|
Index of
Rockwell News
2007 and 2008
Click on underlined dates to view complete story
June 17, 2008 - RMTI Appoints
Dr. James D. Cook to Scientific Advisory Board
June 10, 2008 - RMTI Appoints
Dr. Richard Zager to Scientific Advisory Board
May 20, 2008 - Rockwell to
Present at Barrington Research Healthcare Conference
May 7, 2008 - Rockwell Reports
First Quarter; Sales Increase 31%
Apr. 22, 2008 - RMTI Schedules
Investor Conference Call
March 6, 2008 - RMTI Reports
Q4 2007 Results; Year-end Sales Increase 50%
Feb. 26, 2008 - Rockwell
Schedules Investor Conference Call
Jan. 31, 2008 - Patients Begin
Dosing in NIH Funded SFP Clinical Study
Jan. 23, 2008 - Patient
Enrollment Begins for NIH Funded SFP Clinical Study
Dec. 4, 2007 - FDA Approves
Start of NIH Sponsored Study of Iron Therapy Drug
Nov 29, 2007 - Rockwell
Medical Closes $12.95 Million Financing
Nov. 8, 2007 - Rockwell
Reports Third Quarter Results; Sales Increase 50%
Nov. 6, 2007 - RMTI to Present
at JMP Securities Healthcare Focus Conference
Oct. 23, 2007 - RMTI Receives
Patent Grant for SFP Iron-Delivery in Mexico
Oct. 18, 2007 - Rockwell
Medical Schedules Investor Conference Call
Oct. 3, 2007 - Rockwell Begins
Dosing Patients for SFP Phase IIb Clinical Study
Sep. 19, 2007 - Rockwell
Begins Patient Enrollment for SFP Dose-Ranging Study
Aug. 13, 2007 - RMTI Reports
Second Quarter Results; Sales up 80%
July 19, 2007 - Rockwell
Schedules Investor Conference Call
May 24, 2007 - Rockwell
Receives Japanese Patent for SFP Iron-Delivery
May 10, 2007 - RMTI Reports
Record First Quarter; Sales up 54%
May 8, 2007 - Rockwell Medical
Schedules Investor Conference Call
Mar. 6, 2007 - RMTI Reports
Record Fourth Quarter; Sales up 43%
Feb. 27, 2007 - Rockwell
Medical Schedules Investor Conference Call
Jan. 24, 2007 - RMTI Reports
Favorable Results for SFP
Pre-Clinical
Safety Studies
Jan. 5, 2007 - Rockwell
Medical Upgrades to Nasdaq Global Market
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"
News
Archives
2006 2005 2004 2003 2002 2001 2000
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Index)
Tuesday, June 17, 2008
Rockwell Appoints Dr. James D. Cook to Scientific Advisory Board
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.(Nasdaq:
RMTI), a specialty pharma company focused on drug and device development in the
renal market, reported today that it has added Dr. James D. Cook, an
internationally recognized expert in the field of iron, to its Scientific
Advisory Board (SAB). Dr. Cook has published over 200 peer-reviewed articles on
all aspects of human iron metabolism with emphasis on iron absorption, internal
iron kinetics and the clinical assessment of iron status in a career spanning
over 40 years. Rockwell's SAB currently advises the Company on clinical
development and market preparation for its proprietary iron-maintenance product
SFP, currently in Phase IIb clinical trials. Rockwell's SAB consists of experts
in the fields of renal anemia, iron therapy, nephrology and FDA regulatory
approval.
Dr. Cook graduated from Queen's University, Canada with an M.D. degree in 1960
and M.Sc (Med) in 1963. He obtained his clinical training in Internal Medicine
at Boston City Hospital and hematology training at the University of
Washington, Seattle where he remained on faculty until 1975. He was then
appointed the Phillips Professor of Medical Research and Director of
Hematology, Department of Medicine at the Kansas University Medical Center,
Kansas City, Kansas. Dr. Cook retired from teaching and clinical practice as
Professor Emeritus at Kansas University in 2007.
In the late 1960s Dr. Cook, in collaboration with Dr. Joseph Eschbach, studied
disorders of erythropoiesis and iron absorption in patients with kidney
failure. In his distinguished career, Dr. Cook has served as Chairman on
several national and international research/advisory committees including the
Expert Panel on Iron, International Committee for Standardization in Hematology
(1981); Subcommittee on Nutritional Anemia, American Society of Hematology
(1979); Subcommittee on Iron Methodology, National Committee for Clinical and
Laboratory Standards (1979-95); International Center for Control of Nutritional
Anemia (ICCNA), University of Kansas Medical Center (1982-94), and Iron
Subcommittee, FAO/WHO Expert Consultation on Requirements of Vitamin A, Iron,
Folate and Vitamin B12 (1985). Dr. Cook has also served as a member/consultant
on the Editorial Board, Journal of Nutrition (1978-1983); NIH Hematology Study
Section (1983-1987), Tanzania Nutritional Anemia Consultative Group, Dar es
Salaam, Tanzania (1991-92); US National Committee, International Union of
Nutritional Sciences (1986-1992); Joint Micronutrient Consultative Group,
Nutrition Foundation (1992-94); British Task Force on Iron Nutrition (1992-93);
National Nutrition Council, Stockholm, Sweden (1993); Scientific Subcommittee
on Iron and Heme, American Society of Hematology (2001- 2004); and
International Federation of Clinical Chemistry Working Group on Laboratory
Management of r-HuEPO Therapy (2002-2005).
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We
are excited to have added Dr. Cook to our SAB. Dr. Cook's expertise and wealth
of experience in the iron field will be invaluable to Rockwell as the Company
further exploits the unique properties of SFP that make it ideally suited for
the oral, nutritional and parenteral and enteral administration markets. We
have assembled a first-class team to help facilitate not only FDA market
approval of SFP in ESRD but to also pursue regulatory approval of other SFP
applications within CKD and other new markets as well."
Rockwell's current SAB consists of:
- Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology
and Senior Staff Physician, Henry Ford Hospital, Detroit and lead Principal
Investigator for the Phase II-b dose range study.
- Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of
Medicine, Indianapolis.
- Richard Zager, MD, Director of Nephrology, Fred Hutchinson Cancer Research
Center and Professor of Medicine, University of Washington, Seattle.
- James Cook, MD, former Phillips Professor of Medical Research and Director
of Hematology, and currently Professor Emeritus, Kansas University, Kansas
City, Kansas.
- Bert Spilker, PhD, MD, President Bert Spilker & Associates, LLC.
- Ajay Gupta, MD, Associate Professor of Medicine, UCLA and Charles Drew
University Schools of Medicine, Los Angeles; the inventor of SFP as a
parenteral iron supplement (via hemodialysis and peritoneal dialysis solutions,
intravenously and as an adjunct to parenteral nutritional admixtures. Dr. Gupta
is the Principal Investigator for the ongoing NIH sponsored clinical trial
examining oxidative stress and inflammation in response to SFP versus IV iron.
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide physiological-iron-maintenance-therapy for treatment of anemia, with initial indication for end stage renal disease (ESRD). SFP is delivered direct to the bloodstream of the ESRD patient, via dialysate, during each kidney dialysis treatment, maintaining optimal iron balance, avoiding liver toxicity and decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.
The Company is currently conducting a Phase IIb study and sponsoring an on-going NIH-funded study in anticipation of gaining FDA market approval. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan and the European Union. The U.S. dialysis market for IV-iron delivery is approximately $500 million annually while global market potential is approximately $800 million.
Rockwell is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end stage renal disease (ESRD). There are an estimated 370,000 ESRD patients in the United States growing approximately 3-5% on average each year and approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing nutrients in the dialysis patient's bloodstream.
Rockwell is currently developing unique, proprietary renal drug therapies for both iron maintenance and carnitine supplementation utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy to these patients while decreasing cost.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements which are based on information available to us on the date of this release.
Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond the Company's control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings. The forward- looking statements should be considered in light of these risks and uncertainties. Rockwell does not undertake, and expressly disclaims any obligation, to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
(return to News
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Tuesday, June 10, 2008
Rockwell Appoints Dr. Richard Zager to Scientific Advisory Board
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.(Nasdaq:
RMTI), a specialty pharma company focused on drug and device development in the
renal market, reported today that it has added Dr. Richard Zager, an expert in
acute renal injury and renal failure to its Scientific Advisory Board (SAB).
Rockwell's SAB currently advises the Company on clinical development and market
preparation for its proprietary iron-maintenance product SFP, currently in
Phase IIb clinical trials. Rockwell's SAB consists of experts in the fields of
renal anemia, iron therapy, nephrology and FDA regulatory approval.
Dr. Zager currently serves as the Director of Nephrology at the Fred Hutchinson
Cancer Research Center. He is a board certified internist and nephrologist with
35 years of clinical experience. He has supervised a NIH funded basic research
laboratory for the past 30 years, with a primary interest in acute renal injury
and acute renal failure. His work focuses on cellular pathways of acute oxidant
and non-oxidant injury, and subsequent post-injury adaptive responses. He has
had a particular interest in iron mediated renal injury, as induced by either
porphyrin iron containing proteins (most notably, hemoglobin, myoglobin, or
cytochrome) or by clinically employed iron - carbohydrate complexes (e.g., Fe
sucrose, gluconate, dextrose, as used to treat clinical iron deficiency). He is
an elected member of the Association of American Physicians. Dr. Zager
graduated from Northwestern Medical School and did his post graduate medical
training at UCLA Medical Center, The University of Washington in Seattle,
Boston University, and Harvard Medical School.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated,
We're delighted to have Dr. Zager join our team. His expertise in iron
mediated biochemical and cellular effects will be invaluable as Rockwell
undertakes clinical studies exploring the potential advantages of SFP over the
conventional polymeric iron complexes used for intravenous
administration.
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide
physiological-iron-maintenance-therapy for anemic ESRD patients. SFP is
delivered direct to the bloodstream of the ESRD patient, via dialysate, during
each kidney dialysis treatment, maintaining optimal iron balance, avoiding
liver toxicity and decreasing associated nursing and pharmaceutical IV iron
administration costs. Recent academic studies have shown that more frequent
maintenance doses of iron improve the therapeutic response and benefits of
recombinant erythropoietin treatments.
The Company is currently conducting a Phase II-b study and sponsoring an
on-going NIH-funded study in anticipation of gaining FDA market approval.
Rockwell has licensed exclusive world-wide rights and has secured patents for
SFP in multiple countries, including the three largest dialysis markets in the
world; the United States, Japan and the European Union. The U.S. dialysis
market for IV-iron delivery is approximately $500 million annually while global
market potential is approximately $800 million.
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as "may,"
"might," "will," "should," "believe,"
"expect," "anticipate," "estimate,"
"continue," "predict," "forecast,"
"projected," "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not placed on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond the Company's control or are subject to
change, actual results could be materially different. Factors which could cause
such a difference include, without limitation, the risk factors set forth in
the Company's SEC filings. The forward-looking statements should be considered
in light of these risks and uncertainties. Rockwell does not undertake, and
expressly disclaims any obligation, to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.
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Tuesday, May 20, 2008
RMTI to Present at 2008 Barrington Research Healthcare
Conference
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., today
announced that Robert L. Chioini, President and CEO and Thomas Klema, CFO of
Rockwell Medical Technologies, Inc. will present an overview of the Company at
the Barrington Research Healthcare Conference Wednesday, May 28, 2008. The
conference is being held May 27-28, 2008 at the Hilton Chicago hotel in
Chicago, IL.
Rockwell is a leading, innovative manufacturer and developer of renal drug
therapies and critical products focused on improving the quality of care for
dialysis patients. Dialysis is a process that duplicates kidney function for
those patients who suffer from chronic kidney failure, a condition also known
as end-stage-renal-disease (ESRD). There are an estimated 370,000 ESRD patients
in the United States growing approximately 3-5% on average each year and
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell is currently developing unique, proprietary
renal drug therapies for both iron maintenance and carnitine supplementation
utilizing its dialysate as the delivery mechanism. These exclusive renal drug
therapies support disease management initiatives to improve the quality of life
and care of dialysis patients and are designed to deliver safe and effective
therapy to these patients while decreasing cost.
SFP, the Company's lead renal drug, is a water-soluble iron designed to provide
physiological-iron-maintenance-therapy for anemic ESRD patients. SFP is
delivered direct to the bloodstream of the ESRD patient, via dialysate, during
each kidney dialysis treatment, maintaining optimal iron balance, avoiding
liver toxicity and decreasing associated nursing and pharmaceutical IV iron
administration costs. Recent academic studies have shown that more frequent
maintenance doses of iron improve the therapeutic response and benefits of
recombinant erythropoietin treatments.
The Company is currently conducting a Phase II-b study and sponsoring an
on-going NIH-funded study in anticipation of gaining FDA market approval.
Rockwell has licensed exclusive world-wide rights and has secured patents for
SFP in multiple countries, including the three largest dialysis markets in the
world; the United States, Japan and the European Union. The U.S. dialysis
market for IV-iron delivery is approximately $500 million annually while global
market potential is approximately $800 million.
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as "may,"
"might," "will," "should," "believe,"
"expect," "anticipate," "estimate,"
"continue," "predict," "forecast,"
"projected," "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are forward-looking
statements. While the Company believes these forward-looking statements are
reasonable, undue reliance should not placed on any such forward-looking
statements which are based on information available to us on the date of this
release. Because these forward looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond the Company's control or are subject to
change, actual results could be materially different. Factors which could cause
such a difference include, without limitation, the risk factors set forth in
the Company's SEC filings. The forward- looking statements should be considered
in light of these risks and uncertainties. Rockwell does not undertake, and
expressly disclaims any obligation, to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.
(return to News
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Wednesday, May 7, 2008
Rockwell Medical Reports First Quarter;
Sales Increase 31%; SFP development efforts
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, reported record first quarter 2008 sales of $12.4
million, an increase of 31% over sales of $9.5 million in the first quarter of
last year. Loss per share in the first quarter of 2008 was ($.09) compared to
($.14) in the first quarter of 2007.
First Quarter Financial Highlights
- Record quarterly revenue of $12,412,037 increased 31% or $2.9 million
compared to 2007.
- Sequential revenue growth of 3.9% or $463,000 over the fourth quarter of
2007.
- Strong domestic sales growth.
- Gross profit margins rose 7.8% of sales compared to 2007's first quarter
gross margin deficit.
- SG&A expense included non-cash charges for stock options and warrants
of $335,000.
- SFP related R&D spending of $782,000 was 6.3% of sales.
- Net interest income of $145,000 from the investment of the proceeds of our
November 2007 equity offering.
- Loss of $1.2 million compared to a loss of $1.6 million in the first
quarter 2007.
- Cash position at the end of the first quarter was $10.6 million
First Quarter Business Highlights
- SFP Phase II-b Dose Ranging Study protocol modified to reflect changes to
industry hemoglobin standards.
- National Institutes of Health (NIH) funded SFP study commenced enrollment.
- Initiated executive level search for a Chief Medical Officer and a Senior
VP of Research and Development.
Mr. Robert L. Chioini, Chairman and CEO stated, We
continue to progress on our SFP clinical development programs during the first
quarter, including commencing enrollment for an important NIH funded
comparative study of SFP.
Mr. Chioini also stated, While our primary focus remains on the
advancement of SFP and moving Rockwell into renal drug development, we continue
to grow our dialysis concentrate business and build our distribution channel
which provides us with the commercial platform to effectively penetrate the
dialysis provider market. We are working to improve margins in our concentrate
business in the upcoming quarters as we implement price increases to recover
rising fuel and material costs.
Rockwell will be hosting a conference call to review its first quarter results
and to provide investors with an update on its business development efforts on
Wednesday, May 7, 2008 at 11:00 am EST.
