Australian life sciences companies have pioneered treatments from everything from wounds and burns to cystic fibrosis.
Privately held Ellume made headlines this month when it won a $302 million contract to produce at-home COVID tests for the United States government.
Small-cap Aussie medical device companies are keeping the innovation going with products in development from miniature mobile X-ray scanners to a rapid blood test for bowel cancer, to replace the yucky stool sample tests.
Here’s what they’ve got in the pipeline:
Atomo Diagnotics (ASX:AT1) said in December it expects to launch its rapid HIV professional test in Australia in early 2021. The test delivers results in just 15 minutes and is targeted for use in sexual health clinics, high caseload general public clinics and other community health settings.
Atomo Diagnostic’s US partner, Access Bio, also expects to receive a response from the US Food and Drug Administration on its application for an emergency waiver that would let it sell its COVID-19 antibody test to a wider audience.
AnteoTech (ASX:ADO) expects to launch its COVID-19 antigen rapid detection test by the end of this quarter. The company in November declared a “design freeze” and transferred its technology to its manufacturing partner in Spain, Operon. AnteoTech says the rapid test, which uses a portable reader, will be able to detect whether someone has been exposed to Covid based on their saliva.
Genetic Technologies (ASX:GTG) said on January 28 it was on track to launch its COVID-19 polygenic risk score test for COVID-19 in the first quarter. The test will give individuals an assessment of the chances their disease could become severe or life-threatening if they catch the novel coronavirus.
InteliCare (ASX:ICR) is set to add a broad set of health metrics to its InteliCare Pro dashboard to monitor residents in the aged care sector, which will integrate data such as blood pressure, heart rate and activity levels from smart devices such as Fitbits.
Lifespot Health (ASX:LSH) plans to ask the Therapeutic Goods Administration to approve its medical cannabis inhaler during the first quarter.
Memphasys (ASX:MEM) expects to launch its Felix sperm-separating device, meant for use in fertility clinics, in low-regulatory markets from early 2021. Approval in China is expected to take longer, with Memphasys hoping to launch in the second half of 2022.
PainChek (ASX:PCK) expects to launch an important update to its pain-detecting app in the first quarter. The app uses a smartphone video camera and machine learning to detect pain in the elderly and those with dementia. The update will include a numeric rating scale, making it a universal pain assessment solution, the company says.
Universal Biosensors (ASX:UBI) expects to launch its medical grade biosensor to the wine industry in February. The Sentia product will be able to measure sulphur dioxide “at barrel,” with other products launching to detect glucose, fructose and several acids.
Starpharma (ASX:SPL) expects its Viraleze antiviral nasal spray to be registered in Europe and ready for market in the first quarter. The product has demonstrated significant antiviral activity against coronavirus, says Starpharma, which expects to market it as an additional line of defence for doctors and nurses, essential workers and people in crowded environments.
Second quarter 2021
PainChek expects to receive clearance in the second quarter to sell its infant pain-assessment app in Australia and Europe. The app uses artificial intelligence to look at video of an infant’s face and tell if they’re in pain.
Proteomics International Laboratories (ASX:PIQ) expects to meet in the second quarter with the US Food and Drug Administration about its pre-submission package seeking regulatory approval for a “kit” version of its predictive diagnostic blood test for diabetic kidney disease.
First half of 2021
Cronos Australia (ASX:CAU) expects to expand Bathing Shed, its personal care consumer range of products made from hemp seed oil. The first product in the line is a solid soap for face and body.
Cyclopharm (ASX:CYC) expects to receive FDA approval in the first half for its Technegas radioactive lung imaging agent, an aerosol that is breathed into the lungs to help clinicians diagnose pulmonary embolisms. The product is already available in 60 countries but the US is a key market and Cyclopharm in January held a $30 million capital raising to gear up for the launch.
Next Science (ASX:NXS) plans to launch its XPerience No Rinse Antimicrobial Solution, aimed at preventing postoperative infections in US orthopaedic surgeries, as well as its TorrentX topical wound wash for chronic wounds such as foot and leg ulcers.
