ROCKWELL MEDICAL TECHNOLOGIES, INC.





Index of Rockwell News 2008 & 2009
Click on underlined dates to view complete story

  June 30, 2009   -   RMTI Appoints Ajay Gupta M.D. as Chief Scientific Officer
  June 29, 2009   -  Rockwell Medical Technologies Named to Russell Indexes
  June 5, 2009   -  Renal Business Today publishes article about Rockwell Medical
  May 11, 2009   -  Rockwell Reports Results for First Quarter 2009
  April 30, 2009   -  RMTI Schedules Investor Conference Call
  April 29, 2009   -  RMTI Announces Patient Enrollment Complete for Dose Range Study
  April 16, 2009   -  RMTI Announces Updated DSMB Interim Results
  March 16, 2009   -  RMTI Reports Q4 2008 Results; Sales Increase 20% Year-Over-Year
  Mar 02, 2009   -  Rockwell Appoints VP of Drug Development and Medical Affairs
  Nov. 13, 2008   -  RMTI Reports Third Quarter Results; Sales Gain of 22.2%
  Nov. 4, 2008  -  Rockwell Schedules Investor Conference Call
  Oct 29, 2008   -  DSMB Identifies No Safety Concerns for SFP
  Oct 27, 2008   -  Rockwell to Present at Oppenheimer Healthcare Conference
  Aug 12, 2008   -  RMTI Reports Second Quarter Sales Increase of 15.5%
  Aug. 5, 2008   -  Rockwell Schedules Investor Conference Call
  July 9, 2008   -  RMTI Appoints Dr. Richard Hurrell to Scientific Advisory Board
  June 17, 2008   -  RMTI Appoints Dr. James D. Cook to Scientific Advisory Board
  June 10, 2008   -  RMTI Appoints Dr. Richard Zager to Scientific Advisory Board
  May 20, 2008   -  Rockwell to Present at Barrington Research Healthcare Conference
  May 7, 2008   -  Rockwell Reports First Quarter; Sales Increase 31%
  Apr. 22, 2008   -  RMTI Schedules Investor Conference Call
  March 6, 2008   -  RMTI Reports Q4 2007 Results; Year-end Sales Increase 50%
  Feb. 26, 2008   -  Rockwell Schedules Investor Conference Call
  Jan. 31, 2008   -  Patients Begin Dosing in NIH Funded SFP Clinical Study
  Jan. 23, 2008   -  Patient Enrollment Begins for NIH Funded SFP Clinical Study


Features
  Nov 2005  - Rockwell Predicted as "Future Pharma" by "Crain's Detroit Business"
  June 2005  - Rockwell CEO Receives Entrepreneur of the Year Award
  Oct 2001   - Chioini chosen for  "Forty under Forty"  by "Crain's Detroit Business"


(return to News Index)

Monday, June 30, 2009

Rockwell Medical Appoints Ajay Gupta M.D. as Chief Scientific Officer

Dr. Gupta will support SFP clinical development, utilize SFP technology
to address new anemia-related opportunities and facilitate development of new drugs

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that it has appointed Ajay Gupta M.D. as its Chief Scientific Officer. Dr. Gupta will be responsible for the identification and development of new drug opportunities in the areas of women's health, oncology and parenteral nutrition based on the SFP platform, as well as new drugs for other targeted renal therapies and indications. Dr. Gupta will continue to play an integral role in the development and commercialization of the Company's lead drug Soluble Ferric Pyrophosphate (SFP), indicated for the treatment of iron deficiency anemia in hemodialysis patients.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are thrilled to have Ajay join Rockwell and strengthen our scientific team. His decades of work in both the academic and medical fields, coupled with his extensive knowledge in the anemia and iron space, will be an invaluable asset to us as we continue to drive SFP through clinical development and capitalize on other potential therapeutic opportunities, positioning Rockwell as a dynamic bio-pharma company." Mr. Chioini further stated, "Successful commercialization of SFP will continue to be our primary focus while Dr. Gupta's appointment puts in place a structure that will facilitate the identification, development and commercialization of a pipe-line of promising technologies that we have identified, as well as future opportunities yet to be discovered."

Prior to joining Rockwell, Dr. Gupta spent the last seven years as an Associate Professor of Medicine at UCLA and Charles Drew University Schools of Medicine, Los Angeles, CA where he has had an active nephrology practice. Prior to that, Dr. Gupta served on the faculty at Henry Ford Hospital, Detroit, MI, University of Alabama, Birmingham, State University of New York, Syracuse and Washington University, St. Louis. Dr. Gupta also completed a clinical fellowship in Nephrology from Wayne State University, Detroit, Michigan and a research fellowship in Nephrology from Washington University, St. Louis, Missouri. Dr. Gupta, who is the Founder and Chairman of the Indian Society for Bone and Mineral Research, earned his MBBS degree and completed his residency in Internal Medicine from All India Institute of Medical Sciences (AIIMS), New Delhi. Dr. Gupta is the inventor of dialysate iron therapy using Soluble Ferric Pyrophosphate (SFP) and is also the inventor of intravenous (IV) iron therapy using slow continuous infusion of SFP, including as an adjunct to parenteral nutritional admixtures. He has filed a number of patents in the areas of drugs, medical devices and diagnostic tests.

Dr. Gupta commented, "I'm truly excited to join Rockwell to pursue my life-long passion of focusing on the science and drug development of SFP, and eventually expanding the platform technology to target new markets and unmet needs, specifically in the areas of oncology, parenteral nutrition and women's health. I look forward to working with Dr. Richard Yocum, Vice President of Drug Development and Medical Affairs at Rockwell, to successfully commercialize SFP as well as to help grow our therapeutic pipeline."

About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a molecular and cellular level, similar to normal, healthy, dietary iron uptake. SFP is designed as a continuous maintenance treatment consisting of small iron doses administered with every dialysis session in order to offset iron losses during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatment. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.

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," "projected," "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 the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell 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.

(return to News Index)

Monday, June 29, 2009

Rockwell Medical Technologies Named to Russell Indexes

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, is pleased to announce that it has been added to the Russell 2000, 2500, 3000 and Global Indexes. Rockwell will also maintain its membership in the Russell Microcap Index.

The Russell Index reconstitution process is followed closely by many investors because the Russell Indexes currently have over $4.3 trillion in world-wide assets benchmarked to them. These indices are reconstituted on an annual basis to include the 4,000 largest U.S. stocks, ranking them by total market capitalization. Rockwell's membership in these new Russell Indexes remains in place for one year.

