MIST Inc_preliminary market assessment

MIST, Inc:
Breast Cancer Therapy Monitoring Market
Assessment
!
Medical Care & The Corporation
November 2009
Rosa Hong
Boyd Lever
Laura Nieskens
Sam Stearns

MIST, Inc: Breast Cancer Therapy Monitoring Market Assessment
EXECUTIVE SUMMARY 3...........................................................................................................
BACKGROUND 4............................................................................................................................
PROJECT OBJECTIVES 5............................................................................................................
METHDOLOGY 5...........................................................................................................................
PATIENT WORKFLOW 6..............................................................................................................
MARKET SIZING 10......................................................................................................................
CUSTOMER ECONOMICS 13......................................................................................................
RECOMMENDED MARKET PENETRATION STATEGIES 14..............................................
CONCLUSION 16............................................................................................................................
APPENDICES 18..............................................................................................................................
Appendix 1: Physician Interviews 18....................................................................................
Appendix 2: Physician Interview Guide 19.............................................................................
BIBLIOGRAPHY 20........................................................................................................................
Medical Care and The Corporation 2

EXECUTIVE SUMMARY
MIST, Inc. is a start-up company that has developed a microwave imaging technology to
improve the efficacy of breast cancer screening, diagnosis, and therapy. MIST is considering
forming a separate spin-off entity to address the market for monitoring the treatment of
patients undergoing neoadjuvant chemotherapy (NACT). This study assesses the potential of
the breast cancer therapy monitoring market. Our analysis presents findings on the patient
workflow, market size, and financial viability of therapy monitoring.
Methodology
We conducted extensive primary and secondary research to assess the market for breast
cancer therapy monitoring. Since NACT is a relatively new treatment, standard treatment
protocol is not consistently applied and there is no published information available on the
market size. We interviewed sixteen physicians — including medical oncologists, surgical
oncologists, and radiologists — to develop an understanding of the patient workflow and
quantify the size of the market. Results from these inputs were used in a customized market
sizing model that forecasts the size of the market through 2014. We also used this information
to analyze the financial viability of a dedicated therapy monitoring imaging device from a
customer (hospital) perspective.
Results
We believe the therapy monitoring market is too small to support a stand-alone company. We
estimate the current size of the therapy monitoring market is $6.2M in 2009, growing to
$14.8M in 2014. The key barrier to adoption is the limited usage of NACT. Currently, NACT is
the standard of care for patients with inflammatory breast cancer (4% of total patient
population), and is also administered to between 17% and 100% of patients with Stage III
breast cancer, depending on local treatment protocols. Based on the current market size, and
the presence of competing imaging modalities (e.g., MRI, PET), a stand-along imaging device
dedicated to therapy monitoring would only be economically attractive to the highest-volume
hospitals.
Recommendation
To bring the MIST technology to market, we believe that MIST should pursue screening, the
largest breast cancer application. MIST pursued this application several years ago, but was
dissuaded by the need for expensive clinical trials. We suggest that MIST explore alternative
ways to bring the technology to market, including licensing its technology to more established
imaging providers, pursing grants from the National Cancer Institute, and engaging patient
advocacy groups for support and potential funding.
Medical Care and the Corporation 3

