What it does seems like something out of science-fiction, but the results are very real indeed.
Its technology uses tissue from pigs to treat serious conditions that would otherwise require complex and costly surgery.
The treatment involves removing cellular material from animal and human tissue to leave a matrix that gives a framework for population by the patient’s own cells.
This allows the host tissue to regenerate and repair diseased or wounded body parts.
Expanding in US
The GPO with Premier Inc spans 43 states, with a membership comprised of more than 800 acute care hospitals, 186 different Health Systems and more than 1000 long-term care facilities.
Dermapure has now also been added to the US Veteran Affairs Federal Supply Schedule (FSS).
The FSS group is the largest integrated healthcare system in the US covering almost 9mln people including military veterans in a network of 152 hospitals and 800 outpatient clinics.
Tissue Regenix said that inclusion on the FSS will boost Dermapure’s market presence both in the inpatient and outpatient segments.
Products other than skin repair
The group’s other treatments are also progressing at an impressive rate.
Its dCELL heart valve replacement technology boasts eight years of clinical data with positive results in more than 150 patients.
Clinical data for OrthoPure XT, a porcine tendon, was so compelling the company expects to receive its CE Mark for the product a full six months ahead of schedule, paving the way for a European launch in the first half of this year.
The group has a good track record of keeping to its targets with DermaPure gaining approval from the US government for its state-funded programme Medicare in just eight months.
Meanwhile, “positive discussions” with America’s Food & Drug Administration encouraged Tissue Regenix to apply for a pilot clinical trial.
The US knee surgery space is worth around US$1.4bn alone.
Off-the-shelf knee surgery
Anterior cruciate ligament (ACL) damage is a common injury, and in the 900,000 or so ACL operations done annually, the normal form is to replace the damaged tendon with healthy tendon taken from somewhere else on the body.
Tissue Regenix will offer an “off-the-shelf item” that surgeons can use instead.
By hitting the top two most common knee surgeries, worth around US$4.4bn worldwide, the company is looking to corner this niche 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,” said chief executive Antony Odell.
In the US, there are two options, auto graft, where a tendon is taken from another part of the leg, or human donation – tissue donated from someone who has died.
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.
A much better fit for surgeons
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 makes the product a much better fit for surgeons.
In October, Tissue Regenix said that with more visibility now regarding the appointment of distributors and contract approvals, Dermapure revenues would between US$2.5mln -$3.5mln in the year to January, compared to the 12-month prior period of US$1.2mln.
-- updates for Veteran Affairs news --