Company Press Releases Back
MedaSorb Announces IDE Filing with the FDA
Thursday January 4, 8:48 am ET
Following Approval MedaSorb Will Begin Multi-Site Pilot Study
MONMOUTH JUNCTION, N.J., Jan. 4, 2007 (PRIME NEWSWIRE) -- MedaSorb Technologies Corporation (OTC BB:MSBT.OB - News) today announced that is has submitted an Investigational Device Exemption (IDE) Supplement to the FDA for its CytoSorb(tm) hemoperfusion blood filtration device. The IDE application addresses the use of CytoSorb(tm) for the treatment of Acute Respiratory Distress Syndrome (ARDS) caused by sepsis. The filing, which includes a proposed pilot study, was delivered to the FDA on December 29, 2006. If the proposed pilot study is approved by the FDA, MedaSorb intends to commence clinical trials by the third quarter of 2007.
MedaSorb believes that the use of CytoSorb(tm) as an adjunct to current sepsis treatment methods will lead to improved patient recovery. There are over 750,000 reported cases reported annually in the U.S., resulting in over 215,000 deaths. Sepsis can be caused by a bacterial, viral, fungal or parasitic infection in any number of places in the body, followed by a severe immune system reaction, releasing large amounts of inflammatory cytokines into the bloodstream. MedaSorb's scientists believe that the use of its CytoSorb(tm) device to remove cytokines from the blood may improve the treatment of ARDS and other indications caused by sepsis.
``We want to thank the team of scientific advisors and co-workers who have worked diligently on the protocol development to get the IDE application to the FDA,'' stated Jim Winchester, MD, MedaSorb's Chief Medical Officer. ``We believe that CytoSorb(tm) will be an important addition to the treatment of sepsis due to its unique ability to remove excess cytokines produced by the septic reaction, thereby allowing the immune system to have a more normalized response to fight the infection, lowering mortality rates and allowing faster patient recovery.''
``We look forward to working with the FDA and beginning our initial clinical trials on CytoSorb(tm) later this year,'' said Al Kraus, MedaSorb's CEO, ``This is an important milestone for the company and provides an exciting start to the new year.''
MedaSorb Technologies Corporation is a medical device company headquartered in Monmouth Junction, New Jersey. MedaSorb has developed and is preparing to commercialize a blood purification technology that efficiently 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. During hemoperfusion, blood is removed from the body via a catheter or other blood access device, perfused through a filter medium where toxic compounds are removed, and returned to the body. The CytoSorb(tm) device consists of a cylinder containing the adsorbent polymer beads. The cylinder incorporates an industry standard luer fitting at either end of the device which connects directly to the extra corporeal circuit (bloodlines) on a stand alone basis. As blood passes over the beads in the cylinder, toxins (cytokines) are adsorbed from the blood. MedaSorb believes that potential healthcare applications for its products include: adjunctive treatment and/or prevention of sepsis, prevention of damage to organs donated for transplant prior to organ harvest, prevention of post-operative complications of cardiac surgery, short and long-term treatment of kidney failure, and drug detoxification.
MedaSorb's management team is led by Al Kraus, President and CEO, who has more than twenty-five years' experience managing companies in the dialysis, medical device products, personal computer and custom software industries. Other members of MedaSorb's management team include James Winchester, MD, CMO, Vincent Capponi, COO, and David Lamadrid, CFO.
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: obtaining government approvals including required FDA approvals; 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; 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 8-K filed with the SEC on July 6, 2006, which is available at http://www.sec.gov.
Contact:MedaSorb Technologies Corporation
(732) 329-8885 ext. 816
Source: MedaSorb Technologies