fortis oncology nanomedicine solutions
DESCRIPTION
Targeted nanoparticle tumor ablation. Multi-walled Carbon Nanotubes (MWCNT) are designed with internal antennae tuned to a specific Near Infrared (NIR) laser frequency, which when activated, oscillate at high speeds, generating thermal energy (heat) sufficient to cause cell apoptosis. Using targeting probes, the MWCNT only seek out, attach to, and within, specific cancer cells. The NIR laser is non-invasive, and does not injure the skin. The MWCNT can also be conjugated with probes for very specific imaging for diagnostics purposes using existing MRI technology.TRANSCRIPT
FORTIS ONCOLOGY: NANOTHERMAL MEDICAL DEVICE PRODUCTS TO ERADICATE CANCER
THE COST OF CANCER IS HIGH.EACH OF US HAS BEEN TOUCHEDWITH CANCER IN OUR LIVES; AMOTHER, FATHER, SIBLING, FRIEND.IT IS A LARGE AND GROWINGMARKET AND HUGE HEALTHCAREECONOMIC BURDEN
Worldwide, there are more than12.5M new cancer diagnoses eachyear, and that figure continues toclimb.
The total cost of cancer have beenestimated to be as high as $895billion (US) worldwide.
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CANCER TODAY
http://www.cancer.org/
OUR MISSIONTo bring advanced, nanothermal products to market approval that not only destroy cancer, but spare healthy tissue, without the side effects seen in conventional therapies and in doing so, build a sustainable, profitable business.
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HISTORY OF NANOFORTISONCOLOGY• Founded in 2013 in Winston-Salem, NC
• Technology developed by leading materials science and clinical researchers at Wake Forest University. Fortis holds exclusive licenses to key patent estate
• Product development company utilizing advanced light-absorbing nanoparticles to thermally ablate solid tumors
• More than 5 years of preclinical work completed, including in vitro and in vivoproof-of-concept demonstration
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Frank M. Torti, M.D., M.P.H Executive Vice President for
Health Affairs for the University of Connecticut Health
Center and the eighth Dean of the UConn School of
Medicine.
Torti joined the Health Center from Wake Forest University
School of Medicine where he served as Vice President for
Strategic Programs, Director of the Comprehensive
Cancer Center, and Chair of the Department of Cancer
Biology. In addition, he previously served as the former
Principal Deputy Commissioner, Chief Scientist, and then
Acting Commissioner of the U.S. Food and Drug
Administration.
“CANCER NANOTECHNOLOGY: SMALL, BUT HEADING
FOR THE BIG TIME”NATURE REVIEWS DRUG DISCOVERY
NATURE REVIEWS DRUG DISCOVERY 6, 174-175 (MARCH 2007) | DOI:10.1038/NRD2285
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TECHNOLOGY
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HOW IT WORKS
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TECHNOLOGY DEVELOPMENTMILESTONES
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HOW IS FORTIS ONCOLOGY DIFFERENT?• Many options to achieve maximal thermal ablation and tumor
cell death:
• MWCNT with or without metals;
• a variety of geometries (MWCNT cylinders [straight, bent, folded] or nanospheres;
• doped with contrast agents;
• functionalized with API and/or antibodies (for targeted delivery to cancer cells)
• functionalized for embolization of tumor.
• Passive or active targeting
• Novel nanomaterials which are soluble
• No use of gold nanoparticles thus relieving regulatory burden other groups who use these face
• Non-invasive, more efficacious; utilizes NIR or RF—no probes, more thorough tumor margin ablation
• Significant preclinical studies in large animals in vivo studies demonstrate primary tumor and cancer stem cell ablation
• Products for cancer therapy will follow medical device approval path, not as a drug—reduced time to approval and lower regulatory risk
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ContrastAgent
TargetedDelivery
CytotoxicAgent
THE BUSINESS
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THE FORTIS ONCOLOGY TEAMPaul Rohricht, MS, MBA Chief Executive Officer
• Serial entrepreneur, co-founder of Revivicor, Inc. (acquired by United Therapeutics); co-founder of Symphogen, Inc.
• $500M+ in transactions.
• Formerly CEO, Vedere LLC; CEO, Keractive Beauty LLC; COO Keraplast Technologies, Inc.; Vice President Corporate Development ICx Technologies Inc.; Symphogen A/S, Revivicor Inc., and PPL Therapeutics.
• 1 issued US Patent, 4 pending
• Wharton MBA
• Associate Dean, Dean's Office Associate Professor, Surgery, Translational Science Institute, Wake Forest Baptist Medical.
• Expert in HIPEC Therapy, surgery, oncology treatment.
• Lead or co-author on key academic papers which underpin the Fortis Oncology technology.
• Co-inventor on key applications of Fortis Oncology IP.
• Assistant Professor, Plastic & Reconstructive Surgery, Wake Forest Medical School.
• Expert in cancer/oncogenesis, drugs/therapeutic agents/ pharmaceuticals, engineering/bioengineering, device development, preclinical development.
• Lead or co-author on key academic papers which underpin the Fortis Oncology technology.
• Lead and/or Co-inventor on key applications of Fortis Oncology IP.
