STTR: An Assessment of the Small Business Technology Transfer Program (2016) / Chapter Skim
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Appendix E: Case Studies
Appendix E: Case Studies
Pages 153-242
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is a private company founded in 1984 as sole proprietorship by Melvin Piestrup and incorporated 2 years later in 1986. The company produces a range of high energy neutron sources for industrial and 1 Primary sources for this case study are the interview with Dr.
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Consultations Companies Adelphi Technologies, Inc.; Calabazas Creek Research, Inc.; Creare, Inc.; Ekso Bionics, Inc.; Muons, Inc.; Nanosonic, Inc.; Physical Sciences, Inc.; Stratatech Corporation; Vista Clara, Inc.; Xemed, LLC; Xia, LLC. A diverse set of case studies were selected for inclusion based on a range of selection criteria: extensive company experience with the program; strong comparative company experience with both SBIR and STTR; company experience with STTR (and SBIR)
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In 2013, in collaboration with the University of Florida, Adelphi won a second R&D 100 award for its DD109X High Flux Fast Neutron Source. 2 Adelphi maintains research relationships with a broad range of academic, government, and corporate organizations such as the University of California, Berkeley, the University of Florida, Yale University, Indiana University, Rapiscan, Inc., Engility, Inc., and the Savannah River National Laboratory.
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The Adelphi technology can produce sufficiently high levels of energetic neutrons for many research and industrial applications. The flux rates of Adelphi's neutron sources are controllable.
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Products Adelphi has designed and developed neutron sources, producing sources with neutron energies ranging up to 14 MeV and output levels of up to 1010 neutrons per second. Recently, the company has added neutron detectors to its product line for use in security and healthcare applications.
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From page 158... ...
patents listed in Table E-1. TABLE E-1 Adelphi Technology Patents Patent Number Patent Year 7,177,389 X-ray tomography and laminography 2007 6,992,313 X-ray and neutron imaging 2006 6,765,197 Methods of imaging, focusing and conditioning neutrons 2004 6,674,583 Fabrication of unit lenses for compound refractive lenses 2004 6,545,436 Magnetic containment system for the production of 2003 radiation from high energy electrons using solid targets 6,269,145 Compound refractive lens for x-rays 2001 6,201,851 Internal target radiator using a betatron 2001 5,107,508 X-ray laser 1992 5,077,774 X-ray lithography source 1991 4,951,304 Focused X-ray source 1990 SOURCE: U.S.
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From page 159... ...
Dr. Gary observed that typically 30 percent of SBIR funding and 40 percent of STTR funding is used for subcontracts.
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The work in this case is in a fairly esoteric field with minimal commercial potential, but the project has been highly successful technically.
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For example, CCR partnered with the SLAC National Accelerator Laboratory to improve the performance of cavity resonators in linear 6 Primary sources for this case study are an interview with Dr. Ives on August 21, 2015, and a review of the Calabazas Creek Research web site (http://www.calcreek.com)
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From page 162... ...
The company is also developing products to meet DoE's obligations for the ITER project in France. Technology and Products Electron Beam Devices Although semiconductors have displaced vacuum tubes in many logic and communications applications, there remain important niche applications in television transmitters, satellite communications, material processing, defense, and particle accelerators.
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The resonator operates in combination with strong magnetic fields to transfer electron beam energy into RF radiation. This radiation can be formed into a beam and emitted at right angles to the direction of the original electron beam.
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. CCR is also working as a subcontractor to provide an electron gun for a major classified defense program.
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CCR is also successful in licensing intellectual property developed through SBIR funding. In 2010, Ceradyne acquired the intellectual property rights for "sintered wire" technology that enables the production of a tungsten, reservoir, dispenser cathode with applications in electronic counter measures (ECM)
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and HeatWave Labs, Inc. Its list of recent collaborators includes: • University of California -- Berkeley • Rensselaer Polytechnic Institute • North Carolin State University • University of Maryland • University of Wisconsin • Old Dominion University • SLAC National Accelerator Laboratory • Fermilab • Sandia National Laboratory • General Atomics • Los Alamos National Laboratory • Communications & Power Industries, LLC SBIR/STTR Between 1995 and 2014, SBIR funded 119 projects with Calabazas Creek Research, amounting to nearly $31.4 million.
