ROCKWELL MEDICAL TECHNOLOGIES, INC.

 Home Page 

 The Company 

 Products 

 Kidney Disease 

 Contact us 

 Investment Info 

 Links 






Index of Rockwell News 2006
Click on underlined dates to view complete story

  Nov. 8, 2006   -  RMTI Reports Q3; Increased Sales Projected for Q4
  Oct. 26, 2006   -  Rockwell Medical Schedules Investor Conference Call
  Oct. 25, 2006   -  Rockwell Receives Canadian Patent for Dri-Sate® System
  Oct. 18, 2006   -  RMTI Submits SFP Dose-Ranging Study Protocol to FFDA
  Sep. 28, 2006   -  Rockwell's Proprietary SFP Iron-Delivery Receives
Patent Grant for Poland
  Aug. 9, 2006   -  Rockwell Q2 Report; Increased R&D Spending
for SFP Drug Approval
  Aug. 1, 2006   -  Rockwell Schedules Investor Conference Call
  July 20, 2006   -  WIRB Approves NIH Protocol for Proprietary SFP
  June 27, 2006   -  Rockwell Receives Hong Kong Patent Grant
for Proprietary SFP
  May 24, 2006   -  Rockwell Medical Signs Concentrate Distribution
Agreement for European Market
  May 16, 2006   -  RMTI Signs Supply Contract with Renal Advantage
  May 11, 2006   -  Rockwell Reports First Quarter Sales Up 10%
  May 3, 2006   -   RMTI Schedules Q1 Investor Conference Call
  Apr 20, 2006   -  Rockwell Submits SFP Pre-IND Package to FDA
  Apr 19, 2006   -  Rockwell Receives European Patent Issuance for
Proprietary Iron-Delivery Technology
  Mar. 1, 2006   -  RMTI Reports Q4 and Year-End Sales Increase;
Spendng for FDA Drug Approval Increases
  Feb 21, 2006   -  Rockwell Schedules Investor Conference Call
  Feb 06, 2006   -  RMTI Raises $9.25 Million from Warrant Exercise
  Jan 31, 2006   -  Rockwell Signs Distribution Agreement with Genpharm, Inc.
of Toronto, Canada
  Jan 18, 2006   -  RMTI Signs Exclusive Licensing Agreement to Market
Dialysate Containing Vitamins and Carnitine
  Jan 12, 2006   -  Rockwell Medical Receives $13 Million Supply Order
  Jan 11, 2006   -  RMTI Finalizes Phase III Clinical Trial Protocol; Begins


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"

Most Recent News

News Archives
2005     2004     2003     2002     2001     2000    


(return to News Index)

Wednesday, November 8, 2006

Rockwell Medical Reports Third Quarter;
Projects Increased Sales in Q4

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer of hemodialysis products and developer of specialty pharmaceuticals focused on the end-stage-renal-disease (ESRD) market, reported its third quarter and nine month results today which included increased spending on product development and drug approval costs for soluble ferric pyrophosphate (SFP).

Business and Financial Highlights for the quarter and year to date included:

Third Quarter Financial Highlights

  • Sales were $7,379,200; $449,000 lower than the third quarter of 2005.
  • International sales were $1.5 million lower compared to the third quarter of 2005.
  • Domestic sales increased by over $1 million or 20% over the third quarter of 2005.
  • Sales increased 25.7% sequentially from the second quarter of 2006.
  • Net loss was ($1,621,669) which included $1,621,821 in R&D costs.
  • Net loss per share was ($.14), which included R&D costs of $.14 per share for SFP, vs. EPS of $.02 last year.
Nine Month Financial Highlights
  • Sales were $19.4 million; $1.8 million or 8.6% lower than the first nine months of 2005.
  • International sales were $4.5 million lower than in the first nine months of 2005.
  • Domestic sales increased $2.7 million or 17.3%.
  • Increased market share of independent and smaller chain accounts grew 35.8% over the first nine months of 2005; and represented over 53% of total sales.
  • Net loss was ($3,419,944) which included $3,381,643 in R&D costs.
  • Net loss per share was ($.31) which included R&D costs of $.31 per share for SFP vs. 2005 EPS of $.04.
SFP DevelopmentHighlights
  • Non-clinical testing program for toxicity and safety pharmacology studies progressing toward completion.
  • Favorable SFP safety profile demonstrated in both completed and interim reports from non-clinical testing.
  • Submitted protocol to FDA to begin dose ranging study; on track to begin study in the fourth quarter.
  • Modified National Institutes of Health (NIH) study protocol; on track to begin study in the fourth quarter.
  • Western Institutional Review Board (WIRB) approved modified protocol to begin NIH SFP study.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell Medical Technologies, Inc. stated, “Our third quarter results reflected dynamic changes in our market and business. The continuing withdrawal of a major competitor from the concentrate market is creating significant opportunity for us to expand our business. In addition, our international distributors have substantially increased their order volumes over their orders in the first half of 2006. We anticipate sequentially increasing sales and gross profit margins in the fourth quarter.”

Mr. Chioini also said, “We are actively working towards FDA market approval of our SFP product. We met with the FDA in the second quarter and carefully evaluated their feedback. We have made adjustments to our clinical plan and to the NIH funded study protocol in order to capture additional data to facilitate the FDA approval process. We anticipate beginning human clinical trials before the end of this year.”

Rockwell is actively working towards FDA market approval for its proprietary iron-delivery product SFP, which is designed to provide physiological iron maintenance therapy for hemodialysis patients with end stage renal disease. The U.S. market for intravenous iron products is estimated to be approximately $450,000,000 while the global market is believed to be over $750,000,000. The Company anticipates that human clinical studies will commence this year. SFP was successfully tested in an FDA Phase II clinical trial and was shown to be safe and effective at maintaining iron stores at targeted levels. Non-clinical safety, pharmacology and toxicology testing throughout the first nine months of 2006 have shown a safety profile both consistent with earlier human testing and with the Company's expectations.

Rockwell will be hosting a conference call to review its results and business developments on Wednesday, November 8, 2006 at 11:00 am EST. Investors are encouraged to dial in a few minutes in advance of the call at 866-406-5369 or may listen on the web at http://orion.calleci.com/servlet/estreamgetevent?id=7301&folder=default using Windows Media Player. See www.rockwellmed.com for more details and playback options.