"We are pleased to be included in these new Russell U.S. and Global Indexes." said Robert Chioini, President and CEO. "Russell's industry-leading indexes are highly regarded and we hope that our inclusion will continue to generate additional institutional investor interest in Rockwell as an investment."

Russell 2000 is a leading small cap index that is widely used by investment firms that utilize indexing strategies in their investment portfolios. Rockwell's inclusion in the Russell 2000 Index will make it possible for the Company to be included in those portfolios using the Index as a benchmark for their investments. The Russell 2500 Index measures the performance of the small to mid-cap segment of the U.S. equity universe, the Russell 3000 Index measures the performance of the largest 3000 U.S. companies representing approximately 98% of the investable U.S. equity market; while the Russell Global measures the performance of the global equity and includes approximately 10,000 securities in 70 countries and covers 98% of the investable global market.

For more information about Russell indices, visit www.russell.com.

About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is designed as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 395,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.

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," "projected," "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 the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell 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.

(return to News Index)
Monday, May 11, 2009

Rockwell Medical Reports Results for First Quarter 2009

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD) and iron deficiency anemia, reported first quarter 2009 sales of $12.8 million, up 3.1% from $12.4 million for the same period of 2008. Loss for the first quarter 2009 was ($1.7) million or ($.12) per share compared to ($1.2) million or ($.09) per share for the same period 2008.

First Quarter

  • Quarterly sales of $12.8 million increased 3.1% compared to the first quarter of 2008.
  • Domestic sales increased 5.5% compared to the first quarter of 2008.
  • Gross profit totaled $1.2 million compared to $.7 million in the first quarter of 2008.
  • Gross profit margins increased to 9.3% from 5.8% in the first quarter of 2008.
  • SFP related R&D expense increased 71% to $1.3 million compared to $.8 million in the first quarter 2008.
  • Loss of ($1.7) million compared to loss of ($1.2) million in the first quarter 2008.
Drug Development Progress
  • Completed SFP Phase 2b study enrollment; subject treatments expected to be completed in October.
  • Data Safety Monitoring Board (DSMB) review noted no safety concerns with SFP and recommended continuation of Phase 2b study.
  • Appointed Richard Yocum, M.D. to VP of Drug Development & Medical Affairs in February 2009.

Mr. Robert L. Chioini, Chairman and CEO stated, "We are pleased with our first quarter performance. We continue to make solid progress clinically. We anticipate our Phase 2b data will be available by year end and that our Phase 3 program will begin sometime thereafter. Both our business and clinical development progress is in line with our expectations."

Rockwell will be hosting a conference call to review its first quarter results and to provide investors with an update on its business development efforts on Wednesday, May 7, 2008 at 11:00 am EST.

Rockwell will be hosting a conference call to review its 2009 first quarter results on Monday, May 11, 2009 at 4:15 pm EDT. Investors are encouraged to call a few minutes in advance at (877) 718-5111to listen to the call or on the web at:

http://investor.shareholder.com/media/eventdetail.cfm?eventid=68448&CompanyID=RMTI&e=1&mediaKey=A2FAB283B25BD82A09AC1C359F047CEF

The call will be available for replay for one week at the same link above.

About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is designed as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.

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," "projected," "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 the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell 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.

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three months ended March 31, 2009 and March 31, 2008

(Unaudited)
  3 Months ended Mar 31, 2009 3 Months ended Mar 31, 2008
Sales $ 12,796,772   $ 12,412,037   
Cost of Sales *  11,603,825       11,694,736   
   Gross Profit 1,192,947     717,301   
Selling, General, Admin * 1,560,815     1,289,752   
Research & Product Devel. 1,338,310     782,713   
   Operating (Loss)   (1,706,178)      (1,355,164)   
Interest Expense (Income), net    9,265        (144,991)   
   Net (Loss)  $ (1,715,443)     $ (1,210,173)   
Basic Earnings (Loss) per share $ (0.12)    $ (0.09)   
Diluted Earnings (Loss) per share $ (0.12)    $ (0.09)   
Note:
*The Company has reclassified certain quality assurance and operations management expenses totaling $140,000 from selling, general and administrative expense to cost of sales in the 2008 consolidated income statement to conform with the current year presentation.


Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of March 31, 2009 and December 31, 2008
  Mar. 31, 2009
(Unaudited)
Dec. 31, 2008
Assets
Cash and Cash Equivalents $ 3,353,468 $ 5,596,645
Accounts Receivable,
    net of a reserve of $83,000 in 2009and $97,000 in 2008
4,869,201 5,229,656
Inventory 2,815,829 3,161,625
Other Current Assets     484,898     440,765
    Total Current Assets 11,523,396 14,428,691
Property and Equipment, net 3,263,906 3,249,003
Intangible Assets 235,305 240,656
Goodwill     920,745     920,745
Other Non-current Assets   123,387    120,887
    Total Assets $ 16,066,739 $ 18,959,982

    Liabilities and Shareholders' Equity
Notes Payable & Capitalized Lease Obligations 139,202 176,850
Accounts Payable 3,834,491 5,210,972
Accrued Liabilities    1,240,579     1,464,828
Customer Deposits      208,751     245,186
    Total Current Liabilities 5,423,023 7,097,836

Long Term Notes Payable & Capitalized Lease Obligations

28,976 41,203
Shareholders' Equity:
Common Shares, no par value,
    14,132,712 and 14,104,690 shares issued and outstanding
35,172,916 34,799,093
Common Share Purchase Warrants,
    2,134,169 and 2,114,169 shares issued and outstanding
3,513,815 3,378,398
Accumulated Deficit (28,071,991) (26,356,548)
   Total Shareholders' Equity   10,614,740   11,820,943
    Total Liabilities and Shareholders' Equity $ 16,066,739 $ 18,959,982

(return to News Index)
Thursday, April 30, 2009

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI) announced today that it will hold an investor conference call on Monday, May 11, 2009 at 4:15 p.m. EDT to discuss its first quarter results and to provide investors with a business update. Robert Chioini, Chairman and CEO, and Thomas Klema, CFO, will be hosting the call to review Rockwell's results and answer questions from investors. Rockwell will be releasing results on the same date after the market closes.

The conference call will be held on:

Monday, May 11, 2009
Starting Time 4:15 p.m. EDT
Dial in Number: (877) 718-5111

When calling in please refer to the Rockwell Medical Technologies Investor Conference Call and provide the operator with your name and company affiliation.

Investors who prefer to participate using the internet may access the following link:
http://investor.shareholder.com/media/eventdetail.cfm?eventid=68448&CompanyID=RMTI&e=1&mediaKey=A2FAB283B25BD82A09AC1C359F047CEF

International Investors may dial in directly on 719-325-4789.

Investors who are unable to listen to the Rockwell investor conference call will be able to access a replay via our web site at www.rockwellmed.com.

We appreciate your interest in Rockwell.

(return to News Index)

Wednesday, April 29, 2009

Rockwell Medical Announces Patient Enrollment
Complete for Phase 2b Dose Range Study

- Data Expected in the 4th Quarter of 2009 -

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that patient enrollment has been completed for it's ongoing Phase 2b dose-ranging study for its iron deficiency anemia drug soluble ferric pyrophosphate (SFP).

“We are pleased to have achieved this important milestone following two positive safety reviews from the data safety monitoring board (DSMB). We anticipate having study data available in the fourth quarter of 2009 and shortly thereafter commencing our Phase 3 program,” stated Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell Medical.

The Phase 2b dose-ranging study is a six-month, controlled multi-center, double-blind study consisting of approximately 130 hemodialysis patients at multiple dialysis centers in the United States and Canada. Subjects are randomized to receive one of several concentrations of SFP or placebo in dialysate during their normal three times/week dialysis regimen. The primary objectives of the study are to evaluate both safety and efficacy of SFP at varying dose levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range.

About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is designed as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.

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,'' ``projected,'' ``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 the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell 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.

(return to News Index)

Thursday, April 16, 2009

Rockwell Medical Announces Updated DSMB Interim Results;
No Safety Issues Reported

- Phase 2b trial will continue as planned; 20 µg/dl dose group not needed -

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that the independent Data Safety Monitoring Board (DSMB) providing oversight for the ongoing SFP Phase 2b dose-range study reviewed the unblinded cumulative interim study data and informed the Company that it has identified no safety concerns. The DSMB also determined there is no need to add the highest dose group of 20 µg/dl and recommended continuation of the study with the current five dose groups.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated “We are again encouraged by the DSMB's favorable comments regarding our current SFP Phase 2b study. These recommendations from the DSMB suggest that the data from this study will meet the study objective of identifying the dose of SFP to be carried forward into the subsequent Phase 3 clinical program. We also expect to reach our target for completion of enrollment very soon, as screening for new patients has already met its objective and has been stopped. The successful completion of our SFP development program remains our top priority."”

About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is intended as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States, a number that is growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies not only for iron deficiency in kidney disease, but for other critical care conditions such as oncology and gastroenterology.

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," "projected," "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 the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell 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.

(return to News Index)

Monday, March 16, 2009

Rockwell Medical Reports Fourth Quarter 2008 Results;
Sales Increase 20% Year-Over-Year to $51.6 Million

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported record fourth quarter 2008 sales of $13.5 million, up 13.3% from $11.9 million for the same period of 2007. Loss for the fourth quarter was $3.0 million or ($.22) per share compared to $1.2 million or ($.09) per share for the same period of 2007.

Year-end 2008 results were highlighted by record sales of $51.6 million, increasing over 20% compared to 2007. Loss for the year ended December 31, 2008 was $7.9 million or ($.57) per share compared to $3.7 million or ($.32) per share in 2007. The increased loss was due to higher costs for raw materials and fuel as well as investments in infrastructure to support core business growth.

Fourth Quarter

  • Record quarterly revenue $13.5 million, up 13.3% over fourth quarter 2007.
  • Loss per share ($.22) vs. ($.09) in 2007.
  • R&D costs were $1.3million vs. $0.9 million in the fourth quarter of 2007.
Year End 2008
  • Revenue increased to $51.6 million, up 20% in 2008 compared to 2007.
  • Loss per share ($.57) vs. ($.32) in 2007.
  • Unit volume growth up15% over 2007.
  • Domestic sales increased $5.5 million or greater than 13.4% over 2007.
  • International sales were up 160% or $3.1 million over 2007.
  • 2008 Loss includes a $.9 million charge related to the settlement of a legal dispute.
  • R&D costs were $3.8 million compared to $3.3 million in 2007.
  • Cash on hand $5.6 million.
Drug Development Progress
  • Modified Phase IIb protocol to effectively address black box warning issued by FDA on erythropoietin stimulating agents.
  • Filed patent on SFP proprietary API synthesis process.
  • Completed protocol to begin NIH-funded study.
  • Data Safety Monitoring Board (DSMB) review of Phase IIb dosing indicated strong safety profile for SFP and study continuation.
  • Expanded Scientific Advisory Board to further strengthen expertise in anemia and iron deficiency.
  • Hired experienced Vice President of Drug Development and Medical Affairs to lead clinical development.

Mr. Robert L. Chioini, Chairman and CEO stated, "Overall, we are pleased with our drug development program. We have continued to make solid progress in randomizing patients in our Phase IIb study and we expect to complete enrollment shortly. In the fourth quarter the DSMB recommended that we continue the Phase IIb study, which demonstrated SFP's strong safety profile. We added three new members to our Scientific Advisory Board and we recently hired Dr. Richard Yocum to spearhead SFP's clinical progress. We believe these actions will enable us to advance SFP through to commercialization."

Mr. Chioini also stated, "Our fourth quarter sales and margin results were in line with our expectations, and although margins suffered during the year due to higher raw material and fuel costs, we anticipate improvement in Q1 2009 and going forward. We also expect the investments we made in our quality systems, information technology infrastructure and personnel to provide improved financial results going forward."

Rockwell will be hosting a conference call to review its 2008 fourth quarter and year-end results on Monday, March 16, 2008 at 4:30 pm EDT. Investors are encouraged to call in several minutes in advance at (888) 572-7030 to hear the call or they may listen on the web at the following link: http://investor.shareholder.com/media/eventdetail.cfm?eventid=66691&CompanyID=RMTI&e=1&mediaKey=A2FAB283B25BD82A09AC1C359F047CEF

The call will be available for replay for one week at the same link above.

About Soluble Ferric Pyrophosphate (SFP):

SFP is a novel, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials have shown that SFP delivered during each dialysis treatment, via the Company's dialysate, maintains optimal iron balance and avoids liver toxicity while decreasing associated pharmaceutical intravenous iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world; the United States, Japan and the European Union. The total U.S. market for IV-iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:

Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell's products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for those patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States growing at an annual rate of 4 percent and approximately 2 million ESRD patients world-wide

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Please visit www.rockwellmed.com for more information.

