MINNEAPOLIS, Dec. 07, 2017 — Tactile Systems Technology, Inc. (“Tactile Medical”) (Nasdaq:TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the publication of a functional use study in the medical journal Head & Neck that assessed the Company’s Flexitouch system for the treatment of lymphedema of the head and neck. Flexitouch is the first and only pneumatic compression device that is FDA 510(k) cleared for at-home head and neck lymphedema treatment in the United States.
The Study, titled Usability of advanced pneumatic compression to treat cancer-related head and neck lymphedema: A feasibility study, was conducted by Mayrovitz et al. and included 44 participants. It was designed to evaluate the feasibility of using the Flexitouch system to help patients with head and neck lymphedema self-manage their condition. The American Cancer Society estimates that 400,000 people in the U.S. today have head and neck cancer, with 60,000 new patients diagnosed annually. Ridner et al from Vanderbilt University recently published a study in Lymphatic Research and Biology indicating that greater than 75% of head and neck cancer patients will develop some form of lymphedema following head and neck cancer treatment. With this in mind, this Study assessed aspects including safety, garment fit, treatment comfort, and the participant’s likeliness to use Flexitouch at home. Researchers also measured anatomical areas on the patient’s head and neck before and after treatment in order to assess acute changes in edema, an important indicator of treatment efficacy. The Study found statistically significant reductions in face and neck measurements after a single 32-minute treatment with Flexitouch. Importantly, statistically significant reductions in composite metrics (mean ± SD) of the face (82.5 ± 4.3 cm pre vs. 80.9 ± 4.1 cm post; P < .001) and neck (120.4 ± 12.2 cm pre vs. 119.2 ± 12.1 cm post; P < .001) were reported. Overall, 43% of patients had a >2% reduction in composite face measurements, and 20% of patients had a >2% reduction in composite neck measurements after a single 32-minute treatment. A 2% change in these composite measurements has been established in prior literature as the threshold evidencing clinically significant reduction in head and neck lymphedema. We believe small changes in edema in the head and neck may have a major effect on breathing, swallowing and speaking. Patient-reported outcomes were also positive: 82% of patients found the treatment with Flexitouch comfortable; 61% felt better after a single treatment; and 93% reported that they were likely to use Flexitouch at home. Researchers concluded that Flexitouch is safe, easy to use, and well-tolerated, while demonstrating edema reduction after a single 32-minute treatment session.“We are encouraged by the findings of this study, which provide important clinical support for the safety, effectiveness and patient acceptance of our Flexitouch system in treating head and neck lymphedema,” said Gerald R. Mattys, Chief Executive Officer of Tactile Medical. “We are pleased to offer a new, at-home treatment option for patients suffering from head and neck lymphedema and are excited by the potential long-term outcomes they may be able to achieve through its use.”The study may be found online at: http://onlinelibrary.wiley.com/doi/10.1002/hed.24995/fullAbout Tactile MedicalTactile Medical is a leader in developing and marketing at-home therapy devices that treat lymphedema and chronic venous insufficiency. Our mission is to help people suffering from chronic diseases live better and care for themselves at home. Our unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates, and clinical staff. This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. Tactile Medical takes pride in the fact that our solutions help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions.Legal Notice Regarding Forward-Looking StatementsThis release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “confident,” or “project” or the negative of these words or other variations on these words or comparable terminology. These also include statements about potential long-term outcomes from the use of Flexitouch. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Company’s control that can make such statements untrue, including, but not limited to, adverse results to patients; adverse federal, state and local government regulation; technological obsolescence of the Company’s products; and technical problems with the Company’s research and products. In addition, other factors that could cause actual results to differ materially are discussed in the Company’s filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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