Lipogems, an Italy-based clinical stage- global medical technology company, announced on Wednesday that it has completed enrolment of patients in the ARISE I US FDA IDE study.
The study is intended to evaluate MicroFat versus corticosteriod injection for the treatment of Knee Osteoarthritis (OA). Efficacy and safety outcomes from ARISE 1 are expected to be revealed in 2025.
The double blinded-randomised controlled trial commenced in January 2023 at 20 sites across the United States and at orthopaedic institutions where 173 patients were enrolled. After the lipoaspiration, patients received either MicroFat or corticosteroid injection. The primary endpoints assess improvement in pain and function at one-year post-injection.
HELP Therapeutics' HiCM-188 IND application receives US FDA approval
Ananda's cannabinoid medicines to feature in NHS epilepsy trials
AstraZeneca's Wainzua recommended for EU approval
Astellas Pharma's VYLOY receives US FDA approval
Accord Healthcare wins CHMP approval for Stelara biosimilar Imuldosa
Ionis and AstraZeneca's WAINZUA recommended for EU approval
Novartis receives positive CHMP opinion for Kisqali
Viatris signs exclusive licensing agreement with Lexicon Pharmaceuticals
Adicet Bio receives FDA clearance to expand ADI-001 trials to additional autoimmune diseases
GSK PLC announces acceptance of NDA for gepotidacin by US FDA
SystImmune receives FDA clearance for Phase 1 trial of novel AML therapy
Accord BioPharma's IMULDOSA receives US FDA approval to treat chronic inflammatory conditions
PTC Therapeutics' sepiapterin receives US FDA target regulatory action date
RedHill Biopharma's opaganib selected for Ebola treatment development by BARDA