Ultra Sonographic Perio Probe A painless way to

Ultra. Sonographic Perio Probe A painless way to monitor periodontal disease • Periodontal disease is the current challenge in dentistry –Tooth attachment destroyed in unpredictable site-specific pattern –Early stages of disease painless, so we don’t floss all that much –Treatment effective, but uncomfortable, expensive, uncovered • No reliable clinical indicators of disease activity: need Gold Standard –Mechanical probing inaccurate, subjective, slow, painful –Subtraction radiography only shows bone loss • Diagnostic ultrasound is widely used in other areas of medicine Visual Programs, Inc. Jack Singer (804) 399 -2552

“Oral Health in America: A Report of the Surgeon General” (NIH, 2000) Click on video at right to hear how the new US Probe uses NASA technology to painlessly monitor periodontal disease. Visual Programs, Inc. Jack Singer (804) 399 -2552

Ultrasonography in Medicine Click on video at right to hear how the new US Probe uses ultrasonography adapted from medicine. (Old version of probe shown in video. ) Echocardiography Examples Baby Face in the Womb Transrectal ultrasound of Prostate

Probe tip is placed at gum line with thin ultrasound beam projecting into tissues. Ultrasound Transducer Probe Handpiece Ultrasound waves in coupling water are focused inside of tip to a very thin beam Crest of periodontal ligament reflects ultrasound beam. Echoes are recorded by ultrasound transducer and then analyzed by computer expert system. Visual Programs, Inc. Jack Singer (804) 399 -2552

Probe CAD Drawing Water & Electronics Line Previous Version of Periodontal Probe:

Final Prototype Better balance and feel with contra-angling for easier use Industry standard “quick disconnect” for both cable and coupling water line

Ultra. Sonographic Periodontal Probe Transducer at base of tip sends & receives echoes Hollow tip focuses acoustic beam into periodontal tissues Integral magnetic position sensor. Quick disconnect for signal and couplant lines.

Probe Tips & Transducers

Probe tip is placed at gum line with thin ultrasound beam projecting into the periodontal tissues. Instrumentation is all contained within PC. Ours is currently in a ruggedized case for travel to the various clinical sites. Currently doing side-byside comparison to mechanical perio probing. Visual Programs, Inc. Jack Singer (804) 399 -2552

Easy to Use Computer Interface Will be integrated into practice-management software Footpedal starts flow of coupling water, records & archives data, increments

Conventional Manual Periodontal Probing • Not Sterile • Two people • Subjective • Inaccurate • Slow • Painful • Poor Patient Motivation

Slight flow of water is used to ensure coupling of ultrasound in and out of tissues. Probe tip placed at gum line. Click on the video at left to see the US Probe in use.

Distal-Buccal #31

Buccal #31

Mesial-Buccal #31

Patient motivation is enhanced by graphic output of US Probe: contours vs. numbers Click on the video above to hear about why the US Probe will be better at motivating patients for needed treatment. Visual Programs, Inc. Jack Singer (804) 399 -2552

Sorting out these complex waveforms is the hard part. We have several tens of man-years already invested. We know what works well.

Visual Programs Development Team: Medical College of Virginia College of William & Mary NASA Langley NESB Naval Dental School Old Dominion Univ. Hampton Roads Technology Incubator Applied Research Center National Institute of Dental and Craniofacial Research Center for Innovative Technology Click on the video above to hear more about patient motivation for treatment Visual Programs, Inc. Jack Singer (804) 399 -2552

Processed Waveform Raw Waveform Many waveforms can be “STACKED” to get the image below (left) Pseudo B-Mode Representation Hand Probing at the Same Sties

Funding and Facilities • NIDCR AREA Grant at W&M • CIT Challenge Grant & Matches • NIDCR Phase I SBIR Grant • Summer Faculty Grant at ODU • Early Support from NDS/NASA • Extensive Computer, Ultrasound and Laboratory Infrastructure William & Mary NDE Laboratory Mc. Glothlin-Street Hall (1250 sq. ft. ) Visual Programs, Inc. in Richmond NN Applied Research Center NDE Lab (575 sq. ft. ) & Offices

