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Most often those who claim to have invented the better mousetrap, real or
metaphorically speaking, haven’t - there just isn’t enough of a technological
change to force consumers, businesses or institutions to want to, or need to,
make a change. Call it incremental technology looking for a market.
The opposite end of the scale would be a change so great, a technological
change so much more efficient, so much more attractive a switch is made
without question – from 8-tracks to cassettes to CDs. From black and white TV
to color. From bulky poor quality movies on VHS tapes to slim, lightweight
high quality optics on DVD’s. These examples are all innovations that built
upon an existing technology and truly created better mousetraps that were
universally accepted as such.
Imagin Medical Inc. (CSE:IME, OTC PINK:IMEXF, Frankfurt/Stuttgart Stock
Exchanges:DPD2) has a clear mission.
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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.
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Bladder cancer is the most expensive cancer to treat over the lifetime of
a patient.
 
While initially focusing on the US$500M (US$1 billion global) bladder
cancer imaging market in the United States Imagin expects that its
dual-light, single-screen imaging system will also set a new standard of care
for doctors and surgeons in detecting many other kinds of cancers.
New Standard of Care
The highest level of improvement in any therapy is a “new standard
of care.”
New medical devices have to show they are significantly better than
current equipment to win sales. When a new technology is 5 orders of
magnitude (100,000x) better than existing technology and affordable,
it becomes practically irresistible.
Imagin believes its dual-light, single-screen system will prove to be far
superior to even the best alternatives.
Imagin Medical’s i/Blue Imaging System
With the development of compact color video cameras over 30 years,
urologists have used endoscopes (cystoscopes) combined with white light and
video imaging, to visualize the bladder to detect cancer. Unfortunately it is
well established that malignant lesions may not be visible and not detected
during endoscopic examination with this technology.
In 2010, the FDA approved a combination fluorescing drug and blue light
imaging to improve the visualization of bladder cancer. Although it is
accepted that this method produces better visualization and detection of
malignant lesions, its implementation with the existing instrumentation has
significant shortcomings that become impediments to the wide adaptation of
this technology.
One such limitation is the full hour it takes for the bladder to
metabolize the drug. Additionally, this technique requires that the surgeon
switch back and forth between the white and blue light images. Why? Well the
white image shows the full landscape of the bladder, but doesn’t highlight
the cancer. The blue filtered image shows a highlighted fluorescence image of
the cancer, but without a precise indication of where it is located in the
bladder.
Dr. Stavros Demos invented the i/Blue Imaging System at the Lawrence
Livermore National Laboratory (LLNL) where he 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, to
validate this patented technology (three patents, two pending). Imagin now
holds the exclusive license.
Imagin believes the i/Blue system will produce a far superior approach to
a cystoscopic examination of the bladder by addressing the existing
limitations. Specifically, the Company’s patented simultaneous
acquisition of two different images blends the white and fluorescence images
into one, putting the cancer into context, and enabling the surgeon to better
visualize and resect the cancer. In addition, the advanced design of the
image acquisition will enable visualization of the cancer in less than 15
minutes compared to one hour. This advancement makes i/Blue technology
practical, not only for the O.R. but also in the physicians’ office.
The next generation prototype will be available early in 2017. Clinical
trials will begin in early 2017 and FDA approval is expected in early 2018.
FDA Approval Process
The Imagin system combines (and upgrades) technologies already approved by
the FDA. This is a “me too” study - fluorescent drugs are already approved by
the FDA for use with existing, approved endoscopic light sources and Imagin’s
labeling will not vary from the already FDA approved use of the contrast
agents predicate/comparator blue light lasers and light sources that already
exist in the market for various medical specialties.
All this means Imagin should only need to establish that results from its
system are equivalent to similar concepts to gain approval. A 12-15 month
process is a reasonable timeframe for this type of medical device
application.
The Team
James Hutchens, CEO.Jim is a proven entrepreneur with
over 30 years of experience in general and marketing management in the
medical device industry. As the founder and CEO of Microsurge Inc., a
venture-backed, minimally invasive surgery company, he assembled a management
team, guided the company’s products through the regulatory process, hired a
sales and marketing team, drove revenues to an annual run rate of over $10
million and sold the company. As the founder and CEO of Choice Therapeutics,
an advanced wound care company, Mr. Hutchens implemented similar tactics and
with revenue of $2 million sold the company to Alliqua Biomedical a NASDAQ
list company. At Microvasive Endoscopy, a division of Boston Scientific,
revenues rose from $300,000 to over $20 million during his tenure as Vice
President, Marketing and Sales.
