Consegna Group (ASX: CGP) has eliminated one of the major hurdles in gaining market entry for new products with its BreatheAssist™ Sport technology falling outside the regulatory approval requirements in the U.S., Europe and Australia.
The company has been advised that the BreatheAssist™ Sport product falls outside the U.S. Food and Drug Administration regulation, the European Union Medical Device Directive and the Australian Therapeutic Goods Acts 1989.
The significance of this is that Consegna now has clear access to the US$6.4 billion sport performance apparel market.
Fabio Pannuti, managing director, commented on the milestone:
"We know that BreatheAssist™ Sport is a compelling product for the millions of people who participate in active sports.
"This regulatory advice significantly de-risks the technology and opens the way for Consegna to further optimise the value of this exciting product.
"It is also important to note that it is just one of several iterations in the BreatheAssist™ product suite."
Importantly, removing the regulatory hurdle altogether also supports Consegna's licensing talks, allowing the company and its potential licensors to tap into this massive market.
Pannuti told Proactive Investors today the company is currently in licensing negotiations with a number of groups.
Rod Tomlinson, chairman, said, "With the London Olympics approaching, the company is finalising our Olympic Program and this regulatory advice represents an important part of this program."
Consegna anticipates the release of the BreatheAssist™ Sport product will coincide with the forthcoming London Olympics in July.
Leading Edge Instruments acquisition
As Consegna rapidly approaches commercialisation of its BreatheAssist™ technology, it is finalising the acquisition of the remaining 19% of Leading Edge Instruments.
Earlier this week the company exercised two call options to acquire the remaining stake.
To take Consegna to 100% ownership of Leading Edge Instruments, the company will issue 252 million shares, which were last trading at A$0.03, valuing the transaction at around $7.6 million.
Importantly, there are multiple licensing opportunities for BreatheAssist™, including sport, medication delivery, snoring cessation, aiding sleep apnoea and the filtration of pollen and other airborne pollutants.
The next target market for the BreatheAssist™ technology will depend on the outcome of current licensing discussions.
"We are in discussions on everything from the travel market to the medical delivery market to the snoring market and whichever of those bears fruit in the near-term will be the next one," Pannuti said.