Sensus to Bring FDA-cleared Non-invasive Drug-delivery System and Treatment Alternative to Needles to Dermatologists Beginning [Immediately/Date]
BOCA RATON, Fla. (December 1, 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 Conference 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.
For more information, visit www.sensushealthcare.com.
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Kim Sutton Golodetz
 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.