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
Multiple leading institutions leverage the versatility
of Xoft electronic brachytherapy (eBx) to increasingly treat multiple cancers
NASHUA, N.H. – April 5, 2021 – 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
Investor Relations:
iCAD Investor Relations
[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.