iCAD Launches New Initiatives Leveraging Unique Capabilities of its Robust Product Portfolio to Reduce Health Care System Pressures During the COVID-19 Pandemic

ProFound AI can assist radiologists in prioritizing
patients for breast cancer screening and address the growing mammography
backlog

Xoft breast IORT offers single-fraction therapy alternative
to weeks of daily radiation, reducing resources needed and minimizing patients’
risk of COVID-19 exposure

Today, iCAD launched new initiatives
to address emerging challenges hospitals are facing due to the pandemic of the
coronavirus disease, or COVID-19. iCAD and our portfolio of technologies
supporting cancer detection and therapy continue to offer a strong value
proposition and multiple benefits to clinicians and patients, which may be
particularly relevant in light of the coronavirus outbreak:

ProFound AI™, the
first artificial intelligence (AI) software for digital breast tomosynthesis
(DBT) to be FDA-cleared, provides crucial data, such as Case Scores, which can
help radiologists prioritize which patients should not delay screening and
presents a solution to the growing mammography backlog that will need to be
cleared once COVID-19 passes. It is also clinically proven to decrease the rate
of false positives and unnecessary recalls,1 which reduces resources
needed and minimizes patient risk of COVID-19 exposure.
The Xoft® Axxent®
Electronic Brachytherapy (eBx®) System® offers a single-fraction therapy option
that allows patients who are candidates to replace weeks of daily radiation
with one treatment, delivered at the time of surgery. This could also significantly reduce the healthcare
system resources needed and reduce patients’ risk of COVID-19 exposure.
iCAD is mobilized
to support critical facility and physician needs related to both its Detection
and Therapy businesses.

A ProFound Impact on
Screening

“In recent weeks the
number of people diagnosed with COVID-19 has rapidly increased, placing a
growing burden upon hospitals and clinicians worldwide, and this issue may
continue to proliferate in the near-term. According to recent guidance from the
American College of Radiology and the American Cancer Society, some women
should consider rescheduling routine mammograms to allow hospitals to address
critical COVID-19 cases. Due to this emerging issue, some patients with more
urgent and higher risk factors may be deferred, which could have negative
consequences in the long run,” according to Michael Klein, Chairman and CEO of iCAD.

“Studies from published
academic research show that on average, a mammography provider can expect to
detect up to 6 cancers per 1,000 screening mammograms,2 which
indicates that even in the face of this pandemic, cancer is not going away,”
according to Stacey Stevens, President of iCAD. “Now more than ever, it is
increasingly critical to empower radiologists with the technology to quickly
and effectively prioritize mammography screening.”

“Where breast cancer
screening is concerned, our initiative involving ProFound AI could be
exceptionally helpful for radiologists, as the technology can be used on
patients’ prior year mammograms to prioritize which women may be at higher risk
of developing breast cancer, and thereby should work with their healthcare
provider to determine the availability of expedient follow up screening.
Further, when the threat of COVID-19 passes, physicians and the healthcare
system as a whole will be faced with an enormous backlog of mammograms.
ProFound AI is uniquely positioned to address these emerging challenges,” added
Klein.

“In the face of COVID-19,
improving accuracy and efficiency for breast cancer screening is now more
essential than ever. Using this leading-edge technology, radiologists have the
ability to review prior year mammograms and prioritize which patients should
not delay breast cancer screening based on the technology’s unique Case Score,
which represents a relative level of suspicion for the case containing
potentially cancerous findings that may require further workup,” according to
Mark Traill, MD, radiologist at University of Michigan Health, Metro Health.
“It is clinically proven to help radiologists significantly increase their
productivity. ProFound AI can also reduce the rate of false positives,1
which are not only stressful for patients, but also place a significant
additional burden on providers. Clinicians using ProFound AI will be very happy
they have such a sophisticated tool helping them better position their
screening programs’ recovery from this unprecedented global disruption.”

Trained with one of the
largest available DBT datasets, ProFound AI rapidly and accurately analyzes
each DBT image, or slice, and provides radiologists with key information, such
as Certainty of Finding lesion and Case Scores, which assists radiologists in
clinical decision-making and improving reading efficiency. Featuring the latest
in deep-learning artificial intelligence, the algorithm also allows for
continuously improved performance via ongoing updates.

Single-Fraction
Therapy Shaves Treatment Time to One Day

“The burden COVID-19 is
placing on hospitals is resulting in some healthcare facilities needing to
reschedule surgeries and other procedures, including cancer treatments,” noted
Klein. “As COVID-19 is forcing hospital systems to begin to reframe protocols relating
to the treatment of cancer, our initiative for the Xoft System may help to
address this emerging burden placed on the system and patient concerns related
to potential COVID-19 exposure, as it offers significant time savings benefits
to clinicians and patients.”

