Fiagon Partners with Entellus Medical to Bring Image Guidance Technology to U.S. ENT Medical Offices and Ambulatory Surgery Centers
Austin, Texas (August 10, 2015) – Fiagon NA Inc. a medical technology company that develops and manufactures innovative surgical navigation systems, today announced a partnership with Entellus Medical, Inc. to be the exclusive distributor of Fiagon Image Guidance Systems (IGS) for ENT offices and ENT Ambulatory Surgery Centers across the United States.
Fiagon develops and manufactures innovative surgical navigation systems using the latest generation of proprietary “FlexSensor” electromagnetic based navigation technology. Together, the Entellus XprESS Pro balloon dilation system and the Fiagon image guidance system will provide ENT physicians greater confidence in device placement during ENT procedures.
Fiagon develops and manufactures innovative surgical navigation systems of the latest generation with its proprietary “FlexSensor” technology. In the last several years Fiagon, along with world-renowned physicians, has changed the standard in ENT navigation with its electromagnetic based navigation technology. This unique technology is already been used in oral and maxillofacial surgery, neurosurgery and spine surgery, outside the U.S., mainly in Europe and Asia.
Entellus has led the way in moving balloon sinus dilation from the operating room to the physician’s office, providing proven equivalent results to traditional sinus surgery while delivering a superior patient experience. The addition of image guidance in the office setting will continue to accelerate the OR to office setting shift , and also will deliver potential cost savings to patients and the healthcare system.
“The Fiagon system 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 as physicians increasingly expand the variety of surgical procedures they perform in the office.”
“Our system has been designed with simplicity and ease of use in mind. The result is a system that is tailor-made for the physician’s office while providing 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 U.S. 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.
Fiagon develops and manufactures innovative surgical navigation systems of the latest generation with its proprietary “chip on the tip” technology. In the last years Fiagon, along with world-renowned physicians, has changed the standard in ENT navigation with its electromagnetic based navigation technology. This unique technology is already been used in oral and maxillofacial surgery, neurosurgery and spine surgery, outside the US, mainly in Europe and Asia.
About Entellus Medical:
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 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 and Canada and sells its products through a direct sales force in the United States.
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 management’s current expectations 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 company’s significant operating expenses incurred since inception and expected to incur in the future; its dependence on a limited number of products, including the XprESS family of multi-sinus products; physicians’ willingness to change current practices and continue to adopt office-based balloon sinus dilation procedures; inability to maintain adequate levels of reimbursement for the procedures using the company’s products; the impact of competition within the industry; the company’s substantial dependence on a key license agreement; and the company’s ability to establish and maintain intellectual property protection for its products or avoid claims of infringement. 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 Registration Statement on Form S-1 filed with the Securities and Exchange Commission, or 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 our views to change.
Dr. Alfred Niski
D 16761 Hennigsdorf (Berlin)
Phone: +49 151 11777601