CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces outstanding 12-month data from its first-in-human...

The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City. Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration (FDA) during the current quarter.

Antengene notes Clinical programs, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), and ATG-037 (oral CD73 inhibitor) have shown clinical responses in cancer patients with advanced diseases. And ATG-008 (dual mTORC1/2 inhibitor) continued showing strong clinical activities in the Phase II program, with promising efficacy data in cervical cancer patients compared to benchmarks.

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries. The SWING Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2 mm to 4 mm, and a total lesion length of ≤230 mm for treatment with the Sundance Sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Study subjects will be followed for 36 months post index procedure.

Professor Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi), co-lead investigator of the SWING Trial, is a vascular surgeon at Sydney’s Prince of Wales and Prince of Wales Hospital where he is Director of Operating Theatres, and Director of Surgery and Anesthetics for the South East Sydney Health District. He will review safety and performance data collected through 24 months of follow-up for 35 subjects with occlusive disease of the infra-popliteal arteries who were treated at study sites in Australia, New Zealand, and locations in Europe. Study subjects will be followed for 36 months after the index procedure notes Surmodics.

This collaboration will enable clinical trial sponsors to quantify the histological effects of compounds and gain deeper insight into underlying mechanisms in MASH-targeted therapies using state-of-the-art spatial transcriptomics and AI-powered single-fiber and single-cell digital pathology.

Dr. Peter A. Schneider, Professor of Surgery at University of California, San Francisco and Member of the TRANSCEND Trial Steering Committee, will present the TRANSCEND trial’s safety and efficacy data through 36 months as part of a November 15, 2023 session focused on randomized controlled trial (RCT) updates on new developments in drug coated balloons (DCBs) and drug eluting stents (DESs).

NICO Corporation notes the proof-of-concept study was published in Brain-Computer Interfaces in September and used a modified and miniaturized NICO BrainPath, the world’s first navigated trans-sulcal access technology widely used in Minimally Invasive Parafascicular Surgery (MIPS) for access in the removal of brain tumors and evacuation of hemorrhagic stroke.

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