Tissue Regenix makes its DermaPure product for wound care. (Image from Tissue Regenix)
In the soft-tissue market, Tissue Regenix (LON:TRX) has serious competition, but it still has big plans for growth in the U.S.
The long list of key players in the space includes Acelity, Allergan, (NYSE:AGN) Athersys (NSDQ:ATHX), B. Braun, Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard, Integra Lifesciences (NSDQ:IART), Medtronic (NYSE:MDT), Stryker (NYSE:SYK) and Zimmer Biomet (NYSE:ZBH). Globally, the tissue engineering market appears poised to grow from $5.5 billion in 2017 to $14.5 billion in 2026, according to with a compounded annual growth rate of 11.5% through 2026, according to an analysis by Coherent Market Insights.
The market for tissue engineering is expanding within wound care, burn treatment, orthopedics, neurology, cardiac and urological products. It’s also important in caring for children born without certain tissues or organs, and those with congenital anomalies such as bladder exstrophy, esophageal atresia, and diaphragmatic hernia. The industry faces obstacles, however, including a shortage of human cell sources and difficulties in vascularization of engineered tissues. Political, religious and ethical concerns in the United States. continue to dampen federal funding for research on embryonic stem cells derived from discarded human embryos.
Leeds, England-based Tissue Regenix is working on expanding in Europe and the U.S. and on turning a profit. Founded in 2006, the company’s losses have shrunk from £9.9 million or $12.2 million in 2016 to £8.6 million or $11 million last year, and are projected to fall further to £6.2 million or $8 million in 2019, according to London stock market analytical firm Trinity Delta.
Tissue Regenix entered the U.S. market in 2016, focusing on using its dCell tissue decellularization technology as a wound-care product called DermaPure, designed to regenerate tissue to treat chronic and complex wounds as well as ligament reconstruction and meniscus augmentation. The dCELL process removes cellular and DNA material from biological tissues, leaving intact an extracellular matrix upon which a patient’s cells can regenerate and repopulate, creating new tissue is created that is recognized and accepted by the body, rather than being rejected, according to the company.
The following year, Tissue Regenix bought Universal City, Texas-based CellRight Technologies for $30 million, adding CellRight’s bone regeneration products to its portfolio. Supported by CellRight’s San Antonio based tissue bank, the company plans to launch its OrthoPure HT decellularized human tendon into the U.S. orthopedic market, with an initial focus on addressing cruciate ligament repair. No date has been set.
The company has also developed OrthoPure XT, a decellularized porcine tendon is for cruciate ligament reconstruction. OrthoPure XT is with Tissue Regenix’s notified body in Europe, awaiting a decision on the CE Mark. Following that process, the company intends to start a U.S. clinical trial of OrthoPure XT for anterior cruciate ligament (ACL) repair, according to a Tissue Regenix spokeswoman. The company has submitted two-year clinical data to European regulators.
Meanwhile, Tissue Regenix is developing a U.S. distribution network for its SurgiPure porcine surgical mesh, cleared by the FDA in 2016 for hernia repair. SurgiPure represents the company’s first foray into using decellularized porcine tissue for hernia repair, according to CEO Steve Couldwell.
“That will be new for us really this year and into the next few years,” Couldwell told Medical Design & Outsourcing in an interview.
Couldwell took the helm as CEO in November 2017 after serving on its board of directors since 2013. Couldwell has more than 25 years’ experience in the pharmaceutical and medical device industries, most recently as chief operating officer for Global Sanofi Biosurgery. He previously held a number of roles at Smith & Nephew, including president of orthopedics for Europe and senior VP sales and marketing for the advanced wound management business.
Tissue Regenix signed an agreement with Arthrex in March 2018 to distribute certain CellRight BioRinse sterilization products under Arthrex’s “Allosync” brand in the U.S., followed by one for European distribution of BioRinse in November. BioRinse uses proprietary rinsing agents in multiple combinations designed to kill pathogenic microorganisms, vegetative bacteria and spores, according to CellRight. These agreements with Arthrex, should support sustained growth of Tissue Regenix’s orthopedic division, according to analysts at Trinity Delta.
Tissue Regenix said it recently landed a group purchasing agreement that will open the door for DermaPure access to 1,500 hospitals and 32,500 care providers in the Southeastern U.S., including Florida, termed the second largest state for the use of biological tissues. The company also has three self-funded postmarketing trials for DermaPure going on or due to begin this year.
“There’s a very distinct lack of real-world data available in this space, so we took the decision to try and do something about that ourselves and try and create postmarketing observational trials and clinical trials that will prove alongside our clinical results the superiority in the DermaPure product,” Couldwell said.
In Germany, Tissue Regenix is seeking authorization to manufacture and market a new product, CardioPure, a decellularized aortic pulmonary heart valve. The company decided to start with Germany alone because European regulations limit moving human tissue from country to country, Couldwell explained. That and the uncertainties posed to the business by Brexit drove a decision to approach CardioPure’s launch country-by-country, beginning in 2020.
“We want to first of all launch and get traction within the German market,” Couldwell said. “We’ve identified a number of tissue banks and key hospitals that we can work with in Germany first and foremost, and we want to use Germany as our sort of bridgehead, if you like, into Europe.”
Looking ahead five or 10 years, Couldwell expects at least 70% of Tissue Regenix’s business will come from the U.S., for a couple of reasons.
“No. 1 is the availability of and the ability to move porcine tissue around the world, but the most important, the clinical results we’ve got are very attractive and the economics of porcine tissue are very attractive,” he said. “We can bring a superb product with good clinical evidence and good clinical outcomes into a marketplace.”
