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Biomedical and Medical Imaging Program Presentation






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    Biomedical and Medical Imaging Program Presentation Biomedical and Medical Imaging Program Presentation Presentation Transcript

    • Proposal Evaluation Results Presented to Ohio Third Frontier Commission June 23, 2010 2010 1251 Dublin Road, Columbus, OH 43215 Tel: 614.291.2229 Fax: 614.291.2867 Third Frontier Biomedical Program Third Frontier Medical Imaging Program
    • Proposal Review Team
        • Edward Ungar, President
        • Paula Dunnigan, Project Leader
        • Chuck Meadows
        • Bill Munk
        • Reed Slevin
        • Imaging Experts
          • Tracy Lynn Faber, Ph.D.
          • John C. Gore, Ph.D.
          • Xiaoping Hu, Ph.D.
          • John Oshinski, Ph.D.
        • Industry Experts
          • Lluis Lagarda, M.B.A.
          • Donald S. Lucas, Ph.D.
        • Clinical Experience and Business Background (End-user Perspective)
          • Gordon Butler, M.D.
          • Brian Cox, M.D., M.E.
          • Erin Dunnigan, M.D., M.B.A.
          • Erin Moody, M.D., M.B.A.
    • Overview of Proposal Review Process
      • Focus: Meeting the requirements and intent of the RFP
        • Combination of 3 internal and external reviewers
        • Scoring instrument that reflects criteria in RFP
        • Ranked on basis of average score
      • Focus: Quality of the Investment for Ohio
        • Customized set of questions and written responses
        • Face-to-face meeting (90 minutes)
        • Risk-benefit scoring
          • Technical Risk
          • Commercial Risk
          • Mission Impact
        • Ranked on basis of fit to targets
    • Second Round Evaluation Factors MISSION IMPACT Cluster Formation Ohio Economics Business Model COMMERCIAL RISK Path to Market Corporate Stability Commercial Infrastructure TECHNICAL RISK Technical Reach Resource Limitations Technology Protection Past Performance
    • Second Round Scoring Methodology
    • Competition Overview METRICS TFBP TFMIP Letters of Intent 81 43 Proposals Submitted 28 17 Proposals Passing Administrative Review 25 16 Proposals Making the Competitive Range 10 11 Proposals Recommended for Funding 5 8 FUNDING AVAILABLE TFBP TFMIP TFRDF in RFP $5M $8M WCF in RFP $2M $2M Recommendations: TFRDF $4,985,623 $7,810,869 Recommendations: WCF $0 $1,165,000
    • 2010 Third Frontier Biomedical Program
    • Criteria for Biomedical Awards
      • Preference for cardiovascular medicine, regenerative medicine, and orthopedics
      • Projects leading to new devices, therapeutics, or diagnostics or to modification of an existing product produced in Ohio
      • Commercialization in 3-5 years with Ohio job creation
      • Clinical trials in Ohio
    • TFBP Recommendations for Funding TFRDF TFRDF TFWCF TFWCF Comm. Applicant Requested Cumulative Requested Cumulative Product Date OrthoHelix Surgical $1,000,000 $1,000,000 $0 $0 Orthopedic Therapeutic Device 2011 Designs, Inc. Cardiox Corporation $ 986,373 $1,986,373 $0 $0 Cardiovascular Diagnostic Device 2012 CWRU, School of $1,000,000 $2,986,373 $0 $0 Regenerative Therapeutic Device 2018 Medicine SpineForm LLC $ 999,250 $3,985,623 $0 $0 Orthopedic Therapeutic Device 2012 Lanx, Inc. $1,000,000 $4,985,623 $0 $0 Orthopedic Diagnostic Device 2013 1. 2. 3. 4. 5. 2010 Third Frontier Biomedical Program (TFBP)
    • 2010 Third Frontier Biomedical Program OrthoHelix Surgical Designs, Inc. (TFBP 10-837 / Rank: 1) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $1,224,708 1st Round Score: 81.3 2nd Round Score: 86.1
      • “ Mini/Mega MaxLock Extreme Orthopedic Implants”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: Shaped metal plates and variable angle locking screws for repair of trauma to the bones of the foot, ankle, elbow, wrist, and hand
      • Project: Funding to deploy surgical trays for the 3.5mm Variable Angle Locking System for foot and ankle (approved by FDA on 4/20/10) and to extend this technology to the smaller bones of the hand and foot (2.4mm) with new modules
