Medtech startups make positive clinical progress

Bios Medical 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. 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. 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.

CUTISS reports positive phase 2 study results
CUTISS AG, 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.

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. 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.

Onward: Pathfinder2 study results published
ONWARD Medical, 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 Neuromodulation: Technology at Neural Interface. 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.
The study, sponsored by UK-based Spinal Research, and independently conducted by Neurokinex 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. 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.

(RAN)