MDXG long here... I was unaware that OSIR has a competing product for DFU's. I have a few questions that I searched on but couldn't find an answer...
1. I've read some statements on this board that Grafix will become the SOC and has a more successful rate of healing than any other wound care product. I couldn't find any data to back that up. I found 1 clinical trial on the NIH website that just started recruiting. Can someone point me to a study that has data on closure and healing rates for Grafix?
2. One huge advantage I see for Epifix is that it can be shipped and stored at room temperature with a 5 year shelf life while Grafix has to be shipped frozen then cryopreserved at the clinic. Grafix then has to be thawed and unpacked in a special procedure. How will Grafix overcome this competitive advantage of Epifix?
3. I read somewhere here that the average cost per treatment using Grafix is around $10K. The average cost per closure with Epifix is $3.4K. How will Grafix overcome Epifix’s competitive cost advantage?
4. Epifix completed one clinical trial in Aug 2012 that showed 92% healing rate of DFU’s within 6 wks and has 3 ongoing clinical trials that will be completed before the end of 2Q 2013. Epifix also has multiple VA studies that have demonstrated similar healing rates. At the Desert Foot conference last fall there were 7 posters of study data presented by VA clinics which showed similar results - search on “Desert Foot 2012 Epifix” and the 2nd result should be the list of posters. BTW - I couldn’t find any posters on Grafix. Since Medicare intermediaries generally do not reimburse without clinical data, how will Grafix generate sales in 2013 with one clinical trial that will not be complete until 2014?
You know a red flag when the CEO makes comments about the share price and accuses short sellers and manipulation RED RED RED FLAG
Sentiment: Strong Buy
I disagree. Peterson is a guy who has loyal shareholders and he looks out for them. Basically he reiterated numbers and prospects. Nothing too far fetched.
Randy has learned a lot observing MDXG.
Perhaps now he could learn to stick up for/support his loyal shareholders too.
I'd welcome that.
Other questions raised were about cost, Grafix is price competitive with Epifix. A disadvantage with Grafix (and Ovation) is that they must be stored at -135 degrees Celsious or lower. Remember, these are live adult stem cells that will come back to life once they are thawed and used. Osiris is conducting further studies to determine if their biosurgery products could be stored at a higher temperature.
Insurance reimbursement for in-hospital setting is no problem. Ovation is currently being marketed and used by neurosergeons and spine doctors for spinal fusions. Since the surgical procedures are being performed in a hospital setting, Osiris does not need to have C-Codes and Q-Codes for Ovation. Grafix can be used both in a hospital setting as well as "out house" in a physician's office. Osiris currently has "transitional and permanent pass-through status from the CMS, with C-Cods and Q-Codes for Grafix, which will assist in facilitating reimbursemtn in the physician office setting, offering additional access for Medicare patients." To further facilitate health care reimbursement, Osiris has designed a study to evaluate3 the efficacy and safety of Grafix for DFU's. "The primary efficacy endpoint of this study is complete wound closure, defined as 100% re-epithelialization, by week 12".
I have seen the wonders of Grafix first hand, where other treatments have failed. As I previously reported, there is plenty of room for many treatment procedures, including Epifix. Grafix has many advantages such as the unhealing serious wound, where amputation may have been the standard of care. Grafix also produces little or no scarring, a patients and a plastic surgeons dream come true.
I have no doubt that Grafix is a useful product but wound clinics are very cost conscious their clinicians prefer products that save time and are easy to use.
I see Grafix more as a specialty product and Epifix as a first line product for DFU's. Grafix may have advantages for burns when scarring is an issue but for DFU's I don't see the advantage.
I urge you to look at some of the posters from Desert Foot 2012. There are studies for Epifix that show 100% rate of healing of refractory chronic wounds using an avg of less than 3 applications.
Look at the Wieszbicki poster...86% reduction in amputations...
• Economic benefit of reduced amputations over 2 year period after implementation of advanced therapies = $2,760,000.00
• Based on the results of the first 11 patients treated with Amniotic Membrane Allograft, the clinic quickly decided to make this product its advanced graft therapy of choice. 31% cost savings with EpiFix
• Prior to 2011 the Viera VA averaged 14 amputations per year for the previous 10 years.
• In 2011 they implemented an evidenced-based approach to treating DFUs and utilized advanced therapies to reduce the number of amputations to 3 that year (a 79% reduction compared to the previous 10 year average) and 2 in 2012 (an 86% reduction compared to the previous 10 year average)
In 2012 the clinic began utilizing EpiFix® PURION® processed dehydrated human amniotic membrane allograft.
• The first 11 patients with DFUs treated with the product experienced complete healing.
• The clinic budget for advanced therapies decreased by 31% and the average time to closure decreased by 40% compared to previous experience with living skin equivalents.
