Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Perimeter Medical Imaging AI Inc (PYNKF, Financial) has successfully completed patient enrollment in a pivotal clinical trial for its B SERIES OCT with Image Assist AI, which could be a significant catalyst for the company.
- The company has seen positive commercial traction with its S SERIES OCT, with 14 devices currently in commercial use in the US.
- Perimeter Medical Imaging AI Inc (PYNKF) is pioneering the integration of AI in breast cancer surgical devices, potentially reducing the learning curve for surgeons and expanding its customer base.
- The company anticipates releasing top-line data from the pivotal trial soon, which could support a submission to the FDA for market authorization in 2025.
- Perimeter Medical Imaging AI Inc (PYNKF) has a strong financial position with approximately $9.5 million in cash and cash equivalents as of September 30, 2024, not including additional funds from recent financing activities.
Negative Points
- The company reported a net loss of approximately $4.6 million for Q3 2024, a significant increase from the $345,000 loss in the same period in 2023.
- Operating expenses remained high at approximately $4.5 million for the third quarter, unchanged from the previous year.
- The increase in net loss was primarily due to non-cash expenses related to the revaluation of warrant liability and net foreign exchange loss.
- There is uncertainty regarding the exact timing of FDA authorization for the B SERIES OCT, which could impact the company's go-to-market strategy.
- The current S SERIES OCT is tissue agnostic and lacks specific claims for breast cancer and margin reduction, limiting its marketing potential in the breast cancer space.
Q & A Highlights
Q: How many S series devices are currently in commercial use in the US?
A: There are currently 14 S series devices in commercial use in the US.
Q: Why is the B series product trial important to patients, surgeons, and Perimeter?
A: The trial is crucial as it is the first step in introducing AI into the marketplace. AI acts as a co-pilot for surgeons, helping to identify suspicious areas in images, which can expand the customer base significantly. There are about 8,000 surgeons performing breast surgeries in the US, and AI reduces the learning curve, making the technology more accessible.
Q: Can you explain the workflow of the B series trial and its unique aspects?
A: The trial is split into two parts, focusing on the addition of Image Assist 2.0 for effectiveness. Patients in the device arm undergo standard care and OCT technology, allowing them to be their own control, reducing variability. The effectiveness will be assessed based on these patients.
Q: What is the primary endpoint of the B series trial, and how will it be presented to the market?
A: The primary endpoint is the occurrence of unaddressed margins, meaning the proportion of subjects with at least one unaddressed positive margin after treatment. The analysis will focus on detecting additional margins post-standard care, aiming to reduce re-excisions. The results will be presented with a focus on statistical significance.
Q: How does the introduction of AI impact the use of the B series in surgeries?
A: AI provides a faster turnaround by acting as a co-pilot, allowing surgeons to focus on images of interest, thus improving ease of use and efficiency. This reduces the time required for image review and aids in detecting potential cancer during surgery.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
