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. – October 23, 2020 – 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
[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.