Vyome Holdings (HIND) details VT-1953 market, forecast and valuation in 8-K

Rhea-AI Filing Summary

Vyome Holdings, Inc. furnished an investor presentation and a related product assessment report about VT-1953, its lead clinical candidate for treating symptoms of malignant fungating wounds. These materials are provided as Exhibit 99.1 under Regulation FD and are not deemed filed for liability purposes.

The company also reported that it issued a press release on January 27, 2026, summarizing key findings from an independent U.S. market assessment, commercial forecast, and valuation analysis for VT-1953, which is attached as Exhibit 99.2. Both exhibits are incorporated by reference and include forward-looking statements about business strategy, capital needs, market potential, and future operating results.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 28, 2026

VYOME HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware		1-37897		26-1828101
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

Harvard Square, One Mifflin Place, Suite 400 Cambridge, MA		02138
(Address of principal executive offices)		(Zip Code)

(949) 429-6680

(Registrant’s telephone number, including area code)

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Class		Trading Symbol		Name of Exchange on which Registered
Common stock, $0.001 par value per share		HIND		The Nasdaq Capital Market

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.

Representatives of Vyome Holdings, Inc. (the “Company”) intend to make presentations at investor conferences and in other forums, and these presentations may include the information contained in Exhibit 99.1 attached to this Current Report on Form 8-K. A copy of the presentation materials containing such information that may be disclosed by the Company is attached as Exhibit 99.1 to this report, and the information set forth therein is incorporated herein by reference and constitutes a part of this report.

The Company is furnishing the information contained in Exhibit 99.1 pursuant to Regulation FD and Item 7.01 of Form 8-K promulgated by the Securities and Exchange Commission (“SEC”). This information shall not be deemed to be “filed” with the SEC for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

The information contained in Exhibit 99.1 is summary information that is intended to be considered in the context of the Company’s SEC filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in Exhibit 99.1, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. By filing this report and furnishing this information, the Company makes no admission as to the materiality of any information contained in this report, including Exhibit 99.1.

Forward-Looking Statements

Certain statements made in this filing are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “target,” “believe,” “expect,” “will,” “shall,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” “forecast,” “intend,” “plan,” “project,” “outlook”, and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements, include, but are not limited to, statements contained in this press release relating to the Company’s business strategy, the Company’s future operating results and liquidity and capital resources outlook, the successful Phase 3 completion and anticipated expenses relating to the same, the total addressable pharmacologic market in the United States for malignant fungating wounds, and the estimated peak annual net sales for VT-1953. Forward-looking statements are based on the Company’s current expectations and assumptions regarding the Company’s business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company’s actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. The Company cautions you, therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, the Company’s ability to raise capital to fund continuing operations; our ability to protect the Company’s intellectual property rights; the impact of any infringement actions or other litigation brought against the Company; competition from other providers and products; the Company’s ability to develop and commercialize products and services, including VT-1953; changes in government regulation; the Company’s ability to complete capital raising transactions; and other factors relating to the Company’s industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events that could cause the Company’s actual results to differ may emerge from time to time, and it is not possible for the Company to predict all of them. the Company cannot guarantee future results, levels of activity, performance, or achievements. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.  

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Item 8.01 Other Events.

On January 27, 2026, the Company issued a press release announcing key findings from an independent U.S. market assessment, commercial forecast, and valuation analysis of VT-1953, the Company’s lead clinical candidate for the treatment of symptoms of malignant fungating wounds (MFW). A copy of the press release is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K, and the information set forth therein is incorporated herein by reference and constitutes a part of this report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Product Assessment and Valuation Report (furnished herewith)
99.2		Press Release issued January 27, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	RESHAPE LIFESCIENCES INC.
	By:	/s/ Venkat Nelabhotla
		Venkat Nelabhotla
		President & Chief Executive Officer

Dated: January 28, 2026

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FAQ

What did Vyome Holdings (HIND) disclose in its latest 8-K filing?

Vyome Holdings disclosed that it is furnishing an investor presentation and product assessment report for VT-1953 as Exhibit 99.1, and a press release summarizing an independent U.S. market assessment and valuation analysis for VT-1953 as Exhibit 99.2, both incorporated by reference into the report.

What is VT-1953 in Vyome Holdings (HIND) January 2026 8-K?

VT-1953 is described as Vyome Holdings’ lead clinical candidate for treating symptoms of malignant fungating wounds. The 8-K notes an independent U.S. market assessment, commercial forecast, and valuation analysis of VT-1953, with key findings discussed in a January 27, 2026 press release attached as Exhibit 99.2.

How is Vyome Holdings (HIND) using Exhibit 99.1 in this 8-K?

Exhibit 99.1 contains presentation materials that Vyome Holdings representatives may use at investor conferences and other forums. The company furnishes this information under Regulation FD and specifies that it is not deemed filed or subject to Section 18 liability, except if later specifically incorporated by reference.

What forward-looking topics does Vyome Holdings (HIND) highlight?

The filing’s forward-looking statements address business strategy, future operating results, liquidity and capital resources, successful Phase 3 completion and related expenses, the total addressable U.S. pharmacologic market for malignant fungating wounds, and estimated peak annual net sales for VT-1953, all subject to significant risks and uncertainties.

What risks and uncertainties does Vyome Holdings (HIND) mention?

The company cites risks including its ability to raise capital, protect intellectual property, handle infringement or other litigation, face competition, develop and commercialize products such as VT-1953, respond to regulatory changes, and complete capital raising transactions, noting actual results may differ materially from forward-looking statements.

Are Vyome Holdings (HIND) exhibits 99.1 and 99.2 considered filed with the SEC?

The company states Exhibit 99.1 is furnished under Regulation FD and is not deemed filed or subject to Section 18 liabilities, nor automatically incorporated into other filings. Exhibit 99.2, a press release dated January 27, 2026, is attached and incorporated by reference into this specific report.