Cytomedix Reports Second Quarter 2012 Financial Results and Provides Corporate Update

GAITHERSBURG, MD--(Marketwire -08/14/12)- Cytomedix, Inc. (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, today reported financial results for the three and six months ended June 30, 2012.

Separately, the Company announced that it accepted the early termination of the previously announced exclusivity period granted to a top 20 global pharmaceutical company and ceased negotiations for a distribution agreement for the Company's AutoloGel System in wound care, which would have expired August 30, 2012. The $4.50 million received by Cytomedix to date for this exclusivity was non-refundable. The Company is now free to re-engage with other interested parties experienced in wound care to pursue potential partnerships and commercial agreements for the product.

Financial Highlights for the Second Quarter (all comparisons are with the 2011 second quarter)

Clinical and Corporate Highlights of the Second Quarter and Recent Weeks

Management Discussion

Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, "During the second quarter we continued to make significant strides in advancing our position as a fully integrated regenerative medicine company as we achieved a number of key milestones that position us for future growth. In addition, our commercial products posted record quarterly sales and we made important advances with our products and pipeline.

"The agreement to end the exclusivity period and cease negotiations for an AutoloGel distribution agreement is not a reflection of the clinical or commercial value of AutoloGel in wound care, but rather is a result of a unique set of circumstances with the potential partner that precluded arriving at a favorable outcome. I want to emphasize that the decision is in no way tied to the final CMS determination for CED. Moreover, we received $4.50 million in non-dilutive financing for providing the exclusivity period and are now in a position to reengage in discussions with other interested potential partners. We are encouraged by the interest in PRP in wound care since the CMS final decision was published. With the early release of the exclusivity period, we will accelerate discussions with potential experienced wound care partners.

"We were very pleased that CMS reversed its long-standing non-coverage decision for autologous PRP and has now agreed to coverage through its CED program. This provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with AutoloGel consistently experience clinically significant health outcomes. Importantly, payment for the product under CED is expected to be sufficient to cover the anticipated cost of collecting the evidence. We have already begun our interaction with CMS following the release of the final decision memo and look forward to further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."

Commenting on clinical progress with the Company's ALDH bright cell technology, Mr. Rosendale said, "Our Phase II RECOVER-Stroke trial has expanded to new sites and we look forward to our next milestone, which will be the DSMB safety assessment following the treatment of the initial 30 patients. We reasonably expect this to occur during the fourth quarter and continue to maintain that the ALDH bright cell population offers a novel and differentiated cell population with significant clinical upside. In addition we were pleased to report the initiation of a Phase I collaboration with the Duke University Medical Center with funding from the Robertson Clinical & Translational Cell Therapy Program. We expect to announce and initiate another sponsor-funded Phase II clinical study by year end in a peripheral arterial disease indication. These studies are intended to leverage our positive clinical experiences in critical limb ischemia and stroke.

"The first half of the year was marked by significant progress in areas that are important to our strategic plan. We expect the second half of the year to be equally productive as we work toward achieving a number of value-creating clinical and corporate milestones," concluded Mr. Rosendale.

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Cytomedix Reports Second Quarter 2012 Financial Results and Provides Corporate Update

LifeCell gets 50,000 customers in stem cells banking

Chennai, Aug 14 (IBNS)

Stem cells derived from the umbilical cord are known to have the potential to treat over 75 serious medical conditions.

To enhance awareness, LifeCell partnered with model and actor Lisa Ray, who had undergone successful stem cell therapy for treatment of blood cancer.

Lisa continues to endorse the brand.

Whilst India is the worlds largest birthing country, the penetration of the stem cell storage has been a dismal 0.2pc compared to the global average which is between 5pc in the US to as high as 25pc in Singapore.

LifeCell said it believes that poor awareness rate and per capita income are the primary reasons for low penetration in the Indian market, yet is optimistic that India would soon reach the global benchmarks.

