Oran Diagnostics LLC
A medical device company
Monday, October 8, 2012
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Oran Diagnostics, LLC has licensed and is developing and validating novel non-invasive and minimally invasive assays that are based on the measurement of OS (Serum Oxydative Stress) in blood and other biologic and organic fluids and materials using a patented process known as thermochemiluminescence (TCL).
All assays are run on the Company’s proprietary, patented platform technology known as the TCL Analyzer ™. In stark contrast to existing assays for OS that target a single source or particular molecule, TCL analyzes systemic levels of OS, providing critical information about disease status. In short, TCL and the TCL Analyzer ™ are game changers, being the first and only tool available to make OS a useful biomarker.
Oran’s clinical development plan will first focus on two applications. Oran’s lead indication is a non-invasive method for assessing embryo viability for in vitro fertilization (IVF), known as TCL-EV™. TCL-EV™ is performed by analyzing the OS profile of the media in which embryos are cultured. Oran’s second application is an accurate, easy-to use screening test that has been shown to be effective at aiding physicians in risk-stratifying patients diagnosed with heart failure (HF), and is known as TCL-HF™. TCL-HF™ is performed on a venous blood sample.
In addition to clinical applications, Oran will pursue in parallel the utility of OS measurements as a screening tool in the neutraceutical market, allowing manufacturers of antioxidant (AO) supplements and AO-rich foods to establish a direct connection between consumption and reduction of systemic levels of OS.
TCL will also play a key quality control role in biomanufacturing applications. Oran’s mission is to become the leading provider of OS assays to the clinical and scientific community.
The TCL Analyzer ™ is currently the only high throughput, robust, accurate, and cost effective device that can measure OS for practical clinical application. The procedure takes about 10 minutes per sample to complete. Multiple samples can be analyzed in parallel. The device is suitable for routine laboratory use or point-of-care applications and offers a rapid, cost-effective and non invasive or minimally invasive method for measuring systemic levels of OS. The TCL Analyzer™ is in its third generation of development, and has already been used in a wide variety of clinical studies and research applications.
Oran’s lead and secondary clinical indications (TCL-EV™ and TCL-HF™) target a combined addressable worldwide market of over $2 billion. Additional clinical applications, screening applications in the neutraceutical market, and quality control applications in the biomanufacturing sector increase the combined global addressable markets to over $8 billion.
Commercial success of the TCL Analyzer will depend on the accumulation of data demonstrating clinical and commercial utility, including validation of findings made in prior published proof-of-principle studies. The Company’s goal is an initial fund raising target of $1,750,000. This first tranche of $1,750,000 will allow the Company to complete the reengineering and manufacturing of the 4th generation TCL Analyzers, commence execution of validation studies for TCL-EV™, commence additional TCL-HF™ studies, establish collaborations in additional clinical areas as well as the neutraceutical and biomanufacturing sectors and establish company offices in the EU.
Once phase one financing and actions are well under way, the Company expects to raise up to an additional $7,250,000 to support continued development of validated applications and go-to-market activities. Emphasis will be placed on exploitation of the neutraceutical market (low barriers to entry, minimal regulatory concerns, large addressable market); remaining applications will be prioritized based on results of studies.
Oran’s corporate headquarters is located in suburban Philadelphia. Oran is establishing its initial EU presence in France as this gives Oran access to a number of high profile clinical collaborators in infertility, a favorable regulatory environment, access to world class research and development capabilities and a solid foundation from which to conduct a commercial launch throughout the EU and Asia.
TCL and the TCL Analyzer ™ are protected by patents issued in the US, China, Japan, Russia, Canada, Australia, Israel and the EU. There are currently no other technologies that measure OS using TCL.
3 Major Issues
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- Oran’s technology (TCL) has potential application in a wide variety of clinical and consumer product arenas. Credible data has been acquired in two clinical applications; other applications are speculative, but existing research and market demands make for a series of compelling stories.
Which application should we lead with, and why?
- Oran’s co-founder and CEO (me) is a former transactional and regulatory attorney in the life science and health care arena.
That being the case, how should Oran structure the management team to attract investors?
- Phase 1 of Oran’s “go-to-market” strategy consists of building a series of 4th gen instruments, conducting a series of larger, more robust studies using these instruments (a “value creation point”), and use the resulting data to raise a subsequent round of funding to support commercialization (Phase 2). This strategy was designed to minimize the amount of early stage funding required. Feedback on this strategy has intermittently included guidance to raise more money than is needed, because “asking for too little does not look good.” Oran does not need much capital to execute phase 1 of its strategy (the studies are relatively inexpensive—this can be explained separately). This is less than $2M. Funds necessary for commercialization following phase 1 would be substantially larger (>$10M). That said, how should we structure the raise?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Bruce Goldstein, President and CEO of Oran, will deliver the Company's "Elevator" Pitch to the Group
8:20 - A Panel will address 3 Major Issues for the Company
9:00 - Open discussion: members and guests
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