MedaSorb Receives European Approval for CytoSorb Clinical Trial in Sepsis
Posted on: Monday, 6 August 2007, 09:19 CDT
MedaSorb Technologies Corporation (OTCBB: MSBT) (FRANKFURT: HQE.F) announced today that the German Ethics Committee approved MedaSorb to proceed with a clinical trial using the CytoSorb(TM) device in the treatment of sepsis. The trial will enroll up to 75 patients with acute respiratory distress syndrome or acute lung injury in the setting of sepsis. A successful trial will support the application process to obtain CE Mark, which is the regulatory pathway for approval to market a medical device in the European Union.
"Receiving approval to begin this clinical trial in Europe is a major milestone for the company," MedaSorb's CEO, Al Kraus commented, "We have a solid plan to navigate the CE Mark application process and we are confident in our CytoSorb(TM) device." MedaSorb is currently recruiting investigational sites and believes patient enrollment will begin in October of this year.
The company estimates the European sepsis market potential is over $6 billion. Sepsis is the second most frequent cause of death in hospitals, and kills approximately 1,400 people worldwide every day. Sepsis is a systemic response to infection or other trauma to the body, which often causes organ failure and has a high mortality rate of 28-50%. There are an estimated one million cases of sepsis in the United States each year with worldwide estimates exceeding two million cases. Sepsis remains one of the greatest and least publicly recognized challenges of clinical medicine.
The CytoSorb(TM) medical device has been shown effective in pre-clinical testing at removing cytokines, which are believed to be key mediators in the inflammatory and often deadly response of the immune system to sepsis. MedaSorb believes CytoSorb(TM) will be clinically effective as an adjunctive therapy in the treatment of sepsis, by reducing the harmful level of cytokines in patients.
Citing their earlier published quarterly statement, MedaSorb has received conditional approval from the United States Food and Drug Administration (FDA) to conduct its CytoSorb clinical study for acute respiratory distress syndrome (ARDS) in the setting of sepsis. MedaSorb will continue to work with the FDA to obtain approval for additional patients in the study.
About MedaSorb
MedaSorb Technologies Corporation is a medical device company preparing to commercialize blood purification technology that effectively removes toxic compounds from circulating blood. MedaSorb's initial products, CytoSorb(TM) and BetaSorb(TM), are known medically as hemoperfusion devices and incorporate proprietary adsorbent polymer technology. Management believes the potential healthcare applications for its products include: adjunctive treatment of sepsis, prevention of damage to organs donated for transplant prior to organ harvest, prevention of post-operative complications of cardiac surgery, the short- and long-term treatment of kidney failure and drug detoxification. MedaSorb is headquartered in Monmouth Junction, New Jersey. http://www.medasorb.com/
Safe Harbor Statement
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. MedaSorb Technologies Corporation believes that its primary risk factors include, but are not limited to: ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; obtaining government approvals, including required FDA and CE Mark approvals; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Current Report on Form 10KSB filed with the SEC on April 30, 2007, which is available at http://www.sec.gov
Contact: For Investor Relations Craig Bird or Charlie Forshee Segue Ventures LLC CHbird@segue.bizCforshee@segue.biz Investors Message Board: http://finance.groups.yahoo.com/group/MedaSorb (215) 885-4981 Or MedaSorb Technologies Corporation David Lamadrid (732) 329-8885 ext. 816 DavidL@medasorb.com
SOURCE: MedaSorb Technologies Corporation
Source: MARKET WIRE
Related Articles
- SMPTE 2008 to Honor Entertainment Technology Innovators From Top Corporations and Universities at Gala Event
- Northern California Foot and Ankle Center Santa Rosa Enrolling Patients With Chronic Diabetic Foot Ulcers for Matrix Clinical Research Trial
- MedaSorb Completes Key Step to Begin Clinical Study in Europe for CytoSorb(TM) in the Treatment of Sepsis
- Fox Interactive Media Acquires Interactive Advertising Technology Company Strategic Data Corporation
- Visual Healthcare Technology Will Power Clinical Module for Anesthesia Practice
- AstraZeneca's Statement on the Cost-Effectiveness Findings of the Clinical Antipsychotic Trials of Intervention Effectiveness-Schizophrenia (CATIE-SZ)
- UTEK Corporation Completes Technology Transfer With Cyberlux Corporation
- WHO seeks greater openness in clinical drug trials
- Clinical Characteristics and Treatment Responses of Tuberculosis in Patients With Malignancy Receiving Anticancer Chemotherapy*
- Nuclear Medicine in Clinical Diagnosis and Treatment
User Comments (0)

RSS Feeds