Item 4.01 Changes in Registrant's
Certifying Accountant.
On September 7,
2017, Calmare Therapeutics Incorporated (the “Company”), upon the approval of the Audit Committee (the “Committee”)
of the Board of Directors of the Company, notified Mayer Hoffman McCann CPAs, the New York Practice of Mayer Hoffman McCann P.C.
(“Mayer Hoffman”), the Company’s current independent registered public accounting firm, that it would be dismissed
from that position effective immediately.
The audit reports
of Mayer Hoffman on the Company’s consolidated financial statements as of and for the years ended December 31, 2016 and 2015
did not contain any adverse opinion or disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope
or accounting principles. During the Company’s two most recent fiscal years ended December 31, 2016 and December 31, 2015,
and in the subsequent interim period through September 7, 2017, there were no (1) disagreements with Mayer Hoffman on any matter
of accounting principles or practices, financial statement disclosures, or auditing scope or procedures, which disagreements, if
not resolved to the satisfaction of Mayer Hoffman, would have caused Mayer Hoffman to make reference to the subject matter of the
disagreements in connection with its reports; and (2) events of the type listed in paragraphs (A) through (D) of Item 304(a)(1)(v)
of Regulation S-K, except for the material weaknesses reported in the Company’s Annual Report on Form 10-K for the period
ended December 31, 2016.
Mayer Hoffman’s
report of the consolidated financial statements as of and for the years ended December 31, 2016 and 2015, contained a separate
paragraph stating “[as] more fully described in Note 1, the Company has incurred operating losses since fiscal year 2006
and has a working capital and shareholders’ deficit at December 31, 2016. These conditions raise substantial doubt about
the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described
in Note 1. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability
and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.”
The Company provided
Mayer Hoffman with a copy of this Current Report on Form 8-K prior to its filing with the Securities and Exchange Commission (“SEC”)
and requested that Mayer Hoffman furnish the Company with a letter addressed to the SEC stating whether or not Mayer Hoffman agrees
with the above statements. The letter from Mayer Hoffman is filed with this Current Report on Form 8-K as exhibit 16.1.
On September 13,
2017, the Company, upon the approval of the Committee, appointed BDO USA, LLP (“BDO”) as its new independent registered
public accounting firm to audit the Company’s financial statements for the year ending December 31, 2017.
During the Company's
fiscal years ended December 31, 2016 and 2015 and the subsequent interim period through September 13, 2017, neither the Company
nor anyone on its behalf has consulted with BDO regarding (i) the application of accounting principles to a specific transaction,
either completed or proposed or (ii) the type of audit opinion that might be rendered on the Company's financial statements and,
neither a written report nor oral advice was provided to the Company that BDO concluded was an important factor considered by the
Company in reaching a decision as to accounting, auditing or financial reporting issues, or (iii) any matter that was the subject
of a disagreement (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions), or (iv) any “reportable
event” (as described in Item 304(a)(1)(v) of Regulation S-K).