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Company History

Improving patient outcomes with innovative drug therapies.

Company History

1995

January

Rob Chioini starts Rockwell Medical selling dialysis kits and ancillary items out of a 10×20 foot room
1996

January

 

New 35,000 sq ft site open in Wixom, MI for production of dialysis concentrate

 

March

 

First gallon of dialysis concentrate produced

 

1998

January

 

Successful IPO on the NASDAQ stock exchange under symbol RMTI

 

December

 

Launch Dri-Sate® Dry Acid Mix System and SteriLyte® Liquid Bicarbonate

 

2001

July

 

Move into new 51,000 sq ft manufacturing facility in Michigan

 

October

 

Second 51,000 sq ft manufacturing facility added in TX

 

2002

January

 

Rockwell secures worldwide license for proprietary SFP iron delivery technology

 

General

 

Key sales milestone is achieved as Rockwell surpasses $10M in revenue

 

2005

March

 

60,000 sq ft faciltiy in South Carolina becomes third manufacturing site

 

June

 

Ernst & Young names Rob Chioini Entrepreneur of Year in Michigan GLR

 

General

 

Company reaches $25M in revenue

 

2006

February

 

Successful warrant conversion raised $9.3M for SFP safety and pharmacology studies

 

2007

Mid – 2007

 

Completion of final preclinical study

 

November

 

Successful $13M financing for Phase IIb clinical study

 

2008

General

 

Key sales milestone is achieved as Rockwell surpasses $50M in revenue

 

2009

April

 

Enrollment for Phase IIb study completed.

 

September

 

Successful $22M financing for SFP clinical development

 

October

 

Phase IIb clinical study completed

 

2010

October

 

Received US patent for GMP-grade SFP iron formula

 

General

 

300+ employees and 55 trucks making deliveries across the US

 

2011

March

 

Began enrollment for Phase III CRUISE clinical studies & PRIME ESA-sparing study

 

July

 

Acquired generic Vitamin-D drug to market and sell to dialysis patients

 

2012

February

 

Successful $17.5M financing for Phase III clinical trial

 

April

 

Enrollment for PRIME clinical study completed

 

May & July

 

Enrollment for CRUISE-1 and CRUISE-2 clinical studies completed

 

2013

February

 

Successful completion of PRIME study. Met primary and secondary endpoints

 

March

 

Successful $12.9M equity financing for Phase III clinical trial

 

April

 

Submitted Calcitriol data for FDA approval

 

May

 

Successful $40.3M equity financing for Phase III clinical trial

 

June

 

Successful $20M debt financing for Phase III clinical trial

 

July & September

 

CRUISE-1 and CRUISE-2 Phase III Efficacy clinical trial completed. Met primary and secondary endpoints.

 

October

 

Phase III safety data published. Met primary and secondary endpoints

 

General

 

DaVita 5-year national supply agreement

 

General

 

FDA approval of Triferic trade name

 

2014

February

 

Completed Triferic long term safety study

 

March

 

Submitted Triferic New Drug Application to FDA

 

May

 

FDA accepts Triferic New Drug Application

 

October

 

Exclusive long-term agreement with Baxter International for concentrates. $52.5M cash, equity and milestone payments.

 

November

 

FDA Advisory Committee recommends Triferic for iron maintenance therapy

 

November

 

Successful $58.5M equity financing for new growth opportunities

 

2015

January

 

Received U.S. Food and Drug Administration approval for Triferic iron maintenance therapy

 

March

 

Initiated clinical programs for delivering Triferic TPN Solution, Triferic PD Solution, Triferic IV Solution, and Triferic Orphan Indication

 

June

 

Received reimbursement code for Triferic; requested confirmation of separate reimbursement from CMS

 

September

 

Triferic US Commercial drug launch

 

2016

January

 

Initiated congressional, provider, patient and
healthcare professional support strategy for securing separate reimbursement
for Triferic from CMS

 

February

 

Exclusive License Agreement with Wanbang Biopharma to Commercialize Triferic in China. $39M cash, milestones and product revenue stream.

 

February

 

Files Triferic IND for Rare Orphan Disease Iron-Refractory, Iron-Deficiency Anemia (IRIDA)

 

2017

March

 

Announces ESA Sparing, Compositions and Use Patent in China

 

December

 

Announces exclusive Triferic international license agreements in Chile and Peru