BACKGROUND
Microwave Imaging System Technologies, Inc. (MIST) was founded in 1995 by Dr. Keith Paulsen
and Dr. Paul Meaney of the Thayer School of Engineering to commercialize research in
microwave technology. The company’s mission is to improve the efficacy of breast cancer
screening, diagnosis, and therapy. Supported by a $6M Phase II SBIR Grant investment from
The National Institutes of Health (NIH), MIST has developed a microwave-based breast imaging
system which provides high-contrast images for breast cancer applications. The MIST device
provides similar performance to competing modalities, is more comfortable than
mammography, and cheaper and less invasive than both MRI and PET. MIST’s proof-of-concept
device has been demonstrated on more than 150 patients at Dartmouth-Hitchcock Medical
Center (DHMC).1
The breast cancer market can be divided into three segments: screening, diagnostics, and
therapy monitoring. Between 2004 and 2006, MIST hired a CEO and sought financing to pursue
the breast cancer screening market. In 2006, these efforts were supported by a project team
from the Medical Care and the Corporation course at Tuck, which articulated the value
proposition of using the MIST device in therapy monitoring. This work was incorporated into2
the MIST business plan as a potential secondary market, but the size of the market was not
determined.
As a result of these efforts, MIST soon found that screening was a difficult market for a
startup to penetrate, due to the amount of investment needed to conduct a clinical trial. The
current standard of care in the diagnosis market is biopsy, which is unlikely to be displaced
due to the high precision and accuracy of this procedure. To move forward, the founders of
MIST have been considering creating a separate entity to address the market for breast cancer
therapy monitoring. This potential application uses imaging techniques to monitor the
response to a course of NACT (chemotherapy applied prior to surgery). The therapy
monitoring market has less competition from alternative modalities, like mammography, and
requires lower investment in clinical trials.
Dartmouth Entrepreneurial Network: Microwave Imaging System Technologies. Retrieved 1 November1
2009 from www.dartmouth.edu/~denet/startups/profiles/MicrowaveImagingSystemTechnologies.htm
Crawford, Stacy; Stephen Keel, and Sarah Ketchum. “Microwave Tomographic Imaging for Monitoring2
Tumor Progression During Neoadjuvant Chemotherapy.” 15 November 2006.

PROJECT OBJECTIVES
The goal of this project is to assess the market for breast cancer therapy monitoring, and
recommend the best approach to penetrate the market. Specifically, our goal is to answer the
following questions related to the patient workflow, market sizing, and market penetration
strategies:
• Patient workflow
o What are the standards of care for treating breast cancer patients with NACT?
o Who are the key decision makers in the treatment planning process?
• Market sizing
o What is the current size of the breast cancer therapy monitoring market?
o How fast is this market expected to grow over the next five years?
• Market penetration strategies
o Is the therapy monitoring market an attractive opportunity for MIST?
o What course of action should MIST pursue in order to bring its device to
market?
This project is expected to contribute to a full business plan to be completed by MIST.
METHDOLOGY
Given the novelty of our research topic and the absence of widely accepted standards of care
regarding the use of NACT, we focused our efforts on conducting primary research. We
interviewed medical oncologists, surgical oncologists, and radiologists. We contacted over 60
physicians at over 40 medical centers, and were able to interview 16 of them. While the
majority of our contacts were from academic medical centers in the Northeast, we also spoke
with physicians at community centers in other regions of the country. A list of interviewees as
well as the interview guide can be found in the Appendix.
Our primary research was supplemented with secondary research, consisting of medical
journals, scientific articles, and the National Comprehensive Care Center’s clinical guidelines
for treating breast cancer. While these sources were helpful in framing some of the issues3
associated with NACT, we found the physician interviews to be most influential in shaping our
understanding of the patient workflow and market size.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology, Breast3
Cancer, V.1.2010.

We used the results of our primary and secondary research as inputs into a customized market
sizing model that projects the size of the breast cancer therapy monitoring market, in
patients, scans, and dollars over the next five years. Using this model, we performed
sensitivity analysis on two key uncertainties: price per scan, and penetration among patients
with Stage III breast cancer. We also analyzed the economic attractiveness of the device to
several types of providers, using published data on breast cancer volumes.
PATIENT WORKFLOW
As illustrated in Figure 1, four types of physicians are involved in the diagnosis and treatment
of breast cancer.
Figure 1: High-Level Breast Cancer Treatment Workflow
Given that our project centers on evaluating the NACT market, we focused our efforts on
understanding the patient flow after diagnosis. To understand each part of the workflow in
more detail, we interviewed surgical oncologists, medical oncologists and radiologists. Key
insights from our discussions are outlined below.
Surgical Oncologists and Medical Oncologists
Medical and surgical oncologists, the physicians responsible for treatment planning, prescribe
NACT for two reasons. Primarily, NACT is used as a cancer control measure that prevents
“distal failure,” the spread of cancer to surrounding organs from the breast. Secondarily,
NACT is used to downstage the size of the breast tumor(s) to potentially prevent mastectomy,
or full breast removal, in favor of lumpectomy, a less-invasive surgery resulting in partial
breast removal.

