Osiris is still under control of the shorts. Those investors who have not done their due diligence will not have a stomach for this biotech and will sell to soon. There will be a lot of ups and downs as long as the shorts are in control. Soon the fundamentals will speak loud and clear and the shorts will limp away badly wounded. This is a buying opportunity. A real gift to buy at these prices. If you really followed this stock and you did your due diligence, you will appreciate the opportunity to buy at these levels. I am a buyer. Read the transcript. Take notes. Talk to doctors, patients, sales people. See the before and after results. Scour the internet. This is a no brainer. You have to be patient and let the flower open up and show its beauty. It is happening now....
So what is the consensus? Is it possible that Zack's has a poor analyst that did not do his due diligence? Or is it possible that Zack's is working with the Street? My gut feeling is that the analyst was simply overwhelmed with all of his workload and did not listen to the conference call or look at the financials. I talked to another knowledgable investor who believes it is a hit piece.
I do believe that Wednesday will be a big day. As previously stated, I am not looking for a surge in earnings outside of the anticipated booked 50 million sale of Prochymal to Mesoblast. Serious biosurgery sales earnings will come later. Future earnings will increase dramatically quarter over quarter. I want to hear Lode talk about the increase in sales people, not just for the current quarter ending later this month. I want to hear how many new sales people he expects to have by the end of the year. I know management does not and will not project future earnings, at least not yet. But give us a clue. Does management realistically expect sales to double, triple or quadruple this year? Will management give us an update concerning insurance reimbursement for out patient sales? Lode, you have some large shoes to fill. Dr. Mills was a class act. Now, it is up to you. Go get 'em.
...when you do your due diligence, you are at peace. I am patient. I wait. I have been waiting along time. But I know what I have. I have done extensive due diligence and I have put my money on Osiris. I have a winner now. But it will be a much larger winner. Do your own due diligence. I have uncovered gems. They just need to be plucked and polished. It will happen. You will be amply rewarded in time. I sleep easy knowing what I have and what I have uncovered.
Isn't that odd. You can always buy shares when you want to. Yes, you are correct. You can always buy shares when you want to. But at what price? The shorts will always be able to buy shares from each other. This will be a game that I am waiting for knowing that it can and will happen at any time. S Q U E E Z E. You gotta luv it!
“Bobby is walking again,” Misner said. “I did have to amputate fifth toe and fifth metatarsal, so he doesn’t have a completely normal foot. But if he wants to go for a walk, he can. If he wants to work, he can work. He has a leg with a very minimal disability.”
Rice is also pleased with the outcome of the treatment.
“Dr. Misner is a great doctor. Without him I wouldn’t be here right now. He isn’t just a doctor to me—he’s a friend.”
Moving forward, Misner will be sharing his findings with the medical community. He has already received requests worldwide for findings on his procedure, as well as several requests from patients with similar precarious conditions. Misner is eager to see the work continue, but knows it will take more than him to find the future of stem cells in limb salvage.
“The work has to be replicated, it has to be improved on,” Misner said. “We have to change the mindset that if you have necrotizing fasciitis, you amputate to save the life. Now we can move from amputation to limb salvage.”
“Osiris is at the forefront of significant breakthrough medicine,” said Osiris Therapeutics Chief Operating Officer Lode Debrabandere. “As a result, the most catastrophic medical cases are brought to us. When you have people who can’t afford the products, you can put your money better into donating products than into marketing and advertising. Our products need to be used. That is more important.”
The investment Misner and Osiris made in Rice’s foot slowly began to yield results. Between December 2011 and May 2012 the stem cells regenerated tendon, ligament, fat, bone, and skin.
“Stem cells have been used before to regenerate these components individually—but they have never been used in complex care,” Misner said, “never to address all of these tissue parts at one time.”
An additional surprise came during a later treatment session when a nurse tickled Rice’s foot. Rice jerked his foot slightly and exclaimed that it tickled. The words passed without notice, until Rice realized the significance of the moment.
Feeling had returned to his leg. The stem cells were regenerating his long-damaged nerves. In time, after more than 10 treatment sessions over six months, Rice’s leg was almost completely healed.
With Misner agreeing to donate his time, and Osiris agreeing to donate nonembryonic stem cell products Grafix and Ovation, Misner prepared to begin the treatment. When the first of the stem cell products arrived, Misner took them to the -75 Fahrenheit cold storage at the hospital, where he opened the container to inspect what he would be working with.
What Misner found were 2×2 tissue squares half the thickness of Saran wrap that contained stem cells, connective tissue, growth factors, and skin growing cells. What he didn’t find were recommended procedures for administering the stem cell treatment.
