More than 150 U.S. patents could be at stake if the World Trade Organization (WTO) were to adopt an intellectual property waiver as originally proposed by India and South Africa.
Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.
Caris Life Sciences Inc. raised $830 million in a capital growth round led by Sixth Street Partners, the latest show of private investors’ zeal for backing precision medicine ventures. The infusion, which includes $235 million in equity financing, will be used for continued commercial expansion and to advance its liquid biopsy platform. T.R. Price Associates Inc., Silver Lake, Fidelity Management & Research Co. LLC were significant contributors in the round.
PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.
The discovery of synthetic lethality between BRCA mutations and PARP inhibitors ranks has led to major advances in the treatment of BRCA-mutated cancers. Mutations in BRCA1 and BRCA2 can leave cells with a deficiency in homologous repair (HR). And that deficiency can make them vulnerable to PARP inhibitors, which block alternate DNA repair pathways, as well as platinum-based treatment, which induces DNA mutations that BRCA-deficient cells are unable to cope with.
PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
LONDON – Neogenomics Inc. reported it plans to acquire Inivata Ltd., taking up a $390 million fixed price option to purchase the liquid biopsy specialist eight months early. The option was agreed to in May 2020, when Neogenomics made a $25 million minority equity investment in Inivata and was granted the right to acquire the rest of the company by the end of 2021.
My01 Inc. has received FDA clearance for its My01 Continuous Compartmental Pressure Monitor with full Bluetooth capabilities. The device is intended to help doctors diagnose and avert the risks of developing compartment syndrome, a potentially devastating complication of certain fractures and trauma injuries.
PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis.
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