Prognosis is a horizon scanning service that monitors emerging health technologies as they go through clinical trial development and the regulatory approval process.
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Epidiolex is an oral liquid formulation of a highly purified extract of cannabidiol (CBD). CBD is a non-psychoactive component of Cannabis sativa (marijuana) that has demonstrated anticonvulsant activity in preclinical models of epilepsy. It is proposed for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years of age and older.
The Organ Care System (OCS) Lung is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation. Commonly referred to as the “lung in a box,” it is a portable device on a removable mobile base that integrates a wireless monitor, perfusion module, ventilator, batteries, gas cylinders, and proprietary solutions for organ maintenance. The lung is removed from the donor and immediately attached to the OCS Lung, which perfuses and ventilates the organ. The transplant team is able to continuously monitor lung function during transport and...
Crysvita is a subcutaneously injected recombinant fully human monoclonal IgG1 antibody against fibroblast growth factor 23 (FGF23) intended for treatment X-linked hypophosphatemia (XLH) in adults and children aged 1 year and older. Crysvita is designed to bind to and inhibit excessive biological activity of FGF23. By blocking excess FGF23 in patients with XLH, Crysvita is intended to restore normal phosphate reabsorption from the kidney and increase the production of vitamin D, which enhances intestinal absorption of phosphate and calcium.
The SSO2 Therapy system is under FDA review for use in acute anterior myocardial infarction patients following percutaneous coronary intervention (PCI) performed within 6 hours of symptom onset. The system delivers supersaturated oxygen mixed with the patient’s own blood to the left anterior descending coronary artery, with the goal of further reducing infarct size.
AR101 is a proprietary formulation of peanut protein and pharmaceutical-grade ingredients intended for treatment of peanut allergy. AR101 is provided in pull-apart capsules containing gradual escalating doses. AR101 capsules are taken according to a proprietary up-dosing oral immunotherapy regimen known as CODIT (characterized oral desensitization immunotherapy). Patients who respond to CODIT must continue to take a daily maintenance dose of AR101 to sustain desensitization.