Here's a portion of a letter from the new CEO that came out today. This is their plan for 2020...
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LOOKING FORWARD TO 2020:
"We enter a brand-new year excited by the many opportunities that lay before us with ample cash (approximately $13 million) and the support and encouragement of our many stakeholders.
Our highest priority in 2020 will be to advance the SkinGun™ through our regulatory program so we can obtain approval for conducting clinical trials, initially for establishing the safety of our device.
While there are no guarantees of obtaining regulatory consent for our clinical trials, our confidence is strengthened by peer-reviewed publications and by the compelling visual outcomes of the more than 70 burn patients (see pictures here) experimentally treated with an early version of the technology underlying the SkinGun™.
Our goal is to bring our therapy to the tens of millions worldwide who suffer from burns, chronic and acute wounds, and scars, an estimated $45 billion market in the U.S. alone."
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Notice that he writes the highest priority in 2020 for Renovacare is trying to get approval JUST TO BE ABLE TO CONDUCT CLINICAL TRIALS. Everything that is written ("70 burn patients, peer-reviewed publications, etc.) is VERY OLD NEWS! This is where they were at least 3 years ago! NO REAL PROGRESS TOWARDS PRODUCT COMMERCIALIZATION! All they've done is to hire a few big names to get some publicity - with nothing but empty promises behind the scenes. The $13 million that they have will be used to buy more publicity and pay their expensive new hires. Where will the tens of millions of dollars come from to perform the needed Clinical Trials to submit to the FDA?
Their main competitor (Avita Medical) ALREADY HAS FDA APPROVAL FOR THEIR SPRAY-ON RECELL PRODUCT - AS WELL AS THEIR OWN MANUFACTURING FACILITY, MARKETING/SALES FORCE AND ACTUAL PRODUCT SALES! They also are in the midst of 2 more Clinical Trials (for more uses) with several more CT's lining up behind those (and the money and know-how to run them). By the time Renovacare actually conducts a Clinical Trial (if they ever do) Avita Medical will have a stranglehold on most of the indications in the market.
