Impeto Medical Responds to Published Allegations by LD Technology LLC ("LD")
SAN DIEGO, March 5, 2015 /PRNewswire/ -- In response to the incorrect assertions by LD, distributed by Marketwired in Miami, FL on February 12, 2015. Impeto Medical SAS and its U.S. company are both of strong financial health and their SUDOSCAN® devices have been proven to provide accurate results, as clinical research has indicated. Furthermore, Impeto prefers to have the courts decide this dispute rather than the press.
There are more than 40 articles written by Key Opinion Leaders, published by significant peer-reviewed scientific journals that scientifically demonstrate that Impeto's SUDOSCAN® devices perform as advertised. These devices have been well accepted by Medical doctors in the U.S. and throughout the world. LD's assertions to the contrary are simply incorrect.
Impeto's SUDOSCAN® device was listed as a predicate device within LD's first 510(k) application and subsequent clearance. For example, LD stated on its June 29, 2010 510(k) Premarket Notification Number K102166, that with regard to its EIS-GS device there is "Substantial equivalence [–] Predicate legally marketed device[:] SUDOSCAN 510(k) number 100223: Manufacturer Impeto Medical…. Similarities[:] Same intended use and same technology." Thereafter, LD's February 16, 2013 510(k) (2) Premarket Notification for its Sudopath device used the June 29, 2010 510(k) as the predicate. In other words, in its FDA documents, LD admits that its Sudopath device uses the same technology as the prior SUDOSCAN® device of Impeto.
Impeto's D&B credit is in good standing. Additionally, Impeto has strong shareholders which support the company's' research for the past decade and to protect the R&D investments through strong worldwide patents and patent applications.
LD's press release assertions are incorrect, especially regarding Non-Disclosure Agreements and allegedly improperly used information. The French courts have already ruled that Impeto and its engineers had acted properly and did not violate any rights of LD or its French predecessor.
Impeto has sued LD and its officer Albert Maarek in the U.S. District Court for the Southern District of Florida in civil action no. 1:15-cv-20109. The causes of action brought by Impeto Medical SAS against LD and Maarek assert infringement of three U.S. Impeto patents, infringement of Impeto's SUDOSCAN® trademark, and false advertising. The Impeto patents and trademark registration were properly issued by the U.S. Patent and Trademark Office, and Impeto is confident in its position. Impeto prefers to have the courts decide this dispute rather than the press.
Impeto medical SAS was founded in 2005 in Paris. See website: http://www.impeto-medical.com.
Impeto medical Inc was created in 2011 as a full subsidiary of SAS. See website: http://www.sudoscan.com
SOURCE Impeto Medical SAS
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