IRADIMED CORPORATION Provides Regulatory Update and Schedules First Quarter Conference Call
April 01 2016 - 4:00PM
IRADIMED CORPORATION (NASDAQ:IRMD)
CURRENT NEWS
With regard to IRADIMED CORPORATION’s November 2014 510(k)
application for the MRidium 3860+ MRI compatible IV infusion pump,
we have been notified by the FDA in a letter dated March 23, 2016
received via email that our 510(k) application was denied with a
finding of non-substantial equivalence. This finding was due
to a lack of human factors data demonstrating that its Dose Errors
Reduction System (DERS) was adequately validated and that we may
resubmit a new 510(k) application with data showing our infusion
pump to be substantially equivalent to similar devices in the
market. Specifically, the agency stated that two of fifty-six
test subjects in the Company’s human factors tests unintentionally
bypassed the DERS feature, thus avoiding the DERS hard dose limits
that healthcare institutions can program into the Company’s MRI
compatible MRidium 3860+ infusion pumps.
BACKGROUND
In September 2014 we were required by the FDA to stop selling
our MRI compatible infusion pump systems and submit a new 510(k)
application. In response we halted domestic shipments of our
infusion pumps and the DERS feature. In November 2014 we
filed the requested 510(k) and in December 2014, with the FDA’s
consent, we resumed shipping the infusion pump product without the
DERS feature. In January 2015, again with the FDA’s consent,
we resumed shipping the DERS feature. While the recent letter
denying this 510(k) application did not withdraw the FDA’s consent
to our continued marketing of the infusion pump with the DERS
system, we cannot guarantee that the FDA will not change its
position on allowing the continued marketing of our MRI compatible
infusion pump systems.
ACTION PLAN
The Company intends to appeal this determination to a higher
level within the agency. The Company anticipates submitting
its appeal to the FDA by April 23, 2016.
“We are disappointed with FDA’s determination and, although we
have the opportunity to resubmit another 510(k), we intend first to
appeal it to a higher level within the agency. We look forward to
the FDA’s continued consent of uninterrupted sales of the MRidium
3860+, which fulfills an important public health need in support of
patients who require MRIs while receiving continuous infusion,
during the appeal process or during any future filings. As
the only MRI compatible IV infusion pump, FDA in the past agreed
with us that this public health need justified the availability of
our pump,” said Roger Susi, President and Chief Executive
Officer.
FIRST QUARTER CONFERENCE CALL
The Company announced that it will release its first quarter
2016 financial results before the market opens on Friday, April
29th. IRADIMED management will host a conference call
the same day beginning at 11:00 a.m. Eastern Time to discuss those
results and to answer questions.
Individuals interested in listening to the conference call may
do so by dialing 1-844-413-1781 for domestic callers, or
1-716-247-5767 for international callers, and entering reservation
code 84649088.
The conference call will also be available real-time via the
Internet at www.iradimed.com/en-us/investors/index.php and
selecting Events & Presentations. A recording of the call
will be available on the Company’s website for 90 days following
completion of the call.
About IRADIMED CORPORATION
IRADIMED CORPORATION is the only known provider of
non-magnetic intravenous (IV) infusion pump systems that are
specifically designed to be safe for use during magnetic resonance
imaging (MRI) procedures. We were the first to develop an infusion
delivery system that largely eliminates many of the dangers and
problems present during MRI procedures. Standard infusion pumps
contain magnetic and electronic components which can create radio
frequency (RF) interference and are dangerous to operate in the
presence of the powerful magnet that drives an MRI system. Our
patented MRidium MRI compatible IV infusion pump system has been
designed with a non-magnetic ultrasonic motor, uniquely-designed
non-ferrous parts and other special features in order to safely and
predictably deliver anesthesia and other IV fluids during various
MRI procedures. Our pump solution provides a seamless approach that
enables accurate, safe and dependable fluid delivery before, during
and after an MRI scan, which is important to critically-ill
patients who cannot be removed from their vital medications, and
children and infants who must generally be sedated in order to
remain immobile during an MRI scan.
MRidium is a trademark of IRADIMED CORPORATION.
For more information please visit www.iradimed.com.
Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Act of 1995,
particularly statements regarding our expectations, beliefs, plans,
intentions, future operations, financial condition and prospects,
and business strategies. These statements relate to future events
or our future financial performance or condition and involve
unknown risks, uncertainties and other factors that could cause our
actual results, level of activity, performance or achievement to
differ materially from those expressed or implied by these
forward-looking statements. The risks and uncertainties
referred to above include, but are not limited to, risks associated
with the Company’s ability to receive clearance of its 510(k)
submission, additional actions by or requests from the FDA
(including a request to cease domestic distribution of products)
and unanticipated costs or delays associated with resolution of
these matters; our reliance on a single product; unexpected costs,
expenses and diversion of management attention resulting from the
FDA warning letter; potential disruptions in our limited supply
chain for our products; a reduction in international distribution
as we focus on fulfilling orders from our U.S. backlog; actions of
the FDA or other regulatory bodies that could delay, limit or
suspend product development, manufacturing or sales; the effect of
recalls, patient adverse events or deaths on our business;
difficulties or delays in the development, production,
manufacturing and marketing of new or existing products and
services; changes in laws and regulations or in the interpretation
or application of laws or regulations.
Further information on these and other factors that could affect
the Company’s financial results is included in filings we make with
the Securities and Exchange Commission from time to time. All
forward-looking statements are based on information available to us
on the date hereof, and we assume no obligation to update
forward-looking statements.
Media Contact:
Chris Scott
Chief Financial Officer
IRADIMED CORPORATION
(407) 677-8022
InvestorRelations@iradimed.com
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