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Most agencies do not have a Phase III policy in place that supports commercialization of technology developed in the SBIR/STTR program. Recent experience with a national laboratory suggests that operations within agencies are not following the Phase III directives in the current SBIR law.
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CCR previously applied for many such topics, and received awards, but realized that it was difficult to build a sustainable business on 6-7 percent profit margins. The company has become much more selective about which SBIR/STTR awards it applies for, with a greater emphasis on commercialization potential.
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From page 169... ...
Creare's labs are staffed with approximately 40 highly skilled electrical and mechanical technicians, machinists and support staff who typically support approximately 100 concurrent experimental projects in its laboratories. Creare also maintains research relationships with a broad range of university, government, and corporate R&D organizations.
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From page 170... ...
At the same time, it also works with these numerous prime contractors including LMACo, NGC, BHT, ATK, P&W 16 as well as Tier 1 suppliers. Engineering Services Creare provides engineering services to a diverse, international customer base, including both government and industrial clients, in a broad range of industries.
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Navy aircraft carriers. Advanced Manufacturing Creare develops advanced materials processing and component fabrication techniques, both as end products for clients and as means to build components for other projects.
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Over the same period, the U.S. government and other clients purchased additional engineering services from Creare that totaled 10 times the magnitude of the initial SBIR funding in this area.
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Nearly 40 percent of Creare's total revenues come from Phase III commercialization activities related to past SBIR/STTR programs. 17 National Aeronautics and Space Administration, "Small Business/SBIR: NICMOS Cryocooler -- Reactivating a Hubble Instrument," Aerospace Technology Innovation, vol.
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174 APPENDIX E TABLE E-3 Creare Patents Patent Number Patent Year 8,777,529 Mechanism for delivering cryogenic coolant to a rotating tool 2014 8,656,908 Aerosol delivery systems and methods 2014 8,544,462 Systems and methods for aerosol delivery of agents 2013 Device for axial delivery of cryogenic fluids through a machine 2012 8,303,220 spindle 8,215,878 Indirect cooling of a rotary cutting tool 2012 8,061,241 Indirect cooling of a cutting tool 2011 8,021,737 Panelized cover system including a corrosion inhibitor 2011 7,954,486 Aerosol delivery systems and methods 2011 Protective cover system including a corrosion inhibitor and 2010 7,759,265 method of inhibiting corrosion of a metallic object 7,699,804 Fluid ejection system 2010 Magnet locating apparatus and method of locating a magnet 2009 7,561,051 using such apparatus Self-contained breathing apparatus facepiece pressure control 2008 7,373,943 method 7,225,807 Systems and methods for aerosol delivery of agents 2007 7,189,468 Lightweight direct methanol fuel cell 2007 7,183,230 Protective cover system including a corrosion inhibitor 2006 7,100,628 Electromechanically-assisted regulator control assembly 2006 7,053,012 Flexible corrosion-inhibiting cover for a metallic object 2006 6,874,676 Method and structure for welding an air-sensitive metal in air 2005 6,833,334 Flexible corrosion-inhibiting cover for a metallic object 2004 6,794,317 Protective cover system including a corrosion inhibitor 2004 6,444,595 Flexible corrosion-inhibiting cover for a metallic object 2002 6,397,936 Freeze-tolerant condenser for a closed-loop heat-transfer system 2002 6,379,789 Thermally-sprayed composite selective emitter 2002 6,212,568 Ring buffered network bus data management system 2001 6,170,568 Radial flow heat exchanger 2001 6,023,420 Three-phase inverter for small high speed motors 2000 Multilayer ultrasonic transducer array including very thin layer 1999 5,938,612 of transducer elements Ultrasound system and method of administering ultrasound 1999 5,906,580 including a plurality of multi-layer transducer elements 5,748,005 Radial displacement sensor for non-contact bearings 1998 5,399,825 Inductor-charged electric discharge machining power supply 1995 5,145,001 High heat flux compact heat exchanger having a permeable heat 1992
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Started in 1983, where Creare used early SBIR funding to develop FLUENT™, a general purpose code for computational fluid dynamics (CFD)
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Spectra 1984 Spectra is a manufacturer of high speed ink jet print heads and ink deposition systems. Formed around a sophisticated deposition technology developed at Creare, Spectra was acquired by Fujifilm in 2006 and renamed Fujifilm Dimatix.a Fluent 1988 Based on Creare's longstanding expertise in computational fluid dynamics, Fluent began marketing comprehensive computational fluid dynamics software.