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 3-5% on average each year over the last five years. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding status and timing of Rockwell's efforts to obtain FDA approval of SFP, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate (SFP) to capture market share, potential for sales growth, expected customer orders, etc. constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delays or failure to obtain FDA approval of SFP, failure to obtain Medicare or private insurance reimbursement approval, cancellation of an existing purchase order from a major international distributor of our products or failure of such international distributor to order anticipated level of products in the fourth quarter of 2006, delay or failure to be awarded expected new business from a major customer or distributor, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. These forward-looking statements should be considered in light of these risks and uncertainties.

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and nine months ended
September 30, 2006 and September 30, 2005
(Whole dollars)

(Unaudited)
  3 Months ended Sept 30, 2006 3 Months ended Sept 30, 2005 9 Months ended Sept 30, 2006 9 Months ended Sept 30, 2005
Sales $ 7,379,201 $ 7,828,262 $ 19,410,357 $ 21,238,803
Cost of Sales     6,785,796     6,868,274    17,568,497    18,798,954
Gross Profit      593,405       959,988     1,841,860     2,439,849
Selling, General, Admin     592,767     684,809    1,912,544   1,935,114
Research & Product Devel.     1,621,821     74,010    3,381,643    159,831
Operating Income (Loss)    (1,621,183)     201,169    (3,452,327)     344,904
Other Income    -    -      137,468   -
Interest Expense (Expense), net    (486)       (44,992)      32,383      (131,524)
   Net Income  ($1,621,669)  $ 156,177 ($ 3,419,944) $ 350,848
Basic Earnings (Loss) per share $ (0.14) $  0.02 $ (0.31) $  0.04
Diluted Earnings (Loss)per share $ (0.14) $  0.02 $ (0.31) $  0.04

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
September 30, 2006 and December 31, 2005
(Whole dollars)
(Unaudited)
  Sept. 30, 2006 Dec. 31, 2005
Assets
Cash and Cash Equivalents $ 4,034,516 $ 299,031
Accounts Receivable,
    net of a reserve of $92,000 in 2006 and $70,000 in 2005
2,748,827 2,836,072
Inventory 2,547,135 2,051,819
Other Current Assets     257,776     193,158
    Total Current Assets 9,588,254 5,380,080
Property and Equipment, net 2,486,943 2,430,222
Intangible Assets 467,957 394,819
Goodwill     920,745     920,745
Other Non-current Assets    129,584    134,794
    Total Assets $13,593,483 $ 9,260,660

    Liabilities and Shareholders' Equity
Short Term Borrowings $  - $ 1,800,000
Notes Payable & Capitalized Lease Obligations 444,634 522,439
Accounts Payable 2,425,081 1,795,393
Accrued Liabilities     488,741     530,749
Customer Deposits     386,682     33,558
    Total Current Liabilities 3,745,138 4,682,139

Long Term Notes Payable & Capitalized Lease Obligations

414,632 733,723
Shareholders' Equity:
Common Shares, no par value,
    11,475,749 and 8,886,948 shares issued and outstanding
23,052,274 12,628,539
Common Share Purchase Warrants,
    -0- and 3,591,385 shares issued and outstanding
- 1,414,876
Accumulated Deficit (13,618,561) (10,198,617)
   Total Shareholders' Equity   9,433,713   3,844,798
    Total Liabilities and Shareholders' Equity $13,593,483 $ 9,260,660

(return to News Index)
Thursday, October 26, 2006

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., announced today that it will hold an investor conference call on Wednesday, November 8, 2006 at 11:00AM EST to discuss its third quarter results and to provide investors with a business update. The Company intends to release results before the market opens on the same date. 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 will be held on:

Wednesday, November 8, 2006
Starting Time 11:00 AM Eastern
Dial in Number: 866-406-5369
Conference ID#: 8046813

When calling in please refer to Conference ID# 8046813 for the Rockwell Medical Technologies Third Quarter 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 for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7302&folder=default.

Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7301&folder=default

International Investors may dial in directly on 973-582-2847.

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

We appreciate your interest in Rockwell.

(return to News Index)

Wednesday, October 25, 2006

Rockwell Receives Canadian Patent for
Dri-Sate® Dry Acid Concentrate Mix System

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported today that it has received notice from the Canadian Patent Office that its application for its Dri-Sate® Dry Acid Concentrate Mix System has been allowed.

Rockwell's proprietary Dri-Sate® Dry Acid Concentrate Mix System provides an efficient method for dialysis providers to prepare and distribute the dialysate solution needed for dialysis treatment. Dri-Sate® Powder is a better alternative to pre-mixed liquid concentrate solutions that are currently delivered. Dri-Sate® is packaged as a lightweight, condensed powder that is mixed on-site by the technician at the dialysis center, which enables the dialysis center to better utilize storage space that was previously restricted to liquid concentrate storage. Once mixed, the product is equivalent to the acid concentrate provided to the dialysis center in liquid form.

The Dri-Sate® technology provides an automated system designed to work exclusively with the Dri-Sate® Powder. It is compact, easy to operate and requires no additional plumbing installation. All that is required is an electrical outlet and a water source able to produce AAMI quality water, which all dialysis centers in Canada have. For the dialysis provider, the advantages for using the Dri-Sate® Dry Acid Concentrate Mix System include lower cost per treatment, increased storage space, fewer deliveries and greater flexibility.

On January 31, 2006, Rockwell signed an exclusive distribution agreement with Genpharm, Inc., of Toronto, Canada wherein Rockwell will manufacture its dry dialysis concentrate products for Genpharm's Renal Care Products Division. Genpharm will market and distribute both Rockwell's Dri-Sate® Dry Acid Concentrate Mix System and RenalPure® Powder Bicarbonate in Canada under the Rockwell label following regulatory approval. Both Rockwell and Genpharm estimate the Canadian dialysis market for concentrate to be approximately U.S. $24 million annually.

Mr. Rob Chioini, Chairman, CEO and President of Rockwell stated, “This patent is an important step in our business development in Canada. The superior packaging and mixing technology of the Dri-Sate® System, coupled with Genpharm's aggressive Renal Care distribution arm, should position us to develop a strong presence in Canada. We anticipate regulatory approval sometime within the next two quarters.”

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to the estimated size of the Canadian dialysis market and prospective sales constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delay or failure to receive regulatory approval in Canada, general economic conditions, economic conditions in the hemodialysis industry, competitive factors and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Wednesday, October 18, 2006

Rockwell Submits SFP Dose-Ranging Study Protocol to FDA

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported today that it submitted its Soluble Ferric Pyrophosphate (SFP) Dose Ranging Study protocol to the FDA.

