Complete regeneration of the foreskin, with all its neural and vascular infrastructure. For more information please visit our research page.
Why foreskin regeneration?
Contrary to what many people believe, the foreskin provides invaluable sexual and protective functions that are lost to circumcision. Foregen knows that a vast number of men stand to benefit from such a therapy. For a better understanding of why so many people support our project, please visit our foreskin page.
How confident is Foregen that this research will be successful?
As with any scientific project, there is no certainty in outcomes. However, we are utilizing techniques that have already been successful for treating different types of injuries, including severe burns. Dr. Elena Bandioli has more than ten years of experience in decellularizing tissues to extract their extracellular molds and then regenerating them for patients, which is the same fundamental scientific process that Foregen’s success depends on.
Can you share specific details about the ongoing research before it is complete?
We are committed to updating the community on the progress of our research as best we can. However, as is typically the case with novel experimentation, most information and data cannot be shared publicly until the results have been finalized and published in a scientific journal. This is done for multiple reasons, including regulatory requirements by the Italian government and a need for data to be reviewed by multiple parties before release. We thank you for your patience, as this sometimes necessitates that information we share publicly will lack detail initially.
How can I help Foregen reach their goal?
The most direct way to help Foregen is to subscribe as a donating member. This enables us to continue our research and expand our network of opportunities. If you can’t donate, spreading the word, sharing our posts, videos, and news with other people and even making sure others are aware of our organization is an important step towards completing our goal.
How is Foregen different than other forms of foreskin restoration?
Foregen is utilizing tissue engineering techniques to regenerate the entire foreskin with its unique properties, such as the frenulum, ridged band and inner foreskin mucosa. These structures, along with the nervous and vascular network, cannot be reproduced by restoration or plastic surgery.
Does regenerative tissue have the potential to become cancerous?
The risk of cancer in the regenerated foreskin is extremely low. There have been numerous examples of patients with implanted regenerated organs, parts of organs, and tissues dating back almost twenty years and have not reported cancer. The earliest transplant of a regenerated and implanted organ or tissue was in 1998. There have been other successes since then and no reported cancer.
How can Foregen regenerate nerves?
Regenerative medicine and the regeneration of nerves is a complex science. For a cursory understanding, the nerves are regenerated when the extracellular matrix is reseeded with stem cells converted from your cells, along with the foreskin’s tissue. For a more comprehensive understanding beyond the layman’s standard, please consult this thesis titled Regeneration of Peripheral Nerves Using Neuroinductive Biomaterial Scaffolds by Paulina Sierpinski Hill.
Will a restored foreskin interfere with the surgery?
We cannot currently say how restoration will affect our procedure. It may involve removing the restored foreskin and reattaching the regenerated one. However, if we need to create a procedure specifically tailored to restored or restoring men, then we will do so.
Does Foregen use neonatal tissue or embryonic stem cells?
No. Foregen has never used nor will it ever use human cells or tissues derived from any source other than consenting adult donors.
How much will the procedure cost and will insurance be able to cover part of it?
At this time Foregen can only provide an approximation of the final cost, which we estimate could be about $10,000. This is of course subject to change as we continue with our research and approach public release. Unfortunately insurance coverage of the procedure cannot be guaranteed either, which will be highly dependent on the country and how an insurance provider classifies Foregen’s procedure. It’s possible as the culture changes surrounding the topic, there may be an opportunity for coverage, but it must be stressed that this is not assured.
Does Foregen have the personnel to conduct the research?
Yes, Foregen has skilled scientists currently working on our research. Dr. Elena Bondioli has over 10 years of experience in the field of skin regeneration, along with Dr. Valeria Purpura, who is also skilled in the field of regenerative medicine. For more information on personnel, please visit the about page.
Does signing up for the clinical trials early increase your chances of getting in?
While it does register you as interested, it only means that we could potentially select you for the option of human clinical trials. Acceptance will depend on age, health, and other factors. We are not yet at a point to give a full list of requirements.
Will a man’s penis need to stay flaccid for a period of time after the procedure?
Yes, your penis will need to stay flaccid for some time after the procedure in order heal. Penile surgeries are common and there are ways to prevent erections and therefore ensure full healing.
How will you address issues related to scalability?
There are various potential approaches that we intended to explore in order to satisfy future demand for the procedure. One is the use of 3D bioprinting to manufacture the extracellular matrix-based scaffolds. Another is the use of bovine tissue to provide the extracellular matrix-based scaffolds.
Will the procedure need to be submitted for approval by the FDA?
Because our decellularized foreskin extracellular matrix-based scaffolds are classified as a minimally manipulated tissue-based product, it is possible the procedure can be approved without undergoing a lengthy application and review by the FDA. This is because they are not subject to the same FDA regulation that normal medical devices are.
Will I have to go abroad to get the procedure or will it be available in my home country?
As our research is currently being conducted in Italy, it is likely that our therapy will first be approved and available in Europe. While this means that some patients may initially have to travel for the therapy, Foregen will work to make it available in as many countries as possible.
Where does the donor foreskin actually come from?
The donor foreskin is taken from a consenting, potentially deceased, adult male. The donor foreskin will undergo a process called decellularization that strips the foreskin of the donor’s cells and DNA. It is then seeded with your own DNA to regenerate the structures of the foreskin, which means the foreskin will be truly yours.
How far has Foregen progressed in its research so far?
Please visit the our research page for the current roadmap of our research progress.
What about phimosis or if I’ve had it before?
Each foreskin will be custom fit to the patient. Since phimosis is not genetic, but rather caused by some form of scarring or preventable infection, reappearance post-procedure would be extremely unlikely with standard hygiene.
Can the regenerated foreskin be adjusted to fit any penis size?
Yes, both donor tissue and 3D printing models will achieve a foreskin adjusted to every patient.
How will the nerves of the new foreskin work?
The axons in your spine associated with the foreskin have always been used because they are used for the entire penis. We also know the brain can receive sensation from newly transplanted limbs and that the brain retains limb functionality, even long after amputation.
Will you regenerate the frenulum and ridged band?
Our goal is to regenerate all the structures and restore full functionality, including the frenulum and ridged band.
What is Foregen's Federal Tax ID Number?
Foregen's Federal Tax ID Number (EIN) is 98-1006983.