Invitation for Commercialization of DRDC's Real Time 3D(4D) Ultrasound Imaging Digital Technology

Invitation for Letters of Interest from Industry for the commercialization of Defence Research and Development Canada (DRDC) Real Time 3D (4D) Ultrasound Imaging Digital Technology Purpose and Nature of the Letter of Interest (LOI) Defence Research and Development Canada (DRDC) wishes to license the two US patents that define its Real Time 3D (4D) Ultrasound Imaging Digital Technology for further development and commercialization. Private-sector businesses and organizations with expertise and experience in this technology domain and an interest in commercializing this technology are invited to respond. This LOI is neither a call for tender nor a Request for Proposal (RFP). No agreement or contract will be entered into based on this LOI. The issuance of this LOI is not to be considered in any way a commitment by the Government of Canada, nor as authority to potential Respondents to undertake any work that could be charged to Canada. This LOI is not to be considered as a commitment to issue a subsequent solicitation or award a contract for the work described herein. Although the information collected may be provided as commercial-in-confidence (and, if identified as such, will be treated accordingly by Canada), Canada may use the information to assist in drafting performance specifications (which are subject to change) and for budgetary purposes. Respondents are encouraged to identify, in the information they share with Canada, any information that they feel is proprietary, third party or personal information. Please note that Canada may be obligated by law (e.g. in response to a request under the Access of Information Act and the Privacy Act) to disclose proprietary or commercially-sensitive information concerning a Respondent (for more information: http://laws-lois.justice.gc.ca/eng/acts/a-1/). Respondents are asked to identify if their response, or any part of their response, is subject to the Controlled Goods Regulations. Respondents will not be reimbursed for any cost incurred by participating in this LOI. Context DRDC’s 4D Ultrasound Imaging technology consists of an ultrasound matrix planar 32x32 sensor array probe controlled by:

a highly parallelized computing architecture that is based on an eight set of XILINX FPGAs (i.e. Virtex 6); and DRDC’s proprietary 3D adaptive beamformers, that provide volumetric reconstruction with improved angular resolution image quality at 3 MHz probing frequencies with images that are equivalent with those provided by a matrix 64x64 sensor array.1. Brief description of the technology The Problem: Approximately 90% of trauma deaths occur in an accident zone prior to medical or surgical interventions. Lack of intelligent diagnostic tools capable of providing rapid and accurate diagnosis of non-visible internal injuries is the main problem facing medical personnel in mass casualty situations or in under-served regions (civilian sector), and far forward operations (defence sector). To this day, there is no system that provides relevant image data and automated diagnostic tools, capable of detecting, with minimum requirements of training, life threatening injuries within the so-called “golden hour” of trauma diagnosis. The non-specific signs (symptoms) of trauma and the variability of patient reactions to injury result in frequently unreliable physical examinations in trauma settings. The solution to this problem is a mobile, light-weight, easy-to-use, easy-to-operate, trauma detection and assessment system which can be operated not only by specialists but by all emergency first responders. 2. Development Status To address this problem, the Canadian Forces Surgeon General and DRDC have developed hardware and software tools for 4D ultrasound imaging systems to allow for a rapid diagnosis of invisible internal injury in austere and possibly hostile front-line environments. DRDC’s 4D Ultrasound Imaging Technology is embodied in the “Portable 3D/4D Ultrasound Diagnostic Imaging System”, (PUDIS), and consists of a set of novel proprietary adaptive ultrasound beamformers that address the fundamental image resolution problems of current 3D ultrasound systems. This technological alternative is a complete stand-alone 4D ultrasound solution with automated diagnostic capabilities for defence (combat casualty care) and civilian (trauma care) applications requiring minimal training. 3. Current State of the PUDIS Technological Developments The overall technology readiness level (TRL) of the prototype is TRL-6, the result of $5 million invested on the development of the PUDIS system by DRDC. Table 1 summarizes the current TRL for each sub-system. Each sub-system on its own is innovative and new, but the combination makes the result truly unique.

Table 1: Key features and status of the PUDIS experimental prototype (refer to attached document) 4. Remaining Development Continued development by the licensee to TRL-9 will be required for the commercial exploitation and clinical use of the PUDIS technology. Although the above innovative 4D ultrasound imaging technology has been assessed through the development of the PUDIS experimental prototypes deploying a 32x32 phased array ultrasound probe, the next step to convert this technology into an operational 4D medical imaging device for medical use and military far-forward operations requires: Redesign of the current prototype as a robust commercial medical device having marketing clearance approvals by Health Canada, FDA (510K) and CE/CSA. 5. PUDIS potential market In Canada, the potential defence-oriented market for the PUDIS technology is estimated at 12 systems for the naval vessels and 2 to 5 more systems for far-forward operations. This does not take into account the market of the allied nations. However, according to a recent market report, the annual market size for ultrasound devices in civilian emergency care applications is projected to be approximately $480 million CDN by 2020, with a compound annual growth of around 4.5%. In mature markets, such as North America and Europe, future growth is mainly attributed to product commercialization, rising trends in telemedicine that augment the use of ambulatory diagnostic devices, the dearth of skilled medical specialists, the need to ensure a balanced mix of medical staff skills, and efforts to reduce unnecessary use of hospital care. 6. Replies to Invitation All interested organizations should submit a fully articulated proposal expressing an interest to commercialize DRDC’s 4D ultrasound imaging technology as a field-deployable system as defined above. To be considered, responses to this invitation must include the following:

Background information on the organization’s resource base. A statement of how the organization’s capability and expertise will assist in the commercialization of DRDC’s 4D ultrasound imaging technology, as demonstrated by past initiatives in similar developments or technologies, and fit with the organization’s strategic objectives, core competencies and existing products or services. Background information on the education and experience of key scientific, technical and marketing staff (supported by brief resumes) who would be assigned to the project.These proposals will be assessed in terms of their potential benefit, and negotiations will be initiated with the qualified organization(s). 7. Enquiries Because this is not a bid solicitation, Canada will not necessarily respond to enquiries in writing or by circulating answers to all potential suppliers. However, respondents with questions regarding this LOI may direct their enquiries to: Sue Viel Sue.Viel@forces.gc.ca (416) 635-2029 The contact information of the respondent representative must be provided with the response kit. This LOI is subject to amendment. If necessary, these changes will be published on the electronic tendering service of the government. Canada asks Respondents to visit Buyandsell.gc.ca regularly to check for changes, if any. 8. LOI Closing Interested suppliers should email their response to the following email address and ensure that it is received by the date and time indicated on page 1 of this document. Each Respondent is solely responsible for ensuring its response is delivered on time to the correct location: Sue.Viel@forces.gc.ca