Tactile Medical Announces New Clinical Publication Assessing the Use of Flexitouch for the Treatment of Head & Neck Lymphedem...
December 07 2017 - 8:30AM
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/full
About Tactile Medical
Tactile 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
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,”
“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.
Investor Inquiries:
Mike Piccinino, CFA
Managing Director
Westwicke Partners
443-213-0500
investorrelations@tactilemedical.com
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