New Research Presented at Virtual ASTRO Meeting Supports Xoft System for Treatment of Early-Stage Breast Cancer and Gynecological Cancers

iCAD Showcasing Expanded Xoft Platform Including Single-Fraction IORT Solution for Brain and Early-Stage Breast Cancer Tumors

NASHUA, N.H., Oct. 23, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced the Company will showcase 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 will present 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,^i,ii” 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.ⁱⁱⁱ

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.”

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.

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 proprietary 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.

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 future 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 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:
Maria Stanieich, iCAD
+1 (603) 309-1949

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568
jeremy@lifesciadvisors.com

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ⁱ Silverstein, M.J., Epstein, M., Kim, B. et al. Intraoperative Radiation Therapy (IORT): A Series of 1000 Tumors. Ann Surg Oncol 25, 2987–2993 (2018). https://doi.org/10.1245/s10434-018-6614-3
ⁱⁱ Vaidya, JS et al. (2020). Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. BMJ 2020;370:m2836 Accessed via https://doi.org/10.1136/bmj.m2836
ⁱⁱⁱ University of Louisville. Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection. Accessed via https://clinicaltrials.gov/ct2/show/NCT04040400. ClinicalTrials.gov Identifier: NCT04040400.