iCAD Announces Additional Patients Treated Under GLIOX Trial and Continued Global Momentum for Xoft Intraoperative Radiation Therapy (IORT) for Brain, Rectal, Head and Neck Tumor Treatment

NASHUA, N.H., April 05, 2022 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that additional patients have been treated under the international multi-center GLIOX trial and customers globally are continuing to expand use of intraoperative radiation therapy (IORT) for the treatment of multiple tumor types, including brain, rectal, and head and neck cancers using the Xoft® Electronic Brachytherapy (eBx®) System®.

Recently, doctors at Cáceres University Hospital in Cáceres, Spain have successfully treated multiple cases of recurrent glioblastoma (GBM) with the Xoft System, which were performed in preparation for the GLIOX trial, as well as brain metastases, recurrent rectal, and head and neck tumors. In parallel, clinicians at the Miguel Servet University Hospital in Zaragoza, Spain, have utilized Xoft IORT in their cancer treatment regimen for sarcomas and brain metastases, as well as more than 700 breast cancers and 200 gynecological cancers to date.

“The Xoft System offers the flexibility to treat multiple types of tumors with positive clinical outcomes, along with providing time-savings benefits for both patients and clinicians,” said Stacey Stevens, President and CEO of iCAD, Inc. “We are encouraged to see more facilities adding new indications for the Xoft System, as it provides a practical solution that offers the potential to optimize treatment times and reduce side effects, which ultimately enhances patient care.”

“The use of Xoft IORT for multiple cancers, including early-stage breast cancer, gynecological cancers, and nonmelanoma skin cancers, is quickly gaining appreciation globally due to promising data and results substantiating its feasibility as well as real-life treatment experience,” said Dr. Reyes Ibanez, Radiation Oncologist, University Hospital Miguel Servet. “We have used the Xoft System for the treatment of multiple types of tumors at our facility, including breast, skin, gynecological, and now brain tumors. The precision and flexibility afforded by Xoft can spare patients from numerous trips to the hospital and has helped position our facility as a leader in cancer care by offering the versatility to treat a broad range of cancers.”

“We were encouraged by preliminary data supporting Xoft IORT for brain tumors, and we are impressed with the protocol of the GLIOX trial evaluating an innovative therapeutic approach to treat recurrent GBM,” said Dr. Marta Ortega, NS, Cáceres University Hospital. “When we were offered the opportunity to treat patients with Xoft IORT, as well as the chance to potentially join the GLIOX trial, we immediately began using the new approach on patients with GBM and other tumor types. Although it is still early, results thus far are encouraging. This method offers hope for certain types of disease, as it may allow us to select patients for a treatment that could replace weeks of external beam radiotherapy (EBRT).”

Having now treated multiple patients, researchers expect the GLIOX study will validate intriguing results from a prospective two-center comparative study supporting Xoft Brain IORT recently published in Surgical Neurology International.ⁱ Under the guidance of lead investigator, Alexey Krivoshapkin, MD, PhD, professor and head of the neurosurgery department at the European Medical Center (EMC) in Moscow, this study evaluated 15 patients with recurrent GBM who were treated with maximal safe resection and Xoft Brain IORT, and 15 patients with recurrent GBM treated with maximal safe resection and other modalities (control group), between June 2016 and June 2019. As of March 2021, when the study was published, patients treated with Xoft Brain IORT lived for up to 54 months after treatment without recurrence, whereas patients in the control group had a recurrence within 10 months and lived for up to 22.5 months after treatment. Researchers also found there were fewer complications, such as radionecrosis, in the IORT group. Radionecrosis refers to the breakdown of normal body tissue near the original tumor site after radiation therapy. One patient from the IORT group was still alive in early 2022, whereas the patients in the control group are no longer living.

“We are encouraged by the momentum Xoft IORT continues to gain as an efficacious treatment for multiple cancers worldwide,” added Stevens. “It is our mission to deliver transformative innovations to precisely and effectively detect and treat cancer earlier, and we believe Xoft IORT has the potential to provide a lifetime of benefits in a single day, along with added convenience, reduced costs and minimal side effects.”

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 the world’s smallest X-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, which targets cancer cells while minimizing the risk of damage to healthy tissue in nearby areas of the body. For the treatment of certain types of tumors, including brain cancers, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of postoperative external beam radiation therapy (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  
+1-201-423-4492
jburns@icadmed.com

Investor Relations:
iCAD Investor Relations
ir@icadmed.com

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ⁱ Krivoshapkin A, Gaytan A, Abdullaev O, Salim N, Sergeev G, Marmazeev I, Cesnulis E, Killeen T, Tyuryn V, Kiselev R, Syomin P, Spallone A. Prospective comparative study of intraoperative balloon electronic brachytherapy versus resection with multidisciplinary adjuvant therapy for recurrent glioblastoma. Surg Neurol Int. 2021 Oct 11;12:517. doi: 10.25259/SNI_494_2021. Erratum in: Surg Neurol Int. 2021 Dec 10;12:607. PMID: 34754567; PMCID: PMC8571379.