A total of 120 people will be enrolled to the trial at 30 centres across in seven European countries.
Researchers want to assess PeproStat’s ability to control bleeding during surgery in four different procedures - liver, soft tissue, vascular and spinal.
Top line results are expected in the first quarter of next year.
WATCH: Ergomed's Andrew Mackie and Haemostatix's Ben Nichols talk to Proactive's Stocktube about the 'milestone' trial
Ergomed said PeproStat could, potentially be a “disruptive” product in the US$2.5bn market for surgical haemostats.
Current treatments are limited by a range of issues, including slow onset of action, lack of effect on stronger bleeds and long preparation time.
The Ergomed-developed solution eliminates the risk of exposure to blood derived materials, is more stable allowing the formulation of ready-to-use preparations and has a fast mode of action.
“With these advantages we expect the product to gain significant market share,” the AIM-listed drug developer said.
Chief executive, Dr Miroslav Reljanovic, called the phase II study a “major milestone” following Ergomed’s acquisition of Haemostatix last May in a deal worth an initial £8mln.
"We believe that we have a good chance of obtaining successful results, and with that a compelling data package to advance the product into late stage development and commercial collaboration," said Reljanovic.
Ergomed sees sales potential of up to US$500mln and even if this diluted by partner coming on board at some time, it would be still be transformational for the company added Andrew Mackie, chief business officer.
Shares rose 4% to 190p.
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