Investors are encouraged to call in several minutes in advance at (877)
675-4757 to hear the call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=31025&c=RMTI&mediakey=C0AE09FB2CC1F3C09B9E3C3FCE2EBE95&e=0
See www.rockwellmed.com for more details and playback options.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 3-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary renal drug therapies for both iron-delivery(SFP) and
carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism.
These exclusive renal drug therapies support disease management initiatives to
improve the quality of care for dialysis patients and are designed to deliver
safe and effective therapy to patients while decreasing nursing time and supply
cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors and other risks and uncertainties set forth in the Company's SEC
filings, including its Form 10-K for the year ended December 31, 2007 and its
Forms 10-Q filed during 2008. The forward- looking statements should be
considered in light of these risks and uncertainties. We do not undertake, and
expressly disclaim any obligation, to update or alter our statements whether as
a result of new information, future events or otherwise, except as required by
law.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three months ended March 31, 2008 and March 31, 2007
(Whole dollars)
(Unaudited)
|
| |
3 Months ended Mar 31, 2008 |
3 Months ended Mar 31, 2007 |
| Sales |
$ 12,412,037 |
$ 9,474,382 |
| Cost of Sales |
11,554,736 |
9,557,101 |
| Gross Profit (Deficit) |
857,301 |
(82,719) |
| Selling, General, Admin |
1,429,752 |
726,227 |
| Research & Product Devel. |
782,713 |
822,520 |
| Operating (Loss) |
(1,355,164) |
(1,631,466) |
| Interest Expense (Income), net |
(144,991) |
(15,049) |
| Net (Loss) |
$ (1,210,173) |
$ (1,646,515) |
| Basic Earnings (Loss) per share |
$ (0.09) |
$ (0.14) |
| Diluted Earnings (Loss) per share |
$ (0.09) |
$ (0.14) |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of March 31, 2008 and March 31, 2007
|
| |
Mar. 31, 2008 |
Mar. 31, 2007 |
| Assets |
| Cash and Cash Equivalents |
$ 10,641,217 |
$ 11,097,092 |
Accounts Receivable,
net of a reserve of $82,000 in 2008 and $69,000
in 2007 |
4,145,041 |
4,687,229 |
| Inventory |
2,672,153 |
2,559,051 |
| Other Current Assets |
356,892 |
302,573 |
| Total Current Assets |
17,815,303 |
18,645,945 |
| Property and Equipment, net |
2,952,328 |
2,840,331 |
| Intangible Assets |
262,791 |
270,446 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
148,636 |
125,667 |
| Total Assets |
$ 22,099,802 |
$ 22,803,134 |
Liabilities and Shareholders' Equity
|
| Notes Payable & Capitalized Lease Obligations |
192,448 |
194,239 |
| Accounts Payable |
3,418,258 |
2,982,899 |
| Accrued Liabilities |
1,029,197 |
1,122,737 |
| Customer Deposits |
197,548 |
337,396 |
| Total Current Liabilities |
4,837,451 |
4,637,271 |
Long Term Notes Payable & Capitalized Lease Obligations
|
149,268 |
204,837 |
| Shareholders' Equity: |
Common Shares, no par value,
13,823,453 and 13,815,186 shares issued and
outstanding |
33,685,578 |
33,415,106 |
Common Share Purchase Warrants,
1,249,169 and 1,204,169 shares issued and
outstanding |
3,130,169 |
3,038,411 |
| Accumulated Deficit |
(19,702,664) |
(18,492,491) |
| Total Shareholders' Equity |
17,113,083 |
17,961,026 |
| Total Liabilities and Shareholders'
Equity |
$ 22,099,802 |
$ 22,803,134 |
(return to News
Index)
Tuesday, April 22, 2008
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Wednesday, May
7, 2008 at 11:00AM EST to discuss its first quarter 2008 results and to provide
investors with a business update. Robert Chioini, Chairman and CEO, and Thomas
Klema, CFO, will be hosting the call to review Rockwell's results and answer
questions from investors.
The conference call will be held on:
Wednesday, May 7, 2008
Starting Time 11:00 a.m. Eastern
Dial in Number: 877-675-4757
When calling in please refer to the Rockwell Medical Technologies Investor
Conference Call and provide the operator with your name and company
affiliation.
Investors who prefer to participate using the internet may access the following
link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=31025&c=RMTI&mediakey=C0AE09FB2CC1F3C09B9E3C3FCE2EBE95&e=0
International Investors may dial in directly on 719-325-4889.
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)
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Thursday, March 6, 2008
Rockwell Medical Reports Fourth Quarter 2007 Results;
Year-end Sales Increase 50%
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, reported record fourth quarter 2007 sales of
$11.95 million, up 29.5% as compared to $9.2 million for the same period of
2006. Loss per share for the fourth quarter was ($.09) vs. ($.10) for the same
period of 2006.
Year end 2007 results were highlighted by record sales of $43 million,
increasing over 50% as compared to $28.6 million in 2006. Loss for the year
ended 2007 was ($.32) vs. ($.41) in 2006.
Highlights:
Fourth Quarter
- Record quarterly revenue $11,948,905 up 29.5% over fourth quarter 2006.
- Sequential revenue growth of 7.9% over third quarter 2007.
- Loss per share ($.09) a $.01 improvement compared to ($.10) in 2006.
Year End 2007
- Revenue increased to $43 million, up 50% in 2007 compared to 2006.
- Domestic sales increased greater than 70% in 2007.
- Research and development costs were $3.26 million in 2007.
- Loss per share ($.32) a $.09 improvement compared to ($.41) in 2006.
- RMTI stock upgraded to the Nasdaq Global Market Exchange in January 2007.
Renal Drug Therapy Development-SFP
- Commenced Phase II-b clinical study
- Raised gross proceeds of $12.9 million in November 2007 to fund on-going
FDA clinical trial.
- Completed protocol to begin NIH-funded study.
- Completed pre-clinical safety pharmacology and toxicology studies for SFP.
- Received final safety pharm/toxicology reports demonstrating strong safety
profile for SFP.
- Patent grants received for Japan and Mexico.
Mr. Robert L. Chioini, Chairman and CEO stated, Our
fourth quarter marked a significant milestone for our SFP drug development
program. We commenced our Phase II-b human clinical study and successfully
completed a capital raise of nearly $13 million, which we expect will fund our
current FDA clinical development program.
Mr. Chioini also stated, Our concentrate sales increased significantly in
2007 but rising inflation in our primary cost drivers temporarily pressured our
gross margins in the fourth quarter. Going forward, we anticipate margin
improvement in our concentrate business as we pass on inflationary costs to our
customer base, and we expect to continue to solidify our market position which
is currently over 26% of the dialysis provider market.
Rockwell will be hosting a conference call to review its 2007 and fourth
quarter results on Thursday, March 6, 2008 at 11:00 am EST. Investors are
encouraged to call in several minutes in advance at (888) 661-5174 to hear the
call or they may listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=30039&c=RMTI&mediakey=2ABCD2DFF357359EB5B2BDFF66F876B3&e=0
See www.rockwellmed.com for more details and playback options.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 3-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary renal drug therapies for both iron-delivery and
carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism.
