AIR Option 2: Research Allianace Polymer, Polymer-Ceramic and Natural Polymer Based Systems for Soft Tissue and Bone Repair and Regeneration

AIR 选项 2：研究 Allianace 聚合物、聚合物陶瓷和天然聚合物系统，用于软组织和骨骼修复与再生

• 批准号: 1311907
• 负责人: Sangamesh Kumbar
• 金额: $ 80万
• 依托单位: University of Connecticut Health Center
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-15 至 2017-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1311907&HistoricalAwards=false
• 关键词: AIR; Option; Research; Allianace; Polymer

This PFI: AIR Research Alliance project focuses on the translation and transfer of bone and soft tissue regeneration technologies to new products for musculoskeletal repair. Autograft and allograft based products are currently used for repair purposes and have several limitations including suboptimal strength, possible negative immune effects and risks of disease transmission. The new technologies and proposed products overcome the drawbacks posed by autografts and allografts. These new product technologies are potentially stronger, bioactive, more biocompatible and completely degradable while being ideally suited for load-bearing bone healing and soft tissue repair and regeneration applications. There are estimated to be over 1 million bone graft implants performed each year throughout the world. Production costs for the proposed technologies will be in the range of $500 per implant, yielding a $2000 net profit per implant. Our objective in the first 3 years is to achieve a 2% market share of bone grafts (20,000 grafts) which would provide $40 million in revenue per year. Every year, 400,000 rotator cuff repair procedures performed in the US require the use of a tendon augmentation device. Production costs are $1,000 per implant, yielding a $4000 profit per implant. We conservatively believe that 30% of repair operations would benefit from our soft tissue regeneration system (120,000 repairs) and that a 10% market share would be 12,000 repairs. This translates to a profit of 48 million per year. In order to move these technologies to commercialization, we have categorized different products into short-term, mid-term and long-term time frames spanning 1 to 5 years. Short-term products include grafts fabricated from the materials alone without inclusion of any biologics. The short-term products, classified as devices or implants, create a short route to 510k FDA clearance (approval). An ample financial base from the aforementioned products will allow re-investment of R & D efforts toward the commercialization of subsequent products or to pursue an out-license or acquisition exit after subsequent 510k approvals. The strong patent portfolio and constant revenue from the initial product commercialization will create a self-sustainable academic centered innovation ecosystem. All these activities will ensure workforce development, create new jobs and businesses, and foster economic development. Third party partnerships engaged to transfer the technologies to the market domain include technology niche analysis, business plan development, and initiation of new startup ventures for existing products and new products. The potential economic impact is expected to approximate 100 million per year in the next 2 to 3 years which will contribute to the U.S. competitiveness in the orthopaedic device fixation, repair, and regeneration market.Societal impact short term, the proposed devices successfully address issues and drawbacks related to biological grafts currently used and will improve treatment efficiency/cost, enhance patient compliance and contribute to a better quality of life. The developed products will be used as alternatives to current grafts. Identified material compositions and designs may find application in the delivery of growth factors, antibiotics and pain medications for treating a variety of musculoskeletal ailments in the long term. This proposed project has immense economic potential as well as a broad impact in education by bridging the interfaces of chemistry, biology, medicine and materials science.Educationally, the proposed research will focus on the recruitment and training of underrepresented minorities at the undergraduate and graduate levels, thus ensuring a competitive and diverse dissemination of scientific knowledge. Students and fellows will be engaged in business plan development and encouraged to complete an internship with the third party investors to enhance their entrepreneurial skill sets.

这个PFI: AIR研究联盟项目的重点是将骨骼和软组织再生技术转化为肌肉骨骼修复的新产品。自体移植物和同种异体移植物为基础的产品目前用于修复目的，有几个限制，包括次优强度，可能的负面免疫效应和疾病传播的风险。新技术和提出的产品克服了自体移植物和同种异体移植物所带来的缺点。这些新产品技术具有潜在的更强、生物活性、更强的生物相容性和完全可降解性，同时非常适合于承重骨愈合和软组织修复和再生应用。据估计，全世界每年进行的植骨手术超过100万例。拟议技术的生产成本将在每个植入物500美元的范围内，每个植入物产生2000美元的净利润。我们在前3年的目标是获得2%的骨移植物市场份额（20,000个移植物），每年将提供4000万美元的收入。在美国，每年有40万例肩袖修复手术需要使用肌腱增强装置。每颗种植体的生产成本为1000美元，每颗种植体的利润为4000美元。我们保守地认为，30%的修复手术将受益于我们的软组织再生系统（120,000次修复），10%的市场份额将是12,000次修复。这相当于每年利润4800万美元。为了将这些技术推向商业化，我们将不同的产品分为短期、中期和长期，时间跨度为1至5年。短期产品包括仅由材料制成的移植物，不含任何生物制剂。短期产品，被归类为器械或植入物，为510k FDA批准创造了一条捷径。上述产品的充足财务基础将允许研发工作的再投资，以实现后续产品的商业化，或在随后的510k批准后寻求外许可或收购退出。强大的专利组合和最初产品商业化的持续收入将创造一个自我可持续的以学术为中心的创新生态系统。所有这些活动将确保劳动力发展，创造新的就业机会和企业，促进经济发展。将技术转移到市场领域的第三方合作伙伴关系包括技术利基分析，商业计划制定，以及针对现有产品和新产品发起新的创业企业。潜在的经济影响预计在未来2到3年内每年约1亿美元，这将有助于美国在骨科器械固定、修复和再生市场的竞争力。短期的社会影响，提议的设备成功地解决了目前使用的生物移植物相关的问题和缺点，并将提高治疗效率/成本，增强患者的依从性，并有助于提高生活质量。开发的产品将作为目前移植物的替代品。已确定的材料组合物和设计可能在长期治疗各种肌肉骨骼疾病的生长因子、抗生素和止痛药的输送中得到应用。这个拟议的项目具有巨大的经济潜力，并通过连接化学、生物学、医学和材料科学的界面，对教育产生广泛的影响。在教育方面，拟议的研究将侧重于在本科和研究生两级征聘和培训代表性不足的少数民族，从而确保科学知识的竞争性和多样化传播。学生和研究员将参与商业计划的制定，并鼓励他们完成与第三方投资者的实习，以提高他们的创业技能。