Market Cap 18.31M
Revenue (ttm) 0.00
Net Income (ttm) -21.82M
EPS (ttm) N/A
PE Ratio 0.00
Forward PE N/A
Profit Margin 0.00%
Debt to Equity Ratio 0.00
Volume 218,800
Avg Vol 1,155,812
Day's Range N/A - N/A
Shares Out 19.25M
Stochastic %K 69%
Beta 0.94
Analysts Hold
Price Target $12.50

Company Profile

enVVeno Medical Corporation, a clinical-stage medical device company, focuses on the development of bioprosthetic tissue-based solutions to enhance the standard of care in the treatment of venous disease. The company's lead product is the VenoValve, a replacement venous valve for the treatment of venous chronic venous insufficiency. Its VenoValve implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh. The company also develops e...

Industry: Medical Devices
Sector: Healthcare
Phone: 949 261 2900
Address:
70 Doppler, Irvine, United States
Flying_Trader2
Flying_Trader2 Oct. 3 at 3:45 PM
$NVNO Continued… 3 of 3 That phrasing is quite close to the notion behind the Hawthorne effect (i.e. participants improving merely because they are in a study or under observation), although the public statements don’t exactly use the term “Hawthorne effect.” So, yes — the FDA did in effect argue that some of the benefit seen might be due to that kind of “study participation effect” / bias, rather than being fully attributable to the device.
2 · Reply
Flying_Trader2
Flying_Trader2 Oct. 3 at 3:43 PM
$NVNO Here’s a breakdown of what is known (and what is not confirmed publicly) from the sources: What the FDA argued (publicly known) In its N A letter, the FDA stated that the favorable results on the revised Venous Clinical Severity Score (rVCSS), pain scores, and quality-of-life measures were not sufficient by themselves to establish a favorable benefit–risk profile. The FDA noted that the absence of a specific hemodynamic measurement that correlates with patient improvement was a gap. Without that, it was harder to be confident that the device’s effect (rather than other influences) caused the clinical improvements. Importantly, the FDA explicitly flagged concerns about bias and “the possibility that clinical improvement occurred as a result of the patients being enrolled in a study” (i.e. that the act of being observed or participating could itself improve outcomes) rather than from the VenoValve therapy. Continued....
0 · Reply
Flying_Trader2
Flying_Trader2 Oct. 3 at 3:40 PM
$NVNO I asked AI if FDA was claiming a "Hawthrone Effect" in the SAVVE study and this is what it said. While the FDA also stated there was a "gap" in the hemodynamic measurement data, that was sited as the reason they could not confirm the medical improvements were the result of the device and not the study (Hawthorne Effect). I believe NVNO can successfully show there is overwhelming evidence that it was the device that yielded the medical improvements and not some "Hawthrone Effect" as the FDA is arguing. So I do think there is hope here.... From AI: Yes — according to publicly available summaries and press‐releases, the FDA did raise a concern in Envveno’s Not-Approvable (N A) letter that some of the observed clinical improvements in the SAVVE study might reflect bias or the effect of just being in a study, rather than being fully attributable to the VenoValve device itself. Continued...
0 · Reply
TexasBandit11
TexasBandit11 Oct. 3 at 1:31 PM
$NVNO come on $1 time to start climbing l…
0 · Reply
ConsistencySpike
ConsistencySpike Oct. 3 at 1:21 PM
0 · Reply
Jordan1857
Jordan1857 Oct. 1 at 3:02 PM
$NVNO I told about $WWR you are still on time to buy it! My new position is $WU easy money!
1 · Reply
SPYmyQQQ
SPYmyQQQ Oct. 1 at 12:03 PM
🚀 New Signal ✅ 💊 $NVNO 🗓️ Oct 1, 2025 💵 Entry: $0.9200 🎯 Target (Opt.): $1.09 (+18.49%) 👉 Check bio for full access
1 · Reply
highnihilism
highnihilism Oct. 1 at 10:16 AM
$BELFB Bel Fuse Trade Count: 1 | Total $: 1.9 K | 0.13 × 90-Day Avg $: 15.3 K | Call $: 1.9 K | Put $: 0 | % Single-Leg: 100% | % Multi-Leg: 0% | % Contingent: – $NVNO Enveneo Medical Trade Count: 9 | Total $: 1.9 K | 0.15 × 90-Day Avg $: 12.9 K | Call $: 1.9 K | Put $: 0 | % Single-Leg: 100% | % Multi-Leg: 0% | % Contingent: – $NVDQ 2X Inverse Nvidia Daily Target ETF Trade Count: 38 | Total $: 2.3 K | 0.41 × 90-Day Avg $: 5.6 K | Call $: 1.9 K | Put $: 400 | % Single-Leg: 86% | % Multi-Leg: 11% | % Contingent: 3% $LAZ Lazard Trade Count: 11 | Total $: 5.4 K | 0.05 × 90-Day Avg $: 109.3 K | Call $: 1.9 K | Put $: 3.5 K | % Single-Leg: 100% | % Multi-Leg: 0% | % Contingent: –
0 · Reply
Flying_Trader2
Flying_Trader2 Oct. 1 at 5:28 AM
$NVNO I asked AI for examples where an initial rejection based on clinical data was later overturned on appeal and unfortuantely it didn't find any (many were later approved for Mfg issues). Here is what AI had to say: Some CRLs did cite clinical data issues (lack of "substantial evidence of effectiveness" etc.), but in those cases, in order to eventually gain approval, additional clinical data or new trials were required. That is, the “overturn” was via resubmission / supplemental data, not via successful appeal of the original decision without new clinical work So I guess the question will be do they proceed with the heart valve or do another trail for the leg valve. They don't have enough money for both and perhaps not even enough for either. Although I expect the leg valve study would be very focused for what the FDA is looking for.
2 · Reply
Flying_Trader2
Flying_Trader2 Sep. 29 at 3:31 PM
$NVNO So, Berman makes a pretty compelling case in that video, who thinks there is a >75% chance of approval on appeal ? 50% ? 25% ? 0% ?.... And if it is not approved how far do you think it will fall given they do have well over a buck/sh in cash and no debt.
5 · Reply
Latest News on NVNO
enVVeno Medical Updates Regulatory Status of VenoValve(R)

