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...