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He said.............
the same thing they have been telling all other e-mailers
They-senior officers have not taken any salary
Dedicated developing a start up takes time
They had nothing to do with the losses in the market
Sales will "soon" ramp up
Listen, I understand I invested in a pinky company and there are major risks with it but it is an insult to my psyche for company to assume that by putting up fluff "PR" it is OK.....it is not OK!
They have to show contracts with numbers(including costs of doing business) and sales figures; no more "FLUFFY" PR!
asif
Anthony,
Yesterday I e-mail the "CEO" also and got a prompt reply! I guess if you do not have anything to sell or do you would sit next to a computer and reply e-mails!!
My complain was pretty similar to yours and I asked him, 3 years in business what have you got to show?
Food business is a in favor--out of favor business, how long before a copy cat product will over take these guys?
My point was very straight forward, show us the sales or everything else is a just a "fluff" shell game.
He did not like what I said but neither do the investors who have been sitting around for something to happen!
asif
Dilution>>>>>>>>>>
I think this decline can be attributed to someone selling on pretty sustain pace.
The question is why are they selling?
Why would Mantour sell when they will benefit from the rise in PPS
Is someone selling their warrants?
What is the point in selling at this stage, the study results came in great?
Anyone has a opinion.
asif
asif
What is going on? What does it take to get this over >5.00. I do not know what MM are doing here?
Anything else would have flown off the top and gained atleast 100% on news of this magnitude.
asif
I am confused........
According to the PR today are they saying the trial have begun?
Then why do they say that first patient will get dosing in mid summer this year?
help>>>
flyasif
I read the article
Are there any misrepresented facts in what Ian said in his article? I do not see anyone refuting what he pointed out?
This would be a good DD if anyone can refute anything? do the Kay sisters indeed run the other company including the brother KAY?
asif
Here is a new way to get stem cells
I am not sure if this was posted but this is through Newsweek report, stem cells galore without embryo!(Long Article)
All Natural: Why Breasts Are the Key to the Future of Regenerative Medicine
* By Sharon Begley Email Author
* October 20, 2010 |
* 7:08 pm |
* Wired November 2010
http://www.wired.com/magazine/2010/10/ff_futureofbreasts/
To be in the company of Chris Calhoun is to encounter breasts, and encounter the damn things anytime, anywhere—including over a plate of spaghetti in a bustling Manhattan restaurant.
On this spring afternoon, the 44-year-old CEO of San Diego-based biotech company Cytori Therapeutics pulls out his laptop, launches a PowerPoint presentation, and there they are: conical and cantaloupy, As through Ds, beige and pink and taupe and tan, more breasts than you might see in a women’s locker room, never mind in the middle of a lunch table.
A passing waiter does a double take at this lively slide show, but Calhoun is oblivious. He’s talking excitedly about how these women’s bodies led him and his team of scientists to a discovery in tissue engineering, a process that could well be one of the most momentous medical advances of the 21st century: the use of stem cells—specifically stem-cell-enriched adipose (fat) tissue—to enhance, heal, and rebuild injured or damaged organs.
A few taps on his laptop reveal the unsettling “before” images of these seemingly normal breasts. There: a breast with a divot the size of a plum taken out of the bottom from a lumpectomy. There: a chest as flat as a floor mat from a double mastectomy. There: one so misshapen after a partial mastectomy, it’s possible to determine what it actually is only because of its healthy companion. “We realized that for these women there was a huge unmet need for a disruptive change in technology,” Calhoun says of the work that has consumed his team of researchers and surgeons for the past eight years. “It’s the first practical cell therapy.” He pauses. “And it’s breasts.” Which means cancer victims with breasts mutilated by surgery—as well as women who are simply unhappy with their natural assets—can now grow a new and improved pair, with raw materials harvested from their own body fat.
But breast augmentation is just one development (so to speak) in the company’s more ambitious plan: to introduce stem cell medicine to the mass market—and not using the ethically fraught kind of stem cells from human embryos. Instead, based on almost a decade of trials that Cytori and its academic partners have performed on cell cultures, lab rodents, and now humans, they believe their engineered flab cells can treat more organs than you find in a French butcher shop. Chronic heart disease? Check: In human studies released in May, the cells improved patients’ aerobic capacity and shrank the size of the infarct (tissue killed by lack of blood). Heart attack? Check: A human clinical trial, also reported in May, found that the cells increased both the blood supply to damaged heart muscle and the volume of blood that the heart pumped. Kidney injury as a result of cancer therapy? Check: In recent rat studies, the cells improved kidney function. Incontinence after prostatectomy? Check: Another recent study reported that, by 12 weeks after injection, the cells had decreased the amount of urine male volunteers were leaking by 89 percent. If Calhoun and his scientists succeed, they won’t just create more cleavage. They’ll make practical a whole new field, one that medical visionaries have dreamed of for decades: regenerative medicine.
It makes sense to apply Cytori’s technology to enhance breasts instead of, say, repair urinary sphincters as a strategic way to move the patented technology out of rats and into people as soon as possible. Hearts, kidneys, and even sphincters have to work in order for us to survive. But we can live just fine without breast tissue, and, outside of feeding offspring, breasts don’t have to do much. The fact is, the scientific and regulatory hurdles to getting Cytori’s cells into clinical use will be easier to clear for breasts than for other tissue: Breasts simply aren’t as necessary as other organs, so the bar for proving to regulators that the technology works will be lower.
