Sinexus has changed its name to Intersect ENT. Intersect has reported that its initial focus is a bioabsorbable drug eluting stent to treat patients with chronic sinusitis.
The company also reported the initiation of its US pivotal clinical study to evaluate the safety and effectiveness of its new steroid-eluting bioabsorbable stent in patients undergoing sinus surgery. The prospective, randomized, blinded, multicenter study is guided by thought leaders in sinusitis care.
Lisa Earnhardt, president and CEO, said: “Intersect is a name that represents our mission of connecting drugs and devices to physicians and patients in need. While our initial products target sinusitis, we plan to apply our novel technologies to the broad range of conditions treated by Ear, Nose and 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.”
Neil Bhattacharyya, associate professor at Harvard Medical School / Brigham & Women’s Hospital, said: “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.”
Marple said: “Patients with chronic sinusitis tend to require extensive oral steroids, which can lead to a multitude of side effects. Intersect’s new stents may alleviate the need for oral steroids and have the potential to become a powerful treatment option for sinus sufferers.”