WP1:
Activities:
SentryX has initiated its first-in-human clinical trial for Bupi-Ring. The trial consists of two cohorts of six patients. The first cohort undergoes instrumented spine surgery with 4 pedicle screws and 4 Bupi-Rings. The second cohort receives 6 pedicle screws and 6 Bupi-Rings. Each cohort contains three patients undergoing open procedures (single surgical wound) or minimally invasive surgeries (separate incisions for each screw) with Bupi-Ring. The main outcome is whether the measured concentrations of bupivacaine in the blood remain below known toxic thresholds. Additional safety and preliminary efficacy outcomes are also included in the study. Positive results from this study will serve as the basis for a clinical trial application for a single pivotal trial in approximately 200 patients, which will be essential for the approval of Bupi-Ring in Europe and the United States.
Main achievements so far:
The first cohort of six patients has been fully included in the study. The data for these patients has been reviewed by an independent data safety monitoring board (DSMB), who have recommended to proceed to the second cohort. In the second cohort, 3/3 patients have undergone minimally invasive surgeries. The inclusion of patients for the open procedures is currently ongoing.
WP2:
Activities:
To formulate and initiate a definitive market access strategy, SentryX will explore strategic partnerships for the commercialisation and distribution of Bupi-Ring in Europe and the United States. Because Bupi-Ring is universally compatible with commercially available pedicle screws, several scenarios can be conceived: exclusive deals with large pharmaceutical or MedTech companies, or non-exclusive models where SentryX directly supplies hospitals whilst outsourcing distribution and sales.
Main achievements so far:
The funding round has been initiated. Prior to the round, SentryX already had several discussions with various large MedTech companies and VCs. Now, the investor deck has been sent out and the data room largely prepared. Several discussions have already taken place with leading MedTech companies, with positive initial feedback. A definitive position is yet to be taken by these companies. Contacts with Venture Capital firms and Family offices have been initiated, from whom an initial response is expected soon.
SentryX has previously presented its scientific evidence at two global conferences. The initial results of the Phase Ib clinical trial will also be presented at several international conferences in the coming year.
WP3:
Project management:
The objectives of project management are to ensure that the project itself runs smoothly, effectively and on budget, to provide frequent progress updates, and to keep professional and societal stakeholders engaged and aligned. Progress reports will be provided to the funding body for the grant component of the EIC Accelerator. This work package also includes operational expenses, including in-house consultancy and intellectual property protection.
Main achievements so far:
The first progress meeting has been concluded successfully, with the project on track and on budget. As the second 12-month progress meeting is coming up, the project is still on track and expected to be completed well within the proposed timeframe.
