SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
CURRENT REPORT Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): February 26, 2020
(Exact Name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation)
|(Commission File Number)||(IRS Employer Identification No.)|
|1025 Willa Springs Dr., Winter Springs, FL||32708|
|(Address of Principal Executive Offices)||(Zip Code)|
(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 (see General Instruction A.2. below):
|¨||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.
On February 26, 2020, iRadimed Corporation (the “Company”) issued a press release announcing the retirement of Francis Casey, Vice President of Regulatory and Quality Assurance, effective June 30, 2020 after originating and leading the Company’s regulatory efforts since 2004. iRadimed appointed Steven Kachelmeyer as Vice President of Regulatory Affairs and Quality Assurance, succeeding Mr. Casey, effective March 10, 2020. Mr. Kachelmeyer will report to Leslie McDonnell, President and Chief Executive Officer.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press release dated February 26, 2020.|
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.
|Date: February 26, 2020|
|Name: Chris Scott|
|Title: Chief Financial Officer|
IRADIMED CORPORATION Announces Retirement of Francis Casey and the Appointment of Steven Kachelmeyer as Vice President of Regulatory Affairs and Quality Assurance
Winter Springs, Florida, February 26, 2020 – iRadimed Corporation (NASDAQ: IRMD) announced the retirement of Francis Casey, Vice President of Regulatory Affairs and Quality Assurance, effective June 30, 2020 after leading the Company’s regulatory efforts since 2004. iRadimed appointed Steven Kachelmeyer as Vice President of Regulatory Affairs and Quality Assurance, succeeding Mr. Casey, effective March 10, 2020. Mr. Kachelmeyer will report to Leslie McDonnell, President and Chief Executive Officer.
“Under Fran’s leadership, iRadimed gained regulatory approvals in the U.S., Europe and many other countries for the world’s only non-magnetic MRI compatible infusion pump and patient vital signs monitor. On behalf of the Board of Directors and everyone at iRadimed, I would like to congratulate Fran on his retirement and thank him for originating and guiding our regulatory function, providing many key contributions to the success of the Company,” said McDonnell.
“Steve is a deeply experienced Regulatory and Quality executive in the medical technology industry. I am confident he will continue to build a world-class regulatory and quality system to support our rapid growth. We are excited to add him to the executive team,” said McDonnell.
About Steven Kachelmeyer
Mr. Kachelmeyer has extensive experience in the medical technology industry. Prior to his appointment at iRadimed, Mr. Kachelmeyer spent over 3 years at Merz North America Inc. as its Executive Director of Regulatory and Quality Affairs. Prior to that, Mr. Kachelmeyer was employed at GE Healthcare for 30 years where he spent over 15 years in regulatory and quality roles of increasing responsibility, eventually departing as a Regulatory and Quality Executive focused on clinical affairs. Mr. Kachelmeyer is experienced in all phases of new product registrations and maintaining compliance with the FDA and other international regulatory bodies. Mr. Kachelmeyer has also participated in industry groups responsible for developing international product standards. He earned a Bachelor’s Degree in Engineering, Technology and Electronic Technology from DeVry Institute of Technology and a Masters of Business Administration degree from the Keller Graduate School of Management.
About iRadimed Corporation
iRadimed Corporation is a leader in the development of innovative magnetic resonance imaging (“MRI”) compatible medical devices. 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 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 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 safely and accurately monitor a patient’s vital signs 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 their 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.
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 an EC Certificate or CE Mark for our existing products and product candidates, 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; potential disruptions in our limited supply chain for our 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.
Chief Financial Officer