BIOSAFE Medical Technologies, Inc.

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The Future for Dentistry


Early detection
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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

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The First Article On Healthy Heart Dentistry and
In Office Blood Testing June 2007
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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.

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• 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

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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

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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

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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)

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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

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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.

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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.
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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.

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Laboratory Accreditation
The College of American Pathologists
accreditation is the highest national standard
program in the United States.
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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.

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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

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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.

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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.

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ORDER THE TESTS AT www.HealthyHeartDentistry.com
Dr. Ron Schefdore
Fax [phone] CELEBRITYSMILES_at_aol.com