iCAD Announces Promising Clinical Data to be Presented on Treatment of Early-Stage Breast and Gynecological Cancers at ESTRO 2020 Online Congress

Rhea-AI Summary

iCAD announces new clinical data supporting the Xoft Axxent Electronic Brachytherapy System presented at the ESTRO 2020 meeting.

The studies affirm the system's efficacy in treating early-stage breast and endometrial cancers, showcasing its viability as an alternative to traditional methods. Key findings highlight significant radiation dose reductions to adjacent organs, enhancing patient safety. Since 2015, over 600 early-stage breast cancer and 150 gynecological cancer patients have been treated using the Xoft system, which is FDA-cleared and CE-marked for multiple cancer types.

Positive

• New clinical studies demonstrate the efficacy of Xoft for early-stage breast and endometrial cancers.
• Xoft system shows reduced radiation exposure to surrounding healthy tissue compared to traditional methods.
• Over 600 breast cancer patients and 150 gynecological cancer patients treated using Xoft since 2015.

Negative

• None.

Growing Body of Evidence Supports Xoft Platform Across Multiple Cancer Types

NASHUA, N.H., Nov. 25, 2020 (GLOBE NEWSWIRE) --  iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that researchers from Miguel Servet University Hospital in Zaragoza, Spain, will present new data from three clinical studies supporting the efficacy of the expanded Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of early-stage breast and endometrial cancers during the European Society for Radiotherapy & Oncology (ESTRO) 2020 meeting held virtually November 28 through December 1.

The Company will highlight the latest technology for the expanded Xoft platform, including its full suite of applicators for existing and emerging applications in the virtual Xoft booth.

“We’re thrilled to have new clinical evidence presented at ESTRO 2020 to further demonstrate the value of the Xoft System for the treatment of early-stage breast and gynecological cancers,” said Michael Klein, Chairman and CEO of iCAD. “In particular, we are encouraged by the results indicating that our GYN eBx application is a feasible alternative to high dose rate (HDR) brachytherapy with radioactive Iridium 192, providing the same clinical benefits, yet with a marked reduction in radiation exposure to nearby organs at risk.

“Two other posters evaluating Xoft IORT pave the way for future research to fine-tune individual patient treatment plans,” continued Klein. “These data complement our growing body of research supporting Xoft’s advanced, multi-platform system for the efficient and targeted treatment of multiple cancer types.”

Clinicians from Hospital Universitario Miguel Servet first adopted the technology in 2015. Since that time, they have treated more than 600 early-stage breast cancer patients and 150 gynecological cancer patients with the Xoft IORT System. Information and a summary of the research being presented during the ESTRO 2020 Program are listed below:

• PO-1144: “Adjuvant Electronic Brachytherapy for Patients with Endometrial Cancer,” presented by María Cerrolaza, MD, Miguel Servet University Hospital. This study analyzed 193 patients from 2015 to 2019, where one group was treated with Xoft eBx combined with external radiation and one group was treated with Xoft eBx. Researchers established that electronic brachytherapy for endometrial cancer as a feasible alternative to HDR brachytherapy, equal in effectiveness to Iridium 192, with long-term benefits for patients., Xoft eBx provided the same dosimetric coverage in the area of treatment as traditional brachytherapy with a marked reduction in dosage to organs at risk.
  
  
• PO-1319: “Design of a Phantom for Verification of IORT Treatments and In Vivo Dosimetry Simulation,” presented by Sergio Lozares, MD, Miguel Servet University Hospital. Researchers created 3D printed phantoms that allowed them to create simulations to measure possible radiation doses in nearby organs, such as the lung and heart, where it is not possible to place a detector to perform in vivo dosimetry. Results calculated the maximum doses to radiochromic film representing the left lung and heart of 20 patients treated from the left breast measured retrospectively. Researchers concluded it was possible to measure and verify doses in the lung and heart for IORT treatments, enabling more accurate recommendations for a particular type of treatment.
  
  
• PO 1350: “In Vivo Dosimetry with XR-RV3 Radiochromic Films in Intraoperative Radiotherapy of the Breast,” presented by Sergio Lozares, MD, Miguel Servet University Hospital. The study examined the results of 480 patients treated with IORT from May 2015 – October 2019 with treatment verification and in vivo dose measurements to understand the in vivo dose in the skin. Researchers concluded the skin doses were low with less than 1% of the cases exhibiting early toxicity of acute grade 3 dermatitis and no cases of higher grade.
  

“Traditionally, HDR intracavitary brachytherapy using Iridium 192 seeds has been used for patients with endometrial cancer, but the recent development of electronic brachytherapy based on a miniaturized X-ray source has important advantages over HDR,” said Martin Tejedor, MD PhD, Chairman of Aragon Radiation Oncology Multihospital Clinical Unit (UCMORA). “The ability to precisely target cancer cells while preserving surrounding healthy tissue has significantly improved patient outcomes. Our study found long-term advantages with Xoft eBx, providing the same benefits as traditional methods with a reduction in radiation toxicity to at-risk organs.”

The Xoft system is FDA-cleared and CE-marked for the treatment of cancer anywhere in the body including early stage breast cancer, gynecological cancers and non-melanoma skin cancer. Emerging applications include prostate, colorectal and brain cancers. Treatment with Xoft IORT is accelerating treatment times and minimizing COVID-19 exposure to patients and clinicians.

Last month, new 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.

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.

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 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.

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 

FAQ

What were the key findings of the iCAD Xoft clinical studies presented at ESTRO 2020?

The studies indicated that the Xoft system is an effective treatment for early-stage breast and endometrial cancers, offering reduced radiation exposure to surrounding organs compared to traditional HDR brachytherapy.

How does the Xoft system compare to traditional brachytherapy for cancer treatment?

The Xoft system provides similar treatment effectiveness as traditional HDR brachytherapy while significantly lowering radiation exposure to at-risk organs, thus enhancing patient outcomes.

How many patients have been treated with the Xoft system since its adoption?

Since its adoption in 2015, more than 600 early-stage breast cancer patients and 150 gynecological cancer patients have been treated using the Xoft IORT System.

What is the significance of the studies presented at the ESTRO meeting for iCAD's future?

The positive data support the further adoption of the Xoft platform and may enhance its market acceptance as a safe and efficacious treatment alternative in oncology.

What types of cancers can the Xoft system treat?

The Xoft system is FDA-cleared and CE-marked for treating early-stage breast cancer, gynecological cancers, and non-melanoma skin cancer, with emerging applications for other cancer types.