Mayur Abhaya, Managing Director and CEO said, When we launched our services in 2004 the medical fraternity was not even aware of the concept of stem cell banking. It was our responsibility to create awareness amongst both the doctors and the expectant parents about its enormous scope in the future."

The stem cell storage industry is growing at a rate of 30-40pc per year. More and more innovative services have been launched in the space of stem cell preservation such menstrual blood banking. (IBNS)

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LifeCell gets 50,000 customers in stem cells banking

Rasheda Ali, Daughter of Legendary Muhammad Ali and Advisory Board Member of BrainStorm, Visits Company Laboratories …

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies and CNS therapeutics, announced that Rasheda Ali Walsh, daughter of the legendary Muhammad Ali, visited the Companys laboratories as well as its cleanrooms at Hadassah Medical Center, where she received a briefing on the companys clinical trial conducted there. Ms. Ali Walsh, an internationally known advocate for promoting research and awareness of neurodegenerative diseases, is a member of the Advisory Board of BrainStorm.

BrainStorms President, Mr. Chaim Lebovits, and CEO Dr. Adrian Harel accompanied Ms. Ali Walsh for a meeting with Prof. Dimitrios Karussis, Principal Investigator of the Companys ongoing Phase I/II clinical trial at Hadassah, and Prof. Tamir Ben-Hur, Head of the Neurology Department. The group discussed the latest innovative treatments for neurodegenerative diseases and BrainStorms leading role in this area.

Having heard so much about the recent positive interim safety report and the outstanding progress being made by BrainStorm at Hadassah, I felt the need to actually meet the team in person, commented Ms. Ali. The amazing work being done here gives a ray of hope to patients and families worldwide that autologous stem cell transplants may be the answer theyve been waiting for to overcome neurodegenerative diseases.

According to Dr. Adrian Harel, BrainStorms CEO, The support and encouragement by world-renowned individuals like Rasheda Ali is important for increasing awareness of the need for a cure for debilitating neurodegenerative diseases. We are hopeful that this awareness will lead to more widespread efforts by governments and health organizations worldwide to fund research in this area and provide assistance to patients and their families.

About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel-Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.

Safe Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as may, should, would, could, will, expect, likely, believe, plan, estimate, predict, potential, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorms forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or managements beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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Rasheda Ali, Daughter of Legendary Muhammad Ali and Advisory Board Member of BrainStorm, Visits Company Laboratories ...

Stem cell cure for implants under research at Toronto hospital

TORONTO To arthritis patients, they still seem like wonders of modern medicine: artificial hip and knee implants that curb chronic pain.

In fact, 14,000 Canadians a year receive hip replacements and more than 21,000 undergo knee replacements, the numbers soaring over the last decade.

If Dr. Nizar Mahomed and colleagues at the University Health Network (UHN) in Toronto succeed with fascinating new research, however, such surgery will eventually become a thing of the past.

The operations are, in fact, anything but panaceas, never really restoring people to their healthiest state, and often requiring replacement when the implant wears out, acknowledges Dr. Mahomed, head of orthopedics at the UHNs Toronto Western Hospital.

With those limitations in mind, the UHN is pursuing research that aims to find a biological cure for joints decimated by osteo-arthritis, the most common form of the disease. Most dazzling among several experiments is a project that uses stem cells to create bone and cartilage, which researchers hope can be turned into a sort of organic joint implant that would fuse with existing tissue and regenerate diseased knees and hips.

Theoretically, the limits imposed on artificial joint-replacement patients would be forgotten.

If we can find biological repair options, then basically were restoring the joint back to its native health state, Dr. Mahomed said. There would be no restrictions. You could go and run a marathon if youd like. And theres no concern that it is going to wear out, because weve basically restored it back to its [original] state of health.

The research is prodded along by the reality of a field that in some ways has progressed little in recent decades. Drugs used today for osteo-arthritis simply treat the symptoms and are essentially the same as prescribed 30 years ago, said Dr. Mahomed.

Joint replacements, the last-ditch treatment, have been around for half a century. Neither is anything like a cure.