“The Xoft System offers
the ability to deliver an entire course of treatment to an early-stage
breast cancer patient in just one day, at the time of lumpectomy, which not
only frees up space in hospitals and allows clinicians to focus on more
critical needs, it reduces immunocompromised patients’ time in hospitals and
therefore minimizes their potential exposure to the virus,” Stevens added.

“Clinical guidelines from several national medical
societies support an abbreviated course of radiation for appropriate breast
cancer candidates, and a growing body of clinical evidence suggests Xoft breast
IORT is a viable alternative to traditional radiation therapy,” 3,4,5
according to Barbara Schwartzberg, MD, Western Surgical Care. “IORT with the Xoft
System offers significant cost savings and quality of life benefits to
patients, while enabling them to get the cancer care they need in just one day,
versus weeks of daily radiation treatments. As healthcare systems adjust to the
emergent needs relating to the coronavirus, IORT offers a valuable solution for
early-stage breast cancer patients, and physicians delivering their care.”

The American Society for Radiation Oncology (ASTRO)
recently recommended shorter courses of radiation therapy, such as intraoperative
radiation therapy (IORT) and hypofractionated radiation therapy, for
appropriate patients in its recent recommendations on COVID-19.6
Recognizing the potential for staff reductions, ASTRO advised radiation
oncologists to follow evidence-based guidelines while striving for the shortest
possible course of radiotherapy, where appropriate. The overall goal is to
reduce the risk of transmission of COVID-19 and to allow cancer care to
continue for those most likely to benefit.

For the treatment of early-stage breast cancer, IORT with
the Xoft System offers a single-fraction therapy option that allows patients
who are candidates to be treated for breast cancer in just one day. This
targeted treatment option enables some women to potentially replace four to six
weeks of daily fractions of post-operative external beam radiation therapy
(EBRT) with a single-fraction of radiation that can last as little as eight
minutes, thereby reducing the amount of time women need to be in the hospital
and allowing doctors to treat more women in less time.

In addition to early-stage breast cancer, Xoft IORT
technology is also being explored in the treatment of other types of tumors.
iCAD recently announced the first metastatic brain tumor was treated in the
U.S. with IORT using the Xoft System at the James Graham Brown Cancer Center at
the University of Louisville. The Xoft System is also currently being studied
for the treatment of other types of brain tumors in leading institutions
worldwide, including the European Medical Center, one of the largest private
medical clinics in Russia and an international leader in comprehensive care and
oncology. The Company continues to work with key neurosurgeons to enroll
patients in a multi-institutional study on Xoft IORT for the treatment of
recurrent glioblastoma (GBM).

Homegrown Technology Positioned to
Sustain in the Face of Pandemic

“iCAD has quickly
mobilized to support critical facility and physician needs related to both
sides of our business,” said Scott Areglado, Chief Financial Officer of
iCAD.

“Health systems are
increasingly seeking alternative ways to accomplish daily clinical challenges,
drive operational efficiency, and streamline patient management, and our
technologies are well-positioned to address this demand, particularly as
facilities fight against COVID-19,” added Klein. “Our world-class core
technology is homegrown and entirely manufactured in the United States. We have
minimal reliance upon outside vendors or external suppliers, and therefore we
will continue to be able to offer our cutting-edge solutions to more hospitals
and imaging centers as demand continues to grow. We are partnering and
collaborating with virtually all of our OEM and PACS partners, particularly
those aligned with our risk and remote access support initiatives, and we are
also partnering with healthcare systems and large imaging chains to get these
proven technologies into peoples’ hands as fast as possible.”

References:

Conant, E et al. (2019). Improving
Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for
Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4).
Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096
Conant,
E. et al. (2020). Five Consecutive Years of Screening with Digital Breast
Tomosynthesis: Outcomes by Screening Year and Round. Radiology. Accessed via https://doi.org/10.1148/radiol.2020191751.
Correa,
Candace et al. (2017) Accelerated Partial Breast Irradiation: Executive summary
for the update of an ASTRO Evidence-Based Consensus Statement. Practical
Radiation Oncology, Volume 7, Issue 2, 73 – 79. Accessed via https://www.practicalradonc.org/article/S1879-8500(16)30184-9/fulltext.
Schwartzberg,
BS. et al. (2018). Application of 21-gene recurrence score results and ASTRO
suitability criteria in breast cancer patients treated with intraoperative
radiation therapy (IORT). American Journal of Surgery. 216(4): 689-693.
Accessed via https://www.americanjournalofsurgery.com/article/S0002-9610(18)30097-7/fulltext
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
American
Society for Radiation Oncology (ASTRO) COVID-19 Recommendations to Radiation
Oncology Practices. (2020). Accessed via https://www.astro.org/Daily-Practice/COVID-19-Recommendations-and-Information