Invitae Corp. has inked a definitive agreement to acquire Genosity Inc., a genomics company with a technology platform for next-generation sequencing (NGS) assays, for approximately $200 million in cash and stock. Separately, the medical genetic testing company reported a $1.15 billion investment, led by Softbank Group subsidiary SB Management, to support ongoing growth initiatives. San Francisco-based Invitae expects the Genosity platform to accelerate the development and launch of its oncology products, including three tests that won FDA breakthrough device designation. Read More
Nevro Corp.'s spinal cord stimulation system cut diabetic neuropathy pain in half or more in 85% of patients in a study published on April 5 in JAMA Neurology. Patients receiving the stimulation treatment delivered by the Senza system experienced an average reduction in pain of 76% at six months in the largest clinical largest trial to date to evaluate the use of spinal cord stimulation (SCS) in painful diabetic neuropathy (PDN). Read More
The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth. Read More
TORONTO – Exact Imaging Inc. has secured C$5.1 million (US$4 million) from the Business Development Bank of Canada and federal Export Development Canada to drive adoption of its Exactvu micro-imaging platform for real-time imaging of the prostate. Company CEO Randy Aucoin said it’s been a slow process getting street cred for his prostate imager, investing “tens of millions of dollars” in a direct sales force that eventually installed 100 systems in the U.S., Europe and Canada. Read More
PARIS – Holistick Medical SAS reported a $5 million round for development of the first generation of a light-activated implant for a patent foramen ovale (PFO). Truffle Capital provided the startup with $4.6 million, while Bpifrance provided $470,000 in non-dilutive funding. “This robust financing provides us with the resources needed to catapult our strategy forward and reinvent the treatment of heart defects such as PFO, which can be associated with occurrence of stroke in young people,” Boris Warnack, CEO of Paris-based Holistick Medical, told BioWorld. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acutus Medical, Inari Medical, Renalytix AI, Sengine Precision Medicine. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baebies, Compleware, Cyduct, Dexcom, Eyekor, Welldoc. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Electrocore, Orthofix, Surgical Information Sciences, Vysioneer. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge. Read More
Keeping you up to date on recent developments in cardiology, including: Space flight, swimming both hard on LV mass; Workaholism a bad deal for coronary artery disease patients; New approach to stem cell therapy effective in animal models of HF. Read More