Given these reasons for treatment, NACT is considered useful for two classes of women.
Women with inflammatory breast cancer (IBC), a rare and aggressive disease that blocks the
lymph vessels in the skin of the breast, always receive NACT. In addition, women with Stage III
breast cancer, which is characterized by locally advanced tumors, are considered for NACT.
The women with Stage III breast cancer who typically receive NACT are the elderly, who are
not candidates for mastectomy given the fragility of their health, or those women involved in
clinical trials.
Apart from IBC and Stage III patients, NACT is not part of the current standard of care for
breast cancer patients. This lack of protocol creates significant variation in NACT utilization
across different hospitals. The estimates collected from our physician interviews ranged from
10-20% at Dartmouth-Hitchcock Medical Center in New Hampshire and Danbury Hospital in
Connecticut, to 30% at M.D. Anderson Medical Center in Texas, to 40-60% Cancer Care
Northwest in Washington.
Part of this variation in NACT utilization could be due to the sequence of treatment planning
process at the cancer centers. An oncologist at Cancer Center Northwest explained that at her
clinic, surgeons and medical oncologists work together on an integrated care team to
determine which treatment regime will work best for the patient. As a result, NACT
utilization rates are relatively higher than those at other clinics. At other centers, patients
are routed directly to surgery after a biopsy detects cancer, and thus the decision to give the
patient NACT is never considered.
Future Expectations for the Market
Surgical and medical oncologists expect growth in the number of patients receiving NACT for
three reasons: shifting patient demographics, pending research regarding improved survival
benefits, and logistical issues associated with scheduling breast reconstruction surgery.
Breast cancer disproportionately affects older women. From 2002-2006, the average age of
diagnosis was 61. Whereas only 10.5% of women diagnosed are between the ages of 35 and4
44, 23.7% are diagnosed between the ages of 55 and 64. As the baby boomers reach5
retirement age, an increased number of women will fall into this higher risk pool. As
discussed previously, elderly patients are more likely to utilize NACT than younger patients,
National Cancer Institute, “SEER Cancer Statistics Review, 1976-2006”.4
Ibid.5

due to other preexisting conditions that make mastectomy infeasible. For example, if a
woman has a weakened heart, she may not be a candidate for mastectomy, and therefore
NACT is required to downsize the tumor.
In addition to the changing demographics, the results of pending research regarding improved
survival benefits could increase NACT usage. I-SPY 2 is a collaborative effort among the
National Cancer Institute, academic investigators, the US Food and Drug Administration, and
the pharmaceutical and biotechnology industries to predict therapeutic response to
chemotherapy regimens with imaging and molecular analysis. The study is being conducted in
an “adaptive phase II clinical trial design in the neoadjuvant setting for women with locally
advanced breast cancer.” While the results of the study are not yet conclusive, many of the6
oncologists we spoke with believe that it is likely to demonstrate that NACT provides
additional survival benefits over adjuvant chemotherapy.
Finally, increasing logistical challenges associated with scheduling breast reconstruction
surgery may lead to an increase in NACT usage. A single breast reconstruction can take six to
eight hours, and a bilateral reconstruction between ten and twelve. Given the time required
to perform these operations, surgeons generally schedule their time months in advance. Many
women who want to have reconstruction book it and opt for NACT in the meantime.
Radiologists
There was some variety in the use of monitoring therapies across the radiologists we
interviewed. While there was consensus that patients would receive an initial screening
before beginning NACT, there were disparate views regarding whether this patient would be
monitored using an imaging modality during the chemotherapy regime.
Pre-NACT imaging
Before beginning a NACT regime, medical oncologists order a baseline imaging test to
determine certain characteristics of the tumor, such as size and exact location. It is important
to obtain this baseline information before chemotherapy begins so that the medical team will
be able to determine who the tumor has responded to the treatment.
Mid-cycle imaging
Very few radiologists recognize the value in mid-cycle imaging. While one radiologist
explained that he conducts mid-cycle imaging on approximately 30% of his patients, the
Barker, AD, CC Sigman, GJ Kelloff et all. “I-SPY 2: An Adaptive Breast cancer trail Design in the Setting6
of Neoadjuvant Chemotherapy”. Clinical Pharmacology & Therapeutics (2009) 86. 97-100