These exclusive renal drug therapies support disease management initiatives to
improve the quality of care for dialysis patients and are designed to deliver
safe and effective therapy to patients while decreasing nursing time and supply
cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors and other risks and uncertainties set forth in the Company's SEC
filings, including its Form 10-KSB for the year ended December 31, 2006 and its
Forms 10-Q filed during 2007. The forward- looking statements should be
considered in light of these risks and uncertainties. We do not undertake, and
expressly disclaim any obligation, to update or alter our statements whether as
a result of new information, future events or otherwise, except as required by
law.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and twelve months ended
December 31, 2007 and December 31, 2006
(Whole dollars)
(Unaudited)
|
| |
3 Months ended Dec 31, 2007 |
3 Months ended Dec 31, 2006 |
12 Months ended Dec 31, 2007 |
12 Months ended Dec 31, 2006 |
| Sales |
$ 11,948,905 |
$ 9,228,502 |
$ 43,045,304 |
$ 28,638,859 |
| Cost of Sales |
11,073,295 |
8,268,797 |
40,015,466 |
25,837,294 |
| Gross Profit |
875,610 |
959,705 |
3,029,838 |
2,801,565 |
| Selling, General, Admin |
1,084,987 |
748,875 |
3,374,458 |
2,801,565 |
| Research & Product Devel. |
944,281 |
1,396,333 |
3,263,733 |
4,777,976 |
| Operating (Loss) |
(1,153,658) |
(1,185,503) |
(3,608,353) |
(4,637,830) |
| Interest Expense (Income), net |
9,185 |
(30,468) |
110,542 |
(62,851) |
| Net (Loss) |
($1,162,843) |
($1,155,035) |
($3,718,895) |
($4,574,979) |
| Basic Earnings (Loss) per share |
$ (0.09) |
$ (0.10) |
$ (0.32) |
$ 0.41 |
| Diluted Earnings (Loss) per share |
$ (0.09) |
$ (0.10) |
$ (0.32) |
$ 0.41 |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of December 31, 2007 and December 31, 2006
|
| |
Dec. 31, 2007 |
Dec. 31, 2006 |
| Assets |
| Cash and Cash Equivalents |
$ 11,097,092 |
$ 2,662,873 |
Accounts Receivable,
net of a reserve of $66,085 in 2007 and $72,500
in 2006 |
4,687,229 |
3,474,402 |
| Inventory |
2,559,051 |
2,660,098 |
| Other Current Assets |
302,573 |
261,473 |
| Total Current Assets |
18,645,945 |
9,058,846 |
| Property and Equipment, net |
2,840,331 |
2,587,771 |
| Intangible Assets |
270,446 |
457,846 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
125,667 |
127,625 |
| Total Assets |
$22,803,134 |
$13,152,833 |
Liabilities and Shareholders' Equity
|
| Notes Payable & Capitalized Lease Obligations |
194,239 |
369,551 |
| Accounts Payable |
2,982,899 |
2,920,258 |
| Accrued Liabilities |
1,122,737 |
1,114,592 |
| Customer Deposits |
337,396 |
48,274 |
| Total Current Liabilities |
4,637,271 |
4,452,675 |
Long Term Notes Payable & Capitalized Lease Obligations
|
204,837 |
326,045 |
| Shareholders' Equity: |
Common Shares, no par value,
13,815,186 and 11,5500,349 shares issued and
outstanding |
33,415,106 |
23,147,709 |
Common Share Purchase Warrants,
1,204,169 and -0- shares issued and
outstanding |
3,038,411 |
- |
| Accumulated Deficit |
(18,492,491) |
(14,773,596) |
| Total Shareholders' Equity |
17,961,026 |
8,374,113 |
| Total Liabilities and Shareholders'
Equity |
$22,803,134 |
$13,152,833 |
(return to News
Index)
Tuesday, February 26, 2008
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Thursday,
March 6, 2008 at 11:00AM EST to discuss its fourth quarter and 2007 results and
to provide investors with a business update. Robert Chioini, Chairman and CEO,
and Thomas Klema, CFO, will be hosting the call to review Rockwell's results
and answer questions from investors.
The conference call will be held on:
Thursday, March 6, 2008
Starting Time 11:00 a.m. Eastern
Dial in Number: (888) 661-5174
When calling in please refer to the Rockwell Medical Technologies Investor
Conference Call and provide the operator with your name and company
affiliation.
Investors who prefer to participate using the internet may access the following
link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=30039&c=RMTI&mediakey=2ABCD2DFF357359EB5B2BDFF66F876B3&e=0
International Investors may dial in directly on (913) 905-3226.
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)
 |
Thursday, January 31, 2008
RMTI Reports Patients Begin Dosing
in NIH Funded SFP Clinical Study
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products focused on the end-stage-renal-disease (ESRD)
market, announced today that the National Institutes of Health (NIH) sponsored
clinical study for Soluble Ferric Pyrophosphate (SFP), Rockwell's physiological
iron-maintenance-therapy drug, has entered active treatment phase with the
initiation of dosing.
The clinical design is a 9-month, 30-patient, prospective, randomized,
open-label, multi-center, controlled clinical trial of the safety and efficacy
of physiological iron maintenance in ESRD subjects by delivery of SFP via
hemodialysate. ESRD subjects receiving maintenance hemodialysis will be
enrolled and randomized to receive hemodialysis using dialysate solutions with
SFP or conventional solutions lacking iron at every dialysis session with the
goal of maintaining iron balance within a tight hemoglobin range.
- Primary End-points:
- Efficacy: The amount of therapeutic IV iron needed by subjects in the group
receiving SFP in their dialysate versus those who do not.
- Safety: Safety and tolerability determined by clinically significant
changes on vital signs, clinical laboratory measures, and incidence and
severity of adverse events.
- Secondary End-points:
- Hemoglobin maintenance and variability within optimal target range.
- Efficiency of iron delivery to the erythron.
- Incidence and time to development of iron deficiency and iron overload.
- Markers of inflammation and oxidative stress.
Robert L. Chioini, Chairman and CEO of Rockwell stated,
Beginning the successful dosing of dialysis patients in this NIH
sponsored study is another significant milestone in our clinical path for
gaining FDA market approval for SFP. We expect to share news of our clinical
progress as it becomes available.
About National Institutes of Health
The National Institutes of Health (NIH), http://www.nih.gov, a part of the US 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 sponsored
scientists investigate ways to prevent disease as well as the causes,
treatments, and even cures for common and rare diseases.
About Soluble Ferric Pyrophosphate (SFP)
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 dialysis treatments. SFP is a highly
stable and non-polymeric iron salt and is designed to be administered directly
into the bloodstream, overcoming the need for iron release from
reticuloendothelial stores in the liver and other organs. The ferric iron core
is tightly chelated to a pyrophosphate shell that facilities transfer of iron
from transferrin to ferritin, by-passing the liver. Compared to intravenous
(IV) iron administration, previous human clinical study results indicate that
SFP can deliver iron (via dialysate) safely and effectively and can maintain
iron balance in dialysis patients within the target range, while at the same
time decreasing associated nursing and pharmaceutical IV iron administration
costs. Recent academic studies have shown that more frequent maintenance doses
of iron improve the therapeutic benefits of recombinant erythropoietin
treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA
market approval. Patents for SFP have been secured in the United States, Japan
and the European Union covering the largest commercial markets for iron
supplementation. Rockwell estimates that the U.S. dialysis market for IV iron
delivery is approximately $480 million annually while the global market
potential is approximately $800 million annually.
About Rockwell Medical Technologies, Inc.
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
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, cleaning blood and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary formulations for both iron-delivery and carnitine/vitamin-delivery
utilizing its dialysate as the delivery mechanism. These novel technologies are
designed to deliver safe and effective renal therapy to ESRD patients while
decreasing nursing time and supply cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward- looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended September 30, 2007 and its Form 10-KSB for the year ended
December 31, 2006. The forward- looking statements should be considered in
light of these risks and uncertainties. We do not undertake, and expressly
disclaim any obligation, to update or alter our statements whether as a result
of new information, future events or otherwise, except as required by
law.
(return to News
Index)
 |
Wednesday, January 23, 2008
RMTI Announces Patient Enrollment Begins
for NIH Funded SFP Clinical Study
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products focused on the end-stage-renal-disease (ESRD)
market, announced today that patient enrollment has started for a National
Institutes of Health (NIH) sponsored clinical study for Soluble Ferric
Pyrophosphate (SFP), the Company's physiological iron-maintenance-therapy drug.