It’s also a booming market. In 2009, women forked over $964 million to plastic surgeons for breast augmentation, which edges out nose jobs as the most commonly performed plastic surgery in the US.
Photo: Robyn Twomey
If Calhoun and his team succeed, they won't just create more cleavage. They'll make possible a whole new field: regenerative medicine.
Photo: Robyn Twomey
More is driving that trend than just media-hyped views of beauty. Breast cancer is a major factor. Incidence of the disease has risen from 105 per 100,000 women in 1975 to 125 per 100,000 today (though it peaked at 141 per 100,000 in 1999), and the survival rate has increased: 75 percent of women diagnosed in 1975 lived at least five more years, compared with 90 percent today. That means more women will live more years after a lumpectomy or mastectomy. Most of these survivors would just as soon live those years with something that resembles what they had before, thank you very much. Yet only 30 percent of women facing mastectomy are even offered a consultation with a plastic surgeon, notes Michael McGuire, president of the American Society of Plastic Surgeons and an associate professor of surgery at UCLA. And only 25 percent of women who lose a breast to cancer get a new one. (In 2009, there were 86,424 breast reconstructions.)
There is also demand from a burgeoning demographic no one would have predicted 15 years ago: young women choosing bilateral prophylactic mastectomy after testing positive for mutations in genes—known as BRCA1 and BRCA2—that increase the risk of breast cancer by a factor of five compared with that for women without the mutations. Others are diagnosed with cancer in one breast, have a mastectomy, and decide to have the healthy breast removed as well. In a 2009 study of women undergoing all forms of surgery for breast cancer, published in Annals of Surgical Oncology by researchers led by surgical oncologist Todd Tuttle of the University of Minnesota, 29 percent opted for this “contralateral prophylactic mastectomy.” Among just mastectomy patients (that is, excluding those who had a lumpectomy or other breast-sparing surgery), the rate of taking out the good with the bad was an astounding 56 percent—even though studies find no survival advantage in removing the healthy breast. Yet Tuttle hears it all the time: I never want to go through this again. “Younger and more- educated women are the ones choosing to go this route,” he says. And despite the improvements in silicone implants, they’re still vulnerable to ruptures and may eventually need to be replaced. What’s more, inserting a single implant after cancer surgery can leave a woman asymmetric: It stays put while the surviving breast sags. It’s no wonder, then, that women all over the world are desperate for a better option.
Here’s the weird thing about breasts: They are a point of obsession, vulnerable to the mercurial whims of mass culture. But one thing remains constant: In every era, a whole lot of women are convinced they have the wrong kind.
For better or for worse (mostly for worse), science, or a rudimentary facsimile thereof, has always been eager to help. European women of the 16th century applied a cumin-seed paste with a cloth soaked in water and vinegar to their breasts to keep them small and firm. In the late 1800s, the Princess Bust Developer consisted of a cream and a nifty device resembling a toilet plunger to increase cup size. Starting in the 1940s pinup era, there were liquid silicone oil injections for breast enlargement (bad idea: leakage, inflammation, granulomas) followed, in 1962, by silicone-filled implants.
Given this history of far-fetched augmentation schemes, it’s not entirely unfathomable that a plastic surgeon would one day realize the secret to enhanced breasts was hidden in a pair of love handles. In 1999, Marc Hedrick, then an assistant professor of surgery at UCLA, was doing yet another liposuction, and not a little suck-out-a-few-ounces-around-my-thighs-please-doctor procedure, either. He vacuumed 8 liters—more than 2 gallons—of fat from his patient. Scientists had long wondered whether fat tissue might contain stem cells. “If it does, then here we are, stupid plastic surgeons, doing the stupidest procedure on the face of the earth,” says Hedrick, 48, now sitting in the La Jolla, California, offices of Cytori, which he cofounded in 2002. “I’d just taken 8 liters out of some woman and dumped it in the trash. I asked myself, are there really stem cells in there?”
Meanwhile, a postdoctoral fellow named Min Zhu had become bored with the rheumatology research she was doing and was looking for a new field. She joined Hedrick’s lab in spring of 1999, and he set her to the task of finding out once and for all whether there were stem cells in fat. Determining the qualities of a stem cell (versus a regular one) requires proving that it can differentiate into many cells, but Zhu hit a brick wall even before she could attempt that: After she isolated candidate stem cells from fat, the things refused to grow, let alone differentiate.
