Company Data
Traded Market: CSE - IME
Traded Market: OTC - IMEXF
Outstanding Shares: 61,772,634
Public Float: 41,772,634
52 Week High: $ 0.285, Low: $ 0.07
Web Site:
www.imaginmedical.com
Introduction
Imagin Medical is developing imaging solutions for the early detection of cancer through the use of endoscopes. The Company believes it will radically improve the way physicians detect cancer. Imagin’s initial target market is bladder cancer, a major cancer worldwide, the sixth most prevalent in the U.S., and the most costly cancer to treat due to a greater than 50% recurrence rate. 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.
Developed at the Lawrence Livermore National Laboratory, this advanced, ultrasensitive imaging technology is based upon improved optical designs, patented computer technology and advanced light sensors.
Revolutionary Technology
Imagin Medical is developing the i/Blue™ Imaging System to help detect bladder cancer and reduce its recurrence by dramatically improving the urologist’s ability to visualize, identify and remove cancerous cells.
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 determine feasibility. Imagin has since licensed the technology from LLNL and moved the final stages of development to the University of Rochester Laboratory for Laser Energetics (LLE).
One Image
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 interior of bladder to detect cancer. With this technology, it is well established that malignant lesions may not be visible and not detected during endoscopic examination.
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. IME’s advanced combination of optical/light sensor technology, patented computer technology, white light and near-infrared fluorescence delivers superior images in less than 15 minutes vs. the one hour required by conventional systems. The time savings is expected to increase the efficiency of the Operating Room and reduce healthcare costs by potentially enabling the procedure to be performed in the less expensive physician’s office for follow-up exams.
A second limitation of current imaging technology is 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. This technology requires that the surgeon switch back and forth between the white and blue light images. Why? The white image shows the full landscape of the bladder, but doesn’t highlight the cancer.
Imagin Medical’s i/Blue system cleans, reprocesses, blends and displays the image of the bladder and cancer onto one monitor.
Imagin’s i/Blue system also increases sensitivity for detecting the cancer specific contrast agent by 5 orders of magnitude (100,000X). This advancement improves the surgeon’s ability to detect even flat cancers and to visualize their margins for more complete removal, reducing the risk of recurrence and slowing the progression of the disease.
Investment Highlights
Key Investment Risks Removed, High Investment Return
- Revolutionary technology that will reduce bladder cancer recurrence rates. Expanding from there into other cancers and non-cancer indications
- Limited R&D risks. This is an execution play – Imagin Medical and it’s disruptive game changing technology is the result of years of effort and millions of dollars spent at Lawrence Livermore
- Experienced medical device management team that has done it before
- Strong acquisition market. Most medical device companies grow by acquisition, not organically. Imagin Medical believes that the Company will have significant value and multiple liquidity options.
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.
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
Human clinical trials and regulatory submission will happen in early 2017. Commercial distribution is expected to start in 2018.
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.