牙科創新：精選主題.pdf

1、Innovation in Dentistry:Select Topics2024 Exan SummitMay 16,20242Henry Schein Global Innovation CenterFounding Purpose in 2015:COE:Using gated process,perform diligence of healthcare innovations identify best opportunities map to 1+Henry Schein BUs(300 of them)for commercialization.R&D:”Skunkworks”s

2、oftware team develops innovative software solutions.Strategy/Expertise:Articles,lectures,company strategyOpportunity Sources:Hundreds of potential opportunities from company,suppliers(existing+prospective),customers,entrepreneurs,universities,research centers,investors,etc.Solutions of Interest:Clin

3、icalPractice ManagementSupply ChainSupply ChainClinicalPractice ManagementEfficienciesAutomationInventory+Auto-replenishImprove customer experienceMarketing IntelImagingIoT,NLP,RPMInfection ControlMaterialsDevicesDecision SupportEarly DiagnosticsOffice workflow,automationCloud/mobileIoT,Smart Dev.Ex

4、tensions for PM/EHRSupport3Agenda3Oral Cancer and Point-of-Care TestingMinimally-Invasive Dentistry:Demineralization+Remineralization2 23 31 1Artificial Intelligence:History and Technology,Use in DentistryGreen Solutions4 45 5Innovations for Periodontal Therapy4What is Artificial Intelligence?5What

5、is Artificial Intelligence?Machine Learning(ML)AI technology that learns through iterative use and self-improves the software.Clinical Decision Support(CDS)Systems that assists doctors in making diagnostic and therapeutic decisions more accurate,faster.Computer Vision AI-enabled software that“reads”

6、,analyzes,interprets images.Used with healthcare images,e.g.,radiographs,is a powerful clinical decision support tool.Natural Language Processing(NLP):Ability of software to understand/respond to voice and text.Generative AI:AI that generates/creates something on its own,typically in response to NLP

7、 query.Large Language Models(LLMs):ML models using immense amounts of data to predict the next token(text)based on the surrounding context.Gen AI depends on the use of these.Gemini,Bedrock and ChatGPT contain trillions of data elements.Software that mirrors,resembles human thought,reasoning;learns a

8、utonomously6What is Artificial Intelligence?Not really new Long history in books,movies,science fiction.Term originates 1955 proposal for 1956 Dartmouth conference.AI Automation:AI bases decisions on experiential learning(machine/deep learning).Presented with new situations,reasons to answer.Need fo

9、r AI in Healthcare:Provider,healthcare staff shortages Aging populations Need to project healthcare remotely Need to control/reduce cost Need to improve outcomes Alarming increases in chronic diseaseSoftware that mirrors,resembles human thought,reasoning;learns autonomouslyFirst Robot in Movie(1940)

10、Star Wars(1977)Isaac Asimov(1950)The Jetsons(1962)John McCarthyMIT,StanfordMarvin MinskyMIT7Generative AII asked GenAI about GenAI9AI:Hype vs.RealityButHype Outstrips RealityCannot approach complexity,power of human brain;wont for a very long time,if ever.Hasnt stopped people worrying about machines

11、 surpassing our intelligence,enslaving us.The Hype in 1968 2001:A Space Odyssey2001:A Space OdysseyThis is how we imagined AI in 1968.The HAL 9000*takes over the ship as survival mechanism.*Heuristically programmed ALgorithmic computerThe Hype in 2024The Reality in 2024 Interest/Use expanding rapidl

12、y10AI:Cyber Security A Double-Edge SwordAI Aiding CybersecurityAI Threatening CybersecurityTom Hanks Deep Fake of Him Promoting Dental PlanUS Senator Richard Blumenthal Hearing on AI(5.16.23)11The Technology Driving AI12AI and Computing:Beginnings Massive Computing Power:Massive computing power is a

13、pplied for this software to test results of inputs and outputs.High-Bandwidth Communications:Most AI solutions process data on cloud-based servers and deliver the results to local workstations and mobile devices.This requires very high-speed,low latency communications.Big Data:AI is dependent on hug

14、e amounts of data collected,parsed,stored,and exploited by its software to make decisions.Miniaturization:The ability to package intelligent processing into devices that are very compact.Neural Networks:Smart computer algorithms simulating how the human brain works;e.g.,simulating synaptic connectio

15、ns between the nerves in our brains.Machine and Deep Learning:An ability for AI systems to get smarter with experience with little or no human interaction.As data is accumulated,the systems learn which paths create the shortest and correct results and reprogram their systems.Critical that the data u

