Company: PFSA
Filing Date: 2025-08-29
Form Type: S-1
Source: 0001213900-25-082672
Chunk: 163

Company: Profusa, Inc.
Filing Date: 2025-08-29
Form: S-1
Chunk 163
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 needle can take measurements in the interstitial space of a patient. These needles, however small, elicits a “foreign body response” within the patient as the body’s natural defense mechanism against objects that are recognized as foreign. The foreign body response begins to encapsulate the sensing needle of these CGMs in scar tissue and renders the data from these sensors unreliable within a matter of days. This is the major reason the longevity of these CGMs is limited to approximately 7 -14days. A longer -term12 -monthsolution where a sensor is surgically implanted into a patient’s body is available as well, however the sensor requires a surgical implantation with sutures to close the surgical wound. This approach has a limitation of a much more invasive deployment procedure and associated higher cost. 102 All data is from the manufacturer website. The products provided in this chart are: • Dexcom G6 • Abbott Freestyle Libre 2 • Medtronic Guardian Connect • Senseonics Eversense E3 Profusa’s CGM Product (Lumee Glucose) is not approved in the United States. The > 270 days usage time is based on the data acquired through Profusa’s glucose program clinical study. Profusa’s Technology It is Profusa’s belief, based on an understanding of the biological response to current available sensors, that a viable solution that could provide data for clinical utility and wide -scaleadoptions, needs to have the following three key characteristics: direct measurement of the body’s chemistry to enable accuracy, ease of deployment of the platform and long -termfunctionality to encourage adoption by a large population, and low cost to breakdown the economic barrier for adoption by those who can benefit from this data stream. Profusa’s sensor platform has the potential to deliver on these requirements and are composed of the following components: • Hydrogel Sensor Profusa’s passive sensor is composed of a class of materials called hydrogels, which are similar to the material from which modern contact lenses are made. The sensor is designed to overcome the effect of the foreign body response and thus has been demonstrated to be able to collect biochemical data for up to 6 -monthsin the case of Lumee Oxygen, and up to 9 -monthsbased on the data acquired through Profusa’s glucose program clinical study. This hydrogel scaffolding is soft and pliable and serves as the base material on which specific fluorescent molecules are bound. These fluorescent molecules bind specifically to the analyte of interest and their fluorescent characteristics change depending on whether the analyte is