Start of the clinical field study with Dr. Matthias Ponfick from the Sana Paraplegia Center in Rummelsberg

Following the approval of the inContAlert BladderMate™ as a medical device in the EU, the time has come: the first patients can now trial the wearable in a clinical field study. In cooperation with head physician Dr. Matthias Ponfick and the Sana Paraplegia Center in Rummelsberg, users can continuously integrate the BladderMate™ into their everyday lives and receive a timely alert when their bladder is full and should be emptied.

The launch was preceded by more than eight years of technology development. It all originated in the master's thesis of CTO and Co-Founder Tristan Zürl and, supported by funding from the Medical Valley Award and the EXIST research transfer program, found its way out of the academic environment of the University of Bayreuth to inContAlert GmbH. Over the past year, the innovative NIR technology was implemented into a final wearable, the inContAlert BladderMate™, and received the CE mark under the EU Medical Device Regulation (MDR).

In the clinical field study, it is now to be demonstrated for the first time that the inContAlert BladderMate™ can optimize the bladder management of patients with neurogenic bladder dysfunction – for example following a spinal cord injury, multiple sclerosis, Parkinson's, spina bifida, stroke, or bladder cancer – so that both premature and delayed bladder emptying can be prevented. In this way, patients can avoid unnecessary catheterizations in their everyday lives just as much as harmful bladder overfilling or involuntary voiding.

At this year's congress of the German-Speaking Medical Society for Paraplegiology (DMGP), Dr. Matthias Ponfick presented the first real-world interim results of the field study. The results are promising, and the feedback from the key opinion leaders in attendance was extremely valuable for inContAlert. It feeds directly into the next steps, which will follow in the coming months.