- Commercial revenue increased approximately 5.8% to $11.1 million compared to the same period in 2023
- Gross profit margin of 86.4%
- Launched PermeaDerm, a co-branded biosynthetic wound matrix, in the U.S. on March 23, 2024
Future Milestones
- RECELL GO, a device which provides consistent disaggregation of skin to produce RECELL Spray-On Skin Cells, is currently undergoing a 180-day interactive review by the U.S. Food and Drug Administration under the Breakthrough Devices Program; the 180-day period will end on May 30, 2024
- Plan to submit a PMA supplement for RECELL GO mini, which is designed to address smaller wounds. This submission will fall under the Breakthrough Device designation, which has been granted to RECELL for burns, RECELL for full-thickness skin defects, RECELL for repigmentation of stable depigmented vitiligo lesions, and RECELL GO
- Expect to submit both our post-market study (TONE) treating patients with stable vitiligo, and separate health economics study for publication by year-end
Financial Guidance
- Commercial revenue for the second quarter 2024 is expected to be in the range of $14.3 to $15.3 million
- Commercial revenue for the full-year 2024 is expected to be in the lower end of our previously provided guidance range of $78.5 to $84.5 million, reflecting growth of approximately 57% at the lower end of the range over the full-year 2023
- Expect to achieve previously given guidance of cashflow break even and GAAP profitability no later than the third quarter of 2025
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