Tissue Regenix (LON:TRX) is a company about to take-off, and chief executive Antony Odell had a clear message for current and potential investors: “watch this space.”
The firm recently began its OrthoPure XT (Porcine tendon) trial treating two patients in Spain with ruptured anterior cruciate ligaments (ACL).
It expects this to be the first step to its rapid commercialisation within the Orthopaedics market, with hope for regulatory sign-off in the form of a CE Mark in the EU by 2017.
Tissue Regenix (TRX) has a good track record of keeping to its targets with its wound care product DermaPure gaining approval from the US government for its state-funded programme Medicare … in just eight months.
“We have had an extremely successful run this year of securing Medicare approval reaching around 65% of Medicare beneficiaries, and we have done some amazing things here with the team in the US,” Odell said.
TRX is a wound care expert, with its Dermapure product being used to rebuild cells in the most difficult of wounds.
Potentially the biggest area of growth for the firm, however, could be its ‘off the shelf’ tendons used in knee repairs.
The trial in Spain saw its OrthoPure XT tendons used in ACL repair – the second most common knee injury surgery in the world.
The company is also in the process of recruiting patients for its OrthoPure XM (Porcine Meniscus) treatment for meniscal tear surgery, also known as a cartilage tear – the most common knee surgery.
By hitting the top two most common knee surgeries, worth around US$4.4bn worldwide, the company is looking to corner this niche market.
The US knee surgery space is worth around US$1.4bn alone, and Odell said: “We have had some initial discussions with the US Food and Drug Administration (FDA) and will continue dialogue with them about the tendon and meniscus products over the next few months.”
Its ground-breaking tendon work, along with the already released wound care product DermaPure, meant broker Jefferies added the firm to its list of drug industry buys for 2016.
The broker reckons OrthoPure XM (Meniscus) will be launched for commercial use in the EU by the end of next year, and recently upped its forecasts based on this, with total company sales expected to be around £18mln for the year.
The reason for the optimism, is that the OrthoPure products are so different from anything else out there on the market.
Put simply, Tissue Regenix takes a tendon or cartliage– either from a human or from a pig – treats it and uses it to replace damaged tissue within the body.
This process, which has had remarkable early results, could revolutionise the market.
“Knee repair technology and procedures really haven’t evolved for the last 30 years so the idea of having an ‘off the shelf’ tendon is actually very attractive to surgeons,” chief executive Odell said.
In the US, there are two options, auto graft, where tendon is taken from another part of the leg, or human donation – tissue donated from someone who has died, he said.
In the EU, there are synthetics available, Odell concedes, but these are so poorly thought of that most surgeons prefer not to use them, and there’s not a lot else in the pipeline for ACL and cartilage tears either.
While 3D printing, a growing phenomenon in the healthcare sector, could one day be able to replace bones, and even parts of organs, tendons are more difficult.
Odell said: “There are a lot of interactions that cannot be replicated by 3D printing so we do not see it as a threat to our business.”
He said that the tendon TRX uses is so close to the original that would be nearly impossible to replicate with 3D printing.
Stem cell research, another down-the-line rival to TRX, also has its issues.
Odell said: “There are still big questions to answer in terms of how you manage live cells which are extremely difficult to handle and transfer that into a hospital.”
This is where Tissue’s tendons come into their own, as they can be handled easily and are convenient to transport and use within a hospital setting.
What’s more, the fact they can be stored at room temperature and have significantly longer shelf lives than other tendons make the product a much better fit for surgeons.
With talks already begun with the FDA, and in Europe, and a superior product to anything currently on the market, it is not surprising that Jefferies is expecting big things from Tissue Regenix in the coming year.