AOTI, INC. (AIM: AOTI), a medical technology group specialising in durable wound healing and amputation prevention, reported on Monday that the Centers for Medicare and Medicaid Services (CMS) will hold a public Contractor Advisory Committee (CAC) meeting on 11 December 2024. The meeting, facilitated by Durable Medical Equipment Medicare Administrative Contractors (DME MACs), will review potential revisions to the Oxygen and Oxygen Equipment Local Coverage Determination (LCD) to include Topical Oxygen Therapy for wound healing.
The CAC will assess clinical evidence and discuss its relevance to the requested LCD changes, informing CMS's decision-making process. Following the CAC, DME MACs are expected to publish a proposed LCD and have up to 365 days to finalise it.
Founded in 2006, AOTI offers innovative non-invasive therapies like TWO2 to treat chronic wounds and reduce hospitalisations and amputations, supported by robust RCT and real-world data. Regulatory clearances include FDA, CE Mark, MHRA and multiple other national agencies.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval