8-K: Odyssey Health Secures Global Rights to BreastCheck

Odyssey Health, Inc. has acquired exclusive worldwide sub-licensing rights to BreastCheck, a non-invasive breast abnormality test, aiming to enter the growing breast cancer diagnostics market.

Summary

• Odyssey Health, Inc., through its subsidiary Odyssey Medical Devices, Inc., entered into a Master Technology and Sub-license Agreement with NeuRX Health, Inc. on October 14, 2025.
• The agreement grants Odyssey exclusive, worldwide, royalty-bearing rights to use, modify, improve, sublicense, and commercialize 'BreastCheck,' a non-invasive test for breast abnormalities.
• BreastCheck is described as a safe, accurate, and low-cost method for routine monitoring, intended as an adjunct to established procedures like clinical breast examination and mammography.
• The technology behind BreastCheck is FDA registered in the United States and registered with relevant regulatory authorities in the European Union and the United Kingdom.
• The breast cancer diagnostics market is currently valued in the low tens of billions of dollars and is projected to double or more over the next 8-10 years.
• Odyssey expects to begin commercialization and generate initial revenue from BreastCheck in the near future, marking its transition from a development-stage to a revenue-generating medtech company.
• Consideration for the sublicense includes a payment to NeuRX Health, Inc. equal to a redacted percentage (***%) of net cash proceeds actually received by Odyssey from draws under its current equity line of credit, after satisfying payment obligations to Debt Holders.
• Odyssey's obligation to pay this cash consideration will cease once the current equity line of credit is exhausted, terminated, or if Odyssey sells, disposes of, or spins out the BreastCheck product and/or Odyssey Medical Devices, Inc. into a separate company.
• Odyssey will also pay NeuRX a royalty for each BreastCheck unit sold, pursuant to a separate Royalty Agreement.
• The closing of the transaction is subject to certain conditions, including the delivery of all regulatory documentation (FDA approvals, international regulatory approvals, clinical trial data) at least three business days prior to closing.

Sentiment

Score: 7

Explanation: The agreement represents a significant strategic positive for Odyssey Health, positioning it in a large and growing market with a regulatory-approved product. However, the financial terms related to the equity line of credit are partially redacted, and the transaction is subject to closing conditions and various risks, introducing some uncertainty regarding execution and full financial impact.

Positives

• Secures exclusive, worldwide rights to BreastCheck, a non-invasive breast abnormality test, positioning the company in a significant medical device market.
• BreastCheck is FDA registered in the U.S. and registered with regulatory authorities in the EU and UK, indicating established regulatory clearance for key markets.
• The test is non-invasive, can be done at home in 15 minutes, and provides immediate results, potentially increasing accessibility and early detection of breast abnormalities.
• Entry into the rapidly growing breast cancer diagnostics market, currently valued in the low tens of billions of dollars and projected to double or more in the next 8-10 years.
• Management expects to begin commercialization and generate initial revenue from BreastCheck in the near future, signaling a transition from a development-stage to a revenue-generating medtech company.
• The product has the potential to significantly impact breast cancer early detection, a critical factor in improving survival rates for an estimated 317,000 new invasive cases in US women in 2025.

Negatives

• The exact percentage of net cash proceeds from the equity line of credit to be paid to NeuRX Health, Inc. as consideration is redacted (***%), making the precise financial impact unclear.
• The cash consideration obligation is conditional and will cease if the current equity line of credit is exhausted, terminated, or if the BreastCheck product or subsidiary is sold/spun out, indicating a potentially finite or conditional revenue stream for the licensor.
• The agreement is subject to certain closing conditions, including the delivery of all regulatory documentation and fully executed ancillary agreements, which could delay or prevent the transaction's completion.
• The company's reliance on an existing equity line of credit for consideration could imply potential future dilution for shareholders.