The SFP Dose Ranging Study design is a double-blinded, randomized, multi-center, parallel groups, placebo controlled study. Subjects will undergo hemodialysis treatment three times per week for 36 weeks followed by a one week treatment-free follow-up. Rockwell is currently on schedule to begin enrollment for the study in the fourth quarter of this year.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are encouraged by the solid progress we continue to make towards obtaining FDA approval for our proprietary SFP product. This study will enable us to define the optimal dose for iron maintenance therapy for a majority of ESRD patients, as well as determine the minimum and maximum dose limits for those special ESRD patients who may need more or less iron.”

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron called Ferric Pyrophosphate. SFP is designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatment. Rockwell has licensed the exclusive world-wide rights to the SFP patent and is in the process of seeking FDA approval to market the product.

Compared to intravenous (IV) iron administration, early clinical study results have shown that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs.

Rockwell has licensed the exclusive rights to the patents for the SFP technology which grant the Company the right to manufacture and market the combination drug/device. Rockwell estimates that the U.S. dialysis market for IV-iron delivery represents approximately $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively in those markets. For more information on SFP visit Rockwell's website at www.rockwellmed.com/ironnews.htm.

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release including statements regarding FDA approval to market SFP, the market potential for iron supplementation and the ability of SFP to compete for market share once approved by the FDA constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Thursday, September 28, 2006

Rockwell's Proprietary SFP Iron-Delivery
Receives Patent Grant for Poland

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported that the Polish patent was granted for its proprietary drug, Soluble Ferric Pyrophosphate (SFP). The patent covers the "Method and Pharmaceutical Composition for Iron Delivery administered via Dialysate in Hemodialysis and Peritoneal Dialysis Patients".

Rockwell's proprietary iron-delivery product SFP is a soluble form of iron designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during a dialysis treatment. Rockwell has licensed the exclusive rights to SFP and its patents and is in the process of seeking FDA approval to market the product.

Compared to intravenous (IV) iron administration, early clinical study results have shown that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs. Rockwell estimates that the U.S. market for IV iron delivery is as much as $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively for those markets. Visit Rockwell's website at www.rockwellmed.com/ironnews.htm for more information on SFP.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “This patent approval is another important step for protecting our proprietary drug-delivery delivery technology internationally.”

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.
Certain statements in this press release including statements regarding FDA approval to market SFP, the market potential for iron supplementation and the ability of SFP to compete for market share once approved by the FDA constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Wednesday August 9, 2006

Rockwell Reports Q2;
Increased R&D Spending for SFP Drug Approval

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer of hemodialysis products and developer of specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported its second quarter and six month results today which included increased spending on product development and drug approval costs for soluble ferric pyrophosphate (SFP). Second quarter 2006 loss per share was ($.13) with $.12 per share spending on SFP. First half 2006 loss per share was ($.16) which included $.16 per share spending on SFP.

Business and Financial Highlights for the quarter and year to date included:

Second Quarter Financial Highlights:

  • Sales of $5.9 million were $1.9 million lower than second quarter 2005.
  • Salesdecreased primarily due to a delay in filling an international order for dialysis kits.
  • Domestic sales increased 9.1% in the second quarter compared to the second quarter of 2005.
  • Dri-Sate Dry Acid Concentrate volume increased 10% sequentially over the first quarter of 2006.
  • Net losswas ($1,509,057) which included $1,311,085 in R&D costs.
  • Net lossper share was ($.13), which included R&D costs of $.12 per share for SFP, vs. EPS of $.01 last year.
SFP Development Highlights - 2006 to date:
  • Successfully completed financing to begin funding FDA approval process for SFP.
  • Commencednon-clinical testing program consisting of 19 toxicity and safety pharmacology studies.
  • Met with FDA to discuss plans for commercialization of SFP.
  • Received FDA feedback on SFP product development plans in June.
  • Advanced clinical plan, incorporating FDA recommendations.
  • Continued preparation to commence pivotal studies in late 2006.
  • National Institutes of Health (NIH) study protocol filed with FDA.
  • Manufactured SFP concentrate for use in NIH funded $500.000 study.
  • Western Institutional Review Board approved protocol for NIH SFP study.
  • NIH nine-month SFP study on track to begin enrollment in third quarter of 2006.
First Half 2006 Financial Highlights:
  • Sales of $12.0 million were $1.4 million or 10.3% lower than the first half of 2005.
  • Sales toour major international distributor were $3 million lower in the first half of 2006.
  • Domestic sales increased 16.1% over the first half of 2005.
  • Independent and smaller chain account sales increased 28.7% over the first half of 2005.
  • Net loss per share was ($.16) which included R&D costs of $.16 per share for SFP vs. first half 2005 EPS of $.02.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell Medical Technologies, Inc. stated, “Regarding our SFP progress, we are on schedule and actively working towards FDA market approval. Our second quarter and year-to-date results were consistent with our expectations for both our SFP development progress and our financial investment to accomplish that objective. Our timeline for commencing our final clinical studies remains on schedule. We are also pleased with the progress of our on-going non-clinical testing program for SFP.”

With respect to first half sales results, Mr. Chioini stated, “Our domestic concentrate business is progressing as we anticipated. Our independent and regional chain volume increased 29% in the first half of the year. In the near term, we are encouraged by the developments in our competitive marketplace as we continue to secure additional concentrate business at higher prices than in the past. Regarding our international business, our sales results were impacted by the order pattern of our major international distributor which serves a single customer for us and which ordered $3 million less in the first half of 2006 compared to 2005. We are advised that orders from this distributor will increase in the second half of 2006.”

Rockwell is actively working towards FDA market approval for its proprietary iron-delivery product SFP, which is designed to provide physiological iron maintenance therapy for hemodialysis patients with end stage renal disease. The U.S. market for intravenous iron products is estimated to be approximately $400,000,000 while the global market is believed to be over $750,000,000. The Company anticipates that pivotal studies will commence in the fourth quarter of 2006. SFP was successfully tested in an FDA Phase 2 clinical trial and was shown to be safe and effective at maintaining iron stores at targeted levels. Non-clinical safety, pharmacology and toxicity testing continuing throughout 2006 have had favorable results and been in line with expectations.

