U.S Nationwide Commercial Availability of the VenSure™ Balloon Sinus Dilation System and Cube™ Navigation System Highlight Intersect ENT’s Continued Commitment to Providing Innovative, Solutions for Patients with Chronic Rhinosinusitis
VenSure and Cube Join the Company’s Portfolio of Localized Drug Delivery Creating an Integrated Offering of ENT Technologies to Treat CRS
MENLO PARK, Calif.–(BUSINESS WIRE)–Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced the U.S. nationwide commercial availability of the VenSure™ Balloon Sinus Dilation System and Cube™4D Navigation System with VirtuEye™ photo registration. 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.”
About Intersect ENT
Intersect ENT is a global ear, nose and throat medical technology leader dedicated to transforming patient care. The Company’s steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care. In October 2020, Intersect ENT acquired Fiagon AG Medical Technologies, a global leader in electromagnetic surgical navigation solutions with an expansive portfolio of ENT product offerings, including the VenSure sinus dilation balloon, which is FDA-cleared in the US, that complement the Company’s PROPEL® and SINUVA® sinus implants and extend its geographic reach.
For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.PROPELopens.com and www.SINUVA.com.
Intersect ENT, PROPEL®, and SINUVA® are registered trademarks of Intersect ENT, Inc in the US and other countries. VenSure, Cube and VirtuEye have pending trademark applications.
About VenSure
The VenSure Nav Balloon Device is intended for use in conjunction with the Cube Navigation System during sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia. The Cube Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy. The navigation system must not be used in patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators, programmable CSF shunts or with monopolar pacemakers (older designs, with lower resistance to interference) or ICD’s.
For full listing of indications, contraindications, warnings and precautions and adverse effects, please see each product’s Instructions For Use: www.VenSureandCube.com. Rx only.
PROPEL® Steroid Releasing Sinus Implants
The PROPEL family of products are the first and only bioabsorbable steroid releasing sinus implants approved by the FDA to maintain patency and locally deliver steroid to the sinus mucosa in patients 18 years of age or older after sinus surgery. Clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery, PROPEL sinus implants mechanically prop open the sinuses and release mometasone furoate, an advanced corticosteroid with anti‐inflammatory properties, directly into the sinus lining then bioabsorb. PROPEL’s safety and effectiveness for use in ethmoid sinuses is supported by Level 1‐A clinical evidence from multiple clinical trials, which demonstrates that PROPEL implants reduce inflammation and scarring after ethmoid sinus surgery, thereby lessening the need for post‐operative oral steroids and surgical interventions. PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
SINUVA® Steroid Releasing Sinus Implant
SINUVA is a non‐surgical, corticosteroid‐eluting implant for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery. Its innovative 2‐in‐1 design incorporates a self‐expanding, bioabsorbable implant structure along with the targeted delivery of an anti‐inflammatory corticosteroid, mometasone furoate. It provides localized drug delivery for up to 90 days directly to the site of disease. By nature of its design as an office‐administered implant with direct delivery of anti‐inflammatory medication, SINUVA minimizes the reliance on patient compliance. SINUVA is clinically proven to reduce polyps and the need for revision nasal surgery, as well as improve the symptoms of nasal polyps, nasal obstruction, congestion and decreased sense of smell.
IMPORTANT SAFETY INFORMATION FOR PROPEL SINUS IMPLANTS
The PROPEL sinus implants are indicated to maintain patency and locally deliver steroid to the sinus mucosa in patients 18 years of age or older after sinus surgery: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus/frontal sinus opening and PROPEL Contour for the frontal/maxillary sinus ostia.
Contraindications include patients with intolerance to mometasone furoate (MF) or hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implant in pregnant or nursing females have not been studied. Risks may include, but are not limited to pain/pressure, displacement of the implant, possible side effects of intranasal MF, sinusitis, epistaxis and infection. For full prescribing information see IFU at https://www.IntersectENT.com/techologies/. Rx only
SINUVA Indication & Important Safety Information
INDICATION
SINUVA Sinus Implant is a prescription steroid‐releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.
IMPORTANT SAFETY INFORMATION
Who should not use SINUVA?
Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.
What should I tell my doctor before receiving SINUVA?
Before you receive SINUVA, tell your doctor about all medical conditions you have including nasal/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.
What are the possible side effects of SINUVA?
Serious side effects of SINUVA can include:
- Local reactions including nosebleed and injury to nerves or blood vessels in the nose/sinus.
- Serious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.
- Weakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.
- Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure.
Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.
The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following adverse reactions have been identified during post‐approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds. Tell your doctor if you have any side effects that bother you or don’t go away.
Risks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.
SINUVA is made from materials designed to soften over time and may fall out of the nose on its own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor’s discretion.
Contact your doctor immediately if you have any changes in vision, excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088. For important risk and use information, please see Full Prescribing Information for SINUVA (www.SINUVA.com/PI)
Forward‐Looking Statements
This release contains forward‐looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “look forward,” “confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward‐looking statements. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the company’s products and therapies, the ability to obtain and maintain reimbursement codes for its products, the company’s ability to procure and maintain required regulatory approvals for our products, the company’s ability to grow and expand its business, as well as other risks detailed from time to time in Intersect ENT’s filings with the Securities and Exchange Commission (SEC), including Intersect ENT’s filings on Form 10‐K and Form 10‐Q available at the SEC’s Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein.
Contacts
IR Contact:
Randy Meier, 650‐641‐2105
Executive Vice‐President & CFO
ir@intersectENT.com
Media Contact:
Erich Sandoval, 917‐497‐2867
Finn Partners for Intersect ENT
IntersectENT@finnpartners.com
