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医疗科技初创公司在临床上取得积极进展

Medtech startups make positive clinical progress

startupticker 等信源发布 2025-03-05 00:00

可切换为仅中文


As Brios Medical advances its first clinical trial for its flagship product, HipBeacon, in Australia, Cutiss and ONWARD Medical have completed their phase 2 trials, with the latter publishing its results in

随着 Brios Medical 在澳大利亚为其旗舰产品 HipBeacon 开展首次临床试验,Cutiss 和 ONWARD Medical 已完成其第二阶段试验,后者已发布其结果在

Neuromodulation: Technology at the Neural Interface

神经调节:神经接口技术

.

Bios Medical

生物医学

is developing innovative technology to improve mobility and quality of life for hip fracture patients. Their flagship product, HipBeacon, is the world's first implantable hip mobility sensor designed to collect personalized patient data. The company has launched its first clinical trials in Australia, initially focusing on patients with ankle joint fractures.

正在开发创新技术,以改善髋部骨折患者的生活质量和行动能力。其旗舰产品 HipBeacon 是世界上首个可植入的髋关节活动传感器,旨在收集患者的个性化数据。该公司已在澳大利亚启动了首次临床试验,最初专注于踝关节骨折患者。

The study aims to validate the technology while promoting remote patient monitoring and home-based rehabilitation. As part of the trial, patients will wear fracture boots equipped with Biosensor technology, continuously measuring load-bearing and mobility parameters for personalized, data-driven recovery.

该研究旨在验证这项技术,同时促进远程患者监测和基于家庭的康复。作为试验的一部分,患者将穿着配备生物传感器技术的骨折靴,持续测量负重和移动参数,以实现个性化的、数据驱动的康复。

Designed for long-term monitoring, the system is user-friendly—patients simply sync their data once per day via smartphone with a single button press..

该系统专为长期监测而设计,用户友好——患者只需每天通过智能手机按一次按钮即可同步数据。

CUTISS reports positive phase 2 study results

CUTISS报告了积极的二期研究结果

CUTISS AG

CUTISS股份公司

, the Zurich-based startup at the forefront of tissue engineering therapy and regenerative medicine, announced positive long-term efficacy and safety readout in Phase 2 clinical trials of denovoSkin™ in reconstructive surgery as well as in burns treatment. The data reaffirm the role of denovoSkin™, an autologous, bio-engineered dermo-epidermal skin graft, in reducing the need for donor site harvesting and minimizing scarring, leading to improved patient outcomes following skin surgery compared to autografting which is today’s standard of care..

总部位于苏黎世的初创公司,处于组织工程治疗和再生医学的前沿,宣布了其在denovoSkin™二期临床试验中的长期有效性和安全性结果,该产品用于重建手术及烧伤治疗。数据再次证实了denovoSkin™的作用,这种自体、生物工程真皮-表皮皮肤移植物减少了对供体部位采集的需求并最小化疤痕形成,与现今标准护理的自体移植相比,能够改善患者在皮肤手术后的效果。

While denovoSkin™ offers the key advantage of sparing donor sites and eliminating the need for large-scale skin harvesting, these Phase 2 data readouts also demonstrate that denovoSkin™ provides patients with significant improvements in terms of skin pliability, flexibility, relief, and overall scar quality when compared to standard of care in an intra-patient control setting.

虽然denovoSkin™的主要优势在于节省供体部位并消除了大规模皮肤采集的需要,但这些第二阶段的数据读数也表明,与患者内对照设置中的标准护理相比,denovoSkin™在皮肤柔韧性、灵活性、缓解程度以及整体疤痕质量方面为患者提供了显著改善。

Following this achievement, CUTISS is advancing into Phase 3 trials in the E.U. for burn patients, having received authorization from the European Medicine’s Agency (EMA) in December 2024..

在此成就之后,CUTISS正在欧盟推进针对烧伤患者的第三阶段试验,并于2024年12月获得了欧洲药品管理局(EMA)的授权。

Onward: Pathfinder2 study results

前进:Pathfinder2 研究结果

published

已发布

ONWARD Medical

向前医疗

, a specialist in spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, has announced the publication of positive results from the investigator-sponsored Pathfinder2 Study in

,一家专注于脊髓刺激疗法以恢复脊髓损伤(SCI)和其他运动障碍患者的运动、功能和独立性的公司,宣布了研究者赞助的Pathfinder2研究的积极结果发布在

Neuromodulation: Technology at Neural Interface.

神经调节:神经接口技术。

The peer-reviewed paper details findings from a one-year trial demonstrating that ONWARD ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers.

同行评议论文详细介绍了为期一年的试验结果,证明在社区康复中心对脊髓损伤患者实施ONWARD ARC-EX疗法结合基于活动的康复训练可显著改善功能。

The study, sponsored by UK-based

该研究由英国赞助

Spinal Research

脊柱研究

, and independently conducted by

,并由以下机构独立开展:

Neurokinex

神经动力学

at its network of community-based rehabilitation centers, enrolled 10 participants with chronic cervical or thoracic SCI. Participants experienced gains in upper body strength, trunk control, and balance, without any indication of plateau in therapeutic benefit after one year of treatment. Some participants also improved lower body movement and enhanced hand and arm strength, especially in grip and dexterity.

在其社区为基础的康复中心网络中,招募了10名患有慢性颈或胸脊髓损伤的参与者。参与者在上半身力量、躯干控制和平衡方面取得了进步,治疗一年后没有出现疗效平台期的迹象。部分参与者还改善了下半身运动能力,并增强了手和手臂的力量,尤其是在握力和灵巧性方面。

Additionally, 3 participants improved their American Spinal Injury Association Impairment Scale (AIS) classification, and 4 demonstrated changes in their neurological level of injury, results that reinforce the long-term benefits of continued access to ARC-EX Therapy and suggest further gains may be achievable with extended treatment..

此外,有3名参与者的美国脊髓损伤协会损伤量表(AIS)分类得到改善,4名参与者的损伤神经学水平发生变化。这些结果进一步证实了持续接受ARC-EX治疗的长期益处,并表明延长治疗可能会带来更多的进步。

(RAN)

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