16、sed to train models is as unbiased as possible.Charles Babbages Analytical Engine(1822)ENIAC-First Programmable Computer(1945)IBM PC First IBM Microcomputer(1981)Apple 1 First Apple Microcomputer(1976)13AI:Key Technologies Massive Computing Power:Massive computing power is applied for this software

17、to test results of inputs and outputs.High-Bandwidth Communications:Most AI solutions process data on cloud-based servers and deliver the results to local workstations and mobile devices.This requires very high-speed,low latency communications.Big Data:AI is dependent on huge amounts of data collect

18、ed,parsed,stored,and exploited by its software to make decisions.Miniaturization:The ability to package intelligent processing into devices that are very compact.Neural Networks:Smart computer algorithms simulating how the human brain works;e.g.,simulating synaptic connections between the nerves in

19、our brains.Machine and Deep Learning:An ability for AI systems to get smarter with experience with little or no human interaction.As data is accumulated,the systems learn which paths create the shortest and correct results and reprogram their systems.Critical that the data used to train models is as

20、 unbiased as possible.1464-bit,32 CPU Cores,80 GPU Cores,5.8B transistors,3.5+GHz,128GB RAM,32TB SSD8-bit,1MHz,48K RAM,Cassette storageAI Technology:Increasing Computing Power8-bit,1 MHz,4k RAM32-bit,233MHz,32MB RAM,4GB HDD24-bit,6MHz,16MB RAM,20MB HDD16-bit,4.77MHz,16K RAM,5 1/4”Floppy 4-bit,1MHz,2

21、k RAM,32k Storage1 Billion x Storage;Power;MemoryApollo 11 Guidance Computer(AGC)An overload condition causing AGC to reboot.Note that Mission Control says this is only an issue if it recurs which it does,over and over.With 30 seconds of fuel left and the computer not working well,Neil Armstrong lan

22、ded the LEM on his own.15AI:Key Technologies Massive Computing Power:Massive computing power is applied for this software to test results of inputs and outputs.High-Bandwidth Communications:Most AI solutions process data on cloud-based servers and deliver the results to local workstations and mobile

23、 devices.This requires very high-speed,low latency communications.Big Data:AI is dependent on huge amounts of data collected,parsed,stored,and exploited by its software to make decisions.Miniaturization:The ability to package intelligent processing into devices that are very compact.Neural Networks:

24、Smart computer algorithms simulating how the human brain works;e.g.,simulating synaptic connections between the nerves in our brains.Machine and Deep Learning:An ability for AI systems to get smarter with experience with little or no human interaction.As data is accumulated,the systems learn which p

25、aths create the shortest and correct results and reprogram their systems.Critical that the data used to train models is as unbiased as possible.16AI Technology:Internet Bandwidth/Latency16250+Mbps+100ms latency300 bps+200 ms latencymore online speed(bandwidth)8 Gbps+70%diagnosed in stages III or IV.

26、51%5-year survival rate;those that survive suffer severe morbidity.Contributing Factors:Age(most 60+),family history,alcohol,tobacco,HPV,geography(50%of all cases in Asia),race(higher incidence in blacks,Hispanics).These Statistics are Tragic!How Do We Do Better?1World Cancer Research Fund Internati

27、onal154Oral Cancer+POC Testing in DentistryCurrent State:Dr.Manu Dua,33,dentist,Calgary,Albertano risk factors for oral cancer:non-smoker,athletic,healthy eaterDiscovers lesion on tongue“It cant be cancer.Im too young.”Endures surgeries,cancer spreading,33 rounds of chemotherapy and radiationDr.Paru

28、l Dua Makkar&Dr.Sanjukta Mohanta.When A Dentist Dies from Oral Cancer.December 2,2021.https:/ as lichen planus*Symptoms worsen;Biopsy reveals Stage 2 squamous cell carcinomaDies at age 34*Autoimmune dermatologic condition,presenting as white patches in oral cavity55Oral Cancer+POC Testing in Dentist

29、ryCurrent State:Dr.Sigmund Freud,Father of PsychoanalysisReproduced from The Oral Cancer Foundation websiteIn 1923,when he was 67 years old,Freuds very heavy cigar smoking began to produce outward indications of the painful cancer that would kill him.Freud developed a growth in his mouth that later

30、turned out to be cancer of the soft palate.He waited years before showing anyone the growth in his mouth.An operation was eventually performed the first of thirty-three operations for cancer of the jaw and oral cavity which he endured during the sixteen remaining years of his life.At the advanced st

