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BIOSAFE Medical Technologies, Inc.

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250 at Quest vial of blood and inconvenient ... 2002; 48(8) 1272-78. Special Issue: Cancer Diagnostics: Discovery and Clinical Applications. ... – PowerPoint PPT presentation

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Title: BIOSAFE Medical Technologies, Inc.


1
The Future for Dentistry


Early detection
2
Introduction
  • In early 2006 Dr. Ron Schefdore achieved CLIA
    certification to perform moderately complex,
    in-office, finger stick blood tests on his dental
    patients before and after periodontal treatment
    in the dental office. This was a first for a
    general dentist.
  • Today a better alternative is the use of FDA
    approved individually packaged tests avoiding
    lengthy and costly CLIA certification.
  • A patient consent form is contained in every kit.
    Lab accurate results are faxed to the dentist and
    mailed to the patient within 10 days

3
The First Article On Healthy Heart Dentistry and
In Office Blood Testing June 2007
4
WHY do blood screenings??
  • Improve the health of your patients and in some
    cases proven to save their life.
  • According to the ADA, as many as 72 of adults
    have periodontal disease. Research shows perio
    disease can elevate cholesterol, blood sugar, and
    C-Reactive Protein levels.

5
  • In the first year of incorporating the Healthy
    Heart Dentistry protocol and in office blood
    testing 20 periodontal patients of Dr.
    Schefdores were referred to their physician due
    to elevated levels of HbA1c, hsCRP, and/or
    cholesterol.
  • Early detection of high risk of heart
    disease/stroke, diabetes, prediabetes, systemic
    cancers, and more were diagnosed by physicians
    due to Healthy Heart Dentistry and In Office
    Blood Tests on these patients

6
Why do blood screening??
  • An opportunity to supply a new level of patient
    care setting you apart as an advanced, unique,
    and caring dental office
  • You will attract patients willing to pay for
    perceived better care
  • Local and national media attention
  • Referrals from other health care providers

7
In-Office screenings
  • Benefits
  • No special certification needed!
  • No large vials of blood.
  • Inexpensive and quick to take
  • Patient can take home or do in the office
  • Free shipping to our CAP accredited, and NCEP
    certified laboratory
  • Customized patient lab reports sent directly to
    your office and patients home
  • FDA approved, convenient, and easy to use
  • A patient consent form with every test kit

8
Laboratory Analyzed Tests
  • Diabetes Risk Assessment
  • (Instant and Hemoglobin A1c)-Fasting required
  • Hs C- Reactive Protein
  • (hsCRP)
  • Cholesterol Panel
  • (Total cholesterol, HDL,
  • LDL, and Triglycerides)
  • Fasting required)
  • Anemia Meter
  • (Other tests are available for personal use at
    healthyheartdentistry.com)

9
Convenient and Easy-to-Use

Test Kits Include
  • Laboratory Authorization Form-Patient consent
    form
  • 2 Single-use Lancets
  • BIOSAFE Enhanced Blood Collection Card
  • Alcohol Prep, Gauze Pad and Bandage
  • Easy-to-understand Instructions
  • Postage paid, Return mail Envelope


10
Processing and Reporting

  • Sample is received in the laboratory.
  • Sample is tested using technically advanced
    laboratory methods.
  • Lab Report is fax to dental office and mailed
    directly to patient.
  • Lab report includes NCEP interpretation.
  • Custom laboratory report allows direct messaging
    to consumers.

11
Enabling Technology
Dry Blood Specimen
Liquid Blood Specimen
Rapid Test
Our expertise in blood stability, blood
transportation, and self-collection brings
diagnostics closer to patients and consumers.
12
Service Area
  • Through the use of USPS delivery, Healthy Heart
    Dentistry can service all of North America from
    one centralized laboratory, reducing patient
    costs and standardizing lab results.
  • Samples can be shipped from the desert heat of
    Arizona to the coldest regions of Alaska without
    worry about specimen stability.
  • In addition, our laboratory has processed
    samples for patients in 27 other countries.