Her breakthrough came when she figured out that rather than using the standard fibroblasts as feeder cells in her culture, she would use blood. “She just brute-forced it,” Hedrick says. “She was forging her own trail—with a machete.” Using blood to nourish and grow the stem cells, Zhu managed to induce them to differentiate into three lineages: first bone and cartilage, then muscle, and then neuron. She walked into Hedrick’s office and said, “I think I have something.” In April 2001, the scientists published in the journal Tissue Engineering their discovery that adipose tissue is chock-full of stem cells.[color=red][/color]
At the same time that Zhu was making her breakthrough, Cytori’s Calhoun was running a medical device company called MacroPore Biosurgery, and one of his salespeople told him about a plastic surgeon at UCLA named Marc Hedrick, who was doing some interesting tissue work. Curious, Calhoun arranged a sit-down with Hedrick. After some pleasantries, the surgeon dropped his bombshell: We’ve found stem cells in fat tissue. And it’s the mother lode. The cells are in the padding around hips, thighs, abdomen, and flabby upper arms in such quantity that it isn’t even necessary to culture them—get them to grow and proliferate in lab dishes—to harvest an abundant supply. There is roughly one adipose stem cell per 100 fat cells. (By comparison, bone marrow contains one per 250,000 to 400,000 cells.) “Marc said, we can get these cells out, it has nothing to do with embryos, and their potential is enormous,” Calhoun recalls. “I loved him the moment I met him.” That love was worth $1 million, the amount of MacroPore’s money that Calhoun invested in the company Hedrick was starting, called StemSource.
By 2002, Calhoun had persuaded MacroPore’s board to sell a division of the company to Medtronic, the big medical-device maker, for $21 million. Calhoun turned around and used the cash to buy StemSource, inking the deal in October 2002. (MacroPore changed its name to Cytori Therapeutics in July 2005.)
Although StemSource’s original business plan had been to bank stem cells, once it had been acquired by MacroPore, the focus switched to therapeutic uses for those adipose stem cells. Since Hedrick’s surgical practice focused on children with facial defects, he thought the cells could be coaxed to make bone in kids with a cleft palate. But as he and his UCLA team did more studies, Hedrick says, “we realized that although the cells could make bone, what they were really good at was making a new blood supply. We felt like if we could target that, it would be the key to every ischemic disease,” in which tissue dies for want of an adequate blood supply—and therefore oxygen. “That led us to reconfigure the company to investigate using the cells for heart attack patients.”
As he and his team conducted rodent studies for heart disease (at one point, Cytori had hundreds of animals in its labs), Hedrick thought if adipose stem cells could yank heart tissue back from death’s door by restoring blood flow, maybe the cells could keep other tissue alive and healthy. The radiation that women typically undergo after lumpectomy or mastectomy, for instance, damages the surviving tissue and destroys the local blood supply. “The tissue gets hard, and that makes it difficult to reconstruct or put an implant in,” Calhoun says. And thus the idea of using adipose stem cells to reconstruct the breast was born.
By 2003, Hedrick and Calhoun were pushing ahead with research on using their stem cells to repair hearts damaged by heart attack or chronic disease. But at the same time, they were grappling with the challenge of repairing patients after partial mastectomy and lumpectomy. It’s something that’s always been a problem for surgeons: Building only part of a breast with conventional methods, it turns out, is more difficult than constructing a whole new one, because it requires what UCLA’s McGuire delicately calls “local tissue rearrangement and/or flaps rather than implants.” In other words, the doctor squeezes and smooshes and moves tissue to fill in divots and missing quadrants and, with luck, turns what might have been reduced to an A cup during a cancer operation into a match for the B or C on the healthy side. The result, alas, can be “very much less than optimal,” McGuire admits. “It’s difficult to re-create the shape.” And ironically, given how grateful most breast cancer patients are if they can have a lumpectomy rather than a total mastectomy, such breast-sparing surgery can leave a woman with an aesthetically irreparable breast. With tumors smaller than an inch across, lumpectomy leaves a gouge of up to twice that size, says surgeon Jan Vranckx of Leuven University Hospitals in Belgium: “Breast-conserving surgery is good at keeping the cancer from returning only if it is followed by radiotherapy, but that leaves scars and rigid, badly healing tissue. Yet the defects are often regarded as too small to do a full reconstruction.”
Calhoun and Hedrick wanted to test their cells on the damaged breasts that other doctors couldn’t be bothered with. But Hedrick knew that bringing adipose stem cells into the clinic required more than biology. It also required technology. When Hedrick originally outlined his vision for Calhoun in 2000, he showed him drawings of a device to isolate the stem cells from liposuctioned fat en masse. “We were thinking a box,” Hedrick says. “We need some kind of box.”
After $200 million in R&D, the “box” became the Celution System. It looks like a souped-up photocopier. But instead of taking in originals and spitting out replicas, it turns liposuctioned fat into breast-making gold. The process to fix a lumpectomy divot begins when a surgeon pierces a patient’s tummy with a syringe and sucks out about 360 cc (12 fluid ounces) of fat, which is the pink-orange color of a Pacific sunset. Each syringe takes about five minutes to fill; to treat an average divot requires eight to 10 syringes’ worth. The fat is squirted into the Celution device. A proprietary mix of enzymes digest the scaffolding that holds the tissue together, freeing the cells; the centrifuge separates the adipose tissue from the stem cells, which form a pellet at the bottom of the tube. Those cells are then combined with some of the remaining liposuctioned fat-tissue cells. The result, now a pale pink suspension containing millions of the stem and regenerative cells, is ready to go. The whole process takes about two hours.
