We cannot assure you that we will receive any proceeds in connection with
securities offered by us pursuant to this prospectus. Unless otherwise
provided in the applicable prospectus supplement, we intend to use the
net proceeds from the sale of our securities by us under this prospectus
for general corporate purposes, including the development and
commercialization of Neutrolin, research and development of other product
candidates, potential product acquisitions and/or potential acquisitions
of complementary businesses, and working capital and capital expenditures.
We will set forth in the applicable prospectus supplement our intended use
for the net proceeds received from the sale of any securities by us.
Pending the application of the net proceeds, we intend to invest the net
proceeds generally in short-term, investment grade, interest bearing
securities.
We compete with established pharmaceutical and medical device companies that
are pursuing other forms of treatment for the same indications we are pursuing
and that have greater financial and other resources. Other companies may
succeed in developing products earlier than we do, obtaining FDA or any
other regulatory agency approval for products more rapidly, or developing
products that are more effective than our product candidates. Research and
development by others may render our technology or product candidates
obsolete or noncompetitive, or result in processes, treatments or cures
superior to any therapy we develop. We face competition from companies
that internally develop competing technology or acquire competing
technology from universities and other research institutions. As these
companies develop their technologies, they may develop competitive
positions that may prevent, make futile, or limit our product
commercialization efforts, which would result in a decrease in the
revenue we would be able to derive from the sale of any products.
There can be no assurance that any of our product candidates will be
accepted by the marketplace as readily as these or other competing
treatments. Furthermore, if our competitors’ products are approved
before ours, it could be more difficult for us to obtain approval from
the FDA or any other regulatory agency. Even if our products are
successfully developed and approved for use by all governing regulatory
bodies, there can be no assurance that physicians and patients will accept
any of our products as a treatment of choice.
Furthermore, the pharmaceutical and medical device industry is diverse,
complex, and rapidly changing. By its nature, the business risks associated
therewith are numerous and significant. The effects of competition,
intellectual property disputes, market acceptance, and FDA or other
regulatory agency regulations preclude us from forecasting revenues or
income with certainty or even confidence.
Company Description
We are a development stage pharmaceutical and medical device company that
seeks to in-license, develop and commercialize therapeutic products for the
treatment of cardiac and renal dysfunction, specifically in the dialysis and
non-dialysis areas. Specifically, our goal is to treat kidney disease
by
reducing the commonly associated cardiovascular and metabolic
complications — in effect, “treating the kidney to treat the heart.” As of
the date of this prospectus, we have licensed all of the product candidates
in our pipeline.
We have the worldwide rights to develop and commercialize our product
candidates, CRMD003 (Neutrolin R) and CRMD004, that we believe address
potentially large market opportunities in the instances in which a central
venous catheter is used, such as hemodialysis, intensive care units,
oncology and total parenteral nutrition patients.
Our primary product candidate in development is Neutrolin for the prevention
of catheter-related infections in the dialysis and non-dialysis markets,
which we believe addresses a medical need and a potentially large market
opportunity. Neutrolin is a liquid formulation designed to prevent central
venous catheter infection as well as catheter obstruction, also referred to
as maintenance of catheter patency, in central venous catheters, which we
initially plan for use in hemodialysis catheters. There are approximately
780,000 hemodialysis patients in the United States and the European Union.
We believe the patients undergoing hemodialysis using a tunneled central
vein catheter will be our initial target market. We project 91,000 patients
in the European Union and 104,000 patients in the United States. These
patients represent nearly 30 million hemodialysis sessions per year, which
we believe represents a market potential of approximately $300 - $400
million.
During the third quarter of 2011, we received a notice from the U.S. Food
and Drug Administration, or FDA, that Neutrolin had been assigned to the
Center for Drug Evaluation and Research, or CDER. As a result of this, and
given our limited resources, we decided to change our business strategy and
focus the majority of our resources on the research and development of
Neutrolin rather than CRMD004 and to seek regulatory and commercialization
approval for Neutrolin in Europe through a CE Mark application rather than
pursue FDA approval at this time. During the first half of 2011, we
submitted our design dossier to TÜV SÜD, the European notified body managing
our CE Mark application. In the fourth quarter of 2011, we successfully
completed our stage 1 audit with TÜV SÜD.
On October 10, 2012, we received ISO 13485:2003 certification from TÜV SÜD.
This certification, which is a stand-alone standard developed by the
International Organization for Standardization, is the globally recognized
standard that outlines consistent international processes for the design
and manufacturing of medical devices, including many supply chain functions
such as assembly, packaging, warehousing and distribution. Compliance with
ISO 13485 is often seen as a step towards achieving compliance with European
regulatory requirements. The conformity of medical devices and in-vitro
diagnostic medical devices according to applicable EU standards must be
assessed before sale is permitted. The preferred method to prove conformity
is the certification by a notified body of the quality management system
according to ISO 9001 and/or ISO 13485 and ISO 14971. The result of a
positive assessment is the issuance of a certificate of conformity allowing
the CE Mark and the permission to sell the medical device in the European
Union.
We have successfully completed the stage 2 audit with TÜV SÜD . We
anticipate receiving a CE Mark approval by the end of the fourth quarter
of 2012 or in the first quarter of 2013 . If we obtain CE Mark approval in
Europe, we intend to launch Neutrolin for the prevention of catheter-related
bloodstream infections, or CRBI, and maintenance of catheter patency in
hemodialysis patients in Europe in the first half of 2013. However, we
cannot be assured of CE Mark approval of Neutrolin or the planned
commercialization timeline.
We are currently exploring the various means of launching Neutrolin in
Europe, whether through a distributorship or partnership arrangement, or
otherwise, and plan to initially launch in Germany. Assuming the receipt
of a CE Mark and the launch of Neutrolin, we intend to meet with the FDA
to determine the pathway for U.S. approval of Neutrolin, which we expect
will entail a Phase 3 trial.
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We were organized as a Delaware corporation on July 28, 2006 under the name
“Picton Holding Company, Inc.” and we changed our corporate name to
“CorMedix Inc.” on January 18, 2007. Our operations to date have been
primarily limited to organizing and staffing, licensing product candidates,
developing clinical trials for our product candidates, establishing
manufacturing for our product candidates and maintaining and improving our
patent portfolio.
Our executive offices are located at 745 Route 202-206, Suite 303, Bridgewater,
NJ 08807. Our telephone number is (908) 517-9500. Our website address is
www.cormedix.com.