Not at all. Our device does not go through the penis, doesn’t damage the urethra or resect prostatic tissue. As a result, there is no risk to any sexual or urinary functionalities. There is no post op catheter.

> As a result, there is no risk to any sexual or urinary functionalities.

You can say "based on [X], we believe the risk of [Y] is insignificant." Saying there is "no risk" is far too sweeping a claim given the level of evidence it sounds like you've gathered.

You are correct - we will have to back our claim through clinical evidence.

However, there is no risk to urinary function, because we do not insert anything through the penis. There is no damage to the urethra. Similarly, sexual dysfunctions happen because of damages to prostatic nerves when folks are poking stuff through the prostate or cutting things out. Its similar to saying that getting a BPH procedure poses no risk to your eyesight.

My statements are based on the 200+ patients done through bilateral sclerotherapy of varicocele patients, which is an inferior version of our procedure. But I agree with you point - we will prove it out through our own clinical studies.

Got an anatomical diagram for us visual thinkers?

Not at this time, apologizes. As we move along, we intend on releasing data and images through publications.

However, if you are into reading scientific papers, you can look up microsurgical anastomosis for varicocele treatment by Belgrano and Flati (separate bodies of work). That should give you an idea and good visual picture of the procedure.

Thanks for the shout out. I am the CEO of Vivifi medical. We are building off the gat and Goren’s work and making it better and more robust. More importantly making it more accessible to patients through urologists. Our early clinical trial data from Panama is looking highly encouraging and we are working hard to bring this to the market in the fastest manner possible.

I had a look at your trial description (https://clinicaltrials.gov/study/NCT06424912)

Are you planning to publish the longitudinal data, esp. of endpoints 2 and 3 (prostate size, urinary flow). It would greatly add to the public understanding of this procedure. Why didn't you go for PSA? It's easy to obtain altough one probably wouldn't expect significant changes in this short time frame.

Yes, that’s the intent post study completion.

We are collecting PSA data as well. It’s a useful parameter for prostate cancer.

Have you found that with your procedure, to quote the blog piece, "new venous bypasses grow to replace the destroyed spermatic veins," as found in Gat and Goren's work in follow ups? Or is the long term data not there yet?

Thank you for taking a risk on this by the way. As someone who has family history it's heartening to know there are people taking this seriously.

We actually bypass the spermatic vessels. There is historical evidence that bypassing the spermatic vessels is a superior way to treat varicoceles. So our procedure shouldn’t have the recurrence (of varicoceles or bph) concerns. But this needs to be established through long term studies.

Thanks for sharing your story. It’s stories like yours — people with family histories and real-world experiences — that fuel everything we’re doing.

We are currently gathering insights to better understand patient preferences and would greatly appreciate your input. If you are interested in participating in a short survey, please contact us at [email protected]. Thank you for helping us shape the future of patient care.

Excellent work, keep it up!

On a selfish note, it'd be nice if it were available from Urology Austin sometime in the next 10-15 years.

Thank you for the kind words!

Urology Austin is certainly on our radar and we will reach out to multiple urology practices as we head towards product launch.

Is the procedure still possible/advisable after a TURP?

Yes, our procedure could be done before or after any other BPH treatment out there, including TURP.

Would this procedure be advisable on someone currently with varicocele, less than 40 years old, and with family history of prostate cancer (both grandfathers)?

While we think this procedure has the potential to be a prophylactic treatment, there is no evidence to back that up.

There is a recent study, however, published by Cleveland clinic that demonstrated higher prostate cancer recurrence rates in patients with high local testosterone levels (around the prostate) post prostatectomies.

Also this procedure is not currently approved for treatment of prostatic issues. But if varicocele results in testicular pain, it’s often times treated.