Renelon Excerpts from Today Form 10 Filing
Here are the key excerpts on today's filing about Renelon. I know we had already heard that the current generation device/drug wasn't a perfect solution. Interesting that while it cannot transform cells to a regenerative state, it can still prevent scarring of skin. Anyone care to explain how that might be happening?
Excerpts
While we may elect to submit a 510(k) notification for regulatory clearance of our Renelon device, we have never submitted a 510(k) notification before and may be unsuccessful in obtaining clearance for our Renelon device. In addition, Renelon may not be classified by the FDA as a 510(k) device and may be required to be developed through a Premarket Approval (PMA) application, as an investigational new drug (IND), or regulated as a drug/device combination.
We plan to initiate our first device application for RenelonTM, a first-generation iTR product, in 2018 and subsequently initiate three clinical trials of cell- and drug-based therapies, each targeting large unmet needs in age-related medicine.
RenelonTM is a first-generation iTR product candidate designed to promote scarless tissue repair and is planned to be developed as a topically-administered device for commercial development.
We are performing research to optimize AGEX-iTR1547 in order to initiate preclinical studies of the agent on the scarless regeneration of the heart during congestive heart failure. In addition, RenelonTM, a first generation product candidate, utilizes a repurposed drug formatted in HyStem and is planned for initial development as a device for topical application. We plan to file a device application for Renelon in 2018. While not capable of fully transporting cells back to a regenerative state, the anticipated ability of Renelon to impart scarless repair could provide significant benefits to patients.