It’s worth pausing here to ask just what, exactly, these magic cells are. Cytori calls them adipose-derived stem cells, or adipose-derived stem and regenerative cells, and sometimes adipose-derived progenitor cells. “These things have gone through the ringer in choosing a name,” says biomechanical engineer Kent Leach of UC Davis, who has used whatever-they-are to treat bone cysts in racehorses. A stem cell, by definition, is able to differentiate into any of the 200-plus kinds of cells in the human body, just as the cells of a days-old embryo can (and do). Cytori’s are unlikely to ever show that range of differentiation. But they can differentiate into fat, bone, and muscle—among other tissues—depending on which signaling molecules they are exposed to. In a petri dish, the scientists provide those “this is what you will be when you grow up” molecules. In nature—that is, an embryo in a womb—biology somehow does.
Now that they had their box, the Cytori team faced one more hurdle: finding suitable subjects. “There aren’t good animal models for breast reconstruction after cancer,” Hedrick says. “That’s why we went to humans so soon.”
They found their humans in Japan, where the company had connections to surgeons through their business partners. But Japan made sense for another reason: There, the disfigurement of a mastectomy or lumpectomy is tantamount to social banishment. Much of a traditional woman’s social life centers on public baths, and those whose breast cancer has left them deformed seldom go. When Keizo Sugimachi, a surgeon and president of Kyushu Central Hospital in Fukuoka, learned what Cytori was developing, he launched an investigator-initiated (as opposed to Cytori-sponsored) trial, dubbed Restore 1. Over the course of six months in 2006, he treated 20 women who’d had a partial mastectomy two to five years before. It was also the first clinical use of Cytori’s Celution System. Hedrick assisted on nearly all of the procedures and helped orchestrate how each would progress. They developed it all on the fly, using a lot of guesswork. How much fat do you extract? How many cells do you add back into the mix? How do you combine the liposuctioned fat with enzymes and growth factors and the other magic potions (all trade secrets) in the Celution machine? Do you overtreat, giving a woman more cell-enhanced tissue than you think is needed in case some of it doesn’t take? Where do you make the incision in the breast to inject the cells? How do you deal with scarring from the radiation most mastectomy patients get after surgery? “I think we just guessed right,” Hedrick says. “We solved a lot of the problems in the first operation. If it didn’t work, it was because we put too much in, or didn’t treat the scar, or didn’t prepare the tissue bed right.”
They got better with each case, improving the protocol as they went. In December 2007, Sugimachi told the San Antonio Breast Cancer Symposium that all 20 of the women in Restore 1 tolerated the procedure just fine, none had an immune response, and 79 percent were satisfied with the outcome. There was no significant loss of breast size between one month and the final assessment 12 months later. That was a crucial barometer, given what happens when plastic surgeons inject fat alone, which was a popular cosmetic-surgery technique in the 1980s and 1990s: The injected fat tended to vanish into the surrounding tissue several weeks later like butter into the crannies of a hot English muffin. (Women who opted for this method were encouraged to think of breast enhancement like a dye job—once the effect fades, go back for another session.) But Cytori’s adipose stem cells stuck around.
This is because Cytori’s cells are not becoming breast tissue, as you might assume if you heard that someone was using stem cells for boob jobs. You don’t sprinkle the cells in petri dishes and come back in a few weeks to find a crop of breasts. Instead, the fat cells in the Celution mixture provide the volume, filling the divot in the lumpectomy, the missing quadrant in the quadrantectomy, or the empty skin pouch in the mastectomy. Think of them as the big dumb grunts of the battalion. The regenerative cells in the mixture encourage the growth of a blood supply. They’re the clever engineers who provide the supply lines that the fat cell grunts need to survive. And that combination is what promises to distinguish the breasts built with—and now let’s switch to the more accurate term—adipose regenerative cells from those built with fat injections alone. “If you give the tissue blood, it will survive and not be reabsorbed,” Leuven University’s Vranckx says. Sensation is about as good as before since the relevant nerves are in the skin and muscle (and, with lumpectomies, the nipple remains intact).
It’s the cells’ ability to induce the formation of blood vessels, however, that also makes them attractive as therapy for ischemic heart disease. Although some researchers have claimed that adipose regenerative cells can differentiate into epithelial cells, which can form capillaries and other blood vessels, the evidence is pointing to something more modest but no less useful: The cells churn out proteins, among them vascular endothelial growth factor, that induce surrounding cells to form blood vessels. As a result, cells that had been starved for blood and therefore oxygen are suddenly awash in both.
If the science part of this was figuring out how to process the fat in the box, the art comes in doing the injections. You don’t take a big syringe full of the stuff from the Celution machine and cram it into the breast as if you were filling a cannoli. You meticulously inject hundreds of tiny dollops, like a pè2tissier making little rosettes with a piping tube on a fancy cake. To accomplish that, Cytori created the Celbrush. It has a blunt tip to make tiny cuts that break the scar tissue, transforming it into a biological mesh. As the Celbrush is moved, the surgeon turns a wheel, which releases the tissue half a cc at a time. “You do that hundreds of times and you create a lattice with stem cells,” Hedrick says. Adds Calhoun, “It’s really as close to sculpture as anything done in plastic surgery today.” The injection area is not painful afterward, while the liposuction site is only slightly sore. Patients go home that day.