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Dr. Rozzi said that a direct linear path from Phase I to Phase II to a Phase III transition was very rare.
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Rozzi, Creare utilizes SBIR and STTR in the same way: Creare only applies for SBIR or STTR awards if the company can see a clear path to transition and/or commercialization. This could mean developing a specialty product -- e.g., the cryocooler for Hubble and other space programs, or the turbo pumps developed for the first Mars rovers with NASA SBIR funding, which have now been adapted for other space program at NASA such as the Curiosity Mars rover.
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From page 179... ...
STTR Creare has worked to developed a network of potential academic partners, and is usually aware of the best RI partner might be. In some cases this is an FFRDC, although the latter usually want full payment of their contract up front, and require approval of a CRADA.
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Ekso was founded in 2005 by Nathan Harding, Homayoon Kazerooni, and Russ Angold, all members of the Berkeley Robotics and Human Engineering Laboratory at the University of California 21 Primary sources for this case study are the interview with Dr. Kurt Amundson, R&D Projects Director, August 21 2015, a review of the Ekso web site, and related company documents and SEC filings.
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Media interest remains strong with recent stories from 60 Minutes, Forbes, and National Public Radio among others. 22 At present, Ekso has two principal business areas: medical technology and engineering services with plans to accelerate go-to-market plans for their Industrial division after recent Equipois acquisition.
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Battery-powered motors drive the legs, replacing the patient's deficient neuromuscular function. For patients with some motor ability intact (for example, after a stroke or an incomplete spinal cord injury)
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Causes of serious and permanent limitation in "mobility include stroke, spinal cord injury, cerebral palsy and multiple sclerosis." 26 According to the company's 2015 10-K, the potential market for its medical and rehabilitative products is considerable (see Table E-5) TABLE E-5 Potential Commercial Markets for Ekso Medical Products Percent Estimated as Potential Ekso Total Incidence Annual Incidence Users Stroke 795,000 30 Spinal cord injury 300,000 14,000 80 Traumatic brain 285,000 30 injury Cerebral palsy 764,000 10,000 10-30 Multiple sclerosis 400,000 10,000 10-30 SOURCE: Ekso Bionic 2015 10K.
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All are potential competitors to Ekso in its core rehabilitation segments. Engineering Services In addition to further developing it rehabilitation exoskeleton, Ekso is developing systems for able-bodied applications of the technology.
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Special Operations Command (SOCOM) are the principal customers for contracted engineering services.
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A series A round in December, 2010 was followed in June, 2012 with a $9.1 million series B 30 The company 30 "UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM D," (June 22, 2012)
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These include upfront licensing fees from Lockheed for military exoskeleton technology and from OttoBock Healthcare Products Gmbh for technologies used in prosthetics and related areas. Ekso and SBIR/STTR Between 2005 and 2014, SBIR/STTR funded 13 projects worth $5.03 million with Ekso and its predecessor Berkeley Bionics.
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More recently, Ekso has received STTR awards from SOCOM at DoD, for work on the TALOS program.
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Dr. Johnson spent most of his career at National Labs, initially Lawrence Berkeley National Laboratory (LBNL)
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Muons also hires post docs who work within research partner national labs while supported by the company. Muons supports PhD students working on SBIR-STTR grant topics, where three women and one man received their degrees in the last two years.
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Burning the spent nuclear fuel from the current fleet of nuclear reactors is vastly superior to throwing away its enormous internal energy and just piling it in a hole in the ground for 100,000 years. Safety: Being subcritical, fission stops when the accelerator is switched off and passive air cooling is sufficient to maintain safe reactor temperature.
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Business Model and Customers Muons is a small research oriented firm with changing commercial ambitions. Its funding was in large part derived from SBIR-STTR awards, along with some consulting revenues mostly from national labs.
