Petros is a pre-revenue healthcare technology company that has wound down its legacy pharmaceutical business and is now focused entirely on developing a software platform to help drug companies navigate the FDA's new Rx-to-OTC switch regulatory pathway, known as the ACNU Rule. The ACNU Rule, finalized in December 2024, allows prescription drugs with complex safety profiles to move to OTC status, provided an assistive technology helps consumers make safe, appropriate self-selection decisions. Petros is building that assistive technology. The platform has two components: a SaaS hosting and compliance tool to manage regulatory and labeling requirements, and a SaMD (Software as a Medical Device) consumer-facing interface that uses algorithmic logic — and potentially AI and electronic health records — to guide consumers in deciding whether a given OTC product is right for them. Petros intends to license this platform to pharmaceutical companies rather than develop drugs itself, making the model asset-light, with licensees handling manufacturing and supply chain. The company targets both traditional pharma companies looking to switch prescription drugs to OTC and consumer health companies expanding into direct-to-consumer products. The platform is still in early development, no licensing agreements have been signed, and no FDA-approved ACNU products yet exist in the market. Petros currently operates with 3 full-time employees and has generated no revenue from this new business model.
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