Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
EMERGING COMPANY SHOWCASE APRIL 13, 2010 CO-HOSTED BY CO-HOSTED BY PECIAL THANKS TO OUR CORPORATE SPONSORS SPECIAL THANKS TO OUR CORPORATE SPONSORS Hibernaid .................................................................. 1 Cell Microsystems....................................................... 3 Enci Therapeutics, Inc. ................................................ 5 BioRxn ....................................................................... 7 Clinical Sensors .......................................................... 9 RealTromins ............................................................. 11 Synereca ................................................................. 13 Vascular Pharmaceuticals, Inc. ................................. 15 G-Zero ....................................................................17 NextRay .................................................................. 18 UNC Emerging Company Showcase, 2010 HIBERNAID, INC. Hibernaid, Inc. has developed a therapeutic approach to lowering body temperature to treat ischemia-reperfusion injury such as acute brain injury. OVERVIEW There are over a million patients that suffer devastating brain injury and there is no pharmaceutical therapy for these patients. Hibernaid, Inc. is a University of North Carolina-Chapel Hill pharmaceutical spin-off company dedicated to development of medications to treat acute brain injury and other ischemia-reperfusion injuries. TECHNOLOGY Cold water drowning victims and cardiac arrest clinical trials demonstrate that lowering body temperature in humans dramatically improves neurological outcome after acute brain injury. Humans are non-hibernating mammals that do not like to cool, so dangerous drugs must be administered to deactivate normal thermoregulatory mechanisms (shivering, vasoconstriction, etc) to allow cooling (hypothermia). Currently, the only methods available to cool patients are external or intravascular devices. Dr. Laurence Katz, founder of Hibernaid, develops pharmaceuticals that lower body temperature by resetting the brain’s thermostat. When the brain’s thermostat is lowered the body spontaneously cools without the need for dangerous drugs or bulky, nonportable cooling devices. Pre-clinical trials demonstrate the success of pharmaceutical resetting of the brain’s thermostat to cool in both small and large mammals with and without acute brain injury. MARKET POTENTIAL Hibernaid develops products that offer the potential to treat or prevent acute brain injury from diseases such as post-cardiac arrest resuscitation syndrome, ischemic and hemorrhagic stroke, traumatic brain injury, subarachnoid hemorrhage, and spinal cord injury. Hibernaid also develops products for the treatment of intractable fever and other potentially life-threatening conditions that currently have limited or no effective pharmacological therapy available to improve outcome. Our first target market will be post-cardiac arrest resuscitated patients, which has a total addressable market of approximately $900 million in the United States with 250,000 annual U.S. cases. There are an additional 500,000 cardiac arrest cases in Europe and Japan each year. Cardiac arrest is a well defined population that has already demonstrated efficacy for improving neurological outcome. HBN-1 Cardiac Arrest 250,000 HBN-2 Traumatic Brain Injury 230,000 The CSO, as an emergency medicine physician and former HBN-3 paramedic, also has experience conducting clinical trials with this Stroke group of patients. In addition, the American Heart Association 780,000 and ILCOR have issued guidelines recommending the use of hypothermia. We also plan to expand into other vital organ ischemia-reperfusion markets (e.g. myocardial infarction) HBN-∞ Other vital organs indications that will require more complex Heart (heart attacks), kidneys (renal failure), etc development programs. STRATEGY Hibernaid’s lead intellectual property, HBN-1, is a pharmaceutical preparation that combines FDA-approved and marketed generic drugs in a single formulation. HBN-1 is intravenously administered to critically ill patients for induction of clinically relevant hypothermia. HBN-1’s combination of vasopressin, lidocaine and ethanol produces an unexpected synergy that induces hypothermia without the unwanted side effects of shivering and other stressors during cooling. HBN-1 produces predictable dose response curves and displays rapid onset without tolerance, respiratory compromise or hypotension. The development program qualifies for the FDA’s 1 UNC Emerging Company Showcase, 2010 expedited 505(b) (2) regulatory/development pathway, which is easier, faster and less expensive to complete than the typical full development effort required to register a new chemical entity for approval. An NDA filing is possible within three years of funding. Hibernaid has completed pre-clinical trials for HBN-1, and 34is preparing to file an IND application and begin Phase 1 clinical trials by mid 2011. Aside from IP and fast track to market, other competitive advantages of our program include the ability to initiate cooling prehospital (portability), no capital startup cost for hospitals (cooling devices range from $30-45,000), a low toxicity profile and an experienced management team. MANAGEMENT TEAM Stephen J. Petti, CEO “Serial entrepreneur”; Successful fund-raiser, company builder and manager, with a demonstrated record of significant ROI exit implementations. Navigated three recent businesses from first money through IPO (eventual $300M market cap), M&A (acquired for $25M+), and a co-development deal (royalties/milestones), each within 3 years. Extensive Pharma and global drug development experience; six NDA’s; Fellow, American Heart Association and Stroke Council; Member, American Society of Hypertension; Member, Society of Critical Care Medicine; Strategic Advisory Board, Glyconix Corp.; Board of Directors, Blue Note Pharmaceuticals. Laurence Katz, MD, CSO and Founder Associate Professor of Emergency Medicine, UNC-Chapel Hill; Co-Director, Carolina Resuscitation Research Group; leading researcher/clinician in the field of regulated hypothermia; experience running acute medicine clinical trials (hospital and pre-hospital). CONTACT INFORMATION Stephen J. Petti, CEO Phone: 518-279-9297 Fax: 518-279-9047 Email: [email protected] Laurence M. Katz, MD, CSO Phone: 919-969-8170 Email: [email protected] 22 UNC Emerging Company Showcase, 2010 Cell Microsystems Cell Microsystems seeks to commercialize a microfabricated cell array platform that enables high quality cell separations for academic and biotechnology research applications. OVERVIEW Cell Microsystems is a UNC-Chapel Hill spin-out based on a new technology for cell separations. The company will sell a simple, affordable solution for performing this common research technique. The IsoRaft line of products will allow for cell isolations to be performed faster, more easily and more efficiently than ever before, enticing thousands of labs worldwide to adopt our product. TECHNOLOGY The innovative IsoRaft technology enables researchers to quickly scan thousands of living cells on a specialized microarray using a standard microscope, to select individual cells of interest and to collect them without harm. Using this technology, biologists and medical scientists will be able to develop completely new cell assays that save weeks of time and effort, allowing them to perform research that hasn’t been technically possible in the past. The technology will be disruptive in the cell isolation and separation marketplace, with the potential of capturing significant market share from competing products. Products: IsoRaft Array The consumable product