Dr. Mordechai S. Nosrati, MD, Associate Professor of Clinical Medicine at
Keck-USC School of Medicine and co-principal investigator stated, SFP in
dialysate allows for the slow infusion of iron over a 4-hour dialysis session
and physiologically mimics how the human body normally handles and processes
dietary iron, thereby potentially mitigating the side effects associated with
intravenous iron such as release of free iron and excess storage of iron in the
liver. I'm very excited to participate in the study of this revolutionary
advancement in iron delivery.
The NIH sponsored study is a 9-month, 30-patient, two-site, randomized,
controlled, clinical study that will examine maintenance of hemoglobin, iron
parameters, need for intravenous iron and oxidative stress markers in patients
receiving SFP via dialysate versus patients receiving conventional iron-free
dialysate. New data from this important study is expected to be published in
late 2008.
About National Institutes of Health
The National Institutes of Health (NIH), http://www.nih.gov, a part of the US 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 sponsored
scientists investigate ways to prevent disease as well as the causes,
treatments, and even cures for common and rare diseases.
About Soluble Ferric Pyrophosphate (SFP)
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 dialysis treatments. SFP is a highly
stable and non-polymeric iron salt and is designed to be administered directly
into the bloodstream, overcoming the need for iron release from
reticuloendothelial stores in the liver and other organs. The ferric iron core
is tightly chelated to a pyrophosphate shell that facilities transfer of iron
from transferrin to ferritin, by-passing the liver. Compared to intravenous
(IV) iron administration, previous human clinical study results indicate that
SFP can deliver iron (via dialysate) safely and effectively and can maintain
iron balance in dialysis patients within the target range, while at the same
time decreasing associated nursing and pharmaceutical IV iron administration
costs. Recent academic studies have shown that more frequent maintenance doses
of iron improve the therapeutic benefits of recombinant erythropoietin
treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA
market approval. Patents for SFP have been secured in the United States, Japan
and the European Union covering the largest commercial markets for iron
supplementation. Rockwell estimates that the U.S. dialysis market for IV iron
delivery is approximately $480 million annually while the global market
potential is approximately $800 million annually.
About Rockwell Medical Technologies, Inc.
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
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, cleaning blood and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary formulations for both iron-delivery and carnitine/vitamin-delivery
utilizing its dialysate as the delivery mechanism. These novel technologies are
designed to deliver safe and effective renal therapy to ESRD patients while
decreasing nursing time and supply cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward- looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended September 30, 2007 and its Form 10-KSB for the year ended
December 31, 2006. The forward-looking statements should be considered in light
of these risks and uncertainties. We do not undertake, and expressly disclaim
any obligation, to update or alter our statements whether as a result of new
information, future events or otherwise, except as required by law.
(return to News
Index)
 |
Tuesday, December 4, 2007
RMTI Reports FDA Approves Start of NIH Sponsored Study
of Iron Therapy Drug, SFP
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, reported today that the FDA has approved
initiation of a National Institutes of Health (NIH) sponsored clinical study
for Rockwell's proprietary drug-delivery product SFP for chronic hemodialysis
patients.
The NIH sponsored study is a 9-month, 30 patient, two site, randomized,
controlled, clinical study that will examine maintenance of hemoglobin, iron
parameters, need for intravenous iron and oxidative stress markers in patients
receiving SFP via dialysate versus patients receiving conventional iron-free
dialysate. Patients in both groups are eligible to receive intermittent
intravenous (IV) iron sucrose per protocol if iron deficiency develops. The NIH
sponsored study is being conducted by independent investigators and is
scheduled to begin shortly with results expected to be published late in 2008.
Dr. Ajay Gupta, lead principal investigator and inventor of SFP stated,
This study will examine the hypothesis that SFP maintains iron balance
and hemoglobin while significantly reducing the need for supplemental IV iron
and without causing oxidant stress and inflammation.
The National Institutes of Health (NIH), a part of the US 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 health and save lives, NIH sponsored scientists investigate ways
to prevent disease as well as the causes, treatments, and even cures for common
and rare diseases.
About SFP (Soluble Ferric Pyrophosphate) - Rockwell's Lead Renal Drug
Product
SFP is a water soluble form of iron designed to provide
physiological-iron-maintenance-therapy for anemic ESRD patients. SFP is
uniquely delivered via dialysate directly to the bloodstream, during each
kidney dialysis treatment. The physiological mode of action and ease of
delivery of SFP is a highly stable, non-polymeric, simple iron salt that is
administered directly into the bloodstream, avoiding liver build-up and
toxicity thus overcoming the need for iron release from reticuloendothelial
stores in the liver and other organs. The ferric iron core is tightly chelated
to a pyrophosphate shell which facilitates transfer of iron from transferrin to
ferritin, bypassing the liver entirely. Based on results of an initial Phase II
clinical study and compared to IV iron administration, SFP delivered via
dialysate, has shown to be a safe and effective method for maintaining optimal
iron balance in dialysis patients while at the same time reducing nursing and
physician time and pharmaceutical IV iron costs currently associated with IV
iron administration. Furthermore, recent academic studies have shown that more
frequent maintenance doses of iron improve the therapeutic response and
benefits of recombinant erythropoietin treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is
collaborating with the FDA in its development. Rockwell has secured patents for
SFP in multiple countries, including the United States, Japan, and the European
Union, covering the largest commercial markets in the world for dialysis and
iron supplementation. The Company has patents issued and pending in a number of
other countries as well.
Rockwell estimates the current U.S. IV-iron market is $480 million and the
global IV-iron market is approximately $750 million. The Company believes the
U.S IV-iron market has the potential to grow to $1 billion within the next 10
years while the world-wide market could reach $1.5 billion. Rockwell's
dialysate products are used as the delivery method for SFP. Rockwell's current
share of the U.S. dialysate market is estimated to be 26%.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary renal drug therapies for both iron-delivery and
carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism.
These exclusive renal drug therapies support disease management initiatives to
improve the quality of care for dialysis patients and are designed to deliver
safe and effective therapy to patients while decreasing nursing time and supply
cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended September 30, 2007 and its Form 10-KSB for the year ended
December 31, 2006. The forward- looking statements should be considered in
light of these risks and uncertainties. We do not undertake, and expressly
disclaim any obligation, to update or alter our statements whether as a result
of new information, future events or otherwise, except as required by
law.
(return to News
Index)
 |
Thursday, November 29, 2007
Rockwell Medical Closes $12.95 Million Financing
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, announced today that it has raised $12,950,000 in
gross proceeds from a private placement of its common shares.
The private placement consisted of several institutional investors and the unit
offering price of $6.00 was comprised of one share of common stock and a
warrant to purchase 0.50 shares of common stock. The Company issued 2,158,337
common shares at $6.00 and issued warrants to purchase 1,079,169 common shares
at an exercise price of $7.18.
Robert Chioini, Rockwell's CEO, commented The $12.7 million in net
proceeds is expected to fund the remaining expenses relating to the development
and approval of our proprietary iron maintenance therapy drug, SFP (Soluble
Ferric Pyrophosphate), used to treat iron deficiency in anemic dialysis
patients.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary renal drug therapies for both iron-delivery and
carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism.
These exclusive renal drug therapies support disease management initiatives to
improve the quality of care for dialysis patients and are designed to deliver
safe and effective therapy to patients while decreasing nursing time and supply
cost. The Company 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.
About the Securities Issued
The securities sold in this private placement have not been registered under
the Securities Act of 1933, as amended, and may not be offered or sold in the
United States absent registration or an applicable exemption from registration
requirements. As part of the transaction, the Company has agreed to file a
resale registration statement on Form S-3 with the Securities and Exchange
Commission within 45 days for purposes of registering the resale of the shares
of common stock, and the shares of common stock underlying the warrants, issued
in the offering.
This notice is issued pursuant to Rule 135c under the Securities Act of 1933
and does not constitute an offer to sell or the solicitation of an offer to buy
the securities, nor shall there be any sale of the securities in any state in
which such offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of such state. Any
offering of the securities under the resale registration statement will only be
by means of a prospectus.
