Global Medisafe makes it to market

Newcastle-based Global Medisafe Holdings has commenced the launch of its first Clik-Lok safety syringe products in Europe.

The company, which operates in Australia through subsidiary Clik-Lok Australia, last month received CE certification for a safety syringe designed so the needle can be retracted into the barrel after use for easy disposal.

While this initial certification only covers the sale of syringes without needles, Global Medisafe managing director Yvette Dolan said this “is not a marketing disadvantage due to being able to use [the syringe] with any standard needle”.

The company’s European trading entity, C-LA Europe, will undergo an ISO13485 audit in July which, if successful, will allow the company to sell its syringes with needles attached or on the side of the package.

Global Medisafe has had a storied path to market.

The syringe products were originally designed by Newcastle native Allan Walsh, a product development professional with over 30 years’ experience in multiple industries. Walsh’s wife, a veteran nurse, asked Walsh to develop a solution to needlestick injuries back in 2003.

Walsh and Walton co-founded Global Medisafe in 2005 based on the design work, but in 2008 the company went into liquidation. The assets were bought out by a company that then took back the name of Global Medisafe Holdings.

The majority of shareholders remain the same post-liquidation, and the company is 95% owned by investors based in Newcastle.

Dolan said the company decided to start with a European launch in part “due to the size of the market” and in part because the company was advised during certification that it is easier to receive European CE approval first, and then apply with the TGA and the US FDA.

Once the European/ISO certification process is complete, Dolan said the company will start the process of securing Australian approvals.

The company also plans to seek certification in other markets, including Canada, and may pursue licensing arrangements in countries such as Brazil, Russia and China.