      • Projected Impacts:
        • Estimate that $0.90 in revenue generated per quarter for each $1 invested in surgical trays
        • Products generated over $10 million in 2009; expected to increase to over $50 million by 2013 with creation of 80 Ohio jobs
        • Current manufacturing is done by out-of-state contractors
        • TF funding will allow hiring of quality engineer to promote Ohio supplier development with goal of eventually bringing manufacture in-house
    • 2010 Third Frontier Biomedical Program Cardiox Corporation (TFBP 10-866 / Rank: 2) TFRDF Requested: $986,373 WCF Requested: $0 TOTAL Requested: $986,373 Cost Share: $1,538,889 1st Round Score: 62.3 2nd Round Score: 83.3
      • “ Validation and Commercialization for Non-Invasive Detection of Cardiox Shunts”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $986,373
      • Product: Non-invasive diagnostic system for detecting Patent Foramen Ovale (PFO) to prevent strokes, mini-strokes, and potentially migraine headaches
      • Project: Funding to support multi-center clinical trials, in-vivo animal studies to confirm quantitative accuracy, and preparation of 510(k) application and additional patent filings
      • Projected Impacts:
        • Initial equity investments of $2.8 million for this start-up have come primarily from Ohio
        • Window of opportunity is opening as minimally invasive products to close PFOs are in the process of gaining approval in Europe and the U.S
        • Completion of in vivo animal and clinical studies is expected to lead to additional investment capital to fund commercialization
        • Manufacturing is currently done by contract producers in WA and CA with certification for both devices and pharmaceuticals
        • Goal is to bring order fulfillment, inventory, kit assembly, and manufacturing in-house within 18 months after launch
    • 2010 Third Frontier Biomedical Program Case Western Reserve University, School of Medicine (TFBP 10-833 / Rank: 3) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $1,000,000 1st Round Score: 67.3 2nd Round Score: 70.9
      • “ Clinical Development of MultiStem ® for Treatment of Spinal Cord Injury” _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: Use of Multistem  adult stem cell product for suppressing neuroinflammation, suppressing nerve cell retraction, and promoting regrowth
      • Project: Funding for expanded rat studies to support a request for Phase I IND clinical studies for the treatment of human patients suffering from spinal cord injuries
      • Projected Impacts:
        • Athersys has two co-development partnerships for other end-use applications for Multistem  and has raised over $180 million
        • Production is outsourced to a contract manufacturing organization, and Athersys intends to partner with a large pharmaceutical company in the central nervous system market for sales and distribution
        • Such a partnership could be expected to raise $20 – 50 million for clinical trials
        • Athersys intends to create pilot plant in Ohio by 2012; commercialization is planned for 2018
    • 2010 Third Frontier Biomedical Program SpineForm LLC (TFBP 10-810 / Rank: 4) TFRDF Requested: $999,250 WCF Requested: $0 TOTAL Requested: $999,250 Cost Share: $999,250 1st Round Score: 79.3 2nd Round Score: 70.6
      • “ Clinical Study and Commercialization of an Idiopathic Scoliosis Growth Modulation System”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $999,250
      • Product: Less invasive, non-fusion device for a surgical procedure intended to arrest spine curve progression in patients with scoliosis
      • Project: Funding for first clinical trials of the device in Ohio (IDE approved by FDA) that will lead to multi-center trials, new opportunities for equity funding, and commercial introduction
      • Projected Impacts:
        • Company has raised $2.5 million (significant investment from Ohio sources) and key individuals show strong ties to Ohio
        • Commercial introduction is planned for 2012 in Europe and 2013 in the U.S.
