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Re: Adamb2 post# 100102

Wednesday, 04/08/2020 1:37:17 PM

Wednesday, April 08, 2020 1:37:17 PM

Post# of 111073
CaverStem® has both the pedigree of being developed by leaders in the field of stem cell treatments and the proven long-lasting efficacy to stand apart from other less effective ED treatments such as Gainswave®, shockwave therapy, and platelet rich plasma (P-Shot®). It also is the only stem cell based treatment for ED that falls within the FDA’s guidelines for stem cell treatments and specifically exception 21 CFR 1271.15(b). This FDA guidance allows for removing and implanting “human cells, tissues, and cellular or tissue-based products” (HCT/Ps) into the same individual from whom they were removed (autologous use) and implanting the HCT/Ps within the same surgical procedure, However to be compliant, the HCT/Ps must remain in their original form, which means that they are only rinsed, cleaned, sized, or shaped in the procedure. CaverStem® meets all of these requirements via our patented protocol utilizing autologous bone marrow derived stem cells. Stem cell treatments offered by other practitioners utilizing adipose, cord, and amnionic derived stem cells do not meet this exception due to manipulation of cells and/or the cells not originating in the patient being treated. Therefore CaverStem® is also the only patented and FDA compliant stem cell treatment for ED.
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