The company said yesterday that it is creating grafts with its Epicel skin replacement product for newborn Ja’bari Gray, who has been in intensive care since being born earlier this year with skin only on his head, according to the report.
Doctors are still unsure as to what is causing Gray’s condition, according to the BBJ, having previously diagnosed the child with epidermolysis bulls, a rare genetic condition that causes the skin to be fragile and blister easily. That diagnosis was later rejected after genetic tests came back negative, according to the report.
The Epicel product, intended for use in treating burns, uses a patient’s own cells to grow dozens of permanent replacement skin grafts over two to three weeks, according to the report. The company is adapting the Epicel product for Gray, and said that it is not frequently used for off-label cases.
Off-label uses of the Epicel product are so rare that Vericel said it hasn’t collected any data on long-term outcomes, according to the BBJ. Chief medical officer Jon Hopper offered that despite the limited info, there have been no negative safety outcomes, with a 90% survival rate among patients who received the grafts.
The company still plans on focusing on Epicel’s ability to treat serious burns, according to the report, and said it is not actively seeking to expand its label to include cases like Gray’s.
Last week, Vericel said that it inked an exclusive U.S. licensing and supply agreement with MediWound (NSDQ:MDWD) for its NexoBrid biological product, and reported first quarter earnings that missed expectations on Wall Street.
DeviceTalks Minnesota's leadership track is designed to provide attendees with insights on topics such as:
Use code SAVE15 to save 15%!