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," "projected," "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 the Rockwell's SEC filings. Thus, actual results could be materially different. Rockwell 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.

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and twelve months ended
December 31, 2008 and December 31, 2007
(Whole dollars)

(Unaudited)
  3 Months ended Dec 31, 2008 3 Months ended Dec 31, 2007 12 Months ended Dec 31, 2008 12 Months ended Dec 31, 2007
Sales $ 13,537,674 $ 11,948,905 $ 51,666,033 $ 43,045,304
Cost of Sales    13,248,807    11,073,295    48,694,478    40,015,466
Gross Profit      288,876       875,610     3,016,555     3,029,838
Selling, General, Admin     2,087,942     1,084,987    7,271,617   3,374,458
Research & Product Devel.     1,272,416     944,281    3,830,134    3,263,733
Operating (Loss)   (3,071,491)   (1,153,658)   (8,085,196)   (3,608,353)
Interest Expense (Income), net    (38,657)     9,185      (221,139)     110,542
   Net (Loss)  ($3,032,834)  ($1,162,843) ($7,864,057) ($3,718,895)
Basic Earnings (Loss) per share $ (0.22) $ (0.09) $ (0.57) $  (0.32)
Diluted Earnings (Loss) per share $ (0.22) $ (0.09) $ (0.57) $ (0.32)

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of December 31, 2008 and December 31, 2007
  Dec. 31, 2008 Dec. 31, 2007
Assets
Cash and Cash Equivalents $ 5,596,645 $ 11,097,092
Accounts Receivable,
    net of a reserve of $97,000 in 2008 and $69,000 in 2007
5,229,656 4,687,229
Inventory 3,161625 2,559,051
Other Current Assets     440,765     302,573
    Total Current Assets 14,428,691 18,645,945
Property and Equipment, net 3,249,003 2,840,331
Intangible Assets 240,656 270,446
Goodwill     920,745     920,745
Other Non-current Assets    120,887    125,667
    Total Assets $18,959,982 $22,803,134

    Liabilities and Shareholders' Equity
Notes Payable & Capitalized Lease Obligations 176,850 194,239
Accounts Payable 5,210,972 2,982,899
Accrued Liabilities    1,464,828     1,122,737
Customer Deposits      245,186    337,396
    Total Current Liabilities 7,097,836 4,637,271

Long Term Notes Payable & Capitalized Lease Obligations

41,203 204,837
Shareholders' Equity:
Common Shares, no par value,
    14,104,690 and 13,815,186 shares issued and outstanding
34,799,093 33,415,106
Common Share Purchase Warrants,
    2,114,169 and 1,204,169 shares issued and outstanding
3,378,398 3,038,411
Accumulated Deficit (26,356,548) (18,492,491)
   Total Shareholders' Equity   11,820,943  17,961,026
    Total Liabilities and Shareholders' Equity $18,959,982 $22,803,134

(return to News Index)
Monday, March 2, 2009

Rockwell Medical Appoints Richard Yocum, M.D.,
as VP of Drug Development and Medical Affairs

Dr. Yocum will spearhead clinical development
of lead product SFP and renal therapeutics pipeline

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that it has appointed Richard Yocum, M.D. to Vice President of Drug Development and Medical Affairs, a newly formed position. Dr. Yocum will be responsible for leading the clinical development of Soluble Ferric Pyrophosphate (SFP), the Company's proprietary iron maintenance product currently progressing through a U.S. Phase 2 clinical study, as well as overseeing all aspects of clinical research and development.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We welcome Richard to the Rockwell team. He brings a wealth of experience and knowledge in clinical development and has coordinated clinical drug development processes across the United States, Europe and Japan. In addition, he has direct hands-on experience in all stages of the clinical development process, from pre-IND through post-marketing trials. We are confident that Richard's expertise will enable Rockwell to successfully bring SFP to the market, as well as to develop proprietary SFP related extensions to penetrate additional markets.”

Prior to joining Rockwell, Dr. Yocum spent 15 years in clinical drug development and project team management within the biopharmaceutical industry. Dr. Yocum worked as Vice President, Clinical Development & Medical Affairs at Halozyme Therapeutics; as Vice President, Clinical Development & Medical Affairs at Chugai Pharma USA; as Executive Medical Director of Clinical Research at Ligand Pharmaceuticals and as Associate Director of Clinical Research at Gensia. Dr. Yocum graduated summa cum laude from Dartmouth College and earned his medical degree from Johns Hopkins University School of Medicine. He later completed his internal medicine residency at the University of California San Diego and had a General Medicine practice for 11 years.

Dr. Yocum commented, “Rockwell is an exciting company with a breakthrough iron product to treat anemia. I believe SFP addresses an important unmet need for patients, has high probability of FDA market approval and the potential to improve the standard of care for dialysis patients throughout the world. I look forward to working with Rob and the rest of the Rockwell team to guide SFP through clinical development, and ultimately market approval.”

About Soluble Ferric Pyrophosphate (SFP):
SFP is a novel, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials have shown that SFP delivered during each dialysis treatment, via the Company's dialysate, maintains optimal iron balance and avoids liver toxicity while decreasing associated pharmaceutical intravenous iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world; the United States, Japan and the European Union. The total U.S. market for IV-iron is approximately $500 million annually while global market potential is approximately $850 million.

About Rockwell Medical Technologies:
Rockwell is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell's products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for those patients who suffer from ESRD. There are approximately 375,000 ESRD patients in the United States growing at an annual rate of 4 percent and approximately 2 million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell is developing a pipeline of drug therapies not only for iron deficiency in kidney disease, but for other critical care conditions such as oncology and gastroenterology.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "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. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond the Company's control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings. The forward- looking statements should be considered in light of these risks and uncertainties. Rockwell does not undertake, and 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.

(return to News Index)

Thursday, November 13, 2008

Rockwell Medical Reports Second Quarter Sales Increase of 15.5%;
Margins Increase Sequentially

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., an innovative specialty pharma company developing renal drug therapies and manufacturing dialysate products, reported third quarter 2008 sales of $13.5 million, an increase of 22.2% over sales of $11.1 million in the third quarter of last year. Sales for the first nine months of 2008 were $38.1 million, an increase of 22.6% over the first nine months of 2007. Loss per share in the third quarter of 2008 was ($.18) compared to ($.04) in the third quarter of 2007. Loss per share in the first nine months of 2008 was ($.35) compared to a loss per share of ($.22) in the first nine months of 2007.

