Tissue Regenix hurt by cost of US activity

​The York-based group​ said additional development expenditure and ​the cost of ​establishing​ ​commercial operations in the US had hit the bottom line​.​

The group said it has achieved a lot in the past six months including the commercial roll-out of​ ​its​ ​dCELL DermaPure product in the US.

The firm’s dCELL decellularisation process removes DNA and other cellular material from animal and human tissue leaving a tissue scaffold which is not rejected by the patient’s body. This can then be used to repair diseased or worn-out body parts.

In the six months to July 31, ​the group’s losses rose from £2.1m to £3.4m.

​In its wound care division, the company said it is making good progress on the commercialisation of its range of regenerative medicine products based on the dCELL process.

It added that the launch of DermaPure in the US will allow it to target the £900m a year market for skin substitutes.

Tissue Regenix USA has developed a distribution network covering ​over 80​ per cent​ of the US​.

​In orthopaedics, the company has gained approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to start the first UK clinical trial of its dCELL meniscal device to help knee repairs.

The group’s CEO ​Antony Odell said this is a critical step towards gaining EU clearance and a CE Mark to enable full commercialisation of the dCELL meniscus product.

​​“Tissue Regenix has achieved much in the past six months including starting the commercial roll-out of our dCELL DermaPure product in the USA; gaining approval from the MHRA for a UK clinical trial on dCELL meniscus products; progressing our diabetic foot ulcer trial in the US and increasing our global patent portfolio.

“These milestones maintain our planned progress and build successfully on our strategic focus on the wound care and orthopaedic markets, following the positive data from the UK clinical trial into dCELL dermis patches, and our decision to commercialise this product in the USA in 2013.

​“​The launch of DermaPure as our first product in the USA represents a significant step for the ​group.​”

​He added that ​gaining approval to start a human clinical trial on porcine dCELL® meniscus, which is derived from pigs, will provide a foundation for securing a CE mark in the UK.

“This represents a critical step in the process to enable full commercialisation of the dCELL meniscus product and allow it to be used by clinics and doctors to help UK and European patients,” he said.

Tissue Regenix has a range of patents protecting its products and is adding to these by working with the University of Leeds.