One of the UHN projects is generating cartilage and bone using both embryonic stem cells and those that can be extracted from bone marrow, blood or even fat of any adult patient.

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Stem cell cure for implants under research at Toronto hospital

Summer school students help scientists advance stem cell research at USC

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For many Southern California high school students, summer is synonymous with surf, sand and sun. But, for some of Los Angeles' top math and science students, the lure of the beach and traditional summer fun fizzles fast when compared to microscopes, slide kits and real-life stem cell research.

Armed with little more than protective gear and enthusiasm, 20 overachieving teenagers have been clocking 40-hour weeks in the lab at USC's Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research.

Among them is 17-year-old Brian Tom of Lincoln Heights.

Its fascinating because stem cells have all this potential to heal these degenerative diseases like Multiple Sclerosis and Alzheimer's," says Tom, a senior at Bravo Medical Magnet in Los Angeles. "It's amazing how you can create multiple tissues from one cell."

Stem cells offer promise as a treatment or cure for many diseases because they can be can induced to morph into other cell types such as brain, muscle or skin cells. Stem cells can also divide without limit, which gives them the potential to repair and replace damaged tissue.

You can just imagine the possibilities," says Sophie McCallister, a 17-year-old senior at Harvard-Westlake School in Los Angeles. McCallister works with a USC mentor on cardiac cell regeneration.

Two programs, one goal

McCallister and nine other students are in a program that's privately funded by two donors with ties to USC. Meanwhile, Tom and his summer school classmates are studying under a statewide program funded by the California Institute of Regenerative Medicine (CIRM), a voter-created agency that funds stem cell research throughout California.

CIRM has invested $1.7 million in nine high school summer programs statewide for three years.

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Summer school students help scientists advance stem cell research at USC

The making and unmaking of stem-like, aggressive breast cancer cells

Public release date: 9-Aug-2012 [ | E-mail | Share ]

Contact: Garth Sundem garth.sundem@ucdenver.edu University of Colorado Denver

Breast cancers that depend on the hormones estrogen and progesterone are susceptible to treatments targeting these hormones. Take away this dependence and you lose a valuable treatment option. A University of Colorado Cancer Center study published as a featured article in the journal Oncogene shows how progesterone does just this by suppressing a key microRNA, progestins return breast cancer cells to a stem-cell-like state in which they haven't yet differentiated, and are thus more resistant to chemotherapies and more likely to carry a poor prognosis.

"The reason we were looking into the possible role of microRNAs in the dedifferentiation of breast cancer cells into this aggressive, chemo-resistant phenotype is that microRNAs tend to be good, druggable targets. Because one microRNA may regulate many genes involved in a cancerous signaling pathway, we hoped to find one target with many beneficial effects," says Diana Cittelly, PhD, postdoctoral fellow at the CU Cancer Center and the paper's first author. The study was a collaboration between the CU Cancer Center labs of Jennifer Richer, PhD, and Carol Sartorius, PhD.

Specifically, the study shows that progestins regulate miRNA-29 a molecule that helps to decide which of a cell's genes are and are not turned into proteins. This regulation of miRNA-29 creates a cascade that stimulates breast cancer cells to revert back to a stem-like state, marked by proteins CD44 and CK5. In animal models, these stem-like cells helped breast cancer evolve around the blockages of current treatments..

"We can manipulate this miRNA-29 in cell lines," Cittelly says, "and we hope technology isn't too far in the future that will allow us to deliver miRNA-29 in human cancers as well."

Turn off the role of miRNA-29 and the hope is that breast cancers won't be able to gain stem cell-like traits and lose their hormone dependence.

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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

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The making and unmaking of stem-like, aggressive breast cancer cells

Olympic Horse Used Stem Cell Therapy

Ravel, a horse competing at the 2012 London Olympics, underwent stem cell therapy treatment that helped heal a possibly career-ending injury to one of his legs, according to the Helen Woodward Animal Center in California.

