SALT LAKE CITY, UT / ACCESSWIRE / October 11, 2018 / ProLung, Inc. (“ProLung” or the “Company”) today released a letter to its shareholders with an important intellectual property and regulatory update.
ProLung® is pleased to announce receipt of a new Notice of Allowance for our proprietary algorithm by the United States Patent and Trademark Office (“US P.T.O.”). ProLung also met last month face-to-face with the FDA at their headquarters near Washington, DC to collaboratively review elements of the Company’s future De Novo application. Mr. Jared Bauer, interim CEO, announced, “The opportunity to gain firsthand feedback from the FDA on our proposed regulatory approach and our progress towards building out our intellectual property portfolio are important milestones for ProLung and its shareholders.”
Intellectual Property Update
ProLung’s newest Notice of Allowance by the US P.T.O. covers critical advancements and refinements to our proprietary algorithm, which calculates the likelihood a patient with an indeterminate lung nodule has lung cancer. This new patent provides ProLung with another valuable corporate asset. In conjunction with the new Japanese patent that was announced in March 2018, ProLung has an increasingly impressive intellectual property portfolio comprised of sixteen patents, notices and applications covering Australia, Canada, China, the European Union, Japan, Mexico, New Zealand, South Korea, and the United States. “This patent is due in large part to Michael Garff’s determined efforts over the past few years and will help protect the Company’s competitive advantage,” said Mr. Robert Gempeler, attorney at Kunzler Law representing ProLung.
ProLung is currently making careful final preparations to break the data blind from its pivotal clinical validation Study (PL-208) and is taking full advantage of new opportunities to expand its strategic network of regulatory, statistician and medtech advisors and consultants. The Company is benefiting from their direct expertise in our field and unique insight from past experiences.
On September 13, 2018, ProLung and its team of regulatory, statistical and product development consultants met collaboratively with the FDA to discuss the FDA’s feedback regarding ProLung’s Statistical Analysis Plan (SAP), which was sent as a Pre-Submission meeting request (Pre-Sub) on June 1, 2018. A Pre-Sub is designed to be an iterative process to help innovators like ProLung provide the necessary safety and efficacy data in order to gain marketing clearance while potentially saving time in the long run. ProLung is grateful for the FDA’s Pre-Sub response to our proposed SAP. Their constructive feedback reaffirms the Company’s strategic decision to pursue the Pre-Sub pathway prior to breaking the blind of its pivotal clinical validation study (PL-208 Study).
The FDA suggested ProLung update its PL-208 Study and corresponding SAP to use Positive Predictive Value (PPV) and Negative Predictive Value (NPV) as co-primary endpoints in lieu of its prior primary endpoint of Relative Risk and secondary endpoints of Sensitivity and Specificity (statistical terms are defined below). In addition, the FDA reviewed the PL-208 Study protocol and expressed a concern that the Company’s prior research on repeatability only evaluated healthy volunteers and did not evaluate the ProLung Test target population (patients with indeterminate lung nodules). The FDA recommended that a repeatability study be conducted using subjects who are part of the target population of the ProLung Test. The FDA also had suggestions, questions, and concerns regarding indications for use, study design, mechanism of action, risk assessment, and statistical approaches.
- Positive Predictive Value (PPV): probability that subjects with a positive ProLung Test result truly have cancer
- Negative Predictive Value (NPV): probability that subjects with a negative ProLung Test result truly do not have cancer
- Relative Risk: comparative likelihood the high and low risk groups have cancer, as determined by the ProLung Test results
- Sensitivity: proportion of patients with cancer that are correctly identified as such
- Specificity: proportion of patients without cancer that are correctly identified as such
About ProLung, Inc.
ProLung is the world leader in innovative predictive analytics technology and non-invasive tests for the risk stratification of indeterminate pulmonary nodules in the lung. ProLung’s mission is to make a difference in time for lung cancer patients. The Company develops, tests, and commercializes solutions which are designed to accelerate the time to diagnosis and expand the therapeutic window for lung cancer patients. ProLung’s predictive analytics platform for lung cancer risk stratification is approved for sale in the European Economic Area (CE0120) and investigational use in the USA.
This release may contain forward-looking statements regarding projected business performance, operating results, financial condition and other aspects of the Company, expressed by such language as “expected,” “anticipated,” “projected” and “forecasted.” Please be advised that such statements are estimates only and there is no assurance that the results stated or implied by forward-looking statements will actually be realized by the Company. Forward-looking statements may be based on management assumptions that prove to be wrong. The Company and its business are subject to substantial risks and potential events beyond its control that would cause material differences between predicted results and actual results, including the Company incurring operating losses and experiencing unexpected material adverse events.
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SOURCE: ProLung, Inc.