IRADIMED CORPORATION Withdraws 510(k) with Plans to Resubmit After Further Discussions with FDA
October 10 2022 - 8:00AM
IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today
announced that the Company voluntarily withdrew its 510(K)
application on October 5, 2022, for its next-generation MR IV pump.
Roger Susi, President and Chief Executive Officer of the
Company, commented, “We have been engaged in several productive and
positive discussions with the FDA. The FDA requested additional
information that was not feasible to provide within FDA’s review
deadline; therefore, we decided to withdraw our application to
provide us more time to understand and resolve the FDA’s concerns.
We are confident that after working with the FDA, we will be able
to submit a 510(k) application that leads to a timely clearance for
the MRidium 3870 Infusion Pump System. It is important to note that
this withdrawn 510(k) is for a future product and in no way affects
our current revenue-generating product portfolio.”
The Company also announced selected preliminary financial
results for the third quarter ended September 30, 2022.
Third-quarter revenue is expected to be approximately $13.4
million, up 23% from the prior year and above the Company’s
third-quarter guidance of $13.1 million - $13.3 million.
“These third quarter preliminary results represent our highest
revenue quarter. It also continues a four-quarter trend of record
revenues. Orders booked in the quarter exceeded our shipments as we
continue to add to our extensive backlog. Domestic unit orders
booked in the quarter for our current MRidium 3860 Infusion Pump
System were the highest over the last three years, demonstrating
the continued strong demand for this product,” said Roger Susi. “As
we enter the remainder of 2022 and onward into 2023, we are
positioned to continue to achieve our growth objectives with our
current products,” Mr. Susi added.
About IRADIMED CORPORATION
IRADIMED CORPORATION is a leader in developing innovative
Magnetic Resonance Imaging (“MRI”) compatible medical devices. We
develop, manufacture, market, and distribute MRI-compatible medical
devices and accessories, disposables, and services relating to
them.
We are the only known provider of a non-magnetic intravenous
(“IV”) infusion pump system designed to be safe during MRI
procedures. We were the first to develop an infusion delivery
system that eliminates many dangers and problems during MRI
procedures. Standard infusion pumps contain magnetic and electronic
components which can create radio frequency 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
unique features to deliver anesthesia safely and predictably 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 essential to critically ill patients who cannot be removed
from their vital medications and children and infants who must
generally be sedated to remain immobile during an MRI scan.
Our 3880 MRI-compatible patient vital signs monitoring system
has been designed with non-magnetic components and other unique
features to monitor a patient’s vital signs safely and accurately
during various MRI procedures. The IRADIMED 3880 system operates
dependably in magnetic fields up to 30,000 gauss, which means it
can operate virtually anywhere in the MRI scanner room. The
IRADIMED 3880 has a compact, lightweight design allowing it to
travel with the patient from the critical care unit to the MRI and
back, resulting in increased patient safety through uninterrupted
vital signs monitoring and decreasing the amount of time critically
ill patients are away from critical care units. The features of the
IRADIMED 3880 include wireless ECG with dynamic gradient filtering;
wireless SpO2 using Masimo® algorithms; non-magnetic respiratory
CO2; invasive and non-invasive blood pressure; patient temperature,
and optional advanced multi-gas anesthetic agent unit featuring
continuous Minimum Alveolar Concentration measurements. The
IRADIMED 3880 MRI-compatible patient vital signs monitoring system
has an easy-to-use design and effectively communicates patient
vital signs information to clinicians.
For more information, please visit www.iradimed.com.
Forward-Looking Statements
This press release contains forward-looking statements (i.e.,
statements which are not historical facts). Readers are cautioned
not to place undue reliance on forward-looking statements, which
speak only as of the date that they are made, and which reflect
management's current estimates, projections, expectations or
beliefs and which involve risks and uncertainties that could cause
actual results and outcomes to be materially different. Risks and
uncertainties that may affect the future results of the company
include, but are not limited to, impacts of the COVID-19 pandemic,
including the impact of existing and new variants, and measures
taken in response; potential disruptions in our limited supply
chain for our products; the Company’s ability to receive FDA 510(k)
clearance for new products and product candidates; unexpected
costs, delays or diversion of management’s attention associated
with the design, manufacture or sale of new products; the Company’s
ability to implement successful sales techniques for existing and
future products and evaluate the effectiveness of its sales
techniques; additional actions, warnings or requests from the FDA
or other regulatory bodies; our significant reliance on a limited
number of products; a reduction in international distribution;
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:
John “Jack” Glenn
Chief Financial Officer
IRADIMED CORPORATION
(407) 677-8022
InvestorRelations@iradimed.com
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