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

NASHUA, N.H., March 23, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced the launch of new initiatives to address emerging challenges hospitals are facing due to the pandemic of the coronavirus disease, or COVID-19. The Company and its 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:

  1. 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
  2. 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.
  3. 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.
  4. 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
  5. 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
  6. 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

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI™ is a high-performing workflow solution for 2D and 3D mammography, or digital breast tomosynthesis (DBT), featuring the latest in deep-learning artificial intelligence. In 2018, ProFound AI for Digital Breast Tomosynthesis (DBT) became the first artificial intelligence (AI) software for DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same year. It offers clinically proven time-savings benefits to radiologists, including a reduction of reading time by 52.7 percent, thereby halving the amount of time it takes radiologists to read 3D mammography datasets. Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent and reduced unnecessary patient recall rates by 7.2 percent.1

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 risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, 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.

Contacts:
Media inquiries:
Jessica Burns, iCAD  
+1-201-423-4492
jburns@icadmed.com

Investor relations:
Jonathan Wexler
+1-203-247-8767
jonathan@scopeir.com

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