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Tactile Systems lymphedema treatment system OKd by FDA

June 1, 2017

Tactile Systems Technology, Inc. (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.


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