Sep 15, 2025, 8:45 AM EDT - 19 days ago

enVVeno Medical Updates Regulatory Status of VenoValve(R)


Hancock Jaffe To Rebrand As enVVeno Medical

Sep 22, 2021, 7:09 AM EDT - 4 years ago

Hancock Jaffe To Rebrand As enVVeno Medical


First U.S. Patent Issues on Hancock Jaffe VenoValve

Apr 7, 2021, 1:40 PM EDT - 4 years ago

First U.S. Patent Issues on Hancock Jaffe VenoValve


Hancock Jaffe Announces Executive Promotions

Dec 30, 2020, 4:15 PM EST - 5 years ago

Hancock Jaffe Announces Executive Promotions


Flying_Trader2
Flying_Trader2 Oct. 3 at 3:45 PM
$NVNO Continued… 3 of 3 That phrasing is quite close to the notion behind the Hawthorne effect (i.e. participants improving merely because they are in a study or under observation), although the public statements don’t exactly use the term “Hawthorne effect.” So, yes — the FDA did in effect argue that some of the benefit seen might be due to that kind of “study participation effect” / bias, rather than being fully attributable to the device.
2 · Reply
Flying_Trader2
Flying_Trader2 Oct. 3 at 3:43 PM
$NVNO Here’s a breakdown of what is known (and what is not confirmed publicly) from the sources: What the FDA argued (publicly known) In its N A letter, the FDA stated that the favorable results on the revised Venous Clinical Severity Score (rVCSS), pain scores, and quality-of-life measures were not sufficient by themselves to establish a favorable benefit–risk profile. The FDA noted that the absence of a specific hemodynamic measurement that correlates with patient improvement was a gap. Without that, it was harder to be confident that the device’s effect (rather than other influences) caused the clinical improvements. Importantly, the FDA explicitly flagged concerns about bias and “the possibility that clinical improvement occurred as a result of the patients being enrolled in a study” (i.e. that the act of being observed or participating could itself improve outcomes) rather than from the VenoValve therapy. Continued....
0 · Reply
Flying_Trader2
Flying_Trader2 Oct. 3 at 3:40 PM
$NVNO I asked AI if FDA was claiming a "Hawthrone Effect" in the SAVVE study and this is what it said. While the FDA also stated there was a "gap" in the hemodynamic measurement data, that was sited as the reason they could not confirm the medical improvements were the result of the device and not the study (Hawthorne Effect). I believe NVNO can successfully show there is overwhelming evidence that it was the device that yielded the medical improvements and not some "Hawthrone Effect" as the FDA is arguing. So I do think there is hope here.... From AI: Yes — according to publicly available summaries and press‐releases, the FDA did raise a concern in Envveno’s Not-Approvable (N A) letter that some of the observed clinical improvements in the SAVVE study might reflect bias or the effect of just being in a study, rather than being fully attributable to the VenoValve device itself. Continued...
0 · Reply
TexasBandit11
TexasBandit11 Oct. 3 at 1:31 PM
$NVNO come on $1 time to start climbing l…
0 · Reply
ConsistencySpike
ConsistencySpike Oct. 3 at 1:21 PM
0 · Reply
Jordan1857
Jordan1857 Oct. 1 at 3:02 PM
$NVNO I told about $WWR you are still on time to buy it! My new position is $WU easy money!
1 · Reply
SPYmyQQQ
SPYmyQQQ Oct. 1 at 12:03 PM
🚀 New Signal ✅ 💊 $NVNO 🗓️ Oct 1, 2025 💵 Entry: $0.9200 🎯 Target (Opt.): $1.09 (+18.49%) 👉 Check bio for full access
1 · Reply
highnihilism
