Company to Share Probability Values from its Knee Osteoarthritis (KOA) Study; Analyses Conducted Support Confidence in Initiation of Confirmatory Phase 3 Trials in 2022
Commercial Business Strategy Demonstrates Sustainable Double-digit Growth Potential in Multiple Underpenetrated Markets
MIMEDX Increases 2021 Adjusted Net Sales Outlook to between
LINK: Virtual Investor Day Begins at
Key Insights to Be Shared at
KOA Clinical Program
- Additional analyses from and next steps for the KOA clinical program
- Third-party biostatisticians validated the statistically significant and clinically meaningful improvement in
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain at three and six months, respectively (p=0.032 and p=0.009), WOMAC Function (p=0.046 and p=0.009), and WOMAC Total (p=0.038 and p=0.008) for the Pre-Interim Analysis Cohort of 190 patients. - Root-cause analysis has determined that the potency of the investigational product faded as it aged, which resulted in the study’s failure to meet its primary endpoints. An intense examination of study results identified this factor as the primary difference in clinical responses observed between the Pre-Interim Analysis Cohort of 190 patients and the Post-Interim Analysis Cohort of 256 patients.
MIMEDX proprietary biochemical and biological tests detected this reduced potency, related to age of the investigational product used in the Phase 2B KOA study. The Company is confident in its manufacturing processes and proprietary tissue engineering know-how and has a clear path forward.
- Third-party biostatisticians validated the statistically significant and clinically meaningful improvement in
- Based on the clinically meaningful and statistically significant data from the Pre-Interim Analysis Cohort of 190 patients in the Phase 2B trial, published retrospective data, extensive real-world clinical use, and ongoing scientific mechanism of action research, the Company believes that future planned KOA trials have an increased probability of success, benefitted by the learnings gained from the exploratory Phase 2B KOA clinical trial.
- Commencing in 2022,
MIMEDX expects to initiate Phase 3 trials for its KOA candidate, with a Biologics License Application (BLA) filing anticipated in late 2025, and will work closely with theU.S. Food & Drug Administration (FDA) in advancing these trials.
Robust Commercial Growth Potential
MIMEDX anticipates achieving sustainable growth of 11-14% across its vibrant commercial portfolio. This above-market growth rate comprises:- An increase in its Advanced Wound Care business, driven by broadened product access across multiple underpenetrated markets, along with commercial excellence initiatives.
- An increase in its Surgical Recovery business, driven by market development, product innovation and increased clinical and economic evidence.
- An increase in its international markets, driven in part by its Japanese commercial strategy.
- The Company also has a robust near-term product pipeline, with two new product launches anticipated in the first half of 2022.
Outlook for 2021
The Company now expects that adjusted net sales for fiscal year 2021 will be between
Investor Day speakers and topics include:
Company Updates
Timothy R. Wright , Chief Executive Officer,MIMEDX Peter M. Carlson , EVP, Chief Financial Officer,MIMEDX
Musculoskeletal Pipeline
KOA Key Findings & Path Forward
Robert B. Stein , M.D., Ph.D., EVP, Research and Development,MIMEDX Michelle Massee , AVP, Product Development,MIMEDX Thomas M. Mick , M.D., Medical Director, Clinical Development,MIMEDX Vibeke Strand , M.D.,Stanford University School of Medicine Kris J. Alden , M.D., Ph.D., Orthopaedic Surgeon, Hip, Knee & Shoulder Reconstruction
Commercial Business
Growth Strategy & Market Opportunity
Rohit Kashyap , Ph.D., EVP, Chief Commercial Officer,MIMEDX John Harper , Ph.D., SVP, Research & Product Development, Chief Technology Officer,MIMEDX William H. Tettelbach , M.D., Principal Medical Officer, Head of Medical Affairs,MIMEDX Bidhan B. Das , M.D., Colon, Rectal &General Surgeon Caroline Clarke , M.D., Plastic, Reconstructive & Cosmetic SurgeonJonathan Labovitz , D.P.M.,Western University of Health Sciences
Registration Details
A live webcast will be available on the Events page of the Investors section of the Company’s website at www.mimedx.com at the time of the event. To register for the webcast, participants must use access code ‘MDXG.’ Participants will have the opportunity to submit written questions to
Important Cautionary Statement
This press release includes forward-looking statements. Statements regarding: (i) future sales or sales growth; (ii) the status, timing, causes and expected results of the Company’s clinical trials and planned regulatory submissions, and our expectations regarding the timing of any trial or regulatory submission and eventual BLA approvals; (iii) the results of future scientific studies; and (iv) the effectiveness of amniotic tissue as a therapy for any particular indication or condition. 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, and many other factors; (ii) the status, timing, results and expected results of the Company’s clinical trials and planned regulatory submissions, and our expectations regarding our ability to potentially accelerate the timing of any trial or regulatory submission, depend on a number of factors including favorable trial results, patient access, and our ability to manufacture in accordance with Current Good Manufacturing Practices (CGMP) and appropriate chemistry and manufacturing controls; (iii) the Company may change its plans due to unforeseen circumstances, or delays in analyzing and auditing results, and may delay or alter the timeline for future trials, analyses, or public announcements; (iv) the results of scientific research are uncertain and may have little or no value; (v) 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; (vi) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (vii) we may alter the timing and amount of planned expenditures for research and development based on the results of clinical trials and other 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
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