Entellus Medical Announces Release of XprESS(TM) Ultra Multi-Sinus Dilation System
Entellus Medical, Inc. 3 hours ago GlobeNewswire
PLYMOUTH, Minn., Feb. 13, 2015 (GLOBE NEWSWIRE) — Entellus Medical, Inc. (ENTL), a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced the release of the XprESS(TM) Ultra Multi-Sinus Dilation System, the third device in the XprESS family of balloon sinus dilation systems.
XprESS Ultra provides the precision, versatility and control of the XprESS family of balloon sinus dilation systems while adding an even sleeker profile device to the XprESS family. The sleek profile and design of XprESS Ultra allows for smooth movement through tight nasal passages and easy endoscopic viewing of the treatment area while the malleable tip can be reshaped to meet the unique challenges of patients with extremely narrow sinus drainage pathways. “Entellus makes very intuitive products. The XprESS Ultra is a thinner tool that makes tight access easier,” said Dr. Rajiv Pandit, MD, Dallas ENT, Dallas Sinus Institute. With the addition of XprESS Ultra, the XprESS family now offers a choice of features to address patient needs and meet physician preferences.
The XprESS family of products are used by Ear, Nose and Throat, or ENT, physicians to treat patients with symptomatic inflammation of the nasal sinuses and open narrowed or obstructed sinus drainage pathways using balloon sinus dilation. “The addition of XprESS Ultra to the XprESS family of devices highlights our ongoing commitment to making it even easier for ENT specialists to offer the benefits of balloon sinus dilation to patients suffering from sinusitis,” said Robert White, President and Chief Operating Officer, Entellus Medical, Inc.
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.
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.