        • Sales are projected to reach $25 million annually by 2015
        • Company plans to have its own sales and marketing functions and is working with two Ohio contract manufacturing organizations to produce implants and surgical trays
    • 2010 Third Frontier Biomedical Program Lanx, Inc. (TFBP 10-825 / Rank: 5) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $1,000,000 1st Round Score: 69.7 2nd Round Score: 70.3
      • “ Lumbar Motion Monitor Commercialization in Ohio”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: Lumbar motion monitor (LMM) device capable of quantifying the extent of a low back disorder my monitoring the motion function characteristics of a patient’s low back
      • Project: Funding for upgrade of an initial mechanical prototype to an electronic version with new software algorithms, custom circuit boards, a redesigned harness, and security protection, and for conducting clinical studies
      • Projected Impacts:
        • Lanx has demonstrated Ohio ties through a long-term sponsorship of $6 million at OSU and use of the database created by William Marras (Honda Endowed Chair Professor, Director of Biodynamics Lab) that is based on 25 years of his research
        • Lanx, which is headquartered in CO, is financially stable, has about 200 employees, and has commercialized 15 product lines of spinal implants and associated instrumentation
        • Lanx will establish its Diagnostic Division at TechColumbus’ TechStart Incubator and will remain there through its alpha testing when it will relocate to larger facilities in the Columbus area
        • Company has committed to support a staff of up to 20 employees during the project period; sales of the LMM product are projected to exceed $11 million by 2015
    • 2010 Third Frontier Medical Imaging Program
    • Criteria for Medical Imaging Awards
      • Projects leading to new products, manufacturing process or technologies related to medical imaging
      • Adaptation or modification of existing medical imaging devices or components manufactured in Ohio
      • Already achieved technical proof-of-concept with evidence of end-user interest
      • Ohio job creation and commercialization in 3-5 years
    • TFMIP Recommendations for Funding TFRDF TFRDF TFWCF TFWCF Comm. Applicant Requested Cumulative Requested Cumulative Product Date The Ohio State University $1,000,000 $1,000,000 $ 740,000 $ 740,000 7T MR Imaging Equipment 2012 Neoprobe Corporation $1,000,000 $2,000,000 $0 $ 740,000 Diagnostic Imaging Agent 2011 Philips Healthcare $ 999,175 $2,999,175 $0 $ 740,000 PET/CT Cardiovascular Imaging 2013 Equipment InfraRed Imaging $ 812,000 $3,811,175 $0 $ 740,000 Peripheral Cardiovascular 2012 Systems, Inc. Imaging Device Quality Electrodynamics $1,000,000 $4,811,175 $0 $ 740,000 7T MR Imaging Coil 2012 GE Healthcare $1,000,000 $5,811,175 $0 $ 740,000 Pediatric Coils for MR Imaging 2013 Technologies EXCMR, Ltd. $ 999,694 $6,810,869 $ 425,000 $1,165,000 Diagnostic Device for MR 2010 Cardiac Imaging CardioInsight $1,000,000 $7,810,869 $0 $1,165,000 Cardiac Diagnostic Imaging 2011 Technologies, Inc. System 1. 2. 3. 4. 5. 6. 7. 8. 2010 Third Frontier Medical Imaging Program (TFMIP)
    • 2010 Third Frontier Medical Imaging Program The Ohio State University (TFMIP 10-936 / Rank: 1) TFRDF Requested: $1,000,000 WCF Requested: $740,000 TOTAL Requested: $1,740,000 Cost Share: $1,740,000 1st Round Score: 79.3 2nd Round Score: 83.2
      • “ Multi-transmit Platform Technology for High and Ultra-High Field MR Imaging”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,740,000
      • Product: 2-channel transmit capabilities for the 7T MRI system
      • Project: Create a functional 2-channel system and demonstrate its improved imaging capabilities in neuroanatomy/neurofunctional, neuro-oncology, vascular, and musculo-skeletal applications at OSU
      • Projected Impacts:
        • Philips has annual sales of $1 billion in MR systems and has created an Ultra-High Field Research Center in Cleveland
        • This technology will be needed to remain competitive with other equipment providers
        • If this project is successful, Philips has committed to support the development of 8-channel technology for the 7T system and to have that work done in Cleveland
        • Multi-channel transmit technology will be scaled up in 2013 resulting in 37 jobs and $10 million in additional annual revenues
    • 2010 Third Frontier Medical Imaging Program Neoprobe Corporation (TFMIP 10-904 / Rank: 2) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $1,140,252 1st Round Score: 63.3 2nd Round Score: 81.6