Rockwell will be hosting a conference call to review its results and business developments on Wednesday, August 9, 2006 at 11:00 am EST. Investors are encouraged to dial in a few minutes in advance of the call at 888-896-0862 or may listen on the web at http://orion.calleci.com/servlet/estreamgetevent?id=7067&folder=default using Windows Media Player. See www.rockwellmed.com for more details and playback options.

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 3-5% on average each year over the last five years. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding FDA approval, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate (SFP) to capture market share, potential for sales growth, expected customer orders, etc. constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delays or failure to obtain FDA approval of SFP, failure to obtain medicare or private insurance reimbursement approval, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. These forward-looking statements should be considered in light of these risks and uncertainties.

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and six months ended
June 30, 2006 and June 30, 2005
(Whole dollars)

(Unaudited)
  3 Months ended June 30, 2006 3 Months ended June 30, 2005 6 Months ended June 30, 2006 6 Months ended June 30, 2005
Sales $ 5,869,253 $ 7,791,033 $ 12,031,156 $ 13,410,541
Cost of Sales     5,404,107     6,980,588   10,782,701    11,930,680
Gross Profit      465,146       810,445     1,248,455     1,479,861
Selling, General, Admin     693,935     652,045    1,319,777   1,250,305
Research & Product Devel.    1,311,085     36,422    1,759,822     85,821
Operating Income (Loss)    (1,539,874)     121,978    (1,831,144)    143,735
Other Income    -    -      -   137,468
Interest Income (Expense), net    30,817       (36,522)      32,869      (86,532)
   Net Income (Loss) ($ 1,509,057)  $ 85,456 ($ 1,798,275) $ 194,671
Basic Earnings (Loss) per share $  (0.13) $ 0.01 $  (0.16) $  0.02
Diluted Earnings (Loss) per share $  (0.13) $ 0 .01 $  (0.16) $  0.02

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of June 30, 2006 and December 31, 2005
(Whole dollars)
(Unaudited)
  June 30, 2006 Dec. 31, 2005
Assets
Cash and Cash Equivalents $ 4,748,427 $ 299,031
Accounts Receivable,
    net of a reserve of $86,000 in 2006 and $70,000 in 2005
2,476,690 2,836,072
Inventory 2,544,896 2,051,819
Other Current Assets     472,883     193,158
    Total Current Assets 10,242,896 5,380,080
Property and Equipment, net 2,375,080 2,430,222
Intangible Assets 450,295 394,819
Goodwill     920,745     920,745
Other Non-current Assets    131,542    134,794
    Total Assets $ 9,260,660 $ 9,260,660

    Liabilities and Shareholders' Equity
Short Term Borrowings $     -        $  1,800,000
Notes Payable & Capitalized Lease Obligations 498,800 522,439
Accounts Payable 1,566,277 1,795,393
Accrued Liabilities     560,714     530,749
Customer Deposits     80,916     33,558
    Total Current Liabilities 2,706,707 4,682,139

Long Term Notes Payable & Capitalized Lease Obligations

443,220 733,723
Shareholders' Equity:
Common Shares, no par value,
    11,455,583 and 8,886,948 shares issued and outstanding
22,967,523 12,628,539
Common Share Purchase Warrants,
    -0- and 3,591,385 shares issued and outstanding
- 1,414,876
Accumulated Deficit (11,996,892) (10,198,617)
   Total Shareholders' Equity   10,970,631   3,844,798
    Total Liabilities and Shareholders' Equity $ 14,120,558 $ 9,260,660


(return to News Index)
Tuesday, August 1, 2006

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., announced today that it will hold an investor conference call on Wednesday, August 9, 2006 at 11:00 AM ET to discuss its second quarter results and to provide investors with a business update. The Company intends to release results before the market opens on the same date. 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 call will be held on:

Wednesday, August 9, 2006
Starting Time 11:00 AM Eastern Time
Dial in Number: 888-896-0862
Conference ID#: 7684014

When calling in please refer to Conference ID# 7684014 for the Rockwell Medical Technologies Second Quarter 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 for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7068&folder=default.

Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=7067&folder=default

International Investors may dial in directly on 973-935-8597.

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

We appreciate your interest in Rockwell.

(return to News Index)

Thursday, July 20, 2006

WIRB Approves NIH Protocol for Proprietary SFP

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported that the Western Institutional Review Board (WIRB) has approved the Company's National Institutes of Health (NIH) sponsored study protocol for examining the prospective advantages of soluble ferric pyrophosphate (SFP) delivery via dialysate in hemodialysis patients. The nine-month study is expected to begin in the third quarter of 2006.

The WIRB provides review services for more than 100 institutions (academic centers, hospitals, networks and in-house biotech research), as well as for individual investigators in all 50 states and internationally. The WIRB has worked with all major pharmaceutical and device manufacturers, CRO's and the biotech industry.

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron called Ferric Pyrophosphate. SFP is designed to provide physiological iron maintenance for hemodialysis patients by delivery of SFP via dialysate. Compared to intravenous (IV) iron administration, early clinical study results for SFP have shown that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs.

Rockwell has licensed the exclusive rights to the patents for the SFP technology which grant the Company the right to manufacture and market the combination drug/device. Rockwell is seeking FDA approval to market the product and estimates that the U.S. dialysis market for IV-iron delivery represents $400 million annually, while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively in those markets. For more information on SFP visit www.rockwellmed.com/ironnews.htm.

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's anticipated sales revenue and earnings constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, any breach of a contract by a major customer, competitive factors and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Tuesday, June 27, 2006

RMTI Receives Hong Kong Patent Grant for Proprietary SFP

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported that the Hong Kong Patent and Trademark Office has issued a patent for Rockwell's proprietary SFP product. The patent covers the "Method and Pharmaceutical Composition for Iron Delivery administered via Dialysate in Hemodialysis and Peritoneal Dialysis Patients".

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron called Ferric Pyrophosphate. SFP is designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during a dialysis treatment. Rockwell has licensed the exclusive rights to the SFP patent and is in the process of seeking FDA approval to market the product.

Compared to intravenous (IV) iron administration, early clinical study results have shown that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs. Rockwell estimates that the U.S. market for IV iron delivery is as much as $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively for those markets. Visit Rockwell's website at www.rockwellmed.com/ironnews.htm for more information on SFP.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We believe the markets along the pacific rim hold tremendous potential for SFP. This patent approval in Hong Kong is a significant step toward commercial realization of SFP in an important market. Overall, we are pleased with our progress toward FDA approval."