on which cell isolation and separation takes place. We are able to easily manufacture this product in a non-clean room environment, achieving 95% gross margin. IsoRaft Release Device A small, shoebox-sized control device that allows for use of the IsoRaft Arrays. It mounts onto a standard laboratory microscope. Isolation & Separation Service Cell Microsystems will provide a service in which customers will send us their cells, we perform a separation and send them the resulting isolated clonal cell lines. An IsoRaft Array in a plastic cassette Innovation Separation: Left: Clonal Colonies are isolated and selected on the array. Center: Individual IsoRafts separate clonal colonies while still in adherent state Right: Cells simply grow off the IsoRaft onto tissue culture flask Application: These assays can isolate cancer cells from a fine needle aspiration biopsy, study drugs that cure diseases, and identify stem cells that grow into new tissues. The isolated cells experience no stresses and are completely viable for further growth and expansion. The cells can be rescanned on the array many times, making this technology an extremely attractive alternative to sorting by flow cytometry especially when assays of adherent cells are desired. Cells can be identified based on new sorting criteria that other methods cannot do, for example, cell shape, growth rate or secretion. No other company (including industry leaders) offers a similar product. 3 UNC Emerging Company Showcase, 2010 MARKET POTENTIAL The global $1.3B annual market for cell isolation and separation products hosts an array of expensive, high-tech solutions to biological researchers. Our product will stand completely alone in the low-price space for cell isolation solutions. Our product is 100 times less expensive than competitors while performing better on multiple metrics. It will appeal to academic researchers and small biotechs, both of which are fairly neglected in this market. Achieving even just a 1% market share in a few years will result in millions in revenue. Academic Segment: Academic researchers will be enticed to upgrade from limiting dilution to the IsoRaft Technology based on features and cost benefits. The ability to drastically reduce their isolation and separation project plan time lines and use small sample sizes will be especially enticing reasons to use the IsoRaft System. They will value the abilities to perform cell isolations on very small sample sizes and to sort cell types that have not been previously addressed due to lack of cell survival during the sorting process. All these advantages will provide researchers the opportunity to pursue creation of cell lines or study cells in new, publishable intellectual spaces. In addition to being able to meet all of their needs, the IsoRaft technology will be conveniently available to scientists right in their own lab without the need for a trained technician and complex instrumentation in a core facility. Biotech Segment This segment is driven by the ability to gain a competitive edge over their competition, and will view the IsoRaft system as an enabling technology in order to do so. The same features that are attractive to the academic segment, specifically small sample size and cell type variety, as well as cost savings will be value added criteria. STRATEGY We are currently pre-money and are pursuing seed funding through grant applications. Once funded, the company expects to be able to produce products to place in the laboratories of early adopters. Eventually, the company expects to outsource the manufacture of its consumable microarrays and cell isolation devices, and will focus on marketing its products. A service business to create proprietary cell lines is also contemplated. MANAGEMENT TEAM We are currently in the process of identifying an individual with a proven track record in commercialization of new technologies and a background in the biotechnology industry to address our business needs. CONTACT INFORMATION Nancy Allbritton, M.D., Ph.D. Professor & Chair, UNC/NCSU Joint Department of Biomedical Engineering Professor, Department of Chemistry Email: [email protected], [email protected] Dave McCoy, MBA (Class of 2010) UNC Kenan-Flagler Business School Email: [email protected] Christopher Sims, M.D. Professor, Department of Chemistry Professor, Department of Medicine/Rheumatology Office: 919-962-5203 Mobile: 919-265-8895 Email: [email protected] Yuli Wang, Ph.D. Research Associate, Department of Chemistry Email: [email protected] 44 UNC Emerging Company Showcase, 2010 ENCI THERAPEUTICS, INC. Enci is engaged in the development of a humanized monoclonal antibody as a novel treatment for metastatic breast cancer. OVERVIEW Breast cancer will affect 1 in 8 women in their lifetime, and 40,000 women die annually from this disease. Avastin, in combination with chemotherapy, is first line therapy for patients with Her2/neu negative metastatic breast cancer. Despite the clinical and commercial success of this agent, 70% of patients with metastatic breast cancer are unresponsive to Avastin; further, of those that respond, almost all will progress and die. Therefore there is a critical need to develop angiogenesis inhibitors that will be effective in patients with tumors resistant to Avastin. Enci Therapeutics, Inc. is developing a humanized monoclonal antibody (for which the company has intellectual property) to attack a separate and independent angiogenesis pathway by blocking the activity of SFRP2: a newly discovered protein that promotes angiogenesis and tumor progression in animal models. This agent blocks tumor growth in animal models and based on its mechanism of action may be synergistic with Avastin or work in Avastin-resistant tumors. We believe that endotuzumab, in combination with Avastin and chemotherapy, will improve overall survival in patients with metastatic breast cancer compared to Avastin and chemotherapy alone. TECHNOLOGY The scientific basis for Enci Therapeutics’ technology can be found in 2 scientific publications [Am. J. Path. 172(5):1381-1890 and Cancer Res. 69(11):4621-4628] and in our patent application “Discovery of Novel Targets for Angiogenesis Inhibition”. Our goal was to discover novel angiogenesis targets in breast cancer, and to this end, the founding scientists developed a technique to perform rapid immunohistochemistry and laser capture microdissection of breast tumor vessels and normal vessels, where the quality of the RNA was intact for microarray analyses. The RNA was hybridized to cDNA-microarrays, and gene expression profiles of tumor and normal endothelium were compared. This identified a large number of genes uniquely overexpressed in tumor endothelium, many that encode membrane and secreted proteins which are potential targets for monoclonal antibody development. The founders choose to focus on SFRP2 because this is a secreted protein that has not previously been described to be involved in angiogenesis. Subsequent studies have shown that SFRP2 stimulates angiogenesis in a mouse Matrigel angiogenesis assay in vivo, and activates cellular processes required for angiogenesis by inducing endothelial migration, tube formation, and protecting against apoptosis. Silencing SFRP2 in a malignant endothelial cell tumor (angiosarcoma) resulted in a loss of the ability of the malignant vessels to form tubes, an important component of blood vessel formation. Based on the high expression of SFRP2 in tumor vasculature and its important contribution to angiogenesis, a mouse monoclonal antibody to SFRP2 has been generated that inhibits malignant endothelial cell tube formation in vitro with an IC50 of 5 ug/ml, and inhibits angiosarcoma xenograft growth in vivo at a dose of 4 mg/kg i.v. twice weekly by 