Quarterly Update – Guy Reynolds
As promised during the recent roadshow that Herbert and I did to various large shareholder groups, I wanted to provide everyone with an update.
2018 has been a revolutionary year for the business. We have elected a new CEO, finalized our syringe design, appointed our mould manufacturer, started the FDA process and secured long term financing to get our incredible product to the market.
Most of these will be addressed by Ralph our CTO but I wanted to expand a little on the financing. A fund have subscribed for shares at 3USD to provide us initially with USD 7.65m. This money is needed to get rid of all of our short term financing arrangements and fund the business for the next 2 years. Many shareholders have been incredibly supportive by providing short term loan facilities to enable us to continue operations whilst securing the finance – thank you.
It is fair to say the Fund has taken longer to close its parent fund than we anticipated and many timelines were frustratingly missed. I have received written confirmation that the fund will complete this week.
It is even more exciting because they are paying a sensible price for our stock and are a fantastic fit as a long term partner. They are committed to further funding in order to automate our assembly line and rapidly develop our other product lines as soon as the first syringe has gone through FDA.
FDA submission is still planned for Q1 – Q2 2019 depending on the speed of the mould design and no further testing changes.
I hope everyone had a superb Christmas and are as excited as I am about the future of L.O.M. Thanks for all your support.
Happy New Year!
President, CEO and Director
Technical Update – Ralph Woloschuk
L.O.M. made significant progress in the development of our 3 mL retractable syringe in 2018. We are dedicated to begin production in 2019 and have developed a schedule of events with timelines for our partners.
Toolbox Medical Innovations have completed the design modifications that have enhanced the performance and reduced the per unit manufacturing cost. This has taken additional time but we feel the few extra months has given us the best possible design.
Our mold manufacturer is designing and building 4 cavity high speed production molds to produce all parts. The additional purpose of 4 cavity molds is to provide the manufacturer with the internal flow design that will be used in the 32 or 64 cavity production molds.
The syringes will be assembled, packaged and sterilized at KDL and then sent to our independent laboratory. Additional syringes will be produced for marketing samples and small production runs.
We have analyzed several assembly line and packaging equipment manufacturers and will be contracting the build in early 2019.
We have contracted the FDA submission process to Knoell USA and have begun the pre-submission application that is expected to speed up FDA clearance once the laboratory tests have been completed.
We are well aware of the recent developments between China, USA and Canada and have partners in other countries available if required.
Chief Technical Officer