Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Madorra, Vonco Products.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Edmund Optics, Foundation Medicine, Optec International, Nanomedic, Navigation Sciences, Science 37, Sensyne, T2 Biosystems.
New hires and promotions in the med-tech industry, including: Discovery Life Sciences, Memic Innovative Surgery, Miromatrix Medical, Opsens, Pear Therapeutics, Thimble Point.
ICU Medical Inc. reached an agreement with Smiths Group plc to buy Smiths Medical division for $2.35 billion in cash and stock. The deal represents an improvement in the terms reached between Trulli Bidco Ltd. and Smiths Group in early August for the purchase of the same division. Trulli, a wholly owned subsidiary of Boston-based equity firm TA Associates, offered $2.3 billion with a kicker of $200 million contingent on future performance. “This is a positive for Smiths, and comes as something of a surprise (to us, and we suspect, investors),” said Andy Douglas, equity analyst, at Jefferies Equity Research. “The uplift in value of $0.4 million is helpful, and the opportunity to share more future upside is also a positive.”
LONDON – Oxford Biodynamics plc won a $910,000 grant to help validate real-world use of its epigenetics test for identifying patients who will respond to treatment with checkpoint inhibitor drugs. The award was made as part of the Beau Biden Cancer Moonshot.
Berry Oncology Corp. raised $99.15 million in a series B1 financing round to expand in the early cancer screening industry as it is seeing a growing demand in the sector. This brings the total capital raised to what it says is “the highest level in China’s early cancer screening industry.” The round was led by China Merchants Capital Management Co. Ltd., along with existing investors Qiming Venture Partners and Legend Capital.
The U.S. Department of Health and Human Services (HHS) reported a rescission of a September 2020 policy that would require that the secretary of health and human Services sign off on any rulemaking by HHS agencies. Despite the firestorm of criticism that followed the issuance of the September 2020 policy, attorney Jim Shehan, of Lowenstein Sandler, told BioWorld that the rulemaking process will remain exceptionally cumbersome, leaving in place a status quo that itself has been the target of repeated criticism.
Stryker Corp. has made its second acquisition of the year, picking up Gauss Surgical Inc. – the developer of an artificial intelligence (AI) platform for real-time monitoring of blood loss during surgery. Financial terms of the deal were not disclosed. Kalamazoo, Mich.-based Stryker’s shares (NASDAQ:SYK) were trading 5% higher following the acquisition. Menlo Park, Calif.-based Gauss Surgical’s Triton AI technology aims to fill a void in maternal health by enabling early detection of hemorrhage.