The Shareholders Foundation announces that an investor, who purchased shares of Iradimed Corp (NASDAQ:IRMD), filed a lawsuit over alleged violations of Federal Securities Laws by Iradimed Corp in connection with certain allegedly false and misleading statements made between July 15, 2014 and September 2, 2014.
Investors who purchased shares of Iradimed Corp (NASDAQ:IRMD) have certain options and for certain investors are short and strict deadlines running. Deadline: November 10, 2014. NASDAQ:IRMD investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of purchasers of Iradimed Corp (NASDAQ:IRMD) common shares between July 15, 2014 and September 2, 2014, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that Iradimed Corp allegedly failed to disclose that Iradimed Corp’s infusion pump systems had been significantly modified which could significantly affect the safety or effectiveness of the devices, that as such under applicable federal regulations the Company’s products are “adulterated” and “misbranded”, that Iradimed Corp’s mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850, and that Iradimed Corp failed to disclose the material uncertainties and risks that their products were adulterated or misbranded.
Iradimed Corp reported that its annual Total Revenue rose from $7.69 million in 2012 to $11.34 million in 2013 and that its Net Income increased from $0.97 million in 2012 to $1.94 million in 2013.
On September 2, 2013, Iradimed Corp announced that it received a warning letter from the U.S. Food and Drug Administration (“FDA”) relating to an inspection of the Company’s facility that took place in April 2014.
Iradimed Corp said that the warning letter, among other things, states that a new submission is required under Section 510(k) of the Food, Drug and Cosmetic Act (the “FDCA”) for the Company’s IV infusion pump systems due to periodic updates of the software on the Company’s previously cleared infusion pumps, the mRidium 3860 and mRidium 3850, that the warning letter states that such updates are “significant” modifications that could significantly affect the safety or effectiveness of the devices and therefore the products being sold by the Company are “adulterated” and “misbranded” under the FDCA, and that the warning letter indicates that the mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850.
Iradimed Corp also said that the warning letter requests that Iradimed Corp immediately cease activities that result in the misbranding or adulteration of the mRidium 3860 MRI infusion pump, mRidium 3850 MRI infusion pump, and the mRidium 3860+ MRI infusion pump, such as the commercial distribution of the device.
Shares of Iradimed Corp declined from $10.40 per share on September 2, 2014 to as low as $6.26 per share on September 3, 2014.
On October 24, 2014, NASDAQ:IRMD shares closed at $7.21 per share.
Those who purchased shares of Iradimed Corp have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North – Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com