Cytomedix says proposed National Coverage Determination memo by CMS includes proposal through CED for all three major wound categories; conference call May 10 (CMXI)

Cytomedix, Inc. (CMXI.OB) is a biotechnology company developing advanced tissue regeneration technologies. Its primary focus is on commercializing autologous cell based therapies that facilitate the body’s natural healing processes for enhanced healing and tissue repair.  Its commercial portfolio is based on autologous platelet rich plasma (“PRP”) platform technology, and includes the Angel® Whole Blood Separation System (“Angel®”) and the AutoloGelTM System (“AutoloGel”). 

The company has said that "the Centers for Medicare & Medicaid Services issued a proposed National Coverage Determination memo for autologous blood-derived products for chronic non-healing wounds. In its decision memo CMS has proposed coverage through its Coverage with Evidence Development program for all three major wound categories: diabetic, venous and pressure wounds."

In the CED process, CMS provides payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. Cytomedix says that the proposed decision by CMS bodes well for its ongoing discussions with a top 20 global pharmaceutical company for an exclusive U.S. supply and distribution agreement for AutoloGel in wound care.

A Company conference call was held 10-May at 9:00 ET to discuss the proposed NCD and the CED initiatives. A replay of the conference call will be available beginning two hours after its completion through May 17, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 international) and entering passcode 61561051. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.

Read more at CNN Money. 

Cytomedix Providing Treatment for Diabetic Foot Ulcers (CMXI)

Cytomedix is well positioned to achieve a leadership position in the field of advanced tissue regeneration technologies, with the continuing development and marketing of biologically active products to treat patients with debilitating and life-threatening conditions. Its synergistic Angel® and AutoloGel products place Cytomedix as a leader in PRP technology with FDA indications in the areas of orthopedics and wound care. Both product lines have proven clinical benefits and significant growth potential.

Recently, GBI Research released its Diabetes Therapeutics Market to 2017 report favorably reviewing the global diabetes therapeutic industry and offering that companies like  Cytomedix, Inc. are poised for rapid growth.    

BiotechStockTrader.com then expounded upond these findings with their own in depth analysis of Cytomedix.  Pointing out that diabetic foot ulcers effect 15 percent of patients with diabetes, BiotechStockTrader predicts strong growth for the company, commenting,

"This is where Cytomedix, a leader in the commercialization of innovative autologous therapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells, offers a revolutionary technology that outstrips current wound care therapies and provides a convenient and cost-effective new approach."

See the full presentation from BiotechStockTrader.com below:  

Biotech stock trader april 2012

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Cytomedix Reports Publication of Positive Autologel Wound Healing Data in Ostomy Wound Management (CMXI)

Cytomedix, Inc. (OTCBB: CMXI) is a biotechnology company developing advanced tissue regeneration technologies. Our primary focus is on commercializing autologous cell based therapies that facilitate the body’s natural healing processes for enhanced healing and tissue repair.  Our commercial portfolio is based on autologous platelet rich plasma (“PRP”) platform technology, and includes the Angel® Whole Blood Separation System (“Angel®”) and the AutoloGelTM System (“AutoloGel”). 

The Company has announced the publication of positive clinical data regarding its AutoloGel™ System in the April 2012 issue of Ostomy Wound Management in an article entitled, "A Retrospective, Longitudinal Study to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program." 

According to the press release,

"The purpose of this retrospective study was to capture evidence-based treatment outcomes in limb salvage patients with complex ulcerations treated in Japanese wound care centers using AutoloGel platelet-rich-plasma gel (“PRP”). The study involved 40 wounds in 39 severely compromised patients with comorbidities of diabetes mellitus (DM), lower limb arteriosclerosis, ischemia and infection. The majority of the patient population (34 or 85%) had DM and 24 of those also had arteriosclerosis. Diabetic foot wounds were Wagner Grade lll (77%) (deep ulcers with cellulitis or abscess formation, often with osteomyelitis) and lV (23%) (localized gangrene). Skin perfusion pressures of less than 40 mm Hg were recorded in 25 or 63% of the patients, and less than 30 mm Hg in 20 or 50% of the patients indicating critical limb ischemia which can impair healing. The study included a run-in period of 75.3 days on average, during which revascularization and/or debridement along with standard-ofcare therapy with advanced modalities were administered."