13
Laboratory Accreditation
The College of American Pathologists
accreditation is the highest national standard
program in the United States.
14
Readily Accepted
Consumer acceptance of finger-nick sampling over
that of a venous blood draw is overwhelming.
Here is the summary of an extensive Consumer
Survey
  • Patients prefer finger nick to venous blood draw,
    two to one.
  • 99 said the instructions were easy to read and
    understand.
  • 95 said the collection steps were easy to
    understand.
  • 98.5 said they would recommend a test to others.
  • 97 said they understood the health benefits of
    the test.
  • 72 said the results prompted them to see their
    doctor.

15
costs
  • 66 plus dentist markup for all 3 screenings--
    Cholesterol, HbA1c/ instant chair side glucose,
    and HsCRP
  • 250 at Quest vial of blood and inconvenient
  • 360 at the local Hospital-vial of blood and very
    inconvenient

16
Experience
  • Intellectual Property-BIOSAFE Patents Issued
  • 6,524,533 Device for Collecting and Drying a
    Body Fluid. Issued 2/25/03.
  • 6,454,202 Method for Stabilizing Amino
    Transferase Activity in a Biological Fluid.
    Issued 10/15/02.
  • 6,406,919 Whole Blood Collection Device and
    Method. Issued 6/18/02.
  • 6,216,022 Implantable Optical Measurement
    Device and Method for U sing Same. Issued
    4/10/01.
  • 6,187,531 Method for Correcting for Blood Volume
    in a Serum Analyte Determination. Issued
    2/13/01.
  • 6,176,371 Biological Sample Storage Package and
    Method for Making Same. Issued 1/23/01.
  • 6,040,135 Method for Correcting for Blood Volume
    in a Serum Analyte Determination. Issued
    3/21/00.
  • 5,709,699 Blood Collection and Testing Device.
    Issued 1/20/98.
  • Does not include patents pending.

17
Scientific Publications
  • Maggiore JA, Bui, TL, Grzeda BR, Pirucki TL,
    Batzel DA, Tyrrell SP. Development of a
  • whole blood collection, transport and test system
    for thyroid stimulating hormone. Clin. Chem.
    200147(S)A10. 
  • Grzeda BR, Bui, TL, Tyrrell SP, Maggiore JA.
    Comparison of capillary whole blood with serum
    results in the Hybritech Tandem-MP PSA assay.
    Clin. Chem. 200147(S)A135. 
  • Bui TL, Warner CN, Ildefonso J, Pirucki TL,
    Dewey LM, Maggiore JA. Development of a dried
    blood collection, transport and testing system
    for HDL-Cholesterol. Clin. Chem. 200248(S) A97.
     
  • Bui TL, Warner CN, Ildefonso J, Pirucki TL,
    Dewey LM, Maggiore JA. Development of a dried
    blood collection, transport and testing system
    for total cholesterol. Clin. Chem.
    200248(S)A98. 
  • Grzeda BR, Bui TL, Warner CN, Pirucki TL, Dewey
    LM, Maggiore JA. Development of a dried blood
    collection, transport and testing system for
    triglycerides. Clin. Chem. 200248(S)A106. 
  • Grzeda BR, Bui TL, Warner CN, Pirucki TL, Dewey
    LM, Babich M, Maggiore JA. Detecting and
    monitoring prostate cancer using a novel
    collection and analytical system. Clin. Chem.
    2002 48(8) 1272-78. Special Issue Cancer
    Diagnostics Discovery and Clinical
    Applications. 
  • Maggiore JA. Unsuspected hyperthyroidism. Tech
    Sample, ASCP Press. March 2003.
  • Dewey LM, Maggiore JA, Warner CN, Babich M.
    Assessment of the reference interval for
    thyroid stimulating hormone using the BIOSAFE TSH
    System. Clin Chem. 2003 49(S) A43.
  • Maggiore JA. Discordant hemoglobin A1c in a
    recent onset juvenile diabetic. Tech Sample, ASCP
    Press. April 2004.
  • Catalona WJ, Maggiore JA.  PSA, free-PSA testing
    is still a lifesaver.  Clinical Laboratory
    Products. 34(2) 2005.
  • Maggiore, JA. The clinical utility of total,
    free and complexed prostate-specific antigen in
    advanced metastatic prostate cancer. Tech
    Sample, ASCP Press. March 2005.

18
ORDER THE TESTS AT www.HealthyHeartDentistry.com
Dr. Ron Schefdore
Fax (630) 986 1524 CELEBRITYSMILES_at_aol.com
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