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John Stewart, MD Chief Medical Officer
Nicole Levi-Polyachenko, PhD Chief Scientific Officer
BUSINESS MODEL
• Develop a suite of medical devices specific to a particular disease area;
• License those devices to key players;
• Diagnostic imaging contrast agents
• Prospective licensees include: Potential Licensees: GE Healthcare, Philips Healthcare, Siemens Healthcare, Toshiba Medical Systems Corporation, Hologic, Inc., Hitachi Medical Corporation
• Cancer therapeutic medical devices
• Prospective licensees (in addition to Big Pharma/Biotech) include:
• Image-guided RFA: AngioDynamics, Boston Scientific and Covidien;
• Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical;
• Microwave Ablation: Evident Microwave Ablation (Covidien);
• High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric (GE-) based MRI systems and therefore GE is a potential licensee
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MARKET OPPORTUNITY
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MARKET OPPORTUNITY
Cancer Diagnostic Imaging
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$-
$500,000
$1,000,000
$1,500,000
$2,000,000
$2,500,000
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
MRI Diagnostic Contrast Agent Market Size ($'000M); 5% CAGR http://www.bccresearch.com
http://www.cancer.org
$-
$50,000,000
$100,000,000
$150,000,000
$200,000,000
$250,000,000
$300,000,000
$350,000,000
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Market Size, Worldwide Cancer Therapy Market Size ($'000M), 18.5% CAGRHIPEC
Skin CancerBreast CancerKidney CancerProstate CancerSoft Tissue NeoplasmsBone NeoplasmsBreast CancerBrain Cancer
COMPETITION
• Thermal Abalation
• Image-guided RFA: AngioDynamics, Boston Scientific and Covidien;
• Cryoablation: Endocare, a division of Healthtronics, Inc., Galil Medical;
• Microwave Ablation: Evident Microwave Ablation (Covidien);
• High-intensity focused ultrasound (HIFU): InSightec Ltd. (device works with General Electric (GE-) based MRI systems and therefore GE is a potential licensee;
• Laser Interstitial Thermal Ablation
• Irreversible electroporation (IRE)
• Nanomaterials
• BSD
• Magforce AG
• Nanospectra
• Pharma/Biotech
• All the major players: Roche/Genentech, Pfizer, Merck, BMS, Lilly, GSK, Sanofi, Takeda.
• Top Cancer Drug Sales 2011: Rituxan - $3 billion; Avastin - $2.66 billion, Herceptin - $1.66 billion, Gleevec - $1.51 billion, Eloxatin - $1.2 billion, Alimta - $1.04 billion, Erbitux - $703.3 million, Velcade -$692.7 million, Xeloda - $647.6 million, Tarceva - $564.2 million
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http://www.fiercepharma.com
PRODUCT DEVELOPMENT PLAN
Diagnostic Imaging
• Device production for MRI cancer imaging
• Clinical Trials
• Regulatory Consulting (outsourced)
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Tumor Thermal Ablation• HIPEC device production• Clinical Trials• Regulatory Consulting (outsourced)
Product Development, Tumor Thermal Ablation• Device production for interperitoneal solid
tissue cancer ablation (gastrointestinal, kidney, pancreas
• Clinical Trials• Regulatory Consulting (outsourced)
REGULATORY STRATEGYA regulatory framework is already in place
Clinical trials are underway throughout the world for a variety of indications using nanomaterials in cancer
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CAPITAL RAISE
Use of Proceeds
• Diagnostic Imaging
• Device production for MRI cancer imaging
• Clinical Trials
• Regulatory Consulting (outsourced)
• Tumor Thermal Ablation
• HIPEC device production
• Clinical Trials
• Regulatory Consulting (outsourced)
• Product Development, Tumor Thermal Ablation
• Device production for interperitoneal solid tissue cancer ablation (gastrointestinal, kidney, pancreas)
• Clinical Trials
• Regulatory Consulting (outsourced)
• Ongoing IP prosecution and license obligations
• Staff, General and Administrative (1 FTE, 2 part time FTE)
$5M
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Products
• Products to diagnose and treat:
• Skin, kidney, prostate, soft tissue neoplasms, bone neoplasms
• Advanced MRI contrast agents
• Thermal ablation of cancer devices
• Thermal ablation of cancer with delivery of drugs
Team
• Paul Rohricht, MS MBA, CEO• Serial entrepreneur, co-founder of Revivicor, Inc.
(acquired by United Therapeutics); co-founder of Symphogen, Inc.; $500M+ in transactions.
• John Stewart, MD, CMO• Associate Professor, Surgery, Comprehensive
Cancer Center, Wake Forest Baptist Health
• Nicole Levi-Polyachenko, PhD, CSO• Assistant Professor, Plastic & Reconstructive
Surgery, Wake Forest Medical School
Technology
• MWCNT with various geometries (tube, bent, curved, folded)
• MWCNT + iron and/or other metals
• Functionalized MWCNT + branched structures for delivery of APIs
• Microparticle compositions
• MWCNT + nitrogen and/or boron
IP
• US 8,252,772 “HyperthermicTechnologies and Uses Thereof”
• US 8,501,233 “Compositions and Methods for Treating Cancer”
• Several other patents pending including “Novel Embolizing Therapy for the Ablation of Solid Tumors”
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BUSINESS SUMMARY
CONTACT
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Paul Rohricht MS MBA; CEO Fortis Oncology
+1 704.249.8342
www.fortisoncology.com