Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Hyperfine, Milestone Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beauty Health, Bioventus, Diasorin, Cytek, Egnite, Establishment Labs, Luminex, Nanospot, Prelude, Sophia Genetics, Synergy Laboratories.
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
Affluent Medical SA reported the imminent raising of nearly $14 million to fund development throughout 2023 of its implantable medical devices for treating urinary incontinence and heart valve pathology. Affluent, quoted on the Paris Euronext stock exchange since 2021, issued new shares accompanied by redeemable share warrants with shareholder preferential subscription rights being preserved.
The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
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