An analysis of market trends reveals a
shift to pre-filled, disposable, simple devices that aim
to address convenience, regulatory compliance requirements
and needle phobia/patient compliance. Such systems
are rapidly expanding across therapeutic areas such as multiple
sclerosis (MS), rheumatoid arthritis (RA), fertility, osteoporosis,
hepatitis, oncology, anemia and migraine.
Rheumatoid Arthritis (RA) is
a chronic and debilitating autoimmune disease that affects
an estimated three million people in the United States
and an estimated 20 million individuals worldwide.
According to 2009 survey results published in “Rheumatoid
Arthritis: Insights, Strategies and Expectations” (RAISE
Survey), about 25 percent of people with RA surveyed, who
are currently on a subcutaneous injectable medication,
rely on caregivers or healthcare providers to administer
the medication; while 24 percent of patients who self-inject
experience pain upon injection and 20 percent experience
irritation at the injection site.
Of those people who self-inject, approximately 12 percent
describe the process as somewhat difficult demonstrating
the unmet need for patient-friendly, self-injectable devices
and formulations that are less painful.
Multiple Sclerosis (MS), also
a chronic and debilitating autoimmune disease, affects about
2.5 million people worldwide. The leading approved
therapies are currently administered by daily or weekly self-administered
subcutaneous or intramuscular injections. However,
it is estimated that up to 90% of MS patients have trouble
with self-injection due largely to fear of needles and/or
pain. Consequently, medical experts agree that fear
of self-administering treatment is a major barrier to therapeutic
Milestone’s innovative, patented
computer-controlled drug delivery platform has been designed
to reduce the anxiety and pain of self-administration of
medications for the rapidly expanding home-use market.
The computer-controlled self-administration system provides
a less threatening, virtually painless means for patients
to safely self-administer in-home a variety of injections. Moreover,
certain differentiating features and capabilities of the
invention include the following:
The system provides a means to optimize injection parameters
(injection pressure and flow-rate) for a specific area
of the body for each individual, thus allowing the user
to create a unique injection profile specific to their
own pain tolerance and needs.
The computer-controlled system provides an interactive
learning and teaching experience guiding the user through
the injection experience, thereby reducing the uncertainty
and anxiety of performing the self-administrated injection.
The system provides a means of reducing medical errors
by verifying the authenticity of the drug administered
as well as generating a digital treatment record of the
event that can be reviewed by healthcare professions to
verify self-medication compliance.
The system has been designed to be
compatible with a wide variety of medications that are routinely
prescribed for in-home self-administration.