Bioelectronic medicine startup Setpoint Medical Corp. raised $80 million in a preferred stock financing co-led by new investors Norwest Venture Partners and Viking Global Investors. The company has also secured a line of credit for up to $65 million, bringing total access to capital to up to $145 million. Read More
A meta-analysis found no difference in outcomes between autograft nerve repair and repair using Axogen Inc.’s Avance nerve grafts across all types of nerves and gap lengths up to 70 millimeters. Axogen’s allograft nerves allow patients to avoid the potential complications associated with harvesting the individual’s own nerve to use in repair. The study was published in Plastic and Reconstructive Surgery in January. Read More
Australian biotech company Ferronova Ltd. has secured AU$11 million (US$7.7 million) to advance its nanoparticle platform to assist surgeons more accurately locate and remove malignant cells during treatment of gastrointestinal and brain tumors. Read More
Real-world evidence (RWE) is all the rage in med-tech circles, given the promised efficiencies, but the U.K. National Institute for Health and Care Excellence is especially dialed in on RWE. The agency recently announced that it will expand its use of RWE to include health technology assessments (HTAs), promising a slightly less drag-filled path to clinical adoption in one of the world’s most robust markets. Read More
Four members of the U.S. Senate have inked a draft bill that would require the FDA and the Patent and Trademark Office (PTO) to set up a task force designed to improve communication between the two agencies. This would appear to replicate a bill introduced during the 117th Congress, but not ultimately passed, and there is little clarity this early in the legislative cycle as to the prospects for this latest iteration. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infinity Neuro. Read More
