TW's Take: we believe the VenoValve works and put decent odds on approval through this appeal process.
IRVINE, CA / ACCESS Newswire / September 15, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for...
TW's Take: a disaster for investors. Company changed endpoints and had unmentioned rehospitalizations. Not good.
IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment...
TW's Take: it's not hard to see the VenoValve getting significant traction once approved, which should happen in this quarter. I think the stock is very cheap relative to the upside potential.
Clinical data and cost-effectiveness analysis demonstrates the VenoValve...
TW's Take: we are very close to approval of the VenoValve, which should be a major catalyst for NVNO. Believe the company gets acquired within two years, possibly much sooner.
– Cash burn of $3.8 million in Q2 remains in...
TW's Take: approval is highly likely in the coming months which is hopefully the spark to launch this stock towards a more respectable valuation.
IRVINE, CA / ACCESS Newswire / May 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a...
TW's Take: we continue to believe that the risk/reward behind the VenoValve is excellent and that NVNO is likely acquired sometime in the 6-12 months post approval.
Promising results from the first-in-human study demonstrated that, at three-years post implantation,...
TW's Take: approval later this year is going to change the perception of the stock.
IRVINE, CA / ACCESS Newswire / April 23, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment...
TW's Take: The data continues to be highly supportive of the VenoValve. Approval likely later this year.
IRVINE, CA / ACCESS Newswire / March 31, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for...
TW's Take: NVNO continues to present a strong case for approval of the VenoValve later this year.
Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range
Cash and investments on hand are...
TW's Take: the data continues to be highly supportive of VenoValve. Approval later this year is highly likely and the key catalyst for the stock.
One-year follow-up data demonstrates sustained improvements across venous specific quality-of-life (QoL) indicators.
PMA application...
Last week's newsletter talked about how I couldn't get comfortable with Atomera (ATOM) heading into earnings. This is a company that is like an Amtrak train pulling into the station...the closer it gets, the slower it goes.
The good news...
TW's Take: more excellent data. Approval seems highly likely. Reimbursement coming next could be the spark to light the fire here...been smoldering forever.
Two-year follow-up data from 34 subjects in the VenoValve pivotal trial show sustained clinical improvement and...
TW's Take: the eVVe system is what will drive sales to eventual peaks in the billions. Great progress for a very underloved company.
Successful Completion of All Planned Implants in GLP Study
enVVe Delivery System Demonstrates Consistent Performance
Company Maintains Timeline for...
TW's Take: phenomenal results out of this program sets it up for approval in 2025 and eventual acquisition.
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%...
TW's Take: the data being presented should be excellent and approval is highly likely along with reimbursement codes.
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium
Company to Host a Conference Call with...
TW's Take: excellent news as this is highly likely to be a blockbuster product in rapid fashion after approval.
First wave of implants successfully completed with updated delivery system performing very well
Company on schedule to be in position...
TW's Take: not sure why the company needed to pad the balance sheet, but this is a nice endorsement from some smart shareholders.
IRVINE, CA / September 26, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a company setting...
TW's Take: NVNO is making all the preparations for a big launch next year. Exciting times ahead for the company.
MedTech Marketing Leader with Significant New Product Launch Experience for Cardiovascular Devices
Key Addition to Commercial Team as Company Begins Planning...
TW's Take: the company is doing everything right as they march forward towards approval.
VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA
4 Modules Have Now Been Submitted, Reviewed, and Approved by the FDA
Company...
TW's Take: data from this trial exceeds all expectations.
IRVINE, CA / April 16, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of venous disease, today announced that additional...
TW's Take: this is a solid hire as his experience dovetails nicely into getting the VenoValve acquired by a larger device company post approval.
Appointment bolsters Company’s transition from being a clinical stage to a commercial entity planning for the...
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This morning enVVeno (NVNO) published the top-line results at the six-month mark of their...
TW's Take: outstanding data makes reimbursement and approval highly likely with significant post-approval uptake. I believe this sets the stage for an acquisition within the next 6-12 months.
97% of VenoValve Study Patients Showing Clinical Improvement at Six Months (as...
TW's Take: data next week is the missing ingredient to finally send NVNO to a decent valuation. Next gen product positions them for eventual billion dollar or more exit.
$46.4 million cash and investments on hand sufficient to fund...
TW's Take: looking forward to, what I believe will be, outstanding data presented in just over 2 weeks. These results could be the catalyst that propels NVNO towards a greatly improved valuation and likely sparks interest from potential acquirers.
IRVINE,...
TW's Take: very positive results sets the stage for approval if the efficacy data comes through as expected. We'll see that data in the first half of 2024.
No Deaths or Pulmonary Embolisms Occurring During the 30 Day MAE...
enVVeno (NVNO) put out a hat trick of press releases today. The news ranged from getting $28 million in a private placement to fundamental updates on both their products. On the surface it all seemed great and the stock...
TW's Take: this product has multi-billion dollar potential and it's great to see the timeline moved up by 6 months. Non-surgical implantation is a game-changer that greatly expands the market.
– enVVe development cycle to be reduced by 6 months
–...
TW's Take: company is exceeding expectations on all fronts. Great news.
– 18 VenoValve patients enrolled over the final two months of the study
– Surge in VenoValve demand exceeded the enrollment limit
– Topline safety and efficacy readout and PMA eligibility...
TW's Take: very positive getting top-notch investors to pay above the market. Financing risk now completely eliminated and the company is exceeding timelines on both products as announced in other press releases today. I remain very bullish on NVNO.
Up...
TW's Take: we continue to believe this device is going to succeed and be a big deal for NVNO.
IRVINE, CA / July 14, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care...
TW's Take: trial progressing well, results will come early next year which is a modest delay from the original timeline but expected in any trial run during Covid. Overall, very excited for the future here.
57 patients enrolled to...
TW's Take: our view on NVNO remains that the product will gain approval and substantial sales, but likely remains off investors' radar screens until closer to approval. This PR is more evidence that the company is headed in the...