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Sweet Sensors

Glucose Monitor:                                                                 We have developed a
                                                                                 novel technology to use
• Widely available                                                               any glucose monitor
• Cheap                                                                          without modifications to
• Quantitative                                                                   detect a wide range of
  information                                                                    non-glucose targets at
• $10 billion market                                                             very low concentrations
                                                                                 (such as diseases (e.g.,
However, it can detect                                                           TB), heavy metal ions
only one target: glucose                                                         (e.g., Pb, Hg), organic
and at very high                                                                 toxins, bacteria, viruses
concentrations                                                                   and cancers)



                           Yu Xiang and Yi Lu, Nature Chem. 3, 697-703 (2011).
Business Model Canvas #2
                                                                                     Yi Lu, Tian Lan
                                            Sweet Sensors                            Neil Kane
                                                                                     Chris Sorensen



                      Conferences

                      Product R&D
Glucose monitor                             At home                                          Diabetics
                      QC                                          Product supports
    manufacturers
                                                                                             Clinicians (in rural area)
                      Marketing             Convenient            Patient
Kit manufacturers                                                 network/community          Triage nurses
                      FDA approval for in   Less exposure to
Reagent suppliers     vitro diagnostics     infectious diseases                              Pre-diabetics
                                            in the hospital

                                            Cheaper
                       KOL
                                            More frequent         Retailers (Walgreen)
                       IPs

                       Personnel            Better indicator of   Online vendors (Amazon)
                                            health (diabetic
                                            management)           Direct sales


                    Reagents

                    Manufacture
                                                                          Disposable test kit (used repeatedly
                    Licensing                                             on a regular basis)
                    FDA approval for in
                    vitro diagnostics
Missions accomplished
- VC/patient in China
- Juanzuo Zhou, manager in diagnostic product
distribution in a Chinese biotech firm
- Steve Mayor, M.D., ex-Abbott researcher
- Dr. Lisa Freeman, Veterinarian, Northern Illinois
Univ.
- Research on the FDA approval procedure
Key findings
From Steve Mayer:
    1. Systematically examination of a range of targets
    and pick a test that has NOT been done yet.
    2. Skeptical about going after a large volume market
    first; instead, should look at niche market with high
    value and establish dominance.
    3. Idea of IMMEDIACY.
      The result of the test should induce a immediate action, e.g.,
      food safety related and security related targets.

     hinted us to add an additional value proposition
    “immediacy” and the hypothetical customers
Key findings
From VC/patient (in China):
     4. Confirms the value of the test
     5. Concern of high cost to capture the market


From Lisa Freeman and Juanzuo Zhou:
     6. Opportunity for targets relate to food safety, such
     as melamine detection in raw milk and bacteria
     detection in farm or animal products
Key findings: FDA approval
                                                                     Same
                                                                     characteristics as
                                                                     the predicate
                                              Same intentioned
                                              use as the predicate   Has different
               Substantial equivalence                               technology
             test: as safe and as effective                          characteristics      510(k) fast
               comparing to an existing                              and information      track
                         device                                      submitted to
 Our                                                                 FDA
device
               Not substantial           510(k) approval             Does not raise
                 equivalent                  process                 new questions of
                                                                     safety and
                                                                     effectiveness; as
         1. 510(k): 5M and 1 year                                    safe and as
         2. 510(k) fast track: 50K and 6 months                      effective
Business Model Canvas #3
                                                                                     Yi Lu, Tian Lan
                                            Sweet Sensors                            Neil Kane            10-18-2011
                                                                                     Chris Sorensen



                      Conferences

                      Product R&D           Immediacy?
Glucose monitor                             At home                                          Diabetics
                      QC                                          Product supports
    manufacturers
                                                                                             Clinicians (in rural area)
                      Marketing             Convenient            Patient
Kit manufacturers                                                 network/community          Triage nurses
                      FDA approval for in   Less exposure to
Reagent suppliers     vitro diagnostics     infectious diseases                              Pre-diabetics
                                            in the hospital
                                                                                              Food safety and
                                            Cheaper                                           security related
                       KOL
                                            More frequent         Retailers (Walgreen)
                       IPs

                       Personnel            Better indicator of   Online vendors (Amazon)
                                            health (diabetic
                                            management)           Direct sales


                    Reagents

                    Manufacture
                                                                          Disposable test kit (used repeatedly
                    Licensing                                             on a regular basis)
                    FDA approval for in
                    vitro diagnostics
People we are talking to later this
                  week
1. Natalie Solomon, Senior Scientist, Abbott Labs
2. Peter Saravis, CEO, eVive Health
3. Norbert Riedel, Chief Scientific Officer, Baxter
4. Harlee Sorkin, entrepreneur with medical device
   expertise
5. Dr. Dan Derman, CEO of Northwestern Medical
   Physician's Group at Northeastern Hospital.
6. Diabetes patients support groups at Urbana Champaign
7. Karen Chapman-Novakofski, Professor@UIUC
Critical Success Factors
• Validation of the need
• Validation of the customer segmentation
• Evidence of market accessibility
• FDA regulation for in vitro diagnostics
   – Other applications that do not require FDA approval
• Other options that meet the immediacy criteria
   – E.g., melamine in raw milk (in China), bacteria in food,
     etc…

