1. Reduction in Radiation DoseExposure Using Real TimeEye
Tracking Technology(ControlRad)Steven Nichtberger, MDChairman &
CEO
2. Disclosure Statement of Financial InterestWithin the past 12
months, I or my spouse/partner have had a
financialinterest/arrangement or affiliation with the
organization(s) listed below.Affiliation/Financial Relationship
Company Ownership/Chairman & CEO ControlRad Systems
3. Background Radiation is essential for interventions
Radiation exposure is associated with knownhealth risks for
patients and staff As procedures get longer and more complex,total
exposure is increasing despite incrementaladvances from
manufacturers to reduce dose Dramatic innovation is needed but
mustmaintain image utility and workflow
4. Each interventional fluoroscopy procedure exposesthe patient
and staff to between 250 and 3500 chest x-rays9Deterministic
StochasticDNAdamageReports ofL-side
braintumors3BreastCancerCataracts1-5 GyHair loss3-7 GyBurns6
GySources: 1. Mahesh, Mahadevappa. "Fluoroscopy: Patient Radiation
Exposure Issues."RadioGraphics. The Russell H. Morgan Department of
Radiology and Radiological Science, Johns Hopkins University School
of Medicine, 2001. 2. Cancer Research UK. "Patient
DoseInformation." Last reviewed: September 2008. 3. Cash, Kim,
Laxmaiah, Manchikanti, Moss, Tommy. Risk of whole body radiation
exposure and protective measures in fluoroscopically guided
interventional techniques: a prospective evaluation. BMC
Anesthesiol - NIH. 2003. 4.Mahesh, Mahadevappa. "Fluoroscopy:
Patient Radiation Exposure Issues."RadioGraphics. The Russell H.
Morgan Department of Radiology and Radiological Science, Johns
Hopkins University School of Medicine, 2001. 5. Picano, Eugenio,
and Eliseo Vano. "Abstract."National Center for Biotechnology
Information. U.S. National Library of Medicine, 2011. Web.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3256101/. 6. Brenner,
David, and Richard Doll. "Cancer Risks Attributable to Low Doses of
Ionizing Radiation: Assessing What We ReallyKnow." Cancer Risks
Attributable to Low Doses of Ionizing Radiation: Assessing What We
Really Know. The National Academy of the Sciences of the USA, 2003.
Web. . 7. Wall, and Russell. "The Application of
Cost-utilityAnalysis to Radiological Protection in Diagnostic
Radiology." National Radiological Protection Board, 1988. Web. 8.
Roguin, Goldstein, and Bar. Brain tumours among interventional
cardiologists: a cause for alarm? EuroInt 2012;7:1081-1086. 9.
Initiative to ReduceUnnecessary Radiation Exposure from Medical
Imaging. FDA, February
2010http://controlradsystems.com/controlradsystems/lib4.html
5. Current Approaches to Reduce Exposure Lead Head / axial
skeleton / exposed No protection for patients Orthopedic issues
Collimation Interferes with workflow and reduces context
Infrequently used during cases Incremental technical
innovations
6. The ControlRad SolutionUS Patents 8,445,878 &
8,754,388For patients, physicians, and medical staffexposed to
radiation during interventionalprocedures, our products will
dramatically reduceradiation dose and exposure while
maintainingacceptable image quality, workflow, and utility
ofexisting x-ray systems by delivering the rightamount of radiation
to the right spot at the righttimesupplementing any other
approach.5
7. CRS Solution: Automated radiation reduction by closing
theloop between an eye tracker and a dynamic collimatorAutomatic
reduction in radiationexposure up to
90%CameraImageIntensifierPatientCertifiedCollimatorFilterCRS
Certifiedeye-trackerX rayTubeCRSMonitorProprietarysoftwareSource:
Pietzsch et al., Review of U.S. Medical Device Regulation. Journal
of Medical Devices, Dec. 2007, Vol. 1, p. 283-292Resolution of
peripheral image will not appear diminished to operator in live
system blurring for dmonstration purposes only
8. Large Animal Pilot StudyThe first animal procedure using
amobile c-arm system equipped withthe ControlRad system
documenteddose reduction exceeding 60%1.71 As recorded by Stephen
Balter, PhD
9. Business Model Analogy: Intel Inside CRS sells c-arm
manufacturers the softwareand a license for use with CRS eye
trackersand CRS certified collimators CRS engineers collaborate
with third partiesto develop certified parts Regulatory approval is
integrated into routinec-arm system device filings by manufacturers
C-arm vendors offer the CRS product as anoption on their cath lab
and fluoro systems
10. Reduction in Radiation DoseExposure Using Real TimeEye
Tracking Technology(ControlRad)Steven Nichtberger, MDChairman &
CEO
