At InSitu Technologies, our responsibility doesn’t end when a device leaves our facility.
In many ways, some of the most important work begins once our products are being used by
physicians and helping patients in real clinical settings.

This ongoing commitment is known as Post Market Surveillance, and it plays
a vital role in how we ensure the continued safety and effectiveness of our devices.

Each year, our team conducts a comprehensive review of product performance in the field.
We evaluate customer feedback, patient follow-up information, manufacturing quality data,
regulatory submissions, and adverse event reports from across the medical device industry.
The goal is simple: to understand how our products are performing in the real world and
identify opportunities for improvement.

What Does This Process Involve?

Our team carefully reviews feedback from physicians and clinical staff who use our devices
every day. We examine patient follow-up reports to understand long-term outcomes and recovery
trends. We also monitor our manufacturing processes to ensure consistency and identify areas
where quality can be enhanced.

In addition, we review publicly available adverse event data from across the covered stent
market. Looking beyond our own products allows us to compare performance, identify industry
trends, and stay alert to potential safety concerns that may emerge elsewhere in the field.

What We Found in 2025

The results of our 2025 Post Market Surveillance review were encouraging.

Throughout the year, no complaints were reported for the Celosia Coronary Covered Stent.
There were no recalls and no return goods authorizations. Clinical follow-up information
showed patients continuing to recover well, with vessel patency maintained and no reported
device-related complications.

We also made several important manufacturing improvements during 2025. These included the
implementation of a new cleanroom environment with improved workflow, upgrades to our
packaging process, and the addition of a dedicated ePTFE sub-assembly station designed to
further reduce bioburden and endotoxin levels.

Before production resumed, all affected processes underwent revalidation testing and
successfully met all requirements.

Why Post Market Surveillance Matters

For us, Post Market Surveillance is much more than a regulatory requirement. It is one of
the ways we remain accountable to the physicians who rely on our products and to the patients
whose health depends on them.

By continuously monitoring performance, reviewing data, and learning from real-world
experience, we can identify issues early, make meaningful improvements, and maintain the
high standards that guide everything we do.

This commitment to quality and patient safety remains at the heart of InSitu Technologies.
We will continue this work year after year because improving health and extending life is
not just our mission. It is our responsibility.