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Sweet sensors

  • 1. Sweet Sensors Glucose Monitor: We have developed a novel technology to use • Widely available any glucose monitor • Cheap without modifications to • Quantitative detect a wide range of information non-glucose targets at • $10 billion market very low concentrations (such as diseases (e.g., However, it can detect TB), heavy metal ions only one target: glucose (e.g., Pb, Hg), organic and at very high toxins, bacteria, viruses concentrations and cancers) Yu Xiang and Yi Lu, Nature Chem. 3, 697-703 (2011).
  • 2. Business Model Canvas #2 Yi Lu, Tian Lan Sweet Sensors Neil Kane Chris Sorensen Conferences Product R&D Glucose monitor At home Diabetics QC Product supports manufacturers Clinicians (in rural area) Marketing Convenient Patient Kit manufacturers network/community Triage nurses FDA approval for in Less exposure to Reagent suppliers vitro diagnostics infectious diseases Pre-diabetics in the hospital Cheaper KOL More frequent Retailers (Walgreen) IPs Personnel Better indicator of Online vendors (Amazon) health (diabetic management) Direct sales Reagents Manufacture Disposable test kit (used repeatedly Licensing on a regular basis) FDA approval for in vitro diagnostics
  • 3. Missions accomplished - VC/patient in China - Juanzuo Zhou, manager in diagnostic product distribution in a Chinese biotech firm - Steve Mayor, M.D., ex-Abbott researcher - Dr. Lisa Freeman, Veterinarian, Northern Illinois Univ. - Research on the FDA approval procedure
  • 4. Key findings From Steve Mayer: 1. Systematically examination of a range of targets and pick a test that has NOT been done yet. 2. Skeptical about going after a large volume market first; instead, should look at niche market with high value and establish dominance. 3. Idea of IMMEDIACY. The result of the test should induce a immediate action, e.g., food safety related and security related targets.  hinted us to add an additional value proposition “immediacy” and the hypothetical customers
  • 5. Key findings From VC/patient (in China): 4. Confirms the value of the test 5. Concern of high cost to capture the market From Lisa Freeman and Juanzuo Zhou: 6. Opportunity for targets relate to food safety, such as melamine detection in raw milk and bacteria detection in farm or animal products
  • 6. Key findings: FDA approval Same characteristics as the predicate Same intentioned use as the predicate Has different Substantial equivalence technology test: as safe and as effective characteristics 510(k) fast comparing to an existing and information track device submitted to Our FDA device Not substantial 510(k) approval Does not raise equivalent process new questions of safety and effectiveness; as 1. 510(k): 5M and 1 year safe and as 2. 510(k) fast track: 50K and 6 months effective
  • 7. Business Model Canvas #3 Yi Lu, Tian Lan Sweet Sensors Neil Kane 10-18-2011 Chris Sorensen Conferences Product R&D Immediacy? Glucose monitor At home Diabetics QC Product supports manufacturers Clinicians (in rural area) Marketing Convenient Patient Kit manufacturers network/community Triage nurses FDA approval for in Less exposure to Reagent suppliers vitro diagnostics infectious diseases Pre-diabetics in the hospital Food safety and Cheaper security related KOL More frequent Retailers (Walgreen) IPs Personnel Better indicator of Online vendors (Amazon) health (diabetic management) Direct sales Reagents Manufacture Disposable test kit (used repeatedly Licensing on a regular basis) FDA approval for in vitro diagnostics
  • 8. People we are talking to later this week 1. Natalie Solomon, Senior Scientist, Abbott Labs 2. Peter Saravis, CEO, eVive Health 3. Norbert Riedel, Chief Scientific Officer, Baxter 4. Harlee Sorkin, entrepreneur with medical device expertise 5. Dr. Dan Derman, CEO of Northwestern Medical Physician's Group at Northeastern Hospital. 6. Diabetes patients support groups at Urbana Champaign 7. Karen Chapman-Novakofski, Professor@UIUC
  • 9. Critical Success Factors • Validation of the need • Validation of the customer segmentation • Evidence of market accessibility • FDA regulation for in vitro diagnostics – Other applications that do not require FDA approval • Other options that meet the immediacy criteria – E.g., melamine in raw milk (in China), bacteria in food, etc…

Editor's Notes

  1. Team introduction, glucose meter for detection of targets other than glucose
  2. In the past week, our effort was focus on validating our customer segments. Is the diabetes market valid?
  3. The conversation with Steve Mayer hinted us that there is some other attractive market with a new value proposition, IMMEDIACY.
  4. The easy way is prove substantial equivalence, 50K, 6 months and can be carried out by a third party. If not, normal 510(k) process.