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SAN FRANCISCO – (Business Wire) – March 19, 2024 Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced that it will report its year-end financial results for 2023 via pre-recorded conference call and webcast on Monday, March 25, 2024 at 1:30 PM PT / 4:30 PM ET.

Teleconference Details:

Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 434944

Webcast Link

https://www.webcaster4.com/Webcast/Page/2865/50026

About Tivic

Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors.  For more information visit http://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, many of which are out of Tivic’s control. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of relevant risks and uncertainties, and other important factors, 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, 2022, filed with the SEC on March 31, 2023, 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.

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com ...Read More

SAN FRANCISCO –  February 21, 2024 Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today that enrollment in its pilot clinical study of a proprietary approach to non-invasive vagus nerve stimulation (VNS) has been completed.

VNS is a growing market that is part of the $8.3B global neurostimulation market, which has a projected CAGR of 12.2%, according to Global Market Insights. Implanted VNS is currently used in the treatment of various neurologic and psychiatric disorders and is being tested in systemic inflammatory diseases. Tivic is testing a proprietary approach to more precisely influence vagus nerve signals, while enhancing effectiveness and safety with a non-invasive treatment.

The pilot study utilized a new neurostimulation approach with 20 individuals during which the data collection and analysis were performed by researchers at The Feinstein Institutes for Medical Research. This work aims to provide more precise targeting strategies for VNS and more control over the types of physiologic effects that result from stimulation.

“With study enrollment completed less than six months from initiation, we are looking forward to receiving and analyzing the final study results. This is one of the studies underway to expand Tivic’s non-invasive bioelectronic portfolio to new clinical uses beyond our existing product line,” said Jennifer Ernst, CEO at Tivic.

Previously, the company has announced:

  • April 2023: Tivic, The Feinstein Institutes for Medical Research Announce Pilot Study to Test Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
  • April 2023: Tivic Expands Bioelectronic Portfolio:  Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation
  • April 2023: Tivic Health Expands Clinical Study of Post-Operative Pain in Nasal and Sinus Surgeries
  • August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation

About Tivic

Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://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, including, without limitation: final results of the study, once commenced;  market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, 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, 2022, filed with the SEC on March 31, 2023, 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.

 

 

Media Contact:

Morgan Luke

Morgan.Luke@tivichealth.com

 

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com ...Read More

Articles

Tivic Health Announces Launch of New and Improved ClearUP 2.0

By Ryan Sabia

January 8, 2024

SAN FRANCISCO - Tivic Health® Systems, Inc. ("Tivic") (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, announced today the launch of the second generation of Tivic ClearUP. The new and improved Tivic ClearUP 2.0, now with a new chip for power management for faster charge and longer battery life, is available starting today on TivicHealth.com.

ClearUP 2.0 is a clinically proven way to clear congestion and relieve sinus pain. It is an FDA-approved, 100% drug-free and non-addictive way to reduce sinus pain, pressure, sinus headaches, and congestion due to colds, flu, and allergies.

Based on clinical trials of ClearUP:

  • 88% of subjects see meaningful improvement in congestion symptoms

  • 74% experience pain relief on the first use

  • 82% prefer ClearUP to other sinus treatments

  • 10 minutes after treatment, patients reported relief of sinus pain

ClearUP provides an effective, non-invasive and drug-free alternative to over-the-counter medications, using gentle microcurrents to treat symptoms of sinus and nasal inflammation. The bioelectronic device locates treatment points along the cheek, nose and brow and emits gentle microcurrent stimulation for precise, targeted relief that you control. There is no mess, pills or sprays, and its ergonomic design fits in the palm of your hand so you can bring it everywhere you go and experience relief from sinus pain anytime, anywhere. The use of neuromodulation devices is growing throughout the medical industry, offering a new method of helping patients who do not respond to existing remedies.

About Tivic

Tivic Health Systems, Inc. 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, including, without limitation: unknown or unexpected defects with the new ClearUP 2.0 design; market and other conditions; supply chain constraints; macroeconomic factors; and unexpected costs, charges or expenses that reduce Tivic's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, 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, 2022, filed with the SEC on March 31, 2023, 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.

Max Borges Agency

Tivic@maxborgesagency.com

...Read More

Tivic Health to Report Third Quarter 2023 Financial Results on November 14th Via Conference Call and Webcast

By Ryan Sabia

November 7, 2023

SAN FRANCISCO -
Tivic Health® Systems, Inc. ("Tivic Health", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced that it will report financial results for the third quarter 2023 via pre-recorded conference call and webcast on Tuesday, November 14th, 2023 at 1:30 PM PT / 4:30 PM ET.

Teleconference Details:

Toll Free: 888-506-0062

International: 973-528-0011

Participant Access Code: 302318

Webcast Link

https://www.webcaster4.com/Webcast/Page/2865/49228

About Tivic

Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic's patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic's non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic's first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://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, many of which are out of Tivic's control. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of relevant risks and uncertainties, and other important factors, 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, 2022, filed with the SEC on March 31, 2023, 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.

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

...Read More

Tivic Health Announces Proposed Public Offering of Common Stock

By Ryan Sabia

July 14, 2023

SAN FRANCISCO -
Tivic Health® Systems, Inc. ("Tivic", "Company", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced that it intends to offer and sell shares of its common stock in a public offering. All of the shares of common stock are being offered by Tivic. Tivic intends to use the net proceeds of the offering, if any, for working capital and general corporate purposes. Consummation of the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Maxim Group LLC is acting as the sole placement agent, on a reasonable best efforts basis, for the offering.

A shelf registration statement on Form S-3 (File No. 333-269494) relating to the securities being offered was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 1, 2023, and became effective on February 8, 2023. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at syndicate@maximgrp.com. Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus, together with the information incorporated by reference therein, for more complete information about Tivic and the proposed offering. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Tivic

Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic's patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic's non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic's first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://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, including, without limitation: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering; the company's financial condition; the company's ability to raise additional capital, if and when necessary; clinical trial results for the company's product candidates; market, economic and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, 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, 2022, filed with the SEC on March 31, 2023, 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.

Media Contact

Kayleigh Westerfield

Kayleigh.Westerfield@tivichealth.com

Investor Contact

Hanover International, Inc.

ir@tivichealth.com

...Read More

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

By Ryan Sabia

February 23, 2023

SAN FRANCISCO -
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.

Media Contact:

Kayleigh Westerfield

949-632-3439

Kayleigh.Westerfield@tivichealth.com

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

...Read More

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