Well, it’s worth clearing up a few things.The company reported back in April that it was ready to submit a 510 for its liquid spray device. Readers shouldn’t confuse this with the technology that is making headlines right now. The device is designed to – and to quote here – create a well-dispersed spray of wound care and/or irrigation fluids. The assumption is that the company will use the same device to spray its stem cells onto wounds, but right now, it’s only seeking 501 for irrigation.
With that said, once that’s in place, RenovaCare can push into clinical trials that investigate the efficacy of the device in the stem cell indication, and that’s what is going to grab (and hold) the headlines going forward.
The process is as follows: get a 501 approved so that the device can be marketed, and then run some clinical tests with the stem cell technology (called CellMist) to try and demonstrate clinical benefit. Then use the data derived from these studies to market the device in the investigated indications (wound care, burn healing etc.) as opposed to just an irrigation fluid sprayer.
There seems to be some confusion surrounding this right now, mainly rooted in the suggestion the 501 will open the gate to commercial sales in the stem cell application right off the bat – that’s not the case.
It will, however, open the gate to clinical trials, and there’s plenty of reactive potential as these trials get going. With stocks like this, it’s the hype that surrounds the technology that will generally dictate share price. Without such an interesting potential application, RenovaCare wouldn’t be of any interest to us – it’s got a long path to commercial sales in burn healing, if it ever gets there. Then there’s the up and downstream to take in to consideration. What will a facility need from an infrastructure perspective to underpin the use of this device? What training will a physician need? Are there any limitations to its efficacy that will limit its market (we suspect there are)? All of these things are going to add time and money to a development process – one that in another company might not be worth a second look.
