Theres big news for the 600,000 people in the U.S. who receive
radiation therapy as part of cancer treatment each year. A tiny
implantable device incubated at NC State and being commercialized
by Sicel Technologies, Inc., may soon allow doctors to customize
radiation treatments based on the patients own biological
information and response to therapy. Such
targeted treatments are expected to decrease patient hospitalization
and costs, and may well save more lives than todays treatments.
The M-STAR DVS (dose verification system) is the result of an ideal
combination of need and know-how. Dr. Charles Scarantino, a radiation
oncologist at the Rex Healthcare Cancer Center, knew all about the
need. Dr. Troy Nagle, an NC State professor of electrical engineering,
provided the know-how.
Scarantino and Nagle first developed the concept for implantable
oncology devices in 1997 and were granted the seminal patent for
Sicel Technologys products. Oncologists need a monitoring
method to provide continuous data on tumor physiology, says
Scarantino. Current procedures, such as biopsy, MRI and PET, can
be invasive and costlyand the information gathered is only
one snapshot in time. We need to know things like the actual
radiation dose hitting the tumor, the tumor temperature during hyperthermia
treatment, the uptake and retention of chemotherapy drugs, and parameters
like pH or oxygen, he explains. Sensors can provide
doctors information so they can ensure proper dose control and protect
healthy and sensitive surrounding tissue.
Co-founded by Scarantino, Nagle, and the experienced entrepreneurial
management team of Bob and Claudia Black, Sicel Technologies set
up shop on NC States Centennial Campus in 1999. Today, the
company has filed 11 patents, two of those owned jointly with NC
State, and one licensed exclusively from NC State. With employment
at 19 and significant expansion planned, Sicel has moved to larger
labs and raised $7 million in investment capital, and is currently
preparing for product launch and manufacturing ramp-up.
Initial focus is on the M-STAR DVS, which can be implanted into
or around tumors using a minimally invasive injection device. The
sensors will measure total dose during each of the dozens of radiation
treatments for a typical patient, wirelessly transmitting their
data to a hand-held monitor using radio frequency coupling.
With help from Dr. David Russlander at NC States College
of Veterinary Medicine, Sicels first device was tested last
year in animals. Pivotal trials on humans are in progress at Rex
Healthcare, Duke University Medical Center, and additional sites.
These trials are demonstrating that the product is safe and
that the technology works, says Scarantino. The next
step will be to
determine whether, using the data provided by the sensor, oncologists
can achieve better results by customizing patient treatments.
Upon FDA approval, Sicel plans to sell the M-STAR DVS to a select
group of 50 radiation oncology centers serving as proving grounds
for the clinical utility of the sensor. Beyond that,
says Claudia Black, Vice President of Operations and Finance, the
Sicel platform for implantable sensors to guide cancer therapy creates
a global market in the $2 billion range.
The Sicel vision is for many kinds of sensors, including one to
measure uptake of radioactively labeled drugs, allowing the clinician
to choose the most effective drug and determine its effect
on tumor metabolism. Recently, a patient commented that he
wished tumors could talk, says Scarantino. I think they
can talk, and I think now for the first time, were going to
able to listen.
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