Tissue Regenix Brings in $39M To Advance dCell Technology

Nuala Moran

BioWorld International Correspondent

LONDON – Closing the year with some cheer for the sector, Tissue Regenix Group plc has raised £25 million (US$39 million) in a placing, enabling the regenerative medicine specialist to begin to advance several programs in parallel.

"We found the market very receptive. This helps us to immediately progress our product pipeline in parallel, rather than in series," Antony Odell, managing director told BioWorld International.

Tissue Regenix' products revolve around dCell, a technology developed by immunologist Eileen Ingham at Leeds University for completely decellularizing soft tissue from human and porcine sources, rendering it completely free of any cellular matter or viral or bacterial contamination. There has been no evidence of any immune reaction or any infection in any trials, or in the approved use of the company's products.

The decellularized material retains all the biomechanical properties of the extracellular matrix of the original tissue. After transplant this scaffold is colonized with cells from the recipient, creating a living tissue that grows and repairs itself in the same way as the original it replaced.

These tissue replacement products are stored at room temperature, are available off the shelf and have a shelf life of 12 months meaning Tissue Regenix has a far simpler supply chain than regenerative medicine companies working to commercialize cell-based therapies.

"Our product can be handled like a medical device, but it has the ability to recruit the recipient's own cells to do the repair job," Odell said.

The decellularization technology has allowed Leeds-based Tissue Regenix to register its products as devices rather than the far more exacting route to market of seeking registration as advanced tissue therapies.

"We've already had our vascular patch approved, and quite clearly our products qualify as devices in Europe. We're talking to the FDA and [believe] the same will be true for the U.S.," Odell said. The company is due to respond to questions raised by the FDA by Jan. 20, 2012.

The cash infusion leaves Tissue Regenix poised to carry out preclinical and clinical trials to expand the applications of its porcine-derived vascular patch beyond the current approval in repair of lower limb vasculature, to cardiac reconstruction, dura repair after brain surgery and hernia repair.

In knee repair, the company is pointing its sights at the large orthopedic companies, with full meniscus replacement and a ligament development program that has anterior cruciate ligament repair as its first target.

"This will slow the flow of patients to the big devices companies, and people will be demanding our products as first line treatments," said Odell.

In addition, there are plans to develop a decellularized porcine heart valve product. Although porcine valves have a history of use to replace human valves, existing products rely on chemical fixation to mask their antigenic component and prevent immune rejection. However, this also kills the tissue, so that although the valves function well they have no capacity for regeneration.

Tissue Regenix also has a collaboration under which the UK's National Health Service Blood and Transplant Service is carrying out a clinical trial in the use of dCell in preparing human donor dermal patches for use in the treatment of chronic wounds.

In the fully underwritten placing, Tissue Regenix issued 181.8 million shares at 13.75 pence each. This will give the company, which floated on London's Alternative Investment Market in June 2010, a market capitalization of £90 million. The placing includes a significant investment from Invesco Asset Management of London, which is picking up 153.3 million shares and will own 23.5 percent of the equity.

Approximately £9 million of the new money will be used to fund the expansion of quality assurance, regulatory affairs and manufacturing, with the first new regulatory filing arising from the expanded development programs expected in 2013.

Beyond the planned commercial programs, Odell said Tissue Regenix is involved in basic research scoping other potential applications of the dCell technology. One possibility is decellularized porcine livers. Given the ability of the liver to regenerate, it may only be necessary to provide a small section of scaffold to effect a full repair, Odell noted.

In total, Tissue Regenix says the core technology could be used to make between 20-30 different tissue replacement products. With their ability to spark endogenous repair processes, the company's products will be positioned between conventional orthopedic devices and synthetic scaffolds and porcine-derived replacement tissues on one hand, and cell therapies on the other.

While offering advantages over synthetic devices, Tissue Regenix does not face the same risks as cell therapies.

"It's not clear how cell therapies are going to stack up," Odell said. "While there's a lot of elegant science in stem cells, there's also a lot of regulatory uncertainty."