I don't normally recommend stocks and I know it's probably not a good idea to clutter up the Anteris discussion with comments about other companies but this company's situation is so much like Anteris' that I think it's well worth mentioning here.
Full disclosure: I have a large position, at least for me, in this stock. My initial investment is about equal to my initial investment in AVR/AMEUF. I am not trying to pump the stock, this is a long term hold for me so I'm not selling a share anytime soon and the company has no plans to raise money as their most recent quarterly filing states that they have enough cash to fund operations into 2025.
The company is located in the US and the stock trades on the Nasdaq so folks in Australia will need to have access to Nasdaq traded stocks to buy it.
The stock is enVVeno Medical, NVNO.
They have the world's first replacement leg valve to treat venous insufficiency and it's currently in clinical trials. Their valves are made from porcine tissue.
I'll give an overview and provide resources so any of you who are interested can go further in-depth and make up your own minds.
What I like:
They could have a monopoly on a potentially massive market that currently offers patients no good options for treatment. Their FIH trial with 11 patients for their surgically implanted leg valve was run in Colombia and returned good results, and they are now running what they expect to be a pivotal trial in the US with a 75 patient population. They expect enrollment to be completed by the middle of this year and to finish data collection by the end of the year. The Premarket Approval submission to the FDA is expected sometime later next year and commercialization of the surgically implanted valve is targeted for 2025.
I really like that enVVeno continues to innovate. They announced a trans-catheter version of their leg valve late last summer and the FIH trial for that device should be starting soon in Colombia. They have their own manufacturing facility. They state that they have sufficient money to fund operations into 2025. Perceptive Advisors is a large shareholder and owns more than 8% of the company's shares. The company also has been awarded the coveted Breakthrough Device designation by the FDA.
What I don't like:
They could have a better CEO in my opinion. His money raising in the past hasn't been optimal but they seem to have gotten that sorted. Enrollment for the potentially pivotal trial has been inexcusably slow. They announced the pivotal trial's first procedure in Oct 2021 and are still maybe 4 months from completing enrollment, and there are only 75 patients with more than 20 hospitals and clinics participating. Last August the CEO said that he would personally visit each trial site to get things moving faster but the company still recently lengthened its timeline for complete enrollment from Q1 of this year to the middle of this year.
But there may be a silver lining. enVVeno hired a new Vice President of Clinical Operations last August, a fellow named Kevin Belteau who spent 23 years supervising clincal trials for Medtronic, so he's very experienced. We may have recently seen evidence of him taking over trials operations as some trial sites have been listed as terminated on the official Clinicaltrials.gov website while other sites have been added. It seems like he's making the necessary changes to get the trial finished.
The company has a current market cap of about $81 million AUD. There are 9.5 million shares outstanding with 16.1 million fully diluted, so there are a good bit of warrants and options. An analyst I talked to that covers the company expects the valves to eventually sell for $8,000 to $10,000 US. Their potential patient population is in the millions and they could obviously be a good buyout candidate.
There is not a good discussion board for NVNO as it's a very obscure stock at this point. disallowed gets a little activity but not much.
For more information:
The most recent video presentation can be watched or downloaded here:
The most recent quarterly filing, which is well worth the read if you are interested in investing (if there's one thing the US government does well, it's requiring public companies to provide very detailed filings):
https://www.sec.gov/ix?doc=/Archives/edgar/data/1661053/000149315222029717/form10-q.htm
All of the company's filings are viewable here:
https://www.sec.gov/edgar/browse/?CIK=1661053&owner=exclude
Info on the pivotal trial:
https://clinicaltrials.gov/ct2/show/NCT04943172
enVVeno's website:
https://envveno.com/
(20min delay)