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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.
by tacon 1y ago
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/ https://www.vivifimedical.com/
[2] https://www.texasheart.org/people/william-e-cohn/ https://www.texasheart.org/people/william-e-cohn/
- unixhero 1y agoDo you end up impotent or with incontinence?
- tusharsharma09 1y agoNot 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.
- varelse 1y ago[dead]
- sizzle 1y agoGot an anatomical diagram for us visual thinkers?
- tusharsharma09 1y agoNot 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.
- directevolve 1y ago> 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.
- tusharsharma09 1y agoYou 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.
- tusharsharma09 1y agoThanks 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.
- derektank 1y agoHave 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.
- tusharsharma09 1y agoWe 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.
- pstuart 1y agoIs the procedure still possible/advisable after a TURP?
- tusharsharma09 1y agoYes, our procedure could be done before or after any other BPH treatment out there, including TURP.
- aquafox 1y agoI had a look at your trial description (https://clinicaltrials.gov/study/NCT06424912 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.
- bigfatfrock 1y agoSuper interesting, thank you for your candid post - keep crushing in life as it sounds like you already are, good person! Hope you are staying healthy.
- mmooss 1y agoNothing in the parent differs from a product promotion; there are no alternatives, no negatives, no considerations, nothing but praise - even of a member of the board of advisors.
- A_D_E_P_T 1y ago> there are no alternatives, no negatives, no considerations, nothing but praise 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.
- aantix 1y agoI have a really enlarged prostate. 4x the normal size. 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?
- sahilagarwal 1y agoIn case you missed it, there's a comment parallel to yours by the founder of the company. They also provide their email in a child comment to that. Link: https://news.ycombinator.com/item?id=43804502 https://news.ycombinator.com/item?id=43804502