Adiana, Inc. Reports Completion of Treatment Phase of EASE Transcervical Sterilization Trial
REDWOOD CITY, California, May 9, 2005 - Adiana, Inc. reported today that it has successfully completed all treatments in the EASE clinical trial. The EASE (Evaluation of the Adiana system for Sterilization using Electrothermal energy) trial is an investigation of the safety and effectiveness of Adiana's permanent transcervical contraceptive technology.
A total of 612 women were treated with the Adiana system at 14 centers in the United States and two international centers. The average treatment time was 12 minutes and physicians were able to successfully place the device bilaterally in 95% percent of the study's subjects. There were no serious device-related adverse events during treatments and no unusual or unexpected reports of discomfort, pain or bleeding during subsequent wearing. In nearly 4,800 women-months of reliance on the device for contraception (the approximate equivalent of 100 women relying upon the device for contraception for four years), there has been just one reported pregnancy in a patient with properly placed devices.
Ted Anderson, MD, PhD of Nashville, Tennessee said, "the Adiana system is fast, simple and easy to use and I completed several treatments in less than six minutes. I was able to place the devices successfully in 52 out of 53 patients." James Presthus, MD of Minneapolis, Minnesota concurred, "I performed all Adiana procedures in my office where patients are far more comfortable than in an intimidating operating room. They liked the fact that, in most instances, I was able to complete the procedure with only over the counter medicine and local anesthetics." Noting the significance of the Adiana implant residing entirely within the patient's fallopian tube, Alan Johns, MD of Fort Worth, Texas remarked "because women sometimes require other interventions later in life such as endometrial ablation or in vitro fertilization, not having metal extending into uterine cavity may be an important advantage for the Adiana system when considering other devices."
The Adiana technology is a catheter-based system that delivers sixty seconds of temperature-controlled radiofrequency energy to each fallopian tube followed by placement of a soft, porous biomaterial matrix that is smaller than a grain of rice. The catheter is delivered through a thin hysteroscope that is placed through the vaginal canal and into the uterine cavity. Unlike traditional laparoscopic tubal ligation surgery, there are no incisions and treatments can be performed utilizing local anesthesia in a doctor's office. The EASE Trial is evaluating safety and the ability of the Adiana system to successfully occlude fallopian tubes and prevent pregnancy.
It is important to note that this is an interim report of preliminary results only. Additional patient follow up is on-going and a complete data set, including long term follow-up on all 612 women, will be required for the final data submission to the United States Food and Drug Administration.
Adiana, Inc. is a private company that is currently developing a proprietary non-incisional technology for permanent contraception for women. The Adiana system is an investigational device and is not available for sale in the United States.