2018 Biotechnology Awards

52 GHP / Biotechnology Awards 2018 , Established in 2005, ProLung’s mission has been to make a difference in time for lung cancer patients who face an under-prioritized and highly stigmatized disease. President and CEO Steven C. Eror and his team are single-mindedly focused on making a difference in time for lung cancer patients by commercializing the ProLung Test. Lung cancer is the leading cause of cancer deaths worldwide, killing more than colorectal, breast and prostate cancers combined. The disease has the lowest five-year survival rate of all major cancers at 17% and is the single largest cancer killer in the USA and world. 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 may wait months, or even years, receiving multiple CT scans to confirm malignancy in the lungs. Unfortunately, this wait can often prove fatal as the cancer BI180032 Best Medical Technology Company 2018 – USA & Best Lung Cancer Predictive Analytics Risk Testing Platform: The ProLung Test ProLung® is theworld leader in innovative predictive analytics technology and non-invasive biomarkers for the risk stratification of lung cancer. ProLung’smission is tomake a difference in time for lung cancer patients.We profile the firmand explore the crucial solutions it provides. 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 low-dose CT scan (LDCT) of the chest. The screen is amplifying the clinical need as it identifies up to 24 million patients with IPNs who will experience a narrowing treatment window as they wait. ProLung addresses this need at a critical time with its breakthrough predictive analytics test, The ProLung Test™. The test uses precision proprietary volume-averaging or volumetric bioconductive technology to non-invasively collect biomarker data in patients with IPNs. The patient’s data is analyzed to produce a personalized score indicating the likelihood of malignancy in the lungs. Their wait can be reduced from months and years to one day. Patients at high-risk may be accelerated to biopsy and diagnosis, expanding the therapeutic window. Patients at low-risk may avoid futile biopsies and justify fewer follow- up CT scans. The ProLung Test is non- invasive, non-radiating, rapid and accurate. ProLung’s predictive and personalized approach to help physicians quantifiably determine risk of malignancy is a significant step forward in the management and treatment of lung cancer. The ProLung Test is designed to add efficiency to the LDCT screen and create significant cost savings for CMS. The ProLung Test is available for sale in Europe (CE 0120). The company is anticipating US FDA clearance based on its pivotal clinical validation research at 15 premier US cancer centers. As part of its commitment to safety and quality, ProLung has partnered with an army of physician investigators around the USA at 15 sites (MD Anderson Cancer Center, the Mayo Clinic, Stanford Health Care, Loyola University Medical Center, Henry Ford Health System, MUSC Health, UCLA Health, Beth Israel Deaconess Medical Center, Harvard Medical School, etc.) to validate the ProLung Test. In late 2017, ProLung achieved a major milestone by completing patient enrolment (n=420 patients). This data will support the firm’s FDA submission and subsequent commercialization in the USA. Alongside its collaborations with external experts, in 2017 Mr. Eror expanded his team of medtech professionals at ProLung to 14 employees. To ensure that his team more fully understood the importance of their work, they all participated in the LUNGevity Breathe Deep SLC memorial 5k run to support a grassroots lung cancer advocacy group. 2017 was a watershed year for ProLung. Mr. Eror raised more than $8M in private funding to ready the company to submit its ProLung Test to the FDA and commercialize globally. Through Mr. Eror’s tireless dedication, ProLung is poised for commercial success in 2018. Contact: Steven C. Eror, President and CEO Website: www.prolunginc.com

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