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Dear Foregen supporters,

Thanks to the phenomenal support of our dedicated community, Foregen made significant progress in July, and we are excited to share the highlights with you:

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Final Report of Animal Trials

We expect to receive the final report of the animal trials (rat and sheep) this month. The report will allow us to finalize our surgical plan for human patients. These data will also allow us to put together our overall plan for human clinical trials and apply for government approval.

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Meeting to Develop Surgical Plan

This month, Dr. Dan mon O’Dey will meet with Dr. Angela Palumbo, members of her veterinary team, and Dr. José Vega to discuss the results of the animal trial. This will allow Dr. O’Dey to become more familiar with the use of ECMs in a surgical context and provide him with the necessary information to finalize his surgical plan for use in human experimentation.

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Dr. José A. Vega’s Research Proposal

Foregen Founder Vincenzo Aiello recently traveled to Spain to meet with Dr. José Vega, Dean of the Sensory Organs and Peripheral Nervous System (SINPOS) research group at the University of Oviedo. Dr. Vega presented his proposals to the Foregen Board of Directors on how to ensure reinnervation of not only the nerve endings in the foreskin ECM, but also the specialized nerve structures, such as mechanoreceptors and Meissner corpuscles. Dr. Vega has more than 40 years of experience on this subject. He will submit a formal research proposal to Foregen this month.

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Vincenzo Aiello meets with Dr. José Vega in Ovieda, Spain

HistologiX

Multiple tissue providers have been identified to support the histology study we’ve contracted with HistologiX. The first provider has already begun collecting samples and shipping will take place soon. We are currently working with additional providers to supply additional samples. HistologiX will begin the histological analysis shortly after receiving the tissue samples.

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Searching for CROs

We have begun searching for Contract Research Organizations (CROs) worldwide to potentially partner with to manage our future human clinical trials. We aim to identify reputable, effective, and affordable CROs that can fulfill Foregen’s need to successfully complete human trials that will not only demonstrate a successful procedure, but ensure that it will meet regulatory standards as widely as possible.

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Scaling to Meet Potential Future Demand

Foregen continues to meet with research institutes that we could potentially partner with in the future to refine applicable technologies for our project. Such technologies could allow us to scale to meet potential future demand for the therapeutic use of our surgical procedure. They could also allow us to further optimize the procedure to meet the needs of individual patients. These technologies could potentially include bioreactors, bioengineered ECMs, and tissue stretching technologies. This is a long-term endeavor that depends on successful human trials, and will require time.

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‍Fundraising

Thanks to our incredibly generous and supportive community, Foregen has raised a total of $19,508 in July! These funds enable us to secure laboratory space, materials, and staff necessary for our research. We are deeply grateful for your support.

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

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Sincerely,

Ryan Jones

Chief Operations Officer

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