Electromed, Inc. Announces U.S. Food and Drug Administration 510(k) Clearance of Fifth Generation HFCWO Airway Clearance Generator
November 30 2022 - 9:00AM
Business Wire
Electromed, Inc. (NYSE American: ELMD) a leader in innovative
airway clearance technologies, today announced that it received U.S
Food and Drug Administration (“FDA”) 510(k) clearance of the
SmartVest® Clearway® Airway Clearance System, which is designed for
High Frequency Chest Wall Oscillation (“HFCWO”) therapy. The
SmartVest Clearway system, an updated and modern approach to HFCWO,
offers an enhanced patient experience with proven patient
outcomes.1
“It is our goal to make home airway clearance easier and more
convenient for patients, while continuing to provide a superior
product, proven outcomes, and outstanding patient service,”
commented Kathleen Skarvan, President and Chief Executive Officer
of Electromed. “SmartVest Clearway meets these goals with its
intuitive touch screen, the lightest weight generator on the
market, and smaller footprint than our previous generation which
continues our history of innovation in HFCWO therapy. We are proud
to further our mission and assist more patients to breathe easier
and improve their quality of life.”
The SmartVest Clearway system uses HFCWO, a clinically proven
therapy that helps clear the lungs of excess secretions, thereby
reducing the risk of respiratory infections and hospitalizations
for those suffering from a chronic lung condition.1 HFCWO delivers
alternating pulses of air into a vest garment that rapidly
compresses and releases the chest wall, resulting in an oscillation
in airflow within the airways that acts to loosen, thin, and propel
mucus toward the major airways where it can be expectorated. The
SmartVest Clearway Airway Clearance System is designed to deliver
high frequency chest wall oscillation to promote airway clearance
and improve bronchial drainage. The SmartVest System is indicated
when external chest manipulation is the physician’s treatment of
choice to enhance mucus transport. HFCWO therapy is often
prescribed for illnesses such as non-cystic fibrosis bronchiectasis
(NCFB) and other chronic pulmonary conditions.
Limited market release of the device in the U.S. will begin in
the coming weeks.
About Non-Cystic Fibrosis Bronchiectasis
NCFB, or bronchiectasis, is an irreversible, chronic lung
condition characterized by enlarged and permanently damaged
bronchi. There are an estimated 600,000 people in the United States
with this diagnosis.4,5 The condition is associated with recurrent
lower respiratory infections, inflammation, reduction in pulmonary
function, impaired respiratory secretion clearance, increased
hospitalizations and medication use, and increased morbidity and
mortality.2,3,4
About Electromed, Inc.
Electromed manufactures, markets, and sells products that
provide airway clearance therapy, including the SmartVest® Airway
Clearance System, to patients with compromised pulmonary function.
It is headquartered in New Prague, Minnesota and founded in 1992.
Further information about Electromed can be found at
www.smartvest.com.
Cautionary Statements
Certain statements in this press release constitute
forward-looking statements as defined in the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as
“anticipate,” “assume,” “believe,” “expect,” “may,” “potential,”
“should,” “will,” and similar expressions, including the negative
of these terms, but they are not the exclusive means of identifying
such statements. Forward-looking statements cannot be guaranteed,
and actual results may vary materially due to the uncertainties and
risks, known or unknown associated with such statements. Examples
of risks and uncertainties for the Company include, but are not
limited to, the duration, extent and severity of the COVID-19
pandemic, including its effects on our business, supply chain,
operations and employees as well as its impact on our customers and
distribution channels and on economies and markets more generally;
the competitive nature of our market; changes to Medicare,
Medicaid, or private insurance reimbursement policies; changes to
state and federal health care laws; changes affecting the medical
device industry; our ability to develop new sales channels for our
products such as the homecare distributor channel; our need to
maintain regulatory compliance and to gain future regulatory
approvals and clearances; new drug or pharmaceutical discoveries;
general economic and business conditions; our ability to renew our
line of credit or obtain additional credit as necessary; our
ability to protect and expand our intellectual property portfolio;
the risks associated with expansion into international markets, as
well as other factors we may describe from time to time in the
Company’s reports filed with the Securities and Exchange Commission
(including the Company’s most recent Annual Report on Form 10-K, as
amended from time to time, and subsequent Quarterly Reports on Form
10-Q and Current Reports on Form 8-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 press release. We
undertake no obligation to update them in light of new information
or future events.
_____________________________ 1 Sievert CE, et al. 2016.
Respiratory Therapy, 11(4), 34–38. 2King PT et al. COPD.
2005;2(1):27-34. 3Alzeer AH et al. BMC Pulm Med. 2007; 7:17. 4Seitz
AE et al. Chest. 2012; 142(2), 432–439 5 Henkle E, et al. Chest.
2018;154(6), 1311–1320.
EM00639.2022-11
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version on businesswire.com: https://www.businesswire.com/news/home/20221130005036/en/
Brad Nagel, Chief Financial Officer (952) 758-9299
investorrelations@electromed.com
Mike Cavanaugh, Investor Relations ICR Westwicke (617) 877-9641
mike.cavanaugh@westwicke.com
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