Cytomedix to Present at Sixth Annual Noble Financial Equity Conference

ROCKVILLE, Md., June 1, 2010 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will participate in the Sixth Annual Noble Financial Equity Conference taking place June 7-8, 2010 at the Seminole Hard Rock Hotel in Hollywood, Florida.

Martin Rosendale, President and CEO of Cytomedix, will present a corporate update on Tuesday, June 8, 2010 at 1:30 p.m. ET in which he will provide an overview of Cytomedix, including an update on the integration of its recent acquisition of the Angel® Whole Blood Separation System and the activAT® Autologous Thrombin Processing Kit from the Sorin Group.

Company management will be available for one-on-one meetings with investors participating in the Noble Financial Equity Conference. For those who would like to schedule an appointment with Cytomedix's management, please contact Anne Marie Fields, Lippert/Heilshorn & Associates, Inc., at 212-838-3777 or at afields@lhai.com or contact your Noble Financial representative.

The presentation will be video webcast live at www.cytomedix.com where it will also be archived for 90 days.

About Cytomedix

Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP") in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from platelet poor plasma. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its products. Cytomedix is also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Most notably is its anti-inflammatory peptide (designated "CT-112") that has shown promise in pre-clinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.

Minimallly invasive option to partial nephrectomy and the 5 % to 10 % risk of bleeding and need for transfusion

DALLAS – June 4, 2010 – A minimally invasive technique used to destroy kidney tumors with an electrically controlled heating probe showed similar effectiveness as surgical removal of tumors in curbing cancer recurrence rates for up to five years after treatment.
In an article available online in the journal Cancer, Dr. Jeffrey Cadeddu, professor of urology and radiology at UT Southwestern Medical Center, reported the outcomes of more than 200 patients who were treated with radiofrequency ablation (RFA).
Once the diagnosis of tumor is confirmed and the RFA technique is agreed upon, a needle-like probe is placed inside the tumor. The radiofrequency electricity waves passing through the probe heat up tumor tissue and destroy it. Surgeons view the RFA procedure with the aid of imaging devices such as computed tomography (CT scan).
Of the 208 patients who underwent the RFA procedure, 160 were diagnosed with renal cell carcinoma, a type of kidney cancer that is slow-growing but malignant and able to spread easily to other organs. Those patients had three- and five-year survival rates of more than 95 percent.
"These types of cancers aren't typically fast-growing, but there are between 40,000 and 50,000 cases of kidney cancers diagnosed each year in the United States," Dr. Cadeddu said. "The fact that cancer survival rates were comparable to surgical interventions is very encouraging."
Currently, many patients who are diagnosed with primary tumors that originate inside the kidney are treated surgically.
"The standard treatment is usually a partial nephrectomy, where the surgeon removes the tumor and some surrounding tissue via open or laparascopic surgery," said Dr. Cadeddu. "With surgery, there is a 5 percent to 10 percent risk of bleeding and an associated need for transfusion, as well as an increased chance of readmission for the patient. Of course, the recovery time is longer as well."
With open surgery, surgeons go in through a patient's abdomen or flank to remove the kidney tumor. A laparascopic partial nephrectomy involves doctors accessing the organ through several small incisions in a patient's abdomen. The recovery time for open surgery is about six to eight weeks and three to four weeks for laparascopic procedures.
With RFA, 90 percent of the patients are able to go home the same day, said Dr. Cadeddu, but the real advantage to RFA is its superior preservation of kidney tissue.
"Preserving kidney function has been clearly demonstrated to maximize quality of life and length of life for patients with kidney tumors," Dr. Cadeddu said. "Whenever possible, we try to save as much of the kidney as we can."

Devices, Drug Cut Bleeding Risk in PCI

Combining the direct thrombin inhibitor bivalirudin (Angiomax) with vascular closure devices was associated with the lowest rate of bleeding complications in patients undergoing percutaneous coronary intervention (PCI), a large database analysis showed.

Among more than 1.5 million PCI patients in the National Cardiovascular Data Registry (NCDR), 0.9% suffered bleeding complications when both bivalirudin and vascular closure devices were used, according to Steven P. Marso, MD, of the University of Missouri in Kansas City, and colleagues.

