Helio Genomics and Halub Medical Co. Announce Strategic Partnership to Commercialize HelioLiver Dx in The Gulf Cooperation Council and Middle East

IRVINE, Calif., Oct. 25, 2024 (GLOBE NEWSWIRE) — Helio Genomics (“Helio” or “the Company”), an AI-driven biotechnology company specializing in diagnostics technology and test development for cancer detection, today announced the strategic partnership, in commercializing HelioLiver Dx in Saudi Arabia, with Halub Medical Co., a healthcare company for Saudi Arabia, GCC and Middle East. The test is expected to be commercially available in Saudi Arabia and The Gulf Cooperation Council (GCC) in Q1 2025, with the following 12-month revenue for Helio expected to exceed $10 million dollars.

“We are honored to partner with Halub Medical, a top healthcare provider in the Middle East,” said Shu Li, PhD, Founder and Executive Chairman of the Board of Directors of Helio Genomics. “There are about 25–30% of the worldwide population with non-alcoholic fatty liver disease (NAFLD), which can lead to an increased incidence of liver cancers. We believe HelioLiver Dx can significantly improve the current standard of care, and we are thrilled to contribute to the success of Saudi Arabia’s Health Cluster.”

“We are very pleased to introduce HelioLiver Dx to Saudi Arabia,” said Sheikh Ahmed Almalki, Chairman of Board of Directors of Halub Medical and Founder of Smo Elfaker and Dr. Omar Almalki, CEO Halub Medical. “The breakthrough liver cancer screening test, based on the pivotal trial conducted by 50 of the top medical institutions in the U.S. led by Stanford Medical Centers, demonstrates 4-times better sensitivity. In addition, we believe that a blood-based test such as HelioLiver Dx will have a significantly higher adherence rate, up to 9-times, compared to the current standard of care, ultrasound.”

“With the introduction of the world leading AI-multi-modal platform technology and Helio’s world-renowned scientific team to the Health Cluster of Saudi Arabia, we are looking forward not only to saving lives by much better liver-cancer screening technologies, but also co-developing many other new early detection tests for major degenerative diseases,” said Dr. Talal A Almalki, CEO of Health Cluster, Ministry of Health, Saudi Arabia.

About HelioLiver Dx

HelioLiver Dx is a multi-analyte blood test that analyzes cfDNA, methylation patterns, serum protein markers and demographic information to detect early-stage HCC. HelioLiver achieved superior sensitivity and non-inferior specificity compared to ultrasound, the current standard of care for HCC surveillance, as demonstrated by the results of the ENCORE and CLiMB clinical trials. HelioLiver Dx has received a Category I Current Procedural Terminology Proprietary Laboratory Analyses, or CPT PLA, code from the American Medical Association, effective October 1, 2022, which establishes a reimbursement pathway and facilitates expected Medicare coverage for increased access and potential broader adoption of HelioLiver in the United States. Based on the results of the CLiMB trial, Helio submitted its PMA application for HelioLiver to the FDA in the second quarter of 2024 for authorization as a Class III medical device. Prior to FDA approval, HelioLiver will remain commercially available in the United States in a CLIA laboratory as a laboratory developed test, or LDT. 

About Helio Genomics

Helio Genomics is a commercial-stage, AI-driven biotechnology company focused on developing pioneering diagnostics for early cancer detection and prevention. Committed to improving global cancer survival rates, Helio Genomics specializes in blood-based diagnostic technologies, utilizing advanced approaches liquid biopsy and DNA methylation analysis to detect cancer at its earliest stages.

The company’s flagship product, HelioLiver, is a multi-analyte blood test dedicated to the early detection of hepatocellular carcinoma (HCC), a common and aggressive form of liver cancer. By evaluating cell-free DNA (cfDNA) methylation patterns, serum protein markers, and demographic data, HelioLiver integrates AI and multi-marker analysis to deliver a highly sensitive and specific diagnostic tools. Helio pipeline portfolio includes multi-cancer early detection (MCED) testing, focusing on cancers like liver, breast, and lung, which are notoriously challenging to detect early.

As a science-driven company, Helio Genomics collaborates with clinical and academic institutions worldwide to advance cancer diagnostics, striving to make these solutions accessible and affordable on a global scale. For more information, please visit https://heliogenomics.com/.

About Halub Medical Co.

Halub Medical Co., based in Taif, Saudi Arabia, is a leading healthcare provider specializing in the distribution of laboratory diagnostic test kits across the GCC and Middle East, as well as advanced dermatology and aesthetic procedures. Known for high-quality diagnostic solutions, Halub Medical supplies a comprehensive range of test kits, supporting diverse medical and laboratory needs—from infectious disease detection and hormone level assessment to genetic testing and biochemical analyses. This distribution expertise enables healthcare facilities throughout the region to enhance their diagnostic capabilities with reliable and precise testing solutions.

In addition to its diagnostic services, Halub Medical Co. features a premier facility for dermatology and aesthetic treatments, offering state-of-the-art laser services, including tattoo removal, permanent hair reduction, acne and scar revision, skin resurfacing, and vascular therapies. The center’s specialized treatments also address pigmented lesions, wrinkle reduction, vascular issues, body contouring, and laser-assisted lipolysis, catering to the most advanced skincare and aesthetic needs.

Complementing these services, Halub Medical’s training center provides expert medical training and certification programs, empowering healthcare professionals to excel in both diagnostic and aesthetic fields. Recently, the owner extended their healthcare commitment by opening a rehabilitation center focused on addiction recovery, further enhancing healthcare support within the community. For more information, please visit https://halubmedical.com.

Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com