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iCAD's Xoft Brain IORT demonstrates significant improvement in overall survival in recurrent glioblastoma

Press releases may be edited for formatting or style | August 31, 2021 Business Affairs Rad Oncology
NASHUA, N.H. – August 31, 2021 – iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that encouraging results from a prospective two center comparative study evaluating the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of recurrent glioblastoma (GBM), were presented at the American Association of Neurological Surgeons (AANS) 2021 annual scientific meeting held virtually last week.

The study, titled "Recurrent Glioblastoma Management with Maximal Safe Resection and Intraoperative Balloon Electronic Brachytherapy: Two Centers Study," is under the guidance of lead investigator, Alexey Krivoshapkin, professor and head of the neurosurgery department at the European Medical Center (EMC) in Moscow, Russia. The comparative study evaluated 15 patients with recurrent GBM who were treated with maximal safe resection and Xoft intraoperative radiation therapy (IORT), and 15 patients treated with maximal safe resection and other modalities (control group), between June 2016 and June 2019.

In the IORT group, as of March 2021, both the overall survival (OS) and local progression free survival (locPFS) continued to be superior to those in the control group. The median OS after re-resection was 11.0 months for the IORT group, versus 8.0 months for the control group; the median locPFS for IORT was 8.0 months, versus 6.0 months for the control group. Patients treated with Xoft Brain IORT lived for a range of 4 to 54 months after treatment without recurrence, whereas patients in the control group had a recurrence within 2 to 10 months and lived for a range of 2 to 22.5 months after treatment.

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"The interim results from this comparative study are very promising and the data adds to a growing body of research validating Xoft intraoperative radiation therapy (IORT) as an innovative treatment option for a variety of cancers, including recurrent GBM," said Michael Klein, Chairman and CEO of iCAD. "GBM is one of the deadliest of cancers and recurrence almost always occurs. This innovative application for the Xoft System has the potential to not only impact patients' quality of life but also to extend their survival, as further evidenced by this important research presented during the major neurosurgery conference, AANS."

Researchers also found there were fewer complications for the IORT group, as only two patients in the IORT arm developed radionecrosis, versus four patients who developed radionecrosis in the control arm. One patient from the IORT group was still alive when this data was collected, whereas none of the patients in the control group survived.

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