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Q&A: Temperature-guided Catheters by Hepta Medical

Q&A: Temperature-guided Catheters by Hepta Medical
Chest radiology. X-ray diagnostic. Doctor examining lung film scan. Image: i-Stock.

Hepta Medical, a French medical device company, has secured a U.S. patent for its innovative microwave ablation probe, designed for minimally-invasive early-stage lung cancer treatment, featuring advanced temperature sensing technology.

Hepta Medical, a pioneering medical device company based in Suresnes, France, has recently marked a significant milestone in its mission to revolutionize lung cancer treatment. On May 5, 2024, the U.S. Patent Office approved the publication of a non-provisional patent application. Originally filed in 2021, the publication covers the innovative design of Hepta Medical’s microwave ablation probe. This device incorporates cutting-edge microwave radiometric temperature sensing technology. It offers a minimally invasive solution for early-stage lung cancer therapy. 

The approval of this patent solidifies Hepta Medical’s position in the field, complementing the company’s previously granted European patent and extending its protection through at least 2039. Founded in 2019, Hepta Medical emerged from MD Start, the renowned medical device incubator backed by Sofinnova Partners. 

Hepta Medical’s breakthrough probe delivers precise thermal energy through the airway, minimizing trauma while ensuring effective tumor ablation. The device’s real-time temperature sensor enhances safety and efficacy.

Hepta Medical CEO Thomas Bancel sat with us for an interview at biotech hub DocCity Suresnes LifeSciences, where the company is based.

Thomas Bancel: Hepta Medical is focused on using microwave ablation, which is similar to how a microwave oven heats food. It has a lot of potential for treating early-stage lung cancer because it’s minimally invasive, safe, and efficient. The problem with existing ablation methods is that they can be unpredictable—patients react differently. You might ablate too much tissue, damaging healthy lung, or too little, leaving the cancer behind.

What sets Hepta Medical apart is our innovative temperature sensor at the tip of the probe. This sensor monitors how the patient’s tissue reacts in real time, allowing us to control the ablation process much more precisely and account for patient variability. This innovation is key to making the procedure safer and more effective.

Thomas Bancel: We are still in the preclinical phase, but we’ve demonstrated efficacy in animal studies. We recently closed a funding round to move from a validated prototype in these animal models to a clinically-ready device. The next step is to transfer the manufacturing process to certified partners, which will take around a year.

After that, we’ll begin clinical trials in humans, starting with three pilot studies to assess safety. Each pilot study will involve 10 to 15 patients and will eventually lead to larger pivotal trials in the following years. Our goal is to have market access within 3 to 4 years with a device that includes real-time monitoring of the ablation zone, ensuring safer and more efficient procedures.

Thomas Bancel: The temperature sensor in the probe continuously monitors the temperature at the tip, which is where the ablation happens. This real-time feedback allows us to adjust the procedure on the spot, depending on how the patient’s tissue reacts.

If the tissue is being ablated too much, we can stop to avoid damaging healthy lung tissue. If it’s not enough, we can extend the procedure to ensure the cancer is fully treated. This ability to monitor and adjust in real-time ensures that the ablation zone grows as needed but stays within safe limits, improving both safety and efficacy.

Thomas Bancel: By using an airway approach instead of the traditional percutaneous route, we hope to eliminate the major risk associated with lung ablation procedures, which is pneumothorax. When you insert a needle through the chest into the lung, it can detach the lung from the thoracic cage, causing a pneumothorax that requires drainage and increases the risk of infection.

Our approach, which avoids puncturing the lung, should significantly reduce these risks. The procedure should last under two hours, and we aim for it to be compatible with outpatient settings—meaning the patient could leave the hospital the same day. Like any procedure, there are inherent risks, but by monitoring the ablation in real-time, we believe we can mitigate many of the common issues with current methods.

Thomas Bancel: Thermal ablation procedures are already used for treating tumors in other organs, like the liver. However, when applied to the lung, the challenge has been the risk of pneumothorax and the unpredictability of how much tissue will be ablated. By using our sensor-equipped microwave ablation technology, we aim to address both of these issues.

Over the next few years, we will build clinical evidence to support our technology’s integration into standard lung cancer treatment protocols. We plan to start with small pilot studies in humans within the next year, followed by larger pivotal trials. Our goal is to have commercially available treatment for lung cancer within four years. While that might seem fast for some, it can feel too long for patients waiting for better options.

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