Avita Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, announced today that the Food & Drug Administration (FDA) has approved a supplement to the Company’s Investigational Device Exemption for its ReCell® Autologous Cell Harvesting Device. The approved protocol for treatment of burn injuries has been simplified from the previously-approved Continued Access protocol and the number of approved investigational sites has increased from 8 to 15.
To date, treatment of patients with the ReCell® device under Continued Access was done according to a complex protocol requiring a randomized comparison between two distinct areas of burn injury, with one area treated using conventional skin grafts and one area treated with more expanded autografts applied in combination with Regenerative Epithelial Suspension (RES) from the ReCell® device. The newly approved protocol allows for the use of RES with expanded (meshed) autografts without requiring the randomized comparison to a conventional graft. This change makes the protocol more straightforward for burn teams and patients. Furthermore, the Continued Access protocol is complementary to the Compassionate Use protocol in that participants’ burn injuries can range from 5-50% of their total body surface area, whereas the Compassionate Use is limited to the most extensive of burn injuries.
“Based on what we have seen this product do, confirmed by the recent positive analysis of the study results, consenting a patient to have an area of their burn injury treated without ReCell purely for purposes of comparison causes concern from a medical perspective. The new Continued Access protocol, without a comparison, allows us to continue use of ReCell with more focus on what’s best for the patient,” said Dr James H Holmes IV, Medical Director of the Burn Center at Wake Forest Baptist Medical Center.
The Continued Access provision of the FDA’s Investigational Device Exemption (IDE) guidance allows doctors to access a medical device while the premarket approval (PMA) application is under review, if “there is a public need for the device,” and “there is preliminary evidence that the device is likely to be effective and no significant safety concern have been identified for the proposed indication.” The FDA’s principles on granting the Continued Access further state that “it could be contrary to public health to prevent access to potentially safe and effective new devices during an evaluation period.”
The PMA application for the ReCell® device was submitted September 27, 2017, and is currently under review by the FDA.
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