31、ages of his long disease,he had to use a special prosthesis,which covered the defect in his palate.He called this prosthetic appliance“the monster”.Freud died of oral cancer(physician-assisted)in 1939,at the age of eighty-three.He smoked until the end.56Oral Cancer+POC Testing in DentistryCurrent Sc

32、reening Methods:Standard of Care:Visual exam+palpation of lymph nodes.Recent Methods:Results using light fluorescence(e.g.,Velscope),brush biopsy(e.g.,OralCDx),etc.discouraging.MethodSensitivity%Specificity%Visual Exam6474Light-Based Device9316Brush Biopsy5229Vital Staining5039MRNA Lab Testing457257

33、Oral Cancer+POC Testing in DentistryNew Breakthroughs:New products coming online using genomics and proteomics.Capable of diagnosis in stage 0 or 1 when disease highly treatable and 5-year survival 90%.Minimally or non-invasive sampling using bodily fluids,including saliva.Results sometimes in minut

34、es.Tests run at the point-of-care or in lab.Very highly sensitive and specific.Inexpensive,often reimbursable.Survey of 15,000 Henry Schein customers very encouraging:80%will likely or definitely conduct the test,most without reimbursement.Slight preference for in-office vs.lab.58Oral Cancer+POC Tes

35、ting in DentistryHenry Schein and Oral Cancer Screening:Partnering with customers,especially large DSOs,universities,Henry Schein can uniquely,profoundly elevate the standard of care and save tens of thousands of lives.Changing the Paradigm Unique Opportunity for Dentistry:People tend not to visit t

36、heir physicians until/unless they dont feel well.With cancer,this often leads to late-stage diagnosis,poor outcomes.These same people see their dentist/hygienist 1-2x/year;running simple POC tests can catch oral/systemic disease early,when very treatable.Oral Cancer Screening:Two tests almost ready,

37、both sampled,using saliva,in practice,one run in a lab(Viome)and the other run in the practice(Vigilant).Other Tests:Additionally,a team of medical and dental TSMs*readying several other kinds of POC tests to be marketed to dental professionals.59Oral Cancer+POC Testing in DentistryHenry Scheins Ora

38、l Cancer Test Portfolio:Vigilant Biosciences BeVigilant OraFusionSample:Saliva,collected in practiceWhere Test Run:In-PracticeResults:12 minutesAvailability:After FDA clearanceRequires CLIA Certificate?YesViome Life Sciences Oral Health Pro+CancerDetectSample:Saliva,collected in practice or patient

39、homeWhere Test Run:In Viomes high-complexity labResults:1-2 weeks posted to portalAvailability:NowRequires CLIA Certificate?No60POC Testing:Vigilant BiosciencesIn-Practice Salivary Liquid Biopsy Oral Cancer ScreenBeVigilant Orofusion System:Non-invasive,biomarker-based rapid test for screening those

40、 at high risk for oral cancer run at POC.Components:Sample:Saliva,collected via simple oral rinse.Cartridge:Lateral flow.BeVigilant Reader:Immunochromatographic reader capturing test data.Improves accuracy.Where Run:In practice,at POC.Time to Run:Sample to results in 12 mins.Analysis:Uses AI+immunoc

41、hromatography.Results:Reports risk,not disease,as Low,Moderate,Elevated.If moderate or elevated Refer to OMS for biopsy.Performance:Sensitivity=95%;Specificity=95%Regulatory:US:Expect FDA clearance Q1 24;Requires CLIA waiverEU:Has CEVigilant Biosciences:Oral diagnostics company weve been working wit

42、h since 2014 with a singular focus on an FDA-cleared oral cancer screening test to market in the US and EU.61POC Testing:Viome Life SciencesIn-Lab Salivary Liquid Biopsy Oral Cancer ScreenOral Health Pro with CancerDetect:Oral Cancer:Non-invasive,biomarker-based rapid test for screening those at hig

43、h risk for oral cancer run in Viomes lab.Additional Tests:Other tests measuring markers for perio disease and risk,caries risk,aspects of oral microbiome.Time to Run:1-2 weeks.Analysis:AI-enabled RNA analysis(Metatranscriptomic).Performance:Sensitivity=95%;Specificity=95%Regulatory:FDA:Currently LDT

44、.Has FDA breakthrough.CLIA:No requirement as practice not running test.Results:Reports disease as early as stage 0.Results posted as report to secure portal.Negative:To patient,providerPositive:To provider;note to patient to consult doctor.Includes clear guidance on next stepsViome Life Sciences:Gen

45、etics company,founded by Naveen Jain,that has a set of products mostly for consumers to analyze their genetic make-up of gut flora and advising on health and wellness.62Oral Cancer+POC Testing in DentistrySurvey of 15,000 dental professionals very encouraging:75%will likely or definitely conduct the

