MONMOUTH JUNCTION, N.J., Sept. 19, 2006 (PRIMEZONE) -- MedaSorb Technologies, Inc. (OTCBB:MSBT) announced today that they intend to file an Investigational Device Exemption (IDE) with the FDA by the end of the year for CytoSorb(tm)'s Drug Detoxification indication. The Company is in contact with the FDA regarding an informal guidance meeting to confirm its approach for testing and development of the indication while preparing the final documentation for the submission. MedaSorb is confident the performance of CytoSorb(tm)'s adsorbent bead technology for Drug Detoxification is superior to current charcoal filter technology for removing drugs toxins from the blood stream in overdose traumas. MedaSorb anticipates this will be the first indication to achieve 510K approval for CytoSorb(tm).
The Company is pleased with the progress they are making in regards to their Sepsis Treatment indication. MedaSorb believes that CytoSorb(tm) will be an important adjunct to the current treatment of Sepsis. Sepsis is an out of control inflammatory response that attacks the infecting organism but also damages the patient and leaves the immune system weakened; by removing the excess cytokines produced by the inflammatory response, the company believes, CytoSorb(tm) improves the chances of survival and speed of recovery for the patient. There are 750,000 sepsis cases and 250,000 sepsis related deaths in the U.S. annually. MedaSorb expects to file their IDE for the treatment of Sepsis by the end of the 1st quarter 2007. They are currently conducting meetings with their Medical Advisory Board to complete a detailed clinical trail protocol for delivery to the FDA as part of their IDE submission. The company anticipates the commencement of clinical trials for Sepsis in the second half of 2007.
Al Kraus, the President and CEO of MedaSorb said, "The Company is working diligently with our scientific staff, the Medical Advisory Board and the FDA to submit our filings for both Drug Detoxification and Sepsis indications for CytoSorb(tm) as expected. The company has sufficient resources to commence the Sepsis clinical trails, and we are excited about moving forward on both indications."
About MedaSorb Technologies
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. 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, now the Company's President and Chief Executive Officer, 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, who are now officers of the Company, include James Winchester, MD the Company's Chief Medical Officer, Vincent Capponi the Company's Chief Operating Officer, and David Lamadrid, the Company's Chief Financial Officer.
Forward-Looking Statements
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 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 8-K filed with the SEC on July 6, 2006, which is available at www.sec.gov