ASTRO 20: New Research Presented on Use of iCAD's Xoft for Early-Stage Breast, Gynecological Cancers

iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions showcased the expanded platform for the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® at the American Society for Radiation Oncology (ASTRO) Virtual Annual Meeting, October 24-28, 2020. Researchers presented new data supporting the Xoft System for the treatment of early-stage breast cancer and gynecological cancers, as the Company showcases the latest in technology for Xoft including its full suite of applicators for existing and emerging applications in the virtual Xoft exhibition booth.

“The Xoft System offers the flexibility to treat multiple types of cancers within the same facility, with added mobility, and time-savings benefits for patients and clinicians alike,” according to Michael Klein, Chairman and CEO of iCAD. “This innovative treatment platform offers a one-step targeted treatment option for early-stage breast cancer and certain types of brain tumors, which may contribute to a reduction in the healthcare system resources needed for breast cancer patients during the COVID-19 pandemic while also offering significant cost benefits for patients.”

The Xoft System is a 50 kV radiation oncology treatment solution that uses a miniaturized X-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site while minimizing risk of damage to healthy tissue in nearby areas of the body. The isotope-free radiation requires minimal shielding, enabling medical professionals to remain in the room during treatment.

A growing body of evidence continues to support the Xoft System across multiple cancer types. During the meeting, researchers will present new data supporting the Xoft System for early-stage breast cancer and endometrial cancers:

- “Intra-Operative Electronic Brachytherapy in the Treatment of Early Stage Breast Cancer – A Multi-Center Trial, Technique and Preliminary Results,” presented by A.M. Nisar Syed, MD, Radiation Oncology, Todd Cancer Institute, MemorialCare Long Beach Medical Center involved 1,200 patients with early-stage breast cancer treated with Xoft IORT from May 2012 to July 2018 across 27 institutions worldwide. Researchers concluded that IORT with the Xoft System is safe, with low morbidity, low local recurrence and excellent cosmetic results.

- “Adjuvant Electronic Brachytherapy for Patients with Endometrial Cancer,” presented by Arantxa Campos, MD, examined the results of treating 236 patients with endometrial cancer from September 2015 to May 2020, with a median follow up of 34 months. Researchers concluded that Xoft electronic brachytherapy is a feasible alternative to HDR brachytherapy for the treatment of endometrial cancer that offers long-term benefits for patients, staff and the overall health system.

iCAD will also host virtual discussions with Drs. Syed and Campos with updates on their latest research for eBx and IORT with the Xoft System. Register to join via: https://www.xoftinc.com/astro2020.html.

“Our ongoing research with the Xoft System for early-stage breast cancer corroborates the mounting long-term evidence supporting 50 kV IORT as a treatment option that is as effective as weeks of daily radiation fractions, , ” according to Dr. Syed. “Xoft IORT can spare patients who are candidates from the need to make multiple trips to the hospital for treatment, with the added benefit of fewer side effects and comparable recurrence rates. It not only offers added convenience for women, especially those living in remote areas who must travel great distances for radiation, it may be particularly comforting for women who want to minimize their potential risk of COVID-19 exposure.”

Earlier this week, new, encouraging research supporting the Xoft System for the treatment of recurrent glioblastoma (GBM) was presented at the European Association of Neurosurgical Societies (EANS) Virtual Congress by Alexey Gaytan, MD, PhD, a neurosurgeon at the European Medical Center (EMC) in Moscow, Russia. The latest results demonstrate significant improvement in overall survival (OS) and local progression-free survival (locPFS) in patients with recurrent GBM treated with Xoft Intraoperative Radiotherapy (IORT) versus patients treated with external beam radiation therapy (EBRT) and systemic therapy.

The study, under the guidance of Lead Investigator, Alexey Krivoshapkin, MD, PhD, a neurosurgeon at the EMC, involves 28 patients with recurrent GBM who were treated between August 2016 and June 2019. All patients underwent maximal safe resection. Researchers concluded that IORT of recurrent GBM is feasible and provides encouraging local progression-free and overall survival, with a manageable toxicity profile, and that further clinical trials are warranted.

As of May 2020, 5 patients from the IORT group were still alive, whereas none of the patients in the EBRT group survived. Our earlier release of January survival data included 7 patients surviving as of mid-December 2019. The survival of patients in the IORT group ranged from 16 – 59 months after the initial GBM diagnosis. As previously disclosed, the EBRT group survival ranged from 5.5 – 38.5 months after initial GBM diagnosis.

In addition, the first metastatic brain tumor was treated with IORT in the U.S. using the Xoft System at the James Graham Brown Cancer Center at the University of Louisville. The procedure marked the start of a clinical trial on IORT for patients with large brain metastases treated with neurological resection, led by Shiao Yuo Woo, MD, FACR, radiation oncologist at the James Graham Brown Cancer Center.

iCAD recently assembled a panel of experts to expand research on Xoft Brain IORT to multiple leading cancer centers worldwide. The Company is also exploring other emerging applications for the Xoft System, including the treatment of early-stage rectal tumors.

“The Xoft System remains a leading force in the trend towards more personalized cancer treatment,” added Klein. “As cancer treatment becomes increasingly targeted and value-based, we will continue to work with the clinical community to explore and advance cancer treatment, with the goal of improving outcomes, increasing treatment accessibility and offering unparalleled value for clinicians and patients alike.”