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COMMITMENT AND CONTINGENCIES
6 Months Ended
Jun. 30, 2026
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENT AND CONTINGENCIES

NOTE 9 — COMMITMENT AND CONTINGENCIES

 

From time to time, the Company may be subject to legal proceedings and claims arising in the ordinary course of business. As of June 30, 2026, the Company was not a party to any material legal proceedings. The Company had no material loss contingencies requiring accrual or disclosure other than the commitments described below.

 

Insomnia FDA Study:

 

On April 17, 2026, the Company entered into a Scope of Work (“SOW”) with Lindus Health Limited (“Lindus Health”), pursuant to a previously executed Master Services Agreement (“MSA”), to provide clinical research organization services for the Company’s pivotal clinical trial of its HALO Clarity device (the “Pivotal Study”).

 

Under the SOW, the Company is obligated to make payments to Lindus Health upon the achievement of specified project milestones and for reimbursable pass-through expenses incurred in connection with the Pivotal Study. Direct fees under the SOW total approximately $945,000, exclusive of certain pass-through expenses. During the three and six months ended June 30, 2026 the company incurred approximately $353,000 and $374,000, respectively, under this SOW, including certain pass-through expenses.

 

The term of the SOW continues until completion of all services described therein, unless terminated earlier in accordance with the MSA. The SOW provides that certain changes to the Pivotal Study, such as addition of new clinical sites, increases in enrolled participants, protocol amendments after study start-up, amendments to critical analyses, extension of study duration, and requests for additional platform features or integrations, will require a change order, which may result in adjustments to the scope, budget, or timeline.

 

Subsequent to June 30, 2026, and prior to the issuance of these unaudited condensed consolidated financial statements, the Company entered into a novation agreement pursuant to which Curavit Clinical Research, Inc. assumed Lindus Health’s rights and obligations under the MSA and SOW. The novation did not materially modify the Company’s rights or obligations under the agreements.