majority of radiologists we spoke with did not find this necessary. For women with large
tumors, changes can often be detected through a clinical exam, instead of through imaging.
For most women, surgery is the end goal, and because of this some radiologists believe that
the additional cost associated with mid-cycle imaging cannot be justified.
Post-NACT imaging / Pre-operative imaging
Among the radiologists we interviewed, there seemed to be consensus on the purpose of pre-
operative imaging: it allows the surgeon to have advanced information about the quantitative
characteristics of the tumor. Because the rationale for NACT is often to downstage the tumor
so that the patient can receive a lumpectomy rather than a mastectomy, it is important for
the surgeon (and the patient) to know the extent to which the chemotherapy has been
successful in achieving this end.
A Journal of Clinical Oncology study found that mastectomy candidates who receive NACT are
8% more eligible for lumpectomy (67.8% vs. 59.8%). It is interesting to note, however, that7
the medical community is starting to see an increase in the percentage of women who elect
the more invasive surgery, even after they become eligible for a lumpectomy. Among younger8
women in particular, patients seem to be opting for the more aggressive surgery in order to
avoid the subsequent monitoring exams and potential recurrence that are associated with
lumpectomy. While it is unclear whether this trend will reverse in the future, it is clear that
the advanced information about the size of the tumor may be less important to the surgeon if
he will be performing the more aggressive surgery anyway.
MRI as the Modality of Choice
The therapy monitoring that accompanies NACT is used to determine the response of the
cancer to the treatment. While there was consensus that MRI was the best modality that is
currently available, radiologists are not completely satisfied with it. The most commonly
raised concerns are about false positives and false negatives. One radiologist mentioned a
recent patient whose pre-operative MRI showed that the tumor had decreased in size
substantially, creating a sense of relief for that patient. Upon operating on the patient,
however, the surgeon found that the tumor had fractured into multiple smaller pieces that
Fisher, Bernard, John Bryant, Norman Wolmark, et al. “Effect of Preoperative Chemotherapy on the7
Outcome of Women with Operable Breast Cancer.” Journal of Clinical Oncology, Vol. 16, No 8. August
1998. pp. 2672-2685.
Nelson, Roxanne. “Breast Cancer Patients Increasingly Opting for Mastectomy. Medscape Medical8
News. 1 August 2009.

had been dispersed throughout the breast. While this story is merely an anecdote, it reflects
a broader concern among radiologists that the information inferred from current monitoring
modalities may be inaccurate.
However, the role of monitoring is more dubious in its potential benefits: a U.K. study
analyzing the role of MRI in breast cancer found no significant benefit in terms of reducing
the reoperation rates in the six months following the initial procedure . This indicates that9
monitoring during NACT does not provide any data for surgical planning, but underscores the
reports that therapy monitoring is primarily used for biological information gathering on
tumor response.
Monitoring therapy as preference sensitive care?
Amid the fact that medical oncologists and radiologists see limited value in the use of
monitoring therapies, they did suggest that patients tend to be in favor of monitoring
imaging. Perhaps as shared-decision making practices become more widely adopted and the
patient has more influence over the type of treatment she receives, we will see an increase
in the use of monitoring therapy.
MARKET SIZING
In order to determine the relevant market size for the MIST device, we created a five-year
forecast for the breast cancer therapeutic monitoring market. Based on our analysis, we
estimate a market size of $6.2M in 2009, growing to $14.8M in 2014. The section below details
our methodology for this approach.
Our analysis was based on a number of assumptions about the expected changes in the market
drivers:
Turnbull, L. “Magnetic Resonance Imaging in Breast Cancer: Results of the COMICE Trial.” Breast9
Cancer Research, 10 (Supplement 3) July, 2008. pp. 10.

