Item 4.01. Changes in Registrant’s Certifying Accountant.
(a) On August 2, 2016, the Audit Committee of the Board of Directors
(the “Audit Committee”) of Medgenics, Inc. (the “Company”) approved the dismissal of Kost Forer Gabbay
& Kasierer (“E&Y Israel”), with its principal office in Tel Aviv, Israel, as the independent registered public
accounting firm of the Company effective August 4, 2016. The Company felt it will be appropriate to change from E&Y Israel,
the Israel member firm of Ernst & Young Global Limited (“E&Y Global”) that has traditionally serviced the Company,
to E&Y Global’s U.S. member firm, Ernst & Young LLP (“E&Y LLP”), in connection with the scale-up
of the Company’s U.S.-based research and development operations.
The reports of E&Y Israel on the Company’s consolidated
financial statements for the fiscal years ended December 31, 2015 and 2014 did not contain any adverse opinions or disclaimers
of opinion, and were not qualified or modified as to uncertainty, audit scope or accounting principles.
During the fiscal years ended December 31, 2015 and 2014 and
through the date of this Form 8-K, the Company had no disagreements with E&Y Israel on any matter of accounting principles
or practices, financial statement disclosure or auditing scope or procedure which if not resolved to the satisfaction of E&Y
Israel, would have caused E&Y Israel to make reference to the subject matter in its reports on the Company’s consolidated
financial statements for such periods.
The Company provided E&Y Israel with a copy of this Current
Report on Form 8-K and requested from E&Y Israel a letter addressed to the U.S. Securities and Exchange Commission indicating
whether or not it agrees with the above statements. A copy of E&Y Israel’s letter dated August 4, 2016 is attached as
Exhibit 16.1 to this Current Report on Form 8-K.
(b) On August 2, 2016, the Audit Committee approved the engagement
of E&Y LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2016, effective August
4, 2016.
During the Company’s two most recent fiscal years and
through the date of its engagement of E&Y LLP, neither the Company nor anyone on its behalf consulted with E&Y LLP regarding
either (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit
opinion that might be rendered with respect to its financial statements, and no written report or oral advice was provided to the
Company by E&Y LLP that was an important factor considered by the Company in reaching a decision as to any accounting, auditing
or financial reporting issue; or (ii) any matter that was the subject of a disagreement (as that term is defined in Item 304(a)(1)(iv)
of Regulation S-K promulgated under the Securities Act of 1933, as amended, and the related instructions) or a reportable event
(as that term is defined in Item 304(a)(1)(v) of Regulation S-K) relating to the Company.