Isoplexis Corp. has debuted on the Nasdaq, pricing its initial public offering of 8.3 million common shares at $15.00 per share. Shares of the proteomics platform developer (NASDAQ:ISO) were trading slightly under at $13 following the listing. The offering is expected to close on Oct. 12, 2021. The Branford, Conn.-based company is aiming to raise $125 million from the public market to accelerate commercialization of its cell analysis platforms. The single-cell proteomics systems are automated, benchtop products designed to reduce therapeutic development timelines. Read More
Limbix Health Inc. released data demonstrating a 21% remission rate and 29% response rate for Sparkrx, its prescription digital therapeutic, in adolescents who completed the program as recommended. The company presented study results on Oct. 8 at the 2021 American Academy of Pediatrics National Conference in San Francisco. Read More
PARIS – A Russian research consortium has discovered that coating magnetic nanoparticles with a non-magnetic silica shell significantly decreased the viability of cancer cells in a low frequency alternating magnetic field. This discovery may augur new therapeutic prospects for nanotechnology combined with medical imaging. Read More
TORONTO – Radialis Medical Inc. has submitted FDA premarket notification for a positron emission tomography system (PET) that targets specific organs for low dose imaging and may be flexible enough to assess many different diseases. The Radialis PET camera is under clinical investigation at Toronto’s University Health Network and Princess Margaret Cancer Center for its ability to assess anomalies in breast cancer. Read More
Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification. Rather than provide a list of risk classes for specific device types, the guidance provides a framework by which the manufacturer does its own evaluation of the inherent risk of the device, opening the door to disagreements between the manufacturer and its notified body. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytosorbents, Limflow, Medalliance, Todos Medical. Read More