The Key Findings of the study are as follows:

• During the run-in period, no wounds healed and wound measurements for area, depth and volume actually increased
• Following AutoloGel treatment, 32 or 83% of wounds healed in an average of 145.2 days (p=0.00002) using an average of 6.1 treatments
• Mean changes over time in area (p=5.0x10-7), depth (p=1.2x10-6), and volume (p=7.3x10-5) were all statistically significant

Dr. Chugo Rinoie, DPM, ABPO, CWS, Chief of Podiatric Surgery, Wound Healing Center, Methodist Hospital of Southern California, Arcadia, CA, Medical Director, Millennia Wound Management, Inc, Los Angeles, CA, as well as a corresponding author of the publication, noted,

"These data demonstrate that autologous PRP gel can be used to heal long-standing, chronic Wagner III and IV wounds in patients with diabetes and moderate-to-severe peripheral arterial disease whose skin perfusion pressure indicates poor healing prognosis and probable limb amputation. Further, the associated wound care database now comprises over 200 wounds from Japanese AutoloGel patients."

Martin P. Rosendale, Chief Executive Officer of Cytomedix, commented, 

“We are delighted to have this compelling data published in a peer-reviewed journal as this study demonstrates that patients with chronic diabetic wounds and compromised arterial flow can heal and avoid limb amputation with AutoloGel treatment. These data support and validate previous studies showing that AutoloGel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care. The complexity and comorbidities associated with these wounds would have excluded them from any randomized controlled trial making this real world comparison study even more compelling. We believe data such as these strongly support our case for a positive National Coverage Determination from the Centers for Medicare & Medicaid Services to cover autologous PRP gel for the benefit of the various stakeholders interested in improving clinical wound care outcomes while lowering overall costs.”

Dr. Rinoie will be presenting these positive data in a poster presentation at the upcoming Symposium on Advanced Wound Care-Spring 2012 being held in Atlanta, Georgia from April 19-22, 2012.

 Read more at Cytomedix.com. 

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Cytomedix ($CMXI) Reports 2011 Fourth Quarter and Full Year Financial Results

Daily Dose Commentary: According to their press release, CMXI is tight on cash: “Cash and cash equivalents as of December 31, 2011 were $2.25 million compared with $0.64 million
as of December 31, 2010. The Company used $4.24 million to fund operating activities during 2011”. The key question is how will they move forward with Aldagen’s clinical programs ?

Cytomedix, Inc. (OTCBB: CXMI) is a biotechnology company developing advanced tissue regeneration technologies. Their primary focus is on commercializing autologous cell based therapies that facilitate the body’s natural healing processes for enhanced healing and tissue repair.  Their commercial portfolio is based on autologous platelet rich plasma (“PRP”) platform technology, and includes the Angel® Whole Blood Separation System (“Angel®”) and the AutoloGel^TM System (“AutoloGel”). 

Cytomedix (OTC/BB: CMXI) announced its financial results for the fourth quarter and year ended December 31, 2011.  The Company reported a total revenue increase of 129% to $2.96 million from $1.29 million the prior quarter and a year total revenue increase of 85% to $7.25 million from $3.91 million in 2010.  The Company attributed the increase to higher sales of the Angel and AutoloGel Systems as well as a non-refundable option fee.  

Chief Executive Officer of Cytomedix Martin P. Rosendale commented,

 "2011 was an exceptional year for Cytomedix, and was one in which we significantly strengthened the Company and positioned it for future growth and business expansion. The Angel business continues to grow nicely, posting double-digit sales increases, and we have made substantial progress with the AutoloGel system both with business development and reimbursement initiatives. We significantly strengthened our balance sheet with the early retirement of the remaining debt from the Angel acquisition and the $2.0 million non-refundable option payment received from our potential strategic global pharmaceutical partner for AutoloGel. Importantly, we recently expanded our commitment to regenerative medicine with the acquisition of Aldagen in February 2012, and we are now a significantly more diversified business with both commercial products and a robust pipeline of promising regenerative technologies."

Read the full press release here.  

Data From American College of Cardiology: $NBS, $BAX, $ASTM, $CMXI

Data came out over the weekend in Advance of the American College of Cardiology meeting in Chicago. The article reviews the Focus-CCTRN trial which uses autologous bone marrow to treat heart disease in a Phase II trial.  Specifically the trial evaluates the injection of bone marrow in ischemic cardiomyopathy.   This trial is similar to what Baxter is working on in their phase III trial using not bone marrow but what they believe is the active cell in marrow, CD 34+ cells. Incidentally this is similar to what NeoStem is doing with the Phase II Amorcyte Heart Attack “PRESERVE” trial which is using IRA (Infarct related artery) injection of CD 34+ cells (NeoStem is also doing the manufacturing for Baxter).
 