Third Quarter Financial Highlights:

  • Quarterly sales of $13.5 million increased 22.2% or $2.5 million compared to 2007
  • Domestic sales were up 12.3% compared to the third quarter of 2007
  • Sequential domestic revenue increased 11.1% in the third quarter over the second quarter.
  • Gross profit decreased due to higher than expected transportation costs.
  • SG&A expense in 2008 included a litigation settlement charge of $750,000 and non-cash charges for stock options and warrants of $0.3 million.
  • SFP related R&D spending of $1.0 million or 7.3% of sales in 2008.
  • Loss of ($2.5 million) compared to a loss of ($.4 million) in the third quarter 2007.
  • Cash position at September 30, 2008 was $7.5 million.
Nine Month Financial Highlights:
  • Sales increased 22.6% or $7.0 million to $38.1 million in the first nine months of 2008 vs. 2007
  • Domestic sales increased 16.7% while international sales were up 147% compared to the first nine months of 2007.
  • Gross profit increased by $573,000 or 26.6% compared to the first nine months of 2007.
  • SG&A expense in 2008 included a litigation settlement charge of $750,000 and non-cash charges for stock options and warrants of $1.1 million.
  • R&D expense was $2.6 million for the first nine months of 2008 compared to $2.3 million in the first nine months of 2007.
  • Loss of ($4.8 million) compared to a loss of ($2.6 million) in the first nine months of 2007.
SFP Business Highlights:
  • Data Safety Monitoring Board (DSMB), which oversees the SFP Phase IIb dose-range study, met in October and cited no safety issues; recommended continuation of study.
  • More than 1,500 doses of SFP administered amongst Phase IIa, Phase IIb and National Institutes of Health (NIH) study with no serious adverse events reported.
  • Implemented changes to SFP Phase IIb study protocol to accelerate enrollment.
  • Increased number of SFP clinical trial sites to 25+.
  • NIH study continuing to enroll patients.
  • Added significant expertise to the Company's Scientific Advisory Board with the appointment of additional iron experts in the renal field.
  • Progressed in recruitment of a Chief Medical Officer.

"We continue to make progress on our SFP clinical development and have focused efforts on completing our Phase IIb study," stated Mr. Robert L. Chioini, Chairman and CEO of Rockwell. Mr. Chioini also stated, "The DSMB's recent positive review of SFP and the ongoing trial strengthens our confidence in this innovative drug and its superior safety profile. We will also continue to expand Rockwell's scientific team to advance the development of SFP and explore future opportunities in the specialty pharma market with an emphasis on renal drug therapies."

Rockwell will be hosting a conference call to review its third quarter results and to provide investors with an update on its business development efforts on Thursday, November 13, 2008 at 4:30 pm EST.

Investors are encouraged to call in several minutes in advance at (877) 604-9669 to hear the call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=34179&c=RMTI&mediakey=D10A5E1DF7A97FB10085D02719B0AE67&e=0

See www.rockwellmed.com for more details and playback options.

Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing necessary nutrients in the dialysis patient's bloodstream. Rockwell is currently developing unique, proprietary renal drug therapies for iron maintenance utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy while decreasing cost.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our anticipated future financial condition, operating results, cash flows or business plans, as well as the timing and cost of obtaining FDA approval of our new SFP product, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors and other risks and uncertainties set forth in the Company's SEC filings, including its Form 10-K for the year ended December 31, 2007 and its Forms 10-Q filed during 2008. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS

For the three and nine months ended September 30, 2008 and September 30, 2007
(Unaudited)
  3 Months ended Sept 30, 2008 3 Months ended Sept 30, 2007 6 Months ended Sept 30, 2008 6 Months ended Sept 30, 2007
Sales $ 13,533,986 $ 11,073,774 $ 38,128,359 $ 31,096,399
Cost of Sales    12,755,377     9,953,863    35,400,671    28,942,171
   Gross Profit      778,609      1,119,911     2,727,688     2,154,228
Selling, General, Admin    2,314,188     765,457    5,183,675    2,288,903
Research & Product Devel.     993,262     735,393    2,557,718    2,319,452
   Operating (Loss)    (2,528,841)    (380,939)    (5,013,705)    (2,454,127)
Interest Expense (Income), net     (17,795)       51,973      (182,482)     101,924
   Net (Loss) $ (2,511,046) $ (432,912) $ (4,831,223) $ (2,556,051)
Basic Earnings (Loss) per share $ (0.18) $ (0.04) $ (0.35) $ (0.22)
Diluted Earnings (Loss)per share $ (0.18) $ (0.04) $ (0.35) $ (0.22)

ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS

As of September 30, 2008 and December 31, 2007
  Sept 30, 2008
(Unaudited)
Dec. 31, 2007
   Assets
Cash and Cash Equivalents $ 7,481,792 $ 11,097,092
Accounts Receivable,
    net of a reserve of $82,000 in 2008 and $69,000 in 2007
5,356,536 4,687,229
Inventory 3,166,566 2,559,051
Other Current Assets     535,437     302,573
    Total Current Assets 16,540,331 18,645,945
Property and Equipment, net 3,332,569 2,840,331
Intangible Assets 248,338 270,446
Goodwill     920,745     920,745
Other Non-current Assets    116,850    125,667
    Total Assets $21,158,833 $22,803,134

    Liabilities and Shareholders' Equity
Notes Payable & Capitalized Lease Obligations 187,682 194,239
Accounts Payable 3,977,321 2,982,899
Accrued Liabilities    2,252,257    1,122,737
Customer Deposits    331,043    337,396
    Total Current Liabilities 6,748,303 4,637,271

Long Term Notes Payable & Capitalized Lease Obligations

58,190 204,837
    Shareholders' Equity:
Common Shares, no par value,
    13,834,953 and 13,815,186 shares issued and outstanding
34,224,870 33,415,106
Common Shares Purchase Warrants,
    1,414,169 and 1,204,169 warrants issued and outstanding
3,413,433 3,038,411
Accumulated Deficit (23,323,714) (18,492,491)
   Total Shareholders' Equity   14,352,340   17,961,026
    Total Liabilities and Shareholders' Equity $21,158,833 $22,803,134

(return to News Index)
Tuesday, November 4, 2008

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI) announced today that it will hold an investor conference call on Thursday, November 13, 2008 at 4:30PM EST to discuss its third quarter 2008 results and to provide investors with a business update. Robert Chioini, Chairman and CEO, and Thomas Klema, CFO, will be hosting the call to review Rockwell's results and answer questions from investors. Rockwell will be releasing results on the same date after the market closes.