“I called the company because no protocol was included,” Misner said. “Osiris responded that the reason we are giving these to you is there is no protocol. However, being in wound care I had extensive experience in using biologic skin. This was similar.”
The tissue transplant was a slow, tedious process. The squares, which thawed slowly, were peeled off of their backing and placed directly on what was left of Rice’s leg using microscopic forceps.
“It sounds simple, but it can be a difficult substance to work with,” Misner said. “It is similar to Saran wrap in that it balls up. But it is 10 times harder to work with because you can’t throw it away since each square is expensive.” Each is valued at approximately $2,000.
Covering a wound as large as Rice’s required 10 or more squares. With the treatment being repeated every three weeks for more than six months, the cost for the stem cell products alone quickly rose above $250,000, making the products donated by Osiris a significant investment—especially when considering that the case was unprecedented and Rice lacked health insurance.
Given the severity of Rice’s situation, Dr. Spence Misner ’73 was called in. Misner, who had been practicing foot and ankle pathology for more than 30 years, specialized in limb salvage, treating high-risk patients with critical wounds on the verge of losing a leg.
If Rice was hoping for a different answer from Misner, he would be disappointed. Misner initially came to the same conclusion as other physicians. Rice would lose his leg.
“The usual standard for treating a flesh-eating infection is immediate amputation,” said Misner, a 1973 psychology alum. “You would rather lose a leg than lose a life.”
Misner knew that in taking Rice’s leg, he would also be taking his livelihood. The doctor brought Rice into surgery twice, each time cutting away more infected flesh. By the time he finished, barely anything aside from tendon, bone, and an open wound remained from 6 inches above Rice’s ankle to his toes. Weeks of advanced wound care yielded little progress. Despite Misner’s skill, the situation was beginning to look hopeless.
Fortunately, Misner had a breakthrough. One of the sales representatives that he was acquainted with mentioned a company he worked with, Osiris Therapeutics, that developed several stem cell products. Misner called the company and explained Rice’s situation. Osiris agreed to donate anything that Misner needed, however, a stem cell tissue transplant on this level had not been attempted.
“I told Bobby he had a choice,” Misner said. “We can either amputate your leg, or we can try a procedure that has never been done. If it works, you have a leg. If it doesn’t work, you are not out anything.”
Rice agreed to give it a try.
Bobby Rice never expected that cutting his foot could reshape his entire life.
The Dalton, Georgia, carpet layer was walking trash to the dumpster outside his apartment when he stepped on broken glass. Rice felt no pain and because of his profession, was used to dealing with scratches and cuts. He bandaged his foot and didn’t think any more of it.
At least he tried not to.
But the glass had created a hole in his foot that constantly drained, ruining his socks. Rice was still not in any pain, so he decided to use a remedy that he had success with many times before. He superglued the wound shut.
The draining ceased, but the real problems were just beginning, as the wound quickly became infected. The infection began traveling up through Rice’s foot, ankle, and eventually lower leg. His leg began to swell and change color from shades of blue and green to patches of black. Yet it was still easy for Rice to ignore since he wasn’t in any pain.
Eventually fevers of 104 degrees, nausea, and shaky limbs accompanied Rice’s discolored flesh. His nausea was so severe that he went more than 21 days holding down nothing except Sprite. Finally, after blacking out on the floor in his apartment, Rice knew that something was very wrong. He called a cab and was taken to the hospital.
Doctors examined Rice and quickly identified the problem. Rice’s leg had become infected with necrotizing fasciitis, more commonly known as flesh-eating bacteria. An undiagnosed diabetic, Rice also suffered from diabetic neuropathy, which had destroyed the nerves in his legs and explained why he couldn’t feel what should have been a painful injury.
The decision for the physician examining Rice’s leg was clear: amputate.
“I didn’t want to lose my leg,” Rice said. “I asked to see someone who didn’t want to cut my leg off.”
Hiring the right sales people is an art and you will make a few mistakes. But hiring isn't just about hiring. You must also fire. This is a business, when a sales person underperforms, you have to make the tough decision and axe that likeable person. Go get'em tiger!
Now that you have been promoted to Vice President and General Manager of Wound Care, it is up to you to hire the very best sales people to sell Grafix all over the United States. I imagine that this is probably the busiest time ever for you expanding the sales work force to meet the projected and desired sales results. You will make some mistakes in hiring your new sales force but that is okay. You have a brand new product that has already been approved for inpatient reimbursement. I assume that outpatient reimbursement will be approved in the very near future. Your sales people need to be trained, educated and should be very excited to sell the very best wound care product on the market today for chronic and nonhealing wounds. Now that Dermagraft has in essence been disbanded, you should be able to get the cream of the crop sales people. Those sales people already have an "in" with the doctors and hospital administrators. Now go sell and show your worth. I will see you at the annual shareholders conference and I expect results.
