The FDA will be piloting three products for the treatment of end-stage renal disease (ESRD), including an artificial kidney, as part of an ongoing program to expedite the availability of medical technology.

The wearable artificial kidney is being developed by Blood Purification Technologies Inc., of Beverly Hills, Calif. It was among 32 product applications submitted to the Innovation Pathway 2.0, a fast-track system for the approval of medical devices with a focus on ESRD. Under the program, developers will have the opportunity to openly collaborate and discuss their findings with the FDA.

The program also selected an implantable Renal Assist Device in development at the University of California, San Francisco, as well as a Hemoaccess Valve System designed by CreatiVasc Medical in Greenville, SC.

According to a press release, the FDA chose ESRD because its treatment depends on medical device technology, with Medicare alone covering 75% of ESRD health care costs.

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WIXOM, Mich., Apr 19, 2012 (GlobeNewswire via COMTEX) -- Rockwell Medical /quotes/zigman/66259/quotes/nls/rmti RMTI -1.07% , a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency and secondary hyperparathyroidism, announced today that it has hired Raymond Pratt, M.D., as Chief Medical Officer. Dr. Pratt will oversee the clinical development and FDA regulatory process for Rockwell's Soluble Ferric Pyrophosphate (SFP) and manage all aspects of clinical research and development for SFP and new drug indications.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are very pleased to have Dr. Pratt join Rockwell and lead our clinical team. Dr. Pratt has close to 20 years of drug development experience in all phases of the clinical development process and in multiple therapeutic areas, including nephrology. His experience and leadership will be invaluable to us as we go through the process of obtaining FDA market approval for SFP and other future indications. We look forward to the strategic contributions Dr. Pratt will make during this exciting time for Rockwell Medical."

Prior to joining Rockwell, Dr. Pratt worked at Shire Pharmaceutical Development from 2003-2010, as Vice President R&D and the Scientific leader in the Emerging Business Unit and Renal Business Unit. Previous roles at Shire included Vice President Global Clinical Medicine and Global Clinical Affairs and head of U.S. Clinical Development. Dr. Pratt was instrumental in the FDA approval of Fosrenol ESRD indication and CKD non-dialysis indication in the EU and U.S. He was responsible for 3 NDAs as well as multiple EU marketing applications and sNDA's. He has managed 10 different drugs through all stages of global development for Renal and CNS Indications. He was the principal in numerous meetings with multiple divisions at the FDA and was presenter at two FDA advisory committee meetings. Prior to working at Shire, he was Senior Director, Clinical Research and Development at Eisai Medical Research from 1994-2003 where he was head of CNS and Internal Medicine clinical development.

Dr. Pratt received his M.D. from the University of Illinois College of Medicine. He served six years in the U.S. Army Medical Corps including a period as Director, Dialysis Services at the Walter Reed Army Medical Center. He was Assistant Professor at Cornell Medical College and Johns Hopkins University School of Medicine. At Johns Hopkins he was the recipient of a NIH Physician Scientist Award as well as a Shannon Award for new investigators.

Dr. Raymond Pratt, M.D., newly appointed Chief Medical Officer at Rockwell commented, "I am very excited to join Rockwell Medical. I believe SFP is a truly novel method of iron delivery and would greatly benefit dialysis patients throughout the world. It has great potential for several other indications that we intend to pursue and I am looking forward to playing a leadership role in creating an innovative and world class drug company at Rockwell."

About Rockwell Medical:

Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. The Company is currently developing unique, proprietary renal drugs to treat anemia and secondary hyperparathyroidism. Rockwell's lead drug candidate for iron therapy treatment is called SFP. SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism is expected to be available commercially later in 2012, addressing a $350M U.S. market.

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration for its drug products into the commercial markets, Calcitriol in 2012 and SFP upon FDA market approval.

Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html .

The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan", "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical's SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Rockwell Medical Technologies, Inc.

        CONTACT: Michael Rice, Investor Relations, (646) 597-6979
        

(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.

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PHOENIX, April 18, 2012 -- Dr. Rajeev Agarwal of Phoenix,AZ is ranked among the top physicians in the nation based on patient reviews.

PHOENIX, April 18, 2012 /PRNewswire-USNewswire/ -- Patients' Choice has announced that Dr. Rajeev Agarwal was one of a select few physicians honored with the prestigious 2011 Compassionate Doctor Certification.

(Photo: http://photos.prnewswire.com/prnh/20120418/DC90016)

Each year, nearly 100 million patients across the U.S. access websites like Vitals (http://www.vitals.com), UCompareHealthCare (http://www.ucomparehealthcare.com), and Patients' Choice (http://www.patientschoice.org) to provide feedback about experiences with their physicians.

Only those physicians with near perfect overall and bedside manner scores, as voted by their patients, are selected for the Compassionate Doctor recognition. Of the nation's 720,000 active physicians, only 3% were accorded this honor in 2011.

The Compassionate Doctor certification is part of the Patients' Choice recognition program, where patients rate and vote for their favorite doctors.

Dr.Rajeev Agarwal commented on the recognition: "This is quite an honor for me. I am very pleased to have been selected and grateful to my patients who went out of their way to rate me and give me positive reviews."

About Dr. Rajeev Agarwal: a short profile by and about the honoree:

Dr. Rajeev Agarwal underwent medical schooling at India's premier institute of medical sciences, AIIMS, in New Delhi. He completed his residency in Pediatrics at the University of Texas Medical Branch at Galveston. To further his learning in subspecialty medicine he joined the fellowship program in Pediatric Nephrology at The University of Florida at Gainesville. Under the program he also conducted bench research at Ohio State University.

For more information on this Compassionate Doctor, please visit Dr. Rajeev Agarwal's profile on PatientsChoice.org.

Following the publication of Dr.Rajeev Agarwal's selection as a Compassionate Doctor, American Registry seconded the honor and added Dr. Agarwal to The Registry™ of Business Excellence. An exclusive recognition plaque has been designed to commemorate the honor. The doctor's custom wall plaque is shown here.

For more information on Dr.Rajeev Agarwal, located in Phoenix,AZ please call 480-585-5233, or visit www.AgavePediatrics.com.

This press release was written by American Registry, LLC, with approval by and/or contributions from Dr. Agarwal and was distributed by PR Newswire, a subsidiary of UBM plc.

Patients' Choice provides in depth information on doctors in your area who have been recognized and awarded for outstanding patient care and expertise.  The Compassionate Doctor certification is the honor role of physicians who have received the highest overall and bedside manner ratings by their patients.

American Registry, LLC, recognizes excellence in top businesses and professionals. The Registry™ includes over 2 million significant business and professional recognitions. For more information, search The Registry at http://www.americanregistry.com.

Contact Information: Dr.Rajeev Agarwal Phone: 480-585-5233

SOURCE American Registry

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