The results of the study are fascinating. They showed that the greatest efficacy was shown in those patients who received the greatest number of CD 34 cells.
 
Specifically the article states: 

"A regression analysis showed that higher CD34 cell or CD133 cell counts were associated with greater absolute unit increase in LVEF. The range of CD34 was 0.5% to 6.9% (SD, 1.2%). Assuming that differences of 1.96 for SD or 2.4% are more likely due to biological variability, the effect of differences in CD34 cell level beyond that expected due to natural variability was examined, using a 3% level to be conservative. Every 3% higher level of CD34 cells was associated with on average a 3.0% greater absolute unit increase in LVEF in a multiple variable model that included age and treatment as predictor variables (3.06 [95% CI, 0.14-5.98];P=.04)."

This article seems to confirm what NeoStem’s Chief Medical officer, Andrew Pecora MD, and Phase II Trial Investigator, Arshed Quyyumi MD, FRCP wrote in their Letter to the editor (Published in JAMA, March 14, 2012) that reviews the results from another Bone Marrow Trial (The Late TIME trial) that was presented last Fall at the American Heart Association (AHA).

“In the Late TIME trial, treated patients received a median CD34 cell dose of 3.8±1.5x106 cells, well below 10x106 CD34 cells. Additionally, in vitro SDF-1 mobility of the infused cells was not measured and may have been adversely affected by the absence of autologous serum in the infused product. Future studies must account for the quantity and mobility of infused (potent) cells before conclusions regarding efficacy are made.”

Daily Dose Conclusion: A lot of work has been done with Bone Marrow cells and its all shown trends but there have not been any home runs. The data seems to be pointing to the active ingredient (there may be more than one, that’s for sure) is CD 34+ cells. Patinets with greater numbers of these cells  are showing efficacy. The Amorcyte Phase 1 data was very compelling showing a statistically valid correlation between the number of CD 34 + CXCR4+ cells and the effect on both perfusion and infarct size. The fact that Baxter is also pursuing a CD 34+ cell approach is validating. The trial is being run by Dr. Doug Losordo  who is considered a Key Opinion Leader (KOL) and Pioneer in cell therapy. Dr. Losordo’s team last summer published the results of experiments that showed that among all the various cells present in marrow, it is the CD 34+ cells that generate the greatest amount of blood vessel growth.

Daily Dose Equities - Effect of Transendocardial Delivery - CCTRN TrialThis article showed in a sub-group analysis that patients with higher numbers of CD34+ cells did best.

View more documents from ProActive Capital Resources Group

Daily Dose Equities - Exosomes from Human CD34 + Stem Cells

This article is published by Dr. Doug Losordo, who since the article was printed, has joined Baxter to run their CD 34+ Cardiac Ischemia Trial (Angina – heart pain).

View more documents from ProActive Capital Resources Group

Daily Dose Equities - Intracoronary Bone Marrow

Two Letters to the Editor of JAMA; 1) Dr Hung Q Ly MD, MSC, FRCPC and 2) Drs. Arshed Quyyumi and Andrew Pecora (NeoStem) discuss the flaws in the LATE-Time trial.

View more documents from ProActive Capital Resources Group

Key markets covered include:

• Stem Cell Research
• Cardiac Heart Repair
• Benefits of using your own cells
• Stem Cell Trials
• Heart Attack Cell Therapy
• Proof of Concept
• Clinical Trial Data

Cytomedix $CMXI - 2011 Financial Results Call on Friday, March 30, 2012

Cytomedix, Inc. (OTCBB: CMXI), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will release financial results for the three and twelve months ended December 31, 2011, following the close of the market on Thursday, March 29, 2012.

Martin Rosendale, Chief Executive Officer, and Andrew Maslan, Chief Financial Officer, will host a conference call beginning at 10:00 a.m. Eastern Time on Friday, March 30, 2012, to discuss the fourth quarter and year end 2011 financial results and to answer questions. Shareholders and other interested parties may participate in the call by dialing 888-679-8034 (domestic) or 617-213-4847 (international) and entering passcode 23291244. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.

A replay of the conference call will be available beginning two hours after its completion through April 6, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 78509324. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.

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Cytomedix ($CMXI) in American Heart Journal For Positive Phase I Clinical Data Using ALD-201 to Treat Ischemic Heart Failure

Cytomedix, Inc. (OTCBB: CMXI) develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDH(br)") technology, currently in a Phase 2 trial for the treatment of ischemic stroke.

