SBIR Phase I: Biofabrication of a collagen fabric by scaled-up electrochemical compaction

SBIR 第一阶段：通过放大电化学压实生物制造胶原蛋白织物

• 批准号: 1913847
• 负责人: Subba Shankar
• 金额: $ 22.5万
• 依托单位: COLLAMEDIX INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1913847&HistoricalAwards=false
• 关键词: SBIR; Phase; Biofabrication; collagen; fabric

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in the development of a highly biocompatible implant material made from collagen that can be used to treat a variety of medical conditions, including stress urinary incontinence, pelvic organ prolapse, hernias, and orthopedic injuries. Many people suffer from these conditions, but the current treatments are suboptimal. Most current implants for the repair or support of these soft tissue problems are made from polypropylene, which has significant clinical problems, including chronic inflammation and pain. The FDA recently ordered the removal of all synthetic implants for pelvic organ prolapse from sale in the US due to patient safety issues. Stress urinary incontinence affects 22% of women aged 45-64 years, and an estimated 9.2 million women in the US alone will have pelvic organ prolapse by 2050. These women have life-altering disorders, often limiting them from working, caring for their families, exercising, traveling, etc. New technology to safely treat these disorders is urgently needed. The current project will advance the development of a safe, natural, and effective implant material presently not available to these women. Reimbursement for these procedures under Medicare and private insurance are in place.This Small Business Innovation Research (SBIR) Phase I project seeks to advance the manufacturing of electrocompacted collagen threads which can be used for a variety of medical implants. The existing lab-scale manufacturing process for the production of the collagen threads will be developed into a scaled-up commercial ready process. Key goals include speeding up the thread production, decreasing the need for operator intervention, and improving the efficiency of converting the collagen feedstock into thread, all while maintaining thread strength and process repeatability. This is critical to ensuring that products developed from this technology can be produced in commercial volume and will be priced within existing medical insurance reimbursements. Achieving these goals will greatly de-risk this technology, enabling the attraction of further investment capital and the continuation of product development.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是开发由胶原蛋白制成的高度生物相容性植入材料，可用于治疗各种医疗疾病，包括压力性尿失禁，盆腔器官脱垂，疝和骨科损伤。许多人患有这些疾病，但目前的治疗方法并不理想。目前用于修复或支持这些软组织问题的大多数植入物由聚丙烯制成，其具有显著的临床问题，包括慢性炎症和疼痛。由于患者安全问题，FDA最近下令从美国的销售中移除所有用于盆腔器官脱垂的合成植入物。压力性尿失禁影响了22%的45-64岁女性，估计到2050年，仅美国就有920万女性将患有盆腔器官脱垂。这些妇女患有改变生活的疾病，往往限制了她们的工作，照顾家人，锻炼，旅行等，迫切需要安全治疗这些疾病的新技术。 目前的项目将促进开发一种安全，天然和有效的植入材料，目前这些妇女还无法获得。这项小型企业创新研究（SBIR）第一阶段项目旨在推进可用于各种医疗植入物的电压实胶原蛋白线的制造。用于生产胶原线的现有实验室规模生产工艺将被开发为扩大规模的商业就绪工艺。主要目标包括加快线的生产，减少操作员干预的需要，提高胶原原料转化为线的效率，同时保持线的强度和工艺的可重复性。这对于确保从该技术开发的产品能够以商业规模生产并在现有医疗保险报销范围内定价至关重要。实现这些目标将大大降低这项技术的风险，从而吸引更多的投资资本并继续产品开发。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。