ASX Health Stocks: Resapp gets TGA and CE mark approvals for its cough-counting app
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is down by 0.15% at the time of writing, compared to the broader index which is down by 0.40%.
Resapp Health (ASX:RAP) has just received the world’s first regulatory approvals for its cough counter smartphone application.
The company reported that an Australian Therapeutics Good Administration (TGA) clearance and European CE Mark certification have now been received for the technology.
ResApp’s standalone cough counter application tracks cough frequency using only a smartphone.
Cough frequency is a key factor in determining and managing respiratory disease progression, and may also be valuable in clinical trials involving a broad range of diseases.
Traditionally, the only way to measure the cough frequency is by subjective self-reporting, which is labour intensive and inaccurate.
ResApp’s proprietary machine learning algorithms solve this issue by accurately identifying coughs from audio recorded using the smartphone’s in-built microphone.
The technology is already being used by global biopharma AstraZeneca to monitor patients participating in a lung cancer clinical trial, ResApp said.
With the new regulatory approvals, the app is now listed on the Australian Register of Therapeutic Goods (ARTG), and is available for sale in Europe as a class I medical device.
“The ability to measure cough frequency using only a smartphone is a highly scalable solution that has a number of broad clinical applications,” said Resapp’s CEO, Dr Tony Keating.
The RAP stock price rose by 7% earlier this morning on the news before retreating.
AdAlta (ASX:1AD) +6.25%
The CAR-T focused company had its AGM this morning in which it outlined the progress made on its i-body enabled T CAR-T cells as a cancer therapeutic.
The company signed a collaboration agreement with US-based Carina Biotech in August to work on AdAlta’s i-bodies, which have been billed as the “next generation antibodies”.
In pre-clinical studies, the i-body enabled CAR-T cells were capable of in-vitro killing of cancer cells, without affecting the original cells.
The Alzheimer’s focused company said that target enrolment has been reached in the XanaMIA Part A trial of 105 participants, with results expected in Q2 of 2022.
The trial is assessing its lead drug Xanamem in older healthy patients (aged 50 to 80 years old) to see if it’s effective in improving cognition, compared to placebo.
The study is targeting 5mg and 10mg of Xanamem doses, and aims to treat patients suffering from Alzheimer’s Disease, Fragile X Syndrome and depression.
Vectus Biosystems (ASX:VBS) +2.75%
The fibrosis and high blood pressure focused company said the Trial Safety Review Committee has given approval to proceed to the next dose level of 100mg for its Phase 1/ib clinical trial of VB0004.
The VB0004 trial will study patients that have mild to moderate hypertension with low cardiovascular risk.
The committee has reviewed the 2mg, 10mg and 30mg doses of VB0004, but has now given approval to proceed to the next dose level of 100mg, after no adverse events were observed at any of the three doses studied to-date.
The company has now completed its strategic acquisition of MiRTLE Medical, a maker of an MRI-compatible 12-lead ECG system.
Imricor has acquired approximately 2% of the equity in MiRTLE for US$200,000.
In May this year, MiRTLE received a CE mark certification for its 12-lead ECG (electrocardiogram) system, which allows the system to be sold in European countries.
Oceania Healthcare (ASX:OCA) unchanged
The NZ-based aged care homes provider reported a 19.7% increase in EBITDA to $36.5m for the first half, compared to the same half last year.
The aged care business has continued to perform well in NZ throughout the period despite COVID- 19 disruptions, with revenue increasing by 10% since the previous year’s half.
Truscreen (ASX:TRU) unchanged
The cervical cancer focused company delivered strong revenue growth of 25%, and an operating loss of $1.26m for the half year, which is a 20% reduction over the same period last year.
COVID-19 had impacted its operations in Russia and Vietnam, but unit sales in the US were 35% higher YOY despite new cervical cancer screening devices installed in hospitals hampered by ongoing restrictions.