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Muons has partnered with 9 national labs: • Argonne National Laboratory • Brookhaven National Laboratory • Fermi National Accelerator Laboratory • Thomas Jefferson National Accelerator Facility • Los Alamos National Laboratory • Lawrence Berkeley National Laboratory • National High Field Magnet Laboratory • Oak Ridge National Laboratory, • Pacific Northwest National Laboratory
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From page 194... ...
that are sometimes required for STTR grants with National Labs often include a section detailing how the labs will make available specific lab and office space". The company first used STTR grants to develop new ideas for a muon collider, addressing the technical problems of cooling beams of muons so they were are dense enough to make such a machine possible.
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Because Muons has such long and deep connections with national labs, its staff know most of their counterparts at the labs, so the connection is always positive. Still, lab administrators in general tend to view STTR awards as small projects.
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The company hired several chemists to pursue these new areas, and is now concentrating on materials production rather than electronic products SBIR/STTR awards led to a considerable amount of positive press, Dr. Lalli noted, and this led to more awards and then on to three separate Phase III contracts within three years.
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The company has licensed nine patents from Virginia Tech, covering electrostatic self-assembly processing and use, and is establishing its own intellectual property portfolio in the next step toward commercialization. Currently, NanoSonic has one patent that generally relates to self-formation of a transparent, abrasion-resistant optical coating on solid plastic substrates that protect a solid substrate from wear and/ or provide properties such as magnetism, electrical conductivity, and UV absorption.
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Materials NanoSonic also sells advanced materials directly. Metal rubber sheets are a highly flexible and electrically conductive elastomer, which can be stretched to 1,000 percent of its original shape while staying conductive.
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It is worth noting that this product has little-to-no toxic byproducts. Finally, NanoSonic has also been working on optical fiber cables.
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SBIR/STTR NanoSonic has received 281 SBIR/STTR awards, 243 SBIR and 38 STTR. (206 were Phase I and 75 Phase II)
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A typical partnership might involve making the materials at the company, with the university providing technical help in measuring performance. For example, in STTR programs with Colorado State University, the partner there is an expert in the measurement of radiation-resistant materials measurement, and also has the necessary equipment in the university lab.
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(PSI) is a private company founded in 1973 by Robert Weiss, Kurt Wray, Michael Finson, George Caledonia, and other colleagues from the Avco-Everett Research Laboratory.
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In the 1980s, with SBIR support, PSI expanded into medical imaging and imaging chemically reacting flows. In the 1990s, PSI extended further into research on materials (especially chemical sensors)
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Commercialization: Subsidiaries, Spin-offs, and Licensing When PSI sees commercial potential in a technology, senior management evaluates the opportunity to determine how to address the opportunity. PSI subsidiaries tend to replicate the R&D culture of the parent company (publication in peer-reviewed journals, use of SBIR funding)
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Q-Peak has also had substantial success in acquiring SBIR/STTR funding, having received 110 SBIR/STTR awards, worth $29.4 million. Eight percent by value have been STTR awards.
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In addition to engineering services, Faraday also markets rectification equipment and effluent decontamination reactor hardware. Faraday Technology has had success generating SBIR/STTR funding, receiving 90 SBIR/STTR awards, worth $21.0 million.
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In 2006, PSI received a Tibbetts Award. 40 According to the PSI web site, PSI licensing income recently exceeded $1 million annually following the successful commercialization of its ophthalmic technologies.
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of PSI patent portfolio has been published in the past 5 years which suggests that PSI's patent strategy has changed. Partnerships PSI maintains research relationships with a broad range of university, government, and corporate R&D organizations.
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From page 209... ...
The remaining 10 percent were funded by the Department of Agriculture, the EPA, the Department of Homeland Security, and the National Aeronautics and Space Agency. Over the more than 30 years that PSI has received SBIR/STTR funding, STTR awards account for just under ten percent by value.
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PSI has had a number of successful STTR projects. One focused on imaging of the retina, and stretched over several STTR awards, starting with NIH support.
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Commercial review was probably not as insightful, but noone can perfectly see the path to commercialization. Efforts have been made to improve commercial review, and DoE in particular has tried to raise awareness and improve quality.
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Both the core technology, Stratagraft®, and the world's first genetically enhanced human skin, Expressgraft™, are being evaluated in late-stage and early-stage clinical trials, respectively. The late-stage clinical development supporting the StrataGraft® product is in part funded by a $247 million contract with Biomedical Advanced 45 Primary sources for this case study are the interview with Barbara-Allen Hoffmann conducted on April 9, 2015, and a review of the Stratatech web site (http://www.stratatechcorp.com)
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Keratinocytes are the cells that make up approximately 90 percent of the outer layer of human skin known as the epidermis. The value of the NIKS® cell line lies in its ability to regenerate the epidermal component within a fully stratified human skin tissue.
