Endoscopy is often used in the prevention, early detection, diagnosis,
staging, and treatment of cancer.
X-rays and CT scans can show physical changes within the body and give
information about the size, shape, and location of the changes. Endoscopes
show details like color and surface texture allowing doctors to see exactly
what’s going on.
If you go to a doctor exhibiting certain symptoms, endoscopy could be used
to find the cause:
- Long-term hoarseness - Laryngoscopy to look at the vocal
cords
- Trouble swallowing - Upper endoscopy
- Anemia (low red blood cell counts) with an unknown cause
- Colonoscopy
- Blood in stool - Colonoscopy
Colonoscopy and sigmoidoscopy are used to look for cancer in people who
have no symptoms by screening for colon and rectal cancer. They also help
prevent cancer by finding polyps (growths in the bowels) that could become
cancer. Thoracoscopy and laparoscopy can be used to find out if cancer has
spread into a patients thorax or abdomen.
Most endoscopes can, with an attached tool, take small tissue samples –
called a biopsy. Instruments passed through an endoscope can also be used to
cut out growths, a cautery or laser can be used to burn or vaporize them.
Minimally invasive surgery
Many types of endoscopic tools have been developed to let doctors perform
minimally invasive surgery.
When endoscopy is used for the abdomen it is called laparoscopic surgery.
Instead of one long incision several small cuts are made - usually in the
chest or abdomen. A video endoscope – a thoracoscope or laparoscope – is put
through one of the holes so that the surgeon can see inside during the
operation.
This type of surgery, called video-assisted thoracoscopic surgery or VATS,
can also be used to treat small lung cancers. It can also be used for the
colon (laparoscopic colectomy), prostate (laparoscopic radical
prostatectomy), and some other organs.
Patients, physicians, providers, and payers have wholeheartedly embraced
minimally invasive therapy for many reasons:
- Minimally invasive therapy obviates the need for major
open-surgery procedures.
- Minimally invasive therapy produces much less of the
sequelae (a condition that is the consequence of a previous disease or
injury) of open surgery procedures.
- Minimally invasive therapy leaves minute scars versus
open-surgery procedures.
- Minimally invasive therapy results in shorter hospital
stays and reduced outpatient treatments.
- Minimally invasive therapy results in a much more rapid
return to normal activity.
- Reductions in length of hospitalization and the ability
to return to work much sooner are economically attractive.
The demand for endoscopy as a tool in cancer detection
has been increasing significantly because of the growing preference for
minimally invasive surgeries, which reduce patients’ pain, speed recovery and
reduce the overall costs to the healthcare system.
The endoscope is the most important weapon in the minimally invasive
therapy arsenal.
Other factors driving the growth of global endoscopy include:
- Aging population
- Increasing prevalence of diseases that require endoscopy
procedures
Bladder cancer
Fact; Advances in bladder cancer treatments, let alone a breakthrough,
have been sloth like in coming - no new products have been developed and
Urologists have been using the same diagnosis and treatment methods for
decades.
According to the National Cancer Institute (NCI) bladder cancer is the
sixth most common cancer in the United States and the third most common
cancer in men, with over 72,000 new cases diagnosed annually (380,000
worldwide). It is estimated that approximately 577,400 people are currently
living with bladder cancer in the United States, generating over 1,500,000
physician consultations per year, and that approximately 16,000 individuals
will died from the disease in 2015.
Bladder cancer facts:
- Low grade non-muscle bladder cancer has a reoccurrence
rate of 40%. High grade non-muscle bladder cancer has a reoccurrence
rate of 70%. The average reoccurrence rate for this type of cancer is
nearly 50%, which is one of the highest reoccurrence rates of all
cancers.
- Bladder cancer is the most expensive cancer to treat in
the US.
- Bladder cancer represents 4.6% of all new cancer cases
in the U.S.
- In 2016, it is estimated that there will be 76,960 new
cases of bladder cancer and an estimated 16,390 people will die of this
disease.
- Age: Seniors are at the highest risk of developing
bladder cancer.
