Business
Elutia Reports Fourth Quarter and Full Year 2023 Financial Results: Anticipates CanGarooRM® Clearance Decision in First Half of 2024
SILVER SPRING, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”) today provided a business update and reported
About this update from Elutia, Inc.
[{"type":"text","content":"SILVER SPRING, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”) today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023. Business Highlights: Achieved strong annual revenue growth for both proprietary product lines, with sales increasing for SimpliDerm by 38% and CanGaroo by 3.4%.Submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA” or “Agency”) for CanGarooRM, Elutia’s next-generation drug-eluting biomatrix product.FDA review and interaction for CanGarooRM has resulted in no requests for additional data to date. The Company remains on track for a clearance decision in the first half of 2024.Successfully closed the divestiture of the orthobiologics business, generating gross cash proceeds of $14.6 million.Established a Strategic Advisory Committee of industry experts to prepare for commercial launch of CanGarooRM. \"After years of pioneering development, we are on the verge of introducing the drug-eluting biomatrix that promises to remove compromise from patient care,\" stated Dr. Randy Mills, Elutia’s Chief Executive Officer. \"In 2023, we completed the groundwork for our flagship product, CanGarooRM, resulting in a high-quality submission to FDA. Since then, our interactions with the Agency have been positive, and we look forward to a clearance decision in the first half of this year.\" Dr. Mills continued, \"I’d like to thank our dedicated commercial and operational teams, who, throughout this process, have stayed laser-focused, delivering robust sales figures across our SimpliDerm and CanGaroo product lines. They are now focused on a coordinated and disciplined product rollout of CanGarooRM, ensuring its full potential is realized.\" CanGarooRM Update In December 2023, Elutia submitted a 510(k) premarket notification to the FDA for CanGarooRM following a successful pre-submission meeting with the FDA. The Company is in ongoing discussions with FDA regarding the submission. To date, clarification requests from the Agency have been limited to items within the new submission, and no additional data has been requested. Elutia expects the FDA's clearance decision in the first half of 2024 and is preparing for commercial launch. CanGarooRM is uniquely positioned for success in the d...