- Regenerative medicine company AVITA Medical (AVH) has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food and Drug Administration (FDA) to investigate the RECELL System for the treatment of vitiligo
- Vitiligo is a disease that results in a loss of colour or pigmentation in patches of skin and affects roughly 6.5 million people in the U.S.
- CEO Dr Mike Perry says the IDE is an important milestone for the company as it looks to advance RECELL
- RECELL is an alternative and new way to treat burns and reduces the reliance on donors
- Avita is down 2.55 per cent with shares trading for 47.8 cents each
AVITA Medical (AVH) has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food and Drug Administration (FDA) to investigate the RECELL System for the treatment of vitiligo.
Vitiligo is a disease that results in a loss of colour or pigmentation in patches of skin and affects approximately 6.5 million people in the United States. There is currently no cure or a method of limiting the spread of the disease.
The RECELL System is used to prepare Spray-On-Skin Cells using samples from the patients own skin. This provides a new way to treat burns and reduces the need for donors.
Chief Technology Officer Andrew Quick is looking forward to advancing the RECELL System to clinically treat vitiligo.
“The data from the pivotal trial will form the basis of the FDA submission for consideration to expand the use of the RECELL System for repigmentation of depigmented lesions associated with stable vitiligo,” he explained.
CEO Dr Mike Perry says the IDE is an important milestone for the company.
“Globally, the RECELL System is approved for additional skin applications, including vitiligo, which is supported by a substantive body of clinical evidence with patients internationally and in peer-reviewed publications, providing us with valuable experience and confidence in pursuing expanded labelling in the U.S.,” he said.
Avita is down 2.55 per cent and currently selling shares for 47.8 cents each at 3:41 pm AEST.