- Sex: Men are three times more likely than women to have
bladder cancer.
- Race: Whites have a much higher risk of developing
bladder cancer than other races.
Bladder cancer is generally identified in the clinic by a procedure called
cystoscopy, an endoscopy in the bladder.
When detected early, bladder cancer can be treated successfully. Initial
treatment of bladder cancer is based on a tumor’s clinical stage, determined
by how deep the tumor is thought to have grown into the bladder wall, and
whether or not it has spread beyond the bladder. Other factors, such as
the size and grade of the tumor, may also affect treatment options.
Unfortunately, bladder cancer has a very high rate of recurrence, one of
the highest among the cancers. Because of the high risk of recurrence,
patients who have been treated for bladder cancer undergo follow-up endoscopy
every 3-6 months. For the rest of the patient’s life, a cystoscopy on a
quarterly, semi-annual or annual basis is essential.
It is estimated that over 4 million cystoscopies are performed each year
and approximately US$4B is spent on bladder cancer surveillance annually.
Bladder cancer is the most expensive cancer to treat over the lifetime of
a patient.
The majority (about 70%) of bladder cancers are superficial meaning they
are only in the lining of the bladder. However, if left undiagnosed and
untreated, these cells can invade the muscle wall which could require
complete removal of the bladder - a radical cystectomy.
It is important that cystoscopy imaging be both:
- Highly sensitive by being able to detect subtle cancer
- Specific meaning able to distinguish between benign and
cancerous tumors
These two attributes enable surgeons to
remove cancerous tissue at an early stage.
While cystoscopy is the “gold standard” for a routine surveillance exam
it’s well known that standard cystoscopy has insufficient sensitivity and
specificity. This is particularly true for flat appearing cancers that blend
in with the bladder and may be confused with inflammation.
Various experimental studies demonstrate a 4-10% rate of missed
bladder tumors by conventional cystoscopy – ie. carcinoma in situ bladder
cancer (CIS) 4 is a high grade cancerous lesion, often diffuse and difficult
to visualize it can be a very aggressive form of the disease.
There is an important need to improve the ability of endoscopy to 1.
identify suspicious bladder lesions without missing any cancers and 2. to
characterize bladder lesions as benign or malignant with high accuracy.
The most common symptom of bladder cancer is blood in the urine
(hematuria) with little or no pain. It should ALWAYS be assessed by a
physician.
Let’s look at current endoscope technology as it involves cancer.
White Light and Cancer
White light is the standard convention and it’s what’s commercially
available in all endoscope devices manufactured today. White light has been
utilized in endoscopes for decades to guide the physician and surgeon so they
can see cancerous growths that protrude above an organs surface, do biopsies
and remove suspicious growths.
White light is comprised of energy in the form of electromagnetic
radiation that vibrates at many different wavelengths. Wavelengths between
390 nm and 780 nm are visible to the human eye and produce the different
colors of the spectrum.
White light has limitations in visualizing certain cancer types because:
- White light cannot pass through tissue or blood
- White light cannot illuminate tumors beneath the skin
surface.
- White light is not effective in visualizing the borders
of the tumor to determine where it begins and ends (the margins),
especially after the initial removal of the main mass. If the surgeon
does not remove all the cancerous growth, and a few cancerous cells
remain, the tumor can grow back and spread, or metastasize to other
parts of the body
- Malignant and premalignant tumors that are flat or very
small may look similar to normal tissues. As a result, a physician may
not be able to identify some aggressive cancers. In order to be safe,
they may collect random and repeat biopsies as the only possible way to
ensure that cancer is not missed in high-risk patients
To summarize, white light has visualization limitations for all cancer
types because white light cannot pass through tissue or blood and cannot
illuminate tumors beneath the skin surface. White light is also not effective
in visualizing the borders or margins of the tumor to determine where it
starts and ends especially after the initial removal of the main mass.
