Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 299

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 299
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, the Lumee Glucose revenue numbers were cross -referencedand viability -checkedwith the patient launch numbers for existing competitor the Freestyle Libre CGM system. Abbott was used as a reference point since it is a recent entrant to the market as well as their platform use -case, and Abbott’s launch numbers are indicated in existing Wall Street sell -sideanalyst coverage. In the United States, Abbott showed more than 100,000 patients for end of year 2018, after personal -useCGM launch end of 2017. Abbott was used as a reference point and not as a target for the patient numbers Profusa expects to achieve. According to the JPMorgan DexCom analyst report from 2019, Abbott’s Freestyle Libre was launched at the end of 2014 and achieved usage numbers of 185,000 in 2016, 450,000 in 2017, 774,625 in 2018 and 1,529,000 in 2019, and more than 2 million people in early 2020. 2 Profusa’s management considered additional companies including DexCom and Senseonics. These companies were excluded from Profusa’s comparative review due to: (1)The timing of their product launch. For example, in the case of Dexcom, their launch was during the time where CGM adoption, and physician/user education on the benefit of CGM, was at its infancy. Clinical data on the advantage of CGM usage was sparce at that time, and current market conditions to launch a new CGM product is significantly different than when Dexcom launched their platform; and (2)The product use case. Profusa management excluded companies such as Senseonics due to their requirement of surgical procedure implanting their sensors into the patient, as this user barrier is inconsistent with the Profusa platform. Total Operating Expenses •The operating expense assumptions are based on a number of estimates including internal and third -partyestimates in published literature, and other business and economic data. Key drivers of the operating expense are Cost of Sales, Sales and Marketing, Research and Development, and General and Administrative expense. 18 •Cost of Sales estimates were based on current manufacturing quotes received for manufacturing Profusa’s Lumee Oxygen reader. Management used past experience and market data to estimate the potential cost reduction as a result of manufacturing the device in higher volumes in later years. •Additional key assumptions included in the cost of sales estimates: •Cost of sales per patient assumes the use and