Thom McMahon, Director of Sales.Thom worked at Karl Storz
for over 25 years, and was Storz’ #1 sales rep for 10 years. With over 35
years in the business, he is on first-name basis with most of the leading
urologists in the Northeast. His experience covers the gynecology,
laparoscopic surgery, GI endoscopy, wound care, cardiology, urinary
incontinence and regenerative technologies markets.
Michael G. Vergano, Vice President Operations - Michael
has been president of The Harvest Group Inc. since 1998, where he has
provided project management, product development, packaging, quality systems,
operations, manufacturing engineering, and system/process design and
validation services for start-ups as well as major medical corporations. His
medical device experience includes the gynecology, laparoscopic surgery, GI
endoscopy, dental imaging and implants, wound care, cardiology, urinary
incontinence and orthobiologic regenerative technologies markets.
Stephen Ruggles, Dir. of Quality Assurance and Regulatory
Affairs.Steve has over 30 years of experience in domestic and international
regulatory affairs, operations management, manufacturing quality assurance,
R&D, and supply chain management for early stage companies and large
multinationals. As Director of QA / RA for Cambridge Endoscopic Devices, Mr.
Ruggles led the effort to earn and maintain ISO 13485 registration, CE Mark,
and compliance with Japan’s jPAL. Prior to Cambridge Endo, he served eight
years at Becton Dickinson as a Supply Chain Quality Engineer, R&D Quality
Engineer, Quality Manager and Regulatory Compliance Manager.
Ken Daignault has almost 30 years’ experience in the
medical device field, with an emphasis in urology. He has held senior level
management positions in major medical device companies, most recently with
Boston Scientific as Director of R& D, Urology. He has also held
positions at Kendall Healthcare (now Covidien) and CR Bard, one of the
world’s largest urology companies. Ken has been involved in all aspects of
the medical device business, from product development and the design of
protocols and procedures for bench and animal pre-clinical testing, to
building long-term strategies for multiple-product portfolios at various
stages of development. Ken has strong relationships within the urology field
and with key medical institutions, as well as a track record of bringing
products from concept through successful product launch.
Dr. Stavros G. Demos, Technical Scientific Advisor.A
prolific inventor and scholar, Dr. Demos is a laser materials expert.
Companies using his technologies include Muse Microscopy, Near Infrared
Imaging, and Biosense/Webster. He holds 20 patents and has published more
than 115 scholarly journal articles. He is the original inventor of the
i/Blue system and is continuing to work with Imagin in developing the
technology. Imagin has forged an agreement with UC Davis and the University
of Rochester Laboratory for Laser Energetics where Dr. Demos will continue to
support Imagin’s development team through clinical evaluations and FDA
submittal.
Dr. Ralph deVere White, Medical Advisor.One of the
world’s leading authorities on bladder cancer, Dr. deVere White is the author
of more than 300 peer-reviewed scientific articles. Dr. deVere White is the
director of the UC Davis Comprehensive Cancer Center and a professor of
urology at the university. He will actively consult with the Imagin team as
questions arise about bladder cancer.
Dr. Edward Messing, Chief of Urology at the University of
Rochester Medical Center. Dr. Messing is a renowned expert in the diagnosis
and treatment of cancers of the bladder, prostate, kidney, and other
genitourinary organs. He has conducted extensive research in the basic
biology of bladder and prostate cancers and has been the principal
investigator on numerous clinical studies for the detection, prevention and
treatment of genitourinary cancers. Dr. Messing received his M.D. degree from
New York University, performed his surgery training at NYU-Bellevue Hospital
and his Urology Residency at Stanford University. He was Director of the
Urologic Oncology Program at the University of Wisconsin and assumed his
current position at the University of Rochester School of Medicine and
Dentistry in September 1995.
