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iCAD’s Xoft Brain IORT Demonstrates Significant Improvement in Overall Survival in Recurrent Glioblastoma According to Comparative Study

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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 2 to 22.5 months after treatment

NASHUA, N.H., Aug. 31, 2021 (GLOBE NEWSWIRE) -- 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.

“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.

Additionally, a subgroup analysis of patients with post-operative contrast-enhancing volume (POCEV) of ≤ 2.5cm3 showed more favorable outcomes for patients in the IORT group. The median locPFS for the 8 patients treated with IORT in this subgroup was 16.5 months, whereas the median locPFS for the control group was 8.0 months. The median OS after re-resection for the IORT group was 21.25 months, versus 11.0 months for the control group. Researchers concluded that the results are encouraging and that further clinical trials are warranted.

“Treatment options for patients with recurrent GBM are extremely limited,” said Alexey Gaytan, MD, PhD, a neurosurgeon at the EMC, and the ePoster author presenting at AANS. “As such, we are encouraged by the interim results that demonstrate significant improvement in OS and locPFS in recurrent GBM patients with maximal safe resection plus Xoft Brain IORT compared to re-resection followed by various alternative adjuvant therapy options (mostly external beam re-irradiation plus chemotherapy). This innovative approach is equivalent to multiple sessions of external beam radiation therapy (EBRT), yet with minimized risk of radiation dose to neighboring healthy tissues. We encourage collaboration on further multidisciplinary, multicenter clinical trials as the initial data is promising.”

To investigate the potential benefit of Xoft IORT beyond recurrent GBM, iCAD is developing an observational patient registry to capture and analyze data from all patients with any type of brain tumor treated with IORT. The results of this registry will help identify patients who may benefit most from IORT and to help clinicians understand the place of IORT in an overall therapeutic regimen for brain tumors.

In addition, an international multi-center study—the GLIOX trial—is designed to compare Xoft IORT plus Avastin® (bevacizumab) to the investigational arm of RTOG-1205 (EBRT plus bevacizumab) to help confirm early Xoft IORT results previously reported.

“We continue to be inspired by the widespread interest from worldwide key opinion leaders and international centers in Xoft Brain IORT and the GLIOX trial to evaluate this new approach to local control of recurrent GBM,” said Klein.

Worldwide, 308,102 new cases of brain and nervous system tumors were diagnosed in 2020.i In the U.S., the incidence of metastatic brain tumor diagnosis is approximately 200,000 people annually.ii GBM is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months.iii,iv Treatment for brain tumors typically involves surgical removal, followed by radiation therapy or chemotherapy.

The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site while minimizing the risk of damage to healthy tissue in nearby areas of the body. IORT with the Xoft System allows radiation oncologists and surgeons to work together to deliver a full course of radiation treatment in one day, at the time of surgery, while the patient is under anesthesia. Once the tumor has been surgically removed, the Xoft System’s miniature x-ray source is inserted inside a flexible balloon-shaped applicator, which is then placed inside the tumor cavity, filled with saline, and used to deliver a single dose of radiation directly to the tumor bed. For the treatment of certain types of brain tumors, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of post-operative EBRT with a single fraction of radiation.

About iCAD, Inc.
Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com and www.xoftinc.com.

Forward-Looking Statements
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any prior results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve positive results from this or any future studies, business and strategic objectives, the ability of IORT to provide flexibility, mobility or other advantages, to be more beneficial for patients than traditional therapy or to be accepted by patients or clinicians, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Media Inquiries:
Jessica Burns, iCAD

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568

i WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2020. Accessed via https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
iii Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK470003.
iv Pan E, Prados MD. Glioblastoma Multiforme and Anaplastic Astrocytoma. In: Kufe DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC Decker; 2003. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK12526/.