MIMEDX Provides Update on AXIOFILL Request for Designation (“RFD”) from FDA - Seite 2

Mr. Capper continued, “We have been working diligently to mitigate the impact of any potential disruption related to AXIOFILL, including through our recent acquisition of exclusive rights to a bovine-derived collagen particulate from Regenity Biosciences. With the introduction of this new product later in the year and with our efforts to keep AXIOFILL on the market long-term, we look forward to continuing to address a variety of patient care needs with our best-in-class portfolio of healing solutions. Finally, we do not currently anticipate the ongoing matter related to AXIOFILL will require us to change our full year 2024 financial guidance, which we issued on our February 28, 2024 earnings conference call.”

Important Cautionary Statement

This press release includes forward-looking statements. Statements regarding: (i) future sales or sales growth; (ii) our 2024 financial guidance issued on February 28, 2024; (iii) the impact of the FDA’s determination letter and our lawsuit against the FDA on our 2024 financial goals and expectations for future financial results; and (iv) our ability to classify AXIOFILL as a HCT/P under Section 361 and the legal and regulatory options available to us regarding such classification. Additional forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," “goal,” “outlook,” "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations.  Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment and many other factors; (ii) the Company may change its plans due to unforeseen circumstances; (iii) the results of scientific research are uncertain and may have little or no value; (iv) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (v) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (vi) we may alter the timing and amount of planned expenditures for research and development based on regulatory developments. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.