The conference call will be held on:

Thursday, November 13, 2008
Starting Time 4:30 p.m. EST
Dial in Number: 877-604-9669

When calling in please refer to the Rockwell Medical Technologies Investor Conference Call and provide the operator with your name and company affiliation.

Investors who prefer to participate using the internet may access the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=34179&c=RMTI&mediakey=D10A5E1DF7A97FB10085D02719B0AE67&e=0

International Investors may dial in directly on 719-325-4880.

Investors who are unable to listen to the Rockwell investor conference call will be able to access a replay via our web site at www.rockwellmed.com.

We appreciate your interest in Rockwell.

(return to News Index)

Wednesday, October 29, 2008

Rockwell Announces Updated DSMB Results;
Identifies No Safety Concerns for SFP

- Phase II-b trial to continue as planned -

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a specialty pharma company focused on drug and device development in the renal market, reported today that the independent Data Safety Monitoring Board (DSMB) providing oversight for the SFP Phase II-b iron maintenance therapy dose-range study reviewed the cumulative safety data from the ongoing clinical study and informed the Company that it has identified no safety concerns. The DSMB also recommended the continuation of the study with no modifications.

"We are encouraged by the DSMB's favorable comments regarding our current Phase II-b iron maintenance therapy dose-range study. We are pleased with the safety profile of SFP. Amongst all clinical studies to date, more than 1,500 clinical doses of SFP have been administered without a single adverse reaction," stated Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell. "In an effort to increase the speed of patient enrollment and to complete the trial more rapidly we have increased the number of clinical trial sites to 25-30, from 10. The successful completion of our SFP development program remains our top priority."

About SFP:
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide physiological-iron-maintenance-therapy for treatment of anemia, with initial indication for end stage renal disease (ESRD). SFP is delivered direct to the bloodstream of the ESRD patient, via dialysate, during each kidney dialysis treatment, maintaining optimal iron balance, avoiding liver toxicity and decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. The Company is currently conducting a FDA Phase IIb study and sponsoring an on-going NIH-funded study in anticipation of gaining FDA market approval. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan and the European Union. The total U.S. market for IV-iron is approximately $525 million annually while global market potential is approximately $800 million.

About Rockwell Medical Technologies:
Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing necessary nutrients in the dialysis patient's bloodstream. Rockwell is currently developing unique, proprietary renal drug therapies for iron maintenance utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy while decreasing cost.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "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. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond the Company's control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings. The forward-looking statements should be considered in light of these risks and uncertainties. Rockwell does not undertake, and 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.

(return to News Index)

Tuesday, October 27, 2008

Rockwell Medical to Present at 2008
Oppenheimer 19th Annual Healthcare Conference

WIXOM, Mich. - Rockwell Medical Technologies, Inc. (Nasdaq: RMTI), a specialty pharma company focused on drug and device development in the renal market, today announced that Robert L. Chioini, Chief Executive Officer, will present at the Oppenheimer 19th Annual Healthcare Conference at the Waldorf Astoria Hotel in New York.

The Rockwell presentation will take place on Tuesday, November 4, 2008 at 2:40PM EST.

About Rockwell Medical Technologies:
Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing nutrients in the dialysis patient's bloodstream. Rockwell is currently developing unique, proprietary renal drug therapies for both iron maintenance and carnitine supplementation utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy to these patients while decreasing cost.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "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. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond the Company's control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings. The forward- looking statements should be considered in light of these risks and uncertainties. Rockwell does not undertake, and 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.

(return to News Index)

Tuesday, August 12, 2008

Rockwell Medical Reports Second Quarter Sales Increase of 15.5%;
Margins Increase Sequentially

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., an innovative specialty pharma company developing renal drug therapies and essential dialysate products, reported second quarter 2008 sales of $12.2 million, an increase of 15.5% over sales of $10.5 million in the second quarter of last year. First half 2008 sales of $24.6 million increased 22.8% over the first half of 2007. Loss per share in the second quarter of 2008 was ($.08) compared to ($.04) in the second quarter of 2007. Loss per share in the first half of 2008 was ($.17) compared to a loss per share of ($.18) in the first half of 2007.

Second Quarter Financial Highlights:

  • Quarterly revenue of $12.2 million increased 15.5% or $1.6 million compared to 2007.
  • Domestic sales were up 16.4% compared to the second quarter of 2007
  • Sequential domestic revenue increased 5.5% in the second quarter over the first quarter although total sales were 1.9% lower due to lower international orders compared to the first quarter.
  • Gross profit margins rose sequentially 2.1 percentage points to 9.0% compared to the first quarter but were down 1.6 percentage points compared to the second quarter of 2007.
  • SG&A expense included non-cash charges for stock options and warrants of $.3 million.
  • SFP related R&D spending of $.8 million was 6.4% of sales.
  • Loss of ($1.1 million) compared to a loss of ($.5 million) in the second quarter 2007.
  • Cash position at June 30, 2008 was $9.7 million.
Six Month Financial Highlights:
  • Sales increased 22.8% or $4.6 million to $24.6 million in the first half of 2008 vs. 2007
  • Domestic sales increased 19.1% while international sales were up 94% compared to the first half of 2007.
  • Gross Profit margins increased 2.8% to 7.9% compared to the first half of 2007.
  • SG&A expense included non-cash charges for stock options and warrants of $.7 million.
  • R&D expense was $1.6 million in the first half of 2008 and in the first half of 2007.
  • Loss of ($2.3 million) compared to a loss of ($2.1 million) in the first half of 2007.
SFP Business Highlights:
  • Added significant expertise to the Company's Scientific Advisory Board with the appointment of three additional renal failure and iron experts in the renal field.
  • Modified SFP Phase II-b Dose Ranging Study protocol to reflect changes to industry hemoglobin standards.
  • Modified SFP Phase II-b Dose Ranging Study protocol to accelerate enrollment and study completion.
  • Commenced enrollment for a 9-month National Institutes of Health (NIH) funded SFP study.
  • Commenced recruitment for a Chief Medical Officer.

Mr. Robert L. Chioini, Chairman and CEO stated, "Our SFP clinical development program continues to progress and we are confident that we have taken necessary actions to complete the trial as effectively as possible. We have increased the resources devoted to development and revised the protocol to facilitate enrollment wherever practical. We look forward to advancing the SFP study and expanding our senior management team as we begin to distinguish ourselves within the specialty pharma market. Overall, second quarter results were in line with our expectations."