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It mimics natural human skin, with both dermal and fully-differentiated epidermal layers. StrataGraft® skin tissue is easily sutured to a wound bed, provides barrier function, and is anticipated to serve as a source of factors promoting the natural skin regeneration process.
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Based on the NIKS® cell line, StrataTest® is a human skin model for in vitro consumer product testing, drug discovery and toxicity screening. Like StrataGraft®, StrataTest® tissue is composed of both epidermal and dermal layers, and displays the same physical, chemical and histological characteristics of human skin, enabling better prediction of in vivo biological responses than monolayer skin culture technologies.
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From 2001 to 2003, it received Phase I SBIR awards from four NIH centers -- National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of General Medical Sciences, National Cancer Institute, and National Institute of Environmental Health Sciences -- followed in 2004 by the first Phase II award from NIGMS. Subsequently, Stratatech also received awards from NIDDK and NIA.
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8,790,636 Human skin equivalents expressing exogenous polypeptides 2014 8,685,463 Dried and irradiated skin equivalents for ready use 2014 8,580,314 Dried and irradiated skin equivalents for ready use 2013 8,092,531 Human skin equivalents expressing exogenous polypeptides 2012 7,988,959 Method of treatment using organotypically cultured skin tissue 2011 comprising NIKS® cells that express exogenous HIF-1a 7,955,790 Skin substitutes with improved barrier function 2011 7,915,042 Keratinocytes expressing exogenous angiogenic growth factors 2011 7,888,496 Kit for species specific DNA detection 2011 7,807,148 Organotypically cultured skin tissue comprising NIKS® cells that 2010 express exogenous HIF-1a 7,674,291 Human skin equivalents expressing exogenous polypeptides 2010 7,541,188 Skin substitutes and uses thereof 2009 7,501,238 Skin Substitutes for irritancy testing 2009 7,498,167 Keratinocytes expressing exogenous angiogenic growth factors 2009 7,462,448 Species specific DNA detection 2008 7,407,805 Skin substitutes with improved barrier function 2008 6,974,697 Skin substitutes with improved barrier function 2005 6,846,675 Skin substitutes and uses thereof 2005 SOURCE: U.S. Patent and Trademark Office.
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From page 218... ...
Allen-Hoffmann stressed that the SBIR/STTR program at NIH had provided absolutely critical funding for Stratatech. She said that she had no doubt that her company and its associated products would not be in existence 49 Stratatech, "Stratatech Awarded BARDA Contract Valued up to $47.2 Million for Advanced Development of StrataGraft® Skin Tissue for Thermal Burns," Press Release, July 31, 2013, accessed at http://www.stratatechcorp.com/news/20130731.php.
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From page 219... ...
Although program officers in general have a strong commitment to the SBIR/STTR program, the SBIR program coordinators possess specific knowledge and can be extremely helpful in guiding investigators. She recommended that small companies make sure that they established contact with the program coordinators.
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VISTA CLARA, INC. 50 Vista Clara is a private company founded in 1997 by Dr.
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First, the magnetic spins in a sample are aligned using a magnetic field, and second a radio pulse perturbs the aligned fields. The exact frequency of the pulse depends on the atom to be detected and the strength of the magnetic field.
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56 David Walsh, "Multicoil low-field nuclear magnetic resonance detection and imaging apparatus and method," U.S. Patent 8,451,004, May 28, 2013, http://patft.uspto.gov/netacgi/nphParser?
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Corona is a portable system for evaluating the hydrological characteristics of soil cores. Using the same technology as a MRI scanner, Corona exposes a sample to a strong magnetic field and then a series of electromagnetic pulses.
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As a result, systems are typically bought by government agencies or their prime contractors, according to Dr. Walsh, which tends to mean a slow sales cycle.
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Starting in 2008, Vista Clara received further Phase II SBIR and STTR awards from DoE, which have according to Dr. Walsh allowed it to gain 57 "Vista Clara secures leading position in China," http://www.vista-clara.com/news/vista-clarasecures-leading-position-in-china/.