Figure 2: Market Sizing Assumptions
While the majority of our inputs are self-explanatory, our determination of the Stage III NACT
treatment rate, monitoring therapy penetration, and scans per patient per year warrant
further explanation.
Stage III NACT Treatment Rate
Our estimate of the current percentage of patients receiving NACT (17%) is based on the
compilation of our physician interviews. The majority of the physicians we spoke with
assumed that approximately 15-20% of all Stage III breast cancer patients receive NACT. While
the majority of the interviewees suggested that the utilization of NACT for Stage III patients
would increase, only Dr. Kaufman was able to give us a sense of the potential magnitude of
that growth. Dr. Kaufman suggested that in the future, he would expect approximately half of
all women diagnosed with Stage III breast cancer to receive NACT. The primary reason for this
increase includes the aging of the population, which will result in a larger proportion of cases
being inoperable at the time of diagnosis due to pre-existing health concerns (e.g. weak
heart, weak lungs). We assumed that NACT penetration for breast cancer patients would
increase linearly, from 17% today to 50% in 2014.
Monitoring Therapy Penetration
Almost all of the physicians we spoke with employed some form of monitoring for patients
receiving NACT. However, one physician at Massachusetts General Hospital reported that only
15% of the patients receive monitoring therapy. Other physicians also described the use of
Forecast Drivers Assumption Data Source
US Female Population 1% CAGR US Census Population Projection
Breast Cancer Incidence
(per 100,000)
123.31 (2009)
132.41 (2014)
American Cancer Society (2009);
Journal of Clinical Oncology (forecast)
% IBC Patients 4% Physician interviews
IBC NACT Treatment Rate 100% Physician interviews
% Stage III Patients 30% American Cancer Society
Stage III NACT Treatment Rate
17% (2009)
50% (2014)
Estimate from physician interviews
Monitoring Therapy Penetration 90% Estimate from physician interviews
Scans / Patient / Year 2 Estimate from physician interviews
Price per scan $200 June 2006 MIST Presentation

clinical exams for patients with particularly large tumors. Based on our research, we believe
that almost all patients undergo NACT receive some sort of monitoring. However, we used a
90% penetration assumption rate in our model to account for these two alternative
perspectives.
Scans per Patient per Year
As discussed earlier in this section, the majority of the medical oncologists we spoke with
order imaging prior to beginning NACT and at its completion. We counted both of these scans
as “therapeutic monitoring,” as we assumed that the MIST device could be used in both
instances.
Based on these assumptions, our market sizing model delivered the following results:
Figure 3: Therapy Monitoring Market Size ($000)
In order to test the sensitivity of our model to different assumptions, we evaluated scenarios
in which both the price per scan and the Stage III NACT penetration could increase
significantly. As Figure 4 illustrates, even with very generous penetration and pricing
assumptions, we estimate a total market size of approximately $132M in 2014. Given the
presence of an installed base of competing modalities, we believe it is unlikely for MIST to
realize the full market opportunity.
Patient Flow 2006 2007 2008 2009 2010 2011 2012 2013 2014
US female population (MM) 151.7 153.1 154.6 156.0 157.5 159.0 160.5 162.0 163.6
Growth rate 0.9% 0.9% 0.9% 0.9% 0.9% 0.9% 0.9% 1.0% 1.0%
Incidence (per 100,000) 123.04 123.15 123.24 123.31 125.23 127.10 128.92 130.69 132.41
Growth rate -0.9% 0.1% 0.1% 0.1% 1.6% 1.5% 1.4% 1.4% 1.3%
Number of patients (000s) 186.7 188.6 190.5 192.4 197.2 202.0 206.9 211.7 216.6
% with inflammatory breast cancer 4% 4% 4% 4% 4% 4% 4% 4% 4%
Inflammatory penetration 100% 100% 100% 100% 100% 100% 100% 100% 100%
% with Stage 3 breast cancer 30% 30% 30% 30% 30% 30% 30% 30% 30%
Stage III penetration 17% 17% 17% 17% 23% 30% 37% 43% 50%
# Treated with NaCT (000s) 16.8 17.0 17.1 17.3 21.7 26.3 31.0 36.0 41.1
% treated with NeoAdjuvant Chemo 9% 9% 9% 9% 11% 13% 15% 17% 19%
Penetration of monitoring therapy 90% 90% 90% 90% 90% 90% 90% 90% 90%
Patients with monitoring therapy 15.1 15.3 15.4 15.6 19.5 23.6 27.9 32.4 37.0
Treatment frequency (scans/patient) 2 2 2 2 2 2 2 2 2
Price per scan ($) 200$ 200$ 200$ 200$ 200$ 200$ 200$ 200$ 200$
Monitoring Market Size ($000s) 6,049$ 6,110$ 6,171$ 6,233$ 7,809$ 9,456$ 11,172$ 12,958$ 14,813$

