New Data Supports iCAD’s Xoft Brain IORT as Feasible Treatment for Recurrent Glioblastoma

Rhea-AI Summary

iCAD, a leader in medical technology, announced promising results for its Xoft® Electronic Brachytherapy System aimed at treating recurrent glioblastoma (GBM). Data from a prospective study, presented at the European Congress of Neurosurgery, indicated significant improvements in overall survival and local progression-free survival in patients treated with Xoft compared to traditional therapies. Among 28 patients, those receiving Xoft had survival rates from 16 to 59 months, while none in the external beam radiation therapy group survived beyond 38.5 months. This innovation may enhance treatment options for aggressive brain tumors.

Positive

• Presentation of promising clinical results for Xoft System at the European Congress of Neurosurgery.
• Significant improvement in overall survival (OS) and local progression-free survival (locPFS) in patients treated with Xoft versus external beam radiation therapy.
• Survival of patients using Xoft ranged from 16 to 59 months after diagnosis, while the external group had a maximum survival of 38.5 months.

Negative

• None.

New, Encouraging Results and Overall Patient Survival Numbers to be Presented at European Congress of Neurosurgery 

NASHUA, N.H., Oct. 19, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that new, promising clinical results supporting the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of recurrent glioblastoma (GBM), will be presented at the European Association of Neurosurgical Societies (EANS) Virtual Congress, October 19- 21, 2020.

New Data from the ongoing prospective study, entitled “Four-year experience of maximal safe resection with intraoperative balloon electronic brachytherapy for recurrent glioblastoma,” (AS-EANS-2020-00135) will be presented 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 latest results are extremely encouraging, as they underscore the potential of Xoft IORT for recurrent glioblastoma while illustrating the impact our innovative technology may have on the treatment of the most aggressive primary brain tumors,” said Michael Klein, Chairman and CEO of iCAD. “GBM has a median survival of 10-12 months^i,ii and almost 297,000 cases of brain and nervous system tumors are diagnosed worldwide each year,ⁱⁱⁱ with inevitable recurrence; however, this data is promising and may offer hope to patients and their families.”

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.

“We continue to be greatly encouraged by these clinical results and the benefits this treatment offers to patients with GBM,” said Professor Krivoshapkin. “There is no standard approach on how to treat patients with recurrent GBM and the repeated use of EBRT in recurrent brain tumors is often limited by a relatively high risk of radiation toxicity. Intraoperative balloon electronic brachytherapy has the potential to deliver the required prescribed single focal dose that is equivalent to multiple sessions of EBRT while minimizing radiation dose to neighboring healthy tissue.”

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 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.

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:
Amy Cook, iCAD
+1 (925) 200-2125
acook@icadmed.com

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

1. Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK470003.
   
   
2. Pan E, Prados MD. Glioblastoma Multiforme and Anaplastic Astrocytoma. In: Kufe DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC Decker; 2003. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK12526/.
   
   
3. WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2018. Accessed via https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.

FAQ

What are the latest results for iCAD's Xoft System presented at the European Congress of Neurosurgery?

The data showcased significant improvements in overall survival and local progression-free survival for recurrent glioblastoma patients treated with the Xoft System compared to traditional therapies.

What is the survival rate for patients treated with the Xoft System?

Patients treated with the Xoft System had survival rates ranging from 16 to 59 months post-diagnosis, as opposed to the external beam radiation therapy group, which had no survivors beyond 38.5 months.

Who presented the data on Xoft at the European Congress of Neurosurgery?

The data was presented by Dr. Alexey Gaytan, a neurosurgeon at the European Medical Center in Moscow.

When was the data on iCAD's Xoft System announced?

The data was announced on October 19, 2020, at the European Association of Neurosurgical Societies Virtual Congress.

What type of therapy is the Xoft System designed for?

The Xoft System is an electronic brachytherapy system designed for the treatment of various cancers, including recurrent glioblastoma.