Daily Dose Conclusion: This is not new news for Aldagen (now part of CytoMedix) but does remind us that among the various cells in bone marrow, there are specific populations of cells, in this case, ALD-br cells, that are prolific elicitors of neoangiogenesis (capable of forming and fostering new blood vessel formation) . Our expectation is that CytoMedix will focus on CLI trial. Recall that Aastrom is now in a pivotal trial with their bone marrow (expanded cells) and PluriStem (PSTI) is hoping to begin their Phase II trial with their placental derived (allogeneic) cell product. From a COGS view point it’s likely that PSTI's product will be the cheapest to make, and Aastrom has the lead to the marketplace. Also know that in the wings are the adipose derived players such as Cytori and even device make Thermogenesis (KOOL). This could be local processing and also a very cheaply produced product. As such we have our concerns regarding the classic SWAT (Strength, Opportunities, threats & Weakness) and how each of the CLI players will score on these metrics.

Today's Press Release: CMXI announced that positive data from a Phase 1 clinical trial of ALD-201 to treat ischemic heart failure were published in the March 2012 online edition of the American Heart Journal. In the study, ALD-201 was considered safe and demonstrated initial evidence of improved blood flow and improved clinical status. ALD-201 is a population of biologically instructive adult stem cells (aldehyde dehydrogenase bright cells, or ALDH(br)) that are selected from the patient's own bone marrow using the ALDH enzyme as a marker. The article is titled:

"Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure." 

The randomized, double-blind, placebo-controlled Phase 1 study included 20 heart failure patients with no treatment options. The primary end point was safety and secondary end points included several well-accepted clinical measurements. The patients received either an injection of ALD-201 directly into the heart muscle, or an injection of an equivalent volume of placebo using the same catheter delivery system. Investigators assessed patients for endpoints for the first six months after the injection and then followed them for an additional six months.

In the study ALD-201, including injection into the myocardium, was considered to be safe and well tolerated. After six months, the subjects who received ALD-201 demonstrated an improvement in MaxVO2, a measure of the body's ability to take up oxygen during exercise, while the placebo group did not. These findings support the ability of ALDH(br) cells to promote angiogenesis and restore blood flow to the ischemic heart muscle.

Commenting on the results of the Phase 1 study, Principal Investigator, Emerson C. Perin, M.D., Ph.D., Director of the Stem Cell Center at the Texas Heart Institute at St. Luke's Episcopal Hospital, and the Adult Cardiology Texas Heart Institute at St. Luke's Episcopal Hospital in Houston, noted,

"The preliminary evidence suggests improved perfusion and a trend toward improved functional capacity in no-option heart failure patients treated with ALDH(br) cells. Importantly, we presented a unique approach for selecting a diverse population of active cells for cell therapy by using a physiologic rather than a single phenotypic marker, which may result in the isolation of a more efficacious population comprising the multiple cell types required for ischemic repair."

About Ischemic Heart Failure

Ischemic heart failure is caused by a reduction of blood flow to the muscles of the heart, which is most commonly caused by an obstruction of the arteries feeding blood to the heart tissue. As a result, the insufficient provision of oxygen and nutrients reduces the heart's ability to pump blood efficiently to the rest of the body. Current treatment options for ischemic heart failure include surgical procedures, bi-ventricular pacers, drug therapies, implantable cardiac defibrillators, and ventricular assist devices. For some patients, these treatments are not effective or appropriate. Once ischemic heart failure patients have exhausted all potential revascularization options, their only other option is a heart transplant, if they are eligible.

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Aastrom ($ASTM) Raises Capital - $40 MLN Private Placement

Aastrom Biosciences (ASTM) completed a $40M private placement with Eastern Capital ($1.81 -$0.01) Net proceeds to Aastrom, after placement fees and other offering expenses, are ~$38M.

The company intends to use the net proceeds from the financing for general corporate purposes, including research and development expenses related to the pivotal Phase 3 REVIVE-CLI clinical trial with ixmyelocel-T initiated in February 2012.

At closing, Aastrom issued approximately 12,300 shares of Series B convertible preferred stock to Eastern Capital at a price of $3,250 per share.

The shares will accrue dividends at a rate of 11.5% per annum during the 5-year term.

The Series B preferred stock is convertible into shares of the company's common stock only after 8-Mar-17 at a rate of 1,000 common shares for one preferred share.

There were no warrants issued in connection with the financing and Eastern Capital will not take a board seat.

Daily Dose Conclusion: This strikes us as a last resort financing. Aastrom has the capital to see the CLI trial to its conclusion, and if the trial hits, they can pay off this "expensive financing" and if it does'nt its essentially the end of Aastom. As such we view this deal as raising risk for investors and making the "B" in Binary now a capital letter.

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