US Regulatory Update TOUCH CMC 1 Thumb Prosthesis Enters New Enrollment Phase for Thumb Carpometacarpal OA

Publication date context February 13 2026 sets the scene for a new US study of the TOUCH CMC 1 Thumb Prosthesis for thumb carpometacarpal joint osteoarthritis. The study status is Not yet recruiting, indicating enrollment has not begun and the trial remains in early planning or regulatory steps.

The conditions described in the source text are osteoarthritis of the thumb and specifically the thumb carpometacarpal joint. The intervention under study is a device named TOUCH CMC 1 Prosthesis. Sponsors listed are Keri Medical SA and MCRA, an IQVIA business. The US focus signals regulatory oversight in the United States and a path toward later enrollment and potential device evaluation in patients when approved for trials.

For reference the ClinicalTrials.gov record is linked here: NCT07405983 ClinicalTrials.gov.

What is the TOUCH CMC 1 Thumb Prosthesis study about

The trial centers on a device called TOUCH CMC 1 Prosthesis intended to treat osteoarthritis at the base of the thumb. The condition is described as osteoarthritis of the thumb and the and the thumb carpometacarpal joint. The sponsors are Keri Medical SA and MCRA, an IQVIA business. The device under evaluation is a single element prosthesis for the thumb CMC joint. The Not yet recruiting status means no participants have been enrolled yet and the study is in the early phase of design and oversight. The sponsor and trial team will prepare regulatory submissions and site qualifications before any enrollment is allowed.

ClinicalTrials.gov record: NCT07405983 remains the official source for status updates, enrollment details and protocol information.

Who is conducting the study and what is the scope of enrollment

The sponsor list includes Keri Medical SA and MCRA, an IQVIA business. The device under investigation is TOUCH CMC 1 Prosthesis and the target population is patients with osteoarthritis of the thumb CMC joint. Not yet recruiting indicates recruitment has not started, which means no data on safety or performance is available yet. As this is a US trial the conduct will follow US regulations for medical devices and any related human subject protections.

Readers should anticipate future updates that will clarify sites, enrollment criteria, endpoints and interim findings once enrollment begins.

What regulatory context applies to this device trial

The report follows a regulatory style that presents the device aims and safety considerations without asserting efficacy. The wording reflects the fact that the device is being studied under a regulatory pathway and that sponsor statements are identified as such. The Not yet recruiting status indicates that the trial is in the pre enrollment stage with regulatory activities such as protocol finalization and site readiness preceding any patient involvement. Clinicians and regulatory affairs teams should monitor official postings for updates on enrollment progression, amendments to the protocol and any safety communications.

Conclusion and implications for practitioners

At this stage the study is in a pre enrollment phase in the United States. Clinicians, regulatory specialists and device developers should monitor the official record for enrollment status, protocol updates and any safety communications. This article provides a regulatory oriented summary based on the information available and emphasizes reliance on the primary source for definitive status.