Multi-center research presented at ASTRO 2018 shows IORT with the Xoft
System is safe with low recurrence and low morbidity in the treatment of breast
cancer

 

Company marks 20 years of innovations in targeted cancer care at the
conference

 

NASHUA, N.H. and SAN ANTONIO, Texas (Booth #3457) – (October
23, 2018) – iCAD, Inc. (NASDAQ:
ICAD), a global medical technology leader providing innovative cancer
detection and therapy solutions, today announced new clinical research demonstrating
positive outcomes supporting the use of the Xoft® Axxent®Electronic Brachytherapy (eBx®) System® for the
treatment of early-stage breast cancer. Preliminary results demonstrated that
IORT using the Xoft System is safe with excellent local control and cosmesis,
and low morbidity. The analysis of the international, multi-center trial was
unveiled during an oral presentation at the 60th American Society
for Radiation Oncology (ASTRO) annual meeting at the Henry B. Gonzalez
Convention Center in San Antonio, Texas.

 

“We are pleased that clinical results from
our global installed base continue to highlight the therapeutic value of this state-of-the-art
treatment option,” said Ken Ferry, CEO of iCAD. “In addition, it is an honor to
mark our 20th year of innovations in targeted cancer care among
healthcare providers who are making an important difference each day in the lives
of their patients. We look forward to continuing to partner with radiation
oncology leaders worldwide to precisely and effectively treat cancer in the
years to come.”

 

In the presentation, A.M. Nisar Syed, MD, Principle
Study Investigator, and Medical Director, Radiation Oncology & Endocurietherapy,
MemorialCare Cancer Institute, Long Beach Memorial Medical Center, and
Professor of Radiation Oncology, UCI Medical Center and Harbor-UCLA School of
Medicine, detailed clinical techniques and outcomes of IORT using the Xoft
System at the time of breast conserving surgery with findings based upon ASTRO suitability
criteria. The trial enrolled 1,201 patients between May 2012 and July 2018 at 28
international and United States-based institutions. With a median follow up of 2
years, less than one percent of patients had cancer regrowth (ipsilateral
recurrence) or developed new primary cancers in the other breast. Treatment was
well tolerated with grade 3, 4 and 5 adverse events occurring in only 37
patients. Mean treatment time was 10.5 minutes.

 

“Our research continues to demonstrate
significant promise in the treatment of early-stage breast cancer with IORT
using the Xoft System. Preliminary outcomes show that a single fraction of
radiation with the Xoft System yields excellent results in patients meeting
specific selection criteria,” said A.M. Nisar Syed, MD. “By greatly reducing
the number of treatment patients receive as compared to traditional radiation
therapy, IORT provides valuable advantages to patients including shorter
treatment times, fewer side effects, reduced costs and improved quality of life.”

 

In addition to the new data release at the
annual meeting, iCAD hosted a series of in-booth expert presentations and
peer-to-peer learning opportunities led by the following global experts:

  • Paulo Costa, MD, Radiation Oncologist,
    Instituto CUF Porto, Breast Surgery Unit Senhora da Hora, Matosinhos, Portugal
  • Charles Wesley Hodge, MD, Radiation
    Oncologist, Florida Hospital Celebration Health, Celebration, Fla.
  • Chun-Shu Lin, MD, Chief, Department of
    Radiation Oncology, Tri-Service General Hospital, Taipei City, Taiwan
  • A.M. Nisar Syed, MD, Medical Director, Radiation Oncology &
    Endocurietherapy, MemorialCare Cancer Institute, Long Beach Memorial Medical
    Center, Long Beach, Calif.

IORT
with the Xoft System uses a miniaturized X-ray source to deliver one precise,
concentrated dose of radiation to a tumor site at the time of breast-conserving
surgery (lumpectomy). The treatment can be completed in as little as eight
minutes, making it possible for appropriately selected patients to replace six
to eight weeks of post-operative EBRT with a single treatment. The Xoft
System is cleared by the U.S. Food and Drug Administration, CE marked, and
licensed in a growing number of countries for the treatment of cancer anywhere
in the body, including early-stage breast cancer, non-melanoma skin cancer, and
gynecological cancers. It has been used to successfully treat more than 15,000
patients worldwide.
For more information, please visit www.xoftinc.com.

 

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.

 

“Safe Harbor” Statement under the Private
Securities Litigation Reform Act of 1995

 

Certain statements contained in this News Release
constitute “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. 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 defend itself in litigation
matters, to achieve business and strategic objectives, the risks of uncertainty
of patent protection, the impact of supply and manufacturing constraints or
difficulties, uncertainty of future sales levels, protection of patents and
other proprietary rights, 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”, “would”, “could”,
“consider”, “project”, “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, including the 10-K for the year ended December 31, 2017,
available on the Investors section of our website at http://www.icadmed.com and on the SEC’s
website at http://www.sec.gov.

 

Contact:

 

Media Inquiries:

 

ARPR, on behalf of iCAD, Inc.

Paul Barren, (855) 300-8209

paul@arpr.com

 

Investor Relations:

LifeSci Advisors, on behalf of iCAD, Inc.

Jeremy Feffer, (212) 915-2568

jeremy@lifesciadvisors.com