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Revolutionizing Blood Glucose Monitoring With LabStyle Innovations 0 comments
Oct 17, 2014 9:34 AM | about stocks: DRIO, DRIOD
Interview with LabStyle Innovations President and Chief Executive Officer, Erez Raphael, 10 October 2014
Q1. Where does LabStyle Innovations stand as regards to Dario?
A. Dario in the very near future has the potential to replace standalone glucose meters and their lancing, lancets, strips, most of which have the testing components separated from one another which we believe is a cumbersome design. We will make Dario the first social network-powered diabetes management system, no doubt about that. Dario will truly epitomize our product motto -Thriving with diabetes, together.
2013 culminated with the receipt of the CE Mark that allows Dario to be marketed and sold in 32 countries in Europe and certain other countries. Our ongoing soft launch has been the success story for 2014. Importantly, in Q2 2014, we were granted reimbursement status in the UK.
We are very close to getting regulators in South America and Asia to approve Dario sales, as well as reimbursement. We expect to update the marketplace about new territories over the next few weeks.
Q2. Do you have plans for North America?
A. Absolutely. US and Canada are big markets for self monitoring blood glucose meters. Diabetes is Canada's biggest health threat, with the prevalence rate increasing by more than 70% over the last decade. In US, 1 in 11 people have diabetes. 1 in 3 have prediabetes and 90% of them do not know that. In Jan 2014, we sought FDA approval for Dario under Section 510(k) of the Food, Drug and Cosmetic Act. We have had multiple dialogue with the FDA. We are on track to be delivered the final decision sometime later this year. We are working very hard to achieve our goal of bringing Dario to the people in North America. We are almost there.
Q3. Very encouraging. Please tell us about the company's financial health. There have been concerns regarding the ability of the company to build a meaningful market and sales.
A. Our worldwide soft launch in New Zealand, UK, Italy, Netherlands, Australia has been very promising. We are now transitioning to a full scale launch.
Remember that Dario is a start-up competing with some of the giants in the SMBG industry, with the likes of Roche, J&J and Abbott making up 90% of the market. We expect intense competition, and it is good for the SMBG market. Having said that, most glucose meters in the market lack an interface with a smart mobile device and none has the software applications associated with Dario. We believe this will distinguish Dario as an alternative in the marketplace. Our cash position is good until March 2015. Dario will be in US and Canada households before that, pending FDA clearance later this year.
Q4. And finally, do you have the manufacturing and distribution network up and running? How much will it cost?
A. We recently raised $4.2 million, exactly for the purposes of ramping up our Dario production and strengthening our distribution capabilities. David Edery was the lead investor in this non-brokered deal, with a $3 million investment. Dario's management is confident of achieving the upcoming key milestones in a timely manner, the way they have delivered in the past. Dario has come a long way since 2012/2013. The market has not been kind to us. We understand that. But ultimately, you can not keep a good man down, in our case a good product. I take pride in the hard work every member of our team has put in. We have a long road ahead of us. It is an exciting time.
