Tissue Regenix's losses widen as company pushes towards significant milestones

For the six months ended 31 July, revenue increased by 150% to £631,000 when compared to the same period the previous year, while its operating losses widened by about 34% to £5.52m in line with its expectations.

With finance income of £81,000, which was down 30% from last year, and a research and development tax credit of £280,000 the loss after tax was £5.16m, which was up 40%. Of this, £5.08m was credited to the equity holders of the parent company.

Revenue from the wound care business rose to £631,000 from £244,000 while commission costs were rose to $290,000 from $100,000, which was 32.5% of sales. Guidance for full-years margin and commission percentage remained at about 80% and 37.5%, respectively.

For the orthopedics business, costs increased 23% to £1.3m due to clinical trial expenditure, while overall costs for the company remained flat at £1.4m.

The company was debt free and had a cash balance at the end of July of £13.51m, down 46%.

AIM-listed Tissue Regenix , which was spun out from the University of Leeds in 2006, signed its first group purchasing order contract in the US for wound care product DermaPure and gained Medicare approvals for the product with 93% now covered.

The firm gained a premarket notification, known as a 510k market clearance, for SurgiPure XD, a reconstructive tissue matrix, which was the first US Food and Drug Administration approved product, with an expected launch in the second half of 2017.

During the first half of the year, the process of the company’s patented decellularisation technology called dCELL, which removes DNA and other cellular material from animal and human tissue leaving tissue scaffold, was also approved by the FDA.

The regulatory process for the OrthoPure XT, an orthopedic product, was shortened and the company expects to launch it in Europe in the first half 2017 as CE European approval anticipated six months ahead of schedule.

Tissue Regenix’s GBM-V tissue bank joint-venture in Rostock, Germany carved out a path for human tissue applications in mainland Europe, with initial focus on CardioPure, dCELL heart valves, and DermaPure.

Significant milestones ahead

The company said the next twelve months promised significant milestones including the launch of the first orthopaedic application in Europe, the launch of its second wound care product, SurgiPure XD in the US and the ongoing regulatory submissions to the German authorities for decellurised tissues to be treated at GBM-V.

“Alongside this, the continued growth of DermaPure, as evidenced by these results, and the ongoing development of our orthopaedic business within the US ensure that we remain on track to end our year accomplishing our corporate goals, and we look forward to reporting our progress over the coming months.”

Shares in Tissue Regenix Group were down 4.79% to 17.38p at 1405 BST.