alexpitti
Posted - 10 hours ago
I watched the $nvno presentation with the 2 docs and it went well. I'm confused on why my source is so negative and the stock is valued near $0.
peapope
Posted - 15 hours ago
$NVNO imagine an incredible biotech breakthru managed by a moron. That is NVNO
Icemanja
Posted - 17 hours ago
$NVNO Long-term investors have gotten too comfortable, with the garbage performance of the stock. Time to start calling out the POS management for what it is. Put IR on blast
tuckerabbott
Posted - 18 hours ago
$NVNO almost hard to believe.
beaches911
Posted - 18 hours ago
$NVNO Note for newbies, this stock never ever fails to go down on good news.
beaches911
Posted - 18 hours ago
$NVNO Well that's all the swing traders exiting
haupman
Posted - 19 hours ago
$NVNO yesterday the press release said "potential approval in second half of next year." Are they just being conservative?
Flying_Trader2
Posted - 19 hours ago
$NVNO Not exactly the reaction I was expecting to the presentation...
SteelWheels
Posted - 19 hours ago
$LCTX Another Beauty pick by TW Research just one of many $INMB,$INAB,$TFFP,$NVNO,
Icemanja
Posted - 20 hours ago
$NVNO IP is valued at less than 10 million at this point. 48mil in cash , FDA approval possibly in a few months and still zero interest or offers. The real question is Why ?
BigGreenCandle
Posted - 20 hours ago
$NVNO Gap down tomorrow under 3 ? lol Wouldn't that be classic.
Icemanja
Posted - 21 hours ago
$NVNO In Berman eyes the company and stock is doing great.
ILikeDaStocks
Posted - 21 hours ago
$NVNO I have a strong position in the company and see enormous upside, but why is ownership by company insiders so minimal? Anyone know?
vishav99
Posted - 22 hours ago
$NVNO started a position of 300 shares.
Gap to fill. Moreover I believe in tech.
alexpitti
Posted - 22 hours ago
$NVNO crazy you only get 1 small gain on submission. my contact tells me he knows a few people who still work there and it's not going well. but who knows if he is right
peapope
Posted - 23 hours ago
$NVNO no partnership = dilution with these clinical biotechs
haupman
Posted - 23 hours ago
$NVNO need to have a long long timeframe with this one. There are always substantial sellers here.
cdsnuts93
Posted - 1 day ago
$NVNO Underrated portion of the data release
- 94% of patients that had an MAE experienced a clinically meaningful benefit of > 3 points.
DonCorleone77
Posted - 1 day ago
$NVNO From ACCESSWIRE: "enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium" Key Takeaways: -- 85% Clinical Meaningful Benefit Responder Rate -- 7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort -- 75% Median Reduction in Pain (VAS) -- 87% Median Ulcer Area Reduction -- 97% Target Vein Patency Rate -- Improvement in All Patient Reported Quality-of-Life Indicators -- Company to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time IRVINE, CA / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S. Among the data being presented at VEITH are: Eighty five percent (85%) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS). 7.91 point average rVCSS improvement among the rVCSS responder cohort. Clinical meaningful benefit was shown across all CEAP diagnostic classes of subjects (C4(b), C4(c), C5, C6) enrolled in the study. Ninety seven percent (97%) Target Vein Patency rate at one year. Hemodynamic data from the study showed a positive correlation between rVCSS improvement and systemic reflux time improvement. rVCSS is a clinically validated scoring system used to track the regression or progression of venous diseases. The FDA previously indicated to the Company that a 3 or more-point improvement in rVCSS would be evidence of the VenoValve's clinical meaningful benefit. Subjects in the VenoValve pivotal study also experienced a median reduction in pain of seventy-five percent (75%) at one year as measured by Visual Analog Scale (VAS). Additionally, among subjects with venous ulcers (CEAP C6), the median ulcer area was reduced by eighty seven percent (87%) at 12 months. Patient reported outcomes in the VenoValve pivotal study also demonstrated improvements in quality of life and disease symptoms (VEINESqol/sym, EQ5D). "The number one concern for clinicians and where other attempts to replace venous valves have failed in the past is that they have occluded or completely blocked blood flow in the targeted refluxing vein. With a ninety seven percent (97%) Target Vein patency rate at one year, and eighty-five percent (85%) of the subjects in the VenoValve study experiencing a clinical meaningful benefit, the VenoValve should be a compelling potential option for physicians and patients with no effective treatment options from the devastating impacts of severe, deep venous CVI," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We are pleased with the one-year safety and efficacy profile of the VenoValve from the pivotal study and look forward to our upcoming interactions with the FDA as they evaluate our clinical data and complete the additional steps that are a part of the PMA review process." The Company will also update the pivotal trial safety profile of the VenoValve at VEITH, reporting Major Adverse Events (MAEs) through one year of: one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) Target Vein Thromboses, ten (10) Surgical Pocket Hematomas, four (4) Other Bleeds, and seven (7) Deep Wound Infections. Of the subjects that experienced an MAE, there was no long-term negative impact on clinical improvement as ninety-four percent (94%) of the subjects who experienced an MAE (not including the unrelated death) also experienced a clinical meaningful benefit (≥ 3 point rVCSS improvement) at one-year, compared to baseline. Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year. The VenoValve® is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company is also developing enVVe®, a next-generation, transcatheter based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians. The Company will host a video conference call today at 2:00 PM Eastern Time following the VEITH presentation, with the presenting Primary Investigators. To access the call visit the Events page on the Investor section of the Company's website.
laste_rounde
Posted - 1 day ago
$NVNO There was a reason this was referred to as the Holy Grail at the Chicago conference. Has priority review with breakthrough designation. FDA is slow and overworked but seems like a no brainer
vwon55
Posted - 1 day ago
$NVNO take us the the promiseland
haupman
Posted - 1 day ago
$NVNO so now we know why there were only 74 patients at the end.
laste_rounde
Posted - 1 day ago
$NVNO Outstanding data as expected. Looking forward to the webinar.
haupman
Posted - 1 day ago
$NVNO figures this is going to open down today. Just massive sellers in this thing.
vishav99
Posted - 1 day ago
$NVNO 4 years of consolidation should result in big pop! Starting a position here!
haupman
Posted - 1 day ago
$NVNO this guy is sitting at the $3.61 ask in big quantities
haupman
Posted - 1 day ago
$NVNO data is coming soon and yet someone is already leaning on the ask, at yesterday's closing price.
