Baxter and DEKA Announce FDA Acceptance of Investigational Device Exemption for Home Hemodialysis System
Clinical Program to Commence in Mid-2011
DEERFIELD, Ill., November 18, 2010 - Baxter International Inc. (NYSE:BAX) announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for a Home Hemodialysis (HD) system in development through a collaboration between DEKA Research and Development Corp., HHD LLC, and Baxter. The IDE approval allows the companies to initiate a clinical study in patients undergoing hemodialysis treatment.
"This regulatory milestone is an important step in our efforts to advance the care of patients with end-stage renal disease," said Carlos Alonso, president of Baxter's global Renal business.
"We are gratified to achieve this milestone in support of this new Home Hemodialysis device," said Dean Kamen, founder of DEKA.
DEKA and Baxter expect to begin a clinical study in mid-2011 in the U.S. to assess device performance and safety in patients undergoing hemodialysis. Twenty-four patients at up to five dialysis centers will each be studied for ten weeks. The study will take approximately six months to complete. Successful completion of this study will allow DEKA and Baxter to continue on the pathway towards regulatory approval in the U.S., which will likely include additional clinical studies in dialysis patients and may support an indication for nocturnal hemodialysis. The companies expect to seek regulatory approval of the Home Hemodialysis system in the U.S. in 2013.
An additional study, scheduled to begin in 2011 in Canada, will focus on device performance and safety in a nocturnal setting. Successful completion of this study will support regulatory approval in Europe, which is expected in 2012.
About DEKA and HHD, LLC
Based in Manchester, NH, DEKA is a research and development company of almost 400 employees comprised of engineering, manufacturing and quality assurance professionals focused on the development of new technologies that span a diverse set of applications. The company was founded in 1982 by Dean Kamen, an inventor who holds more than 450 U.S. and foreign patents, many of them for innovative medical devices that have expanded the frontiers of healthcare worldwide. HHD, LLC owns and licenses certain intellectual property assets expected to be utilized in the home hemodialysis program.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning the Home Hemodialysis system in development through a collaboration between DEKA Research and Development Corp., HHD LLC, and Baxter, including with respect to clinical studies and expectations regarding regulatory approvals. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: actions of regulatory bodies and other governmental authorities; additional clinical results demonstrating the safety and effectiveness of the system; satisfaction of regulatory and other requirements; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.