InspireMD, Inc. (NASDAQ:NSPR) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET

Company Participants

Chuck Padala - IR, LifeSci Advisors

Marvin Slosman - CEO

Craig Shore - CFO

Conference Call Participants

Benjamin Haynor - Alliance Global Partners

Operator

Good morning, and welcome to the InspireMD Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to Chuck Padala with LifeSci Advisors. Thank you. You may begin.

Chuck Padala

Thank you, operator, and good morning, everyone. Thank you for joining us for the InspireMD fourth quarter and full year 2022 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and Craig Shore, Chief Financial Officer.

During this call, management will be making forward-looking statements, not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. They involve risks and uncertainties that may cause actual results to differ materially from those expressed in the forward-looking statements. For more information about these risks, please refer to the risk factor described in InspireMD's most recently filed periodic reports on Form 10-K and 10-Q filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. The call contains time-sensitive information that is accurate only as of today, March 30, 2023. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

It is now my pleasure to turn the call over to Marvin Slosman, CEO of InspireMD. Please go ahead, Marvin.

Marvin Slosman

Thank you, Chuck. And thanks to everyone for joining the call. I want to start this morning with a regulatory note as our revenue results for the fourth quarter were impacted by the cessation of CGuard shipments due to a temporary expiration of our CE Mark on November 12, 2022. This was due to well-documented significant delays by the European regulatory bodies in the processing of applications and audits under the new Medical Device Regulation, or MDR, recertification process.

By way of background, the MDR replaced the Medical Device Directive, or MDD, which had historically governed the approval and marketing of medical devices in the EU until May 2021. The MDR deadline for transition to updated certification has taken more than three years with multiple revisions, delays and requirement changes, putting the entire medical device industry serving the EU markets at risk.