iCAD announces additional patients treated in the GLIOX study and continued global momentum for Xoft intraoperative radiation therapy (IORT) for the treatment of brain, rectal, head and neck cancer

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Several leading institutions are leveraging the versatility of Xoft electronic brachytherapy (eBx) to treat an increasing number of cancer types

NASHUA, NH, April 05, 2022 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD), a leading global medical technology company providing innovative solutions for cancer detection and therapy, today announced that it has enrolled additional patients as part of the international Multi-center GLIOX study and customers worldwide are expanding the use of intraoperative radiation therapy (IORT) for the treatment of multiple tumor types, including brain, rectal and head and neck cancer Xoft® Electronic Brachytherapy (eBx®) System®.

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

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

“The use of Xoft IORT in multiple cancers, including early-stage breast cancer, gynecological cancers and non-melanoma skin cancers, is rapidly gaining recognition around the world as promising data and results demonstrate its feasibility and practical treatment experience,” said Dr. Reyes Ibanez, Radiation Oncologist, Miguel Servet University Hospital. “We have used the Xoft system at our facility to treat multiple types of tumors including breast, skin, gynecological and now brain. The precision and flexibility Xoft offers can save patients numerous hospitalizations and has helped position our facility as a leader in cancer care by providing the versatility to treat a broad spectrum of cancer types.”

“We were encouraged by preliminary data supporting Xoft IORT in brain tumors and we are impressed with the protocol of the GLIOX study, which is evaluating an innovative therapeutic approach to treat recurrent GBM,” said Dr. Marta Ortega, NS, University Hospital of Cáceres. “When we were presented with the opportunity to treat patients with Xoft IORT and potentially participate in the GLIOX study, we immediately began applying the new approach to patients with GBM and other tumor types. While it’s still early days, results so far are encouraging. This method offers hope for certain types of diseases as it could allow us to select patients for treatment that could replace weeks of external beam radiation therapy (EBRT).”

Now that they have treated multiple patients, the researchers expect that the GLIOX study will validate intriguing results from a prospective two-center comparative study supporting the recently published Xoft Brain IORT Surgical Neurology International.I Led by study leader Alexey Krivoshapkin, MD, PhD, Professor and Head of the Department of Neurosurgery at the European Medical Center (EMC) in Moscow, this study evaluated 15 patients with recurrent GBM treated with maximally safe resection and Xoft Brain IORT and 15 patients with recurrent GBM treated with maximally safe resection and other modalities between June 2016 and June 2019 (control group). At the time of study publication in March 2021, patients treated with Xoft Brain IORT lived up to 54 months post-treatment without recurrence, while patients in the control group experienced relapse within 10 months and up to 22.5 months post-treatment lived. The researchers also found that 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 following radiation therapy. One patient from the IORT group was alive in early 2022, while patients in the control group are no longer alive.

“We are encouraged by the momentum that Xoft IORT is gaining as an effective treatment for multiple cancer types worldwide,” added Stevens. “Our mission is to provide transformative innovations to accurately and effectively detect and treat cancer sooner, and we believe Xoft IORT has the potential to deliver lifelong benefits in a single day, along with added convenience, reduced cost and… minimal side effects. ”

the Xoft system is FDA cleared, CE marked and approved in a growing number of countries to treat 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, targeting cancer cells while minimizing the risk of damaging healthy tissue in nearby areas of the body. For the treatment of certain types of tumors, including brain tumors, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of postoperative external beam radiation therapy (EBRT) with a single radiation fraction.

About iCAD, Inc.
Headquartered in Nashua, New Hampshire, iCAD® is a leading global medical technology company providing innovative solutions for cancer detection and therapy. For more information visit www.icadmed.com and www.xoftinc.com.

Forward-Looking Statements
Certain statements in this press 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 that could cause the Company’s actual results, performance or achievements to differ materially from any prior results, performance or achievements expressed or implied by such forward-looking statements . looking statements. These factors include, but are not limited to, the Company’s ability to achieve positive results from this or future trials, business and strategic objectives, IORT’s ability to provide flexibility, mobility or other advantages to be more beneficial to patients than conventional therapy or acceptance by patients or physicians, the impact of supply and manufacturing limitations or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or governmental regulations, changes in Medicare or other reimbursement policies, risks associated therewith our existing and future debt obligations, competitive factors, the effects of a downturn in the economy or the markets in which the company serves; and other risks set forth 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 these forward-looking statements, which speak only as of the date on which the statement is made. The company undertakes no obligation to provide updates to the information contained in this press release. For additional disclosures regarding these and other risks iCAD faces, please see the disclosures in our public filings with the Securities and Exchange Commission, which are available in 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
[email protected]

Investor Relations:
iCAD Investor Relations
[email protected]

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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 for recurrent glioblastoma . Surgery Neurol Int. Oct 11, 2021; 12:517. doi: 10.25259/SNI_494_2021. Erratum in: Surg Neurol Int. Dec 10, 2021; 12:607. PMID: 34754567; PMC ID: PMC8571379.

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