A clinical trial in Europe in 2008 and 2009, called Restore 2, used the next generation of the Celution machines, also with tantalizing results. It studied women who’d had a partial mastectomy, including Irene MacKenzie, 51, who works for the national health service in Scotland. She was diagnosed with breast cancer six years ago, and after a partial mastectomy was told by her surgeons that reconstruction wasn’t necessary, let alone possible.
MacKenzie had heard about a surgeon, Eva Weiler-Mithoff of the Glasgow Royal Infirmary, who might be able to help. MacKenzie sought her out and in the spring of 2008, Weiler-Mithoff called and told her about the Restore 2 trial, for which she was a lead investigator. MacKenzie signed on. She liked the results but in January 2009 returned to Weiler-Mithoff for another go. “She told me maybe we should have put more cells in, so I went back,” says MacKenzie, who now pronounces herself delighted with her new breast. In December 2009, Weiler-Mithoff told the San Antonio Breast Cancer Symposium that the procedure improved breast deformity in most of the 31 patients who were assessed, with the new breasts holding up for the six to 12 months that the women had been followed. How the new breast felt and moved on the chest wall kept improving. “One of the most striking aspects of the trial was how happy the patients were” with their new breast, says Weiler-Mithoff, who compares the injections to putting in “little pearl strings of fat.” The women, she says, “felt whole again.” MacKenzie’s need for a touch-up, however, shows that not everyone gets the desired results the first time. In fact, all but one of Vranckx’s post-mastectomy patients needed at least two procedures. The Celbrush, after all, is the instrument of an artist. “So far, we’ve been able to repair defects that we couldn’t before,” Vranckx says. “But it can take eight hours to do two breasts—eight hours bringing one droplet after another to the breast. It’s sculpting, and not everyone can be a sculptor.”
Restore 1 showed that Cytori’s cells could rebuild breasts lost to cancer. The next logical step was trying it out for breast augmentation. Perhaps not surprisingly, once again this happened in Japan. The country has a strong and entrenched cultural prejudice against putting anything foreign into one’s body; organ transplants were slow to be adopted in Japan and still remain rare. But if that ick factor is the immovable object, the Western-inspired desire for bigger breasts is the irresistible force.
In late 2007, cosmetic surgeon Tatsuro Kamakura of Cosmetic Surgery Seishin in Japan began a study of the Celution System for breast augmentation, eventually enrolling 20 women. In 2008 he told the Congress of the Japan Society of Aesthetic Surgery that the first three patients kept their new volume and that the tissue remained soft and natural. He had injected an average of 160 cc of stem-cell-loaded fat droplets, boosting breast circumference an average of 4 centimeters (1.6 cup sizes). In commercial use, a new breast could run about $2,000 to $2,800, depending on physician charges. “It’s probably a $1 billion market,” Calhoun says. “You can buy an appliance with a 30 to 40 percent unpleasant rate or you can use your own cells. Which would you choose?”
But the possibilities aren’t boundless. “It’s not a substitute for implants for women who want to look, um, unnaturally large,” Hedrick says. “You can’t take a flat-chested woman and make her look like a dancer at a strip club. We’re not targeting that market. If they don’t care about looking natural, let them do silicone. The goal of this is a natural, soft-tissue feeling. Plus, there is a whole new market of women who would love another 100 to 200 cc but would never have an implant. I think that’s bigger than the current breast implant market”—a sea of women who wouldn’t consider a silicone implant but who would be intrigued by the opportunity to have their breasts plumped with cells from their own bodies while reducing the fat in their hips and abdomen to boot.
Typically, experimental medical treatments go through years of testing in animals before they reach people, but as women in Japan were being treated with Cytori’s cells, the company was still conducting studies on animals to assess the safety of the procedure. As recently as 2007, Cytori’s principal scientist, John Fraser, was performing key experiments on mice. The problem is that the reason adipose regenerative cells work—inducing the formation of blood vessels—is also the reason they might be dangerous, especially to cancer survivors. Such angiogenesis, after all, is what allows metastatic tumors to thrive. But Fraser’s experiment showed that in mice, the adipose regenerative cells did not trigger the formation of breast tumors, promote their growth, or cause them to metastasize to the lungs. The human trials have not followed the women for very long, so it is still possible that a dangerous side effect like cancer—much worse than needing a touch-up, as Irene MacKenzie did—will emerge.
“People do challenge me: ‘Why are we moving so fast?’” Fraser says, standing in a corridor adorned with posters of scientific results he and his colleagues have presented at conferences. Hedrick jumps in: “It’s because we think like doctors taking care of patients. We have a lot of doctors working here. When we felt there was clear sailing, we hit the gas pedal. Where we felt there were obstacles, we slowed down.” Adds Fraser, “We’re not cowboys.”
