Clinical Competitor Analysis:
There are a number of competitors with products in the marketplace and under development. The distinguishing factors for market success will include efficacy, ease of use, cost, and long term benefits. The Hopkins technology is being optimized not only at the biomaterial's level, but also at the cellular level. Following are some of the major players in the field:
Genzyme Tissue Repair's Carticel® and its second generation products represent the market leader at present.
Smith & Nephew has introduced a new implant that applies the latest advances in medical technology to an established repair technique in the field of arthroscopic surgery. Called FasT-Fix AB Meniscal Repair System, the system was first launched in April 2001.
OsteoBiologics, Inc. is also focused on the research, development and manufacturing of bioabsorbable tissue-engineered scaffolds and instrumentation to identify and repair musculoskeletal tissue.
The autologous cartilage transplant CaReS®- Cartilage Repair System - offered by ARS ARTHRO AG® is a 3D mechanically stable transplant based on patient specific autologous cartilage cells and a unique patent pending collagen matrix.
BioTissue Technologies has developed the Autologous Chondrocyte Graft BioSeed®-C for the treatment of defective joint cartilage.
IsoTis is developing tissue-engineered products, including skin, bone and cartilage for use in clinical settings.
Isto Technologies is involved in the development of engineered tissues and chemical compounds for the repair and regeneration of human tissue.
Orquest is involved in the development of orthobiologic products for bone and cartilage regeneration, using combined technology from tissue biology and biomaterial science.
Osiris Therapeutics, Inc. is a researcher and developer of regenerative human stem cell technologies for eventual use in therapeutic products.
OsteoBiologics is a developer and manufacturer of bioabsorbable tissue-engineering scaffolds (IMMIX) for the repair and replacement of musculoskeletal tissues.
ReGen Biologics designs, develops and manufactures minimally invasive implants and medical devices for the repair and regeneration of damaged or degenerating cartilage in the knee.
There are other therapies such as Synvisc's injectable rooster-derived extracellular proteins and also nonbiological implants, such as Sulzer Orthopedics' UniSpacer, designed to provide reduced friction between the joints.
Sentiment: Strong Buy
Excellent post. There are and will be many drugs and biosurgery products competing for market share for all types of medical procedures, many of them using adult stem cells.
This is an exciting time! Many will fail for a variety of reasons. Obviously efficacy and safety are paramount. Cost may very well be the deciding factor. But speed and availability of the drugs and products may be even more important. So let’s put everything into perspective:
First, there is plenty of room for many of these drugs and products. I personally like the allogeneic drugs and products compared to the autologous ones. I believe that both methods work and perhaps the autogolous method could be superior. But the time and the individual higher cost to regenerate one’s own stem cells could make this method ineffective. If you have a heart attack, you cannot wait as your heart muscle deteriorates. If you have severe burns or open leg ulcers, you cannot wait .
Then we have the slight problem of years and years of clinical trials and study times for all of the potential drugs. And even if these new drugs are successful in a Phase III Clinical Trial the FDA may still not approve or could request additional trials and study times. And years later the FDA could still decide to reject the drug submission.
I believe Osiris is in front with their many patents and intellectual rights guarding their universal off the shelf biosurgery products and also with their drug, Prochymal. There is plenty of competition now for Grafix, but I believe Grafix Prime and Grafix Core are the best of breed of all of the biosurgery products. Ovation stands alone. Very little competition. Osiris apparently has a lock. And then there is Cartiform, a game changer.
There is also Athersys and Mesoblast which have mesenchymal stems cells with indications paralleling all of those of Prochymal and MiMedx with EpiFix which is outselling Grafix, especially in the VA system.
The examples you have mentioned apply primarily for Ovation and Cartiform. The one advantage we have with Ovation is a track record of success with the first generation Osteocel and Randy's guarantee that Cartiform is superior to everything on the market.
This market area is so deep and complex that it is difficult determine what is going to happen with the exception of Prochymal. We are leading with Prochymal. So, a Switzerland approval and good AMI data should be meaningful. Trying to figure out how biosurgery will shake out is impossible, so we are relying on the "endorsement" of a big partner to confirm our hunch that Osiris is a good investments, and I say hunch because even Oz who has spent many an hour researching now admits that Grafix is not the slam dunk he once thought it was. There is real competition within this space.
1. Additional Prochymal approval, hopefully in Switzerland. A sight for sore eyes it would be.
2. A partner to confirm our underlying belief that we have something in Osiris.
3. Profit. Like Pete is turning in. Real Southern-Style, stick to your ribs, profit.
The list provided is great, but it is actually much deeper than this in terms of competition. But, we recently got 6 Grafix patents, and we have rebuilt a guy's foot. Stay tuned because as far as I can tell, all of us are flying completely blind. What was once so clear with Prochymal's approval in Canada has become suddenly very difficult to understand.
Sentiment: Strong Buy
Stats makes a very good point stating the difficult path to approved implementation of Canada's Prochymal for GvHD. Pediatric patients only! Let's assume, sorry if it's offensive, Canada has the same Expanded Access Program which the FDA awarded OSIR, that also being adult access to Prochymal for GvHD. For severe liver or gastro with adults would Canada eliminate access since it's only approved for children?
That's a scenario. May not even be correct. Point is, there's a spectrum from only pediatric access to universal access to all GvHD types followed with the Phase 4 confirmatory trial. That makes sense.
All alternatives are extremely complex....up to the point of a redo.
So, a previous statement of a possibility of OSIR being unable to negotiate reimbursement of Prochymal User Fees are quite real, at least until a predictable use can be measured.
Sentiment: Strong Buy
This may be an example of "coals to Newcastle" but here's another competitor for Osiris' Grafix product. It is produced a company which has been on my radar for well over a year, Avita Medical. It's sole product right now is ReCell, also known as spray-on-skin. It is in the late stage III of FDA trials in the US but has been approved in numerous countries overseas. It takes a small piece of the patient's own skin (autologous), breaks it down, sprays it back on the wound. Process takes about 30" max. Its uses include for burns and ulcers, and I believe heals 100% for burns in about 10 days and high percentage for ulcers. No chance of rejection because it's the patient's own cells. Stock trades in Australia avh.ax and in the States as AVMXY (equals 20 shares of AVH). The AVH trades for .11 or .12 and the AVMXY for roughly 20 times that.