The startup company is Vivifi Medical[1] and they have clinical trials underway with ten men in a Central American country (El Salvador?). They claim that BPH reverses in a few months after their procedure. Their procedure uses a minimally invasive tool of their own invention to snip the vertical blood vessels that are backflowing from age and gravity, and splice them into some existing horizontal blood vessels. On their board of advisors is Dr. Billy Cohn[2], the wildly innovative heart surgeon who is famous for shopping for his medical device components at Home Depot. Dr. Cohn is on the team building the BiVACOR Total Artificial Heart. Vivifi presented their estimated timeline to FDA approval, with proposed general availability in 2028. My personal BPH will be at the head of the line for this procedure.
As far as a startup, their TAM is about 500 million men. I had the Urolift procedure for BPH three years ago, and it cost about $15K on the Medicare benefits statement, though Urolift's clips amounted to only a few thousand dollars. Similarly, Vivifi's charges for this procedure are only a few thousand dollars per procedure, but it holds the promise of being a final solution. Currently Urolift is much less disruptive than TURP, which needs a couple of days in the hospital and almost always leads to retrograde ejaculation (into the bladder).
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.
Thanks for sharing your story. It’s stories like yours — people with family histories and real-world experiences — that fuel everything we’re doing.
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.
We are collecting PSA data as well. It’s a useful parameter for prostate cancer.
On a selfish note, it'd be nice if it were available from Urology Austin sometime in the next 10-15 years.
His account is over ten years old, and active. Maybe he's just impressed? Why don't you provide alternatives or negatives, if you can? Cynicism for cynicism's sake is pointless.
Urology Austin is certainly on our radar and we will reach out to multiple urology practices as we head towards product launch.
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.
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.
Had it biopsied because it showed a large PSA value (17).
Biopsy came back negative. Psa density function actually puts my levels in normal range.
I still have difficulties urinating.
Currently taking medication to reduce the size of my prostate, but not happy about the meds because of the sexual side effects.
Would this procedure help me?
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.
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.