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

这个小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是开发一种由胶原蛋白制成的高度生物相容性植入材料，可用于治疗各种疾病，包括压力性尿失禁、盆腔器官脱垂、疝气和骨科损伤。许多人都患有这些疾病，但目前的治疗方法并不理想。目前大多数用于修复或支持这些软组织问题的植入物都是由聚丙烯制成的，这有明显的临床问题，包括慢性炎症和疼痛。由于患者安全问题，美国食品和药物管理局最近下令从美国销售所有用于盆腔器官脱垂的人工合成植入物。压力性尿失禁影响22%年龄在45-64岁的女性，估计到2050年仅美国就有920万女性患有盆腔器官脱垂。这些妇女患有改变生活的疾病，常常限制她们工作、照顾家庭、锻炼、旅行等。迫切需要安全治疗这些疾病的新技术。目前的项目将推动一种安全、自然、有效的植入材料的开发，目前这些女性还无法获得。在医疗保险和私人保险下，这些程序的报销已经到位。这个小企业创新研究（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。现有的实验室规模的生产胶原蛋白线的工艺将被发展成一个大规模的商业准备的工艺。主要目标包括加快螺纹生产速度，减少操作人员干预的需要，提高将胶原蛋白原料转化为螺纹的效率，同时保持螺纹强度和工艺可重复性。这对于确保利用这一技术开发的产品能够大批量生产，并将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，使其能够吸引更多的投资资本和继续进行产品开发。该奖项反映了美国国家科学基金会的法定使命，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。

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.