Valuation
This business holds rare and highly valuable assets that create significant barriers to entry, including FDA 510(k) clearance, ISO 13485-certified manufacturing, international regulatory licenses, and a portfolio of trademarks and domains. These licenses and IP protections, which often require years and substantial investment to obtain, provide immediate market access, brand security, and global scalability.

The value of its IP, FDA and global licenses as well as its established sales channels, its strong performance, resilient product and large customer base positions the company as a uniquely defensible and high-value opportunity in the regulated medical device sector.

Business Overview
This business is a proven, scalable, and FDA-cleared medical sleep device e-commerce business founded in 2005. Registered in Canada, the company sources its materials and manufactures products in the U.S., currently serving mainly U.S. customers with the remainder of sales distributed globally across 85+ countries. Products are sold through its Shopify website, Amazon, eBay, and Walmart with orders being shipped directly from various fulfillment centers to customers, requiring no direct handling by staff.

With an excellent repeat customer rate and 107K+ email subscribers, this is a mature, compliant, and scalable e-commerce health asset with deep regulatory moats and international distribution infrastructure already in place.
This is a rare opportunity to acquire a medically validated, globally compliant, well established e-commerce business in a high-growth health sector. With strong unit economics, and proven product-market fit, this business is poised for exponential growth under new ownership.

IP and FDA Licenses
With hundreds of thousands of dollars invested in strategic regulatory licenses and intellectual property, these assets represent significant commercial and compliance advantages.
• FDA 510(k) clearance and associated FDA Regulatory Licenses provide immediate market access in the U.S. and trust in the product.
• International Regulatory Licenses, in the UK, the EU, Australia, and Canada, expand global reach and reduce time-to-market abroad.
• Certified ISO 13485-Medical Device Manufacturing and Quality Management System complaint, ensures adherence to stringent global quality standards, enhancing credibility and scalability. Finding a qualified third-party manufacturer with FDA registration, ISO13485 Certification and Quality Management System that conforms to medical devices is no small feat and provides large barriers to entry.
• Registered Trademarks and 205 Domain (URL) Registrations protect brand identity, reduce legal risk, secure a strong digital presence and accelerate brand deployment.

Together, these assets form a key foundation for consumer confidence in the brand, brand protection, competitive differentiation in the highly regulated medical device sector and rapid scaling.

Marketing
The business utilizes a Multi-Channel Marketing Strategy approach:
• Paid Ads: Google, Meta (FB/IG), Amazon PPC, Adroll (remarketing)
• SEO & AI Optimization: Transitioning to Generative Engine Optimization (GEO/AEO) to align with AI-driven search
• Content & Engagement: Blogging, Social Media, Email & SMS
• Influencer Marketing: Active campaigns; growing channel
• Affiliate Marketing

Financial Strength
While recent shifts in consumer behavior and the effects of U.S. trade policy have all contributed to periods of sales pressure across many industries, the company learned during COVID that its product is resilient! The universal and enduring need for quality sleep continues regardless of broader economic conditions, and positions the product as a stable, recession-resistant offering.

Financial Summary
TTM Gross Revenue $659,724 USD
TTM Cash Flow $69,982 USD

TTM Gross Revenue $916,283 CAD
TTM Cash Flow $96,876 CAD