Human Fertility Management
Approximately one in five couples in America experience
difficulties conceiving a child. Boston Rheology has developed an
OTC device to accurately assess the fertile period. This device
is compact and allows for discrete home use in conceiving a child.
The Company believes its product to be more accurate, convenient
and cost-effective than anything currently on the market. The human
fertility instrument (home use rheometer) is based on a discrete,
lip-stick-sized unit and has been proven 98% successful in clinical
trials. With Class 1 classification and on the FDA's "fast
track" for 510k approval, all that remains is the manufacture
of the final instrument to present to the FDA. The Company also
has developed an in-office device for doctors for the same purpose
and has received FDA 510k approval.
Accurate methods for predicting the
duration of a woman’s fertile period and when ovulation will
occur are invaluable in either assisting or preventing conception.
The Boston Rheology test process is used to predict fertility
and ovulation based on the regular variation in the viscosity
of saliva throughout the menstrual cycle. As ovulation is approached,
the viscosity of the saliva begins to decrease from a baseline
value of approximately 30 centipoise, depending on the subject.
This descent will occur over 4-5 days before the viscosity reaches
a minimum value which is roughly 10 times lower than the baseline
value. The time at which the viscosity attains its minimum value
correlates with ovulation and the time of highest fertility. Afterwards
the viscosity will increase and will achieve the original baseline
value in roughly 18-36 hours. The testing device measures the
viscosity of by compressing a small saliva sample between two
plates and then recording the time to separate the plates under
a given force.
This testing method requires an initial month
of data collection for calibration to let the user establish benchmark
values for the maximum and minimum viscosity values and the duration
of the reduction in viscosity which corresponds to the fertile
period; these values will vary for different individuals. However,
only five points are needed to establish the curve. Once the calibration
points have been obtained, the user can then measure her saliva’s
viscosity during subsequent cycles and compare those values with
the calibration curve to determine exactly where she is in the
cycle and whether or not she is fertile and close to ovulation.
One advantage of this testing method is that the results are quantitative
rather than qualitative: the user reads a number as opposed to
having to interpret colors or analyze fern-like structures in
dried saliva as in other tests currently used, described below.
The Boston Rheology testing procedure has been
patented, and the technical feasibility of the testing method
has been demonstrated through clinical tests in which a doctor
performed the tests. Data have shown that the cycle to cycle variability
in the value of the viscosity measured and the timing of the minimum
is small and so after one cycle fertility and ovulation can be
predicted. Separate works-like and looks-like devices have been
designed and fabricated: the looks-like device is no bigger than
a lipstick case, making it convenient for consumer use in and
outside the home.
The Boston Rheology test meets these criteria, and therefore is
a competitive product.
Competitive Products
The Boston Rheology testing procedure has a number of advantages
over existing tests. The three methods of fertility testing on
the market for use at home are urine tests, basal body temperature
monitoring, and observing “ferning” in dried saliva.
Urine-based tests detect the increase in
Luteinizing Hormone (LH) in urine which occurs 24-48 hours prior
to ovulation in women. The disposable testing device that employs
this modality gives binary (positive or negative) results and
cannot pinpoint the time of maximum fertility. Additionally, the
LH surge occurs in a narrow time window with the consequence that
it is possible to miss detecting the LH surge, even with daily
testing.
Measuring Basal body temperature is used
to monitor fertility, as basil body temperature increases by approximately
0.5°F after ovulation has occurred. A disadvantage of this
testing method is that in a given cycle ovulation can only be
determined retrospectively. Therefore this method requires monitoring
daily for several months in order to be able to predict when,
in the following cycles, ovulation will occur. Outside factors
such as emotional stress or illness can also cause body temperature
to increase which may complicate interpretation of the results.
The formation of patterns resembling ferns
is observed in dried saliva close to when ovulation occurs, as
a result of the accompanying hormonal changes. Thus, a user can
track the intensity of these fern-like patterns in order to determine
the time of maximum fertility. Performing this type of test involves
placing a small amount of saliva on the lens of a home-use device,
waiting for the saliva to dry and then observing the dried saliva
through a magnifying lens in the device. The results are qualitative
and require the user to make a comparison between the image observed
on a given day relative to those observed on previous days.
Infertility, the impaired ability to have children,
affects as many as 6.1 million women of reproductive age and is
projected to reach 7.7 million by 2025. Demographers hypothesized
that increases in infertility could be related to two factors.
First baby boomers are entering their later reproductive years
and second, an increasing number of women are pursuing professional
careers and are having children later in life when fertility rates
happen to lower.
The projections and trends imply that there is an increasing need
and demand for women to use ovulation tests that are:
-- Available as home-use/OTC tests (avoid MD visit)
-- Simple, convenient and relatively fast (avoid multiple and
timely procedural steps)
-- Accurate in detection/prediction of entire fertile period (avoid
cycles of testing)
Back to Top
Technical Advantages
-- The tests are convenient and rapid:
unlike other tests, it does not need to be performed daily, minimizing
any inconvenience. Furthermore, the timing from collecting a sample
to obtaining results is shorter than other products.
-- The tests are predictive: for most women,
measurements taken during one cycle can be used reliably to predict
fertility and ovulation in subsequent cycles. Low variability
for individual woman during different cycles has been demonstrated.
-- The tests will have strong user-interface
and ease-of-use: collecting a sample and performing the test
are both straightforward processes.
-- The tests will have ease in interpretation:
the further development of this device will provide a step-change
in the quality and form of information/output currently available
to women for managing fertility.
Back to Top
Market Advantages
-- The tests target an increasing clinical
unmet need: currently 6M women are dealing with infertility
and this trend is on the rise due to more women pursuing professional
careers and having children in later reproductive years when fertility
rates lower. Although 10% of target population are expected to
be unable to use this test, for the majority (90%), it represents
a substantial increase in convenience and in information obtained
through testing.
-- The tests have key competitive and distinctive
advantages: current technologies on the market have a number
of disadvantages, e.g.,
- measurements of basal body temperature only
indicate ovulation retrospectively;
- fern-based saliva tests only provide qualitative information
which can be ambiguous or difficult to interpret; and
- urine-based tests take longer to generate a reading than the
Boston Rheology saliva tests.
-- The tests will have a relatively easy and
fast-track regulatory process for commercialization: ovulation
tests are categorized as Class 1 devices which are viewed as less
risky and requiring minimum control than pregnancy testing.
Back to Top
