Dear Investor,
“It was the best of times,
it was the worst of times,
it was the age of wisdom,
it was the age of foolishness,
it was the epoch of belief,
it was the epoch of incredulity,
it was the season of Light,
it was the season of Darkness,
it was the spring of hope,
it was the winter of despair …”
So begins Dickens’ “A Tale of Two Cities,” and what a great articulation it is of the transformative time we live in. We’re in an era of great inspiration and possibility, but with this opportunity comes the need for tremendous thoughtfulness and responsibility as medical technology is deeply and irrevocably interwoven into the foundation of our healthcare evolution.
Invenio Medical, Inc. has been holding true to delivering a revolutionary Point-of-Care medical device for the rapid identification of Methicillin Resistant Staphylococcus Aureus (MRSA). Insofar, our progress has been remarkable, exceeding normal timeframes in Research & Development, as well as forward momentum with negotiations with manufacturing entities.
In short, as of June 6th, 2018, our research and development team has successfully tested thousands of samples, each cultured from human biological specimens. Each individual test undergoes a complex process, which involves culturing the specimen, followed by isolating the target organism (MRSA). The specimen is then lysed (killed), in which the MRSA isolate is exposed to a chemical wash, thereby releasing the target proteins. These proteins are then identified in our technology via visual identification, as in a traditional overt-the-counter pregnancy test device. We are in discussions with various companies to have both disposable and stationary readers for increased sensitivity and ease-of-use (CLIA waived).
In order to maintain the highest level of sensitivity, and profitability, our aim is to get at least two bids for making the strips. The collection device has been developed, and the potential readers are in the works. Our Research & Development Scientists have already completed our SOP’s and we will then pass this on the manufacturing vendor to replicate what we did (side by side comparison), ultimately creating microlots, and running those against what we both created using samples and controls.
The microlot is then subject to stability testing, clinical testing, etc. and can be used to sample in the field for customer feedback. At that point, the vendor usually makes three production lots, tests them, sets up a validation plan and compares it against an approved predicate device. This component will complete the validation phase, and finally we will have a product ready for sale.
In order to prevent any issues with production, the above validation phase is extremely important. We are very pleased to say that we have exceeded our expectations with timelines on this project. Thanks to a highly sophisticated group of scientists, along with countless hours dedicated by our founders, we are making progress with this revolutionary medical technology.
We look forward to providing you an update in the upcoming weeks.
Best Regards,
Victor R. Lange, JD, PhD
CEO, Invenio Medical, Inc.