      • “ Phase III Clinical Study Supporting Expanded FDA Claims for Lymphoseek ® , a Medical Imaging Agent for Sentinel Lymph Node Mapping in Breast Cancer, Melanoma, and Head and Neck Cancer”
      • _______________________________________________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: Radiopharmaceutical known as Lymphoseek  that can be used to identify sentinel lymph nodes during surgery
      • Project: Expand Phase III head and neck clinical study to enable FDA submission to be amended to include “sentinel lymph node” claim
      • Projected Impacts:
        • Lymphoseek  is poised to enter the market in 2011 with a claim of anatomical delineation regardless of TF funding, but TF funding will speed market entry with the expanded claim by 18 – 24 months
        • Neoprobe, an established company that sells intraoperative gamma detection devices, has annual sales in the range of $10 million; its ability to self-fund the expanded head and neck clinical trials will govern the timing
        • Neoprobe has signed an exclusive sales, marketing, and distribution agreement in the U.S. with Cardinal Health which positions two Ohio companies in this value chain
        • The expanded claim will result in an increase in sales of $15 – 25 million annually for Neoprobe, and a similar increase is likely for Cardinal Health
    • 2010 Third Frontier Medical Imaging Program Philips Healthcare (TFMIP 10-918 / Rank: 3) TFRDF Requested: $999,175 WCF Requested: $0 TOTAL Requested: $999,175 Cost Share: $999,175 1st Round Score: 68.7 2nd Round Score: 79.6
      • “ Absolute Myocardial Blood Flow”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $999,175
      • Product: Upgrade for Philips PET/CT scanner to enable quantitative measurements of myocardial blood flow
      • Project: Higher capacity acquisition hardware and faster image reconstruction will be co-developed by Philips and Case, and clinical validation will be provided by University Hospitals Health System
      • Projected Impacts:
        • PET with this upgrade will provide better assessment of coronary artery disease than SPECT with no increase in radiation exposure
        • Philips has committed to provide funding for commercialization and market entry if this project is successful
        • Manufacturing and sales will be handled through the existing Philips organization in Highland Heights, OH; company makes extensive use of Ohio suppliers
        • Product launch is expected in 2013 and is projected to result in a sales increase of nearly $50 million in 2013 and $100 million by 2015
    • 2010 Third Frontier Medical Imaging Program InfraRed Imaging Systems, Inc. (TFMIP 10-926 / Rank: 4) TFRDF Requested: $812,000 WCF Requested: $0 TOTAL Requested: $812,000 Cost Share: $941,000 1st Round Score: 71.0 2nd Round Score: 77.0
      • “ Completion of Commercialization and Relocation of Manufacturing to Ohio for the INRIS VascularViewer Product Portfolio”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $812,000
      • Product: Peripheral vascular imaging device using near-infrared radiation from a disposable source to visualize both veins and arteries
      • Project: Upgrade current device to a digital version and create light source that can be cost effectively manufactured
      • Projected Impacts:
        • Product is FDA 510 (k) cleared and UL certified
        • Additional venture capital support has been made available conditional upon achieving sales
        • INRIS will move its office operations to OH, will contract with Astro Manufacturing & Design (Eastlake, OH) for manufacturing, and has signed agreement with three distributers
        • The new products are expected to be commercialized in 2012 – 13 and are projected to produce revenues of over $20 million by 2013 and $50 million by 2015
    • 2010 Third Frontier Medical Imaging Program Quality Electrodynamics LLC (TFMIP 10-910 / Rank: 5) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $1,002,806 1st Round Score: 77.7 2nd Round Score: 76.3
      • “ 7 Tesla High-Density MRI RF Coil Development & Commercializaton”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: Knee and breast coils optimized for use with the 7T MRI
      • Project: Prototype and production versions for both coils will be developed and validated by QED with support from Case; project will include an ultra-compact preamplifier and custom designed printed circuit boards, and will extend to clinical evaluations at major medical centers.