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release including statements regarding FDA approval to market SFP, the market potential for iron supplementation and the ability of SFP to compete for market share once approved by the FDA constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Wednesday, May 24, 2006

Rockwell Medical Signs Concentrate Distribution
Agreement for European Market

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), reported today that it has signed an exclusive distribution agreement with a specialty pharma distributor to supply its dialysis concentrate products in Europe.

The Agreement calls for the purchase of Rockwell's Dri-Sate Dry Acid Concentrate Mixing System for distribution into Europe. Under the terms of the Agreement, minimum volumes of Rockwell's Dri-Sate Dry Acid Concentrate are required to be purchased. The product will be marketed under the Rockwell label following European CE regulatory approval. The European dialysis market is the third largest following the U.S. and Japan.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are pleased to have secured this distribution channel into Europe. Our distributor is active in the European dialysis market and we anticipate our Dri-Sate Dry Acid Concentrate Mixing System will sell very well. Much like our Canadian distribution agreement we announced earlier this year, this agreement enables Rockwell to enter the European dialysis market without having to make capital investments for production and distribution facilities in the region.”

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to the estimated size of the European dialysis market and prospective sales constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delay or failure to receive regulatory approval in Canada, general economic conditions, economic conditions in the hemodialysis industry, competitive factors and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Tuesday, May 16, 2006

Rockwell Medical Signs Concentrate Supply Contract
with Renal Advantage Inc.

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative hemodialysis concentrate manufacturer serving the healthcare industry, announced today that it has signed a supply contract with Renal Advantage Inc. (RAI).

RAI is headquartered in Brentwood, TN and is the fourth largest provider of dialysis services in the United States. RAI currently operates more than 70 freestanding renal dialysis centers in 10 states serving approximately 7,000 patients suffering from chronic kidney failure. RAI acquired the centers as a result of DaVita Inc.'s acquisition of Gambro Healthcare US. For more information on RAI visit www.renaladvantage.com.

At the start of the contract, Rockwell will service approximately half of the RAI centers. The general terms of the supply contract call for RAI to purchase concentrate and other products from Rockwell over a 24-month period. The contract is renewable upon mutual consent thereafter. The RAI centers initially serviced by Rockwell are expected to generate more than $1 million in annual sales revenue.

Mr. Rob Chioini, Chairman, CEO and President of Rockwell said, “We are pleased to have the opportunity to supply RAI with our product. The majority of the centers that we will service will utilize our Dri-Sate Dry Acid Concentrate Mixing System, which will benefit both RAI and Rockwell.”

Ms. Angela Newman, Vice President of Supply Chain for RAI stated, “We are very pleased to have Rockwell as a dialysate supplier for our centers. Rockwell has exceptional customer and delivery service and we are confident that having Rockwell as our dialysate provider will benefit RAI as we continue to streamline and consolidate our supply chain functions.”

Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing and delivering high-quality dialysis solutions, powders and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's anticipated sales revenue constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, competitive factors and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Thursday May 11, 2006

Rockwell Medical Reports First Quarter Sales Up 10%;
Increased R&D Spending for Proprietary Drug

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative hemodialysis products manufacturer in the healthcare sector, reported its first quarter results today which included a 10% sales increase over the first quarter last year. Earnings per Share was a loss of ($.03). Increased R&D spending for FDA approval of Rockwell's proprietary iron-delivery drug, Soluble Ferric Pyrophosphate (SFP), reduced earnings per share $.04 in the first quarter.

First Quarter Financial Highlights

  • Sales increased 10% over the first quarter of 2005 to $6,161,903
  • Net Loss was ($289,218) which included $448,737 in R&D costs.
  • Loss per Share was ($.03) which included R&D costs of $.04 per share for SFP.
  • Loss per Share was ($.03) compared to first quarter 2005's EPS of $.01.
  • Raised $9.1 million in gross capital from successful warrant exercise in January.
  • Increased Equity Capital to $11,900,000.
  • Renewed Credit Line of $2.75 million.
SFP Highlights
  • Successfully completed financing to begin funding FDA approval process for SFP.
  • Commenced non-clinical testing program consisting of 19 toxicity and safety pharmacology studies.
  • Eleven studies have been completed to date, five studies are on-going and the final three studies are scheduled to begin in May of this year.
  • Completed designing test protocols for the final 3 non-clinical studies to commence in second quarter.
  • Manufactured commercial batch of SFP concentrate for use in upcoming NIH Study.
  • NIH study design completed and submitted to Institutional Review Board (IRB).
  • Submitted Pre-IND package to FDA containing Phase 3 Protocol in April.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell Medical Technologies, Inc. stated, "Our first quarter marked several important milestones in our history. First, we completed a successful warrant offering which provides us with the resources to aggressively work towards gaining FDA market approval of SFP, a top priority for us. Second, we are well underway with our non-clinical SFP testing program, which is progressing as planned. Finally, our project team completed the SFP Phase 3 protocol which was submitted to the FDA in April. In addition, to achieving these milestones, we were pleased to see our share price appreciate which we attribute to increasing investor recognition of SFP's potential value."

Mr. Chioini also said, "Our strategic initiatives encompass both building our concentrate business and gaining FDA market approval for SFP, but clearly our top priority will be getting SFP, our proprietary iron-delivery drug, to the market as fast as possible. We expect to spend as much as $4 million for SFP testing and development in 2006. We are truly excited about this innovative, proprietary product and its potential to capture market share in what we think will grow to be a billion dollar global market by the end of this decade."

Rockwell is actively working towards FDA market approval for its SFP, its iron-delivery product, which is designed to be a physiological iron replacement therapy for hemodialysis patients with end stage renal disease. The Company anticipates that Phase 3 clinical studies will commence in late 2006. SFP was successfully tested in a Phase 2 clinical trial and was shown to be effective at maintaining iron stores at targeted levels. Safety and pharmacology testing is planned to continue throughout 2006 has had favorable results so far.

Rockwell will be hosting a conference call to review its first quarter developments on Thursday, May 11, 2006 at 11:00 am EST. Investors are encouraged to dial in a few minutes in advance of the call at 888-896-0862 or may listen on the web at http://orion.calleci.com/servlet/estreamgetevent?id=6827&folder=default using Windows Media Player. See www.rockwellmed.com for more details and playback options.

Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing and delivering high-quality dialysis solutions, powders and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 4-6% on average over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding FDA approval, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate (SFP) to capture market share, etc. constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delays or failure to obtain FDA approval of SFP, failure to obtain medicare or private insurance reimbursement approval, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. These forward-looking statements should be considered in light of these risks and uncertainties.

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three months ended
March 31, 2006 and March 31, 2005
(Whole dollars)

(Unaudited)
  3 Months ended March 31, 2006 3 Months ended March 31, 2005
Sales $ 6,161,903 $ 5,619,50
Cost of Sales     5,378,594     4,950,092
Gross Profit      783,309       669,416
Selling, General, Admin     625,842     598,260
Operating Income (Loss)    (291,270)     21,757
Other Income    -    137,468
Interest Expense (Income), net    (2,052)       50,010
   Net Income (Loss)  $ (289,218)  $ 109,215
Basic Earnings (Loss) per share ( $ .03) $  .01
Diluted Earnings (Loss) per share ( $ .03) $  .01

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of March 31, 2006 and December 31, 2005
(Whole dollars)
(Unaudited)
  Mar. 31, 2006 Dec. 31, 2005
ASSETS
Cash and Cash Equivalents $ 5,694,893 $ 299,031
Accounts Receivable,
    net of a reserve of $85,227 in 2006 and $70,000 in 2005
3,064,293 2,836,072
Inventory 2,211,945 2,051,819
Other Current Assets     309,463     193,158
    Total Current Assets 5,893,711 4,241,037
Property and Equipment, net 2,068,157 2,048,665
Intangible Assets 400,499 369,508
Goodwill     920,745     920,745
Other Non-current Assets     128,742     120,597
    Total Assets $ 11,280,594 $ 9,260,660

LIABILITIES AND SHAREHOLDERS' EQUITY
Short Term Borrowings $       -        $    1,800,000
Notes Payable & Capitalized Lease Obligations 516,647 522,439
Accounts Payable 1,617,959 1,795,393
Customer Deposits   145,307     33,558
Accrued Liabilities     384,695     530,749
    Total Current Liabilities 2,664,608 4,682,139

Long Term Notes Payable & Capitalized Lease Obligations

606,856 733,723
    Shareholders' Equity:
Common Shares, no par value,
    11,283,188 and 8,886,948 shares issued and outstanding
22,392,249 12,628,539
Common Share Purchase Warrants,
    25,000 and 3,591,385 shares issued and outstanding
14,042 1,414,876
Accumulated Deficit (10,487,835) (10,198,617)
   Total Shareholders' Equity   11,918,456   3,844,798
    Total Liabilities and Shareholders' Equity $ 15,189,920 $ 9,260,660


(return to News Index)
Wednesday, May 3, 2006

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. -- Rockwell Medical Technologies, Inc.announced today that it will hold an investor conference call on Thursday, May 11, 2006 at 11:00AM EST to discuss its first quarter results and to provide investors with a business update. The Company intends to release results before the market opens on the same date. 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 call will be held on:

Thursday, May 11, 2006
Starting Time 11:00AM Eastern Time
Dial in Number: 888-896-0862

When calling in please refer to Conference ID#7360306 for the Rockwell Medical Technologies First Quarter 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 for Real Player:   http://orion.calleci.com/servlet/estreamgetevent?id=6826&folder=default

Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6827&folder=default

International Investors may dial in directly on 973-935-8597

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 20, 2006

Rockwell Medical Submits SFP Pre-IND Package Containing
Phase III Clinical Protocol to FDA

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative dialysis products manufacturer serving the healthcare industry, reported today that it has submitted a pre-IND package to the FDA for their review. This pre-IND package contains Rockwell's Phase III clinical trial protocol for its proprietary iron-delivery product Soluble Ferric Pyrophosphate (SFP). Rockwell's SFP is designed to provide physiological iron replacement in ESRD patients by delivering iron via dialysate during hemodialysis. Pending FDA approval of its IND development plan, the Company anticipates initiating the Phase III clinical trial during the fourth quarter of 2006.

Rockwell has non-clinical safety studies ongoing in support of the SFP product development. Out of a total of 19 non-clinical safety studies, eleven studies have been completed to date, five studies are on-going and the final three studies are scheduled to begin in May of this year. The final three studies are projected to conclude in the first quarter of 2007.

Based on the results of an FDA approved Phase II study, delivering SFP via dialysate has shown to be a safer and more effective method for maintaining iron balance in dialysis patients, as compared to intravenous iron (IV-iron) administration. Also demonstrated during the study, SFP delivered via dialysate appeared to have a distinct safety advantage for patients in that it transferred the iron load directly from dialysate into the blood plasma, thereby avoiding liver toxicity that may occur during IV-iron administration. The study results also appeared to demonstrate a reduction in the amount of Epoetin-alfa (EPO) needed during the dialysis treatment.

In addition, as compared to IV-iron administration, SFP delivered via dialysate is expected to produce substantial cost savings for dialysis providers by eliminating the nursing time and the medical supplies needed for current IV-iron administration. Cost and liability due to a potential needle-stick is expected to be eliminated as well.

Rockwell has licensed the exclusive rights to the patents for the SFP technology which grant the Company the right to manufacture and market the combination drug/device. Rockwell estimates that the U.S. dialysis market for IV-iron delivery represents $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively for those markets. For more information on SFP visit Rockwell's website at www.rockwellmed.com/ironnews.htm

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are pleased to have submitted our pre-IND package to the FDA. This submission, including the Phase III protocol, should enable us to save valuable time on our development plan for SFP. Our overall goal is to attain FDA market approval of SFP as quickly as possible so that we can provide a safe and effective delivery method for patients undergoing hemodialysis who require physiological iron replacement.”

Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing, and delivering high-quality dialysis solutions, powders, and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6%-8% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding an anticipated commencement on the Company's Phase III clinical trial, non-clinical study timelines, FDA approval, the potential of Rockwell's proprietary SFP, etc., constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Wednesday, April 19, 2006

Rockwell Medical Receives European Patent Issuance for
Proprietary Iron-Delivery Technology

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative hemodialysis products manufacturer in the healthcare industry, reported that the European Patent and Trademark Office has issued a patent for Rockwell's proprietary iron-delivery product SFP, which covers the "Method and Pharmaceutical Composition for Iron Delivery in Hemodialysis and Peritoneal Dialysis Patients". Rockwell reported on August 10, 2005 that the EPTO had allowed its claims for the proprietary drug/device.

