Personalized Breast Cancer Risk Management - · PDF fileTherapy for Menopause Market...
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Personalized Breast Cancer Risk Management Joel Ironstone – Founder Chief Executive Officer
Transcript of Personalized Breast Cancer Risk Management - · PDF fileTherapy for Menopause Market...
Personalized Breast Cancer Risk Management
Joel Ironstone – FounderChief Executive Officer
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Breast Cancer
Source:American Cancer Society, Inc. CDC Mortality Work Tables, 2006
Most prevalent cancer in women
1 in 8 women lifetime risk
50% increase in developing world
Most common cause of death in women 30-50
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Breast Cancer: One Size Does Not Fit All!
Who should start mammography screening?
Who can safely take Postmenopausal Hormone Replacement
Therapy (HRT) to manage their menopause?
Angie & Kathleen
Both 47 years old with
no family history of
breast cancer:
4-6x BC Risk Double BC Risk from HRT
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SenoSENSE Medical Value Proposition
Breakthrough device that will:
• Identify younger women at elevated risk so that they can begin early surveillance including mammography
• Monitor changes in breast cancer risk over time from hormone replacement therapy.
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The Problem:A woman who has
never had a mammogram
does not know her density
&due to radiation,
you can not repeat mammograms
.
Breast Density a Modifiable Risk Factor For Cancer
Fatty Breast Dense Breast
4-6 Cancer Risk!*
*Source: American Cancer Society Facts and Figures, 2012
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The Solution : The Electrical Breast Densitometer™ (EBD)
• Non-ionizing & non-invasive
• 60 second test performed by allied health professional.
• Cost/test ~ $30
• Complementary not competitive with mammo.
• Straightforward regulatory pathway – 510(k)
System
Controller
Disposable
Impedance
Sensor
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Compelling Clinical Study Results
*Interim results presented: Bukhanov et al, 2012:ASCO Breast Cancer Symposium
1. Results Are Reproducible & Precise (drug monitoring)
2. Can differentiate fatty from dense breasts (p<0.0001)
3. AUC, Sensitivity and Specificity all over 90%
0
50
100
150
200
250
300
350
400
<25% 25-50% 50-75% >75%IM
PED
AN
CE
(OH
MS)
BREAST DENSITY
Breast Density vs. Impedance
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SenoSENSE: Outstanding Progress to Date
• Company formed October 2011 (incorporated in Toronto)
• Progress to-date:
Raised ~ $100K (F-F) with which we:
– Designed and constructed functional prototypes
– Successfully recruited CE Mark clinical study(100 patients)
– Filed Patent Applications + Freedom-to-Operate and Patentability assessments
– Initial institutional customer (VIP Breast Imaging) secured
Seeking $500K Financing to European & Canadian Approval
(total financing requirement $4.0M to cash positive)
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SenoSENSE will improve the lives of Millions of Women
Women not currently being screened for breast cancer.
> 75M Women 25M Women (75M Annual Tests)
Drug Monitoring – Hormone Replacement Therapy for Menopause
Market Opportunity > $2.5B
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Initial Market Response
Survey done By Wulf Utian, Founder of NAMS, FACOG, MD:
•6/6 Expert Gynecologists would use
•Patients would pay out of pocket > $50
•Would conduct the test 2-3 times per year
•All have committed to be beta sites
“This would be a great tool to offer patients and would be well received.” John Sunyecz MD, Director, Menopause Rx Women’s Health, Uniontown, PA
“Currently the best we can offer is to find a cancer – this could be a step ahead.” Edward Linn MD, System Chair OB/GYN, Cook County Health System, Evanston, ILL
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Management Team: Strong Domain Experience
25+new products launched
including women’s health products
12 FDA submissions successfully
approved (including PMA)
>$250 millionof annual revenues generated
International and women’s health expertise/industry contacts
Joel Ironstone, Founder & CEOMedical Device Exec, 13 YearsJoel B. Weinstein Founder & CMOFounder of Hologic30+ Years C-level Medical DevicesPaul Chipperton, Ind. DirectorFounder, PMI. Adj. Prof, Queens
Judy Garber, Clinical AdvisorHarvard, Dana FarberPres. American Soc. for Cancer ResearchKevin Hughes, Clinical AdvisorSurgical Director, Breast Screening Program, Mass. General Karina Bukhanov, Clinical AdvisorMarvelle Koffler Breast Centre &Princess Margaret Hospital
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Solid Investment Opportunity with SenoSENSE
• Product that addresses huge unmet global needs.
• High product margins (highly profitable - razor/razor-blade model).
• Expedited development path.
• Straightforward regulatory and reimbursement pathways.
• Near-term exit potential, with anticipated first launch of product in 2014.
• Experienced management team that has “seen it all” and “done it all” in device space.
POTENTIAL TO SAVE LIVES!
Thank You
Personalized Breast Cancer Risk Management
For More Information ContactJoel Ironstone – Founder, [email protected]. 416.567.1147
