Valion Bio, Inc 8-K, filed Apr 11, 2023
Valion Bio, Inc. (VBIO)
About this 8-K
Valion Bio, Inc filed this 8-K on April 11, 2023.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On April 11, 2023, Tivic Health Systems, Inc. (the “Company”) issued a press announcing that it has filed its first patent in Vagus Nerve Stimulation with the U.S. Patent Office. A copy of that press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference
The information set forth under Item 7.01 of this Current Report on Form 8-K (this “Current Report”), including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.
Forward-Looking Statements
This Current Report, including Exhibit 99.1 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Current Report, including Exhibit 99.1 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission, reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Securities and Exchange Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
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Exhibits. |
Exhibit No. |
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Description |
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99.1 104 |
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Press Release, dated April 11, 2023. Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Tivic Health Systems, Inc. |
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April 11, 2023 |
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/s/ Jennifer Ernst |
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Name: Jennifer Ernst |
Exhibit 99.1
PRESS RELEASE
Tivic Expands Bioelectronic Portfolio;
Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation
SAN FRANCISCO – April 11, 2023 – Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today announced that it has filed its first patent in Vagus Nerve Stimulation with the U.S. Patent Office (USPTO), expanding its intellectual property portfolio into new clinical targets.
Tivic’s prior patents and current products have focused on the trigeminal and sympathetic nerve structures. The company’s new filing addresses a novel approach on the state of the art for non-invasive Vagus Nerve Stimulation (nVNS). It includes a novel circuit design for more precise targeting of the signals carried by the vagus nerve, with the potential to offer superior efficacy to alternative nVNS approaches.
Vagus nerve stimulation is of high interest in medicine due to its therapeutic and commercial promise. Originating from the human brainstem, the vagus nerve connects the brain to many vital organs, including the heart, lungs, and immune system organs such as the spleen. The vagus nerve is responsible for the regulation of organ function, carrying sensory information, controlling muscles, and influencing the immune system. Vagus nerve stimulation has been proven effective for conditions including treatment-resistant depression, epilepsy, and migraine.
“Non-invasive stimulation with precision targeting of the vagus nerve is directly in support of our strategic goals to expand our proprietary footprint in bioelectronic medicine,” said Jennifer Ernst, CEO of Tivic. “This patent could advance the field of bioelectronic medicine with a more precise approach to the treatment of cardiovascular, neurological/psychiatric, and systemic inflammatory chronic health conditions without surgery, implants, or pharmaceuticals.”
Tivic currently has five issued U.S. patents, 96 claims, and 20 pending patents in the U.S. and abroad.
Its first commercial product, ClearUP, is an over the counter bioelectronic device that is FDA approved for the treatment of symptoms of inflammation such as sinus pain and congestion. Tivic has proven its ability to innovate by combining science and technology with its expertise in neuroimmunology, medical device product development, and regulatory affairs. This patent filing is Tivic’s first step towards targeting life-threatening or irreversibly debilitating human diseases or conditions that have high costs and could benefit from more effective, patient-centric therapeutic solutions.
Read more about the Function and Benefits of Stimulating the Vagus Nerve here.
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 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: the issuance of the new patent by the USPTO; clinical trial results; FDA approval of any product developed based on the filed patent; 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:
Kayleigh Westerfield
949-632-3439
Kayleigh.Westerfield@tivichealth.com
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com