They might find themselves in an industry shoot-out, however, as the allure of adipose-derived stem cells has drawn other companies to the field. The most flamboyant is AdiStem, based in Hong Kong. Its process, like Cytori’s, begins with liposuction. The fat is mixed with enzymes and centrifuged, then the precipitated cells are centrifuged again. That, however, is where the similarity ends. AdiStem next mixes its cells with plasma and exposes them to laser light, the company claims, to photoactivate stem cell functionality. CEO Vasilis Paspaliaris says the resulting cells can then potentially be used to treat autism, idiopathic pulmonary fibrosis, osteoarthritis of the knee and hip, type 2 diabetes, acne scarring, and hair loss, as well as in post-lumpectomy cosmetic reconstruction. Although Paspaliaris says all the results seem promising, he believes “the most convincing” are those for the face. Some Los Angeles cosmetic surgeons are already using the AdiStem process with face-lifts.
These claims have raised eyebrows. It hasn’t helped that AdiStem posts videos of its autism “treatments” on YouTube or that there are no peer-reviewed scientific papers on use of photoactivation to increase stem cell functionality. AdiStem “is one of many small opportunists who are jumping on the adipose-derived stem cell bandwagon,” Calhoun says. “At the right time, we will protect our markets and enforce our patents, but at present it seems to be a potential waste of capital, resources, and energy.” Cytori’s bigger concern is that although these companies may pose no competitive threat, they are a PR disaster waiting to happen.
Although regulators in Europe and Japan were satisfied with the animal and human studies Cytori submitted for approval of the Celution machine, the US Food and Drug Administration has yet to weigh in. Vranckx, who met with FDA officials, says that despite Fraser’s mouse experiment, the agency is worried about injecting blood-vessel-promoting cells into patients who have had breast cancer. But although Cytori can’t market its Celution System without FDA approval, doctors can purchase it, just as they can prescribe a drug approved for one use for a completely unrelated purpose but can’t advertise it for that use. In fact, the FDA takes the position that as long as cells are removed and returned to the same person in one procedure, a physician does not need approval to do it. Still, without FDA approval, Cytori can’t promote its device; without promotion, it is unlikely to be widely adopted. Cytori is currently in discussions with the FDA for permission to conduct a clinical trial of its device. If the trial is a success—in particular, if there are no adverse effects from the cell injections—the next step would be to seek FDA approval for the entire process or conduct a second trial. Although a lot could still go wrong—surprises in clinical trials have killed many an experimental drug and device—Calhoun hopes positive results will launch his billion-dollar vision of regenerative medicine.
There is one other key feature that the next-generation Celution machine shares with a photocopier, as Calhoun demonstrates. Just as the latter has a touchscreen control panel that displays options (paper size, number of copies, magnification), so does the Celution, only here, the options are organs. “See? There’s a picture of a breast, a heart, a disc in the back,” he says. “You push that and the machine loads different software, which adds the right drugs,” reagents, and other biochemicals to the liposuctioned fat cells. He envisions an iPhone-like business model, with individual doctors devising apps to repair different organs with the perfect slurry of adipose regenerative cells. If it works, the breasts on his laptop will have plenty of company.
Sharon Begley (sbegle@aol.com) is science editor and a science columnist at Newsweek.
I think part of this downtrend is related to dilution
Also I should say from the presentation the trials are pushed back to begein "first Half of 2011"
Why would people hold on to shares they know are going to trend down and not lock in profits. Major news will come from trials and that is 6-months or more from now!
flyasif
Rumit, thanks for the PPT presentation
On page 12 it says.............
Able to pay for both clinical trials, but that will likely not be necessary:
Are they expecting more grants from NIH??? they sound pretty confident!
flyasif
Rocky
First time poster, have been watching ACTC and your postings for a while.I am well invested in ACTC.
I want to thank you for non-opinionated and detail postings that just want me to invest even more and believe in the science more.
I have seen other boards such as NNVC where questions are ridiculed and opinions are manipulated.
Thank you again for being a good moderator. Let us see what the science brings for ACTC and investors.
asif
Hey Nanopatent
People here do not like anything but NNVC here.
I am with you on this RNAi technology, not just because it is RNAi but they have actually proven it works and are in PHASE I trials! Many of them have products close to PHASE I or IND.
Companies such as AVI or ARWR or MDRNA are ALL geting funding from federal research grants because..............they have proven it works!
NNVC by the way keeps on promising and dangling a carrot or PR every week............
asif
I ask the question again anyone???
This is my question
As you are very familiar with current HIV therapy being an MD, isn'nt it true that CDC recommends treating HIV exposure within a hour or two with HAART therapy?
Why do you think that is?
asif
This is my question
As you are very familiar with current HIV therapy being an MD, isn'nt it true that CDC recommends treating HIV exposure within a hour or two with HAART therapy?
Why do you think that is?
asif
Tell me if I am wrong..
I do not think we have anything but NNVC cides providing chemically similar LOCI(similar to T-cell surface loci) for the virus to adhere and thus render it ineffective.
It can be compared to Key-Lock theory where only one enzyme can digest one chemcal or one NNVC particle can mimic site of attachment for viruses just like a T-cell would.
In order for NNVC to stop infection CIDES must be present in overwhelming numbers so no cell surface(especially where that particular virus like to attach eg. lung tissue in case of FLU) at the onset of infection is spared. Now that is little far fetched since viruses and especially Herpes viruses as we know stays dormant in organs and tissues for long time---like HIV.