Rockwell's proprietary product SFP is designed to provide physiological iron replacement in ESRD patients by delivering iron via dialysate during hemodialysis and peritoneal dialysis treatment. Rockwell has licensed the exclusive rights to the SFP patent and is in the process of seeking FDA approval to market the product.

The countries the patent grant will effect are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Compared to intravenous (IV) iron administration, results based on an FDA approved Phase II Study have shown that delivering iron via dialysate is a safer and more effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs. Rockwell estimates that the U.S. dialysis market for IV iron delivery represents $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively for those markets. Visit Rockwell's website at www.rockwellmed.com/ironnews.htm for more information on SFP.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, ““This European patent issuance was expected based on the allowance we had previously received. It is a significant step for Rockwell as it enables us to protect our proprietary technology in a major market. Currently, we are making solid progress in our FDA development process and we expect to achieve several more significant milestones as we work towards market approval.”

Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing, and delivering high-quality dialysis solutions, powders, and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6%-8% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding an anticipated response from the FDA on the Company's Phase III Clinical Trial proposal, non-clinical study timelines, FDA approval, the potential of Rockwell's proprietary Soluble FePPi, etc., and the Company's ability to raise additional capital constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Wednesday March 1, 2006

Rockwell Reports Q4 and 2005 Year-End Sales Increase;
Spending for FDA Drug Approval Increases

WIXOM, Mich. -- Rockwell Medical Technologies, Inc. a leading, innovative hemodialysis products manufacturer in the healthcare sector, reported its fourth quarter and year-end results today. Sales increased 35% in the fourth quarter over last year's fourth quarter and 2005 revenue increased 54% over 2004. Sales increased to $27.7 million in 2005 compared to $18 million in 2004. Spending on FDA drug approval for Rockwell's proprietary iron-delivery product, Soluble Ferric Pyrophosphate (SFP), reduced earnings $.04 per share in 2005.

Fourth quarter 2005 earnings per share was a loss of ($.03) as compared to breakeven in the fourth quarter of 2004. Net loss of ($274,040) in the fourth quarter included $186,000 of drug product spending for SFP related expenses. Earnings per share for 2005 were $.01 as compared to $.02 in 2004. Investments in FDA approval costs for SFP during 2005 totaled $.04 per share. 2005 profit of $76,808 was reduced by $350,000 for SFP related expenses.

Fourth Quarter Highlights:

  • Sales increased 35% over the fourth quarter of 2004 to $6,456,000.
  • AppointedScientific Advisory Board (SAB) to advise on the development and FDA approval of SFP.
  • Commenced Safety Pharmacology Tests for the development and approval of SFP.
  • Completedwarrant exchange resulting in successful exercise and gross capital raise of $9.25 million.
  • Net losswas ($.03) per share and included $.02 per share of SFP development costs.
2005 Highlights:
  • Sales increased $9.75 million, or 54%, to $27.7 million in 2005 as compared to 2004.
  • Significantlyincreased market penetration both domestically and internationally.
  • Expandednational production and distribution footprint with third manufacturing facility in the Southeast.
  • ReceivedEuropean Patent allowance for Rockwell's proprietary iron delivery product — SFP.
  • Completedcommercial SFP manufacturing and testing procedures.
  • NetIncome was $.01 per share and included $.04 of SFP development costs.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell Medical Technologies, Inc. stated, “We are extremely pleased with the progress we made during 2005. Our strategic initiatives encompass both building our core concentrate business and gaining FDA market approval for our proprietary iron-delivery product (SFP), but clearly our top priority will be getting SFP to the market as fast as possible. The fourth quarter was the beginning of accelerated spending on SFP product testing and resulted in increased product development expense for Rockwell; we anticipate that expense will increase substantially going forward. We expect to spend at least $3-4 million for FDA testing and development in 2006 which will be funded from the proceeds from the exercise of our warrants. We are very excited about this innovative, proprietary product and its potential to capture market share.”

Rockwell is seeking FDA approval for its Soluble Ferric Pyrophosphate (SFP) iron-delivery product used to treat dialysis patients with iron deficiency. The Company plans to submit its Phase III protocol for FDA review in the second quarter of 2006 and anticipates that Phase III clinical studies will commence in late 2006. Safety and pharmacology testing commenced in the fourth quarter of 2005 and will run throughout 2006. Safety and pharmacology testing so far has demonstrated favorable results. SFP was successfully tested in its Phase II clinical trial. An independent National Institutes of Health Study is expected to commence treating patients with SFP in May.

Rockwell will be hosting a conference call to review its year end and fourth quarter results on Wednesday, March 1, 2006 at 11:00 am EST. Investors are encouraged to call in five minutes in advance of the call at 888-896-0862 or may listen on the web at: http://orion.calleci.com/servlet/estreamgetevent?id=6516&folder=default using Windows Media Player. See www.rockwellmed.com for more details and playback options.

Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing and delivering high-quality dialysis solutions, powders and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 4-6% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding FDA approval, the potential of Rockwell's proprietary Soluble Ferric Pyrophosphate (SFP) to capture market share, etc. constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delays or failure to obtain FDA approval of SFP, failure to obtain medicare or private insurance reimbursement approval, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. These forward-looking statements should be considered in light of these risks and uncertainties.