66%. No toxicity has been seen at a dose 5 times higher (20 mg/kg), indicating that there is a large therapeutic window. The mechanism through which SFRP2 mediates angiogenesis is through the calcineurin/ NFAT pathway. NFAT is a transcription factor responsible for the transcription of gene involved in angiogenesis, and it is noteworthy that the angiogenic effects of VEGF are also mediated through NFAT activation, but via a different receptor. This suggests that a potential reason for resistance to Avastin is that Avastin is only blocking one of the stimuli of the calcineurin/ NFAT pathway; therefore blockade of both SFRP2 and VEGF may more completely decrease the transcription and halt angiogenesis (leading to an additive effect of endotuzimab and Avastin). MARKET POTENTIAL The potential markets for endotuzimab include oncology and age-related macular degeneration. Our initial focus will be in the Oncology Market, which is a 60 billion dollar industry. SFRP2, the target of endotuzimab, is expressed in a broad variety of tumors (breast, colon, prostate, lung, liver, ovarian, angiosarcoma, pancreas, and renal cell) which are the largest markets in oncology. Therefore endotuzimab ultimately could be useful for a large range of oncology patients. Present therapies with angiogenesis inhibitors include Avastin (a monoclonal antibody to VEGF). We believe that endotuzimab will be better than Avastin, synergistic with Avastin, or work in Avastin-resistant tumors. Avastin is FDA approved for 5 cancers, of which its poorest efficacy is in breast cancer. 5 UNC Emerging Company Showcase, 2010 We have chosen to focus our efforts on showing efficacy of endotuzimab first in patients with metastatic breast cancer, as this would be the easiest entry into the market. There are 150,000 patients living with metastatic breast cancer, and therefore our total addressable market is $8 billion yearly (150,000 patients yearly with a charge of endotuzimab at $53,000 per year). We predict the number of metastatic breast cancer patients that will receive endotuzimab is equivalent to the number of patients receiving Avastin (15,000) which is our target penetration. Assuming an adoption rate of 20% in the first year and an increase by 5% yearly for 5 years, we estimate our 5 year revenue to be 2 billion (39,000 patients x $53,000). STRATEGY Our strategy is to humanize the SFRP2 antibody and conduct pre-clinical GLP toxicology to file an IND with the FDA. We will then perform a first in human Phase I clinical trial, followed by a Phase II randomized trial in patients with metastatic breast cancer. Our exit strategy is a merger and acquisition strategy with a large pharmaceutical company after showing efficacy in Phase II trials. MANAGEMENT TEAM Drs. Patterson and Klauber-DeMore will serve as the company CEO and CSO respectively until full-time executives are identified and recruited. Cam Patterson M.D., M.B.A., F.A.C.C., F.A.H.A. Dr. Patterson is the Director of the UNC McAllister Heart Institute and Chief of Cardiology at UNC, and received an MBA from UNC Kenan-Flagler Business School. Professor of Medicine (Cardiology), Pharmacology, and Cell and Developmental Biology; Ernest and Hazel Craige Distinguished Professor of Cardiovascular Medicine; Chief, Division of Cardiology; Director, UNC McAllister Heart Institute; Associate Chair for Research, Department of Medicine, UNC-CH School of Medicine. Nancy Klauber-DeMore M.D. Dr. Klauber-DeMore is a surgical oncologist at UNC who received her training at Memorial Sloan-Kettering Cancer Center, and research training in Dr. Judah Folkman’s lab at Harvard (Dr. Folkman founded the field of angiogenesis). Associate Professor of Surgery, UNC-CH. Preclinical and clinical studies will be outsourced through highly experienced CRO’s, most likely in the RTP area. The Advisory Board includes Christy Shaffer, former CEO of Inspire Pharmaceuticals; Larry Robbins, from Wyrick, Robbins, Yate & Ponton law firm; and Dr. Lisa Carey, Associate Professor, Medical Oncology at UNCCH; Director, UNC Breast Cancer Center. CONTACT INFORMATION Dr. Cam Patterson, M.D., M.B.A., F.A.C.C., F.A.H.A., Founder and Chief Executive Officer Office: 919-843-5201 Email: [email protected] Nancy Klauber-DeMore, Founder and Chief Scientific Officer 170 Manning Drive Physician's Office Bldg., CB #7213 University of North Carolina Medical School Chapel Hill, NC 27599 Office: 919-966-8007 Email: [email protected] 66 UNC Emerging Company Showcase, 2010 BioRxn BioRxn has patent-pending technology for swine waste bioconversion to electricity with a business model to manage this energy from hog farm to the utilities. OVERVIEW Each year in the United States, 50 million hogs produce enough waste to generate millions of tons of methane, all of which evaporates, creating a greenhouse gas 20-times more hazardous than carbon dioxide. BioRxn has developed a novel, highly-efficient, patent-pending, bio-reactor that uses a community of microorganisms to convert hog waste into methane which can then be converted into electricity via a generator. In so doing, BioRxn is capable of addressing nearly $1 billion in retail electricity needs. Unlike that of our competition, our product is fully compatible with existing hog operations and is more cost effective. Major milestones: 2011: Install “works like” prototype bioreactor capable of servicing 100 hogs. 2012: Raise $1MM to fund our first 10 production bioreactors and to fund R&D on a scaled up bioreactor. Install our first bioreactors capable of servicing 750 hogs each and begin to generate revenues through the sale of electricity to NC utilities. 2013: Expand to other key pork producing states where there is favorable renewable energy legislation. 2015: Become profitable. Expand to other key countries such as India and China. 2016-17: Break even. TECHNOLOGY BioRxn is developing a patent-pending gas-lift multi-phase bioreactor utilizing a community of specialized microorganism to convert hog waste into methane and innocuous fertilizer, three times faster than today’s state-of-theart technology. Each phase of the bioreactor will perform a specific function thereby promoting efficiency. A novel aspect of our technology is that it works with unprocessed hog waste, allowing us to install our bioreactor on the hog farm. All of these attributes combined will enable BioRxn to produce the most methane possible and be more cost-effective than our competition. MARKET POTENTIAL $30MM in NC alone: North Carolina is one of 28 states that have adopted renewable energy portfolio standards, REPS; more specifically, North Carolina prescribes that 0.2% of the retail electricity must come from energy derived from hog waste by 2018, approximately 300,000 MW-hr, nearly $30 million in electricity value. Such energy can be derived from anaerobic digestion. Compared to photovoltaic solar, anaerobic digestion of biomass is expected to be quite cost competitive; as such we expect to be a preferred provider of electricity derived from renewable sources. There are 10 million hogs in North Carolina, another 40 million hogs in the rest of the US, and another 450 million hogs outside the US. In order to achieve our revenue projections of approximately $35 million in 2016, we will require an installed base of approximately 730 bioreactors servicing just over 2.3 million hogs. 7 UNC Emerging Company Showcase, 2010 STRATEGY • Establish patent-protected position. • Develop, own, install and maintain our proprietary bioreactors on hog farms. • Leverage government credits, rebates and offsets to reduce cost structure. • Establish long-term alliances with hog farmers, providing them with cost reductions in exchange for exclusive access to hog waste. • Launch in NC, expand to rest of US