Geneva-based HeroSupport has announced that NYU Grossman School of Medicine is the first US clinical site in its SHIELD study of VENUS SHELL.
Professor Naamit Gerber will serve as principal investigator.
Gerber is professor and vice-chair of education in the department of radiation oncology at NYU Grossman School of Medicine.
She is also co-director of the breast cancer and haematological malignancies disease management groups at NYU Langone’s Perlmutter Cancer Center.
The SHIELD study will assess VENUS SHELL during accelerated partial breast irradiation, or APBI, a form of radiotherapy focused on the area around a breast tumour.
VENUS SHELL is a personalised device designed to hold patients in a face-down position, improve the precision of local radiation delivery and increase comfort during treatment.
Researchers will assess positioning accuracy, reproducibility, clinical workflow and patient comfort.
They will also test the device with optical surface monitoring systems to examine whether skin tattoos used for patient positioning could be avoided.
The study will later open at clinical partner sites in Switzerland.
HeroSupport said any US commercial launch of VENUS SHELL would follow the applicable regulatory process and remain separate from the clinical study.
Led by chief executive and founder Giovanna Dipasquale, HeroSupport is also preparing for wider commercial use in markets where the device has regulatory clearance.
These include Europe, where VENUS SHELL has received CE marking.
The company has opened a financing round to support further clinical development, expansion into new markets and increased production.