Blue Light
Because of the limitations with using white light for visualizing cancers,
various companies have begun using blue light (white light with blue filter)
in conjunction with chemical tumor targeting/imaging agents. This improved
technology introduces a red fluorescence to the tumor and has improved the
ability to visualize cancers and margins.
Tumor visualization with endoscope
using white light (left) and blue light (right) with Photocure’s chemical
called Cysview)
Unfortunately these chemical agents can cause various adverse effects -
including anaphylaxis shock and hypersensitivity reactions - with repeated
usage at the high doses currently required for visualization. The FDA has
limited use of these chemical tumor targeting/imaging agents to just once per
patient. Doctors and surgeons cannot repeatedly examine a patient using these
chemical imaging agents. This creates a huge problem treating patients with
multiple tumors and those with recurrent tumors.
Red Light
Red lightrequires specialized laser light sources, ultrasensitive cameras
and a unique optical design. Currently no commercial instruments are
available using red light.
The Unmet Need
What is acutely needed right
now, across the entire spectrum of the endoscope imaging space/sector, is
an ultrasensitive system that uses white light while simultaneously using
other wavelengths of light to visualize all tumors, and one that requires
only a fraction of the chemical imaging agent so as to reduce the toxicity
allowing multiple usage in patents.
Future endoscopes should also have more advanced cancer detection
technologies so that ultimately no chemical imaging agents would be
necessary.
These future tools should provide ultrasensitive and advanced imaging
capabilities and the system should be capable of being used in a physician’s
office or clinic for diagnosis, in the operating room and ambulatory surgical
center.
Imagin Medical
Imagin Medical (CSE: IME) (OTC: IMEXF) is a biotechnology company founded
to commercialize an ultrasensitive, next generation imaging technology for
extremely accurate visualization of cancers.
Invented by Dr. Stavros Demos at the Lawrence Livermore National
Laboratory (LLNL), this combination optical/laser technology uses white light
and near-infrared fluorescence to accurately visualize and detect
cancer. To validate this technology, Dr. Demos worked for over five
years in collaboration with the UC Davis Comprehensive Cancer Center and Dr.
Ralph deVere White, one of the world’s leading authorities on bladder cancer.
Imagin now holds the exclusive license to this intellectual
property. The Company has entered into an agreement with UC Davis
Comprehensive Cancer Center and the University of Rochester Laboratory for
Laser Energetics in New York, where Dr. Demos will lead the effort to
complete development and support Imagin during clinical evaluations and the
FDA submission.
IME believes it will radically improve the way physicians detect cancer
through the use of endoscopes to image and visualize cancer and/or cancer
markers.
Imagin is developing systems that will potentially enable physicians to
accurately detect cancer with minimal use of, or no toxic contrast agent, and
remove all tumor tissues and cancerous cells completely during the first
procedure. This technology, after having being proven successful in the
operating room, will greatly reduce the chances of cancer recurrence and
allow safe, multiple follow-up screenings for patients that can be performed
during routine monitoring by physicians in an outpatient setting.
Imagin Medical’s advanced ultrasensitive imaging technology is based upon
improved optical designs and components, and advanced light sensors. The
results are:
- Increased sensitivity and specificity for the detection
of cancers and even premalignant lesions.
- A potential decrease in cancer recurrence due to the
ability to completely remove tumor tissues along with the cancerous
cells in the margins.
- A significant commercial advantage to Imagin’s imaging
technology because of its adaptability to all endoscopes that are
currently on the market.
- Easy adoption of Imagin’s two ultrasensitive imaging
designs for use in multiple other applications where endoscopy imaging
is currently utilized.
Imagin Medical’s ultrasensitive i/Blue and i/Red Imaging Systems use white
light in conjunction with the Company’s unique fluorescent wavelengths to
radically improve the physicians ability to visualize (detect) cancer. This
technology is estimated to increase sensitivity to an estimated 5 orders of
magnitude (100,000 x) more than white light alone.