and rest of world thereafter. • Enter into power purchase agreements with utilities, enabling them to meet mandates for renewable energy. • Refine and optimize microorganism communities to achieve faster and more efficient conversion of waste into power. • Develop bioreactors to create revenue from other waste streams: poultry, cattle, human. MANAGEMENT TEAM Jeff Macdonald, PhD., CTO and Co-founder • Associate Professor of Biomedical Engineering, UNC-CH School of Medicine with joint tenure at NCSU. • Scientific Director of the UNC-CH Metabolomics Facility. • Co-Scientific Director of the NCSU/UNC/NOAA Marine MRI Facility at Beaufort. • Ph.D., UC-San Francisco, Department of Pharmaceutical Chemistry. • M.S., UC-Davis, Environmental Toxicology. • B.S., UC-Santa Barbara, Aquatic Biology. Andrey Tikunov, PhD., R&D and co-founder • PhD, Biophysics, Russian Academy of Medical Science, Hematology Research Center. • B.S. and M.S., Physics and Biophysics, Moscow State University. Mike Van Hoy PhD., MBA, Scientific and Business Advisor • 16 years of industrial experience in human diagnostics: R&D, operations, and business development. • PhD, Biochemistry, UT-Austin. • MBA, Strategic Management and Finance, University of Chicago Booth Graduate School of Business. • B.A., Biochemistry, Molecular and Cell Biology, Northwestern University. CONTACT INFORMATION Jeff Macdonald, CEO Office: 919-843-5154 Mobile:919-928-2163 Email: [email protected] S 88 UNC Emerging Company Showcase, 2010 CLINICAL SENSORS Clinical Sensors is developing a miniaturized catheter nitric oxide sensor for the early detection of sepsis to save lives, reduce complications in ICU’s, and decrease health care costs related to the treatment of sepsis. OVERVIEW Clinical Sensors, Inc. was established in 2009 to develop sensors for diagnosing infection in Intensive Care Units (ICUs) and assessing prognosis upon treatment. The company is focused on the development of miniaturized sensors for analysis of sepsis biomarkers to save lives, reduce complications, and decrease health care costs related to the treatment of sepsis. Sepsis, a severe blood infection, is the leading cause of death in non-cardiac ICUs, and the 10th leading cause of death overall in the United States; its occurrence continues to increase at an alarming rate. Sepsis is the result of bacteria that colonize on catheters, and is most problematic for critically ill and immuno-compromised patients that are treated in the ICU. Currently, the diagnosis and treatment of sepsis takes place only when the patient becomes symptomatic (e.g. fever, irregular heart beat and/or blood pressure). At that stage, the infection has evolved considerably and is difficult to treat. Early detection and action are critical for preventing sepsis-related morbidity and mortality, as well as monitoring the effectiveness of its treatment. Current ICU protocol does not allow for sepsis avoidance, as detection is based on symptoms that only become evident after progression of the infection. TECHNOLOGY It is well known that both nitric oxide and nitrosothiol levels are elevated in the human body as an immune response to infection. As such, a device capable of monitoring these biomarkers would be useful for detecting sepsis prior to the onset of major infection and symptoms. To date, these biomarkers have proven notoriously difficult to measure because of inadequate point-of-care technology and interferents in blood. Clinical Sensors, Inc. has negotiated an exclusive license from UNC-Chapel Hill to develop products based on a unique sensor membrane that allows rapid, sensitive, and selective measurement of both nitric oxide and nitrosothiol concentrations in blood (PCT/US2007/018718, Prov. App. No. 61/153,763). Briefly, this technology is based on a polymer membrane that can be easily applied onto a platinum electrode of any geometry to selectively measure nitric oxide over all problematic interferents in blood. This methodology inherently allows for miniaturization and the fabrication of sensors to measure nitric oxide/nitrosothiol levels in blood. In this manner, medical staff may monitor key sepsis biomarker concentrations, allowing for earlier intervention and more effective treatment. MARKET POTENTIAL In 2007, there were 750,000 cases of severe sepsis, resulting in 215,000 sepsis deaths. Over $17 billion is spent treating sepsis yearly. As of October 2008, Medicare stopped all reimbursement for hospital-acquired infections. In turn, hospitals must accept the financial burden of treating ICU patients that become septic, and are thus extremely interested in anti-sepsis technologies. Currently, no early detection devices for sepsis 2 exist. In fact, sepsis is only tested for after the patient develops symptoms. Although two companies manufacture and sell large diameter NO sensors, the selective membranes employed do not allow for sensor miniaturization. PCR and other clinical lab-based techniques lack analysis speed and are more likely complementary to our line of products. STRATEGY Clinical Sensors, Inc. aims to provide a circuit board (razorblade) that reads the output of a disposable sensor (razor) and interfaces to conventional blood gas analyzers. Initial research is focused on establishing the exact timeline for which nitric oxide and nitrosthiol concentrations change, and correlating such concentrations and their rate of change with sepsis severity. Due to the versatility of the sensor membrane technology (e.g., ability to coat any sensor geometry), a secondary program includes developing needle-type nitric oxide sensors to enable wound-healing prognosis of open wounds such as diabetic foot ulcers. Clinical Sensors, Inc.’s business strategy is to operate the company with a lean infrastructure until preclinical testing with the prototype sensors is complete. At that stage, grant funding and/or other fund raising will facilitate clinical studies. 9 UNC Emerging Company Showcase, 2010 MANAGEMENT TEAM Mark Schoenfisch, PhD, Founder Dr. Schoenfisch is a Professor in the Department of Chemistry at the University of North Carolina at Chapel Hill and the founder of Clinical Sensors, Inc. He currently leads all product development and prototype testing. Dr. Schoenfisch has a long history of developing bioanalytical sensors for clinical applications. He is co-founder of Novan, Inc., a successful nanotechnology-based company headquartered in Research Triangle Park, NC. Mr. Kenneth Eheman (General Counsel) Clinical Sensors is represented in legal matters by Mr. Ken Eheman of Wyrick Robbins Yates & Ponton. Mr. Eheman practices in the area of corporate and securities law, including company formation, venture capital financings, private placements, public offerings, mergers & acquisitions and strategic partnerships. At this stage, Dr. Schoenfisch is actively seeking a partner to assume day-to-day management roles and accelerate meeting the above objectives through fund-raising activities and project management. CONTACT INFORMATION Mark H. Schoenfisch, PhD Clinical Sensors, Inc. E-mail: [email protected] 10 UNC Emerging Company Showcase, 2010 REALTROMINS, INC. REALTROMINS is an intelligent monitoring technology for the ICU to continuously assess the changing severity of illness of pediatric patients, and track the success or failure of medical interventions ordered by physicians. OVERVIEW REALTROMINS is a new family of advanced medical devices that provides an early warning to track vital changes in critically ill or hospitalized patients thus identifying high risk individuals to facilitate immediate changes in medical management; improve patient safety and outcomes; and reduce healthcare costs. TECHNOLOGY REALTROMINS is a patent pending (PCT International Application No