Cereno Scientific AB has submitted a clinical trial application (CTA) to the EMA seeking approval for a first-in-human, phase I study of CS-014, a novel histone deacetylase (HDAC) inhibitor drug candidate under development as an antithrombotic treatment.
Just weeks after securing U.S. FDA approval for its flagship system to treat chronic limb-threatening ischemia (CLTI), Limflow SA kept the good news flowing to investors with the announcement of an agreement to be acquired by Inari Medical Inc. in a deal valued at up to $415 million. Inari will pay $250 million in cash at closing with up to $165 million in additional payments going to Limflow based on achievement of specified commercial and reimbursement milestones starting in 2025. The companies expect the deal to close by the end of the year.
University of Chicago spinoff Flow Medical Inc. is finalizing its design of a multi-function catheter to diagnose and treat venous thromboembolic disease – boosted by a $1 million private investment to commercialize the device.
Rapidai Inc. Received U.S. FDA 510(k) clearance for Rapid RV/LV, the latest addition to its pulmonary embolism (PE) solution. Rapid RV/LV uses artificial intelligence to quickly calculate the right ventricle to left ventricle ratio based on an analysis of computerized tomography pulmonary angiograms. The ratio provides critical information for prioritization of PEs and integrates with Rapidai’s triage and notification and workflow products to manage patient care from suspected embolism to treatment.
Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Zylox-Tonbridge Medical Technology Co. Ltd. has obtained marketing approval for its retrievable inferior vena cava (IVC) filter Zylox Octoplus in China. “Zylox Octoplus is approved for the prevention of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the peripheral vasculature,” a spokesperson at Zylox-Tonbridge told BioWorld. The approval is based on a multi-center, randomized and positive control clinical trial in China. The trial was conducted in nine peripheral vascular intervention centers in China.
The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs.
Abbott Laboratories, has acquired Walk Vascular LLC, a deal that brings two devices for peripheral thrombectomy to the Abbott portfolio for peripheral artery disease (PAD). Walk’s two Jeti peripheral thrombectomy devices are cleared in the U.S. for break-up and removal of soft emboli and thrombus, but are in trial for deep-vein thrombosis (DVT) as well, suggesting that Abbott Park, Ill.-based Abbott has availed itself of a technology that could take a big bite out of one of the deadliest and costliest of all circulatory system pathologies.
Vetex Medical Ltd.'s Revene thrombectomy catheter reduced symptoms and improved quality of life in all patients with iliofemoral vein thrombus in a European clinical study. The results were presented at Venous 2021, the annual meeting of the American Venous Forum.
Wall Street has stabilized enough after the recent pandemic-induced volatility to offer enthusiastic support to a med tech generating significant revenue that already reached breakeven during the first quarter. Inari Medical Inc. priced its IPO at the top of an already upwardly revised range to raise $156 million. It sold 8.2 million shares at $19, above the prior range of $17 to $18. Shares of the Irvine, Calif.-based company (NASDAQ:NARI) then more than doubled to hit about $43 on its first day of trading.