Company: PFSA
Filing Date: 2025-04-28
Form Type: S-4/A
Source: 0001213900-25-035718
Chunk: 105

Company: Profusa, Inc.
Filing Date: 2025-04-28
Form: S-4/A
Chunk 105
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downsor write -offs, product expiration and the sale of inventory at discounted prices, which would affect our gross margin and could impair the strength of our brand. Reserves and write -downsfor rebates, promotions and excess inventory will be recorded based on our forecast of future demand. Actual future demand could be less than our forecast, which may result in additional reserves and write -downsin the future, or actual demand could be stronger than our forecast, which may result in a reduction to previously recorded reserves and write -downsin the future and increase the volatility of our operating results. If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market our products, our business may be harmed. We must continue to develop and grow our sales and marketing organization and enter into partnerships or other arrangements to market and sell our products and/or collaborate with third parties, including distributors and others, to commercialize the Lumee™ Oxygen Platform and to achieve commercial success for any of our future products. Developing and managing a direct sales organization is a difficult, expensive and time -consumingprocess. 34 To continue to develop our sales and marketing organization to successfully achieve market awareness and sell our products, we must: •continue to recruit and retain adequate numbers of effective and experienced sales and marketing personnel; •effectively train our sales and marketing personnel in the benefits and risks of our products; •establish and maintain successful sales, marketing, training and education programs that educate health care professionals so they can appropriately inform their patients about our products; •manage geographically dispersed sales and marketing operations; and •effectively train our sales and marketing personnel on the applicable fraud and abuse laws that govern interactions with healthcare practitioners as well as current and prospective patients and maintain active oversight and auditing measures to ensure continued compliance. We may not be able to successfully manage our sales force or increase our product sales at acceptable rates. We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affected. We only recently received CE Mark approval in the EU for our first product, the Lumee Oxygen Platform, and accordingly we have limited experience marketing and selling our products and related services. Sales of our Lumee Oxygen Platform in the EU will depend on our ability to maintain CE Mark approval, including requirements to comply with European Medical Devices Regulation and renew the CE Mark as required. Sales of Lumee Oxygen Platform outside of