• HeraMED’s device is effective for telemedicine in monitoring pregnant women
  • Mesoblast issues strong study results
  • OncoSil announces success in Spain

Just-released results from a clinical trial undertaken by Israel’s Sheba Medical Center conclude that the HeraMED (ASX:HMD)’s HeraBEAT smart foetal HR monitor is accurate, and contributed to the effectiveness of maternal-foetal telemedicine.

The study found that remote telemedicine foetal assessment, which included the usage of the HeraBEAT, is feasible and time-saving.

The pregnant mothers who participated in the study went through an observation telemedicine visit using HeraBEAT self-operated technology, while data were being remotely reviewed via the HeraCARE platform.

Results showed that telemedicine encounter length was measured at 93.1 minutes, significantly shorter than the in-person visit of around 247.2 minutes.

This is a 60% reduction on average, potentially saving over 2.5 hours for both patients and, more importantly, the already stressed medical staff.

“The results are a clear positive for medical professionals worldwide looking for ways to deliver improved healthcare services,” said HeraMED CEO and cofounder, David Groberman.

“An added bonus in the current environment is that the remote monitoring functionality provided by HeraBEAT also helps limit the spread of the Covid-19 pandemic amongst expectant mothers,” he added.


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Mesoblast issues strong study report

Mesoblast (ASX:MSB) announced that treatment of HFrEF patients with rexlemestrocel-L, Mesoblast’s allogeneic “off-the-shelf” product candidate for the treatment of chronic heart failure, resulted in greater improvement.

Improvement is shown in the pre-specified analysis of left ventricular ejection fraction (LVEF) at 12 months, preceding long-term reduction on major adverse cardiovascular events.

Rexlemestrocel-L is an allogeneic mesenchymal precursor cell (MPC) product, being developed by Mesoblast for a variety of indications.

Mesoblast now intends to meet with the US FDA to discuss the totality of the data, and how the outcomes from the trial may support the regulatory approval pathway for rexlemestroc-L.

Oncosil reports success in Spain

The second patient commercially treated with the OncoSil device at the Hospital Universitario de Fuenlabrada in Madrid has undergone a successful resection of the primary tumour.

This follows the announcement in April that Oncosil Medical (ASX:OSL) signed a commercial agreement with the hospital for the treatment of patients with locally advanced pancreatic cancer worth €374k (around $553k).

OncoSil will now continue to work with a number of other institutions in Spain to enable increased patient access to treatments with the OncoSil device.

The OncoSil device is a brachytherapy device that utilises targeted intratumoural placement of Phosphorous 32 microparticles, delivered via ultrasound-guided endoscopy.

Neuren’s parner Acadia submits NDA to the US FDA

Neuren Pharma’s (ASX:NEU) US partner Acadia Pharmaceuticals (Nasdaq: ACAD) has submitted a New Drug Application (NDA) to the FDA for trofinetide – a drug that treats Rett syndrome in adults and paediatric patients two years of age and older.

Acadia has exclusive rights to develop and commercialise trofinetide in North America.

Under the terms of its deal with Neuren, the development and commercialisation of trofinetide in North America is fully funded by Acadia and Neuren may receive potential milestone payments of up to US$455 million.

This includes US$118 million plus double-digit percentage royalties on net sales that Neuren expects to earn over 2022 and 2023 for Rett syndrome in the US alone if the NDA is approved by the FDA.

In addition, royalties will include a milestone payment in 2022 of US$10 million, and another milestone payment in 2023 of US$40 million following the first commercial sale of trofinetide in the US.


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