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Fast-Track proposals will be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 2-4 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary Lymphedema is a clinical expression of an impaired lymphatic circulation. Acquired lymphedema is most often the consequence of regionalized injury to lymphatic vessels as a consequence of trauma, infection, neoplasia, radiation damage, or surgical interventions, especially those that include lymphadenectomy. Secondary lymphedema following axillary lymph node dissection during surgery to remove malignant tissue is the most common cause of lymphedema in United States. Lymphedema is commonly associated with treatment for several types of cancers including breast cancer, melanoma, sarcoma, and gynecological cancers among others. Early stage lymphedema begins as tissue swelling with sense of heaviness and discomfort in affected area. This is followed by transient non-tender pitting edema and development of leathery texture on the skin due to thickening and fibrosis. Without any interventions, non-pitting edema may develop which indicates irreversible stage of lymphedema. Skin in chronic lymphedema is prone to fissures, ulceration, and recurrent cellulitis. Lymphorrhea and Impetigo are also common at this stage. Frequency of acute inflammatory incidences, pain, skin deformities, and reduced hand usage in cases of lymphedema in the arm all lead to frustration, annoyance, anxiety, depression, poor psychological adjustment, and poor body image issues in patients suffering from secondary lymphedema. Lymphedema-related physical disabilities and psychological issues can cause severe limitations and negatively affect personal, work, and social lifestyles. Despite the debilitating physical, psychological, and financial consequences, little progress has been made for the treatment of lymphedema. Current lymphedema treatments mostly involve physiotherapeutic interventions such as massage to manually drain the lymph, multilayer bandaging, topical skincare, compression garments etc. with varying degree of success. Project Goals The goal of this contract topic is to support the development of technologies that prevent, reduce, or eliminate lymphedema Page 76 following removal or radiation of lymph nodes due to cancer in the upper body, i.e. neck, chest, arm(s), or thoracic cavity. These technologies will provide healthcare providers with solutions for preventing and treating lymphedema, which can cause a serious reduction in function and quality-of-life for patients following treatment for cancer. Examples of technologies considered responsive to this solicitation include, but are not limited to; implantable devices capable of modulating the movement of lymph fluid to prevent lymphedema; innovative mechanical devices that can provide real time monitoring and compression throughout daily activities or sleeping hours, or other wearable devices incorporating highly innovative solutions to substantially improve control of lymphedema. The proposed technologies should provide either significant prevention of lymphedema in patients at high-risk of developing it or a long-term solution that reduces/eliminates lymphedema in patients that have the condition. While proposed technologies can have monitoring capability, the technology should include an integrated solution for the prevention or control of lymphedema. Priority will be given to technologies that aim to eliminate or nearly eliminate lymphedema. Activities not responsive to announcement: Proposals for new surgical techniques for lymph node transplant surgery, standard rehabilitation procedures (e.g., massages, techniques, or exercises) for managing lymphedema, or new tools that improve patient education of current rehabilitation procedures will not be considered responsive. Phase I Activities and Deliverables: • Develop a prototype of a device with appropriate specifications. • Demonstrate preliminary proof-of-concept of the device in a suitable animal model or phantom model. • Specify the quantitative technical and commercially relevant milestones that will be used to evaluate the success of the technology. • Identify required specifications necessary to make the device clinic ready. • Develop a regulatory strategy/plan and timeline that is necessary to file a regulatory application for the device. • Implantable device specifications and regulatory plans must include a description of infection risk and plans to test and mitigate the risk of infection or spreading infection. • Present phase I findings and demonstrate the functional prototype system to an NCI evaluation panel via webinar. Phase II Activities and Deliverables: • Build a device according to the specifications developed in Phase I. • Optimize the device design and performance for a clinical setting, and demonstrate the feasibility of this novel device to function in the current clinical workflow and/or in a home setting for patient use. • Demonstrate the safety and efficacy of the device in relevant animal models as required by FDA. • Engage with FDA to refine and execute an appropriate regulatory strategy. If warranted, provide sufficient data to submit a regulatory application to obtain approval for clinical application. • For offerors that have completed advanced pre-clinical work, NCI will support pilot human trials. • Present phase II findings and demonstrate the system via a webinar at a time convenient to the offeror and NCI program staff.
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