Sensus Healthcare Collaborates with CureRays to Provide Oversight to Help Customers Assure Patient Safety, Reliability of Outcomes and Conformance with Regulatory Requirements
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Insights
The collaboration between Sensus Healthcare and CureRays is a strategic move that can potentially expand the applications of Sensus' superficial radiotherapy (SRT) systems beyond oncology. The exploration of new indications, particularly inflammatory diseases such as arthritis, could significantly increase the addressable market for SRT. Inflammation is a common pathway in many diseases and the anti-inflammatory effects of low-dose radiotherapy may offer a non-pharmacological treatment option, potentially reducing reliance on long-term medication.
Moreover, the partnership aims to enhance safety and regulatory compliance in the use of ionizing radiation, addressing state-level regulatory changes. This proactive approach can improve patient outcomes and mitigate risks associated with radiation therapy. The expertise of CureRays, especially under the guidance of Dr. Khan and Dr. Hess, could lead to innovative clinical protocols and improved patient care within dermatology practices.
The medical device sector is witnessing a trend towards multifunctional devices that offer a range of treatment options. Sensus Healthcare's initiative to broaden the utility of its SRT systems aligns with this trend and could position the company favorably in the competitive landscape. By tapping into new therapeutic areas, Sensus may diversify its revenue streams and reduce its dependency on the oncology market. Furthermore, the collaboration's focus on education and navigating the complex regulatory environment for radiotherapy could enhance Sensus' value proposition to dermatology customers, potentially leading to increased adoption of its SRT systems.
As CureRays conducts clinical trials for new indications, positive outcomes could lead to increased investor confidence and a stronger market position for Sensus. However, clinical trials are inherently risky and negative results could impact the company's reputation and financial performance. Stakeholders should monitor the progress of these trials closely.
The tightening of regulations around the use of ionizing radiation in certain states underscores the importance of regulatory compliance in the medical device industry. Sensus Healthcare's alignment with CureRays, which will provide oversight and supervision to ensure patient safety and regulatory adherence, is a strategic response to these changes. This collaboration could streamline the process for Sensus' dermatology customers, helping them to navigate the evolving regulatory landscape.
Understanding the regulatory implications of expanding SRT to new indications is crucial. It involves a thorough review process by the FDA and other regulatory bodies to ensure the safety and efficacy of treatments for non-oncological conditions. The partnership with CureRays could facilitate a smoother regulatory pathway for Sensus' SRT systems, potentially expediting the time to market for new applications.
Physician-run radiation oncology innovator also to research new indications and broaden the market for SRT to include inflammatory diseases
BOCA RATON, Fla., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces a new multi-faceted collaboration with CureRays, a radiation oncology specialist organization based in Atlanta and Grass Valley, Calif.
Under the collaboration, CureRays will provide Sensus’ dermatology customers with oversight and supervision to assure patient safety, quality, reliability of outcomes and conformance with regulatory requirements, in particular in states where regulations covering the use of ionizing radiation have been tightened. In addition, CureRays will research new indications for Sensus’ superficial radiotherapy (SRT and IG-SRT), including inflammatory diseases.
“This collaboration is the culmination of several years of discussion that started early in the COVID-19 pandemic, when we learned that Drs. Khan and Hess were treating COVID pneumonia with low-dose radiotherapy for infectious and inflammatory diseases. We were anxious to help stem fatalities in any way we could, and we’ve been impressed with their commitment to patient care. CureRays is well-versed in our SRT-100 Vision® (IG-SRT) system, which they are utilizing to treat skin cancer and keloids,” commented Joe Sardano, chairman and chief executive officer of Sensus.
“CureRays’ expertise in radiotherapy and their commitment to continuing education led us to engage them to help our dermatologist customers navigate the complex and changing requirements of radiotherapy,” he added. “In addition, we are thrilled to support their efforts to expand the use of our products and broaden our markets, beginning with arthritis.”
CureRays is led by Mohammad K. Khan, M.D., Ph.D., Professor of Medicine, Department of Radiation Oncology at the Emory University School of Medicine, and Clayton Hess, M.D., M.P.H., Medical Director, Radiation Oncology at Sierra Nevada Memorial Hospital in Grass Valley. Dr. Khan serves on the Sensus Medical Advisory Board and Dr. Hess treats patients with a recently-purchased SRT 100-Vision (IG-SRT) at CureRays’ Grass Valley facility. CureRays is focused on three main endeavors – radiation treatments for patients, radiation consulting for physicians and the conduct of clinical trials.
Dr. Khan said, “As a member of the Sensus Healthcare Medical Advisory Board, I am fully aware of the many benefits of a portable device to treat skin cancer. This portability is a key component of SRT’s utility, not only for treating skin cancers, but also for other indications, especially those where patients can be treated bedside or closer to home within their community. CureRays is very excited about the possibility of supporting clinical expansion by investigating SRT beyond its current indications to include a host of malignant and benign conditions.”
Dr. Khan added, “The initial focus on rheumatoid arthritis is driven by four decades of evidence in Europe, where low-dose radiation is standard-of-care in Germany. We will be exploring the use of low-dose radiotherapy in indications where we can control the immune system and inflammation with minimal impact to body structures.”
Dr. Hess said, “SRT has been successfully treating skin cancer for years. It’s the best alternative to surgery for non-melanoma skin cancer. As a practitioner in a small town in the Sierra Nevada foothills, my vision is to bring a non-scaring and effective treatment option not only to my patients, but to support the wider use of SRT in small communities across the United States, not just in large metropolitan areas. My goal is also to help further enhance patient selection against the risks and benefits of radiotherapy.”
About Sensus Healthcare
Sensus Healthcare, Inc. is a global pioneer in the development and delivery of non-invasive treatments for skin cancer and keloids. Leveraging its cutting-edge superficial radiotherapy (SRT and IG-SRT) technology, the company provides healthcare providers with a highly effective, patient-centric treatment platform. With a dedication to driving innovation in radiation oncology, Sensus Healthcare offers solutions that are safe, precise, and adaptable to a variety of clinical settings. For more information, please visit www.sensushealthcare.com.
Contact:
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com
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