Rockwell Medical Provides Corporate and Clinical Update
- Receives Additional Feedback from FDA on its IND Application
"This capital, when combined with the initiatives we completed earlier this year, will extend our cash runway meaningfully, during which time we will continue advancing our Ferric Pyrophosphate Citrate (FPC) development programs and improving our dialysis business," said
Due to the fact that the eventual commercial presentation of FPC) for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting, a single dose sterile unit, is still in development, the planned Phase 2 proof of concept study design requires that three units of the existing FDA-approved IV product be compounded into a single unit for each patient dose. Because of this necessary step, the
"We are pleased to provide the FDA with the additional data requested and fully support the generation of any data that will further assure the safety of the patients that will participate in our study," said
Home infusion therapy is a rapidly growing segment of home healthcare. Many patients receiving home infusion therapy have diseases that are associated with a high rate of iron deficiency and anemia, and current treatment options are not well suited for use in the home setting.
Home health is an area of medicine experiencing significant growth – a trend that will likely continue over the next decade due to an aging US population, the need to control costs, the desire to improve patient outcomes, and the convenience of home healthcare. Home infusion therapy, an important part of some home care regimens, allows patients with diseases requiring regular infusions of intravenous medications to be treated in the comfort of their home and has been proven to be a cost-effective, safe, and efficacious alternative to inpatient care for a variety of therapies and disease states, both acute and chronic. Treating IDA as part of an existing home infusion regimen more effectively, calls for an innovative approach.
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. There can be no assurance that Rockwell Medical will be able to, among other things, receive FDA clearance for its planned clinical trial of FPC in home infusion patients or the timing of any such approval, have sufficient capital to complete a trial in home infusion patients, or maintain timing for planned clinical trials and regulatory filings. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2021, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.
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