PCT/US2007/012736) healthcare IT solution that integrates and analyzes numerous data streams, such as: 1. real time continuous physiologic signals (electrocardiogram); 2. advanced measures of variability of these signals (spectral analysis); 3. physiologic based measures of organ function (serum glucose) and their variability; 4. demographic predictors of mortality; creating a real time, continuously updated risk of mortality score in critically ill and hospitalized children and adults to help clinicians guide these patients back to health. REALTROMINS employs advanced computerized signal processing, statistical analyses, and neural network techniques to allow practitioners to better match resources and treatment to the patient’s changing condition resulting in improved patient safety, decreased mortality and reduced hospital costs. MARKET POTENTIAL Annual global revenue for all monitors (adult, pediatric, neonatal) is estimated at $1.2 billion with 90% of sales in adult ICUs, 8% in neonatal ICUs, and 2% in Pediatric ICUs. Our initial entry to market targets sales to all pediatric hospitals in the US where there are ~ 5500 PICU, 22,000 NICU, and 110,000 non ICU pediatric beds. Additional medical devices are currently being developed for use in adult ICU and non ICU patients where there are an estimated 87,500 ICU beds and 900,000 non ICU beds in the US. The average price per bed for an ICU monitor is between $15,000 and $35,000 while the list price of each REALTROMINS monitor is $15,000. Market expansion to Europe, Canada, Australia, China and Japan will follow. STRATEGY REALTROMINS is currently preparing for the FDA a 510K application for a class II medical device for use in the Pediatric ICU (PICU REALTROMINS). Applications for the Neonatal REALTROMINS and Pediatric Rapid Response REALTROMINS devices are being created concurrently. Once approval is obtained, a clinical trial will be performed to validate the utility of these devices outside of the research hospital (UNC Hospitals). Development of the 2 adult devices (Adult Rapid Response REALTROMINS and Adult ICU REALTROMINS) is currently underway with FDA applications and clinical trials to follow. The intellectual property for this family of medical devices is protected by a pending PCT International Application (No PCT/US2007/012736) and 2 provisional patent filings. The major hurdles to gaining customer acceptance (physician and nurses) will be demonstrating the advanced predictive capabilities of REALTROMINS. This device must have a high degree of sensitivity in identifying impending death AND specificity in limiting false alarms. This will then be used to help guide the necessary interventions required to return these children to health. This will decrease overall mortality and morbidity of critically ill and hospitalized children. The second hurdle will be to convince hospital administrators that purchasing the technology will have advantages to the bottom line. This will be accomplished by: 1) better matching resources to clinical needs thus decreasing costs of expensive human resources, 2) improved bed utilization (ICU vs ward) and 3) shorter length of hospital stay; 4) improved patient safety. In aggregate, this will lead to improved brand value for the health care system. The management team to bring these devices to market is being broadened as FDA 510K submission/approval approaches. 11 UNC Emerging Company Showcase, 2010 MANAGEMENT TEAM REALTROMINS, INC (Chapel Hill, NC USA) management teams consists of: Board of Directors • Keith Kocis, MD, MS, Chairman, and Chief Medical Officer • Daniel Kocis, PhD, President and Chief Technology Officer • Z Haroon, MD, PhD, Business Development Scientific Advisory Board • Charles Schmitt, PhD, Computer Scientist • Stephen Quint, PhD, Biomedical Engineer CONTACT INFORMATION Keith C. Kocis, MD, MS, Co-Founder REALTROMINS 507 Highgrove Drive Chapel Hill, NC 27516 Phone: 919.880.4041 Online: http://REALTROMINS.com http://www.linkedin.com/in/drkeithkocis Email: [email protected] 12 UNC Emerging Company Showcase, 2010 SYNERECA Synereca Pharmaceuticals is developing orally active drugs that target a universal process essential for bacterial survival of antibiotics, which will address the growing problem of bacterial resistance to current antibiotics by restoring or increasing the effectiveness of existing antibiotics. OVERVIEW Synereca Pharmaceuticals was created to address the growing problem of bacterial resistance to current antibiotics by developing orally active drugs that restore or increase the effectiveness of existing antibiotics. The company will initially target a novel, universal process that’s essential for bacterial survival of antibiotics. RecA is a key protein in this pathway that has been the focus of research in laboratory of co-founder Dr. Scott F. Singleton at the UNC Eshelman School of Pharmacy. Synereca’s prototype RecA inhibitors potentiate the killing of a variety of bacteria by a range of antibiotics, including fluoroquinolones and β-lactams, antibiotic classes with over $10 billion in annual global sales. TECHNOLOGY Recent discoveries revealed that bactericidal antibiotics act through a final common pathway of DNA damage, and that inhibiting DNA repair potentiates killing by these antibiotics. Synereca’s initial target is RecA, a key DNA repair enzyme whose actions are essential for bacteria to survive antibiotic treatment. The company plans to develop RecA inhibitors for use in combination therapy with existing antibiotics. RecA is a ubiquitous bacterial protein, with a sequence that is highly conserved across all bacteria. The bacterial SOS response is an inducible survival system that allows bacteria to repair sudden increases in DNA damage. RecA’s two best-characterized biological activities are (1) activating the bacterial SOS response, and (2) directly participating in SOS as a DNA repair enzyme. These RecA functions have been studied in a number of organisms, including the pathogens E. coli, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Neisseria gonorrhoeae, Neisseria meningitids, Streptococcus pneumoniae, Mycobacterium tuberculosis, and Bacillus subtilis (as a surrogate for Anthrax). Although different antibiotic compounds target different biomolecules in a bacterium, the antibiotics that kill bacteria outright share a common mechanism of killing. These bactericidal antibiotics all change the bacteria’s metabolism so that hydroxyl radicals are produced. In turn, the highly reactive radicals damage all biomolecules inside the bacterial cell, especially the DNA. It is the resulting DNA damage that leads to bacterial death. The SOS pathway allows the bacteria to repair the damage to their DNA and survive all but the highest doses of antibiotic. It is well established that RecA mediates the abilities of bacteria such as E. coli, S. aureus, and P. aeruginosa to overcome the DNA-damaging radicals induced by a range of antibiotics. For fluoroquinolones, βlactams, and aminoglycosides, ∆recA strains (lacking RecA) are highly sensitized to the antibacterial agent, improving the sensitivity of E. coli to ciprofloxacin by 16 fold. Cell-permeable small molecules that inhibit RecA could act as strong adjuvants for traditional antibacterial chemotherapies by increasing the therapeutic index. In support of this hypothesis, Dr. Singleton and co-workers previously identified RecA inhibitors by high-throughput screening. The most active hit inhibits RecA’s activities, ttenuates SOS gene activation, and potentiates killing by ciprofloxacin, ampicillin, kanamycin, chloramphenicol, and mitomycin C. Further preliminary results suggest that this prototypic RecA inhibitor is effective against S. aureus, Salmonella, N. gonorrhoeae, and B. subtilis in addition to E. coli. The potentiation of ciprofloxacin’s antibacterial activity by the RecA inhibitor is substantial: a 0.5xMIC dose of ciprofloxacin combined with the RecA inhibitor kills a million-fold more E. coli than without the inhibitor; a 0.5xMIC dose of ciprofloxacin combined with the RecA inhibitor kills E. coli as effectively as 5xMIC dose of ciprofloxacin alone; and the RecA inhibitor reduces the MIC for ciprofloxacin four-fold. In late 2009, Singleton lab personnel screened more than 100,000 compounds of known diverse structures, which were optimized for oral bioavailability and ease of formulation, in the recently established UNC Center for Integrative Chemical Biology and Drug Discovery. The screen identified 235 new inhibitors of RecA in at least 12 chemical structure classes. 13 UNC Emerging Company Showcase, 2010 MARKET POTENTIAL The annual sales of antibiotics are over $36 billion for the major world markets. The market is fragmented: the top ten products account for only 25% of revenues. The remaining 75% comprises hundreds of generics and niche products. The market is segmented both by indication and by the antibiotic class. The most common sites of infection are the lungs, skin, urinary tract, and there are more than 218 million of these infections in the US, Japan, and Europe annually. Because the killing mechanism of bactericidal antibiotics is common among the different classes and RecA is found in nearly all pathogenic bacteria, RecA inhibitors that potentiate bacterial killing could be applied to antibiotics accounting for nearly 90% of the current markets. STRATEGY The discovery of antibiotics in the first half of the 20th century reduced the mortality from infectious diseases in the developed world by 95%, and by the 1970s it was widely believed that bacterial diseases had been conquered. That prediction was overly optimistic: the infectious disease mortality rate jumped by 75% in the period 1980 – 1995, largely due to antibiotic resistance. About 2 million people acquire bacterial infections in U.S. hospitals each year and 90,000 die as a result. Thus, hospital-acquired infections kill more people than HIVAIDS or diabetes each year. Importantly, about 70% of those infections are resistant to at least one of the major classes of antibiotics that had previously been used for treatment. Despite these statistics, the development of new antibiotics has slowed to a crawl: only two antibiotic classes with novel mechanisms of action have been discovered in the last 40 years. Synereca’s strategy represents a fresh approach. Rather than develop new antibiotics in the traditional sense, Synereca will develop RecA inhibitors that synergize existing antibiotics and re-arm them to fight resistant infections. Because the killing mechanism of bactericidal antibiotics is common and RecA is ubiquitous, multiple combination products can be envisaged. This strategy can also be used to develop potentiators of future antibiotics. In addition, in the face of competition from lower-priced generics as patents expire, the launch of fixed-combination drugs (antibiotic plus RecA inhibitor) can either extend the brand or establish an entirely new franchise. MANAGEMENT TEAM Scott F. Singleton, Ph.D. – President and CSO Dr. Singleton is the company’s scientific founder and will continue on the faculty of the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. Dr. Singleton’s research on RecA and its roles in antibiotic resistance has been funded by the NIH since 1998, and he is corresponding author on 20 peerreviewed publications concerning RecA. He holds a Ph.D. in Organic Chemistry from Caltech. W. Bennett Love – Vice President, Business Operations Mr. Love, a co-founder, has held senior management positions in biotech companies since 1990, most recently as Vice President, Business Operations, for Ercole Biotech, Inc., an RNA therapeutics company. Stephen B. Bocckino, Ph.D. – Vice President, Preclinical Research Dr. Bocckino, a co-founder, has 19 years experience in the pharmaceutical industry in a variety of positions in drug discovery and development. He was Vice President of Preclinical Development at Entegrion, and prior to that at Incara Pharmaceuticals, Eli Lilly and Sphinx Pharmaceuticals. He received his Ph.D. in Pharmacology and Toxicology from Rutgers University. Clayton I. Duncan – Chairman of the Board of Directors Mr. Duncan, a co-founder, is an experienced financial and biotech executive who has served for the past 19 years as a CEO in the biotech industry, at CRX Medical, Inc. (subsequently Closure Medical, acquired by Johnson & Johnson), Sphinx Pharmaceuticals Corporation (acquired by Eli Lilly), Incara Pharmaceuticals Corporation, Entegrion, and Ercole Biotech, Inc. (acquired by AVI Biopharma). CONTACT INFORMATION Scott F. Singleton, Ph.D. Synereca Pharmaceuticals, Inc. E-mail: [email protected] 14 UNC Emerging Company Showcase, 2010 VASCULAR PHARMACEUTICALS, INC. Vascular Pharmaceuticals, Inc. is focused on the development and commercialization of novel therapeutics targeting the treatment of diabetes associated complications. OVERVIEW Vascular Pharmaceuticals, Inc (VPI) is a biotechnology company that was founded in 2006 by Dr. David Clemmons based on technology developed at University of North Carolina School of Medicine. The company is focused on the development and commercialization of novel therapeutic products that prevent diabetes related complications such as accelerated atherosclerosis, retinopathy and nephropathy. The company is currently operating as a virtual entity that subcontracts much of the drug development effort to maximize capital efficiency. Our current development efforts are supported by non-dilutive funding including a $1.1M National Institutes of Health STTR Phase II grant and a development partnership with Johnson and Johnson. Our scientific portfolio includes three discoveries from the Clemmons’ laboratory that have been licensed from UNC. Our current focus is on advancing our lead program into human trials by the beginning of 2012. TECHNOLOGY Our most advanced program involves a monoclonal antibody that inhibits ligand occupancy of a specific site (cloop domain) on the cell surface receptor αVβ3 integrin. The αVβ3 receptor is a component of the insulin-like growth factor-I (IGF-I) signaling pathway which has been shown to stimulate smooth muscle cell division and migration, processes necessary to sustain atherosclerotic lesion development. Unlike the IGF-I receptor which is broadly distributed in tissue types, αVβ3 expression is primarily restricted to the vasculature and thus offers a focused approach for smooth muscle cell inhibition specific to plaque development. In addition, the αVβ3 receptor is over-activated in response to hyperglycemia, thereby magnifying its influence in diabetics. Thus, αVβ3 represents an attractive target for selectively inhibiting the unwanted vascular effects of IGF-I in diabetic patients. The monoclonal antibody has been humanized to avoid immunogenicity and is currently in the final testing phase prior to initiating GMP manufacturing. The target αVβ3 integrin is expressed in a limited number of cell types and therefore off target effects should be minimal. Although this is a protein drug, the antibody halflife and potency indicate that once a week subcutaneous administration should be feasible. The antibody has been shown to be efficacious in a porcine model of diabetes and atherosclerosis. It inhibited lesion formation by approximately 58%. Currently this result is being verified in the same animal model using systemic injections. The Company has received a Notice of Allowance in the U.S. and a Decision to Grant from the EU for patents encompassing both the C-loop binding site and functional claims around the effect of inhibition. The patents in both regions will issue in 2010 and an application is pending in Japan. Additional patents are currently pending on two other approaches to inhibit diabetic complications. MARKET POTENTIAL The Centers for Disease Control (CDC) estimates there are over 24 million diabetics in the U.S., while another 57 million adults have pre-diabetes. The health complications associated with the disease are significant ad include enhanced cardiovascular risk, renal impairment, blindness, and peripheral nervous system damage that can lead to amputations. The annual direct healthcare cost of diabetes is estimated at $116 billion, and diabetics incur approximately 2.3 times the healthcare expenditures as non-diabetics. The morbidity and mortality associated with diabetes are significant; the death- rate attributable to heart disease in diabetic adults is approximately 2-4 times that of non-diabetic adults. Based on an assessment of the tradeoff between level of unmet need and clinical development feasibility, we have identified diabetic patients with rapidly progressing coronary atherosclerotic lesions as our initial target population. Approximately 450,000 diabetic patients per year undergo angioplasty in the United States. If these patients are catheterized 15 UNC Emerging Company Showcase, 2010 one year later, at least 50% have significant atherosclerotic lesion progression, highlighting the inadequacy of current treatment options. Given the relative ineffectiveness of statin therapy in effectively treating coronary artery disease in diabetics and the high level of medical costs incurred by this population, chronic care mAb therapies such as Humira and Enbrel represent appropriate price references when estimating revenue potential in this population. The average cost for these agents is approximately $20,000 per therapy year. Assuming a conservative estimate of $10,000 per therapy year for our αVβ3 inhibitor, the revenue potential for the U.S. market alone for this patient population is $2-3billion. Additionally, it is possible that the antibody will be very effective in patients who may develop strokes or in whom amputations are required due to non-healing leg ulcers. Therefore there is potential for further market expansion for other indications based on the same pathophysiologic process. STRATEGY Our strategy going forward is to continue to operate as a virtual entity. We will subcontract for cell line development, GMP manufacturing, toxicology assessment, and Phase 1 clinical trials. We believe that by focusing our efforts on this target, completing milestones and appropriate selection of third party vendors we can achieve the most rapid and most likely successful pathway to initiation of Phase II proof of concept studies. The company will continue studies in various animal models to assess the efficacy of this drug in diabetic retinopathy, nephropathy and nonhealing leg ulcers. Additionally, the two other approaches to targeting diabetic complications licensed to VPI are being evaluated. MANAGEMENT TEAM Dr. David R. Clemmons, Founder and Chief Scientific Officer VPI’s scientific development programs are led by Founder and Chief Scientific Officer Dr. David R. Clemmons, whose laboratory discovered the technologies around which VPI development programs are based. Dr. Clemmons has 33 years experience in developing methods to assess biologic and pathophysiologic actions of IGF-I. Dr. Laura Maile, Co-Founder Working closely with Dr. Clemmons is Co-founder Dr. Laura Maile, VPI’s principal company research scientist. Laura has worked for 11 years in the area of IGF-I and the development of diabetes related complications. Richard Shea, CEO Business operations of the company are led by Richard Shea who brings eighteen years of life sciences industry management expertise to his role as Chief Executive Officer. Rich’s experience includes leadership positions across the pharmaceutical value chain including marketing, managed care, sales management, business development, manufacturing, strategic planning and clinical development at both Merck and within smaller entreprenuerial organizations. Dr. Ken Williams, Chairman of Board of Directors Dr. Williams works with Richard Shea to define VPI’s business strategy. Ken spent 20 years of as Vice President of Development for Quintiles and has significant expertise in the pre-clinical program design and execution, IND filing and Phase I/II clinical trials. Our management team has the broad skill base and experience to successfully progress VPI’s development programs over the next three years. CONTACT INFORMATION VPI, Inc. corporate headquarters is based in Burlington, North Carolina. The research laboratories are based at the UNC School of Medicine. Scientific information: Business development information: 919-966-4735 or [email protected] 919-345-7933 or [email protected] 16 UNC Emerging Company Showcase, 2010 G-ZERO THERAPEUTICS G-Zero Therapeutics is focused on the protection of bone marrow from radiation and chemotherapy-induced DNA damage through GZ’s proprietary PharmacoQuiescence™ (PQ™) mechanism which selectively arrests hematopoietic stem and progenitor cells in the G0/G1 phase of the cell cycle. OVERVIEW G-Zero Therapeutics (GZ) is a small biopharmaceutical company focused on the protection of bone marrow from radiation and chemotherapy-induced DNA damage through GZ’s proprietary PharmacoQuiescence™ (PQ™) mechanism which selectively arrests hematopoietic stem and progenitor cells in the G0/G1 phase of the cell cycle. TECHNOLOGY GZ’s PQTM mechanism works through selective inhibition of kinases, Cdk4 and Cdk6, whose activity drives the cell cycle in hematopoietic stem and progenitor cells (HSPCs). This results in a cell cycle arrest in the G0/G1 phase of the cell cycle of HSPCs. Importantly, most other proliferating cells (including other blood cells) do not require Cdk4/6 activity for proliferation, and therefore such inhibitors do not cause the general toxicity of more global anti-proliferative drugs. In fact, Cdk4/6 inhibitors have been given for prolonged periods to humans (Pfizer) and mice (GZ and others), and such agents have little toxicity at doses which effectively inhibit HSPC proliferation. The HSPC-specific cell cycle arrest protects these cells from chemotherapeutic agents that work through inhibition of DNA replication and whose mechanism of action is S-phase specific. Likewise, the cell cycle arrest prior to or after radiation exposure allows DNA repair within the HSPC cells. MARKET POTENTIAL The US chemoprotection market size is 4 to 8 billion dollars based on the current cytokine-based therapies. This estimate depends on the incidence of Cdk4/6-resistant cancers, and relies on the use of a routinely used clinical diagnostics to determine eligible patients. The US radioprotection market is estimated to be 500+ million dollars. STRATEGY GZ is currently in negotiations to in-license a potent and selective clinical-grade Cdk4/6 inhibitor from a major pharmaceutical company. GZ is in advanced stages (having signed CDA’s and MTA’s) with two large Pharmaceutical companies, and earlier stages with a third. These companies have advanced Cdk4/6-inhibitor programs, but have begun to appreciate that the market for these compounds as anti-neoplastics is very limited. When paired with GZ’s methods-of-use intellectual property, composition-of-matter IP around a clinical-grade Cdk4/6 inhibitor compound will allow GZ to raise sufficient capital from governmental agencies to support early clinical development for the radiomitigation indication. MANAGEMENT TEAM John Chant, Ph.D., CEO & Co-Founder Dr. Chant was previously an Associate Professor