So when virus is ready to come out of cell there may be NO cides around, this if cured can be called a functional cure.
asif
Doc FG How early
in a infectious process does the NNVC cide needs to be in the body for it to be effective?
Like that tekmira study, do we know that NNVC cides will be effective in preventing viruses from attaching and infecting cells let me say 2 hrs post infection 12 hrs post infection??
Do we know? I think by then virus will have already infected many thousands of cells.
asif
Think with me..
introducing DNA?RNA in a cell is offcourse have it's own challenge but imagine there are many many RNA generated (mRNA) daily every moment, what happens to them once their transcription job is over?
They are discarded by cell as waste. So a RNAi particle when it renders a viral RNA/DNA useless that also gets discarded by cells porin functions probably( I am not the expert on this)
asif
Let me try to explain...
If you get a infection...let's say viral infection. Viral particles will be circulating in the body via blood stream and try to find the tissue of affinity...eg. liver cells, lung paranchimal cells etc.
NNVC or anyone who wants to kill this virus must maintain a ongoing presence of CIDES all the time in the body in order to NOT let the viral particle attach to the cell.... CIDES have to present ALL THE TIME! (that is why vaccines with circulating antibody work better with viruses---one reason)
No imagine the speed at which a virus infects a cell, there is no way a person can have injection of a NNVC cide to stop it from entering a cell or many cells.
So here is the exciting part to have a drug or RNAi technology which can actually get to the interior of cells and block the replication of virus very effectively.
Hope this helps
asif
I do not have problem with time it will take...
I know it takes years to get all testing and approvals through FDA, that is given.
It has been claimed here and through e-mial with CEO that "exciting news are coming" just after the QP was getting over.
One can imagine that the "news is coming" is of tests that were COMPLETED, one that were being done since last year. What do we het a big THUD!
HQ was eager to release DENGUE results. Dengue testing was initiated just month or two ago, so if we can release results from this Dengue testing so fast, it is legitimate to ask where are the past due result of tests initiated before DENGUE?
asif
This is such a cool concept!
By the way this Alnylam Pharma and Tekmira are affiliated.
I am just amazed that scientists can cleave a RNA at a specific loci and use it as a primer to either generate new proteins or in this study substitute a "dummy" particle in the RNA base pair.
RNA are the workhorse of the cell so if you deny transcription you can block replication within cell or it's by products.
Just amazing science!
asif
Nano, you are the voice of reason here and source of immense search talent.
Well to answer your question, my education degree as a microbiologist is from India.
I did some post graduate work in biology here and also MBA. When you talk about Dr Harris's work and what she can do for Hunduras, I have first hand witnessed that in India, I used to organize medical camps in villages from my college. We took some Physicians and Pharmacists etc to rural areas and try to help people who literally have no income, no resources, house of mud, no clothes to wear...
Here in US I have interest in research, I have been "investigator" for drug companies, major Pharmas validating their drug studies.
NNVC and other biotechs interest me for monetary reasons offcource but the microbiologist in me wants to see that detective work done and solve a disease such as HIV, FLU, Smallpox, Polio etc.
So I invest in my life's passion hoping they will come through and somehow I may have helped that little child somewhere in rural India or Russia or Honduras. That is it, I do not short stocks, heck I do not even know how to do that. I would like to see NNVC succeed but sincerely I am disappointed by the lack of transparency.
That is my story.
asif
Published article! WOW!
Universal treatment for influenzae, needs more development but where does that leave NNVC with it's unpublished claims of FLUCIDE?
Also I should point out Dr Tenover is a big wig in microbiology, a very respected fellow with great work, I have been luck enough to attend some of his seminars.
asif
The testing protocols for vaccines are totally different from anti-viral agents. Anti-viral agents can show efficacy in hours to days (Post from Daysonthebeach)
Really?, where are the results then?
Ovidius you have always maintained your view
I agree with you. I do not care if the stock was going down but what makes me angry is the FLUFF PR and no news from the testing that was suppose to be done almost a year ago?
How aboutn this for argument: If Dr Seymour was able to release Dengue PR within a month or so of "efficaious result on Dengue" then where are the results from almost a year ago?????
NNVC or CEO or this board members cannot claim that it takes LONGGGGGGGGGGGG time to VET out the results. If the results were even marginally good they would be out! just like dengue( marginally good).
asif
>"Just to set the terminology straight, microbiologists use "petri dishes"<
Just to clarify your terminology, I did not say viruses grow on "AGAR" medium I know that is where bacteria grow PLUS if you want to you can grow viruses in petri dishes.......how...
Lay a confuent growth of let's say E. coli and then introduce E. coli PHAGE particles(viruses)....you will see the distruction of the E. coli growth by invading viruses!
Also I have grown viruses in " petri dishes" all you need is cell line adhered to the petri dish and provide growth suplement every 24-48hrs and you will have viral CPE specific to virus cultivated.....should I explain CPE?
FYI.... Microbiologists are more than bacteriologists, they are also Mycologists, Virologists, Mycobacteriologists and Parasitologists.
asif
Doc FG building trust is a procedural thing for me, nothing personal against NNVC or it's management.
