UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 8-K
 
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 
Date of report (Date of earliest event reported): October 4, 2022
 
IRADIMED CORPORATION
(Exact name of registrant as specified in its charter)
 
Delaware
(State or other jurisdiction of incorporation)
 
001-36534
 
73-1408526
(Commission File Number)
 
(IRS Employer Identification No.)
 
1025 Willa Springs Dr., Winter Springs, Florida
 
32708
(Address of principal executive offices)
 
(Zip Code)
 
(407) 677-8022
(Registrant’s telephone number, including area code)
 
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class:
 
Trading Symbol
 
Name of each exchange on which registered:
Common stock, par value $0.0001
 
IRMD
 
NASDAQ Capital Market









Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Election of New Director

On October 4, 2022, the Board of Directors (the “Board”) of iRadimed Corporation (the “Company”) increased the size of the Board to a total of 5 Directors and elected Ms. Hilda Scharen-Guivel as a Director, both effective October 4, 2022. The Board has not elected Ms. Scharen-Guivel to any Board Committee at this time.

Ms. Scharen-Guivel does not have any material relationships with the Company, and there are no transactions between her and the Company that would be required to be reported under Item 404(a) of Regulation S-K. There is also no arrangement or understanding between Ms. Scharen-Guivel and the Company pursuant to which she was selected as a Director. Ms. Scharen-Guivel will receive compensation generally consistent with that received by non-employee Directors, as described in the Company’s most recent Proxy Statement for the 2022 Annual Meeting of Stockholders.

A copy of the press release issued by the Company on October 6, 2022 announcing the above actions is attached as Exhibit 99.1 hereto.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 
Exhibit No.
 
Description
     
 
 
 
 
104
 
Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
IRADIMED CORPORATION
 
 
 
Date: October 6, 2022
 
 
 
By:
/s/ John “Jack” Glenn                                                           
 
Name: John “Jack” Glenn
 
Title: Chief Financial Officer
 
EXHIBIT 99.1



IRADIMED CORPORATION Announces Appointment of Hilda Scharen-Guivel
to Board of Directors


Winter Springs, Florida, October 6, 2022 – iRadimed Corporation (the “Company”) (NASDAQ: IRMD) today announced the appointment of Hilda Scharen-Guivel to the Iradimed Board of Directors, effective October 4, 2022. Following the appointment of Ms. Scharen-Guivel, the Board will comprise five directors, three of whom are independent.

“We are pleased to welcome Hilda Scharen-Guivel to the Iradimed Board,” said Roger Susi, President and Chief Executive Officer of the Company. “Hilda’s deep experience in regulatory oversight in the medical device industry will be invaluable to Iradimed as we develop new products and grow our business to better serve patients.”

Ms. Scharen-Guivel, 52, is a recently retired Program Director of the Food and Drug Administration Center of Devices and Radiological Health, where she most recently led and implemented the new Medical Device Development Tools program. Her career spans over 25 years within multiple federal agencies, including the U.S. Food and Drug Administration, the Department of Health and Human Services, and the National Institutes of Health. She served on active duty as a Captain of the United States Public Health Service for 27 years. Ms. Scharen-Guivel received a Bachelor of Science in Biomedical Engineering and a Master’s Degree in Engineering from the Catholic University of America.


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 that is specifically designed to be safe for use during 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 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 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 important 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 special 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 allows for the effective communication of patient vital signs information to clinicians.

For more information, please visit www.iradimed.com.