Co-Founder of the company, Mr David Groberman said that the 510K application for the HeraBEAT device is a significant achievement for the company. The United States will represent the company’s largest addressable market if the company gets approval from the FDA. The Board and management of the company will update the shareholders of the progress. The company lately reported that HeraMED has secured a binding and exclusive distribution agreement with Dale Group International, a leading baby and toddler product supplier in Australia. Dale Group International, as per the agreement, became the exclusive Australian distributor of HeraBEAT, which is HeraMED’s medical grade, pregnancy foetal monitoring device. It was specified in the deal that the Dale Group must satisfy a commitment to order a minimum of 9,000 HeraBEAT units over three years. Moreover, Hapvida Saude has ordered for cloud-based, software as a service pregnancy monitoring service HeraCARE from HeraMED. This was a significant milestone for the company as Hapvida is one of the largest healthcare providers, medical insurance companies and hospital owners of Brazil. The company signed a manufacturing agreement with the globally respected medical device manufacturer, Quasar, so that the company can immediately increase HeraBEAT device production and improve manufacturing costs. Quasar is a leading original equipment manufacturer for companies, including Johnson & Johnson, Medtronic, Biosense, and Unilever. The group also gave notice that their AGM will be held at 9.30 am on Wednesday, 29 April 2019. Details of the venue have been mentioned in the released report. On the price-performance front, the stock of HeraMED Limited, at market close on 29th April 2019, was trading at $0.230. The stock has generated a YTD return of 31.43% and a negative return of 9.80% over the past month. Its 52-week high price stands at $0.330, with an average trading volume of 139,938.


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