Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 106

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 106
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 introductions of new or advanced products and associated management services. Introductions of new or advanced products could also adversely impact the commercialization of Lumee™ Oxygen Platform or other existing products to consumers. For instance, the introduction or announcement of new or advanced products may shorten the life cycle of our existing products or reduce demand, thereby reducing any benefits of successful new product introductions and potentially lead to challenges in managing write -downsor write -offsof inventory of existing products. In addition, any new products may have higher manufacturing costs than legacy products, which could negatively impact our gross margins and operating results. Accordingly, if we fail to effectively manage introductions of new or advanced products, our business may be adversely affected. We may experience challenges managing the inventory of monitors and other items, which can lead to excess inventory and discounting of our products, or alternatively insufficient inventory levels. Inventory levels in excess of consumer demand may result in inventory write -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