The Agili-C is an aragonite scaffold implant indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
Pyrukynd (Mitapivat) for Pyruvate Kinase Deficiency
Pyrukynd (mitapivat) is an oral pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
Luminopia One for Amblyopia in Children
The Luminopia One is a software-only digital therapeutic used with commercially available head-mounted displays intended for home use for improvement in visual acuity in amblyopia patients aged 4-7 years associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye care professional.
eCoin Peripheral Neurostimulator System for Urgency Urinary Incontinence
The eCoin Peripheral Neurostimulator is a leadless implantable tibial nerve neurostimulator indicated to treat urgency urinary incontinence (UUI) in patients intolerant to or having inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation (TNS).
Bardoxolone for Chronic Kidney Disease in Alport Syndrome
Bardoxolone is an investigational oral nuclear factor erythroid-derived 2-related factor 2 (Nrf2) activator proposed to slow the progression of kidney disease in patients aged ≥ 12 years with chronic kidney disease caused by Alport Syndrome.
Cognilum Transcranial Photobiomodulation (tPBM) for Autism Spectrum Disorder
Cognilum is a wearable transcranial photobiomodulation (tPBM) device under investigation for the reduction of symptoms of moderate to severe autism spectrum disorder (ASD) in pediatric patients aged 2 to 6 years.
Enjaymo (Sutimlimab-jome) for Cold Agglutinin Disease
Enjaymo (sutimlimab-jome) is an intravenous monoclonal antibody classical complement inhibitor indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease.
Organ Care System (OCS) Liver
The OCS Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assessment of liver allografts from donors after brain death (DBD) or liver allografts from donors after circulatory death (DCD) ≤ 55 years old and with ≤ 30 minutes of warm ischemic time, ma…
Aduhelm (Aducanumab) for Alzheimer Disease
Aduhelm (aducanumab) is an intravenously administered amyloid beta-directed antibody for the treatment of Alzheimer disease.
Leqvio (Inclisiran) for Hypercholesterolemia
Leqvio (inclisiran) is a subcutaneously administered, small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who requi…