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Sensus Healthcare Signs Exclusive U.S. Distribution Agreement with Mattioli Eng. Italia for its TransDermal Infusion System

December 1, 2021
Sensus to Bring FDA-cleared Non-invasive Drug-delivery System and Treatment Alternative to Needles to Dermatologists Beginning [Immediately/Date]

BOCA RATON, Fla, Dec. 01, 2021 — 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 the signing of an exclusive U.S. distribution agreement with Mattioli Eng. Italia S.P.A. for its TransDermal Infusion System non-invasive drug delivery system. Sensus plans to begin marketing this System to dermatologists nationwide beginning immediately.

The TransDermal Infusion System is cleared by the U.S. Food and Drug Administration (FDA) for the local administration of ionic drug solutions into the body for medical purposes, and can be used as an alternative to injections. Sensus’ sales organization will market the system to dermatologists for skin rejuvenation treatments, pre-laser treatments, pre- and post-plastic surgery and other applications. In addition, Sensus plans to make rental programs and leasing facilities available, similar to current programs for its superficial radiation therapy and aesthetic lasers.

The System allows drugs to penetrate the skin’s innermost, hypodermic layer by increasing permeability. Faster than traditional iontophoresis, the TransDermal Infusion System allows delivery of drugs that are otherwise not able to be absorbed including Botox®, hyaluronic acid, lidocaine, collagen and others typically used in aesthetic procedures.

“We are delighted to collaborate with such a globally recognized and highly respected firm as Mattioli Eng. Italia,” said Joe Sardano, chairman and CEO of Sensus Healthcare. “Their device, which we intend to trademark as ‘TransDermal Infusion’ under the Sensus brand, is FDA-cleared for use on any part of the body currently treated with needle injections. This permits various fillers and other injectables to be administered without pain and without patient downtime. We believe this needle-free treatment will be embraced by aesthetic dermatology clinics as a competitive advantage and an advance in patient care.”

Commenting on the agreement, Gian Franco Bernabei, CEO of Mattioli Eng. Italia S.P.A., said, “I am very excited to begin this new collaboration with Sensus. They have a tremendous commercial network, compelling products and, most importantly, exceptional respect among the dermatology community. We look forward to a productive relationship as the Sensus team brings our technology to dermatologists across the U.S.”

Mark S. Nestor, M.D., Ph.D., Director of the Center for Clinical and Cosmetic Research™ and the Center for Cosmetic Enhancement® in Aventura, Florida, and the current President of the American Cutaneous Oncology Society, said, “The clinical and aesthetic dermatology community is excited for the potential of the newest innovative device from Sensus Healthcare. The ‘Transdermal Infusion’ system has been shown to be very effective at transferring topically applied medications, botulinum toxins and hyaluronic acid fillers (HA) into the skin without the need for any cutaneous disruption. Our pilot study presented at the Fall Clinical Dermatology Conference1 showed over an 80% reduction in sweat 30 days after a single topical infusion of 50 units of onabotulinum toxin in the axilla. Additional studies have shown significant cosmetic improvement with topically applied HA. We also look forward to future applications for both clinical and aesthetic Dermatology.”

About Mattioli Eng. Italia S.P.A.

Mattioli Engineering has more than 15 years of commercial success. Its mission is to be fully dedicated to providing new devices and new technologies to the medical community, with a particular focus on dermatology, skin care, cosmetic surgery, plastic surgery and general surgery, and to create a worldwide network of customers experienced in using its devices and relevant techniques successfully.

About Sensus Healthcare

Sensus Healthcare, Inc. is a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for both oncological and non-oncological conditions. The Sculptura™ modulated robotic brachytherapy radiation oncology system provides targeted directional anisotropic radiation therapy (ART) and brachytherapy utilizing our proprietary, state-of-the-art 3D Beam Sculpting™ to treat patients undergoing cancer treatment during surgery, or at the tumor site, fast and efficiently. Sensus also offers its proprietary low-energy X-ray technology known as superficial radiation therapy (SRT), which is the culmination of more than a decade of research and development, to treat non-melanoma skin cancers and keloids with its SRT-100™, SRT-100+™ and SRT-100 Vision™ systems. With its portfolio of innovative medical device products, Sensus provides revolutionary treatment options to enhance the quality of life of patients around the world.

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Forward-Looking Statements

This press release includes statements that are, or may be deemed, ‘forward-looking statements.’ In some cases, these statements can be identified by the use of forward-looking terminology such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential” or negative or other variations of those terms or comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements involve risks and uncertainties because they relate to events, developments, and circumstances relating to Sensus, our industry, and/or general economic or other conditions 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, forward-looking statements are not guarantees of future performance, and 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 the following factors, among others: the continuation and severity of the COVID-19 pandemic, including its impact on sales and marketing; our ability to achieve profitability; our ability to obtain and maintain the intellectual property needed to adequately protect our products, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties; the level and availability of government and/or third party payor reimbursement for clinical procedures using our products, and the willingness of healthcare providers to purchase our products if the level of reimbursement declines; the regulatory requirements applicable to us and our competitors; our ability to efficiently manage our manufacturing processes and costs; the risks arising from our international operations; legislation, regulation, or other governmental action , that affects our products, taxes, international trade regulation, or other aspects of our business; 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 our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

In addition, even if future events, developments, and circumstances 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, except as may be required by applicable law. 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.

LHA Investor Relations
Kim Sutton Golodetz
[email protected]

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1 Nestor MS, Dunn A, Han H, Gade A, Ceci F, Lawson A: A Pilot Study to Evaluate the Safety and Efficacy of Topically Applied Onabotulinum Toxin A Delivered through a Novel Iontophoresis Device in Subjects with Axillary Hyperhidrosis. Poster, Fall Clinical Dermatology Conference, Las Vegas NV October 2021.

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