Consider
While initially focusing on the US$500M bladder cancer market in the
United States Imagin expects that its dual-light, single-screen imaging
system will also set a new standard of care for doctors and surgeons in
detecting many other kinds of cancers. i/Blue offers a more than 100,000X
improvement in sensitivity at revealing cancer cells compared to existing
systems, this should significantly improve patient outcomes.
The Imagin system works with major brands of cystoscopes now in use so
retrofitting , retraining, and peripheral costs are not issues making
Imagin’s practicality a decisive selling point.
Minimally invasive therapy is becoming more and more common in hospitals.
These procedures are performed through tiny incisions (instead of one large
opening) or our body’s natural orifices. The endoscope is the main or central
technological component of minimally invasive therapy.
Imagin’s management has deep medical marketing and product development
expertise with a record of success.
Imagin’s i/Blue system is a disruptive technology with the potential to
achieve multimillion-dollar sales:
- The combined white light/blue light image also allows
the surgeon to operate using a single screen instead of two screens (one
diagnostic, one showing actual tissue), which is currently the most
advanced - and extremely cumbersome - practice.
- Imagin’s system will allow surgeons to begin operations
more quickly - within 15 minutes after dye is administered to the
bladder through a catheter. Current best systems cause a 1-hour delay, a
logistical nightmare in crowded hospitals. The time savings will
potentially reduce healthcare cost by increasing the efficiency of the
Operating Room and enabling the procedure to be performed in the less
expensive physician’s office for follow-up exams.
- Iblue’s greater sensitivity (100,000x) will allow
doctors to remove diseased tissue more thoroughly - which is key to preventing
recurrences.
- 380,000 worldwide new cases of bladder cancer are
diagnosed each year; 76,000 are in the U.S.It is estimated there are
600,000 people in the U.S. living with the fear of their cancer
recurring. The recurrence rate is 40 – 70%. These patients generate 1.8M
physician visits annually as well as additional surgeries.
- $4B is spent in the U.S. on bladder cancer surveillance
annually. It is estimated that over 4M urology endoscopy procedures
(cystoscopies) are performed each year. This makes bladder cancer the
most expensive cancer to treat over the lifetime of a patient, with
approximately 60% of these costs attributable to treatment of
recurrences.
Investor Check list
- Is there a major technological breakthrough that will
change the standard of care in a market?
- Is there a very large patient population that is
significantly underserved and will Imagin’s iblue technology
sufficiently address it?
- Does IME’s technology so significantly change the
economic picture of treating a particular disease that payers will have
almost no choice but to cover it once approved?
- Does iblue reduce the costs of caring for the average
patient? Payers, be they private or public, will be behind the
diagnostics if companies can prove that the tests are effective and that
they save time, money and patients' lives.
- Will iblue get FDA approval?
- Has Imagin’s management team successfully brought other
products to market in previous careers?
Conclusion
Imagin Medical CSE:IME is an opportunity to get in on the ground floor of
a start up business, one having built a truly better ‘mousetrap’ – a
technology that is a far superior product then the standard of care currently
employed in an almost US$50bil global endoscope market.
Imagin Medical CSE - IME,and their significantly improved endoscope
technology, need to be on your radar screen.
aheadoftheherd.com
Richard owns shares of Imagin Medical Inc. (CSE:IME) and Imagin Medical is
an advertiser.
Richard lives with his family on a 160 acre ranch in northern British
Columbia and is the owner of Aheadoftheherd.com.
Richard’s articles have been published on over 400 websites, including:
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Legal Notice / Disclaimer
This document is not and should not be construed as an offer to sell or
the solicitation of an offer to purchase or subscribe for any investment.
Richard Mills has based this document on information obtained from sources
he believes to be reliable but which has not been independently verified.
Richard Mills makes no guarantee, representation or warranty and accepts
no responsibility or liability as to its accuracy or completeness.
Expressions of opinion are those of Richard Mills only and are subject to
change without notice. Richard Mills assumes no warranty, liability or
guarantee for the current relevance, correctness or completeness of any information
provided within this Report and will not be held liable for the consequence
of reliance upon any opinion or statement contained herein or any omission.
Furthermore, I, Richard Mills, assume no liability for any direct or
indirect loss or damage or, in particular, for lost profit, which you may
incur as a result of the use and existence of the information provided within
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