CeloNova's Positive Results From Study Of Embozene Microspheres For Treatment Of Uterine Fibroids
CeloNova BioSciences has released data from THE SPHERE, an 11 center, 8 country European study of uterine fibroid embolization using the Company's Embozene Microspheres. The study results were reported at the 20th Annual International Symposium on Endovascular Therapy.
Patients in the study were followed for six months. According to one of the Principal Investigators, Joachim Kettenbach, MD, Medical University of Vienna, "Technical success was achieved in 98% of the patients. The side-effects of fibroids such as pain and heavy menstrual bleeding were significantly reduced while the patients' quality of life improved substantially."
Embolization is a minimally invasive procedure for uterine fibroids during which an Interventional Radiologist injects microspheres through a tiny catheter to the site of the fibroid. The microspheres -- each about the size of a period at the end of this sentence -- block the blood flow to the fibroids causing them to atrophy. The procedure is an alternative for most women with fibroids to surgical procedures such as hysterectomy or myomectomy. Recovery time is measured in days rather than weeks.
CeloNova's Embozene Color-Advanced Microspheres are the only microspheres that are color-coded by size. They have a hydrogel center and an outer layer of the Company's proprietary coating, Polyzene-F which enhances biocompatibility.
"From the beginning, CeloNova has operated on the principle that our products would give first-rate clinical outcomes for patients and meet the real-world needs of physicians," said Thomas A. Gordy, President and Chief Executive Officer. Gordy continued, "This study shows that Embozene Microspheres embody that philosophy; reducing patients' symptoms while improving their quality of life. Color-coding improves patient safety while simplifying the job of those performing the procedure."