      • Projected Impacts:
        • This 2006 spin-out from Case has annual sales of more than $10 million and has become a recognized world leader in the manufacture of high quality RF coils for MR imaging
        • New coils for the 7T MRI will be developed and manufactured in Ohio and will speed the transition of the 7T unit from a research instrument to clinical approval
        • QED will work with Siemens to commercialize the knee and breast coils, and it has agreements with Philips/OSU and GE to customize 7T RF coils for their MRI scanners
        • These products are expected to be commercialized in 2012 (prototypes will be available for sale in 2010) and are estimated to generate more than $8 million in annual revenues for QED by 2015 with the creation of 39 jobs
    • 2010 Third Frontier Medical Imaging Program USA Instruments / GE Healthcare Coils, Inc. (TFMIP 10-930 / Rank: 6) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $1,614,140 1st Round Score: 65.3 2nd Round Score: 74.9
      • “ MR Imaging and Devices for Pediatric Populations”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: 32-channel pediatric torso array for cardiac imaging of children and pediatric head fixation with integrated imaging coils for MR-assisted surgeries (1.5/3 T MR)
      • Project: Design, build and validate prototype coils at GEHC and conduct external clinical testing on pediatric patients at Cincinnati Childrens’ Hospital and OSU
      • Projected Impacts:
        • This project will provide data to support a 510(k) submission to FDA at its conclusion
        • Potential customer base includes all facilities with 1.5T and 3T MR imaging capabilities who have pediatric patients
        • These coils will be produced at GEHC’s Aurora, OH facility and will make use of an existing Ohio supply chain for components
        • Commercialization of these devices is planned in 2013, and they are projected to generate $70 million in annual revenue by 2015
    • 2010 Third Frontier Medical Imaging Program EXCMR, Ltd. (TFMIP 10-922 / Rank: 7) TFRDF Requested: $999,694 WCF Requested: $425,000 TOTAL Requested: $1,424,694 Cost Share: $1,497,827 1st Round Score: 70.3 2nd Round Score: 74.3
      • “ An In-state Multi-center Evaluation of Treadmill Exercise Stress Cardiac Magnetic Resonance”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,424,694
      • Product: MRI-compatible treadmill that will enable MRI cardiac imaging immediately after exercise
      • Project: Fabricate treadmills and purchase QED 32-channel cardiac received coils for use in clinical trials at Cleveland Clinic, University Hospitals Case Medical Center, The Christ Hospital (Cincinnati), and OSU
      • Projected Impacts:
        • EXCMR is a 2008 spin-out company from OSU and has been existing on grants
        • Company has signed a 3-year agreement with Siemens for exclusive rights to sell the treadmill through its MRI catalog
        • EXCMR plans to establish permanent sales, marketing, engineering, and manufacturing capacity at a central Ohio location after successful completion of the clinical demonstrations
        • Product will be available for sale beginning in 2010 and is expected to generate annual revenues of $14 million by 2015
    • 2010 Third Frontier Medical Imaging Program CardioInsight Technologies, Inc. (TFMIP 10-944 / Rank: 8) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $2,491,990 1st Round Score: 69.0 2nd Round Score: 72.0
      • “ The Atlas Electrocardiographic Mapping System”
      • _______________________________________________________________________________________________________________________________
      • Recommendation: Fund for $1,000,000
      • Product: Electrocardiographic Mapping (ECM) System which produces a non-invasive instantaneous 3-D map of electrical activity in all four chambers of the heart
      • Project: Improve alpha prototype with new sensor array, cabling, software, and signal processing (Battelle); conduct clinical studies at Cleveland Clinic, University Hospitals, and CHU Bordeaux, to demonstrate utility in atrial and ventricular arrhythmias and cardiac resynchronization therapy
      • Projected Impacts:
        • CIT is a 2006 spin-out from Case that has already raised over $7 million in venture funding, chiefly from Ohio sources
        • TF funding will trigger contingent investment; data from clinical trials is needed to secure mezzanine financing
        • CIT is in discussions with major medical device companies to provide sales and marketing support and intends to include Ohio component manufacturers and have the product manufactured by an Ohio medical device company
        • Commercial release of the product is anticipated in late 2011 and is expected to generate $15 million in annual revenues by 2013
    • 2010 Third Frontier Biomedical Program Leadscope, Inc. (TFBP 10-828 / Rank: 6) TFRDF Requested: $983,308 WCF Requested: $0 TOTAL Requested: $983,308 Cost Share: $983,308 1st Round Score: 61.7 2nd Round Score: 63.3
      • “ Predicting Cardiac Toxicity in Humans”
      • _______________________________________________________________________________________________________________________________
      • Product: Database to predict human cardiac adverse effects for chemical compounds
