SinuGeniX is an emerging medical device company focused on commercializing a product family, with initial focus on its patented RegENT™ System, the next generation of balloon dilation sinuplasty (BDS) for the treatment of chronic rhinosinusitis (CRS), which affects approximately 35 million people annually in the U.S. CRS is responsible for more than $8 billion in direct costs annually to the U.S. healthcare system.
One in five CRS patients does not respond to conventional medical therapy; consequently, 500,000 patients annually undergo sinus surgery to relieve their pain and discomfort.
Until 2005, CRS was typically resolved using Functional Endoscopic Sinus Surgery (FESS), requiring anatomical rearrangement that usually leads to post-operative pain, scarring and bleeding, as well as potential structural alteration to a patient’s anatomy that may result in aesthetic defects to the patient’s nose and face.
A new approach to sinus surgery, balloon dilation sinuplasty (BDS), was introduced in 2005. BDS employs a non-compliant balloon that, when dilated, opens up diseased and constricted sinus ostia to relieve sinus congestion. The BDS procedure is not as invasive as FESS. However, BDS creates a significant compression upon the sinus ostia that causes deformation and fracture of the anatomy. In fact, many surgeons purposely deform, fracture and even resect (cut out) the ostia to restore drainage and airflow in pursuit of a viable treatment remedy for their CRS patients.
Since its introduction in 2005, BDS has increased the number of sinus surgeries performed annually. BDS is used by itself in lieu of FESS or in conjunction with FESS. BDS preserves more of the anatomy than FESS and, theoretically, has less complications and failure rates.
However, after nearly a decade in use, users of the BDS procedure have declared that the first generation of BDS has a number of problems, including a restenosis (failure) rate of 17 percent.
SinuGeniX’s next-generation BDS product, the RegENT™ System, for treatment of CRS is designed to replace FESS and gen-1 BDS as a result of RegENT’s greater precision, superior efficacy, and dramatic cost-effectiveness.
The RegENT System is a disruptive technology for diagnosis and treatment of CRS within the sinus cavity, incorporating breakthroughs in miniaturization to improve access and imaging designed to improve the overall ability of ENT surgeons (otolaryngologists) to perform minimally invasive procedures in their office setting.