Business
Elutia Reports 26% Year-Over-Year Sales Growth of Proprietary Products and Strengthened Balance Sheet in Third Quarter 2023 Financial Results
- Anticipate 510(k) filing for transformational Drug-Eluting Biomatrix CanGarooRM in Fourth Quarter SILVER SPRING, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) --
About this update from Elutia, Inc.
[{"type":"text","content":"- Anticipate 510(k) filing for transformational Drug-Eluting Biomatrix CanGarooRM in Fourth Quarter SILVER SPRING, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering drug-eluting biomatrix products, today provided a business update and financial results for the third quarter ended September 30, 2023. Business Highlights: Successfully completed transformation to Elutia, establishing a high growth company dedicated to developing and marketing propriety drug eluting biomatrices.Achieved a significant 44% year-over-year increase in SimpliDerm® net sales and an 11% year-over-year growth in CanGaroo® net sales.Divested Orthobiologics business unit for initial gross proceeds of $15 million, and up to $35.0 million in total proceeds.Closed private placement financing, securing initial gross proceeds of approximately $10.5 million, and up to $26.2 million in total proceeds.Completed validation of an accelerated in-vitro elution assay for CanGarooRM and held productive pre-submission meeting with FDA, paving the way for 510(k) submission in 4Q23.Published case report in peer-reviewed journal Heart Rhythm Case Reports highlighting the benefits of bioenvelopes for reoperative procedures. “This quarter was transformational and I am pleased that Elutia is off to a great start,” said Dr. Randy Mills, President and Chief Executive Officer of Elutia. “Our commercial teams delivered outstanding results, growing our proprietary product lines, CanGaroo and SimpliDerm, by 26% year-over-year. We were particularly excited to see SimpliDerm sales accelerate during the quarter through our partnership with Sientra.” \"Looking ahead, we anticipate submitting our FDA 510(k) filing for CanGarooRM, the most advanced drug-eluting biomatrix product in our pipeline, before the end of 2023. Having completed the necessary validation studies, we recently held a productive pre-submission meeting with the FDA, setting a positive trajectory ahead of a decision in the first half of 2024. We believe CanGarooRM represents our greatest near-term opportunity as we seek to capture a significant share of the CIED envelope market estimated at $600 million,” remarked Dr. Mills. Dr. Mills concluded by commenting on recent financial moves, stating, “Lastly, we completed a private placement of stock and warrants and closed the dive...