Ongoing studies

Real Imaging has partnered with leading hospitals in Israel to conduct clinical studies and is planning to launch international clinical studies at the end of 2011.

All studies used prototypes of the RUTH (RI1, RI2, RI3, RI4) system, as explained below, at different stages of research and development, integrated with MIRA™ technology. All studies are conducted with prototypes of RUTH at different stages of R&D.

RI1	Single optical head
RI2	Single optical head, aperture adjustment
RI3	Single optical head, hardware based synchronization
RI4	Dual optical head

2 Ongoing studies

2.1 Protocol #960-PRL-09011: Collection of raw data of IR imaging for the purpose of developing a device for early detection of breast cancer.

• Study Objective: To evaluate the performance of the next generation of a MIRA™ technology prototype with a dual optical head. This system will also enable the imaging of the outer breast areas.
• Study Population: Women aged 18 years or older summoned for a screening test or a breast biopsy procedure.
• Investigational Device: RI4 MIRA™ technology.
• Study Design: Acquiring raw data of IR and visual images of the right and left breasts simultaneously, using a dual optical head allowing the view of both sides of the breasts.
• Number of subjects enrolled: ongoing
• Duration: September 2009 - ongoing
• Study Sites and Principal Investigators:
  Dr. Maya Cohen - Beilinson Medical Center, Israel
  Dr. Eli Konen - Sheba Medical center, Israel
  Dr. Tamar Sela - Hadassah Medical Center, Israel
  Dr. Myra Shapiro - Meir Medical Center, Israel
  Dr. Mona Rosin - Assuta Medical center, Israel
  Dr. Tanir Allweis - Kaplan Medical center, Israel