Abiopharma

RenovaCare, Inc. is a development-stage biotechnology and medical device company focusing on the research, development and commercialization of autologous (using a patients own cells) cellular therapies that can be used for medical and aesthetic applications. The Company does not have any commercialized products. We are currently developing and testing the CellMist System which is a cell isolation procedure that enzymatically renders stem cells from the patients own skin or other tissues. The resulting stem cell suspension is administered topically with our SkinGun spray device as a cell therapy onto wounds, including burns, to facilitate healing. On May 6, 2021 the Food and Drug Administration gave full-approval of the Companys Investigational Device Exemption (IDE) application to proceed with initial clinical testing of the CellMist System and SkinGun spray device in adult burn patients. The clinical trial protocol is an open-label, single-arm clinical study that is enrolling 14 adult human burn subjects with partial-thickness, second-degree deep thermal burn wounds covering between 10% and 30% total body surface area. The Company may engage up to four (4) U.S. burn centers to conduct the clinical study. Currently, the clinical trial is activated, enrolling and treating patients. The CELLMIST 1 clinical study is expected to reach completion in late 2022.

Additional info from OTC:
RenovaCare, Inc. is a development-stage biotechnology and medical device company focusing on the research, development and commercialization of autologous (using a patients own cells) cellular therapies that can be used for medical and aesthetic applications. The Company does not have any commercialized products. We are currently developing and testing the CellMist System which is a cell isolation procedure that enzymatically renders stem cells from the patients own skin or other tissues. The resulting stem cell suspension is administered topically with our SkinGun spray device as a cell therapy onto wounds, including burns, to facilitate healing. On May 6, 2021 the Food and Drug Administration gave full-approval of the Companys Investigational Device Exemption (IDE) application to proceed with initial clinical testing of the CellMist System and SkinGun spray device in adult burn patients. The clinical trial protocol is an open-label, single-arm clinical study that is enrolling 14 adult human burn subjects with partial-thickness, second-degree deep thermal burn wounds covering between 10% and 30% total body surface area. The Company may engage up to four (4) U.S. burn centers to conduct the clinical study. Currently, the clinical trial is activated, enrolling and treating patients. The CELLMIST 1 clinical study is expected to reach completion in late 2022.