• As a result of these outcomes Amniotic Tissue Allograft became the preferred advanced
Cynical_trader, first let me commend you on some excellent, well thought out posts. You have done your due diligence on Epifix and now you are doing your due diligence on Grafix. Both products have their place in the wound care market as do other "skin substitutes" and closure methods. Epifix does have an advantage with having a longer shelf life and a ready to use product that does not need to be thawed.
The primary difference with Grafix is that Grafix is made from placenta that has been "minimally manipulated". The adult stem cells from the human placenta tissue are robust, concentrated, anti-inflammatory and promote rapid healing and tissue regeneration with minimal scarring. Osiris is just now truly commerciallizing Grafix (Grafix Prime and Grafix Core) and has hired an internal sales force to coincide with their expanding distributorships. There has been little promotion and advertising for these products as Osiris wants the products to speak for themselves. Please dig deeper, quite a bit deeper, and you will see the wonders that these novel products can accomplish. Read tha latest Osiris Therapeutics, Inc Form 10-K filed 3/15/13. Did you research Dr. Misner and Bobby Rice's regrown foot? Have you seen pictures of severe facial burns, before and after, where you can not tell that there was a trace of an accident? Have you seen the before and after pictures of feet, where diabetic foot ulcers have eaten away the heel all the way to an exposed heel bone? Did you know that Grafix and Ovation, are "regulated at 361 HCTT/Ps and not as biologics or drugs and that the FDA does not require premarket approval for HCT/Ps"?
C_T. Both companies likely will do well. The product mix is different, the markets are large so not an either/or situation.
My advice: Buy a few shares of OSIR and continue to share your thoughts and learn more about the "game changing" possibilities of Osiris. Prochymal saves lives, no side effects and the first stem cell biologic ever approved and with extensive patent protection. Much good will follow.
And stay cynical. Kool Aid not a requirement.
Data in small trials have indicated that Grafix heals 70% of recalcitrant DFU's ie those that have failed all/many other treatments. Also, and importantly, Grafix is indicated in infected sites, for instance when osteomyelitis is present. Grafix is used in extensive burns and the photographic results have been startling and rapid. Look through the Osiris website for some pictures.
The addressed market is huge as current SOC heals only 30% of wounds and durability is often quite limited. Other thoughts include tattoo removal, scar revision, stasis ulcers and decubitus ulcers. Also Osiris has an extensive patent portfolio and recently defended successfully against Mesoblast (Teva/Cephalon) on their home court in Australia.
Epifix is a good product. The bet here is that Grafix is much much better.
Best advice is read the Osiris website and filings. This company has the science and staying power to become the next Amgen. Thirty-three million shares with 60% insider ownership. You are still early.
"Grafix is indicated in infected sites, for instance when osteomyelitis is present. "
The current clinical trial contradicts your statement...
Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
On a side note... both OSIR and MDGX with have booths at the The Symposium on Advanced Wound Care and Wound Healing Society in Denver on May 1-5.
Search on "SAWC Spring 2013" to find the website. Click on "Exhibitor Information" then "Exhibitor Floor Plan"... you can search alphabetically for the exhibitor's booth location..
If Osiris has such big plans for their Biosurgery products why did they rent the smallest booth available... way in the back of the exhibit hall?
MiMedix's booth is 6X larger and in a prime location.
Not nit-picking cim, but wanted to point out Yahoo "key statistics" reads 74.24% insider ownership and 14.6% instit. ownership on 32.88M shares outstanding with a 15.36M float....Even Better!
Sentiment: Strong Buy
I've been all over the Osiris website and there are no SEC filings after 2010 in their investor section. There is no clinical trial data on Grafix anywhere on the website or the web for that matter. I also couldn't find any of the 3 abstracts that were presented for Grafix at the 24th Annual Symposium on Advanced Wound Care and Wound Healing Society... on Osiris's website or on the web. I searched on the lead author for the prize winning abstract... Dr. Dana Yoo and it comes up blank. Who is Dr. Dana Yoo?
The 92% healing rate for Epifix was also for wounds that failed prior treatment. How many weeks did it take for Grafix to achieve 70% healing? I'm assuming it's more than 6 weeks since the trial just announced is a 12 wk trial.
Also... why would a wound clinic choose a product for their patients and clinicians to use that must be shipped on dry ice then cryopreserved, requires special handling, is 3X more expensive per successful outcome, has a lower rate of healing and has a longer time to heal?
Dr. Mills is presenting at the Canaccord Genuity Musculoskeletal Conference on March 19th at 9:30am. Listen in and learn. Then you can listen to mdxg's presentation in the afternoon and compare. You've had a nice run from $1 to $5. Trees don't grow to the sky. Bulls make money, bears make money and pigs are taken to the slaughter.