Active Implants获得2600万美元研发膝盖移植物器械
来源:生物谷
时间:2013/9/14 14:42:00
2013年9月14日讯 /生物谷BIOON/ --Active Implants公司最近为其膝盖移植物NUsurface的开发计划筹集到2600万美元的研究经费。此次将由View Capital RIA和River Street Management两家投资公司主导,第一笔约870万美元的经费已经到位。公司计划利用这笔资金在多个国家同步开展研究以便于最后提交FDA申请审核。NUsurface主要是用于患有骨关节炎而导致关节疼痛和失能的患者。
详细英文报道:
Active Implants has secured $26 million in new investor commitments, and the Tennessee startup says it will use the money to support its signature knee implant through some final regulatory trials.
A first tranche of about $8.7 million is in. View Capital RIA and River Street Management led the financing, which also included other investor firms and private investors, chief financial officer Mike Keenan told FierceMedicalDevices.
Plans call for using the money to help fund completion of a multi-center trial for the company's NUsurface meniscus implant, which continues to enroll patients in Europe and Israel, Active Implants noted. Also, plans are underway for a randomized, pivotal clinical trial that will help support the U.S. regulatory approval process, and the funding will help back that effort, too. Executives, meanwhile, are figuring out the most appropriate regulatory pathway, Keenan explained.
NUsurface is made of a composite polymer and is designed to help patients who have osteoarthritis-related pain and disability, where the condition stems from a previous surgery or meniscus-related problems, the company explains. Separately, Active Implants is developing the TriboFit Buffer hip implant. Both products have a CE mark, previous reports have noted.
As far as NUsurface, the company said the product could potentially meet the needs of patients too old for meniscus repair, but too young for a total knee replacement. They see the potential global annual market surpassing $2 billion, but other competitors are also eyeing the space.
Previously, the Memphis-based company raised $47.3 million in three earlier rounds under a different corporate structure, Keenan said. Formed in 2006, Active Implants employs 15 people.
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