zlacker

>>bondar+(OP)
In February I happened to attend a lunch 'n learn presentation at TMCi by a company doing clinical trials based on exactly this venous insufficiency principle. I think I may have been the only one in the audience with gray hair... TMCi is the startup accelerator attached to the Texas Medical Center in Houston.

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).

[1] https://www.vivifimedical.com/

[2] https://www.texasheart.org/people/william-e-cohn/

>>tacon+8s
Do you end up impotent or with incontinence?

>>unixhe+JA
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.

>>tushar+cG
> 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.

>>direct+jr5
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.