Tivic Announces Successful Recertification of ISO 13485 Quality Management System and the European Medical Device CE-Mark

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02/23/2023 - 09:00 AM EST

SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today announced it has received recertification of ISO 13485, the international standard for medical device quality systems. The company also announced the recertification of ClearUP under the European Union Medical Device Certificate (CE-Mark).

"These recertifications support our goals to grow the product pipeline in bioelectronic medicine and expand market access,” said Jennifer Ernst, CEO of Tivic. “Congratulations to the team for successfully achieving these recertifications.”

ISO 13485 is an international standard for quality management systems (QMS) and applies to medical device companies involved in designing, manufacturing, and commercializing medical device products. ISO 13485 has been harmonized as a basis for the implementation of quality management methods into government regulations on medical devices in countries around the world, including the European Union.

About Tivic

Tivic is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and certain other related conditions. For more information visit https://tivichealth.com @TivicHealth.

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Given the existence of risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of certain risks and uncertainties, and other important factors, relevant to the company, any of which could cause Tivic’s actual results to differ from those contained in the forward-looking statements, see Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022, under the heading “Risk Factors”; its Registration Statement on S-1, filed with the SEC on October 26, 2022, and amendments thereto under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.