A little while back, the runner up, was going to build a home right next to Peter. I think the Swiss tax bite got him to rethink.....
Issue Number: Volume 28 - Issue 7 - July 2015
Emerging Advances In Wound Care
Grafix (Osiris Therapeutics). As an alternative to autologous skin grafts, physicians may use the three-dimensional matrix allograft Grafix for acute and chronic wounds such as diabetic foot ulcers, according to the manufacturer Osiris Therapeutics.
A recently published multicenter trial by Lavery and colleagues comparing Grafix to standard wound care for the treatment of diabetic foot ulcers found that a significantly higher proportion of Grafix-treated patients achieved complete healing at 12 weeks (62 percent) in comparison to 21 percent in the standard wound care group.1 The study authors also noted that the Grafix-treated group had lower percentages of adverse events (44 percent versus 66 percent) and wound-related infections (18 percent versus 36.2 percent) than the control group.
Kazu Suzuki, DPM, CWS, notes that Grafix uses the proprietary manufacturing process BioSmart to preserve the inherent properties and structural matrix of fresh placental membrane. Dr. Suzuki says the unique cryopreservation process produces an unaltered extracellular matrix that he calls rich in native collagen, growth factors and resident cells such as fibroblasts, epithelial cells and mesenchymal stem cells. The company says Grafix protects tissue from infection, reduces inflammation and lowers the incidence of scarring. Dr. Suzuki has used Grafix grafts at his facility since last fall.
“We are very impressed with the wound healing results we have seen in our own patients and we now use (Grafix) almost daily in our wound care center,” he says.
Ch47ady, Ted is the best OSIR analyst. I talked to him almost a year ago for about 45 minutes and he also told me that he has to lowball the expected quarterly earnings. A miss could be devastating to the share price.
Have you caught any big fish lately?
The ASM was spectaclar. All you had to do was look at Lode's face. He had a terrible biking accident landing on his face. Half of his face was a bloody mess a couple of months ago. With a slathering of Grafix, his nose grew back! There was no scarring. Just a little red line on the middle of his regenerated nose.
I asked this question directly to Lode at the ASM.
“Has there been any negative feedback with BIO4 due to overgrowth, nonhealing or other potential problems?”
Lode’s answer “None”.
BIO4, like an autograft, contains all four essentials in repairing and regenerating bone defects.
From the Stryker website:
"BIO4 is a viable bone matrix containing endogenous bone forming cells including mesenchymal stem cells, osteoprogenitor cells, osteoblasts, osteoinductive and angiogenic growth factors. BIO4 possesses all four characteristics involved in bone repair and regeneration: osteoconductive, osteoinductive, osteogenic and angiogenic. It is a safe alternative to bone autograft that minimizes the potential for harvest site co-morbidities."
"BIO4 is a safe alternative to traditional bone autografts because patients don’t have to go through a second surgery to harvest bone from the hip – a procedure associated with serious side effects."
"Medtronic’s INFUSE Bone Grafts are synthetic, concentrated proteins called recombinant human bone morphogenetic proteins (rhBMP-2) and were approved by the U.S. Food and Drug Administration (FDA) in 2002 for use in spinal fusion. These synthetic proteins are mixed with collagen from cows and injected into the spine to alleviate pain."
"It is estimated that INFUSE is used in 100,000 spinal fusion procedures a year in the United States and reached $900 million in sales in 2011 alone. Stryker Biotech manufactures a similar product, called OP-1, which was approved by the FDA in 2001 for limited use. Medtronic is the industry leader, with 44 percent of the $1.9 billion bone graft market — which includes allograft bone, cell-based matrices, bone substitutes and demineralized bone – and 90 percent of the bone morphogenetic protein (BMP) market. In addition to spinal surgery, INFUSE is approved for use in tibial fractures and in dental procedures to repair the sinus cavity."
"INFUSE Bone Grafts are risky, however, and can come with dangerous side effects, including infection, male sterility, bone and nerve injury, urinary problems and a possible increased cancer risk. What makes this worse is that Medtronic is accused of paying off doctors to use its products, intentionally hiding the possible side effects and using deceptive marketing practices. A number of people have been injured after using Medtronic’s INFUSE Bone Grafts and have filed lawsuits against the company."
Babykahn, one day we will meet. You are a very astute investor. My podiatrist friend has performed many of these exposed tendon medical procedures, wrapping them with Grafix, all successful.
Grafix could be the plastic surgeons best friend. However, this would have to be used off-label and probably would not qualify for insurance reimbursement. From what I understand, Osiris is not pursuing the use of Grafix for plastic surgery at this time. There are way too many other biosurgery products (and drugs) which are being considered that could have billion dollar sales potential.
What would you say if you saw first hand the miracles of Grafix? For example, suppose you were in a terrible accident and half of your face was completely mangled and you had lost half of your nose?
We all saw first hand at the annual shareholder's meeting this miricle, this particular face was scar free, the nose tissue regenerated. The only outward appearance of any wound indication, was a small red line that appeared half way up the nose. This particular man may still need to have surgery for the broken bones that may still reside underneath the surface....
This was not the "Dalton Foot". This was a more severe case than the Dalton Foot. The podiatrist who treated this patient also was the same doctor who told Dr. Spencer Misner how to use Grafix on Bobby Rice.
A year and a half ago Osiris had 70 employees. There were 12 sales people. Today, Osiris has 250 employees with a little over 100 employed as sales people. Lode re-iterated that each sales person should generate at least one million in sales on an annual basis.
One of the questions asked at the annual meeting was concerning which of the three biosurgery products on the market today, Grafix, Bio4 or Cartiform, has the greatest sales revenues. Lode confirmed that Grafix has the largest sales revenue today. And the follow up question was asked, which of your three biosurgery products that you have on the market today do you expect will have the greatest sales revenue next year and in future years. The answer was BIO4.
Now do the math. How much do you expect total sales will be this year and then next year? And don’t forget about the new meniscus product, Menvivo for torn meniscus, which should be introduced within the next 12 months.
At the recent shareholder’s annual meeting, Lode shared with us some very graphic pictures of a serious foot wound. The wound went from the little toe to the ankle showing and exposed extensor tendon approximately 15 cm long. The length of the wound was 23.5 cm (9 ¼ inches), by 4.5 cm wide (1 ¾ inches) by 1.5 cm deep (.6 inches). This was a very, very nasty wound and the standard of care was amputation below the knee. About three years ago, this patient was treated by a podiatrist who was one of the first doctors to try to salvage this foot by using only Grafix. Osiris provided Grafix free of charge for this case. The wound was fully granulated after eight applications of Grafix. Re-epithelialization of the wound occurred after two months. Capillaries were regenerated. The patient was walking in five months. There was little to no scarring. His foot is back to normal. The patient is a very happy man. You can see him with his family, walking, on page 3 of the 2012 annual report. This is a much bigger deal than the “Dalton Foot.”