In short. We present you with a summary report about our Shareholders’ Meeting.
The event happened on July 4, 2017 in Vancouver.
Herbert Towning, our Chairman opened the meeting punctually at 14:30 hours (Pacific Time) on July 4, 2017.
The agenda outlined that the following matters, amongst others, would be addressed:
- Discuss the financial statements of the Company of the financial year ended May 31, 2016 and the report of the auditor.
- Elect some new board members.
- Appoint the auditors of the Company.
- Some other business that warranted attention.
Shareholders Meeting: Business
During the formal meeting shareholders went ahead and elected all of the five nominees to serve until the next annual meeting of shareholders of the Company, or until their successors are elected or appointed.
- Directors Herbert Towning (President & CEO),
- Dr. Charles Clements (Chief Medical Officer),
- Alan Lawrence (Corporate Secretary),
- Dr. Ken Powell were re-elected, and
- Eric Andreasen was also elected to the Board of Directors of the Company.
The next work that needed attention was the stock option plan and re-appointment of our auditors. The shareholders:
- Approval of L.O.M. medicals stock option plan; and
- Re-appointment of James Stafford, Chartered Accountants as the Company’s external auditor.
With the formal and required part of the Annual General Meeting had been conducted, the board introduced some speakers.
2. Roadmap for going to market
Jeremy Webster gave those in attendance a brief outline of the achievements from the past year.
He showed which design work had been completed over last year.
L.O.M. has engaged a regulatory consultant for taking the necessary steps for getting 510(k) clearance (here the US FDA explains how it works in easy language) and CE marking.
The latter is simply L.O.M.’s declaration that our product meets the requirements of the applicable EC (European Commission) directives. A conformity mark signifies that a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance. According to the classification of the medical device (see MEDDEV 2. 4/1 Rev. 9 June 2010), syringes are surgically invasive devices. This results in a conformity assessment (i.e. tests) that show we deliver as promised.
To get a better understanding you can check out the UK governments webpage:
Our syringes are surgically invasive devices intended for transient use (less than 60 minutes). Rule 2 and Rule 6 will apply.
We also want to pass the China Food and Drug Administration (CFDA) process. For Class II or Class III medical devices, CFDA requires that one demonstrates that the device has been approved by the country of origin.
For European or US companies this means a confirmation of having obtained a CE marking or the 510(k) clearance from the FDA. Either of these must be provided when applying to register a medical device in China as a US or European company.
The company has signed an agreement to get the syringes manufactured. The first batch of 3,000 will be used for testing and marketing.
L.O.M. Laboratories Inc. was granted to more patents in May 2017. These were given for its Second Generation syringe for the USA and Brazil (i.e. “Single-use pneumatic safety syringe providing gas-driven needle retraction”).
Also, Jeremy informed shareholders about continued capital that has been raised.
3. Getting ready for regulatory work
There are a few things that need to be done to be ready to submit documentation to get our device(s) cleared by the FDA according to its 510(k) clearance process. That is some companies do get a positive reply from the FDA within 97 days. But sometimes things can go slower.
Incidentally here are some FDA pages that explain to you what the differences are between getting a device cleared vs. approval from the FDA:
- What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?
- Classify your Medical Device
- Overview of Medical Devices and Their Regulatory Pathways
- What does “FDA approval” mean?
Our partners are now able to have the syringe production molds ready for engineering and completion in about 30 days. This is slightly ahead of our timeline. Most importantly, this will give us the first batch of over 3,000 built syringes by about late August 2017.
Testing protocols are now being prepared. These outline what testing must be done and what type of documenting will be required. This is needed, so the necessary tests can be started by the end of August.
In turn we should be ready to hand in our documentation to get FDA for 510(k) clearance as well as receiving in Europe for CE Marking by the end of the year.
Have your say – join the conversation
Source: 2017 shareholder meeting
- Did you attend the meeting?
- What other information would you like to see?
- How does your friend keep used needles safe – diabetes, etc.?
Looking forward to your comments.