The highest rate, 2.8%, was seen in patients for whom manual compression was the sole means of bleeding control, the researchers reported in the June 2 issue of the Journal of the American Medical Association.

Rates associated with vascular closure devices and bivalirudin alone were 2.1% and 1.6%, respectively (P<0.001>for differences):

6.1%, manual compression
4.6%, vascular closure devices
3.8%, bivalirudin
2.3%, vascular closure devices plus bivalirudin

But Marso and colleagues also found that the combination approach was used more often in low-risk patients. Only 14.4% of high-risk patients had both bivalirudin and closure devices for bleeding control, compared with 21.0% of low-risk patients.

By the same token, 40.3% of high-risk patients had manual compression versus 30.8% of low-risk patients.

"This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI," Marso and colleagues wrote.

"Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI," they added.

The study examined outcomes in 1,522,935 patients undergoing PCI at 935 hospitals participating in the data registry from 2004 to 2008.

Among them, 30,654 had inhospital bleeding complications. These were defined in three ways: serious enough to warrant transfusion or a prolonged hospital stay for management, or leading to a decrease of more than 3 g/dL in blood hemoglobin content.

Bleeding risks were predicted on the basis of age, gender, peripheral vascular disease, renal function, previous congestive heart failure, previous PCI, and whether patients had myocardial infarction with ST-segment elevation. The risk prediction model had been developed previously from NCDR data.

Marso and colleagues suggested several potential explanations for the lower use of the drug-plus-device strategy in high-risk patients.

One is that assessing patients for bleeding risk is neither easy nor common, they indicated. Another is that familiarity with bivalirudin and/or closure devices outside the elective PCI setting may be limited.

"The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies," Marso and colleagues wrote, adding that interventions to encourage pre-PCI risk assessment should be tested.

In a statement, Ralph Brindis, MD, MPH, president of the American College of Cardiology, said the study's findings would themselves help reverse the paradox.

"Assessing a patient's risk of bleeding prior to PCI can help improve its safety by utilizing proven bleeding avoidance strategies for patients most likely to benefit from the procedure," he said. "This study identifies how we can adapt our practices to focus on individual comorbidities and provide even greater high-quality, patient-centered care."

Kirk Garratt, MD, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, commented in a statement that the data do suggest "a synergy between drug and device."

"My only concern is that we don't know how many patients were considered for a closure device but didn't get one," he said.

"We always take a picture of the artery after we put the sheath in, to see if a closure device will work. Sometimes we learn that the artery has been punctured in a way that increases bleeding and prevents use of closure devices," he observed.

The authors noted several limitations of the study. "First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies."

Kuros Completes Patient Recruitment

Zurich, Switzerland, 2nd June 2010 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has completed recruitment in a 200 patient Phase IIb clinical trial designed to assess the efficacy and safety of KUR-113 (Viz.I-040202) in open tibial shaft fractures.
This study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. The aim of the trial is to assess the safety and efficacy of KUR-113 in combination with standard of care (SOC) vs SOC alone. The use of KUR-113 is designed to improve bone healing by reducing the time needed to achieve bone healing as well as the incidence of secondary interventions.
KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth. The trial will assess whether this approach is safe and efficacious.
A total of 200 patients have been randomized and treated in over 31 centers across Europe. The primary endpoint of this study is the proportion of patients healed at 6 months after surgery when compared to SOC alone. Kuros is expecting to report the outcome of this study in the first half of 2011.
Dr. Virginia Jamieson, Chief Medical Officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-113 and we look forward to reporting the results of this novel approach to the treatment of open tibial shaft fractures in the first half of 2011.”
KUR-113 is licensed to Baxter International Inc. under a collaboration and license agreement which was signed in 2005. Following the successful completion of this study, Baxter will take over responsibility for the further development of KUR-113.
Didier Cowling, Chief Executive Officer of Kuros, commented: “Completion of patient recruitment in this large Phase IIb study is another significant step for Kuros. We look forward to broadening the application of this technology to additional orthopedic settings”