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Classified in: Health
Subjects: PDT, FDA

U.S. FDA Grants Market Clearance to Sensus Healthcare's New Sculpturatm Radiation Oncology System


BOCA RATON, Fla., Feb. 26, 2019 /PRNewswire/ -- Sensus Healthcare, Inc. (NASDAQ: SRTS), a medical device company specializing in highly effective, non-invasive treatments for both oncological and non-oncological conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted market clearance for the Company's groundbreaking Sculpturatm radiation oncology system. A single treatment during surgery, Sculpturatm can provide cancer patients and physicians a single radiation treatment at the point of surgery.

"With the creation of Sculpturatm, Sensus is pioneering a new whole approach to radiation oncology that will ultimately benefit both patients and the medical community at large," said Joe Sardano, Sensus Healthcare CEO. "This system has the potential to give surgeons and radiation oncologists at hospitals and cancer centers the ability to eliminate weeks of post-operative radiation treatments that patients have to undergo after surgery. It is a game-changer that will provide a significantly better quality of life for patients post-surgery."

Sculpturatm is a robotic Intraoperative Radiation Therapy (IORT) system that uses patented Beam Sculptingtm capabilities to treat various cancers during surgery. The first Sculpturatm system has been installed at the University of Pennsylvania's Perelman School of Medicine Department of Radiation Oncology.

"Sensus will introduce Sculpturatm into the marketplace to help cancer patients all over the world have a more manageable and effective radiation oncology experience," added Sardano. "Sculpturatm is a paradigm-shifting technology that will not only help doctors to uniquely sculpt exact areas of the body with the radiation beam, but also result in similar or better outcomes to current radiation treatments today, with much less collateral damage."

"Sculpturatm has several exclusive features that make this robotically assisted therapy system vastly different from everything else that's available to patients on the market today," concluded Kal Fishman, Sensus Healthcare Chief Technology Officer. "From its 3D Beam Sculptingtm and respiratory motion tracking to the embedded image guidance and treatment area illumination, Sculpturatm is a first-of-its-kind, best-in-class treatment for cancer patients everywhere that will considerably change the status quo and forever alter how we think about cancer therapy today."

About Sensus Healthcare
Sensus Healthcare, Inc., is a medical device company that is committed to providing highly effective, non-invasive and cost-effective treatments for both oncological and non-oncological skin conditions. Sensus uses a proprietary low-energy X-ray technology known as superficial radiation therapy (SRT), which is a result of over a decade of dedicated research and development. Sensus has successfully incorporated SRT into its portfolio of treatment devices: the SRT-100TM, SRT-100+TM and SRT-100 VisionTM.To date, SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in thousands of patients around the world. With the introduction of Sculptura, Sensus Healthcare is branching out into cancer treatment that goes far beyond skin and will provide a revolutionary treatment option for patients around the world.

For more information, visit https://www.sensushealthcare.com.

Forward-Looking Statements
This press release includes statements that are, or may be deemed, ''forward-looking statements.'' In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately," "potential" or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward looking statements contained in this press release, as a result of, among other factors:   our ability to achieve and sustain profitability; market acceptance of our product lines; our ability to successfully commercialize our products; our ability to compete effectively in selling our products and services, including responding to technological change and cost containment efforts of our customers; our need and ability to obtain additional financing in the future, as well as complying with the restrictions our existing revolving credit facility imposes; our ability to expand, manage and maintain our direct sales and marketing organizations; our actual financial results may vary significantly from forecasts and from period to period; our ability to successfully develop new products, improve or enhance existing products or acquire complementary products, technologies, services or businesses; our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties; market risks regarding consolidation in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third party payors for procedures using our products declines; the level and availability of government and third party payor reimbursement for clinical procedures using our products; our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel; the regulatory requirements applicable to us and our competitors; our ability to manufacture our products to meet demand; our reliance on third party manufacturers and sole- or single-source suppliers; our ability to reduce the per unit manufacturing costs; our ability to efficiently manage our manufacturing processes; the regulatory and legal risks, and certain operating risks, that our international operations subject us to; off label use of our products; the fact that product quality issues or product defects may harm our business; the accuracy of our financial statements and accounting estimates, including allowances for accounts receivable and inventory obsolescence; any product liability claims; limited trading in our shares and the concentration of ownership of our shares; cyberattacks and other data breaches and the adverse effect on our reputation; new legislation, administrative rules, or executive orders, including those that impact taxes and international trade regulation; the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or that limit certain disputes to be brought exclusively in the Delaware Court of Chancery; concentration of our customers in the U.S. and China, including the concentration of sales to one particular customer in the U.S.; and other risks described from time to time in Sensus Healthcare's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.

In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this press release, they may not be predictive of results or developments in future periods. Any forward-looking statements that we make in this press release speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this press release. You should read carefully our "Cautionary Note Regarding Forward-Looking Information" and the factors described in the "Risk Factors" section of our periodic reports filed with the Securities and Exchange Commission to better understand the risks and uncertainties inherent in our business.

Media Contacts:
Caitlin Kasunich / McKenna Miller
KCSA Strategic Communications
212-896-1241 / 347-487-6197
ckasunich@kcsa.com / mmiller@kcsa.com 

Investor Contact:
Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
kgolodetz@lhai.com

SOURCE Sensus Healthcare, Inc.


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News published on 26 february 2019 at 08:00 and distributed by: