Download E C S

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
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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]
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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.
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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]
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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.
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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]
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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.
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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
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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.
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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]
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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.
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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]
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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.
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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]
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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
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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]
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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]
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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.
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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
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