Wow, great news!
The announcement also mentioned that some non-European markets would open with the CE mark. And additionally, this helps in gathering clinical evidence to expand indications in the United States.
Interesting to see what the year still brings.
Whew, the age of miracles is not over!
The process took an unacceptably long time⊠
It feels quite incredible, having actively followed the companyâs operations for almost three years now. Very great news.
I remember when I first read about this invention. I envisioned crackpots in tinfoil or propeller hats tinkering in some dim closet, thatâs how incomprehensible it felt. For once, I understood the importance of looking into things. Slowly I realized, weâre on the verge of something exciting. I bought in. Iâve been waiting patiently. Now expectations are slowly materializing. This is going to be a big deal! Possible price increase on Monday. Iâm definitely not giving up, but something like this warms the heart in these fear-filled times!
Somehow there was a skeptical feeling about whether the CE marking would ever come and whether all factors had been taken into account in the studies (cf. BBS). The million-dollar question is likely how long Bioretec will still be in Hesuli. After the CE marking, this will probably be on the acquisition list of many larger companies.
I truly hope this isnât bought out, that would be a huge disappointment. There are already too many old dividend mills on the Helsinki Stock Exchange; Bioretec, in my opinion, is the most potential or one of the most potential small growth companies on the Helsinki Stock Exchange, which has immense potential to repeat Revenioâs feat and rise hundreds, if not thousands, of percent if the company first commercializes the trauma screw, channels the revenues from it into the product development pipeline from which new hit products are pushed out to the market, and this process is simply repeated again and again while achieving greater economies of scale.
I am strongly long with this stock, and here one must remember what industry we are operating in; the companyâs risk level constantly decreases if things proceed in the right direction. Now the permits are in hand; next, success in sales must be proven, and after that, the ability to allocate capital.
I would strongly downplay those acquisition rumors. Even though the product is good on paper and user experiences have been strong so far, itâs still a long way before someone seriously starts making significant investments and makes an acquisition offer. Only when cash flow is positive and sales are growing can something happen. No one buys a loss-making company that lacks the âproven track record.â
I beg to differ.
Those who know, know.
Hopefully the owners wonât sell and no one will buy, and the products will be a success.
Completely on the same page.
And those who think that the biggest American players in the field do not follow this area, and are not aware of the marketâs first biodegradable metal implant that has received breakthrough status, are mistaken.
Itâs another matter how long a clinical proof buyers want in the local market. Typically, itâs a few years, at least 1-2 years. And of course, how much they are willing to offer for the company.
I sincerely hope that this will become a large and significant Finnish export company. I personally feel itâs an injustice to our capital-poor nation that many of the best companies are sold to foreign ownership (and far too early at that).
A good example is Bayerâs IUDs, which were developed and are still manufactured in Turku:
âPharmaceutical company Bayer is one of Finlandâs largest export companies. Bayerâs Turku factory focuses solely on contraceptive products, and the IUDs produced in Turku are the entire Bayer Groupâs third best-selling prescription drug product. So many IUDs are manufactured in Turku that it is unique on a global scale. Turku can therefore rightfully be called the worldâs contraceptive capital.â
How wonderful would it be if the worldâs biodegradable implants came from Finland?
And before someone says itâs impossible, yes, the worldâs best mobile phones also came from here for a decade.
Good day!
Exit or no exit, a small investorâs wishes donât count for much here. Remeos, as an innovation, is such a market disruptor that itâs hard to see big companies standing by idly. You either develop a similar one yourself or buy a ready-made product/company.
Bioretecâs controlled launch in the USA, with trial use performed by six top hospitals, is already such a level of evidence that, in my opinion, it has convinced big companies, at the latest. 100% treatment result.
Upon completion of the ongoing animal trial for the spinal implant, Bioretecâs intention, as I understand it, is to negotiate a partnership agreement related to the spinal implant. I bet these negotiations could very well be exit negotiations.
What would the exit price then be? Remeos is an innovation of such a caliber, and its future cash flows are of such a magnitude, that I assume the board and main owners understand this value. So, Remeos would likely not move to America for a small sum.
Here are also Luironâs comments on the trauma screwâs CE marking. 
As we understood it, the background was mainly the reform (CE-IVDR) of the EU Medical Device Regulation (MDR, âMedical Device Regulationâ) that came into force on 26.5.2022, whose requirements have been very significant in relation to the processing capacity of the notified bodies responsible for handling applications.
Pardon me, MDR 2017/745 and IVDR 2017/746 are their own distinct regulations, and notified bodies can be certified in relation to one or more legislations. As I understand it, all of Bioretecâs products are medical devices subject to MDR, and IVDR is not relevant except that the same notified body might have applications under IVDR in the queue.
Thanks for the observation, comment corrected! I wrote a bit loosely; these are indeed separate regulations, even though both relate to medical devices and have congested notified bodies. And the MDR relevant to Bioretec came into force a year earlier than the IVDR, even though they were originally enacted at the same time.
It must be said that it warms the heart when the share price has returned to a reasonable level. Even accompanied by significant daily fluctuations.
I also noticed from the updated shareholder lists that the largest owners seem to be holding their positions quite well - no one in the TOP 20 had sold a single share during January.
Years 25 and 26 will be the years for actual commercial demonstration, and the starting position is, in my opinion, excellent. Itâs hard to predict anything, but we are hopeful and eager.
It will also be interesting to see Inderesâ view on the target price now that the offering has been completed and with CE approval in hand.
It would also be interesting to get a new video interview with CEO Alan - one question that comes to mind is about other markets that open up with CE approval. What are such non-EU markets that Bioretec sees as the most potential and significant, which are now opening up with CE approval?