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Dr. Walsh observed that it appears there is no clear connection between the SBIR program and DoE needs elsewhere in the agency.
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Xemed is headquartered in Durham, New Hampshire, and has grown to 10-15 employees over 11 years. The company has broad expertise and IP in the production of hyperpolarized noble gases, and its mission is to develop these inhaled diagnostic agents which are capable of changing the management of respiratory diseases.
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Xemed is addressing regulatory issues, and believes that FDA approval will come -- the company submitted a New Drug Application (NDA) in August 2015, providing details of the Phase 1, Phase 2 and two confirmatory Phase 3 clinical trials that have been completed.
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Recently, lung cancer researchers have also hypothesized that hyperpolarized MRI can be used to refine management of stereotactic conformal radiotherapy for lung cancer. Hyperpolarized Noble Gases Most magnetic resonance imaging (MRI)
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61 Products Hyperpolarized noble gases allow evaluation of a broad range of clinically important lung characteristics. At present, Xemed's collaborators at academic hospitals in the United States and Canada are developing protocols for their use in estimating lung ventilation, alveolar size, small airway dimension, exchange with red blood cells, and other parameters of lung function.
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Xemed has completed two clinical trials of MagniXene®. The Phase 1 trial partnered with researchers at the Brigham and Women's Hospital and Harvard University to evaluate using 129Xe as a contrast agent to study patient safety and preliminary indications of efficacy.
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Collaboration Xemed maintains research relationships with various university laboratories and research hospitals. Xemed worked with the University of New Hampshire and Mass General Hospital in the development of hyperpolarized noble gas production systems and chest coil development.
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64 "Xemed selected to participate in the 2010-2011 NIH SBIR Commercialization Assistance Program," October 1, 2010, https://www.xemed.com/2010/10/xemed-selected-to-participate-in-the2010-2011-nih-sbir-commercialization-assistance-program/; "Commercialization Accelerator Program (CAP) ," August 14, 2015, https://sbir.nih.gov/cap.
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In 2007-2008 the company had received a DoE STTR award to re-examine the utility of hyperpolarized 3He for nuclear physics. A contracting officer within DoE believed that STTR awards could not have an academic PI.
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XIA, LLC 66 XIA LLC (originally X-Ray Instrumentation Associates) is a private company founded in 1988 by William Warburton.
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The company currently derives about 75 percent of its income from product sales, with the rest coming from SBIR and BAA grants and from commercial contracts. 67 The company maintains research relationships with a broad range of academic, government, and corporate entities such as UC Davis, University of Texas at Austin, Michigan State University, Pacific Northwest National Laboratory, Los Alamos National Laboratory, Lawrence Livermore National Laboratory, Institute for Nuclear Physics (Germany)
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From page 237... ...
Other applications include handheld metal detectors using x-ray fluorescence, high-rate gamma spectroscopy for assaying spent nuclear fuel, discrimination of alpha, beta, gamma, and neutron radioactivity for detectors sensitive to the full range of radiation events, and synchrotron-based spectroscopy for characterizing materials properties in pharmaceutical, engineering, and material science. Product Architectures XIA's product line falls into three main digital data acquisition architectures: DXP (Digital X-ray Processor)
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From page 238... ...
For example, incoming data can be processed and sorted according to pulse shape characteristics such a risetime or falltime. The DGF product line provides solutions to a wide range of extremely demanding pulse processing applications in the areas of nuclear physics, strip detectors, and very high resolution gamma-ray spectroscopy.
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solely licensed to XIA and potentially applicable to any hardware or software developed by XIA. SBIR/STTR Between 1990 and 2013, SBIR funded 53 projects with XIA LLC amounting to nearly $14.3 million.
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While DoE scientists continue to seek tools and instruments to assist in their research, these generally have extremely limited commercial potential and hence fail DoE's "return on investment" (as measured only by instrument sales) criteria.
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He found difficult to pass both reviews. His personal view was that small instrument sales that supported the national laboratories' missions were in the national interest and that this class of SBIR topic should be given evaluation criteria that appropriately reflect their values to those missions.
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From page 242... ...
The collaboration had now lasted ten years, advanced the state of the art, and should be seen as quite successful. XIA has not worked collaboratively with the national labs outside the SBIR/STTR program.
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