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Dear Foregen supporters,

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Foregen continues to work steadfastly on preparing for human trials. Thanks to the enduring support of our community, we have made tangible progress towards this goal. Here are the updates:

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Preparing for Human Trials

Our projected timeframe for beginning human clinical trials is mid-2025. We are currently focused on completing the surgical plan, partnering with a reputable Contract Research Organization (CRO), and identifying the most ideal country in which to conduct the trials.

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Dr. O’Dey and the Surgical Plan

We have begun working with renowned surgeon Dr. Dan mon O’Dey to develop a surgical plan to be used in our future human clinical trials. Later this month, he will travel to meet the team that is decellularizing the foreskin Extracellular Matrices (ECMs) that will be used in the human trials. The purpose of this visit is for Dr. O’Dey to learn more about the process, as well as to advise the team on how to best prepare the tissue for surgical application. Following this, he will conduct two cadaver lab sessions to test the surgery. We anticipate the final plan will be completed by the end of this year.

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Animal Trials Completion

The final report on the animal trials is nearly complete, and will be delivered to Foregen this month. This is crucial, as the animal trials data must be included in our application for approval to conduct human trials by the regulatory agency in the country in which we conduct them. After we receive the report, the veterinary team will then work on getting this data published in an academic journal. The publishing process typically takes a few months. We are excited for this important contribution to scientific knowledge to be made, and for the benefit of our supporters.

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HistologiX Update

HistologiX has received the tissue samples it needs to conduct the histology study and has already begun the initial pathological analysis. Five samples were trimmed, embedded, sectioned, and stained last week. Each has been divided into four regions, which means that twenty slides have already been created for the histological analysis. The total amount of slides required should be approximately 48. We anticipate that the histology study will be completed by the end of this year!

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Fundraising

Thanks to our incredibly generous and supportive community, Foregen raised a total of $16,739 in September! These funds are vital in securing laboratory space, materials, and staff required to continue our groundbreaking research. We are deeply grateful for your ongoing support.

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Your donation can make a significant difference. Join us in developing the world’s first regenerative medicine solution for circumcised men!

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Sincerely,

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Ryan Jones

Chief Operations Officer