Dr Kuno van der Post
OmniComm Systems, Inc.
Fort Lauderdale, FL, April 22, 2013 – OmniComm Systems, Inc. (OTCBB: OMCM), a leading global provider of eClinical solutions, announced today that it was selected as the EDC System of choice by Menlo Park, CA based Intersect ENT for its RESOLVE Clinical Study, a Novel In-Office Treatment option for Chronic Sinusitis Patients.
"We selected OmniComm’s system after considering many other options. Our decision was based on TrialMaster’s natural and intuitive user interface, and its ability to seamlessly produce validated SDTM data exports created directly from the TrialMaster database. With SDTM datasets available shortly after commencing patient enrollment, we have significantly sped up the process of managing our study and identifying potential data issues. We anticipate that OmniComm’s state of the art technology will allow rapid database closure, analyses and results that comply with FDA’s expectations,” said James Stambaugh, Vice President of Clinical Affairs and Reimbursement.
Intersect’s new product, a Steroid Eluting Implant for Post Sinus Surgery Patients, is placed in vivo during a routine physician office visit, and is designed as a treatment alternative for patients with recurrent sinus obstruction. The RESOLVE Study plans to enroll 100 patients, at up to 20 U.S. sites.
"We are extremely pleased to be chosen by Intersect ENT to support their new product development," said Stephen Johnson, President and COO of OmniComm. "Intersect has developed a strong reputation for developing local drug delivery solutions to advance clinically proven therapies that improve the quality of life for many patients with ear, nose and throat conditions.” Johnson further stated, "We are delighted to be partnering with them to offer solutions that will help them be more efficient in the collection and management of their clinical product development."
About OmniComm Systems
OmniComm Systems, Inc. (www.OmniComm.com) provides customer-driven Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct life changing clinical trial research. OmniComm's growing base of satisfied customers is a direct result of the company's commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComm's pricing model is easily understood and allows companies ranging from small, to large, to maximize their clinical research investments. OmniComm Systems, Inc. has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey and the United Kingdom, as well as sales offices throughout the U.S. and Europe.
About Intersect ENT
Intersect ENT Inc. (www.intersectent.com), located in Menlo Park, Calif., is an innovator in local drug delivery focused on advancing clinically proven therapy solutions that improve quality of life for patients with ear, nose and throat conditions. The company’s initial products, the PROPEL and PROPEL mini dissolvable steroid releasing implants, are the only products backed by Level 1- A clinical evidence to improve sinus surgery outcomes for patients suffering from chronic sinusitis. Chronic sinusitis is a common condition that affects one out of seven adults in the U.S. and greatly impacts quality of life. The company holds twenty issued U.S. patents and more than 75 patents and pending applications worldwide. Intersect ENT is backed by Kleiner, Perkins, Caulfield, & Byers; U.S. Venture Partners; PTV Sciences; Norwest Venture Partners (NVP); and Medtronic. For more information please visit www.intersectENT.com.
Safe Harbor Disclaimer
Statements made by OmniComm included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as the Company's ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the Company's financial results can be found in the Company's Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.