Biomedical and Medical Imaging Program Presentation
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Transcript of Biomedical and Medical Imaging Program Presentation
2010Proposal Evaluation Results
Presented to Ohio Third Frontier Commission
June 23, 20101251 Dublin Road, Columbus, OH 43215Tel: 614.291.2229 Fax: 614.291.2867
Third Frontier Biomedical Program
Third Frontier Medical Imaging Program
2010 TFBP / TFMIP Proposal Evaluation Results2
Proposal Review Team
TARATEC CORPORATION
• Edward Ungar, President
• Paula Dunnigan, Project Leader
• Chuck Meadows
• Bill Munk
• Reed Slevin
EXTERNAL REVIEWERS (10)
• 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.
2010 TFBP / TFMIP Proposal Evaluation Results3
Overview of Proposal Review Process
FIRST ROUND
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
SECOND ROUND
Focus: Quality of the Investmentfor 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
2010 TFBP / TFMIP Proposal Evaluation Results4
Second Round Evaluation Factors
MISSION IMPACT
Cluster FormationOhio EconomicsBusiness Model
MISSION IMPACT
Cluster FormationOhio EconomicsBusiness Model
COMMERCIAL RISK
Path to MarketCorporate Stability
Commercial Infrastructure
COMMERCIAL RISK
Path to MarketCorporate Stability
Commercial Infrastructure
TECHNICAL RISK
Technical ReachResource Limitations
Technology Protection
TECHNICAL RISK
Technical ReachResource Limitations
Technology Protection
Past PerformancePast Performance
2010 TFBP / TFMIP Proposal Evaluation Results5
Second Round Scoring Methodology
2010 TFBP / TFMIP Proposal Evaluation Results6
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
2010 TFBP / TFMIP Proposal Evaluation Results8
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
2010 TFBP / TFMIP Proposal Evaluation Results9
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 2011Designs, 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 2018Medicine
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
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2010 Third Frontier Biomedical Program (TFBP)
2010 TFBP / TFMIP Proposal Evaluation Results10
2010 Third Frontier Biomedical Program
OrthoHelix Surgical Designs, Inc.(TFBP 10-837 / Rank: 1)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $1,224,708
1st Round Score: 81.32nd 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 TFBP / TFMIP Proposal Evaluation Results11
2010 Third Frontier Biomedical Program
Cardiox Corporation(TFBP 10-866 / Rank: 2)
TFRDF Requested: $986,373WCF Requested: $0
TOTAL Requested: $986,373Cost Share: $1,538,889
1st Round Score: 62.32nd 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 TFBP / TFMIP Proposal Evaluation Results12
2010 Third Frontier Biomedical Program
Case Western Reserve University, School of Medicine(TFBP 10-833 / Rank: 3)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $1,000,000
1st Round Score: 67.32nd 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 TFBP / TFMIP Proposal Evaluation Results13
2010 Third Frontier Biomedical Program
SpineForm LLC(TFBP 10-810 / Rank: 4)
TFRDF Requested: $999,250WCF Requested: $0
TOTAL Requested: $999,250Cost Share: $999,250
1st Round Score: 79.32nd 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 TFBP / TFMIP Proposal Evaluation Results14
2010 Third Frontier Biomedical Program
Lanx, Inc.(TFBP 10-825 / Rank: 5)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $1,000,000
1st Round Score: 69.72nd 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
2010 TFBP / TFMIP Proposal Evaluation Results16
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
2010 TFBP / TFMIP Proposal Evaluation Results17
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 2013Equipment
InfraRed Imaging $ 812,000 $3,811,175 $0 $ 740,000 Peripheral Cardiovascular 2012Systems, 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 2013Technologies
EXCMR, Ltd. $ 999,694 $6,810,869 $ 425,000 $1,165,000 Diagnostic Device for MR 2010Cardiac Imaging
CardioInsight $1,000,000 $7,810,869 $0 $1,165,000 Cardiac Diagnostic Imaging 2011Technologies, Inc. System
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2010 Third Frontier Medical Imaging Program (TFMIP)
2010 TFBP / TFMIP Proposal Evaluation Results18
2010 Third Frontier Medical Imaging Program
The Ohio State University(TFMIP 10-936 / Rank: 1)
TFRDF Requested: $1,000,000WCF Requested: $740,000
TOTAL Requested: $1,740,000Cost Share: $1,740,000
1st Round Score: 79.32nd 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 TFBP / TFMIP Proposal Evaluation Results19
2010 Third Frontier Medical Imaging Program
Neoprobe Corporation(TFMIP 10-904 / Rank: 2)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $1,140,252
