ultrasonographic 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

UltraSonographic Perio ProbeA painless way to monitor periodontal disease

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.


Ultrasonography in MedicineClick on video at

right to hear how the new

US Probe uses ultrasonography

adapted from medicine. (Old

version of probe shown in video.) Baby Face in the Womb

Echocardiography Examples Transrectal ultrasound of Prostate

Probe Handpiece

Ultrasound Transducer

Ultrasound waves in coupling water are focused inside of tip to a very thin beam

Crest of periodontal ligament reflectsultrasound beam. Echoes are recordedby ultrasound transducer and then analyzed by computer expert system.

Probe tip is placed at gum line with thin ultrasound beam projecting into tissues.


Previous Version of Periodontal Probe:

Probe CADDrawing

Water & Electronics Line

Industry standard“quick disconnect”for both cable and coupling water line

Better balance and feel withcontra-angling for easier use

Final Prototype

UltraSonographic Periodontal ProbeUltraSonographic Periodontal Probe

Hollow tip focusesacoustic beam intoperiodontal tissues

Quick disconnectfor signal and

couplant lines.

Transducer at base of tipsends & receives echoes

Integral magnetic position sensor.

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-by-

side comparison to mechanical perio probing.


Easy to Use Computer InterfaceWill 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

Click on the video at left to see the US Probe in use.

Slight flow of water is used to ensure coupling of ultrasound in and out of tissues. Probe tip placed at gum line.

Distal-Buccal #31

Buccal #31

Mesial-Buccal #31

Lingual face/Mandible #1 / Tooth #31

31

2mm4mm

11mm

Depths indicated by mechanical probing. Contour uncertain.

31

Depths and contour indicatedby acoustic probing2mm

4mm

11mm Click on the video above to hear aboutwhy the US Probe will be better at

motivating patients for needed treatment.

Patient motivation is enhanced by graphicoutput of US Probe: contours vs. numbers


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 VirginiaCollege of William & MaryNASA Langley NESBNaval Dental SchoolOld Dominion Univ.Hampton Roads Technology IncubatorApplied Research CenterNational Institute of Dental and Craniofacial ResearchCenter for Innovative Technology

Click on the video above to hear more about patient motivation for treatment


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Pseudo B-Mode Representation Hand Probing at the Same Sties

Many waveforms can be “STACKED” to get the image below (left)

William & Mary NDE LaboratoryMcGlothlin-Street Hall (1250 sq. ft.)

NN Applied Research CenterNDE Lab (575 sq. ft.) & Offices

Visual Programs, Inc. in Richmond

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

Immersion Tank &

Clinical Scanner

Immersion Tank &Micro-XYZ Scanner

Lamb WaveScanners

Prostate Clinical Mockup Scanner

Ongoing Research ProgramFinish preparations for clinical tests (non-scanning)

– Completed, including FDA and IRB approvalsDo cadaver studies at W&M and compare to histology

– Underway via NIDCR grant, jaw segments from NDS BethesdaCompare ultrasound to standard probing on humans

– Getting a clear idea of significant barriers to competition – Beginning tailoring of AI software and refine instrument

Build and test scanning version of instrument– Both laboratory and clinical studies are planned

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– 3D 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 sitesStraightforward because non-invasive, pain-free and no-riskHave already done this at initial clinical sites, others similar

• FDA premarket notification to be via substantial equivalence with diagnostic medical ultrasound


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 $10k). Market and manufacture in-house at 100-1,000/yr $1M-$10M/yr early sales.

– Design for dentist acceptance to build market. About 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.


Financial and Market Projections

• Sell technology on accuracy, lack of pain/patient turnover, office workflow, and visual feedback– Goal is to reduce cost to $1k-$3k 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)

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


•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

UltraSonographic Perio ProbeA painless way to monitor periodontal disease


ultrasonographic perio probe a painless way to monitor periodontal disease

Documents

new us probe

graphicoutput of us

coupling of ultrasound

old version of probe

jack singer804

ultrasound beam projecting

flow of coupling water

gum line