Multi-center clinical trial of MyoSure Hysteroscopic Tissue Removal System initiated

Mar 30 2010

Interlace Medical, Inc., today announced that it has initiated a multi-center clinical trial of the MyoSure Hysteroscopic Tissue Removal System. The purpose of this study is to demonstrate that women experience minimal to no pain or discomfort during a MyoSure procedure, when given a mild oral sedative together with a local anesthetic injected into the cervix. The study will enroll forty subjects at five sites who present with intrauterine polyps and/or submucosal fibroids 3 cm or less in size. Outcomes data will be submitted to a peer-reviewed journal for publication at the conclusion of the study.

"This study is an important step in determining whether the MyoSure treatment option is appropriate for use in a physician's office-setting where its use may provide scheduling convenience for physicians, reduced anxiety and a smaller co-pay for patients and cost savings for insurers. While the MyoSure System has demonstrated an ability to treat all sizes of sub-mucosal fibroids in an ASC or hospital outpatient setting, it's small diameter and ability to remove a 3 cm. submucosal fibroid in 10 minutes or less of cutting time may encourage gynecologists to offer MyoSure treatment to patients who prefer not to have general anesthesia for such a short procedure." said Bill Gruber President and CEO of Interlace Medical.

"I am extremely pleased to be part of this clinical study. As a practicing gynecologist it's important for me to offer my patients effective treatment options. MyoSure is an excellent option for treating abnormal uterine bleeding caused by submuscosal fibroids and polyps. It's safe, effective, and fast. Because no incision is required, patients experience little to no interruption from their daily lives." said Andrea Lukes, M.D., lead investigator.

Patient recruitment is underway at each site, with a planned study completion by the end of March, 2010. Sites include: Andrea Lukes, M.D.- Durham NC; Kelly Roy, M.D.-Phoenix, AZ; James Presthus M.D. Minneapolis, MN; Michael Diamond and James Berman M.D.- Michigan and Ken Konsker, M.D. - Boca Raton, FL.