SBIR Phase II: Regenerative Tissue Filler for Breast Conserving Surgery and Other Soft Tissue Restoration Needs

SBIR II 期：用于乳房保留手术和其他软组织修复需求的再生组织填充物

• 批准号: 2135908
• 负责人: Theodore Puls
• 金额: $ 97.43万
• 依托单位: GENIPHYS, LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2135908&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Regenerative; Tissue

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is its potential to lower healthcare costs and enhance the quality of life for breast cancer survivors, along with those suffering from traumatic injuries, skin ulcers, and other surgical wounds. For breast conserving surgery (BCS), which represents the standard of care for early-stage breast cancer, the most assured way of achieving satisfactory outcomes is complete tumor removal and preservation of breast cosmesis in a single surgery. Unfortunately, the rates of BCS-related complications, deformities, and secondary surgeries remain high (20-40%), which increases healthcare costs and negatively impacts patient quality of life. To address these problems, this project furthers development of an in-situ, scaffold-forming collagen designed as a conformable and regenerative filler for soft tissue defects and voids. This soft-tissue filler has the potential to improve breast surgeons’ ability to provide predictable and pleasing outcomes to their patients. Further, the versatility of this collagen polymer means that it can be used for a variety of other clinical applications (e.g., vocal fold medialization, therapeutic cells, and drug delivery) and to create regenerative tissue products for other areas of major unmet clinical need (e.g., cartilage, skeletal muscle). This Small Business Innovation Research (SBIR) Phase II project seeks to complete the final technical hurdles to commercialize the novel collagen polymer referred to above. Recognizing the significance of collagen as the body’s primary tissue building material, this patented biomaterial platform was designed to be highly purified and to retain collagen’s natural fibril-forming (polymerization) capacity. While this technology offers a broad range of customization potential, this project focuses on development of an in-situ, scaffold-forming collagen to accelerate and improve healing outcomes of complex cavity, tunneling, and deep penetrating tissue defects. The collagen is applied as a conformable liquid, which rapidly transitions to a fibrillar scaffold with soft tissue consistency. Preclinical studies evaluating this product as a breast tissue filler following lumpectomy have documented the following: 1) ease of use, 2) conformability to patient-specific voids, 3) noninflammatory regenerative healing, and 4) compatibility with standard clinical procedures. This SBIR project seeks to achieve key commercialization milestones associated with establishing pilot-scale manufacturing and achieving relevant product regulatory clearance and approval. Specifically, work will include development and validation of scalable processing steps for collagen purification, sterilization, and viral inactivation. This project will also complete most of the non-clinical bench performance and biocompatibility testing necessary for regulatory filings.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.

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是它有可能降低医疗保健成本，提高乳腺癌幸存者的生活质量，沿着那些遭受创伤，皮肤溃疡和其他手术伤口。对于代表早期乳腺癌护理标准的保乳手术（BCS），实现满意结果的最可靠方法是在一次手术中完全切除肿瘤并保留乳房美容。不幸的是，BCS相关并发症、畸形和二次手术的发生率仍然很高（20-40%），这增加了医疗成本，并对患者的生活质量产生负面影响。为了解决这些问题，该项目进一步开发了一种原位支架形成胶原蛋白，设计为软组织缺损和空隙的适形和再生填充物。这种软组织填充物有可能提高乳房外科医生为患者提供可预测和令人满意的结果的能力。此外，这种胶原聚合物的多功能性意味着它可以用于各种其他临床应用（例如，声带中介化、治疗性细胞和药物递送）并产生用于主要未满足的临床需求的其它领域的再生组织产品（例如，软骨、骨骼肌）。该小型企业创新研究（SBIR）第二阶段项目旨在完成上述新型胶原蛋白聚合物商业化的最后技术障碍。由于认识到胶原蛋白作为人体主要组织构建材料的重要性，该专利生物材料平台被设计为高度纯化并保留胶原蛋白的天然纤维形成（聚合）能力。虽然这项技术提供了广泛的定制潜力，但该项目的重点是开发原位支架形成胶原蛋白，以加速和改善复杂腔体、隧道和深穿透组织缺损的愈合结果。胶原蛋白作为适形液体应用，其快速转变为具有软组织稠度的纤维状支架。临床前研究评价了该产品作为乳房肿瘤切除术后的乳房组织填充物，并记录了以下内容：1）易用性，2）符合患者特定空隙，3）非炎症再生愈合，以及4）与标准临床程序的兼容性。该SBIR项目旨在实现与建立中试规模生产和实现相关产品监管许可和批准相关的关键商业化里程碑。具体而言，工作将包括开发和验证胶原蛋白纯化、灭菌和病毒灭活的可扩展处理步骤。该项目还将完成监管备案所需的大部分非临床实验室性能和生物相容性测试。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。