Revakinagene tororetcel (Neurotech Pharmaceuticals Inc.) is an investigational ocular implant that delivers sustained therapeutic doses of ciliary neurotrophic factor to the retina to slow the progression of macular telangiectasia type 2.
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.
Corvia Atrial Shunt (Corvia Medical Inc.) for Heart Failure
The Corvia Atrial Shunt (formerly the InterAtrial Shunt Device [IASD]; Corvia Medical Inc.) is a transcatheter interatrial shunt under investigation for treatment of heart failure with preserved or midrange ejection fraction.
FSYX Ocular Pressure Adjusting Pump (Balance Ophthalmics Inc.) for Open-Angle Glaucoma
The FSYX Ocular Pressure Adjusting Pump (Balance Ophthalmics Inc.) is a negative pressure eye goggle indicated for reducing intraocular pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 millimeters of mercury who are currently using or have undergone another IOP-lowering treatment.
Donanemab (Kisunla; Eli Lilly and Co.) for Alzheimer Disease
Donanemab (Kisunla; Eli Lilly and Co.) is an intravenously administered amyloid beta-directed antibody indicated for the treatment of Alzheimer disease. Treatment with donanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.
Eladocagene Exuparvovec (PTC Therapeutics) for Aromatic L-amino Acid Decarboxylase Deficiency
Eladocagene exuparvovec (PTC Therapeutics) is an investigational gene replacement therapy administered by intraputaminal infusion for the treatment of aromatic L-amino acid decarboxylase deficiency with a severe phenotype in patients aged 18 months and older.
pro2cool (TecTraum Inc.) for Mild Traumatic Brain Injury
The pro2cool device is a portable head and neck cooling device under investigation for the treatment of adolescent mild traumatic brain injury (mTBI; concussion).
Pulmonary Artery Denervation (PADN) Catheter (Pulnovo Medical) for Pulmonary Arterial Hypertension
The Pulnovo Pulmonary Artery Denervation (PADN) catheter is an investigational pulmonary artery catheter intended for radiofrequency ablation of pulmonary nerves to treat pulmonary arterial hypertension (PAH) in adults.
Encoberminogene Rezmadenovec (XyloCor Therapeutics Inc.) for Refractory Angina Pectoris
Encoberminogene rezmadenovec (XyloCor Therapeutics Inc.) is an investigational gene therapy proposed for treatment of refractory angina pectoris. The therapy is administered directly to cardiac muscle via minithoracotomy.
Bulevirtide (Gilead Sciences Inc.) for Chronic Hepatitis Delta Virus
Bulevirtide (Gilead Sciences Inc.) is an investigational, first-in-class, subcutaneously injected virion entry inhibitor proposed for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Midomafetamine (MDMA; Lykos Therapeutics) for Posttraumatic Stress Disorder
Midomafetamine (MDMA; also 3,4-methylenedioxymethamphetamine; Lykos Therapeutics) is an oral synthetic entactogen under investigation in combination with psychological intervention for the treatment of adults with posttraumatic stress disorder (PTSD).