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and twelve months ended
December 31, 2005 and December 31, 2004
(Whole dollars)

  3 Months ended Dec 31, 2005 3 Months ended Dec 31, 2004 9 Months ended Dec 31, 2005 9 Months ended Dec 31, 2004
Sales $ 6,456,152 $ 4,780,070 $ 27,694,955 $ 17,944,710
Cost of Sales     5,890,958     4,072,467    24,689,912    15,139,215
Gross Profit      565,194       707,603     3,005,043     2,805,495
Selling, General, Admin     772,663     636,623    2,867,608   2,396,315
Operating Income     (207,469)     70,980    137,435    409,180
Other Income    -    -      137,468   -
Interest Expense, net    66,571       59,576      198,095      197,658
   Net Income  $ (274,040)  $ 11,404 $ 76,808 $ 211,522
Basic Shares Outstanding 8,795,057 8,553,527 8,674,651 8,546,302
Basic Earnings per share $  (0.03) $ 0.00 $  0.01 $  0.02
Fully Diluted Shares Outstanding 9,891,521 9,199,505 9,356,990 9,305,123
Fully Diluted Earnings per share $  (0.03) $ 0 .00 $  0.01 $  0.02

Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of December 31, 2005 and December 31, 2004
(Whole dollars)
  Dec. 31, 2005 Dec. 31, 2004
Assets
Cash and Cash Equivalents $ 299,031 $ 166,195
Restricted Cash and Cash Equivalents - 8,662
Accounts Receivable,
    net of a reserve of $70,000 in 2005 and $44,500 in 2004
2,836,072 2,302,093
Inventory 2,051,819 1,652,457
Other Current Assets     193,158     111,630
    Total Current Assets 5,380,080 4,241,037
Property and Equipment, net 2,430,222 2,048,665
Intangible Assets 394,819 369,508
Goodwill     920,745     920,745
Other Non-current Assets    134,794    120,597
    Total Assets $ 9,260,660 $ 7,700,552

    Liabilities and Shareholders' Equity
Short Term Borrowings $ 1,800,000 $    452,682
Notes Payable & Capitalized Lease Obligations 522,439 389,602
Accounts Payable 1,795,393 2,124,679
Accrued Liabilities     530,749     481,587
Customer Deposits     33,558     11,005
    Total Current Liabilities 4,682,139 3,459,555

Long Term Notes Payable & Capitalized Lease Obligations

733,723 818,678
Shareholders' Equity:
Common Shares, no par value,
    8,886,948 and 8,556,531 shares issued and outstanding
12,628,539 11,870,909
Common Share Purchase Warrants,
    3,591,385 and 3,761,071 shares issued and outstanding
1,414,876 320,150
Accumulated Deficit (10,198,617) (8,768,740)
   Total Shareholders' Equity   3,844,798   3,422,319
    Total Liabilities and Shareholders' Equity $ 9,260,660 $ 7,000,552


(return to News Index)
Tuesday, February 21, 2006

Rockwell Medical Schedules Investor Conference Call

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., announced today that it will hold an investor conference call on Wednesday, March 1, 2006 at 11:00AM EST to discuss its 2005 results. The Company intends to release its fourth quarter and year end results before the market opens on the same date. 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 call will be held on:

Wednesday, March 1, 2006
Starting Time 11:00AM Eastern Time
Dial in Number: 888-896-0862

When calling in please refer to the Rockwell Medical Technologies, 2005 Year End 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 for Real Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6514&folder=default

Or for Windows Media Player:
http://orion.calleci.com/servlet/estreamgetevent?id=6516&folder=default

International Investors may dial in directly on 973-935-8597

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. There will be no telephone replay.

We appreciate your interest in Rockwell.

(return to News Index)

Monday, February 6, 2006

Rockwell Medical Raises $9.25 Million from Warrant Exercise

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a dialysis products manufacturer serving the healthcare industry, reported today that it has raised $9.25 million in gross proceeds from the exercise of warrants. Rockwell will have 11.3 million shares outstanding after the exercise of approximately 2.4 million warrants at $3.90 each.

Rockwell intends to utilize the majority of the proceeds to fund its efforts to obtain FDA approval for its proprietary iron-delivery product, Soluble Ferric Pyrophosphate (FePPi). Soluble FePPi is a physiological iron replacement therapy for end stage renal disease patients via dialysis. Rockwell's Phase III Clinical Trial protocol has been finalized and is scheduled to be submitted to the FDA during the second quarter of 2006. Pending FDA approval of its development plan, the Company anticipates initiating the Phase III Clinical Trial in late 2006. Rockwell expects its proprietary iron-delivery product to aggressively compete in the $300,000,000 U.S. iron market and the overall $500,000,000-plus global iron market if Rockwell is successful in obtaining governmental and other regulatory approvals.

Thomas E. Klema, Vice President and Chief Financial Officer stated, “We are very pleased with successful completion of this offering. We accomplished our primary objective to raise funds needed for the testing of our drug product. This is a significant infusion of capital for us and permits us to aggressively execute our business development plans.”

Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing and delivering high-quality dialysis solutions, powders and ancillary products that improve the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has experienced an average annual increase of approximately 6% over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Rockwell is currently in the process of developing and gaining FDA approval of a proprietary iron-delivery product which will be administered to dialysis patients via dialysate.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding FDA approval, the potential of Rockwell's proprietary Soluble FePPi, adequacy of capital raised, etc. constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, delays or failure to obtain FDA approval of Soluble FePPi, failure to obtain medicare or private insurance reimbursement approval, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.

(return to News Index)

Tuesday, January 31, 2006

Rockwell Signs Distribution Agreement with
Genpharm, Inc. of Toronto, Canada

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative dialysis products manufacturer serving the healthcare industry, reported today that it has signed an exclusive distribution agreement with Genpharm, Inc., of Toronto, Canada

The Distribution Agreement calls for Genpharm to purchase Rockwell's Dri-Sate® Dry Acid Concentrate Mixing System along with RenalPure® Powder Bicarbonate, as well as SteriLyte® Liquid Bicarbonate and RenalPure® Liquid Acid Concentrate. Rockwell will manufacture its dialysis concentrate products for Genpharm's Renal Care Products Division located in Toronto, Canada. Genpharm will market and distribute Rockwell's product in Canada under the Rockwell label following regulatory approval. Both Rockwell and Genpharm estimate the Canadian dialysis market for concentrate to be approximately U.S. $24 million annually.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are very pleased to have Genpharm as our distributor in Canada. Their aggressive marketing practices and strong relationships with many of the large dialysis providers make them an ideal partner to service the 20,000-plus dialysis patients in Canada. Due to the fact that there are only two major concentrate manufacturers in Canada both supplying mostly liquids, coupled with Genpharm's ability to offer Rockwell's dry concentrates along with their substantial product offering, we believe we can capture significant market share in Canada. This distribution agreement enables Rockwell to enter the Canadian dialysis market without the expense of purchasing and operating an additional manufacturing plant as well as the infrastructure that goes along with it.”

Mr. Denis Carrier, Director of Genpharm Renal Care said, “We are excited about our new partnership with Rockwell Medical Technologies, as it allows us to continue in our mandate to bring the Canadian dialysis community the most innovative medical technologies and pharmaceuticals in the world today. Adding Rockwell's products to our portfolio provides us not only with gre