The Silicon Review
Globally, cancer is the second leading cause of mortality, and the overall rate of cancer-related deaths is also on the rise. Currently, the majority of deadly cancers have no guideline-recommended screening tests available, resulting in a delay in cancer detection. Survival chances are very low in the later stages when compared to early detection. Filling the screening void in cancer control can create an impact on mortality and morbidity reduction.
IONIQ Sciences’ mission is to dramatically improve the cancer landscape with a modern solution for the early detection of multiple cancers. The company was founded in 2004, and it is based in Salt Lake City, Utah. Previously known as ProLung, the company was founded to address lung cancer, which is the most deadly cancer in the USA and worldwide. It kills more than the next three cancers combined. Through its clinical work, IONIQ’s efforts on its ProLung Test™ for lung cancer were recognized by the US FDA with its Breakthrough Device Designation in February 2020. IONIQ’s data suggests that its Electrical Impedance Analytics (EIA) technology is measuring the body’s “early warning system” to the presence of cancer, so an IRB-approved feasibility breast cancer study was initiated in early 2020 and continues to run. Therefore, the team rebranded to IONIQ Sciences in May 2020 to reflect its expanded early cancer detection strategy. Simply put, screening can save lives and money by detecting cancer at its earliest most treatable stages. IONIQ’s lung cancer and breast cancer tests are foundational on its quest to developing a Multi-Cancer Screen. The company is well-positioned to develop a multi-cancer screen by leveraging its lung test, future breast test, proprietary technology, substantial EIA database, and deep clinical experience.
In conversation with Jared Bauer, CEO of IONIQ Sciences
Q. What challenges did you face in your initial years? What can your peers learn from it?
While we didn’t coin the phrase, we live it: We follow the science. We are curious with equal parts of conservation and optimism. We investigate, test, and iterate so that our team discussions are data-driven and factually-based. Through trust and respect, our team is free to brainstorm and present alternatives. As a result, our culture is “one for all and all for one.” This culture also resulted in the conclusion that our technology very well may be measuring the body’s “early warning system” to the presence of cancer, and therefore, we launched our IRB-approved breast cancer feasibility study in early 2020 after our encouraging bench work.
As further validation of our underlying science of Electrical Impedance Analytics, we are honored to count two of the preeminent PhD minds in the field of bioimpedance on growing Scientific Advisory Committee. We expect collaborating with them will help accelerate the expansion from our first planned product, the IONIQ ProLung Test, to a modernized test for multiple cancers.
Q. Tell us about your recent success? Share the experience.
The US FDA’s Breakthrough Device designation for our ProLung Test was a huge accomplishment for our team. It put a tremendous amount of wind in our sails and swagger in our walk. It also served as a strong reminder of the importance of our work – those suffering from cancer deserve a modern solution. At the end of the day, it was the result of a great deal of hard-work by our team. We are very proud of the “Breakthrough” achievement and are eager to submit for marketing clearance in the near future.
Q. Tell us about your company’s vision.
IONIQ Sciences’ vision is to dramatically improve the cancer landscape with a modern solution for the early detection of multiple cancers, thereby expanding the therapeutic window, significantly improving survivability, and reducing the cost of healthcare. We envision a world where cancer is no longer feared – where it is readily treatable and no longer a financial burden. We intend to do this by making early cancer detection an integral part of annual wellness checks. Lives and money can be saved when cancer is detected at its earliest, most treatable stages. Early detection is critical, and IONIQ Sciences is leading the way. We will not be satisfied until the scourge of cancer has been eliminated.
Q. About adaptability, how do you stay relevant to the consumer interests and needs in this high volatile market?
IONIQ Sciences is following a strategic course to develop and commercialize the first-ever FDA cleared Multi-Cancer Screen. The first step on our quest for early detection is commercializing our IONIQ ProLung Test, which has been designated a Breakthrough Device by the US FDA for its life-enhancing potential. We then plan to commercialize our IONIQ Breast Test, which has entered feasibility testing. By following the principles of scientific process, IONIQ Sciences will amass vast amounts of valuable clinical data that we are using to develop the first-ever FDA-cleared Multi-Cancer Screen.
Q. What makes your offerings unique? How do you stand out from the rest?
IONIQ Sciences is taking a modern approach to the early detection of cancer. We believe that we are detecting the body’s earliest response to cancer with our point-of-care solution. The body’s electrical properties change in the presence of cancer. The IONIQ System utilizes Electrical Impedance Analytics (EIA) to take up to 13,125 electrical readings of the body over a 20 minute period. Our proprietary algorithm processes this data to determine the likelihood of malignancy in its earliest, most treatable stages. We are integrating Artificial Intelligence (AI) to improve performance further and expand from our “Breakthrough” IONIQ ProLung Test to a Multi-Cancer Screen. IONIQ’s patented technology allows us to non-invasively detect the presence of malignancy in its earliest stages, potentially improving survival and reducing costs.
Q. As a question on sustainability, where do you see your company a couple of years from now?
IONIQ has conducted seven studies and trials at 24 clinical sites around the world, with more than 1,200 subjects that generated more than 20,000,000 data points. Over the last 15 years, we have worked with premier institutions around the world, accumulating a substantial library of clinical evidence resulting in a Breakthrough Device Designation from the US FDA for our IONIQ ProLung Test. From this foundation, we are transitioning from developing a single Lung Cancer Test to a Multi-Cancer Screen.
Meet the leaders behind the success of IONIQ Sciences
Jared Bauer is the CEO of IONIQ. He joined the company in September 2018. Bauer has focused his professional endeavors on the MedTech industry and is also the CEO of Cibus Biotechnologies Inc. In 2012, Mr. Bauer previously founded Exuro Medical and acquired BurnFree Products. In just two years with a focus on sustainable revenue generation, he led the Exuro Medical team to expand BurnFree distribution to 58 countries, managing regulatory processes, re-working quality systems, and making BurnFree the second largest burn treatment product line in the world. Mr. Bauer currently serves as a trustee at The Oliver Fund, a non-profit he co-founded and Chairman of the BioUtah SLC Biotech Initiative Advisory Committee.
Andy Robertson is the VP Business Development in IONIQ. Mr. Robertson joined IONIQ Sciences in July 2017 and is focused on identifying mutually beneficial strategic partnerships, establishing and strengthening relationships with sales distribution partners, gaining reimbursement and utilizing the IONIQ ProLung Test CE mark. Over the course of more than 20 years in the global medical device or medtech industry, he has held upstream and downstream marketing positions of increasing responsibility, been publicly recognized with marketing awards and launched 15 medical devices.
Michael Garff is the COO of IONIQ. Mr. Garff joined IONIQ Sciences as the Chief Operating Officer in June 2009. At IONIQ, he obtained US FDA Breakthrough Device Designation and European regulatory approval (CE Mark) for the IONIQ ProLung Test, organized and operates manufacturing, acquired clinical sites at premier cancer hospitals, and designed and implemented a certified ISO 13485 quality management system. Currently, he oversees IONIQ’s product development, manufacturing, clinical studies, regulatory affairs, FDA submissions, quality audits, data analysis, and patents.