Most of the recent attention on Regeneus has quite rightly been focussed on the remarkable deal negotiated by Leo Lee with Kyocera for a Japanese licence to manufacture and sell Progenza in that country for knee osteoarthritis treatment.
The deal that was finally negotiated ticks many more boxes than I had expected, and for many pre-existing shareholders, I'm sure it brought a satisfactory end to years of over-promising and under-delivering by the RGS Board.
With Progenza now subject to a well financed commercialisation pathway and market development strategy, my interest is turning to Sygenus which may well have as much or even greater commercial potential than Progenza.
One of the interesting things about Sygenus - being a topical stem cell secretions gel is that for certain indications approvals can be sought for Sygenus as a cosmetic product rather than as a therapeutic product. Now, my understanding is that (for the TGA and the FDA) the approval process can be considerably shorter for a product which is intended to be marketed as a cosmetic product rather than as a therapeutic product.
Looking at the Sygenus pipeline, my guess is that the prerequisite for marketing Sygenus as a topical treatment for either acne or age spots would depend quite comfortably on meeting approval guidelines for a cosmetic product. While the process for meeting approval guidelines for a cosmetic product may be considerably less onerous and time consuming than for a therapeutic product, the rider is that any approved cosmetic product has limitations on the scope of therapeutic claims that can be made.
It is also my guess that most of the other indications for which Sygenus has shown promise as a topical treatment in preclinical work could require meeting approval guidelines for a therapeutic product.
It seems reasonable to assume that for any wound healing indications, approval processes for use of Sygenus would presuppose it being marketed as a therapeutic product. The same could be said for Vulva Lichen Planus.
Use of Sygenus for treatment of various neuropathic and other pain indications would also most likely require therapeutic approval processes to be pursued. Certainly, topical treatment with Sygenus of neuropathic and other pain indications that have shown promise in Regeneus preclinical work (such as for post herpetic neuralgia, peripheral neuritis, achilles tendonitis, rotator cuff tendonitis, tennis elbow and golfers elbow) could only reasonably be marketed on the basis of providing therapeutic benefits.
If I am on the right track here (and I certainly don't claim to be any sort of expert on TGA, FDA and other jurisdictions' regulatory approval processes), one thing that I can't get my head around is this: - if regulatory approval is fairly quickly given in some jurisdictions for use of Sygenus as a cosmetic product providing a topical application for acne and/or age spots, what is to prevent customers loading up on Sygenus and utilising it for a raft of indications such as the suite of neuropathic and other pain indications that are known to have had some therapeutic benefit from application of Sygenus gel in Regeneus preclinical work.
For a shareholder, it's an interesting conundrum but definitely not one that will keep me awake at night.
zeno9
RGS Price at posting:
15.0¢ Sentiment: Hold Disclosure: Held
