2021 FinancialsWell there you have it. The Financials and an Update all in one. I just spent the last half hour reading it and must admit it paints a very alarming picture.
In a nutshell RCS-01, RCT-01 are years away from commercialization. Nowhere did it indicate Yofoto is imminently going to begin Trials in either. Also no indication there are any trials in either remotely close to beginning in Japan.
What is up with RCH-01. Who knows. Shiseido is in a Phase 2 trial but there is no indication when the trial will be completed. The Arbitration may take an additional 3 1/2 months. Replicel is not planning any RCH-01 phase 2 trial at the moment.
Where are we at with Dermaprecise. From the financials:
"We believe that this device will have applications in certain other dermatological procedures requiring injections of specific volumes of material at specific depths and as such, is actively exploring licensing opportunities in these areas. In addition to the programmable variables of volume and depth, the device will also have interchangeable heads for different injection procedures (single and multi-needle). We received our first functioning prototypes for testing in Q3 2017 and, as a result of extensive testing, made several improvements to the components and design to optimize desired functionality through the following 18 months. Final prototypes were signed off on in late 2019 and first run of commercial-grade prototypes were ordered into production in early 2020. This production run was delayed due to COVID-19-related shutdowns across the supply chain. Our company proceeded to produce its first samples of the commercial-grade prototypes in Q2 2021 and is in the early stages of functional and safety testing which is leading to minor design and production iterations based on results. We have yet to sign off on a version of the device which we believe is suitable for serial production. Once this stage of testing and component change is complete, a full manufacturing run units of will be produced for testing over the following months and an application submitted to European regulators for marketing approval. A CE mark will allow our company to commercially launch DermaPrecise in Europe. An FDA approval (such as a 501(k)) will allow our company to commercially launch the DermaPrecise Injector and single-use components in the United States. Either one will allow our company to launch sale of the device and consumables in countries which accept those approvals such as Hong Kong where YOFOTO is already licensed to distribute. The registration of European or US marketing approval in Hong Kong is expected to trigger a $500,000 milestone payment from YOFOTO."
In other words they have yet to produce the final version of the device. Once it is produced it will be tested "over the following months". Well that pretty well takes care of 2022.