Genetic Signatures (ASX:GSS) applied late last year for approval from the Therapeutic Goods Administration to market its 3base EasyScreen STI Genital Pathogen Detection Kit, which can detect 10 of the most commonly encountered sexually transmitted infections. Clearance is expected “soon”, the company said on January 27.
Respiri (ASX:RSH) expects to receive FDA approval for its Wheezo asthma management tool in the first quarter of 2021. The device, a world-first technology that detects the symptoms of asthma and provides an objective measure of airway limitation, is already available in around 500 pharmacies across Australia. The company has also announced plans to execute UK market expansion in the 4th Quarter 2021 and has access to other international markets through is 5 year sales and distribution deal with multinational distributor Cipla.
Second-half of 2021
Next Science is targeted planning to launch its disinfectant for hard surfaces via a global licensing agreement. The global surface disinfectant market is $800 million a year, Next Science says.
eSense-Lab (ASX:ESE) said on January 29 that it is working with Blue Science Solutions and expects to have a completed product line of sanisiter products finished in the second half of the year.
Third-quarter of 2021
CardieX (ASX:CDX) expects to receive clearance from the FDA for its “Pulse” home-based heart health vital monitoring system in September. Approval from regulators in Europe and China should come in about the same time, the company said.
CardieX (ASX:CDX) said on January 29 it expects to release its first wearable in the fourth quarter. The smartwatch is being manufactured by Mobvoi and features CardieX’s cardiovascular health technology.
Medibio (ASX:MEB) expects to launch a consumer mental health app in the USA in the fourth quarter. The app would be based on day and night heart rate activity drawn from wearable devices such as smartwatches, and give users an objective score to manage and measure their stress levels.
MicroX (ASX:MX1) expects to launch a higher-powered mobile X-ray Rover device in the fourth quarter, following regulatory testing and pre-production in the September quarter.
Medical Developments International (ASX:MVP) is expecting to launch its Penthrox “green whistle” painkiller into additional markets in Europe this year. The company is also in talks with the US Food and Drug Administration about what would be required for US approval.
Rhythm Biosciences (ASX:RHY) could apply for a CE Mark for European approval of its ColoSTAT rapid blood test for bowel cancer this year, although it hasn’t provided an exact timeline. A clinical trial to validate the device is still underway.
4D Medical (ASX:4DX) in January began the first US clinical pilot of its lung ventilation analysis software at St Joseph Hospital in Orange County, California. The software allows physicians to diagnose and treat patients with respiratory diseases – including COVID-19 – more efficiently, by providing physicians with a picture of how air moves in the lungs. The clinical pilot is a key part of the software’s commercial rollout, but 4D didn’t say how long it would take.
Micro-X in August applied for Australian approval of its FDA-approved Rover mobile medical X-ray device. The application is still under review, Micro-X said in January , adding the company expects it will be very competitive in the Australian market.
Nanollose (ASX:NC6) is planning to produce the first amounts of its next-generation plant-based fibre for samples and limited commercial use this year.
ResApp Health (ASX:RAP) on February 10 filed a pre-submission package with the US Food and Drug Administration and requested a meeting to discuss approval of its smartphone app to detect lower respiratory tract illnesses in children and adults. The company said it expected to have a number of meetings with the agency this year about the app.
Resonance Health (ASX:RHT) held a pre-submission meeting with the FDA in November about its ALERT-PE software tool to automatically review scans of patients with a suspected pulmonary embolism. The company intends for the tool to triage images for assessment by trained radiologists.
2022 and beyond
Micro-X expects its mobile bomb-detecting device, known as a back scanner imager, to be production-ready by mid-2022.
Universal Biosensors expects to launch its blood glucose monitor to detect diabetes in pet cats and dogs in the first half of 2022. While there are existing products on the market, the company says its device will be superior.
At Stockhead, we tell it like it is. While eSense-Lab and Respiri are Stockhead advertisers, they did not sponsor this article.
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