VenSure Balloon Sinus Dilation System and Cube™ Navigation System Are Commercially Available in the U.S.

VenSure Balloon Sinus Dilation System and Cube™4D Navigation System with VirtuEye™ photo registration are U.S. commercially available reports Intersect ENT^®, Inc.

The VenSure Balloon and Cube 4D Navigation Systems are used in procedures that are designed to improve debilitating chronic rhinosinusitis (CRS) symptoms. VirtuEye photo registration is an exclusive and novel, touchless technology that allows for easy 3D facial registration, pinpoint accuracy, and improved workflow efficiency for balloon sinus dilation (BSD) procedures and other ENT related skull-based surgeries. With the addition of the Cube and VenSure technologies to the already clinically proven portfolio of localized drug delivery products, PROPEL® (mometasone furoate) and SINUVA® (mometasone furoate) sinus implants, the company now offers a more comprehensive and integrated set of treatment solutions for physicians and their patients across the continuum of care of CRS regardless of site of care.

As many as 1 in 8 adults in the United States suffer from CRS, a condition in which the sinuses within the nose and head become swollen and inflamed for three months or longer, causing blockage of airflow and drainage. Over time, the sinuses can become infected leading to inflammation and pain. Up to 60% of CRS patients may not experience significant improvements in their symptoms despite trying multiple over the counter and prescription medications. For these chronic sinus sufferers Intersect ENT offers a range of device, drug and procedural solutions.

“Chronic rhinosinusitis is an underserved and serious condition that can reduce patients’ quality of life, their ability to work and to get restful sleep. There is a clear need for innovative tools and a broadened armamentarium that can help physicians treat patients suffering from CRS,” states Rajiv Pandit, MD, Otolaryngologist at Dallas ENT Head & Neck Surgery. “Balloon sinus dilation offers CRS patients a convenient, less-invasive, lower-cost solution by providing rapid resolution of symptoms with a minimal risk of complications. The VenSure Balloon allows the technique to be tailored and adapted to each patient’s unique anatomy and the use of Cube Navigation System with VirtuEye ensures a simple yet highly precise location of the balloon for optimized placement within the sinus.”

The BSD procedure entails insertion of a balloon, like the VenSure device, to open the blocked sinuses with precision, reducing the risk of complications associated with other, more invasive surgical procedures. Because balloon sinus dilation preserves the integrity of the sinus tissue, it allows for quick recovery times as most patients may return to regular activity as early as the very next day. Additionally, the sinus procedure can be performed in the physician’s office, reducing the need for costly and unsettling hospital stays and expensive medications. The VenSure Sinus Balloon is a simple yet effective device with a slim, ergonomic design that tailors to the user’s hand for efficient maneuverability. The systems responsive feel is driven by its malleability and integrated components intended to optimize visibility and feel. The tip-tracked technology that is incorporated into each instrument helps provide confident and precise placement feedback.

Accompanying the VenSure Sinus Balloon introduction is the Cube 4D Navigation system, a next generation electromagnetic navigation system that is intuitive, simple and precise. The Cube’s compact design and small footprint easily integrates into any cart or tower shelf, preserving valuable procedural room space. The systems intuitive interface with on-screen instructions and audible confirmation tones, as well as an open architecture platform allowing flexibility to track preferred instrumentation, provides simplicity of use for physician users and staff. Exclusive to the Cube 4D system is the innovative and touchless VirtuEye photo registration technology that reduces patient registration time to under 40 seconds, and its ease of use enhances the user experience and improves pre-procedure efficiency. Importantly, VirtuEye is designed to collect over 50,000 patient registration points in one camera shot, which mitigates common tactile tracing errors that can occur with most other registration approaches. As a touchless technology, VirtuEye photo registration also helps to avoid breaking the sterile field by reducing direct interaction between the care team and the patient.

With the launch of our VenSure Balloon Sinus Dilation System and Cube 4D Navigation system with VirtuEye, “Intersect ENT is transforming to become a more diversified, integrated and evidence-based growth company participating across the continuum of care in CRS,” said Thomas A. West, President and Chief Executive Officer of Intersect ENT. “Our portfolio of related but distinct technologies inclusive of our localized drug delivery platforms, PROPEL and SINUVA, along with VenSure and Cube, now provide surgeon’s an integrated toolbox of solutions to treat patients suffering from CRS regardless of site of care. We are proud of our continued leadership in bringing to market innovative novel ENT technologies that address patient and physician need while providing significant growth to our company.”