Sinexus has changed its name to Intersect ENT. Intersect's initial focus is a bioabsorbable drug eluting stent to treat patients with chronic sinusitis, a debilitating condition that affects 37 million people each year and is more prevalent than heart disease or asthma.
"Intersect is a name that represents our mission of connecting drugs and devices to physicians and patients in need," said Lisa Earnhardt, President and CEO. "While our initial products target sinusitis, we plan to apply our novel technologies to the broad range of conditions treated by Ear, Nose, & Throat surgeons. Our goal is to provide less invasive treatment options that result in improved outcomes and reduced need for systemic drugs such as oral steroids which can lead to serious side effects."
The company also announced the initiation of its U.S. pivotal clinical study to evaluate the safety and effectiveness of its novel steroid-eluting bioabsorbable stent in patients undergoing sinus surgery. The prospective, randomized, blinded, multicenter study is guided by thought leaders in sinusitis care.
"Two key requirements for positive outcomes after sinus surgery are maintaining a patent cavity and controlling inflammation. The clinical data from the 100 patients studied to date are encouraging," said Dr. Neil Bhattacharyya, Associate Professor at Harvard Medical School / Brigham & Women's Hospital. Dr. Bhattacharyya serves as Co-Principal Investigator together with Dr. Bradley E. Marple, Professor & Vice Chairman at UT Southwestern Medical Center.
Dr. Marple added: "Patients with chronic sinusitis tend to require extensive oral steroids, which can lead to a multitude of side effects. Intersect's novel stents may alleviate the need for oral steroids and have the potential to become a powerful treatment option for sinus sufferers."
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