Beginning in 2010, the FDA approved blue laser light to be used with
various imaging agents, but only on a one-time per patient basis because of
potentially dangerous side effects. This limitation generally restricts
physicians use of imaging agents for the O.R. so they can take advantage of
this one-time opportunity to operate immediately, if and when cancer is
found.
With the increased sensitivity of the Company’s i/Blue Imaging System, the
dosage of the imaging agent can be reduced by 99%, which means that
physicians can not only perform procedures in the O.R., but they can also
screen the same patient multiple times in the less-expensive office setting.
The smaller dose of the imaging agent is absorbed by the bladder in minutes,
versus one hour, improving the efficiency of the O.R. and the physician’s
office.
Additionally, physicians using today’s standard blue light need to switch
back and forth between the white light and blue light images, which is not
necessary with the i/Blue Imaging System that blends both lights into one
image.
The i/Red Imaging System, the Company’s next advancement, uses a unique
red laser light to illuminate the cancer and requires no imaging agents at
all. This breakthrough totally disruptive technology uses only the
fluorescence produced by the body and tumor itself.
The i/Red Imaging System will dramatically broaden the market to all
cancer specialists using any type of scopes.
Competitive Advantages
Imagin Medical’s advanced ultrasensitive imaging technology will lead the
marketplace in illumination of cancerous cells and provide an improved
surgical outcome as a result of an improved detection and resection, which
will lead to more adequate patient management and follow-up.
Competitive Advantages:
- Can be seamlessly adapted to any type of endoscopic or
other type of imaging device commercially available.
- Based upon improved optical designs and components, and
advanced light sensors. The result is increased sensitivity and
specificity for the detection of cancers, including premalignant
lesions.
- Will decrease bladder cancer recurrence due to the
ability to completely remove tumor tissues along the margins.
- Will add significant ease-of-use for the surgeon and
staff in the O.R. because of the dual imaging capability.
- Use less than 1 percent of the toxic chemical currently
(such as Cysview) used per test. Cysview is already FDA approved.
- Imagin Medicalhasan ultrasensitive red light endoscopy
system that requires no chemical imaging agents.
- Because there is no need for chemical imaging agents,
this system can be used in a physician’s office or clinic for cystoscopy
(diagnosis), and in the operating room (O.R.) or ambulatory surgical
center for tumor removal or resection.
- Imagin Medical has patents covering these imaging
systems that are estimated to be at least 100,000 times more sensitive
in tumor detection than any other devices currently in the marketplace.
- Provide improved detection of cancer superior to what is
currently in the market place.
- The instrumentation involved does not come into contact
with the patient, thus significantly reducing regulatory requirements
and associated expenditures.
- The white light and fluorescence images are recorded and
displayed simultaneously providing an effective real time navigation
tool that can be farther enhanced using processing (such as overlapping
and pseudo-coloring) of the two principal images.
An Execution Play
The company’s products are based on the technology invented by Dr. Stavros Demos at the
Lawrence Livermore National Laboratory (LLNL). Dr. Demos worked in
collaboration with the UC Davis Comprehensive Cancer Center and Dr. Ralph
deVere White, one of the world’s leading authorities on bladder cancer, for
more than five years to prove feasibility. Imagin has moved the final stage
of development to the University of Rochester Laboratory for Laser
Energetics, where Imagin’s engineering team, with the support of Dr. Demos,
will complete additional clinical evaluations and prepare for FDA submission.
Conclusion
Fact; Current cystoscopy has well-documented problems associated with the
limited ability to distinguish cancer from normal tissue.
Imagin’s strategy is to set a new “standard of care” in detecting bladder
and other cancers by introducing game-changing disruptive advances in
endoscope technology with its i/Blue and i/Red combination optical/laser
systems.
Imagin Medical CSE - IME,and their significantly improved endoscope
technology, need to be on your radar screen.
Is advanced endoscopy on your screen?
If not, it should be.
***
Richard owns shares of Imagin Medical (CSE: IME) (OTC: IMEXF)
Richard lives with his family on a 160 acre ranch in northern British
Columbia and is the owner of Aheadoftheherd.com.
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