Ever heard of the Penthrox “green whistle”?

Odds are you’re familiar with this device if you’ve ever hurt yourself enough to end up in an emergency trip to hospital.

This Aussie invention offers fast-acting pain relief while also being non-addictive.

Pain management is a multi billion dollar business, which Medical Developments International (ASX:MVP) is hoping to win a slice of as it rolls out its green whistle globally.

Annual revenue is now running at $19 million (clocked up in the year to June) — up 22 per cent for the year, with sales powered by a 50-plus per cent rise in sales into Europe thanks to expanding market access.

As sales gather momentum in large markets such as France, sales growth is likely to remain buoyant for a while yet.

The big kicker, however, will be getting in the door to the US.

You don’t have to be a close follower of current affairs to know that parts of the US are in the grip of an opioid epidemic, with a number of its big drug companies in the cross hairs of government and regulators.

The government of Ohio is suing five drug makers, for example.

The New York Times recently estimated that deaths from drug overdoses in the US topped 59,000 in 2016, primarily due to opioid addiction, with drug overdoses the leading cause of death among Americans under 50.

“The US has a palpable and significant bias against using opioids, and is actively looking for alternative products,” says Medical Developments chief executive, John Sharman.

“In the management of medium or severe pain, we are the only alternative on the planet.”

Even though its Penthrox product has been administered in millions of cases across Australia, New Zealand, the UK and beyond, additional clinical trials are needed before it can get in the door to sell in the US.

“Anyone that indicates it is a smooth path doesn’t know what they’re talking about,” Sharman said of negotiating with the US Food and Drug Administration (FDA).

Even so, he is confident Medical Developments will win ‘fast track’ status to gain the requisite FDA approvals by 2019, with sales prospective from 2020.

Penthrox planned rollout. Source: MVP August 2017 roadshow presentation.
Penthrox planned rollout. Source: MVP August 2017 roadshow presentation.

While the company has other products such as a respiratory medical device, the real ‘blue sky’ potential lies in a newly developed production platform, which it reckons could revolutionise drug manufacturing.

Developed for the company by the CSIRO, with Medical Developments holding the requisite patent, it represents a technological breakthrough in the production of small molecule pharmaceuticals.

“It is too early for us to crow about but it is sufficient for us to be very optimistic about,” Sharman said.

The new platform technology is being installed at its new plant in Melbourne, which is expected to start-up in the coming months.

The new process has cut costs while lifting production consistency which is critical as the Penthrox device wins access to more markets globally, which involves a step-change in volumes produced.

The breakthrough could have application to producing drugs in the non-steroid anti-inflammatory drug market which, by itself, could open the door to a market with annual sales of more than $5 billion, for example, it reckons.

MVP’s shares have traded between $4.12 and $5.78 over the past year. Shares closed at $5.15 on Friday, valuing the company at $303.7 million.