Aug 10 2015
PLYMOUTH, Minnesota—Entellus Medical, Inc. (“Entellus Medical” or the “Company”) (NASDAQ: ENTL), a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced a collaboration with Fiagon NA Corporation, a manufacturer of the latest generation in innovative surgical navigation systems. The agreement enables Entellus to be the exclusive distributor of Fiagon Image Guidance Systems (“IGS”) for ENT offices and ENT Ambulatory Surgery Centers in the United States. The Company expects the integration of the Entellus XprESS™ Pro Multi-Sinus Dilation System and the Fiagon IGS to provide another level of confirmation to increase physician confidence in device placement.
Entellus Medical is leading the way in moving balloon sinus dilation from the operating room to the physician’s office. The Company’s systems deliver proven results that are equivalent to those obtained through traditional sinus surgery, while at the same time providing an improved patient experience. The addition of the Fiagon IGS in the office setting has the potential to continue the expansion of ENT surgical procedures into the office setting through positive clinical outcomes and reduced costs to both the patient and healthcare system.
“We believe the Fiagon IGS is uniquely suited for the office environment, and we are excited to add this technology to our product portfolio,” said Robert White, President and CEO of Entellus Medical. “Physicians will be able to use the Fiagon system to assist in balloon sinus dilation procedures as well as to guide other surgical instruments, such as microdebriders and suction devices. This is ideal as physicians increasingly expand the variety of ENT surgical procedures they are able to perform in the office.”
“Our system has been developed with simplicity and ease of use in mind. The result is a system that is tailor-made for the physician’s office and that is designed to provide the best possible accuracy, precision and confidence. The combination of the Entellus XprESS Pro and the Fiagon IGS is a win-win for physicians and patients,” said Timo Kruger, CEO of Fiagon.
About Chronic Sinusitis and Balloon Sinus Dilation
Chronic sinusitis affects approximately 29 million American adults, making it one of the most common health problems in the United States. It is more prevalent than heart disease and asthma, and has a negative impact on quality of life with chronic symptoms and effects including facial pain and pressure, headaches, fatigue, loss of smell, and sinus infections.
Surgical treatment of chronic sinusitis routinely involves cutting and removal of sinus mucosal tissue near the opening of a sinus. Use of sinus balloon technology preserves the natural sinus anatomy and enables effective treatment of sinusitis patients in the comfort and convenience of a physician’s office. In-office balloon sinus dilation is a proven, effective alternative treatment to endoscopic sinus surgery and provides patients lasting relief at a lower cost than traditional sinus surgery.
About Entellus Medical, Inc.
Entellus Medical is a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room. Its XprESS family of products is used by ENT physicians to open narrowed or obstructed sinus drainage pathways using balloon sinus dilation. When used as a stand-alone therapy, Entellus Medical’s balloon sinus dilation products are the only devices proven in a sufficiently powered prospective, multicenter, randomized, controlled trial to be as effective as functional endoscopic sinus surgery, or FESS. Patients treated with Entellus Medical’s products in this trial in the ENT physician’s office also experienced faster recovery, less bleeding at discharge, less use of prescription pain medication and fewer post-procedure debridements than patients receiving FESS. Entellus Medical currently markets its products in the United States, Europe and Canada and sells its products through a direct sales force in the United States and the UK. For more information, please visit the Company’s website at www.entellusmedical.com.
About Fiagon NA Corporation
Fiagon develops and manufactures the latest generation in innovative surgical navigation systems with its proprietary “chip on the tip” technology. In the last few years Fiagon, along with world-renowned physicians, have changed the standard in ENT navigation with its electromagnetic based navigation technology. This unique technology is currently in use for oral and maxillofacial surgery, neurosurgery and spine surgery applications outside the United States, primarily in Europe and Asia.
All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current expectations of Entellus Medical’s management and involve known and unknown risks and uncertainties that may cause the performance of the Entellus XprESS Ultra device or Entellus Medical’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the benefits the Company expects to achieve as a result of the collaboration with Fiagon and the integration of the Company’s product portfolio and the Fiagon IGS. Other factors that could cause actual results to differ materially from those contemplated in this press release can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 filed with the Securities and Exchange Commission (“SEC”) and its other reports filed with the SEC. Entellus Medical undertakes no obligation to update or revise any forward looking statements, even if subsequent events cause its views to change.
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