Business
AVITA Medical Reports Second Quarter Financial Results
VALENCIA, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on
About this update from Avita Medical, Inc.
[{"type":"text","content":"VALENCIA, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today reported financial results for the second quarter ended June 30, 2024. Financial Results and Recent Business Updates Commercial revenue of $15.1 million, an increase of approximately 29% compared to the same period in 2023Gross profit margin of 86.2%RECELL GO™ premarket approval (PMA) supplement approved by the FDA on May 29, 2024; first case completed on May 31, 2024Submitted PMA supplement for RECELL GO mini™, designed to address smaller wounds, on June 28, 2024; maintains Breakthrough Device designation ensuring a prioritized 180-day interactive review periodEntered into an exclusive development and distribution agreement with Regenity Biosciences (\"Regenity\") providing AVITA Medical with the commercialization rights to a unique collagen-based dermal matrix following 510(k) clearance “Our second-quarter commercial revenue reached a record $15.1 million, reflecting the effectiveness of our enhanced focus on commercial execution,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “The FDA approval of RECELL GO and our recent submission of RECELL GO mini highlight our progress in expanding treatment capabilities for burn and full-thickness skin defects. Additionally, our agreement with Regenity further enhances our ability to address a full spectrum of clinical needs. We remain committed to establishing RECELL as the standard of care for wound therapy while continuing to transform AVITA Medical into a broad-based wound care company, ultimately improving accessibility and reaching more patients.” Future Milestones Expect Regenity to receive 510(k) clearance for the dermal matrix in the fourth quarter of 2024; following clearance, AVITA Medical will begin to market, sell, and distributePlan to initiate multiple post-market clinical studies to establish the unique synergies between the new dermal matrix and RECELLAnticipate FDA approval of RECELL GO mini by December 27, 2024Expect to submit both our post-market study (TONE) treating patients with stable vitiligo and separate health care economics study for publication by year-end Financial Guidance Commercial revenue for the third quarter ...