|[December 30, 2013]
Electromed, Inc. Receives FDA Market Clearance for the SmartVest® SQL™
NEW PRAGUE, Minn. --(Business Wire)--
Electromed, Inc. (NYSE MKT: ELMD), a global medical device company,
today announced it has received notification from the U.S. Food and Drug
Administration that its next generation SmartVest® Airway
Clearance System, the model SQL™ has been cleared to market.
"SQL solidifies Electromed's innovation leadership by offering a device
that is smaller, quieter, and lighter than our previous versions," said
Kathleen Skarvan, Chief Executive Officer. "We designed the SQL to stand
apart from the competition with features that our patients and
clinicians were asking for. They talked, and we listened." In addition
to being significantly smaller, quieter, and lighter than our previous
versions, some of the features include enhanced ramping, an enhanced
pause feature and more user-friendly graphics.
The model SQL is an electrically powered precursor device designed to
deliver high frequency chest wall oscillation (HFCWO) to promote airway
clearance, improve bronchial drainage and enhance mucus transport under
the order of a physician's prescription. It is prescribed to patients
with a wide range of pulmonary-related health conditions including
bronchiectasis, chronic obstructive pulmonary disease (COPD), cystic
fibrosis, muscular dystrophy, and cerebral palsy. HFCWO has been
demonstrated to reduce lung infections and reduce health care costs
associated with recurrent pneumonias, antibiotic us, and hospital
stays. In addition to the innovative SQL generator, the system boasts a
lightweight soft-fabric garment with several patented features.
"We believe we have the most comfortable and easy-to-use system among
leading HFCWO devices, which leads to therapy adherence and better
patient outcomes," Skarvan added.
Electromed anticipates that the model SQL will be available to the U.S.
market within the next 60 days.
About Electromed, Inc.
Electromed, Inc. manufactures,
markets, and sells products that provide airway clearance therapy,
including the SmartVest® Airway Clearance System, to patients
with compromised pulmonary function. Further information about the
Company can be found at www.electromed.com,
or call 800-462-1045.
Certain statements found in this release may constitute forward-looking
statements as defined in the U.S. Private Securities Litigation Reform
Act of 1995. Forward-looking statements reflect the speaker's current
views with respect to future events and financial performance and
include any statement that does not directly relate to a current or
historical fact. Forward-looking statements can generally be identified
by the words "believe," "expect," "anticipate" or "intend" or similar
words. Forward-looking statements made in this release include the
Company's expectations regarding the availability of the model SQL in
the U.S. market. Forward-looking statements cannot be guaranteed and
actual results may vary materially due to the uncertainties and risks,
known and unknown, associated with such statements. Examples of risks
and uncertainties for Electromed include, but are not limited to, delays
in the production or shipment of our products, the reluctance of
physicians or other healthcare providers to accept a new product, the
impact of emerging and existing competitors, and the effectiveness of
our sales and marketing and cost control initiatives, as well as other
factors described from time to time in our reports to the Securities and
Exchange Commission (including our Annual Report on Form 10-K).
Investors should not consider any list of such factors to be an
exhaustive statement of all of the risks, uncertainties or potentially
inaccurate assumptions investors should take into account when making
investment decisions. Shareholders and other readers should not place
undue reliance on "forward-looking statements," as such statements speak
only as of the date of this release.
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