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Electromed, Inc. Announces U.S. Food and Drug Administration 510(k) Clearance of Fifth Generation HFCWO Airway Clearance Generator

NEW PRAGUE, Minn., November 30, 2022--(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.

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.


View source version on businesswire.com: https://www.businesswire.com/news/home/20221130005036/en/


Brad Nagel, Chief Financial Officer
(952) 758-9299

Mike Cavanaugh, Investor Relations
ICR Westwicke
(617) 877-9641