Here is what I would have done(consider me nobody)if I were NNVC
(1) I would not hint on release of any results to a "CHAT Board"
(2) CEO should stop replying e-mials, hire a PR person
(3) Fix the damn website and post everything current on it
(4) Release the past due testing results ASAP even if they stink!
(5) Terminate the contract? with "Big Pharma" never heard of a
"secret pharma" deal which is not so secret, it's a drag on
stock. If EKC-cide was soo good you will find someone else.
(5) Get your legitimate work published in journals, get some
credibility in market place.
I only take what the management gives me as news I can trust, my judgements are based on my own thinking. Never have shorted this or any other stock.
If I do not like what a company is doing I just liquidate my position untill(if ever) that scenario is resolved.
asif
AZ I never took profits.........until last week and this week
When you begin to doubt, like you said " you just do not know why they would not release results" to me that is the signal in my mind to move on and catch the bus later.
I will wait for the PPS to reach a certain point at which I will be comfortable to get back in.
asif
AZ you make your own judgement call
Do your DD, compare to successful companies, stocks move on trend and emotions of the market in IMO. Emotions are fueled by great product, PROVEN success and what is in the basket of products.
My personal opinion(you do not have to care for my opinion at all) is that we are on a down trend, I do not believe(personal opinion) management has proven anything but initial petri dish tests and they are downright holding back results IMO.
Be careful with your money! no need to get carried away with endless cheerleading.Take your profits when you can.
asif
>"First we have to get through the Pavlovian
response to "Sell On news."<
I know many here will believe only what we choose to believe but if the above quote was true then let's compare apples to apples>
NNVC: $1.61
-0.12 (6.94%)
Volume
333,346 (Above Avg)
Tekmira: $1.45
+0.2303 (18.90%)
Volume
92,400 (Heavy)
News of substance always illicits response and above is the response!
asif
Here is the Quote of the Day!
Quote by George Bernard Shaw,'all progress depends upon unreasonable people'
If asking questions and finding answers in relation to NNVC is considered unresonable(on this board) then so be it! Call me unreasonable!
asif
Nano I agree with you
Anyone can please shoot a e-mial to Dr S? (I am not doing that anymore)
We get those damn Viruses both in and outside of the cells!
asif
>"However, it does mean that Ebola-Cide will be lowered in its priority".
Yes, and that is fine. May be the market share is not so much for NNVC to go after Ebola.
My concern is that if NNVC starts loosing ground then that unigue nature of NNVC technology IMO looses that glamour. I am sure there are other upstarts and Pharmas working on HIV or FLU, who are we to say that we will not loose ground again?
My suggestion to NNVC would be to get their act together and start publishing some of that work. I do not see any merit in NNVC if all I see is debate on IHUB!
Their work has to be debated and published through peer review.
asif
Nano nothing is wacky from you
It would be ideal if NNVC and TIKMIRA can combine forces BUT if I read their technology correctly they already have the drug delivery platform working for them.
asif
Lethal Dose of Ebola
Here is the question: If this test was soo successful and done/confirmed by USMRID then they would have no difficulty getting those SPECIAL VOUCHERS for humanitarian purpose............test was already done by USMRID. IND for Tekmira would be a walk in the park!
In that case NNVC will be left way behind!
asif
Title: Reasoning NNVC
Infla
I do understand your line of thinking or questioning and I agree with website, detailed PRs(instead of finding out on IHUB through CEO e-mails)
You may have different motives but I agree with your thought process. Especially when I see what other biotechs I have invested in such as MDRNA or Tekmira are doing with publications, PR and timely or routinely releasing results as they become available.
asif
Doc FG, do you know of any of the NNVC's work so far have been published in any peer review journals?
I am curious now since I see this tiny company in Canada can get their work published. What have NNVC done with it's claimed success stories, have any of those findings published.
asif
Next phase of work is
Being dedicated just for that challenge. How can you get the medicine to the individual in time or can they formulate something that will work after the exposure and at what interval of time delay.
Great work by Tekmira, may be they will provide great service to men and women suffereing with Ebola or other virus/bacteria in Endemic areas such as Africa.
asif
NNVC should have this kind of line up...........
Tekmira has license or collaborative agreements with a number of leading biotechnology and pharmaceutical companies, including Alnylam Pharmaceuticals Inc., Merck & Co., Inc., Roche, Bristol-Myers Squibb Company, Takeda Pharmaceutical Company Limited, and Pfizer.
Thanks Nano,
That is a astounding achievement, may be Takimira may already have idea on working with other infectious diseases?
Curious, did any of our NNVC's findings make it to any peer reviewed journals? Can someone give me a reference to review it.
I have invested in some siRNA companies and they are not involved in infectious diseases, wonder if the trend will catch on.
asif
and I should believe you because??????? NNVC nor Dr S has promised no such thing.
Second what was promised by Dr S has not materilized so what makes you think I should believe in what your "speculation" is and the PR??
asif
Doc FG is the limitation because we(NNVC) are on OTC market. Is that why NNVC can only sell 1 million shares direct?
If we moved to AMEX will that be higher allowance per year? I hate to see this(Seaside) kind of more deals in future.I Would rather see NNVC sell on open market and see a straighforward dilution.
asif