Immersion Tank & Micro-XYZ Scanner Immersion Tank & Clinical Scanner Prostate Clinical Mockup Scanner Lamb Wave Scanners

Ongoing Research Program ü Finish preparations for clinical tests (non-scanning) – Completed, including FDA and IRB approvals ü Do cadaver studies at W&M and compare to histology – Underway via NIDCR grant, jaw segments from NDS Bethesda ü Compare ultrasound to standard probing on humans – Getting a clear idea of significant barriers to competition – Beginning tailoring of AI software and refine instrument Ø Build and test scanning version of instrument – Both laboratory and clinical studies are planned Ø Second round of clinical studies to build AI software – Multiple instruments at multiple sites to speed everything up • Package hardware and software for Beta testing

Second Round Clinical Studies • Comparison to Mechanical Probing – Continuation of current work: multi-site • Scans Before Flap Surgery – Tri-Contour Maps of: gum line, CEJ, pocket • Scans Before En Bloc Surgery – 3 D Histology ala Visual Human • Condemned Teeth Scans Before Extraction • Fresh Cadaver Scans with Histology

IP and Regulatory Issues • Exclusive license to NASA base patent #5, 755, 571 • Expert system (AI) software and details of probe tip design/fabrication held as trade secrets not patents • Additional patent applications being filed in early ‘ 01 • Trademark name of probe and follow-on products • IRB and FDA research approvals at clinical sites Ø Straightforward because non-invasive, pain-free and no-risk Ø Have already done this at initial clinical sites, others similar • FDA premarket notification to be via substantial equivalence with diagnostic medical ultrasound Visual Programs, Inc. Jack Singer (804) 399 -2552

Financial and Market Projections • Establish market value with early adopters, leading to large dental supply firm buyout or IPO – Early adopters are gadgeteers. Early units will be more expensive (about $10 k). Market and manufacture in-house at 100 -1, 000/yr $1 M-$10 M/yr early sales. – Design for dentist acceptance to build market. ØAbout 400, 000 dental offices. – Technical partnerships being formed for Phase 2. Need larger distribution partner once value is established through niche sales. (Contacts already made) – Continue research funding through government grants, use internal and angel financing to begin manufacturing & distribution. Visual Programs, Inc. Jack Singer (804) 399 -2552

Financial and Market Projections • Sell technology on accuracy, lack of pain/patient turnover, office workflow, and visual feedback – Goal is to reduce cost to $1 k-$3 k and achieve widespread market penetration. – Design disposables into product (tip, charting paper, water couplant w/ prophylactic, software updates) to increase annual revenue. • Displacing manual probing biggest challenge – Controlled-force probes not serious competition – No other “exotic technologies” on the horizon (or beyond) Visual Programs, Inc. Jack Singer (804) 399 -2552

Expected Product Line • Base Model is Walking Probe – Smartly packaged version of current system • Mid-Range Model is Scanning Probe – Magnetic tracking allows continuous mapping • High-End Model is Imaging Probe – B-mode imager for perio offices & researchers • Many Follow-on Probes – Crack Finder, Root Assessor, Implant Checker – Interchangeable handpieces for perio probes

Proven Track Record of Dental Product Commercialization Visual Programs, Inc. Jack Singer (804) 399 -2552

Ultra. Sonographic Perio Probe A painless way to monitor periodontal disease • Periodontal disease is the current challenge in dentistry –Tooth attachment destroyed in unpredictable site-specific pattern –Early stages of disease painless, so we don’t floss all that much –Treatment effective, but uncomfortable, expensive, uncovered • No reliable clinical indicators of disease activity: need Gold Standard –Mechanical probing inaccurate, subjective, slow, painful –Subtraction radiography only shows bone loss • Diagnostic ultrasound is widely used in other areas of medicine Visual Programs, Inc. Jack Singer (804) 399 -2552