Rockwell will be hosting a conference call to review its second quarter results and to provide investors with an update on its business development efforts on Tuesday, August 12, 2008 at 11:00 am eastern time.

Investors are encouraged to call in several minutes in advance at (877) 440-5803 to hear the call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=32850&c=RMTI&mediakey=803E36B7FDC0F7E12EBCE5CA76E150CB&e=0

See www.rockwellmed.com for more details and playback options.

Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing necessary nutrients in the dialysis patient's bloodstream. Rockwell is currently developing unique, proprietary renal drug therapies for iron maintenance utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy while decreasing cost.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our anticipated future financial condition, operating results, cash flows or business plans, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors and other risks and uncertainties set forth in the Company's SEC filings, including its Form 10-K for the year ended December 31, 2007 and its Forms 10-Q filed during 2008. The forward-looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS

For the three and six months ended June 30, 2008 and June 30, 2007
(Unaudited)
  3 Months ended June 30, 2008 3 Months ended June 30, 2007 6 Months ended June 30, 2008 6 Months ended June 30, 2007
Sales $ 12,182,336 $ 10,548,243 $ 24,594,373 $ 20,022,625
Cost of Sales    11,090,558     9,431,207    22,645,294    18,988,308
   Gross Profit      1,091,778      1,117,036     1,949,079     1,034,317
Selling, General, Admin    1,439,735     797,787    2,869,487    1,523,446
Research & Product Devel.     781,743     761,539    1,564,456    1,584,059
   Operating (Loss)    (1,129,700)    (442,290)    (2,484,864)    (2,073,188)
Interest Expense (Income), net     (19,696)       34,335      (164,687)      49,951
   Net (Loss) $ (1,110,114) $ (476,625) $ (2,320,177) $ (2,123,139)
Basic Earnings (Loss) per share $ (0.08) $ (0.04) $ (0.17) $ (0.18)
Diluted Earnings (Loss)per share $ (0.08) $ (0.04) $ (0.17) $ (0.18)

ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS

As of June 30, 2008 and December 31, 2007
  June 30, 2008
(Unaudited)
Dec. 31, 2007
   Assets
Cash and Cash Equivalents $ 9,735,902 $ 11,097,092
Accounts Receivable,
    net of a reserve of $82,000 in 2008 and $69,000 in 2007
4,352,087 4,687,229
Inventory 2,712,486 2,559,051
Other Current Assets     458,715     302,573
    Total Current Assets 17,259,190 18,645,945
Property and Equipment, net 3,179,529 2,840,331
Intangible Assets 256,021 270,446
Goodwill     920,745     920,745
Other Non-current Assets    148,636    125,667
    Total Assets $21,764,121 $22,803,134

    Liabilities and Shareholders' Equity
Notes Payable & Capitalized Lease Obligations 192,466 194,239
Accounts Payable 3,195,379 2,982,899
Accrued Liabilities    1,358,996    1,122,737
Customer Deposits    362,189    337,396
    Total Current Liabilities 5,109,030 4,637,271

Long Term Notes Payable & Capitalized Lease Obligations

101,467 204,837
    Shareholders' Equity:
Common Shares, no par value,
    13,834,953 and 13,815,186 shares issued and outstanding
33,976,532 33,415,106
Common Shares Purchase Warrants,
    1,394,169 and 1,204,169 warrants issued and outstanding
3,389,760 3,038,411
Accumulated Deficit (20,812,668) (18,492,491)
   Total Shareholders' Equity   16,553,624   17,961,026
    Total Liabilities and Shareholders' Equity $21,764,121 $22,803,134

(return to News Index)
Tuesday, August 5, 2008

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., announced today that it will hold an investor conference call on Tuesday, August 12, 2008 at 11:00AM EST to discuss its second quarter 2008 results and to provide investors with a business update. Robert Chioini, Chairman and CEO, and Thomas Klema, CFO, will be hosting the call to review Rockwell's results and answer questions from investors.

The conference call will be held on:

Tuesday, August 12, 2008
Starting Time 11:00 a.m. Eastern
Dial in Number: 877-440-5803

When calling in please refer to the Rockwell Medical Technologies Investor Conference Call and provide the operator with your name and company affiliation.

Investors who prefer to participate using the internet may access the following link: http://investor.shareholder.com/media/eventdetail.cfm?mediaid=32850&c=RMTI&mediakey=803E36B7FDC0F7E12EBCE5CA76E150CB&e=0

International Investors may dial in directly on 719-325-4920.

Investors who are unable to listen to the Rockwell investor conference call will be able to access a replay via our web site at www.rockwellmed.com.

We appreciate your interest in Rockwell.

(return to News Index)

Tuesday, July 9, 2008

Rockwell Appoints Dr. Richard Hurrell,
International Iron Expert, to Scientific Advisory Board

WIXOM, Mich. -- Rockwell Medical Technologies, Inc.(Nasdaq: RMTI), a specialty pharma company focused on drug and device development in the renal market, reported today that it has added Dr. Richard Hurrell, an internationally recognized expert in the field of iron, with a specialty in SFP and its role in nutrition, to its Scientific Advisory Board (SAB).

Dr. Hurrell is the Professor for Human Nutrition and Head of the Laboratory of Human Nutrition at the Institute of Food Science and Nutrition, Swiss Federal Institute of Technology (ETH), Zurich, Switzerland. He specializes in the iron fortification of foods and has helped develop improved methods to fortify food products without causing adverse organoleptic changes. He was awarded the International Prize for Modern Nutrition for studies on the influence of food processing and preparation on food quality and is a member of the British Nutrition Society, the Swiss Nutrition Society and the European Academy of Nutrition. Dr. Hurrell is President of the Swiss Committee of International Union of Nutritional Scientists, the editor of the International Journal for Vitamin and Nutrition Research, and a member of the WHO Task Force on Food Fortification and the WHO International Micronutrient Advisory Group. He has been on the Editorial Board of the Zeitschrift fuer Ernaehrungswissenschaft and The British Journal of Nutrition and on the Editorial Advisory Board of the journal Trends in Food Science and Technology. Dr. Hurrell is a consultant on food fortification to leading multinational food companies and international agencies and was previously the Head of the Micronutrient Research Team and the Coordinator for Infant Nutrition Research at the Nestlé Research Center, Lausanne. Dr. Hurrell has more than 130 publications in the areas of iron bioavailability, iron fortification, iron and iodine nutrition in developing countries, mineral absorption using stable isotopes, influence of food processing on nutritional value of foods. Dr. Hurrell holds a PhD in Nutrition from Cambridge University and BSc Honors Degree in Food Technology from Reading University.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “Dr. Hurrell has accomplished a tremendous amount of work with iron pyrophosphate and is the top expert in iron nutrition at the international level, specifically for SFP, and we are delighted to have him join our Scientific Advisory Board as one of our expert consultants. As we evaluate and develop other SFP applications, outside of iron maintenance via dialysate, we believe Dr. Hurrell's expertise and experience in the industry will be of great benefit to the Company.”