highnihilism Oct. 1 at 10:16 AM
$BELFB Bel Fuse Trade Count: 1 | Total $: 1.9 K | 0.13 × 90-Day Avg $: 15.3 K | Call $: 1.9 K | Put $: 0 | % Single-Leg: 100% | % Multi-Leg: 0% | % Contingent: – $NVNO Enveneo Medical Trade Count: 9 | Total $: 1.9 K | 0.15 × 90-Day Avg $: 12.9 K | Call $: 1.9 K | Put $: 0 | % Single-Leg: 100% | % Multi-Leg: 0% | % Contingent: – $NVDQ 2X Inverse Nvidia Daily Target ETF Trade Count: 38 | Total $: 2.3 K | 0.41 × 90-Day Avg $: 5.6 K | Call $: 1.9 K | Put $: 400 | % Single-Leg: 86% | % Multi-Leg: 11% | % Contingent: 3% $LAZ Lazard Trade Count: 11 | Total $: 5.4 K | 0.05 × 90-Day Avg $: 109.3 K | Call $: 1.9 K | Put $: 3.5 K | % Single-Leg: 100% | % Multi-Leg: 0% | % Contingent: –
0 · Reply
Flying_Trader2
Flying_Trader2 Oct. 1 at 5:28 AM
$NVNO I asked AI for examples where an initial rejection based on clinical data was later overturned on appeal and unfortuantely it didn't find any (many were later approved for Mfg issues). Here is what AI had to say: Some CRLs did cite clinical data issues (lack of "substantial evidence of effectiveness" etc.), but in those cases, in order to eventually gain approval, additional clinical data or new trials were required. That is, the “overturn” was via resubmission / supplemental data, not via successful appeal of the original decision without new clinical work So I guess the question will be do they proceed with the heart valve or do another trail for the leg valve. They don't have enough money for both and perhaps not even enough for either. Although I expect the leg valve study would be very focused for what the FDA is looking for.
2 · Reply
Flying_Trader2
Flying_Trader2 Sep. 29 at 3:31 PM
$NVNO So, Berman makes a pretty compelling case in that video, who thinks there is a >75% chance of approval on appeal ? 50% ? 25% ? 0% ?.... And if it is not approved how far do you think it will fall given they do have well over a buck/sh in cash and no debt.
5 · Reply
_GrAvY_
_GrAvY_ Sep. 29 at 1:39 AM
$AABB $DKNG $NVNO $PG happy sunday funday
0 · Reply
naulster
naulster Sep. 29 at 1:32 AM
$NVNO I know a lot of investors lost a lot of money here & INMB. I'm just curious, does anyone know, if anybody has started any legal action against Tailwinds? If so, could you please email me at [email protected]. Thank you.
2 · Reply
Shlomolench
Shlomolench Sep. 28 at 9:23 PM
$NVNO sitting on 30 k shares @ .85
0 · Reply
Shlomolench
Shlomolench Sep. 28 at 9:23 PM
0 · Reply
_GrAvY_
_GrAvY_ Sep. 26 at 9:05 PM
$AABB $DKNG $NVNO $PG time for some football happy weekend
1 · Reply
Icemanja
Icemanja Sep. 26 at 8:06 PM
$NVNO Not a single word on the Lab results of the non-surgical valve. Is Berman hiding more failed data , or cherry picking results ?
0 · Reply
VirtualInvestor
VirtualInvestor Sep. 26 at 2:12 PM
$NVNO CEO, Rob Berman, discussed the Company’s recent news announcing it filed a request for supervisory appeal to the FDA for the VenoValve in a What This Means. https://www.youtube.com/watch?v=ErZQsmBJeV4&t=47s
3 · Reply
_GrAvY_
_GrAvY_ Sep. 25 at 7:51 PM
$AABB $DKNG $NVNO $PG mangia (dont forget the horseradish)
4 · Reply
_GrAvY_
_GrAvY_ Sep. 25 at 6:30 PM
$NVNO this thing is gonna blow buy all you can
0 · Reply
_GrAvY_
_GrAvY_ Sep. 25 at 5:24 PM
$AABB $DKNG $NVNO $PG happy thuessay
0 · Reply
_GrAvY_
_GrAvY_ Sep. 25 at 1:54 AM
0 · Reply
_GrAvY_
_GrAvY_ Sep. 25 at 1:15 AM
$AABB $DKNG $NVNO $PG isss time for an old fashioned en uhhhh cigar maaaang
0 · Reply