Figure 4: 2014 Therapy Monitoring Market Size ($000)
CUSTOMER ECONOMICS
To further evaluate the market potential of the MIST Device, we analyzed the economic
attractiveness of the system for healthcare providers (Figure 5 and 6). We created scenarios
of the potential number of patients, scans, revenues, and utilization rates for three
institutions covered in our physician interviews: DHMC, Cancer Care Northwest, and the MD
Anderson Cancer Center. This shows the potential revenues associated with different patient
volumes and frequency of NACT usage. We also compared these potential revenue levels to
the costs to purchase the device, using a unit cost from the 2006 MCC presentation.
Our analysis shows that a specialized therapy monitoring device would only be cost-effective
for the largest cancer centers. For example, if the device were to be used at MD Anderson
Cancer Center, a location with high patient volume and frequent NACT usage, a single unit
would achieve approximately 30% utilization and could generate $360K in revenues. However,
at lower volume (but still reasonably large) institutions, like DHMC and Cancer Care
Northwest, therapy monitoring procedures would have under 10% utilization and generate
under $100K of annual revenues. This does not compare favorably with the investment
required to acquire the device, as the depreciation charges would account for a high
proportion of revenues. (As a comparison, publicly-traded diagnostic imaging companies, like
Alliance Healthcare Services and RadNet, operate with depreciation expense at 11% and 18%10
of sales, respectively. ) Based on this analysis, we conclude that, for all but the largest11
hospitals, the MIST device must either serve a larger patient population (like screening
applications), or target a wider variety of medical conditions (like MRI or PET) in order to gain
the utilization levels required to make the device economically attractive to providers, or
make a stand-alone imaging services business work. One potential area for future exploration,
which is outside the scope of our project, is whether the MIST device can be adapted for use
Price Per Scan ($)
% of 14,813$ 100$ 200$ 250$ 500$ 1,000$
Stage III 10% 2,729 5,458 6,822 13,644 27,288
Patients 25% 4,483 8,966 11,207 22,415 44,829
w/ NACT 50% 7,407 14,813 18,517 37,033 74,066
75% 10,330 20,661 25,826 51,651 103,303
100% 13,254 26,508 33,135 66,270 132,539
Alliance Health Services. Form 10-K. U.S. 10 March 2009. Securities and Exchange Commission.10
RadNet, Inc. Form 10-K. 16 March 2009. U.S. Securities and Exchange Commission.11