At least Norway, Iceland, and Turkey fully accept the CE mark.
Then there are other countries where CE marking can facilitate market access: Switzerland, Australia, New Zealand, the Saudis, Canada, Asian countries, etc. The Brits
Edit. FDA approval was extremely important, but since the CE mark covers practically everything possible, I currently consider this a more significant area for the company.
In Europe, there are also over 100 million more people compared to the USA and comprehensive distribution agreements.
Of course, the best margins are made across the pond.
But perhaps at the moment, itâs more important for the company to increase volume and demonstrate that the product sells, rather than focusing on higher-margin sales. Of course, all good things are welcome.
A broad CE mark may also facilitate broader FDA approval, and these generally complement each other wonderfully.
I still donât understand Inderesâ recommendations and target prices, which only look 6-12 months ahead. For example, Nokian Tyres: they go into negative territory with a âbuyâ recommendation, and in the tire sector, theyâve been looking at the Romanian factory, years away since the Russian invasion, and the subsequent scaling of revenue and profit.
But for companies with real competitiveness, such as Bioretec, Nexstim, even after obtaining permits or completing studies, they are not ready to draw scenarios a few years ahead, even if the company has a monopoly product.
Well, Iâm happy to add more since itâs not widely known, just thinking 
As early as next week, if and when we see evidence of sales growth, the risk of a major failure in this story will become quite small.
Most likely, a share offering will still need to be arranged, as commercialization and product development consume cash. However, this should not significantly affect the share price, if sales are performing well by then and investor interest is as high as in the previous offering.
Well, letâs try to explain then:
Changes in the time horizon do not fundamentally affect the return/risk ratio, because the probability of both return realization and risk materialization increases as a function of time. Occasionally, inefficient markets present situations where this ratio is skewed, which in turn offers an opportunity for high-return-expectation investments/recommendations by buying an attractive risk/return ratio or selling a poor one. Most of the time, pricing is, of course, roughly correct. One should not underestimate the markets.
An example of a good buying opportunity is, for instance, the marketâs depressiveness around Bioretecâs latest offering, when it was a clear opportunity to take a more aggressive view. The market has offered good selling opportunities, for example, in the hype following Bioretecâs FDA approval. One of the most striking examples is Faron last spring, when the market focused on a once-in-a-lifetime opportunity while the stock was heading for a crash in a few weeks. In such a situation, for example, the correct time horizon for the recommendation was those few weeks, and the right view at the right time generated significant excess returns.
In my opinion, Bioretecâs potential and risk are roughly in balance at the moment. Of course, there is potential, which has been modeled into the forecasts. On the other hand, significant risk is still associated with many known and unknown factors: for example, the speed of new market formation, which largely determines Bioretecâs future growth (cf. the Aiforia case, where the growth of a promising market is anemic year after year).
The purpose of my analysis is to provide recommendations that, when followed, can outperform holding the stock, i.e., generate excess returns. Essentially, all choices and decisions related to the analysis, including the time horizon, serve this goal. The results so far indicate that the choices have worked. For example, by following our recommendations, a Bioretec investor has generated a +78% return over the last 12 months, according to Bloomberg data. A âholderâsâ return has been +11%. For the entire monitored portfolio, it has gone even better: the 12-month return of the recommendations is +86% (cf. OMXHPI +1%). The conclusion from this is unusually easy: I will continue to do what works and utilize the opportunities the market offers.
Indeed, this is the question mark. The speed at which the market adopts this. So far, not much sales have been seen in the USA. The management promises a success story, and so far, they havenât disappointed; what theyâve said has come true.
Comparing it to Aiforia is severely flawed because Aiforia only provides software (AI), which is in principle âeasilyâ copyable, and Aiforia also doesnât provide anything that isnât already on the market.
Bioretec, on the other hand, has a monopoly in biodegradable products. There is no comparable product, and perhaps there never will be. At least based on research, the product is unique and delivers what it promises.
Competitors have weak results and their products contain rare earth metals.
I wonât list any more differences between Aiforia and Retec, because they cannot be compared.
The only similarity in the companiesâ situations is that sales growth is expected.
Indeed, Bioretecâs stock is illiquid, and even a small piece of news, especially Inderesâ recommendation and target price, can sway it. Although I appreciate your analysis (one of the best analysts in my opinion) I wouldnât give you credit for this one.
The stock was rising to new highs until a âreduceâ recommendation was given â\u003e this started the previous downturn. â\u003e the stock fell -33%, and after the decline, itâs easy for you to issue an âaddâ recommendation and up we go again. Because there is so little trading, the price follows the recommendations of the sole analyst, i.e., you, very closely.
And even if you might be fundamentally right about the price, it doesnât change the fact that your recommendations move the stock price perhaps even more than the companyâs own stock exchange/press releases.
Europeâs population is 750 million. Should such a market area be underestimated?
Here are Antti Siltanenâs pre-earnings comments as Bioretec publishes its Q4 results on Valentineâs Day.
We expect revenue to be roughly at the level of the comparison period. Our expectations are based on distribution agreements in the United States and the growth driven by inventory build-up through them. On the other hand, headwinds are caused by the weakening operating environment in China, which we expect to weigh on the sales of Activa products. We anticipate a weakening of the result due to growth investments. Particular interest is focused on the delivery volumes and sales outlook for the RemeOsâą trauma screw as the company has moved from a controlled launch towards broader commercialization in the United States. Support for the current year also comes from the CE marking received for the trauma screw, which enables sales to begin in Europe.