Encision Receives FDA 510(k) Approval on its AEM EndoShield™ Burn Protection System
BOULDER, Colo., June 27, 2014 /PRNewswire/ -- Encision Inc. (ECIA:PK), a medical device company owning patented surgical technology that prevents dangerous stray electrosurgical burns in minimally invasive surgery, today announced that it has received FDA 510(k) premarket notification approval for its AEM Endoshield™ Burn Protection System ("EndoShield").
"We are pleased to have achieved this milestone towards the introduction of our EndoShield burn protection system," said Greg Trudel, Encision's President & CEO. "EndoShield integrates our patented AEM® technology into a disposable smart cord and eliminates the need for a separate AEM monitor. Feedback from the marketplace has been very positive. Our customers appreciate the advancement of the technology, the increase in ease of use, and the freedom from the constraint of capital expense. We look forward to launching our new device and to increasing the proliferation of advanced AEM monopolar energy and patient safety."
Encision Inc. designs and markets a portfolio of high performance surgical instrumentation that delivers advances in patient safety with AEM technology, surgical performance, and value to hospitals across a broad range of minimally invasive surgical procedures. Based in Boulder, CO, the company pioneered the development and deployment of Active Electrode Monitoring, AEM technology, to eliminate dangerous stray energy burns during minimally invasive procedures.
In accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, the Company notes that statements in this press release and elsewhere that look forward in time, which include everything other than historical information, involve risks and uncertainties that may cause actual results to differ materially from those indicated by the forward-looking statements. Factors that could cause the Company's actual results to differ materially include, among others, its ability to increase net sales through the Company's distribution channels, its ability to compete successfully against other manufacturers of surgical instruments, insufficient quantity of new account conversions, insufficient cash to fund operations, delay in developing new products and receiving FDA approval for such new products and other factors discussed in the Company's filings with the Securities and Exchange Commission. Readers are encouraged to review the risk factors and other disclosures appearing in the Company's Annual Report on Form 10-K for the year ended March 31, 2013 and subsequent filings with the Securities and Exchange Commission. We do not undertake any obligation to update publicly any forward-looking statements, whether as a result of the receipt of new information, future events, or otherwise.
CONTACT: Mala Ray, Encision Inc., 303-444-2600, firstname.lastname@example.org
SOURCE Encision Inc.