Ravel, a regular client of Rodrigo Vazquez of Equine Surgical Services at the center, is believed to be the first Olympian to benefit from a stem cell-based treatment. Ravel is now the highest scoring horse on Team USA at the Olympics.

"Ravel is a high-impact athlete," Vazquez said. "He runs the same risks as any other athlete in a high performance sport and he gets hurt like any other athlete too. But he is something special. He works hard and he's focused and he thrives in his sport. He just didn't want to quit."

The 15-year-old equine athlete, owned by Akiko Yamazaki, was united with his rider Steffen Peters in late 2006. Since then, the team has made history, with Ravel excelling in dressage, which is one of three Olympic equestrian disciplines. It involves riding and training a horse in a manner that develops obedience, flexibility and balance.

Ravel and Peters were the highest placing American pair at the 2008 Beijing Olympics, and have won numerous competitions over the years, including the prestigious Rolex/FEI World Cup in dressage.

Before these victories, Ravel sustained the leg injury. Jessica Gercke, a spokesperson for the Helen Woodward Animal Center, told Discovery News that staff working with competitive horses like Ravel do not wish to reveal detailed information about medical conditions and treatments, since that might affect the perceptions of judges or others.

Vazquez, however, did share that regular check-ups, vaccinations, dentistry and the "emergency treatment with a new technology based on stem cell therapy" helped to heal Ravel after an eight-month break in training.

Adult stem cells can reproduce and differentiate into different types of cells. They continue to be a focus of study for scientists hoping to treat a number of diseases in humans and non-human animals. In horses, to repair cartilage and tendon tissues, scientists have been looking into stem cells derived from bone.

"Bone derived cells in horses are most often obtained from an aspirate (material drawn by suction) of either the hip or sternum with apparent minimal discomfort" to the horse, according to David Frisbie, an associate professor at the Colorado State University College of Veterinary Medicine. "The procedure typically takes less than 15 minutes and can be done standing under light sedation."

Results of clinical studies on horses suggest that stem cell treatment can improve healing rates, overall outcomes, and decrease re-injury rates almost by half. Further studies are needed, however, to better determine dosage and timing specifics.

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Olympic Horse Used Stem Cell Therapy

Stem-cell pioneer banks on future therapies

Shinya Yamanaka aims to produce cell lines from fetal blood cells.

M. Naka/Aflo/Newscom

Progress toward stem-cell therapies has been frustratingly slow, delayed by research challenges, ethical and legal barriers and corporate jitters. Now, stem-cell pioneer Shinya Yamanaka of Kyoto University in Japan plans to jump-start the field by building up a bank of stem cells for therapeutic use. The bank would store dozens of lines of induced pluripotent stem (iPS) cells, putting Japan in an unfamiliar position: at the forefront of efforts to introduce a pioneering biomedical technology.

A long-held dream of Yamanakas, the iPS Cell Stock project received a boost last month, when a Japanese health-ministry committee decided to allow the creation of cell lines from the thousands of samples of fetal umbilical-cord blood held around the country. Yamanakas plan to store the cells for use in medicine is a bold move, says George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts. But some researchers question whether iPS cells are ready for the clinic.

Yamanaka was the first researcher to show, in 2006, that mature mouse skin cells could be prodded into reverting to stem cells1 capable of forming all bodily tissues. The experiment, which he repeated2 with human cells in 2007, could bypass ethical issues associated with stem cells derived from embryos, and the cells could be tailor-made to match each patient, thereby avoiding rejection by the immune system.

Japan is pumping tens of millions of dollars every year into eight long-term projects to translate iPS cell therapies to the clinic, including a US$2.5-million-per-year effort to relieve Parkinsons disease at Kyoto Universitys Center for iPS Cell Research and Application (CiRA), which Yamanaka directs. That programme is at least three years away from clinical trials. The first human clinical trials using iPS cells, an effort to repair diseased retinas, are planned for next year at the RIKEN Center for Developmental Biology in Kobe.

