Stem Cell Bra

Stem Cell Bra is primarily based on bioelectric stem cell homing signals applied to breasts with a gel tape electrode which will comfortably fit in any bra (conforming shape adapting bras are recommended). The patented and patent pending bioelectric signaling sequences release SDF1 and PDGF proteins in breast tissue which serve to call like a homing signal a person’s own stem cells from bone marrow, fat tissue and circulating blood to migrate to breast tissue. Other signals which may be programmed into the Stem Cell Bra include those that control release of tropoelastin for improving elasticity and others for controlling proliferation (multiplication) of recruited stem cells and their differentiation into breast tissue. Additional bioelectric signaling sequences focus on improving blood circulation which in turn helps promote breast tissue growth especially when combined with stem cell recruitment and proliferation.

Stem Cell Bra Plus is the same as above but combined with fat grafting, stromal fraction and stem cell injections and a cocktail of support factors which may include any one of these; PRF, amnio fluid derived exosomes, selected growth factors, selected exosomes, oxygenated nano-particles, small amounts of hormones such as progesterone, micro RNA gel, nutrient hydrogel and breast tissue promoting extracellular matrix.

No. The bioelectric stimulator that we program our bioelectric signaling sequences into does have FDA 510K market clearance as a Class II device only for improving blood circulation, mild pain relief and accelerated healing of muscle injuries. It is not market cleared or approved for breast tissue augmentation. Investigators and our company plan to gather data in carefully designed studies both outside of the USA and within the USA to support an filing with the FDA requesting to add breast augmentation as a cleared indication of use. As of December 31, 2018 this device has not yet been proven to be safe or effective or breast tissue augmentation and is available only for investigational use in properly designed and controlled studies with proper patient consent forms completed and appropriate regulatory clearances where applicable.

The 15 sheep and cows studied so far showed no signs of discomfort. Many of them fell asleep during the procedure. Our own lab members have applied the device their own breasts and report total comfort with only a very small faint pleasurable sensation felt.

It is difficult to know how long the studies will take and how much data the FDA and other regulatory authorities will require before providing market clearance. It could be a number of years. In the meantime access is likely possible by entering a controlled clinical studies outside of the USA or in selected centers in the USA.

The large animal studies that demonstrated 20 to 30% breast tissue growth with no side effects had a stimulation time of 1 hour every other day for 4 weeks.

At this time Stem Cell Bra may only be applied in approved clinics under the supervision of trained cliniciWe do anticipate that after statistically significant controlled clinical studies are completed in clinics a new study will be initiated to examine carefully the safety and efficacy of at home use. We do believe eventually this could be an at home use product but this will likely take a number of years of carefully implemented studies first. Stem Cell Bra Plus which includes fat grafting, stem cells and support factors will always only be available at hospitals and properly equipped clinics much like breast augmentation surgery today.