Sales of Second Generation FIT® continued to exceed both forecast and expectations in 2018 with a 41% increase from FY 2017. And with three brick-and-mortar retailers in the pipeline for 2019, there are no signs of our marquee product losing traction in the North American market. Overseas, Second Generation FIT® is the number one selling test in Denmark and the Czech Republic. Opportunities for growth are abundant specifically in the Middle East, Germany and the UK. In October Pinnacle signed a 10 year exclusive arrangement with Medical Massar based in Jeddah, Saudi Arabia. As of this writing the Second Generation FIT® is SFDA approved and packaged in a dual-format Arabic-English format specifically for Kuwait, Bahrain, Saudi Arabia and the United Arab Emirates.
Beginning in Q4, Pinnacle BioLabs will exit the test phase of the HomeLab PSA, HomeLab TSH, and HomeLab 10 analyte DBS cards and promote these products into the same brick and mortar stores we have gained entry into. Reliable tests at an attractive price-point geared to towards consumers who take a "first person" healthcare approach.
To compliment our suite of laboratory diagnostic tests, Pinnacle plans to apply for 13 separate FDA clearances in 2019, eight of which are already pending approval. Additionally, Pinnacle BioLabs has licensed a biometric testing application that can be cross-sold into brick and mortar stores with no prescription. However, the vast majority will include CLIA waived (laboratory) test kits to be marketing and sold to current customers in the physician office setting. Three years ago we recognized a need for value based test kits as physician office labs become more price sensitive. Pinnacle 10SG was our first price-driven concept test to compete with market leaders. We will apply the same value-driven concept on future tests in the CLIA waived market.
2018 also signaled a shift in data-driven analytics. Pinnacle complies online sales statics, seen on the heat-map below, which dictates deployment of company resources (i.e. advertising, sales staff) based on interest by geography.
Already the #1 selling colon cancer screening test in North America, we can now use the same data to expand our products and brand worldwide. Our CE mark opens the door to the EU marketplace, and MENA (Middle East/North African) countries are serviced by an ultra-reliable network of distribution partners.
And finally, a look at some of our best achievements to date...
Apart from providing ownership and shareholders with a healthy balance sheet and return on investment and customers with an outstanding product they can trust and rely on, Pinnacle also endeavors to do important work and give back in the communities it serves. While we are proud of our accomplishments to date, and excited for what the future holds, we always strive to help others, deliver on promises, and exceed expectations.
Pictured above: The quality control CLIA Lab we opened in August of 2018. The facility is capable of resulting and reporting HPL7 compliant reporting of 400 specimens per hour for hospitals who wish to outsource Second Generation FIT® testing.
The Horizon: Within the next 24 months, we plan to announce a Third Generation, completely incapsulated FIT product that promises to further engage the ever expanding over the counter market.
Pinnacle BioLabs in a federally licensed manufacturer of in vitro diagnostics testing, FDA registration number: 3010982075. Pinnacle BioLabs is a CLIA licensed laboratory, CLIA license number: 44D2125377. NPI number 1497269120.
Pinnacle BioLabs holds several patents and trademarks as it relates to its intellectual property to protect its place in the marketplace.
To learn how Pinnacle BioLabs protects its employees, clients and customers see Pinnacle's Mission, Vision and Values page.