with a wide variety of conditions in order to increase the utilization rate and revenue
potential.
Figure 5: Therapy Monitoring Revenue Opportunity
RECOMMENDED MARKET PENETRATION STATEGIES
The following section describes our thoughts on how to target the breast cancer market.
Given the relatively small size of the therapy monitoring market, and the entrenched role of
biopsy in the diagnostic market, we believe that the screening market represents the most
attractive opportunity to apply the MIST technology to breast cancer treatment. However, as
noted in MIST’s earlier efforts, there are formidable barriers to entry in the screening market,
given the need for larger-sized clinical trials (Figure 6). The following sections present some
preliminary recommendations on alternative approaches for gaining the funding necessary to
penetrate this market.
Figure 6: Breast Cancer Clinical Trial Cost Estimates
Segment the screening market
Facility DHMC
Cancer Care
Northwest MD Anderson
# of new breast cancer patients / year 400 300 3,000
% of Patients Treated with NACT 15% 50% 30%
# of Patients with Therapy Monitoring per year 60 150 900
Patients / week 1.2 2.9 17.3
# of Scans / Patient 2 2 2
Scans / Year 120 300 1,800
Utilization @20 mins / scan & 40 hrs / wk 2% 5% 29%
Price / Per Scan 200$ 200$ 200$
Total NACT Therapy Monitoring Revenue / Year 24,000$ 60,000$ 360,000$
Unit Sales Price (from 2006 MCC project) 56,250$ 56,250$ 56,250$
Depreciation length 5 5 5
Annual Depreciation Costs 11,250 11,250 11,250
Depreciation costs / scan 93.75$ 37.50$ 6.25$
% of sales 47% 19% 3%
Indication # of Patients Cost / Patient Total Cost Source
Therapy Monitoring 400 2,500$ 1,000,000$ Coversations with client
Screening 50,000 500$ 25,000,000$ DMIST Trial
Note: Does not include costs of developing clinical organization

A couple of the radiologists we interviewed mentioned that the high-risk patients screening
market have more favorable economics. These patients can be identified by genetic tests that
determine the likelihood that a woman develops breast cancer over the course of her life.12
Whereas a patient receiving NACT will only require 1-2 scans over the course of her
treatment, high-risk patients need to be scanned each year. This suggests that the lifetime
revenue per patient is greater in the high-risk screening market than in the therapeutic
monitoring market. While MIST was previously deterred from entering the screening market
due to the high costs associated with completing the necessary clinical trials, perhaps this
hurdle would not be as significant given the smaller potential patient pool. We also wonder if
there are sub-segments of the patient population that would particularly prefer the unique
attributes of the MIST device (e.g., comfort).
Explore licensing deals with large incumbents
The largest diagnostic imaging companies have the financial means to bring the MIST
technology to market. Interestingly, most of these companies offer a variety of imaging
modalities (Figure 7), which suggests that they are not “locked-in” to a particular technology,
and may be interested in MIST’s technologies. We think MIST should pursue in business
development conversations with these companies for several reasons, including gaining
knowledge of the market and their strategies, potentially selling them on a licensing deal,
and gaining feedback on any important areas where the MIST technology needs to be
improved.
Figure 7: Leading Diagnostic Imaging Companies
Engage government agencies and patient advocacy groups
Company
Imaging Modality
Mammograph
y
MRI CT PET
GE Healthcare ✓ ✓ ✓ ✓
Hologic ✓
Phillips Healthcare ✓ ✓ ✓
Siemens Healthcare ✓ ✓ ✓ ✓
Toshiba Medical Systems ✓ ✓
Average women have a 12.5% chance (1/8) of developing breast cancer over their lifetime. High-risk12
women are those whose lifetime risk is over 20%.

