MedTech Investment Opportunity,Patented Imaging, FDA Approval Pathway

We are pleased to be consulting with a premier medical imaging start up company. It was founded in Year 2010 by its owner. While essentially still in a start up mode, this company has been engaged in research and development in this space for the past 15 years.

The owner is a pioneer in biomedical imaging. The company specializes in developing proprietary medical imaging devices that combine light and sound to visualize deep tissue structures, vasculature, and microvasculature, aiming to enhance diagnostics, therapy, and surgery for cancer and vascular diseases. The CEO estimates that the company has amassed approximately $25M in patents and IP.

Investment Highlights Proprietary medical imaging technology platform Extensive issued and pending intellectual property portfolio Commercially validated products with installed customer base Scalable manufacturing through established contract partners Multiple high-value clinical market opportunities Significant barriers to entry through proprietary technology and know-how Attractive strategic acquisition opportunity within the medical technology sector Experienced scientific leadership with decades of domain expertise It is an advanced medical imaging company developing a proprietary hybrid imaging platform that combines optical and acoustic modalities to deliver high-resolution, high-contrast, and functional imaging. The company is positioned at a critical inflection point as it advances toward FDA 510(k) clearance for clinical use. Founded by a recognized pioneer in imaging, the company has spent over a decade developing its technology, with approximately $15 million invested to date across founder capital, non-dilutive funding, and commercial development.

It has generated approximately $5 million in revenue through the sale of ~25 preclinical research systems and has achieved extensive third-party validation, including over 200 peer-reviewed publications. The company maintains a robust intellectual property portfolio consisting of 8 core patent families with issued patents across the United States, Europe, and Asia. The company is currently raising a $1 million SAFE followed by a $5 million Series A to complete development, regulatory clearance, and initial clinical commercialization.

The company’s platform enables molecular and functional imaging at high resolution and contrast, addressing limitations in traditional imaging technologies such as ultrasound, MRI, and mammography. Key applications include vascular diagnostics and early cancer detection. Regulatory Pathway The company has identified a clear FDA 510(k) Class II pathway with an estimated timeline of approximately 24 months.

Regulatory costs are expected to be approximately $2 million and are included in the planned capital raise. The global medical imaging market exceeds $50 billion, with strong growth driven by demand for earlier detection, non-invasive diagnostics, and improved clinical outcomes. The company’s initial focus areas include vascular imaging and breast cancer screening, both representing significant unmet needs.

Historical revenue of approximately $5 million has been generated through research system sales. The company forecasts a transition to clinical revenue post-FDA clearance, with projected revenue scaling to over $60 million by 2029 driven by system sales, service contracts, and recurring clinical usage models. Gross margins are expected to improve with scaled manufacturing and commercialization.

Investment Highlights The company is offering a $1M SAFE followed by a $5M Series A to fund final development and regulatory approval.This represents a milestone-driven investment opportunity with upside.