Risks

• Ability to timely and successfully close on the sub-license agreement, as it is subject to certain closing conditions.
• Ability to advance the development and commercialization of BreastCheck under the projected timelines and in accord with the milestones projected.
• Ability to raise capital and obtain funding, non-dilutive or otherwise, for the development and commercialization of BreastCheck.
• Ability to obtain, maintain, and enforce necessary patent and other intellectual property protection for BreastCheck.
• Uncertainties regarding the outcome of the potential benefits, effectiveness, and safety of BreastCheck, including aspects related to administration, manufacturing, distribution, and general economic and market conditions.
• Licensor's compliance with all license obligations it has with Davion Healthcare PLC and Davion Healthcare Corporation, and ensuring the BC Technology remains fully available for Licensee's use without any third-party claims or encumbrances, is a condition for cash consideration payments.
• Failure to reach agreement on key international markets for intellectual property maintenance and enforcement within thirty (30) days of the Agreement's execution would constitute a material breach of the agreement.

Future Outlook

Odyssey Health expects to begin commercialization and generate initial revenue from BreastCheck in the near future, marking its transition from a development-stage to a revenue-generating medtech company. The company anticipates advancing the development and commercialization of BreastCheck under projected timelines and milestones, aiming to capitalize on the rapidly growing breast cancer diagnostics market which is forecasted to double or more over the next 8-10 years.

Management Comments

• "This is a major step forward in our medical device portfolio. Early detection has significantly increased breast cancer survival rates in recent years. It is estimated that this year 317,000 new cases of invasive breast cancer will be diagnosed in women in the United States." Michael Redmond, CEO of Odyssey.
• "We expect to begin commercialization and generate initial revenue from BreastCheck in the near future, marking our transition from a development-stage to a revenue-generating medtech company." Michael Redmond, CEO of Odyssey.

Industry Context

The acquisition positions Odyssey Health to enter the breast cancer diagnostics market, a sector experiencing significant growth driven by technological advances (imaging, AI, genomics), rising incidence of breast cancer globally, and increased emphasis on early detection. The market is currently valued in the low tens of billions of dollars and is projected to double or more over the next 8-10 years, indicating a strong growth trajectory for companies with innovative diagnostic solutions like BreastCheck.

Stakeholder Impact

• Shareholders: Potential for increased revenue and market capitalization due to entry into a growing market, but also potential for dilution from the equity line of credit used for consideration.
• Customers (Patients): Access to a new non-invasive, at-home breast abnormality screening tool, potentially leading to earlier detection and improved health outcomes.
• Employees: Potential for growth and expansion within Odyssey Medical Devices, Inc. as commercialization efforts begin.

Next Steps

• Satisfy certain closing conditions for the Master Technology and Sub-license Agreement.
• Deliver all regulatory documentation (FDA approvals, international approvals, clinical trial data) at least three business days prior to Closing.
• Execute a fully executed Royalty Agreement and a Technology and Material Transfer Agreement between Licensee and Davion.
• Begin commercialization and generate initial revenue from BreastCheck in the near future.
• Advance the development and commercialization of BreastCheck under projected timelines and milestones.
• Negotiate in good faith to identify key international markets for intellectual property maintenance and enforcement within thirty (30) days of the Agreement's execution.

Key Dates

Recommendation

Odyssey Health's acquisition of exclusive global rights to BreastCheck represents a significant strategic move into the rapidly expanding breast cancer diagnostics market. The product's FDA registration and international approvals, coupled with its non-invasive, at-home nature, position it for strong commercial potential. Management's expectation of near-term revenue generation and transition to a revenue-generating medtech company is a strong positive indicator. While the financial consideration involves an equity line of credit and some details are redacted, the overall market opportunity and product readiness suggest a favorable long-term outlook for investors.

Keywords

BreastCheck, breast cancer diagnostics, medical device, sub-license agreement, non-invasive test, early detection, medtech, Odyssey Health, NeuRX Health, Davion Healthcare, FDA registered, intellectual property