Business
Elutia Announces First Quarter 2024 Results: SimpliDerm® Sales Increase 55%, CanGaroo®RM on Track for Second Quarter 2024 FDA Clearance
SILVER SPRING, Md., May 09, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a company pioneering drug-eluting biomatrix
About this update from Elutia, Inc.
[{"type":"text","content":"SILVER SPRING, Md., May 09, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a company pioneering drug-eluting biomatrix products, today provided a business update and financial results for the first quarter ended March 31, 2024. Business Highlights: Generated strong revenue growth for proprietary product lines in the first quarter of 2024, led by SimpliDerm net sales increasing 55% compared to the first quarter of 2023FDA interactions regarding CanGarooRM, Elutia’s antibiotic-eluting biologic envelope, continue to be positiveAddressing the final details for CanGarooRM clearance; anticipate FDA decision in the second quarter of 2024Preparing for launch of CanGarooRM in the second half of 2024 “We are progressing through the regulatory process for CanGarooRM with one goal: FDA clearance in the second quarter for the world’s first antibiotic-eluting biologic envelope,” stated Dr. Randy Mills, Elutia’s Chief Executive Officer. “The pacemaker and implantable defibrillator protection market is valued at $600 million and has only one legacy player offering a fully synthetic envelope. We aim to disrupt this space with our proprietary technology that is both antimicrobial and regenerative, thereby setting a new standard for excellence in patient outcomes.” Dr. Mills continued, “Our Women’s Health team is successfully executing a similar strategy with SimpliDerm, achieving robust sales growth of 55%. This sharp sales increase spotlights the crucial role SimpliDerm plays in supporting a woman’s recovery following mastectomy. I offer my sincere thanks to the entire Elutia CRU for delivering another spectacular quarter.” CanGarooRM Update Following the successful submission of the 510(k) premarket notification to the FDA in December 2023, Elutia has been in positive, ongoing discussions with the Agency and expects to close out any remaining inquiries within the month. As a result, the Company anticipates a positive FDA decision by the end of June 2024. With only one competitor in the $600 million pacemaker and implantable defibrillator protection market, CanGarooRM represents immense potential in the drug-eluting market. In anticipation of the pending regulatory clearance, Elutia continues to fortify its operational and commercial strength and expects to initiate manufacturing and commercial introduction of C...