Reading your comments on trauma, I'm assuming that you missed the following announcement:
https://ir.avitamedical.com/node/11611/pdf"U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the use of its RECELL® System to treat full-thickness skin defects.The expanded indication represents a broad label of full-thickness skin defects, such as wound injuries after traumatic avulsion (e.g., degloving), surgical excision (e.g., necrotizing soft tissue infection), or resection (e.g., skin cancer), thereby dramatically expanding the company’s market opportunity at least five times."and the following results from the clinical study:
Results
Demographics and baseline characteristics. Sixty-five patients with a mean age of 45.7years (range 15-85 years) from 18 clinical sites were enrolled in the study. Majority of subjects were male (44/65, 67.7%). Seventy one percent of subjects were White, 22% were African American and the remainder were American Indian or Alaska Native or other. The types of wound included acute and chronic wounds of necrotizing (35.4%) and other (9.2%)infections, open (16.9%) and closed (6.2%) degloving injuries, fasciotomy/compartment Syndrome (7.7%), surgical (7.7%), crush injury (4.6%), traumatic hematoma (3.1%), flap donor (3.1%), road rash (3.1%), gunshot wound (1.5%) and laceration wound (1.5%). The median size of RECELL-treated and the control-treated areas are 160 cm2 (ranged 80 to1155 cm2) and 156 cm2(ranged 80 to 1155 cm2), respectively, and the wounds are located at arms, legs, back, buttocks, and anterior-torso. The mean affected area was 5.0% (±3.9%)of total body surface area (TBSA).
Effectiveness. Non-inferiority of RECELL-treated areas compared to Control-treated areas in promoting wound closure was established based on the pre-specified non-inferiority margin of 10%. Among the 52 subjects in PP population, 34 (65%) subjects in RECELL group achieved complete wound closure by Week 8. Thirty (58%) subjects in control group achieved complete wound closure by Week 8. The treatment difference (Control minus RECELL) was -7%, with a one-sided 97.5% CI upper bound of 6.2%.
Superiority of RECELL compared to control was established on reduction in donor area requirement for harvesting (p<0.001), in ITT population. Treatment with RECELL required, on average, 27% less donor skin, compared to that required for autografting.Just like you, I'm also looking forward to seeing the full year revenues. They should be close to "Five Zero Million Dollars"
I'm looking forward to FY24 (guidance and actual) more though because JC has said that they're
“on pace next year to grow at a much higher rate”(than 2023 ~ 47% YoY growth).
The following is just me thinking out loud:
With the broad label approval of full-thickness skin defects, some chronic wounds treated in the clinical trial, RECELL is now a treatment option whenever a skin graft is required; it makes me wonder if the ulcer market could be coming back on the radar?
Fig. 1. Pie chart of the distribution of wound types in the United States Wound Registry published by Fife and Carter
(20min delay)