Preclinical proof of concept validation of a novel endoscopic treatment for urethral stricture disease

项目摘要/摘要 CeleFlux正在开发一种医疗设备，使泌尿科医生能够提供持久、微创的 经内窥镜下临时组织移植治疗男性尿路狭窄 植入。尿路狭窄疾病使尿道腔逐渐变窄，类似于疤痕组织带。这 导致尿痛和尿频，并显著降低生活质量。 目前的治疗方案是次优的，需要在(1)微创(内窥镜)之间进行选择 介入与高复发率相关；或(2)高效但长期、复杂的开放重建 做手术。后者需要专门的技能，因此可以进行尿路重建。 有限的。普通泌尿科医生通常不能为复发性狭窄的男性提供明确的治疗方法。重复 内窥镜干预会加重狭窄，并将可治愈的疾病转变为慢性病。我们的目标是 通过弥合这两种方法之间的差距来改变这一点。 CeleFlux正在将一项技术商业化，这项技术使普通泌尿科医生能够为延髓提供根治疗法 尿道狭窄，接近开放重建术的疗效。我们的医疗设备创新简化了 内窥镜下组织移植重建尿路的手术。移植物通过以下途径被输送到目标部位 一种临时植入物，14天后移除。其结果是通过健康的移植物持久地扩大了尿路 缓解尿路狭窄症状。临床需求、用户需求和产品市场匹配度 通过与普通(目标用户)和重建泌尿科医生(疾病)广泛的客户发现进行验证 国家专家)。 关键障碍包括使用我们的设备实现植入，以及临时植入物的安全移除。在这 建议，我们将在一个大型动物模型中评估和解决这些问题。我们的目标是证明一种移植物 在内窥镜下，通过我们的临时植入物可以与通过开放手术(黄金标准)提供的移植物相媲美。 我们还打算证明，临时植入物可以在14天后移除，而不会破坏 粘连移植物。由此产生的结果将说明我们创新的可行性，驱动未来 以商业化为重点的活动，并支持我们的目标，即改变目前男性的临床模式 复发性球部尿路狭窄疾病--远离慢性治疗，转向持久重建。

PROJECT SUMMARY/ABSTRACT CeleFlux is developing a medical device which enables urologists to provide long-lasting, minimally invasive urethral reconstruction to treat male urethral stricture - via endoscopic delivery of a temporary tissue graft implant. Urethral stricture disease progressively narrows the urethral lumen, similar to a band of scar tissue. This results in painful and frequent urination and dramatically reduced quality of life. Current treatment options are suboptimal, requiring a choice between (1) minimally invasive (endoscopic) intervention associated with high recurrence rates; or (2) highly effective but long, complex open reconstructive surgery. The latter requires a specialized skill set, and consequently availability of urethral reconstruction is limited. General urologists typically cannot offer definitive treatment to men with recurrent stricture. Repeated endoscopic intervention worsens the stricture and turns a curable condition into a chronic disease. We aim to change that by bridging the gap between the two approaches. CeleFlux is commercializing a technology empowering general urologists to deliver curative treatment for bulbar urethral stricture, approaching the efficacy of open reconstruction. Our medical device innovation simplifies a procedure to reconstruct the urethra with a tissue graft endoscopically. The graft is delivered to the target site via a temporary implant which is removed 14 days later. The result is a urethra widened by a healthy graft, durably alleviating the symptoms of urethral stricture. The clinical need, user requirements, and product-market fit were validated through extensive customer discovery with general (target users) and reconstructive urologists (disease state experts). Key hurdles include achieving engraftment with our device, and safe removal of the temporary implant. In this proposal, we will evaluate and address these in a large animal model. We aim to demonstrate that a graft delivered endoscopically via our temporary implant is comparable to a graft delivered via open surgery (the gold standard). We also aim to demonstrate that the temporary implant can be removed 14 days later without disruption to the adhered graft. The resulting outcomes will illustrate the feasibility of our innovation, drive future commercialization-focused activities, and support our goal to shift the current clinical paradigm for men with recurrent bulbar urethral stricture disease - away from chronic management and toward durable reconstruction.