Helius Medical (NASDAQ: HSDT) advances 510(k) stroke filing and sets large one-time executive bonuses
Rhea-AI Filing Summary
Helius Medical Technologies reported new executive compensation arrangements and a key regulatory step for its neuromodulation device. The company entered into side letter agreements with President and CEO Dane C. Andreeff and CFO Jeffrey S. Mathiesen, granting one-time discretionary cash bonuses of $890,000 and $610,000, respectively. These cash bonuses will be offset dollar-for-dollar against any future severance, bonus, equity, retirement or other benefits the executives might otherwise receive under company plans or their employment agreements.
In return, both executives agreed that offerings completed on September 18, 2025 do not count as a change in control or trigger a good reason event under their employment agreements. Separately, Helius announced it has filed a U.S. FDA 510(k) submission seeking to expand the label for its Portable Neuromodulation Stimulator device to include gait and balance deficit in patients with chronic stroke symptoms, using data from its Stroke Registrational Program under its existing Breakthrough Device Designation.
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Insights
Helius links sizable one-time executive bonuses to future offsets while advancing a 510(k) stroke label expansion filing.
The company granted one-time cash bonuses of $890,000 to its CEO and $610,000 to its CFO via side letters. A key structural feature is that these amounts will offset any severance, bonus, equity, retirement or other cash benefits otherwise payable, including change-in-control severance and COBRA subsidies, on a dollar-for-dollar basis. That design can cap incremental cash outflows if termination or change-in-control scenarios occur.
In exchange, both executives agreed that offerings consummated on September 18, 2025 do not constitute a change in control or give rise to good reason under their employment agreements. This removes a potential trigger for enhanced severance tied to those financings. Separately, Helius has filed a U.S. FDA 510(k) submission to expand the PoNS device label for gait and balance deficit in chronic stroke, using data from its Stroke Registrational Program under its current Breakthrough Device Designation. The practical impact will depend on FDA’s review outcome and any future disclosures on clinical or commercial plans.
8-K Event Classification
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Item 5.02Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 24, 2025, Helius Medical Technologies, Inc. (the “Company”) entered into side letter agreements with Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer, Treasurer and Secretary (together, the “Side Letters”). The Side Letters provide for one-time discretionary cash bonuses paid to Mr. Andreeff and Mr. Mathiesen in amounts equal to $890,000 and $610,000, respectively (together, the “Cash Bonuses”). The Cash Bonuses will directly offset any severance, bonus opportunity, equity, retirement or other benefit under any plan or arrangement of the Company to which Mr. Andreeff and Mr. Mathiesen would otherwise be entitled.
In consideration of the payment of the Cash Bonuses, each of Mr. Andreeff and Mr. Mathiesen have agreed that the offerings consummated on September 18, 2025, as previously disclosed in the Company’s Current Report on Form 8-K filed on September 18, 2025, do not constitute a Change in Control (as defined Mr. Andreeff’s and Mr. Mathiesen’s employment agreements, as applicable (together, the “Employment Agreements”) or give rise to an event constituting Good Reason under the Employment Agreements. To the extent any amounts become due or claimed to be due to Mr. Andreeff or Mr. Mathiesen under the Employment Agreements or otherwise upon or following any termination of Mr. Andreeff’s or Mr. Mathiesen’s employment with the Company, including without limitation any severance, change-in-control severance, pro‑rata bonus, continued COBRA subsidies, or other cash amounts, such amount will be offset dollar-for-dollar against the Cash Bonuses, as applicable.
The foregoing description of the Side Letters does not purport to be complete and is qualified in its entirety by the terms and conditions of the Side Letters, which are attached hereto as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K (this “Report”) and are incorporated herein by reference.
Item 7.01Regulation FD Disclosure.
On September 25, 2025, the Company issued a press release announced the filing of its U.S. Food and Drug Administration (“FDA”) 510(k) submission for the Portable Neuromodulation Stimulator device label expansion seeking an indication for gait and balance deficit in patients with chronic stroke symptoms. The submission was made with data generated in the Company’s Stroke Registrational Program and was filed under its current FDA Breakthrough Device Designation.
A copy of the press release is furnished as Exhibit 99.1 to this Report and incorporated herein by reference.
Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the press release is as inactive textual references only.
Exhibit 99.1 hereto contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
The information in this Report, including Exhibit 99.1 hereto, is furnished pursuant to Item 7.01 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 that Section, nor shall it be deemed 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
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filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
| Description |
10.1 | Side Letter, dated as of September 24,2025, between the Company and Dane C. Andreeff. | |
10.2 | Side Letter, dated as of September 24,2025, between the Company and Jeffrey S. Mathiesen. | |
99.1 | Press Release, dated September 25, 2025. | |
104 | Cover Page Interactive Data File (embedded within Inline XBRL document). |
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SIGNATURE
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.
| HELIUS MEDICAL TECHNOLOGIES, INC. | ||
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Dated: September 25, 2025 |
| By: | /s/ Jeffrey S. Mathiesen |
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| Jeffrey S. Mathiesen |
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| Chief Financial Officer, Treasurer and Secretary |
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