Tactile Medical Receives FDA 510(k) Clearance for Flexitouch® Plus, with Improved Therapy for At-Home Lymphedema Treatment

MINNEAPOLIS, June 01, 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, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Flexitouch Plus, the third-generation version of its Flexitouch system.

“We have listened to our customers’ suggestions on how we could make our Flexitouch system easier to use and have incorporated this important feedback into a new design to meet our patients’ needs and enhance their at-home treatment,” said Gerald R. Mattys, Chief Executive Officer of Tactile Medical. “In the Flexitouch Plus, we modified the Flexitouch controller and garments to improve the patient experience. We believe the result is an easier to use system that should drive even higher patient satisfaction with the same proven clinical outcomes of our Flexitouch system.”

Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. Lymphedema affects an estimated five million people in the United States. While there is no cure, Tactile Medical focuses on effectively relieving the condition’s symptoms, preventing symptoms from worsening and reducing the risk of skin damage and infection.

Tactile Medical intends to launch a limited market release of the Flexitouch Plus in late 2017, with a full market release expected in 2018.

About Tactile Medical

Tactile Medical is a leader in developing and marketing at-home therapy devices that treat lymphedema and chronic venous insufficiency. 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 Statements:

This 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,” or “project” or the negative of these words or other variations on these words or comparable terminology. 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, the adequacy of the Company’s liquidity to pursue its complete business objectives; the Company’s ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Company’s products; technical problems with the Company’s research and products; the Company’s ability to expand its business through strategic acquisitions; the Company’s ability to integrate acquisitions and related businesses; price increases for supplies and components; and the inability to carry out research, development and commercialization plans. In addition, other factors that could cause actual results to differ materially are discussed in the Company’s filings with the SEC, including the final prospectus for the Company’s initial public offering. Investors and security holders are urged to read these documents free of charge on the SEC's web site 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.

Investor Inquiries:

Mike Piccinino, CFA
Managing Director
Westwicke Partners
433-213-0500
[email protected]

Media Inquiries:

Kristen Weaver
Director of Marketing Communications
Tactile Medical
612-355-5156
[email protected]