1st Round Score: 63.32nd 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 by18–24 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 TFBP / TFMIP Proposal Evaluation Results20
2010 Third Frontier Medical Imaging Program
Philips Healthcare(TFMIP 10-918 / Rank: 3)
TFRDF Requested: $999,175WCF Requested: $0
TOTAL Requested: $999,175Cost Share: $999,175
1st Round Score: 68.72nd 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 TFBP / TFMIP Proposal Evaluation Results21
2010 Third Frontier Medical Imaging Program
InfraRed Imaging Systems, Inc.(TFMIP 10-926 / Rank: 4)
TFRDF Requested: $812,000WCF Requested: $0
TOTAL Requested: $812,000Cost Share: $941,000
1st Round Score: 71.02nd 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 TFBP / TFMIP Proposal Evaluation Results22
2010 Third Frontier Medical Imaging Program
Quality Electrodynamics LLC(TFMIP 10-910 / Rank: 5)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $1,002,806
1st Round Score: 77.72nd 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 TFBP / TFMIP Proposal Evaluation Results23
2010 Third Frontier Medical Imaging Program
USA Instruments / GE Healthcare Coils, Inc.(TFMIP 10-930 / Rank: 6)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $1,614,140
1st Round Score: 65.32nd 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 TFBP / TFMIP Proposal Evaluation Results24
2010 Third Frontier Medical Imaging Program
EXCMR, Ltd.(TFMIP 10-922 / Rank: 7)
TFRDF Requested: $999,694WCF Requested: $425,000
TOTAL Requested: $1,424,694Cost Share: $1,497,827
1st Round Score: 70.32nd 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 TFBP / TFMIP Proposal Evaluation Results25
2010 Third Frontier Medical Imaging Program
CardioInsight Technologies, Inc.(TFMIP 10-944 / Rank: 8)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $2,491,990
1st Round Score: 69.02nd 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 TFBP / TFMIP Proposal Evaluation Results27
2010 Third Frontier Biomedical Program
Leadscope, Inc.(TFBP 10-828 / Rank: 6)
TFRDF Requested: $983,308WCF Requested: $0
TOTAL Requested: $983,308Cost Share: $983,308
1st Round Score: 61.72nd 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 TFBP / TFMIP Proposal Evaluation Results28
2010 Third Frontier Biomedical Program
Syncro Medical Innovations, Inc.(TFBP 10-801 / Rank: 7)
TFRDF Requested: $950,000WCF Requested: $0
TOTAL Requested: $950,000Cost Share: $1,249,873
1st Round Score: 76.02nd 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 TFBP / TFMIP Proposal Evaluation Results29
2010 Third Frontier Medical Imaging Program
FMI Technologies, Inc.(TFMIP 10-925 / Rank: 9)
TFRDF Requested: $1,000,000WCF Requested: $0
TOTAL Requested: $1,000,000Cost Share: $2,347,929
1st Round Score: 60.02nd 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 TFBP / TFMIP Proposal Evaluation Results30
2010 Third Frontier Medical Imaging Program
Imalux Corporation(TFMIP 10-901 / Rank: 10)
TFRDF Requested: $999,000WCF Requested: $0
TOTAL Requested: $999,000Cost Share: $1,110,000
1st Round Score: 56.02nd 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 TFBP / TFMIP Proposal Evaluation Results31
2010 Third Frontier Medical Imaging Program
Interventional Imaging Inc.(TFMIP 10-914 / Rank: 11)
TFRDF Requested: $997,010WCF Requested: $0
TOTAL Requested: $997,010Cost Share: $1,007,503
1st Round Score: 65.02nd 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
2010 TFBP / TFMIP Proposal Evaluation Results33
Example of Anchored Scale Scoring
Biomedical Proposals—Path to Market
1 = Existing internal sales force; strong market position in targetmarket; 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
(LOW RISK)
(HIGH RISK)
2010 TFBP / TFMIP Proposal Evaluation Results34
2010 Biomedical Proposals – Path to Market
TaratecI.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 400orthopedic 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 beendemonstrated; product shows good value proposition
10-866 Cardiox 3.7 New CEO with strong marketing experience with start-up medical device companies recently hired fromBay 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 & externalreps); 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 2previous agreements with major companies for other end-use applications and raised significantdevelopment funding
10-828 Leadscope 4.7 Company claims established relationships with half of major pharmas but has not yet demonstratedsuccessful sales history; strategy is to target smaller pharma; company will sell directly viaconferences/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 pullanticipated (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 potentialpartners 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 forcollaborators to become initial customers but this will depend on the product’s value