Certain statements in this press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995. When we use words such as "may," "might,"
"will," "should," "believe," "expect,"
"anticipate," "estimate," "continue,"
"predict," "forecast," "projected,"
"intend" or similar expressions, or make statements regarding our
intent, belief, or current expectations, we are making forward-looking
statements. While we believe these forward-looking statements are reasonable,
you should not place undue reliance on any such forward-looking statements
which are based on information available to us on the date of this release.
Because these forward-looking statements are based upon estimates and
assumptions that are subject to significant business, economic and competitive
uncertainties, many of which are beyond our control or are subject to change,
actual results could be materially different. Factors which could cause such a
difference include, without limitation, the risk factors set forth in the
Company's SEC filings, including its Form 10-Q for the quarter ended September
30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The
forward-looking statements should be considered in light of these risks and
uncertainties. We do not undertake, and expressly disclaim any obligation, to
update or alter our statements whether as a result of new information, future
events or otherwise, except as required by law.
(return to News
Index)
 |
Thursday, November 8, 2007
Rockwell Medical Reports Third Quarter Results; Sales Increase
50%
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, reported record quarterly sales of $11.1 million
for the third quarter of 2007, up 50% over the third quarter of 2006. Sales for
the first nine months of 2007 increased 60% compared to the first nine months
of 2006. Third quarter loss per share was ($.04) compared to ($.14) in the
third quarter last year. Rockwell's third quarter loss of ($432,912) included
research and development expense of $735,393 for its physiological iron
maintenance therapy drug (SFP).
Third Quarter Highlights:
- Sales increased $11.7 million or 60.2% vs. year ago.
- Domestic sales increased by 72% in the first nine months of 2007 vs. year
ago.
- Net loss of ($2.6) million or ($.22) per share included R&D costs of
$2.3 million.
- Net loss of ($.22) per share improved $.09 per share compared to the first
nine months of 2006.
- Upgraded to the Nasdaq Global Market Exchange.
Nine Month Highlights:
- Sales increased 66% in the first half of 2007 compared to the first half
of 2006.
- Domestic dialysis centers serviced increased over 50% in 2007.
- Net Loss of ($2.1) million included R&D expense of $1.6 million.
- Upgraded to the Nasdaq Global Market Exchange.
SFP Highlights:
- Commenced enrollment and dosing of SFP Phase II-b human clinical trial.
- Completed pre-clinical safety pharmacology and toxicology studies for SFP.
- Received final safety pharmacology and toxicology reports demonstrating a
strong safety profile for SFP.
- Granted SFP international patents in Japan and Mexico.
Third quarter results were in line with our
expectations reflecting substantial domestic market share gains, strong
sequential sales growth and margin improvements over year ago levels, despite
rising inflation on several key cost drivers including fuel and core raw
material costs, stated Mr. Robert L. Chioini, Chairman and Chief
Executive Officer.
Mr. Chioini also commented on SFP, SFP is our lead renal drug therapy
candidate offering high sales and earnings potential world-wide, and we
achieved a significant milestone in Q3 this year when we began dosing patients
in our Phase II-b clinical trial for SFP. Upon completing this study, we
anticipate initiating final Phase III development and ultimately gaining FDA
market approval.
Rockwell will be hosting a conference call to review its third quarter results
on Thursday, November 8, 2007 at 11:00 am EST. Investors are encouraged to call
in several minutes in advance at (800) 776-0087 to hear the call or they may
listen on the web at the following link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=28092&c=RMTI&mediakey=78D663E75CC8CBE67E9D20F7EE8FE739&e=0
See www.rockwellmed.com for more details and playback options.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients whose kidneys have failed to work
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary renal drug therapies for both iron-delivery and
carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism.
These exclusive renal drug therapies support disease management initiatives to
improve the quality of care for dialysis patients and are designed to deliver
safe and effective therapy to patients while decreasing nursing time and supply
cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended September 30, 2007 and its Form 10-KSB for the year ended
December 31, 2006. The forward- looking statements should be considered in
light of these risks and uncertainties. We do not undertake, and expressly
disclaim any obligation, to update or alter our statements whether as a result
of new information, future events or otherwise, except as required by law.
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Income Statements
For the three and nine months ended
September 30, 2007 and September 30, 2006
(Whole dollars)
(Unaudited)
|
| |
3 Months ended Sept 30, 2007 |
3 Months ended Sept 30, 2006 |
6 Months ended Sept 30, 2007 |
6 Months ended Sept 30, 2006 |
| Sales |
$ 11,073,774 |
$ 7,379,201 |
$ 31,096,399 |
$ 19,410,357 |
| Cost of Sales |
9,953,863 |
6,785,796 |
28,942,171 |
17,568,497 |
| Gross Profit |
1,119,911 |
593,405 |
2,154,228 |
1,841,860 |
| Selling, General, Admin |
765,457 |
592,767 |
2,288,903 |
1,912,544 |
| Research & Product Devel. |
735,393 |
1,621,821 |
2,319,452 |
3,381,643 |
| Operating (Loss) |
(380,939) |
(1,621,183) |
(2,454,127) |
(3,452,327) |
| Interest Expense (Income), net |
51,973 |
486 |
101,924 |
(32,383) |
| Net (Loss) |
($ 432,912) |
($ 1,621,669) |
($ 2,556,051) |
($ 3,419,944) |
| Basic Earnings (Loss) per share |
$ (0.04) |
$ (0.14) |
$ (0.22) |
$ (0.31) |
| Diluted Earnings (Loss)per share |
$ (0.04) |
$ (0.14) |
$ (0.22) |
$ (0.31) |
Rockwell Medical Technologies, Inc. and Subsidiary
Consolidated Balance Sheets
As of September 30, 2007 and December 31, 2006
|
| |
Sept. 30, 2007
(Unaudited) |
Dec. 31, 2006 |
| Assets |
| Cash and Cash Equivalents |
$ - |
$ 2,662,873 |
Accounts Receivable,
net of a reserve of $105,930 in 2007 and $72,500
in 2006 |
4,918,464 |
3,474,402 |
| Inventory |
2,793,993 |
2,660,098 |
| Other Current Assets |
317,716 |
261,473 |
| Total Current Assets |
8,030,173 |
9,058,846 |
| Property and Equipment, net |
2,841,601 |
2,587,771 |
| Intangible Assets |
428,930 |
457,846 |
| Goodwill |
920,745 |
920,745 |
| Other Non-current Assets |
125,667 |
127,625 |
| Total Assets |
$12,347,116 |
$13,152,833 |
Liabilities and Shareholders' Equity
|
| Short Term Borrowings |
$ 1,800,000 |
$ - |
| Notes Payable & Capitalized Lease Obligations |
232,984 |
369,551 |
| Accounts Payable |
2,971,652 |
2,920,258 |
| Accrued Liabilities |
851,856 |
1,114,592 |
| Customer Deposits |
45,729 |
48,274 |
| Total Current Liabilities |
5,902,221 |
4,452,675 |
Long Term Notes Payable & Capitalized Lease Obligations
|
240,734 |
326,045 |
| Shareholders' Equity: |
Common Shares, no par value,
11,634,749 and 11,500,349 shares issued and
outstanding |
23,533,808 |
23,147,709 |
| Accumulated Deficit |
(17,329,647) |
(14,773,596) |
| Total Shareholders' Equity |
6,204,161 |
8,374,113 |
| Total Liabilities and Shareholders' Equity |
$12,347,116 |
$13,152,833 |
(return to News
Index)
Tuesday, November 6, 2007
Rockwell to Present at JMP Securities Healthcare Focus
Conference
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, focused on the end-stage-renal-disease (ESRD)
market, today announced that Robert L. Chioini, President and CEO of Rockwell
will present an overview of the Company at the JMP Securities Healthcare Focus
Conference at 12:00pm EST on Tuesday, November 13, 2007. Mr. Chioini will
provide investors with an overview of Rockwell and its lead renal drug therapy
product, SFP.
