The Silicon Review
“ProLung is the world leader in accurate, non-invasive, and radiation-free predictive analytics for the rapid risk stratification of lung cancer.”
Lung cancer is the single most deadly malignancy of all cancers in the USA and around the globe, accounting for more cancer deaths than the next three cancers combined. The 5-year survival rate for lung cancer is just 17% primarily because it is diagnosed in the latest stages of the disease. If it can instead be diagnosed in the earliest stages, the 5-year survival rate increases to nearly 80% or five-times higher.
In view of the above-mentioned scenario, we’re thrilled to present ProLung, Inc.
ProLung®, a medical technology company, focuses on developing, marketing, and selling precision predictive analytical medical devices. Their ProLung Test™ is based upon a proprietary algorithm that is designed to rapidly assess the risk of malignancy of lung nodules suspicious for cancer that have been previously identified by low-dose computed tomography (LDCT) scanning. ProLung accomplishes this by pairing their ProLung System, which consists of medical grade components comprising a probe, scanner, tower, monitor, and keyboard; and their ProLung Test kits.
ProLung was incorporated in 2004 and is headquartered in Salt Lake City, Utah.
Jared Bauer, ProLung, Inc. Interim CEO, spoke exclusively to The Silicon Review. Below is an excerpt.
Q. Why was the company set up? And how did you expand your company and its offerings over the years?
ProLung was founded to ‘make a difference in time’ for lung cancer patients around the world who face an under-prioritized and highly stigmatized disease. Lung cancer is the leading cause of cancer deaths worldwide, killing more than colorectal, breast and prostate cancers combined. There is a severe unmet clinical need to reduce the time required to determine malignancy in patients diagnosed with Indeterminate Pulmonary Nodules (IPNs). Patients with IPNs can wait months, or even years, receiving multiple CT scans to confirm malignancy in the lungs. This wait often proves fatal as the cancer advances and spreads. In 2015, the US Preventive Services Task Force and Centers for Medicare and Medicaid Services (CMS) implemented the first national lung cancer screen utilizing a LDCT of the chest for high-risk individuals. Today, the average five-year survival rate is unacceptable and abysmal where four in five people diagnosed with the disease will not live past five years. Many sadly pass within just six months of their diagnosis. If the disease can instead be diagnosed in the earliest stages, the five-year survival increases 5x to nearly 80 percent using no new treatments or procedures than what is already available. Therefore, ProLung is focused on helping physicians accelerate their diagnosis with its proprietary ProLung Test.
Currently, we’re operating in a pre-commercial phase as we optimize our science and performance in order to support a De Novo regulatory submission to the FDA. To that end, ProLung is in the final stages of a nationwide clinical validation study of 420 patients at 15 nationally-recognized facilities around the USA (MD Anderson, UCLA, Loyola, Huntsman Cancer Institute, UCSD, etc.). This work is expected to buttress our earlier published results in the Journal of Thoracic Oncology (2012) from Johns Hopkins and internal testing.
Tell us about ProLung Test™.
The ProLung Test uses precision proprietary volume-averaging bioconductive technology to collect unique bioconductance data in patients with IPNs and is adjunctive to LDCT scans. The patient’s data is analyzed to produce a personalized risk score indicating the likelihood of malignancy in the lungs. The test is designed to reduce today’s wait from months and years to a single day. Patients at high-risk of malignancy for lung cancer can be accelerated to biopsy and diagnosis thereby expanding the critical therapeutic window. At the other end of the risk spectrum, patients at low-risk of malignancy can avoid futile biopsies and justify fewer follow-up CT scans. The ProLung Test is designed to be non-invasive, non-radiating, rapid and accurate. Its predictive and personalized approach to early detection will be a significant step forward in the management and treatment of lung cancer. The test will add efficiency to the LDCT screen and create significant cost savings for CMS. It is already available in Europe (CE0120) and the company is working towards US FDA marketing clearance with its pivotal validation study work at 15 premier cancer centers across the USA.
Q. What are your challenges?
Our challenge is to deliver a safe, efficacious and cost-effective solution to physicians and lung cancer patients. We fully embrace and respect the importance of correctly diagnosing IPN’s with a high degree of confidence.
There are an estimated one billion people at risk for lung cancer worldwide. We are working towards the commercialization of our ProLung Test in the largest at-risk global populations (USA, Europe, Middle East and China) through our own regulatory clearances and licensing. China alone consumes one in every three cigarettes smoked in the world and may have a high-risk population of over 550 million people.
Leadership | ProLung, Inc.
ProLung is ably led by Jared Bauer, interim CEO and Michael Garff, COO. Mr. Bauer joined the company in August 2018 and has many years of experience as CEO in the medical technology space. Mr. Garff joined nearly ten years ago after working with the Pierre Lassonde New Venture Development Center (University of Utah) where he served as Director from 2007 to 2009, and as a business analyst for the Biomedical Informatics Department of the University of Utah from 2008 to 2009.
Mr. Bauer and Mr. Garff are supported by a seasoned management team with a rich, diverse science and business background.