Those trials will not use cells from Yamanakas Stock. But if they or any other iPS cell trials succeed, demand for the cells will explode, creating a supply challenge. Deriving and testing iPS cells tailored to individual patients could take six months for each cell line and cost tens of thousands of dollars.

Yamanakas plan is to create, by 2020, a standard array of 75 iPS cell lines that are a good enough match to be tolerated by 80% of the population. To do that, Yamanaka needs to find donors who have two identical copies of each of three key genes that code for immune-related cell-surface proteins called human leukocyte antigens (HLAs). He calculates that he will have to sift through samples from some 64,000 people to find 75 suitable donors.

Using blood from Japans eight cord-blood banks will make that easier. The banks hold some 29,000samples, all HLA-characterized, and Yamanaka is negotiating to gain access to those that prove unusable for other medical procedures. One issue remains unresolved: whether the banks need to seek further informed consent from donors, most of whom gave the blood under the understanding that it would be used for treating or studying leukaemia. Each bank will determine for itself whether further consent is needed.

Yamanaka has already built a cell-processing facility on the second floor of CiRA and is now applying for ethics approval from Kyoto University to create the stock. Takafumi Kimura, a CiRA biologist and head of the projects HLA analysis unit, says that the team hopes to derive the first line, carrying a set of HLA proteins that matches that of 8% of Japans population, by next March.

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Stem-cell pioneer banks on future therapies

Marin Dog Receives Relief From Stem Cell Treatment

Stem-cell research is benefiting at least one living creature in Marin County, who would otherwise be living in excruciating athritic pain.

Emma -- the snow-white German shepherd.

Vets at the Northbay Animal Hospital injected the dog with stem cells into 10 of her joints, according to the Marin Independent Journal. The $2,000 treatment has given the 9-year old, 80-pound dog a new lease on live, her owners say.

"She doesn't limp any more," said owner Arthur Latno, in comments to the newspaper, "and she doesn't cry."

Latno is "one of the first" Marin pet owners to try the cutting-edge treatment, which not every vet is willing to endorse, the newspaper reported.

"This (the stem cell procedure) is incredibly promising, but on the other hand there is a lot of homework that needs to be done to determine whether these are valid therapeutic measures," John Peroni, an associate professor at the University of Georgia College of Veterinary Medicine and chairman of the North American Veterinary Regenerative Medicine Association told the newspaper.

More studies, like the ones Peroni as well as counterparts at UC Davis are conducting, are neeed, he said.

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Marin Dog Receives Relief From Stem Cell Treatment

Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care

GAITHERSBURG, MD--(Marketwire -08/06/12)- Cytomedix, Inc. (CMXI) (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma ("PRP") in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development ("CED") program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes.

In the final decision memo, CMS noted that it " ...has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment," and concluded that, "when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS."

"We are extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. This determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel System, experience clinically significant health outcomes," commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.

"Importantly, we believe this decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for a favorable long-term arrangement in the U.S. wound care market, as clarity around the CED evidentiary requirements was a necessary element of the commercial market assessment," added Mr. Rosendale. "In the meantime, our discussions for a distribution agreement to be executed prior to month's end are progressing well."

Related to the evidentiary requirements, CMS outlined in the final decision memo that a research study that uses data collected by a registry can enhance its persuasiveness if it has the following attributes:

Mr. Rosendale added, "This decision appears to indicate that our recent interactions with CMS have been productive, as CMS has acknowledged the rationale we presented for a comprehensive research study that can appropriately encompass practical study designs to meet the evidentiary requirements of CMS. We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."

The complete final decision memo is available on the CMS website at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260.

About Coverage with Evidence Development Program

CED is a process through which CMS provides conditional payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program.

First introduced in 2005 and then refined in 2006, CED links Medicare coverage of specific promising technologies to a requirement that patients participate in a registry or clinical trial. Ultimately, the data generated is intended to be used as the basis for future coverage decisions once it is determined whether a treatment is reasonable and necessary. CED has also been referred to as a way to develop a "learning-based health care system" and the coverage to support it.

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Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care