Tissue Regenix, CellRight Team Up to Improve ACL Repair
Tracey Romero • Fri, September 22nd, 2017
Tissue regeneration technologies require friendly matrices to work.
Which is why the combination of UK-based Tissue Regenix, a leading regenerative medicine company and Texas-based CellRight Technologies, a leading developer of osteoinductive and soft tissue scaffold technologies is so exciting for physicians and their patients.
The first product these two firms hope to bring to the U.S. market is a more natural graft for anterior cruciate ligament (ACL) repair in the United States.
Each company brings to the partnership their own patented technology and product platform, Tissue Regenix in tissue regeneration and CellRight Technologies in regenerative allograft matrices that can be used in spine, trauma, general orthopedic, foot and ankle, dental, and sports medicine surgical procedures.
The technology that Tissue Regenix specializes in is called decellurization technology (‘dCELL technology’). What it does is remove DNA and other cellular material from animal and human soft tissue leaving an acellular (90% cell free) tissue scaffold. The implant is then sterilized which reduces the risk of infection and rejection by the patient’s body after a procedure like anterior cruciate ligament (ACL) reconstruction.
Drew Distin, president of Tissue Regenix Orthopaedics, North America told OTW, “The beauty of the dCELL process is that it provides an off-the-shelf graft option that is readily available and can be stored at room temperature.”
He gave an example of an implant dropping on floor during an ACL reconstruction. It can’t be used now so what can the surgeon do? Will they have to get another graft from the patient, wait for a frozen graft to delivered or reschedule the procedure?
He said, “Because of our dCELL technology, the surgeon can just request a new graft with no added prep time needed. It can just be pulled off the shelf with no time lost. That is the beauty of it. It is so advantageous to have a product that allows the surgeon to make an intraoperative decision if things change during surgery.”
In their orthopedics division, Tissue Regenix is using its dCELL technology to develop OrthoPure HT, a decellurized allograft tendon, as an alternative to harvesting and transplanting the patient’s own ligaments or tendons for a ligament reconstruction. The tissue scaffold re-populates with the patient’s own cells to form regenerated tissue, eliminating donor site complications (a second surgical site) and pain, and operating room time that is associated with autograft surgery.
Other products in development include OrthoPure HM (allograft meniscus), OrthoPure XT (porcine tendon) as well as OrthoPure XM (porcine meniscus). According to Distin, the OrthoPure XT is currently processing through the regulatory body in Europe to obtain a CE Mark.
CellRight Technologies, led by Chief Executive Officer Jesus Hernandez, and located in Universal City, Texas, develops human osteobiologics, basically turning allograft bone into various malleable applications including demineralized bone matrix putty, strips and fibers that can be used in spine, trauma, general orthopedic, foot and ankle, dental, and sports medicine surgical procedures.
The company’s sports medicine products include: dermis, fascia, pre-shaped hemi-patellar tendons (BTB), whole patellar tendons (BTB), Achilles tendons, anterior and posterior tibialis tendons, semitendinosus, gracillis and peroneus longus and brevis tendons.
Considered an industry leader of osteoinductive matrices, CellRight Technologies is committed to making sure both in vivo and in vitro testing are done by an independent laboratory post-sterilization to ensure osteoinductivity. According to Destin, when implants are verified for osteoinductivity they are associated with improved patient and fusion outcomes.
In his role heading Tissue Regenix’s orthopedics division in the U.S., Distin has been overseeing the U.S. commercialization of OrthoPure HT, and had also been searching for a tissue bank to collaborate with.
Distin said, “The best of both worlds was to acquire the right partner. I visited or spoke with many of the tissue processors across the country, but it became pretty apparent early on that they were either not interested in collaborating or they thought that the prospect of using the ‘dCELL’ process in their standard allograft processing would be too difficult. Or it was a combination of the two.”
“The one company, the one guy who didn’t bat an eye was Jesus Hernandez at CellRight who has over 30 years’ experience in the medical field including 25 years’ experience in biologics,” he added.
“The first time I saw their facility it was an eye opener. I had never seen a tissue processor this well organized and this modular with the idea of the growth necessary to adjust to different technologies.”
“There are a lot of similarities across the companies and possible synergies. It was a decision that we thought would benefit both companies,” he said.
“What it really boils down to is that what we deal with at Tissue Regenix is soft tissue and what CellRight deals with is bone so by bringing the two companies together we can create a company that can develop all kinds of innovative solutions for orthopedics today.”
“We share the idea that we want to adapt and introduce new technologies and products but do it in a way that is clinically efficacious. We involve surgeons, we involve medical support team, we involve regulatory and we bring it all together in a controlled launch for each product.”
Distin said that what really attracted them to CellRight was their can-do attitude and their flexible manufacturing concept that allows them to adapt to the changing needs of their customers and to what surgeons and patients are requesting. He explained that for example, if there was a need for more spinal implants, they can easily adjust their manufacturing process to accommodate that need.
Another thing about CellRight that impressed Distin was Hernandez’s vision to maximize the true gift of donation.
“We are all truly cognizant that it all starts with a family’s selfless act of allowing their loved one to be a donor,” he said.
Over the summer plans were put into place for Tissue Regenix to acquire CellRight Technologies and in August the acquisition was finalized. Tissue Regenix will be leveraging the capabilities of CellRight Technologies tissue bank to bring OrthoPure HT to the U.S. market in 2018 to initially address ACL repair.
“We will complete the processing technique in a controlled manner, have tendons implanted by our advisors and KOLs, and build the clinical story around the efficacy of this technology as it related to ligament reconstruction,” Distin said. “Concurrently we will be navigating the FDA regulatory pathway for OrthoPure XT.
“We plan on initially releasing OrthoPure HT in the U.S., while initiating a pilot study for the xenograft tendon in the near future. Currently none of the OrthoPure products are available in the U.S.”
Distin added that they will also be addressing the existing customers of CellRight in spine, sports medicine, extremities, dental, foot and ankle and ophthalmology as well as introducing ‘dCELL’ technology into the CellRight facility.
“We are in the process of integrating the two companies, welcoming the CellRight team into Tissue Regenix and expanding the vision across the whole company.”