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 with Indeterminate Pulmonary Nodules (IPN). 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. To address this situation, ProLung utilizes a patented non-invasive scanning technique called Electrical Impedance Analytics (EIA) combined with a proprietary algorithm. ProLung is focused on developing, testing and commercializing predictive cancer analytics utilizing bioconductance and Artificial Intelligence (AI) which is designed to accelerate the time to diagnose, expand the therapeutic window for cancer patients and reduce the cost burden to healthcare systems.
THE PROLUNG SYSTEM HAS BEEN DESIGNATED A ‘BREAKTHROUGH DEVICE’ BY THE U.S. FDA
The ProLung System is based on the principles of bioconductance where it measures the electrical impedance of the body. Moreover, the company is building upon earlier published research in this field that demonstrated an electrical impedance difference between malignant and benign breast, thyroid and cervical tissue. The Company continues to expand its intellectual property portfolio.
“Lung cancer patients are often diagnosed too late when the disease is in its later stages and when the five-year survival rate is just 17 percent,” says Jared Bauer, CEO, ProLung. Thus, the company is aiming to help physicians shift the diagnosis to the earliest and most treatable stages, to increase the five-year survival rate to nearly 80 percent. Early cancer detection models have repeatedly shown that outcomes are better and treatment costs are lower for earlier-stage cancers than for advanced-stage cancers. Keeping this in mind, the ProLung Test™, ProLung’s first predictive analytics platform for lung cancer, was developed to contribute to significant survivorship increases and treatment cost advantages.
The FDA designated the ProLung Test as a Breakthrough Device in February 2020.
Through this program, the FDA will provide ProLung with expedited reviews and the Centers for Medicare Medicaid Services (CMS) will provide a simpler and faster pathway to reimbursement. The FDA’s Breakthrough Device program is intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Furthermore, this program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval.
As a patient is scanned with the ProLung Test, a tremendous amount of patient-specific data is collected by the company’s system and ProLung believes that AI may help identify previously unrecognized patterns, yielding even greater performance. “The recent advances in AI may provide new avenues to further improve the performance of the ProLung Test,” adds Mr. Bauer.
ProLung is pursuing two development paths concurrently: First, it is focused on gaining FDA clearance to market in order to commercialize its ProLung Test in the USA. Second, the company is also pursuing feasibility research to determine the applicability of its novel EIA system to other cancers. ProLung has already partnered with a hospital to scan breast cancer patients for feasibility research. The company plans to start additional feasibility studies for other cancers shortly.