PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
PERTH, Australia – Health care artificial intelligence (AI) company Harrison.ai has raised AU$129 million (US$97 million) in a series B round that will expand the company’s global footprint by commercializing its comprehensive clinical AI applications.
PERTH, Australia – The FDA has cleared Immunexpress Inc.’s 510(k) for its Septicyte rapid diagnostic test for sepsis that quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. The test uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation.
PERTH, Australia – Medtech newcomer Artrya Ltd. listed on the Australian Securities Exchange (ASX) in an AU$40 million (US$28.6 million) initial public offering to commercialize its software that analyzes heart computed tomography (CT) scans via artificial intelligence (AI) to better diagnose coronary artery disease.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
PERTH, Australia – Australian health technology company Planet Innovation is expanding its footprint into the U.S. with the acquisition of the North American operations of Germany’s medical device manufacturer BIT Analytical Instruments GmbH.
PERTH, Australia – Medical device and analytics company Trajan Group Holdings Ltd. has acquired the business and manufacturing facilities of Axel Semrau GmbH & Co., based in Sprockhövel, Germany, for AU$26 million (US$18.7 million), expanding the company’s global operations. Axel Semrau develops and manufactures laboratory automation and chromatography software and detection systems. The acquisition is the company’s most significant to date and broadens the company’s manufacturing base in Europe, Trajan founder and CEO Stephen Tomisich told BioWorld.
PERTH, Australia – Cardiovascular medical device company EBR Systems Inc. announced a planned AU$110 million (US$79.7 million) initial public offering (IPO) on Australia’s Securities Exchange to bring its wireless cardiac pacing system for heart failure to market. The IPO is planned for Nov. 24, 2021, and the funds raised will allow the company to complete pivotal trials for its wireless, inside-the-left-ventricle-of-the-heart pacing system called WiSE (wireless stimulation endocardially).
PERTH, Australia – Radiopharm Theranostics Ltd. raised AU$50 million (US$36.4 million) in an oversubscribed IPO to advance its platform of radiopharmaceutical products for both diagnostic and therapeutic uses.