      • Project: Mine data from existing databases, in vitro screening, and in vivo adverse events to identify relationships between cardiac toxicity and biological and chemical structure and create products that drug companies can use to facilitate new drug evaluation and approval
      • Projected Impacts:
        • 2002 TAF award for genomics database has resulted in annual sales of approximately $1 million to 60 customers
        • Leadscope believes that the potential customer base for its cardiac toxicity product would be about 5,800 organizations
        • Leadscope has had experience building similar products and projects that this database will have the potential to achieve 80% predictive accuracy
        • Leadscope plans to introduce a commercial product in 2013 and expects to generate nearly $7 million in annual revenues by 2015; ChanTest will sell cardiac toxicity screening services using these tools and will generate nearly $7 million in annual revenues from this service by 2015
    • 2010 Third Frontier Biomedical Program Syncro Medical Innovations, Inc. (TFBP 10-801 / Rank: 7) TFRDF Requested: $950,000 WCF Requested: $0 TOTAL Requested: $950,000 Cost Share: $1,249,873 1st Round Score: 76.0 2nd Round Score: 63.1
      • “ Development of Tracheal Avoidance Feeding Tube System with a Hand Held Electromagnet”
      • _______________________________________________________________________________________________________________________________
      • Product: Magnetically guided feeding tube with external electromagnet for tracheal avoidance in gastric placement
      • Project: Conduct tracheal avoidance clinical study in Ohio on current product, develop an electromagnet-based system to replace the hand-held external magnet, integrate the electromagnet with the feeding tube, qualify Interplex Medical to manufacture the product in Ohio (currently produced in Germany)
      • Projected Impacts:
        • Current product will be introduced for small bowel placement ($20 – 90 million market); gastric placement will increase potential market to $200 million
        • Plan for developing the external electromagnet is still conceptual and would require the use of dry ice; evaluation of the capabilities of Ohio’s cryo-cooling cluster might be considered
        • Product has 510(k) approval and a CPT code; beta test sites have demonstrated significant cost reductions in placing feeding tubes and have become continuing customers
        • Products from this project are expected to generate $24 million in annual sales revenues by 2013
    • 2010 Third Frontier Medical Imaging Program FMI Technologies, Inc. (TFMIP 10-925 / Rank: 9) TFRDF Requested: $1,000,000 WCF Requested: $0 TOTAL Requested: $1,000,000 Cost Share: $2,347,929 1st Round Score: 60.0 2nd Round Score: 57.3
      • “ Commercialization of Organ/Disease Specific Cardiac and Neurologic PET/CT/SPECT Molecular Imaging Systems for Global Markets: A Value Proposition Demonstration”
      • _______________________________________________________________________________________________________________________________
      • Product: Fused modality imaging system that will combine PET, SPECT, and CT subsystems to provide better imaging of the heart and brain
      • Project: Produce both a base-level and pre-production prototype for ScintiStar Neuro and ScintiStar Cardiac, demonstrate performance in clinical trials for cardiac and neuro imaging, and apply for 510(k)
      • Projected Impacts:
        • Cost and performance claims are impressive (7x – 10x better resolution, 3x – 5x better sensitivity, 1/5 the size, 1/5 the cost), but no data are provided to demonstrate the level of cost/performance that has actually been achieved
        • Both new imaging agents do not yet have FDA approval; clinical trials availability is uncertain
        • FMI will need to raise $8 million in Series A funding during the next 6-8 months and another $8 million in Series B funding during the year after 510 (k) approval to bring this product to market
        • FMI plans to rely on the sales and marketing infrastructure of its medical imaging agent collaborators to sell its capital equipment
        • FMI projects that it will generate product sales during the first year of this project (2011). By 2013, FMI estimates that revenues will be $47 million and will increase to $139 million by 2015
    • 2010 Third Frontier Medical Imaging Program Imalux Corporation (TFMIP 10-901 / Rank: 10) TFRDF Requested: $999,000 WCF Requested: $0 TOTAL Requested: $999,000 Cost Share: $1,110,000 1st Round Score: 56.0 2nd Round Score: 54.9
      • “ Fourier Domain (FD) Optical Coherence Tomography (OCT) Imaging System for Real-time 3D Imaging of Epithelium for Pre-invasive and Invasive Cancer”
      • _______________________________________________________________________________________________________________________________
      • Product: Third-generation 3D product that will image the entire cervix and stage the epithelium from normal to pre-cancer levels in real time
      • Project: Design common path interferometer (Optiphase), electronics and software (GVI), algorithms for image reconstruction (GWU), software for calculating depth and brightness (GVI) and application specific probe (Imalux); build prototypes; submit application for 510(k)
      • Projected Impacts:
        • Work plan is identical to 2002 work plan and does not address need for clinical validation or pricing issues