Yes, I concur. A full Medicare coverage, a substantial increase in sales force and a full blown media/education/promotion program would take Osiris to the next level. I expect that this will happen sometime in the near future. I wait patiently. Lode will deliver in time. I am also waiting for the second generation of Grafix, Grafix XC. Bring it on!
Thank you for your keen insight. I hope you short a lot more if you think this is an easy investment to make you rich. Perhaps you are correct. Time will tell. We all sit here waiting patiently. I am patient. Very patient.
I had a follow up discussion this morning with my doctor friend concerning this particular case. The modified foot has healed quite nicely. The doctor will be doing a follow up procedure on his DFU patient today.
The first operation involved cleaning and debriding the infected foot of all dead tissue. Two thirds of the foot remained after surgery. Enough flaps of skin/ tissue were joined together over the remaining bone structure. The flaps were surgically sewn together and Grafix was applied.
The flaps and foot have now healed. There are "ridges" over the surgically modified foot. Todays procedure is more cosmetic. The ridges will be eliminated to have a smoother foot. One more application of Grafix will be applied over the foot. According to the doctor, this should be it. No more Grafix should be needed. The patient will be able to get a specially modified shoe in the very near future.
Ozark, I believe you are probably correct. With the government shut down, the Holidays, the cold weather and the training of the new workforce, the fourth quarter earnings may not be stellar. As far as $80 million in cash and investments, I think you should say $80 million in cash, investments and accounts receivable. ($15 million due in May or June.)
"Mesoblast will pay Osiris US$20 million upon closing of the transaction, with US$15 million in Mesoblast stock payable upon transfer of the assigned assets."
"Osiris will receive an additional US$15 million of cash in 6 months and may receive up to US$50 million in milestones that are contingent on the successful achievement of future late-stage clinical or regulatory targets (e.g., United States or European product regulatory approvals). All contingent milestones are payable in cash or Mesoblast stock, at Mesoblast’s discretion. Osiris may also receive earnout on sales of acquired products, ranging from low single-digit to a 10% cap on annual sales in excess of US$750 million."
With Dermagraft sales losing steam, I imagine that Osiiris is cherry picking the very best talented Dermagraft sales people. These super sales people already are well established and have been admitted to the "inner circle" of hospital administrators and doctors. When you have superior products and a superior sales staff, the future is very bright. Hold tight, the ride has just begun.
Yes, I believe your friend's doctor is correct. Cartiform is " a viable cartilage mesh for articular cartilage repair, primed for MSC activity."
Furthermore, Cartiform "provides the intact 3-dimensional architecture of hyaline cartilage that contains the necessary cellular and molecular components for repair."
I do believe that Pluristem could be one of the few stem cell companies that will actually succeed. But it is still years away with further dilution and a series of big ups and downs. I am afraid of Pluristem primarily for one reason. It is Allo. The paid pumper. Why? I am patient and can wait, but I do not trust management paying Allo. Something is just too fishy. Allo smells like fish.
Specific Study Details
The study involved 55 patients, ages 18 to 60, who underwent a partial medial meniscectomy (the surgical removal of all or part of a torn meniscus) at seven medical institutions. Patients were randomly placed in one of three treatment groups: Group A patients (18) received a "low-dose" injection of 50 million stem cells within seven to 10 days after meniscus surgery; Group B patients (18), a higher dose of 100 million stem cells; and the "control group (19)," sodium hyaluronate only. Patients were assessed to evaluate safety, meniscus regeneration through MRI and X-ray images, overall condition of the knee joint and clinical outcomes through two years. While most of the patients had some arthritis, patients with severe (level three or four) arthritis, in the same compartment as the meniscectomy, were excluded from the study.
Key Study Findings
There was no abnormal (ectopic) tissue formation or "clinically important" safety issues identified.
There was "significantly increased meniscal volume," determined by an MRI in 24 percent of the patients in the low-dose injection group (A) and six percent of the high-dose injection group (B) at one year. There was no statistical increase in meniscal volume at two years.
No patients in the control group (non-MSC group) met the 15 percent threshold for increased meniscal volume.
Patients with osteoarthritis experienced a reduction in pain in the stem cell treatment groups; there was no reduction in pain in the control (non-MSC group).
"The results of this study suggest that mesenchymal stem cells have the potential to improve the overall condition of the knee joint," said Dr. Vangsness. "I am very excited and encouraged" by the results. With the success of a single injection, "it begs the question: What if we give a series of injections?"