46、 test,most without reimbursement.63POC Testing in Dentistry:HS PortfolioPOC Testing Portfolio for the Dental PracticeAssayNameManufacturerCLIA SpecimenLabCPTCDTOral Cancer+Oral HealthOral Health ProfessionalViome Life SciencesLDTSalivaY0296U(active later in 24)N/AHemoglobin A1CA1C NowPTS Diagnostics

47、WaivedWhole Blood-FingerstickN83036D0411Lipid Profile+GlucoseCardioChek PlusPTS DiagnosticsWaivedWhole Blood-FingerstickNLipid:80061Glucose:82948Lipid:N/AGlucose:D0412Lipid ProfileCardioCheckPTS DiagnosticsWaivedWhole Blood-FingerstickN80061N/AGlucoseGlucose 201 SystemHemocueWaivedWhole Blood-Finger

48、stickN82948D0412PT/NRmicroINR SystemiLine MicrosystemsWaivedWhole Blood-FingerstickN85610N/A64Cardiovascular&Diabetes ScreeningDental professionals may be the first touchpoint in the screening and referral of a patient suspected of having cardiovascular disease or diabetes.Why Is It Important to Tes

49、t?Individuals with diabetes are at increased risk and severity of oral diseases as well as an array of micro and macrovascular complications.Oral diseases are documented as affecting insulin sensitivity and blood glucose control which contribute to serious diabetes complications.Diagnosis and treatm

50、ent of dental infections is proven effective in protecting patients with diabetes,resulting in reduced hospitalizations.Periodontal disease is also one of the earliest complications of diabetes and is significantly associated with a risk of cardiovascular disease.In-Office TestingDiabetes Screening:

51、Two types of simple blood tests:glycosylated hemoglobin(HbA1c)and serum glucose.CVD Screening:Medical History Form,Blood Pressure,Cholesterol level testing using a finger stick blood test.65Four Levels of Lab Tests High Complexity:Most stringent and highest test level Labs certified to run these tes

52、ts can run all tests at this level and below.Moderately Complex:One level below high complexity Many physicians offices are certified to run moderately complex tests.Labs certified to run tests at this level can also run tests designated below this level.Waived:Lowest level of test requiring ahealth

53、 care professional It is fairly straightforward for a health care professional to get certified.The tests were discussing here are mostly at this level.OTC:These are tests that can be run in a practice or in a home.66Running Tests in the Practice vs.Sending to a LabSome dental professionals will be

54、more comfortable with collecting the sample and sending it to a lab for running the test;others will want to collect the sample and run the test completely in the practice.Further,as dental professionals will rarely be certified to run tests higher than waived,tests designated as moderately or highl

55、y complex must be sent to a certified lab to be run.Traditionally,tests run by complex analyzers in labs have been more accurate and the decision to run them in the practice vs.the lab has been a trade-off between convenience,cost,and speed vs.higher accuracy.Today,new POC tests run in the practice

56、can often rival the performance of lab-run tests while not sacrificing the convenience.67Running Tests in the Practice vs.Sending to a LabWhats important to appreciate is that CMS(Center for Medicare and Medicaid Services)considers any place a test is run to be a lab.When running a waived test in a

57、dental practice,you are operating as a CLIA certified lab and,as noted above,must have a CLIA Waived certificate.Generally,collecting a test sample requires no special certification,i.e.,a licensed health care professional can collect the sample irrespective of the designation of the test.If you wis

58、h to only collect samples and send them to a laboratory to be run,you do not need a CLIA certificate,as you are not operating as a lab.Said another way,the certification of tests has only to do with the running of tests,not the collection and transfer of test samples.*See next slide for more informa

59、tionabout CLIA licensing.68Minimally Invasive Dentistry:Demineralization/Remineralization69Minimally Invasive Dentistry:Demineralization+RemineralizationWhat This Is:Several new diagnostic and therapeutic dental products coming online helping drive wellness,prevention,reversal of dental decay,better

60、 outcomes,reduced cost,increased revenues.Products require little to no use of rotary instruments or local anesthesia.Provide new ways for dental professionals to effectively treat early caries,providing a new standard of care that is superior to“watching”and waiting.70Minimally Invasive Dentistry:D

61、emineralization+RemineralizationProblem to be Solved:Incipient demineralization and decay leads to tooth decay.Young people,especially,lose tooth structure due to poor OH compliance,sometimes related to orthodontic therapy.Solution:Detect incipient/early signs of demineralization and decay.Use remin