Dr. Hurrell is the sixth iron expert added to Rockwell's current SAB. Rockwell's seven-member SAB currently advises the Company on clinical development for its proprietary iron-maintenance renal drug SFP, currently in FDA Phase IIb clinical trials, as well as proprietary SFP-related extensions and the evaluation of new renal drug opportunities. Rockwell's SAB consists of experts in the fields of renal anemia, iron therapy, nutrition, nephrology, parenteral, enteral and FDA regulatory affairs.

About SFP:
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide physiological-iron-maintenance-therapy for treatment of anemia, with initial indication for end stage renal disease (ESRD). SFP is delivered direct to the bloodstream of the ESRD patient, via dialysate, during each kidney dialysis treatment, maintaining optimal iron balance, avoiding liver toxicity and decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.

About Rockwell Medical Technologies:
Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing nutrients in the dialysis patient's bloodstream. Rockwell is currently developing unique, proprietary renal drug therapies for both iron maintenance and carnitine supplementation utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy to these patients while decreasing cost.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "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. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond the Company's control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings. The forward- looking statements should be considered in light of these risks and uncertainties. Rockwell does not undertake, and 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.

(return to News Index)

Tuesday, June 17, 2008

Rockwell Appoints Dr. James D. Cook to Scientific Advisory Board

WIXOM, Mich. -- Rockwell Medical Technologies, Inc.(Nasdaq: RMTI), a specialty pharma company focused on drug and device development in the renal market, reported today that it has added Dr. James D. Cook, an internationally recognized expert in the field of iron, to its Scientific Advisory Board (SAB). Dr. Cook has published over 200 peer-reviewed articles on all aspects of human iron metabolism with emphasis on iron absorption, internal iron kinetics and the clinical assessment of iron status in a career spanning over 40 years. Rockwell's SAB currently advises the Company on clinical development and market preparation for its proprietary iron-maintenance product SFP, currently in Phase IIb clinical trials. Rockwell's SAB consists of experts in the fields of renal anemia, iron therapy, nephrology and FDA regulatory approval.

Dr. Cook graduated from Queen's University, Canada with an M.D. degree in 1960 and M.Sc (Med) in 1963. He obtained his clinical training in Internal Medicine at Boston City Hospital and hematology training at the University of Washington, Seattle where he remained on faculty until 1975. He was then appointed the Phillips Professor of Medical Research and Director of Hematology, Department of Medicine at the Kansas University Medical Center, Kansas City, Kansas. Dr. Cook retired from teaching and clinical practice as Professor Emeritus at Kansas University in 2007.

In the late 1960s Dr. Cook, in collaboration with Dr. Joseph Eschbach, studied disorders of erythropoiesis and iron absorption in patients with kidney failure. In his distinguished career, Dr. Cook has served as Chairman on several national and international research/advisory committees including the Expert Panel on Iron, International Committee for Standardization in Hematology (1981); Subcommittee on Nutritional Anemia, American Society of Hematology (1979); Subcommittee on Iron Methodology, National Committee for Clinical and Laboratory Standards (1979-95); International Center for Control of Nutritional Anemia (ICCNA), University of Kansas Medical Center (1982-94), and Iron Subcommittee, FAO/WHO Expert Consultation on Requirements of Vitamin A, Iron, Folate and Vitamin B12 (1985). Dr. Cook has also served as a member/consultant on the Editorial Board, Journal of Nutrition (1978-1983); NIH Hematology Study Section (1983-1987), Tanzania Nutritional Anemia Consultative Group, Dar es Salaam, Tanzania (1991-92); US National Committee, International Union of Nutritional Sciences (1986-1992); Joint Micronutrient Consultative Group, Nutrition Foundation (1992-94); British Task Force on Iron Nutrition (1992-93); National Nutrition Council, Stockholm, Sweden (1993); Scientific Subcommittee on Iron and Heme, American Society of Hematology (2001- 2004); and International Federation of Clinical Chemistry Working Group on Laboratory Management of r-HuEPO Therapy (2002-2005).

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are excited to have added Dr. Cook to our SAB. Dr. Cook's expertise and wealth of experience in the iron field will be invaluable to Rockwell as the Company further exploits the unique properties of SFP that make it ideally suited for the oral, nutritional and parenteral and enteral administration markets. We have assembled a first-class team to help facilitate not only FDA market approval of SFP in ESRD but to also pursue regulatory approval of other SFP applications within CKD and other new markets as well."

Rockwell's current SAB consists of:

  • Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology and Senior Staff Physician, Henry Ford Hospital, Detroit and lead Principal Investigator for the Phase II-b dose range study.
  • Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of Medicine, Indianapolis.
  • Richard Zager, MD, Director of Nephrology, Fred Hutchinson Cancer Research Center and Professor of Medicine, University of Washington, Seattle.
  • James Cook, MD, former Phillips Professor of Medical Research and Director of Hematology, and currently Professor Emeritus, Kansas University, Kansas City, Kansas.
  • Bert Spilker, PhD, MD, President Bert Spilker & Associates, LLC.
  • Ajay Gupta, MD, Associate Professor of Medicine, UCLA and Charles Drew University Schools of Medicine, Los Angeles; the inventor of SFP as a parenteral iron supplement (via hemodialysis and peritoneal dialysis solutions, intravenously and as an adjunct to parenteral nutritional admixtures. Dr. Gupta is the Principal Investigator for the ongoing NIH sponsored clinical trial examining oxidative stress and inflammation in response to SFP versus IV iron.
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide physiological-iron-maintenance-therapy for treatment of anemia, with initial indication for end stage renal disease (ESRD). SFP is delivered direct to the bloodstream of the ESRD patient, via dialysate, during each kidney dialysis treatment, maintaining optimal iron balance, avoiding liver toxicity and decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.

The Company is currently conducting a Phase IIb study and sponsoring an on-going NIH-funded study in anticipation of gaining FDA market approval. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan and the European Union. The U.S. dialysis market for IV-iron delivery is approximately $500 million annually while global market potential is approximately $800 million.

Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focus