at Harvard University and has worked at Genentech and Curagen. Norman E. Sharpless, M.D., Co-Founder Dr. Sharpless is an Associate Professor of Medicine and Genetics in the Lineberger Cancer Center at UNC-CH Kwok-Kin Wong, M.D. Ph.D., Co-Founder Dr. Wong is currently an Associate Professor of Medicine at Dana Farber Cancer Institute Jay C. Strum, Ph.D., Scientific Director Dr. Strum has worked at GlaxoSmithKline. He has a Ph.D in Biochemistry CONTACT INFORMATION John Chant, CEO and Co-Founder G-Zero Therapeutics, Inc. Email: [email protected] 17 UNC Emerging Company Showcase, 2010 NEXTRAY NextRay is developing a new medical imaging technology called Diffraction Enhanced Imaging (DEI), which produces superior images than those produced by current x-ray imaging absorption techniques while exposing the patient to less than 1% of the radiation dosage. OVERVIEW NC based development stage medical equipment startup, founded in September 2007, with disruptive and proprietary X-Ray imaging technology licensed exclusively to NextRay by the Office of Technology Development at UNC-Chapel Hill. NextRay is developing a new medical imaging technology called Diffraction Enhanced Imaging (DEI), which produces superior images than those produced by current x-ray imaging absorption techniques while exposing the patient to less than 1% of the radiation dosage. Founders and inventors of the company’s DEI technology include Etta Pisano, MD, Chris Parham, MD, PhD, and Dean Connor, PhD, from UNC-Chapel Hill, and Dr. Zhong Zhong, PhD, from Brookhaven National Laboratory (BNL), NY. In 9/2009, Dr. Meno Nassi, an experienced Silicon Valley MedTech executive and entrepreneur, joined as CEO, and led NextRay’s $0.5M seed round with a promissory series A convertible note, which closed in January, 2010. Participating investors were: Eagle Green Investors, LLC-VA.; IDEA Fund Partners, LLC-NC; and Triple Ring Technologies (TRT), Inc.; Newark, CA, where NextRay’s contract R&D operations are based. NextRay is currently raising a $6M series A round of financing, after having achieved significant milestones since closing the seed round; these include • Allowance to issue by the US PTO in 2/2010 of the key DEI technology patent, and filings of two additional DEI utility patent applications; • Confirmed previously predicted reduction in DEI imaging times for NextRay’s Pediatric and Musculoskeletal (MSK) Radiography system, by independent study and report: Triple Ring Technologies, Inc. DEI Flux Spreadsheet Report, dated 3/11/ 2010; • A high power X-Ray tube DEI system is being constructed at TRT to demonstrate the reduced imaging times, and to determine the engineering design requirements for NextRay’s first clinical prototype system. TECHNOLOGY DEI was developed at the University of North Carolina at Chapel Hill (UNC-CH) in conjunction with Brookhaven National Laboratories (BNL). The technology combines commercially available x-ray tubes and x-ray detectors with inexpensive crystal optics that are used to detect x-ray diffraction. Current x-ray imagers depend upon the absorption of x-rays by the body, which exposes the patient to over 100x the radiation of DEI. NextRay holds an exclusive, worldwide license to US Patent Application No. 11/657,391, which was allowed to issue in February, 2010. This patent protects the breakthrough that enables NextRay’s DEI without the use of a synchrotron. The Company continues to develop its patent portfolio and has 2 pending Utility Applications and 2 pending Provisional Applications, to which NextRay also holds an exclusive worldwide license. Advantages of NextRay-DEI technology: 9 Enhanced Image Detail. NextRay’s DEI technology offers clearer, sharper images with superior soft tissue contrast and detail compared with conventional x-ray images. 9 Low Radiation Dose. NextRay’s DEI provides images of equal or better quality at less than 1% of the dose. This reduces the risk of radiation-induced cancer and other damage to the human genome, a problem that is of great importance to the medical imaging community. NextRay will develop a 2D DEI x-ray imaging device for pediatric and general musculoskeletal radiography procedures, as a natural first step towards the ultimate goal of developing 3D DEI x-ray imaging devices. Product development will be done in collaboration with a contract research, development, and engineering firm located near Silicon Valley, Triple Ring Technologies (www.tripleringtech.com). Triple Ring employs over 70 people, including 18 PhDs, 8 former VPs of Engineering, and over 20 engineers who have experience developing medical imaging equipment. The Company will also leverage expertise in highly specific areas via SAB and consultants. 18 UNC Emerging Company Showcase, 2010 MARKET POTENTIAL Over $1 billion is spent each year on 2D x-ray imagers (NextRay’s first product), and over half of the world’s imaging devices are x-ray based, representing an addressable market of over $12 billion for NextRay. The market is growing at 8% per year. The medical imaging industry is dominated by the healthcare divisions of GE, Siemens, and Philips, which collectively represent over 75% of the market. Other potential competitors include Toshiba, Hitachi, Shimadzu, Fuji, Carestream Health, Virtual Imaging, Imix, and Imaging Dynamics among others. None of these manufacturers are working on significantly lower dose x-ray technologies. Two other small operations are working on the development of low dose, high quality x-ray imaging solutions: Nesch, LLC in Illinois and the Paul Scherrer Institute in Sweden. Nesch is utilizing a similar crystal-based technique to NextRay, but without the benefit of several enabling breakthroughs made by NextRay’s founders, which are patented or patent-pending. Paul Scherrer is utilizing a pin-hole aperture based technique for DEI, which has yet to be proven to work for objects thicker than a millimeter. Brand and reputation are important for selling equipment with expected product life-cycles of over 7 years to hospitals STRATEGY In January 2010, NextRay closed $0.5M in a seed round via a promissory note convertible to Series A venture financing in 2010. The proceeds of the seed round are being spent mainly in contract R&D work at Triple Ring Technologies. This is aimed at demonstrating the engineering feasibility of NextRay attaining the predicted DEI reduced imaging times. MANAGEMENT TEAM Meno Nassi, PhD, Director, President and CEO Dr. Nassi joined NextRay in September 2009. Dr. Nassi is a successful MedTech, Silicon Valley, Entrepreneur R&D Executive (Diasonics, Inc., Cardiometrics, Inc.) – and has been a life sciences startup CEO since 1991. He successfully led an IPO (CFLO-Cardiometrics, Inc.), which he followed by an M&A (ESON-EndoSonics, Inc.). Dr. Nassi has been also successful in closing significant investment amounts through various Silicon Valley venture capital firms and strategic Scientific-Europe). Etta D. Pisano, MD, Founder, Director and CSO Dr. Pisano leads NextRay’s SAB and founding team and is a co-inventor of the technology the Company will commercialize. Dr. Pisano is Vice Dean of School of Medicine and Kenan Professor of Radiology and Biomedical Engineering at UNC-Chapel Hill. Waldo Hinshaw, PhD, and Brian Wilfley, PhD Principle and Chief Scientists, respectively, at Triple Ring Technologies and the Project Managers assigned to the NextRay product development work. They have extensive experience in the fields of X-Ray Medical Imaging and Magnetic Resonance Imaging (MRI). CONTACT INFORMATION Meno Nassi, PhD Email: [email protected] Phone: (415) 517-5834 NextRay, Inc. 1405 Majestic Court Chapel Hill, NC 27517 19 19 UNC Emerging Company Showcase, 2010 NOTES 20 UNC Emerging Company Showcase, 2010 NOTES 20