        • First-generation product received FDA clearance in 2004 & second-generation product will enter market in 2010; third-generation product is projected to be ready for commercialization in 2012
        • Sales of first generation product totaled $784,000 (original projection was for $250 million annually and 20-25 jobs at an Imalux production facility in Ohio); company has been funded by $17 million in grants and investments
        • Imalux projects that the third-generation system will generate $6 million in annual revenue by 2013 and $31 million by 2015
    • 2010 Third Frontier Medical Imaging Program Interventional Imaging Inc. (TFMIP 10-914 / Rank: 11) TFRDF Requested: $997,010 WCF Requested: $0 TOTAL Requested: $997,010 Cost Share: $1,007,503 1st Round Score: 65.0 2nd Round Score: 45.5
      • “ Manufacturing and Development, MRI Guided Treatment of Atrial Fibrillation”
      • _______________________________________________________________________________________________________________________________
      • Product: RF ablation catheter that can be viewed real time inside the patient by MRI for treatment of atrial fibrillation
      • Project: Complete development work required to conduct clinical trials, including bench and imaging tests to demonstrate safety and performance; relocate manufacturing of prototypes from MN to an Ohio subcontractor; and create an Ohio supply chain
      • Projected Impacts:
        • Technology has been licensed from Case, and Case has been a collaborator for phantom and pig studies
        • Prototype production is anticipated at an Ohio contract manufacturing organization and final assembly will be done in-house; clinical trials and product sales will be handled by a partner organization; partners are not yet identified, but acquisition in 6 – 8 years is mentioned as a potential outcome
        • TF funding will assist the company in obtaining STTR Phase II funding and raising Series B funding
        • Human clinical trials will not begin until after this 2-year project with commercial introduction planned in 2014 – 2015; applicant projects sales of nearly $4 million by 2015
    • Example of Anchored Scale Scoring
      • Biomedical Proposals—Path to Market
          • 1 = Existing internal sales force; strong market position in target market; evidence of strong customer pull
          • 10 = Applicant fails to discuss how product will be marketed
      • Other typical scenarios
        • Applicant has signed a marketing agreement with a market leader
        • Applicant is in discussions with a market leader
        • Applicant has hired marketing expertise and developed a conceptual plan
        • Applicant discusses forming a marketing/co-development alliance and has demonstrated the ability to do so in the target market area
        • Applicant intends to build internal marketing competence and create a marketing plan
        • Applicant discusses forming a marketing/co-development alliance in general terms
        • Applicant intends to rely on collaborators and does not present a marketing strategy
        • “ Build it and they will come” approach
    • 2010 Biomedical Proposals – Path to Market Taratec I.D. Applicant Score Assessment of Situation 10-837 OrthoHelix 2.7 Company has an established sales network (6 internal, 125 external reps) with connections to 400 orthopedic hospitals; product in development—market pull not yet evident 10-801 Syncro 3.0 Company currently has a distributor network (25 reps); successful sales history has not yet been demonstrated; product shows good value proposition 10-866 Cardiox 3.7 New CEO with strong marketing experience with start-up medical device companies recently hired from Bay area; marketing plans and organizational structure described 10-825 Lanx 4.0 Company has sales function in CO serving target market in U.S. and abroad (200 internal & external reps); sales function in OH not described; products will be co-marketed with existing product line 10-833 Case/Athersys 4.3 Company plans to sign co-development agreement with major pharma (profile provided); has signed 2 previous agreements with major companies for other end-use applications and raised significant development funding 10-828 Leadscope 4.7 Company claims established relationships with half of major pharmas but has not yet demonstrated successful sales history; strategy is to target smaller pharma; company will sell directly via conferences/exhibitions, publications, and on-line tools 10-836 VasoStar 6.3 Partner will be responsible for developing a partnership arrangement for VasoStar; partner has (Frantz Medical) previously established 2 similar partnerships, but financial arrangements were not described 10-810 SpineForm 7.0 Company will hire a marketing consultant and develop a sales force in Cincinnati; strong market pull anticipated (possible Humanitarian Device Exemption/Humanitarian Use Device designation from FDA) 10-830 Juventis 8.0 Company plans to establish partnership arrangements to access wound healing market, but potential partners have not been engaged; competitive advantage remains to be defined 10-847 Clinic/Parker 8.0 Company has not been formed; sales and marketing plan has not been developed; intent is for collaborators to become initial customers but this will depend on the product’s value