Investors may view the webcast via
http://www.wsw.com/webcast/jmp5/rmti/
Investors may also access the webcast via Rockwell's website at
http://www.rockwellmed.com/invest.htm
Audio replay of this webcast will be archived and available for replay for two
weeks following the conference.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Rockwell's products are used to
maintain life, removing toxins and replacing nutrients in the dialysis
patient's bloodstream.
Rockwell has licensed and is currently developing proprietary renal drug
therapies for both iron-delivery and carnitine/vitamin-delivery utilizing its
dialysate as the delivery mechanism. These exclusive renal drug therapies
support disease management initiatives to improve the quality of life and care
of dialysis patients and are designed to deliver safe and effective therapy to
these patients while decreasing drug administration cost.
About Soluble Ferric Pyrophosphate (SFP) - Rockwell's Lead Renal Drug
Therapy Product
SFP is a water soluble form of iron designed to provide
physiological-iron-maintenance-therapy for anemic ESRD patients. SFP (iron) is
uniquely delivered via dialysate directly to the bloodstream, during each
kidney dialysis treatment. SFP is a highly stable, non-polymeric iron salt that
is administered directly into the bloodstream, avoiding liver toxicity build-up
thus overcoming the need for iron release from reticuloendothelial stores in
the liver and other organs. The ferric iron core is tightly chelated to a
pyrophosphate shell which facilitates transfer of iron from transferrin to
ferritin, bypassing the liver entirely.
Based on an earlier FDA Phase II clinical study, SFP delivered via dialysate,
was shown to be a safe and effective method for maintaining optimal iron
balance in dialysis patients while at the same time decreasing associated
nursing and pharmaceutical IV iron administration costs.
(return to News
Index)
 |
Tuesday, October 23, 2007
Rockwell Receives Patent Grant
for Proprietary SFP Iron-Delivery in Mexico
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of renal drug therapies and
essential dialysate products, focused on the end-stage-renal-disease (ESRD)
market, reported that a Mexican patent was granted for its proprietary drug,
Soluble Ferric Pyrophosphate (SFP). The Mexican SFP patent grant covers the
method and pharmaceutical composition for iron delivery administered in
hemodialysis and peritoneal dialysis patients.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, We
are pleased to add Mexico, estimated to be the 8th largest ESRD market in the
world, to further strengthen and protect our proprietary intellectual property
for SFP worldwide. In conjunction with the successful completion of our SFP
clinical development program, we look to expand into the worldwide markets
through the development of our own distribution channels and/or with an
established international marketing partner.
About Soluble Ferric Pyrophosphate (SFP) - Rockwell's Lead Renal Drug
Therapy
SFP is a water soluble form of iron designed to provide
physiological-iron-maintenance-therapy for anemic ESRD patients. SFP (iron) is
uniquely delivered via dialysate directly to the bloodstream, during each
kidney dialysis treatment. SFP is a highly stable, non-polymeric iron salt that
is administered directly into the bloodstream, avoiding liver toxicity build-up
thus overcoming the need for iron release from reticuloendothelial stores in
the liver and other organs. The ferric iron core is tightly chelated to a
pyrophosphate shell which facilitates transfer of iron from transferrin to
ferritin, bypassing the liver entirely.
Based on previous FDA Phase II clinical study results and compared to
intravenous (IV) iron administration, SFP delivered via dialysate, has shown to
be a safe and effective method for maintaining optimal iron balance in dialysis
patients while at the same time decreasing associated nursing and
pharmaceutical IV iron administration costs. Furthermore, recent academic
studies have shown that more frequent maintenance doses of iron improve the
therapeutic response and benefits of recombinant erythropoietin treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is
collaborating with the FDA in its development. Rockwell has secured patents for
SFP in multiple countries, including the United States, Japan, and the European
Union, covering the largest commercial markets for iron supplementation in the
world. Rockwell has issued and pending patents in a number of other markets as
well. Rockwell estimates that the U.S. dialysis market for IV-iron delivery is
approximately $450 million annually while global market potential is
approximately $750 million.
About Rockwell Medical
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and
developer of renal drug therapies and critical products focused on improving
the quality of care for dialysis patients. Dialysis is a process that
duplicates kidney function for those patients who suffer from chronic kidney
failure, a condition also known as end-stage-renal-disease (ESRD). There are an
estimated 360,000 ESRD patients in the United States growing approximately 4-5%
on average each year. There are approximately 1.6 million ESRD patients
world-wide. Rockwell's products are used to maintain life, removing toxins and
replacing nutrients in the dialysis patient's bloodstream. Rockwell has
licensed and is currently developing proprietary renal drug therapies for both
iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the
delivery mechanism. These exclusive renal drug therapies support disease
management initiatives to improve the quality of life and care of dialysis
patients and are designed to deliver safe and effective therapy to these
patients while decreasing nursing time and supply cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31,
2006. The forward-looking statements should be considered in light of these
risks and uncertainties. We do not undertake, and expressly disclaim any
obligation, to update or alter our statements whether as a result of new
information, future events or otherwise, except as required by law.
(return to News
Index)
Thursday, October 18, 2007
Rockwell Medical Schedules Investor Conference Call
WIXOM, Mich. -- Rockwell Medical Technologies, Inc.,
announced today that it will hold an investor conference call on Thursday,
November 8, 2007 at 11:00AM EST to discuss its third quarter results and to
provide investors with a business update. Robert Chioini, Chairman and CEO, and
Thomas Klema, CFO, will be hosting the call to review Rockwell's results and
answer questions from investors.
The conference will be held on:
Thursday, November 8, 2007
Starting Time 11:00 AM Eastern
Dial in Number: (877) 776-0087
When calling in please refer to the Rockwell Medical Technologies Investor
Conference Call and provide the operator with your name and company
affiliation.
Investors who prefer to participate using the internet may access the following
link:
http://investor.shareholder.com/media/eventdetail.cfm?mediaid=28092&c=RMTI&mediakey=78D663E75CC8CBE67E9D20F7EE8FE739&e=0
International Investors may dial in directly on (913) 312-1427.
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 3, 2007
Rockwell Begins Dosing Patients for SFP Phase IIb Clinical Study
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), announced
today that it has begun dosing patients in its Phase IIb Dose-Ranging Clinical
Study for Soluble Ferric Pyrophosphate (SFP), the Company's physiological
iron-maintenance-therapy drug.
The Phase IIb Clinical Design is a double-blind, multi-center, randomized,
placebo-controlled, nine-month study consisting of up to 130 patients at
multiple dialysis centers in the United States. The primary end points of the
study are to evaluate SFP at varying dosage levels in hemodialysis patients and
to determine the optimal concentration of SFP in dialysate that will maintain
iron balance within their target hemoglobin range. Secondary end points include
evaluating efficacy for changes in hemoglobin levels over time, reticulocyte
hemoglobin content, incidence of systemic infection episodes and to quantify
the amount of SFP iron transferred from the dialysate directly to the blood
during the dialysis session.
Robert L. Chioini, Chairman and CEO of Rockwell stated, Beginning the
successful dosing of dialysis patients is another significant milestone in our
clinical path for gaining FDA market approval for SFP. Going forward, we
anticipate sharing news of our clinical progress as it becomes available.
About Soluble Ferric Pyrophosphate (SFP)
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 dialysis treatments. SFP is a highly
stable and non-polymeric iron salt and is designed to be administered directly
into the bloodstream, overcoming the need for iron release from
reticuloendothelial stores in the liver and other organs. The ferric iron core
is tightly chelated to a pyrophosphate shell, that facilities transfer of iron
from transferrin to ferritin, by-passing the liver. Compared to intravenous
(IV) iron administration, previous human clinical study results indicate that
SFP can deliver iron (via dialysate) safely and effectively and can maintain
iron balance in dialysis patients within the target range, while at the same
time decreasing associated nursing and pharmaceutical IV iron administration
costs. Recent academic studies have shown that more frequent maintenance doses
of iron improve the therapeutic benefits of recombinant erythropoietin
treatments.
Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA
market approval. Patents for SFP have been secured in the United States, Japan
and the European Union covering the three largest commercial markets for iron
supplementation. Rockwell estimates that the U.S. dialysis market for IV iron
delivery is approximately $450 million annually while the global market
potential is approximately $750 million annually.
About Rockwell Medical
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
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, cleaning blood and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary formulations for both iron-delivery and carnitine/vitamin-delivery
utilizing its dialysate as the delivery mechanism. These novel technologies are
designed to deliver safe and effective renal therapy to ESRD patients while
decreasing nursing time and supply cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31,
2006. The forward- looking statements should be considered in light of these
risks and uncertainties. We do not undertake, and expressly disclaim any
obligation, to update or alter our statements whether as a result of new
information, future events or otherwise, except as required by law.
(return to News
Index)
Wednesday, September 19, 2007
Rockwell Begins Patient Enrollment for SFP Dose-Ranging Study
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), announced
today that it has commenced enrollment in its Phase IIb dose-ranging study for
Soluble Ferric Pyrophosphate (SFP), a physiological iron-maintenance therapy
drug.
The Phase IIb dose-ranging study is a nine-month, controlled multi-center,
double-blind study consisting of up to 130 patients at multiple dialysis
centers in the United States. Patients will receive SFP during their normal
three times/week dialysis regimen. The primary objectives of this study are to
evaluate both safety and efficacy of SFP at varying dosage levels and to
determine the optimal concentration of SFP that will maintain iron balance
within the target hemoglobin range, in patients undergoing hemodialysis.
Secondary endpoints include evaluating efficacy for changes in hemoglobin
levels over time, reticulocyte hemoglobin content, incidence of systemic
infection episodes and to quantify the amount of SFP iron transferred from the
dialysate directly to the blood during the dialysis session. Results of this
Phase IIb study are expected by the end of 2008.
Robert L. Chioini, Chairman and CEO of Rockwell stated, We are excited to
initiate this important step in our clinical development plan for SFP, a key
product in Rockwell's renal drug development pipeline. The completion of this
study will enable us to initiate our planned Phase III pivotal study program
for FDA market approval of SFP. Mr. Chioini also stated, We have
assembled a team of top-tier investigators who will be conducting this
important work. Dosing is expected to begin in less than two weeks. As
information is obtained from our Data Safety Monitoring Board it will be
presented to the scientific and investment communities.
Enrollment in the Phase IIb dose ranging study commenced following successful
completion of an extensive pre-clinical safety, pharmacology and toxicology
study program.
About Soluble Ferric Pyrophosphate (SFP)
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 dialysis treatments. SFP is a highly
stable and non-polymeric iron salt and is designed to be administered directly
into the bloodstream, overcoming the need for iron release from
reticuloendothelial stores in the liver and other organs. The ferric iron core
is tightly chelated to a pyrophosphate shell, that facilities transfer of iron
from transferrin to ferritin, by-passing the liver. Based on previous human
clinical study results, and compared to intravenous (IV) iron administration,
Rockwell has shown that SFP can deliver iron via dialysate as a safe and
effective method for maintaining iron balance in dialysis patients within the
target iron range, while at the same time decreasing associated nursing and
pharmaceutical IV iron administration costs. Recent academic studies have shown
that more frequent maintenance doses of iron improve the therapeutic benefits
of recombinant erythropoietin treatments.
Rockwell has licensed the exclusive world-wide rights to the SFP and is
collaborating with the FDA in its development. Patents for SFP have been
secured in the United States, Japan and the European Union covering the three
largest commercial markets for iron supplementation. Rockwell estimates that
the U.S. dialysis market for IV iron delivery is approximately $450 million
annually while the global market potential is approximately $750 million
annually.
About Rockwell Medical
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
and who suffer from chronic kidney failure, a condition also known as
end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in
the United States growing approximately 4-5% on average each year. There are
approximately 2 million ESRD patients world-wide. Rockwell's products are used
to maintain life, cleaning blood and replacing nutrients in the dialysis
patient's bloodstream. Rockwell has licensed and is currently developing
proprietary formulations for both iron-delivery and carnitine/vitamin-delivery
utilizing its dialysate as the delivery mechanism. These novel technologies are
designed to deliver safe and effective renal therapy to ESRD patients while
decreasing nursing time and supply cost. The Company 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 constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use words such as
"may," "might," "will," "should,"
"believe," "expect," "anticipate,"
"estimate," "continue," "predict,"
"forecast," "projected," "intend" or similar
expressions, or make statements regarding our intent, belief, or current
expectations, we are making forward-looking statements. While we believe these
forward-looking statements are reasonable, you should not place undue reliance
on any such forward-looking statements which are based on information available
to us on the date of this release. Because these forward looking statements are
based upon estimates and assumptions that are subject to significant business,
economic and competitive uncertainties, many of which are beyond our control or
are subject to change, actual results could be materially different. Factors
which could cause such a difference include, without limitation, the risk
factors set forth in the Company's SEC filings, including its Form 10-Q for the
quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31,
2006. The forward- looking statements should be considered in light of these
risks and uncertainties. We do not undertake, and expressly disclaim any
obligation, to update or alter our statements whether as a result of new
information, future events or otherwise, except as required by law.
(return to News
Index)
Monday, August 13, 2007
Rockwell Medical Reports Second Quarter Results;
Sales up 80%
WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a
leading, innovative manufacturer and developer of hemodialysis products and
specialty pharmaceuticals focused on improving the quality of care for dialysis
patients in the end-stage-renal-disease (ESRD) market, reported record
quarterly sales of $10.5 million for the second quarter of 2007, up 80% over
the second quarter of 2006. Sales for the first half of 2007 increased 66%
compared to the first half of 2006. Second quarter loss per share was ($.04)
compared to ($.13) in the second quarter last year. Rockwell's second quarter
loss of ($476,625) included research and development expense of $761,539 for
the Company's physiological iron maintenance therapy drug (SFP).
Second Quarter Highlights:
- Sales increased 80% compared to second quarter 2006.
- Sequential revenue growth of 11.3% over the first quarter.
- Continued domestic market share gains in the second quarter.
- Second quarter loss of ($476,625) including R&D costs of $761,539.
- Gross profit margins of 10.6% increased 2.7% over the second quarter of
2006.
- Net loss was ($.04) per share; an improvement of $.10 per share over the
first quarter of 2007.
Six Month Highlights:
- Sales increased 66% in the first half of 2007 compared to the first half
of 2006.
- Domestic dialysis centers serviced increased over 50% in 2007.
- Net Loss of ($2.1) million included R&D expense of $1.6 million.
- Upgraded to the Nasdaq Global Market Exchange.
SFP Highlights:
- Completed pre-clinical safety pharmacology and toxicology studies for SFP.
- Received final non-clinical study reports demonstrating a strong safety
profile for SFP.
- Completed selection of clinical trial sites for dose ranging study.
- Granted SFP patent in Japan, the second largest national ESRD market after
the United States.
Mr. Robert L. Chioini, Chairman and Chief Executive Officer
of Rockwell Medical Technologies, Inc. stated, This quarter our sales
continued to increase as expected and our gross profit margins recovered to
historical levels. We continued to experience aggressive growth in our domestic
business coupled with significant price increases to our customer base, which
were necessitated by high inflation in our key raw material components and
distribution costs. Going forward, we anticipate end-user prices continuing to
increase due to raw material costs being driven higher by increased global
energy costs.
He also stated, Development of SFP has progressed as expected in the
second quarter. We are on target to commence enrollment in our Dose Ranging
Study in the U.S. in September. In addition, we received patent issuance in
Japan, which we view as an attractive market for SFP
Rockwell will be hosting a conference call to review its second quarter results
on Tuesday, August 14, 2007 at 11:00 am EDT. Investors are encouraged to call
in several minutes in advance at (877) 704-5381 to hear the call or they may
listen on the web at the following link:
http://investor.shareholder.com/media/index.cfm?c=RMTI&e=1&mediakey=A2FAB283B25BD82A09AC1C359F047CEF
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 |