Breast cancer detection and treatment is still an area of significant unmet medical need. The
NCI Biomedical Imaging program provides funding for research and clinical trials to speed the
development of promising new products. An example would be the program’s funding of the
DMIST clinical trial for digital mammography. Current programs include opportunities include
funding for Phase I and II clinical trials. Additionally, patient advocacy groups would be13
another constituency to approach for potential funding, or support. Some groups have helped
direct federal funds toward specific areas of biomedical research, and others, like the Susan14
G. Komen Breast Cancer Foundation, offer grants to pursue Phase I and Phase II clinical
trials.15
CONCLUSION
Our primary research suggests that the monitoring market for NACT is not sufficiently large to
justify an independent company. Even after making generous assumptions regarding the NACT
penetration for Stage III breast cancer patients and the price per imaging scan, we do not
believe that therapy monitoring for NACT represents a viable market opportunity.
Furthermore, after looking at the economics from the customer perspective, it does not seem
that many practices have the patient volume to justify a device designed explicitly for breast
examination.
Going forward, we recommend that MIST focus its efforts on the larger screening market, in
addition to therapy monitoring, and identify partners to help finance the necessary clinical
trials to obtain approval for the device. Many of the large imaging companies provide multiple
imaging modalities, suggesting that they may be receptive to MIST given its relative price and
comfort advantages over MRI. Alternatively, we suggest that the company pursue grants from
the federal government or non-profit organizations as a source of potential funding for
clinical trials to validate the technology.
 
National Cancer Institute. Cancer Imaging Program: Current Funding Opportunities. Retrieved 213
November 2009 from http://imaging.cancer.gov/researchfunding/current/currentfunding/.
Dresser, Rebecca. “Public Advocacy and Allocation of Federal Funds for Biomedical Research.” The14
Milbank Quarterly, Vol. 77, No. 2 (1999), pp. 257-274.
Susan G. Komen Breast Cancer Foundation. “Promise Grants, Special Focus – Prevention. Retrieved 215
November 2009 from www.komengrantsaccess.org/files/2010/kgc/pg_rfa.pdf.

APPENDICES
Appendix 1: Physician Interviews
Breast Surgeons
Dr. Isabel Bedrosian, MD Anderson
Dr. Kevin Hughes, MGH
Dr. Kari Rosenkranz, DHMC
Medical Oncologists
Dr. Susan Burdette-Radoux, Vermont Cancer Center
Dr. Mary Chamberlin, DHMC
Dr. Michael Cohenuram, Danbury Hospital (CT)
Dr. Kim Dittus, Vermont Cancer Center
Dr. Peter Kaufman, DHMC
Dr. Joni Nichols, Cancer Center Northwest
Laura Urquhart, APRN, DHMC
Radiologists
Dr. Betsy Angelakis, Lahey Clinic
Dr. Elizabeth Dann, DHMC
Dr. Daniel Indelicato, University of Florida
Dr. Asa Nixon, Concord Hospital (NH)
Dr. Michael Peterson, Avera Sacred Heart Cancer Care (SD)
Dr. Stephen Poplack, DHMC

Appendix 2: Physician Interview Guide
Treatment planning
1. What types of specialists are involved with the treatment of breast cancer? Of treating
patients with neoadjuvant chemotherapy?
2. Who designs a patient’s treatment plan?
3. Who makes the decision to include monitoring therapy? At what point are different
specialists consulted?
4. How long does a typical course of neoadjuvant chemotherapy take?
5. Which patients typically receive neoadjuvant chemotherapy?
a. Description of tumor type / patient profile
b. Percentage of patients receiving neoadjuvant chemotherapy
6. Of those receiving neoadjuvant chemotherapy, which patients typically receive
monitoring therapy?
a. Description of tumor type / patient profile
b. Percentage of neoadjuvant chemotherapy patients receiving monitoring
therapy
Conducting the monitoring exam
1. Who conducts monitoring exams?
2. How much time is allocated for a monitoring exam?
3. How often do they occur? How long is a course of treatment (e.g., monthly over six
months)?
4. What modality is used (e.g., MRI, PET)?
5. When and where are the exams done (e.g. Hospital, Office)?
Changing the treatment plan (if necessary)
1. If the tumor has not changed in size, how frequently is the treatment regime modified
(i.e. what would an oncologist/radiologist do with the information from the monitoring
device? Why is it valuable to get this information after 1 month instead of 6 months, as
you would with an MRI?)
Purchasing Decisions for Imaging Equipment
1. Who purchases the imaging equipment used for monitoring (e.g., MRI, PET, etc.)?
2. Whose budget is it (Hospital, radiology or oncology dept, individual clinics)?
3. Who are the decision makers? Who is involved in / influences the purchase decision?

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