As a general rule, the most successful man in life is the man who has the best information
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.
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.
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 Daignaulthas 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.
Richard (Rick) Mills
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:
WallStreetJournal, USAToday, NationalPost, Lewrockwell, MontrealGazette, VancouverSun, CBSnews, HuffingtonPost, Beforeitsnews, Londonthenews, Wealthwire, CalgaryHerald, Forbes, Dallasnews, SGTreport, Vantagewire, Indiatimes, Ninemsn, Ibtimes, Businessweek, HongKongHerald, Moneytalks, SeekingAlpha, BusinessInsider, Investing.com, MSN.com and the Association of Mining Analysts.
Sign up for Ahead Of The Herd’s free
highly acclaimed newsletter.
***
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 this Report.