Kidswell Bio and Treehill Partners have launched a US-based regenerative medicine company to accelerate clinical development of a novel cell therapy for paediatric cerebral palsy, in a move that combines Japanese scientific expertise with a capital-efficient development model.

The new company, Kidswell USA, has been established to advance Kidswell’s stem cell pipeline, with cerebral palsy as the lead indication. The partners said the structure is designed to streamline clinical execution in the US and improve development efficiency for advanced therapies targeting children with significant unmet medical need.

Cerebral palsy affects an estimated one in 345 children in the US. According to the National Institutes of Health, around 8,000 to 12,000 infants born each year develop the condition. Current treatment options focus largely on symptom management, underlining the need for disease-modifying therapies.

Kidswell is developing stem cells derived from human exfoliated deciduous teeth, known as SHED, as a regenerative platform. Its lead programme, SQ-SHED, has generated early clinical signals in children with cerebral palsy, positioning it as a potential disease-modifying approach rather than purely symptomatic care.

Shinya Kurebayashi, president and ceo of Kidswell Bio Corporation, said: “Kidswell is seeking to develop its most innovative therapies for the US market, and to accelerate this process we have selected partners that will enable us to jointly create a clinical development roadmap. This roadmap will provide the best opportunities for success with the most financially efficient routes, and provide therapies that are commercially viable for the market. This will result in new therapies for underserved indications where patients have few alternative therapeutic options.”

Under the agreement, senior management of Kidswell USA will be provided by Treehill Partners. The London-based firm specialises in healthcare asset and corporate development and will apply its clinical development optimisation model to guide regulatory strategy, capital allocation and operational oversight.

Ali Pashazadeh, ceo and founder of Treehill Partners, said: “Too many promising therapies fail unnecessarily in clinical development or never reach patients due to inefficient development pathways and poor capital discipline. Treehill was built to address this through our Clinical Development Optimisation model, which is designed to accelerate timelines, optimise capital deployment, and increase the probability of regulatory and commercial success. Partnering with Kidswell will speed up the advancement of its cell therapy for paediatric cerebral palsy, a programme with meaningful clinical potential and significant unmet need. This collaboration adds another high-quality asset to Treehill’s growing portfolio, where we apply strategic development expertise to efficiently progress therapies toward approval and value-creating commercialisation.”

The partners have also selected Thermo Fisher Scientific as their preferred development services partner. The US infrastructure and manufacturing capabilities are expected to support clinical supply and regulatory readiness as the programme advances.

The structure reflects a growing trend in cell and gene therapy development, where biotech companies establish dedicated US entities to access capital markets, regulatory expertise and specialist clinical networks. By combining Kidswell’s scientific platform with Treehill’s operational model, the companies aim to de-risk development while maintaining financial discipline.

For Kidswell, which has built its reputation in biosimilars and cell therapies in Japan, the move signals a strategic push into the US regenerative medicine landscape. For Treehill, the collaboration expands its portfolio of development-stage assets in high unmet need indications.

If SQ-SHED continues to demonstrate clinical benefit in cerebral palsy, Kidswell USA could play a central role in advancing a regenerative therapy option for children who currently have limited treatment alternatives.