62、eralization agent to naturally arrest decay rebuild enamel.Using both technologies together enables a patient-friendly,non-invasive,reimbursable method of quickly finding areas of demineralization(incipient caries)and treating painlessly for permanent solution that requires no anesthesia,no drilling

63、 of teeth.Detection of DemineralizationRemineralization71Minimally Invasive Dentistry:Demineralization+RemineralizationStep 1 Detect Demineralization:Concept:Technology to identify incipient caries(caries only in enamel)Incisive Technologies Bluecheck:FDA-cleared paint on liquid that turns areas of

64、demineralization blueCaviSense Toothpick:Quick,inexpensive,single-use-turns yellow when pH 5.5.CALCiViS:FDA-cleared Imaging system using recombinant DNA technology to fluoresce demineralization.Dentrix Detect AI:Our current solution identifies caries on radiographsWe will work on button to filter ou

65、t all but incipient lesions to show providers,patients where areas of demineralization exist and can be treated immediately with remineralization agent.Detection of DemineralizationCaviSenseCALCiViSBluecheck72Minimally Invasive Dentistry:Demineralization+RemineralizationCavities can be prevented wit

66、h remineralization if caught early,however later stage white spots do not respond well,and so fluoride has a lesser effect.But the earliest stages are invisible(“pre-visible”)clinically,precluding early interventionHealthyReversiblePre-visibleVisibleEarliest cariesWhite spotCavityCaries progression(

67、demineralization)Caries reversal(remineralization)?73Minimally Invasive Dentistry:Demineralization+RemineralizationStep 2 Remineralization:Product:Curodont Repair Fluoride PlusRegulatory:FDA 510(k)-cleared paint-on solution.Only solution FDA allows claim of remineralization+regeneration of enamel.Se

68、veral states allow application by assistants.Reimbursement and Economics:As of Jan.,24:New CDT code.Avg.reimbursement expected$70-$150/tooth.Payers anxious to support:Long-term,low-cost preventive solution increasing health,is minimally invasive,washes cost out of system.In combination with deminera

69、lization detection offers patients and providers easy,painless,permanent solution for incipient caries.Remineralization74Green Solutions75Green Solution InnovationsTerracycleTerracycle designing custom program for Henry Schein to market custom-branded green“Zero Waste”disposal boxes for practices.Ho

70、w it Works:Patients encouraged to bring old toothbrush,floss containers,toothpaste containers to hygiene appointments and toss them in the box.Also used for PPE.Practice gives patient new toothbrushWhen box full,Terracycle picks it up,responsibly disposes.Terracycle uses plastics from toothbrushes t

71、o develop community playgrounds and brands to Henry Schein and practice.76Green Solution InnovationsPADM Medical:FDA 510(k)-cleared biodegradable surgical mask,completely disintegrates after disposed of in 4 weeks.Rated to ASTM level 3.77Kona Ozone Disinfectant FaucetChanges plain tap water into aqu

72、eous ozone effective against almost all gram+and gram-pathogens,viruses,mold,mildew.Harmless to usPassively removes biofilm from sink and drains.Disinfects sponges and cleaning cloths.Helps eliminate plastic bottle and nylon wipe waste.Attached to any sink in minutes.FDA class 1 device;EPA registere

73、dProduces 1,080,000(10,000 hours)gallons at estimated thousandth of a cent per gallon.78Background:Created,for the US-govt in response to Sarin gas(Nazi nerve gas)attack in Tokyo subways on March 20,1995,which killed 12 and harmed 1,000.Product:Non-porous surface disinfectant active 7-log kill(highe

74、st possible;99.99999%)kills wide array of bacteria,viruses,biofilms.Far more effective and far less toxic vs.Cavicide.Non-toxic(to humans),non-corrosive,biodegradable.Deployed as spray,foam,fog.Water-based,in 3 parts,mixed on-site.Decon779Innovations in Periodontal Treatment80Perio InnovationsSoften

75、ing TartarEarly-stage companies that create professional-use products that soften/dissolve tartar.The products are considered FDA-exempt for supra-gingival use but require 510(k)for use sub-gingivally.Periodontis TherapeuticsStart-up companies developing periodontal disease therapies for moderate to

76、 severe periodontitis.Consists of cleaning root surface with special bur,then putting specially-formulated paste in sulcus,then gluing it shut with cyanoacrylate.Unlike Arrestin or SRP or surgery,these therapies aimed at not only stopping infection but rebuilding the attachment.Product needs FDA and will be submitted,probably,EOY81Questions?Thank You