PERTH, Australia – Soft tissue regeneration company Aroa Biosurgery Ltd. completed a A$47 million (US$34.72 million) placement on the Australian Securities Exchange that will allow the company to accelerate and broaden its pipeline. What sets Auckland, New Zealand-based Aroa apart from other regenerative tissue companies is the rate of tissue regeneration with Aroa’s scaffold and its affordability, Aroa founder and CEO Brian Ward told BioWorld.
PARIS – Peek Health SA raised $3.5 million in series A funding to ramp development of its 3D pre-op digital planning tools used in orthopedic surgery. This investment was led by two Portuguese venture capital firms: Grosvenor House of Investments SCR SA and Portugal Ventures SA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofourmis, Cepheid, Fluxergy, Nanovibronix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptargroup, BD, Bioventus, Boston Scientific, Consensus Business Group, Draper, EC Healthcare, Graymatters Health, Immunai, Medimaps Group, Medx Xelerator, Medx Ventures Group, Misonix, Nanalysis Scientific, Nebion, One Moon Scientific, Prenetics, Weihai Hengyu Medical Products.
New hires and promotions in the med-tech industry, including: Immunoscape, Lucid Diagnostics, Median Technologies, Metagenomi, Novacyt, PHC Holdings, Pulmatrix, Renalytix, Sapphiros, Venus Medtech.
Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.
PERTH, Australia – After raising A$10 million (US$7.36 million) in its initial public offering on the Australian Securities Exchange, BCAL Diagnostics Ltd. is racing to commercialize its noninvasive, blood-based in vitro diagnostic to detect breast cancer. The Breast Cancer Associated Lipids (BCAL) test is taken via a blood sample and analyzed for lipid biomarkers.
Medtronic plc got a thumbs up from the FDA for two Accurhythm algorithms to detect atrial fibrillation and asystole in patients who have heart rhythm abnormalities. The new artificial intelligence (AI)-based algorithms are designed for use on the company’s Linq II insertable cardiac monitor (ICM). Dublin-based Medtronic said the Accurhythm AI algorithms will be available on its Carelink Network later this year for use with all implanted Linq II devices in the U.S.