ProLung Announces Final Results from its PL-209 Repeatability Study

November 21, 2018

SALT LAKE CITY, UT / ACCESSWIRE / November 21, 2018 / ProLung, Inc. ("ProLung" or the "Company") is focused on reducing the time to diagnosis for lung cancer patients. Today ProLung announced final results from its PL-209 repeatability study.

The ProLung Test is designed to produce a personalized risk score indicating the likelihood of malignancy in the lungs for patients with indeterminate pulmonary nodules (IPNs) by measuring volume-averaged thoracic bioconductance. Patients at high-risk may be accelerated to biopsy and diagnosis thereby expanding the critical therapeutic window. At the other end of the risk spectrum, patients at low-risk may avoid futile biopsies and justify fewer follow-up CT scans.

Michael A. Garff, ProLung Chief Operating Officer, noted, "This is another important milestone in the continuing development and refinement of the ProLung Test that is designed to address an unmet need for lung cancer patients by immediately evaluating IPNs that have been identified by low dose CT scans."

PL-209 Study Design

The repeatability study enrolled sixty subjects, 30 male and 30 female, half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by the same operator on the same ProLung System. Fifty-nine subjects produced evaluable data. Four models (algorithms) were tested. The study was conducted by ProLung.

Study objectives included quantifying the effects of sex, body mass index (BMI), day-to-day subject variability and variability of a single device when volume-averaged thoracic bioconductance was measured with the ProLung Test.

PL-209 Study Summary

PL-209 Statistical Summary

Study Objectives

Summary Statement

Quantify scan variability when measured twice on the same day.

On average, the second score on the same day was 0.0214 (approximately 2%) points lower for Model 1b+age. This difference is statistically significant, but the clinical significance is unknown.

Quantify day-to-day within-subject variability when measured on two different days within one week.

Model 1b+age was very repeatable with an Interclass Correlation Coefficient (ICC)=0.958 (lower bound=0.925, upper bound=0.967), with a 95% confidence interval. This is markedly better than the Stoddard Model (ICC=0.369, lower bound=0.186, upper bound=0.475) used in the Johns Hopkins Study (Journal of Thoracic Oncology, 2012).

Quantify effects of BMI and sex.

There is no statistically significant difference in scores because of either sex or BMI.

Assess tolerability from subjects' perspective and time to complete scan.

No adverse events occurred. Two subjects (3%) reported mild discomfort. All (100%) reported they would do the scan again. Average test time was approximately 18.5 minutes, with a range of 15-24 minutes.

Null Hypotheses

Summary Statement

The null hypothesis is that same-day variability has no effect on scan results (i.e. when scanned twice on the same day).

This hypothesis is rejected. On average, the second score on the same day was 0.0214 points (approximately 2%) below the first score for Model 1b+age. This difference is statistically significant, but the clinical significance is unknown.

The null hypothesis is that BMI has no effect on scan results.

There is no statistically significant difference in scores because of BMI.

The null hypothesis is that sex has no effect on scan results.

There is no statistically significant difference in scores because of sex.

The null hypothesis is that day-to-day variability has no effect on scan results (i.e. when scanned twice on separate days).

This hypothesis is statistically significant, indicating significant repeatability in device scan results as summarized by ICC estimates for Model 1b+age.

PL-209 Study Discussion

The repeatability study addressed several questions regarding use of the ProLung Test. One significant limitation of this study is that no subjects with known pulmonary nodules or malignancy were enrolled. It is unknown whether pulmonary nodules or malignancy affect the repeatability of the ProLung Test. While the study showed statistically significant variability of approximately 2% when testing the same subject twice on the same day, the clinical impact of this finding is unknown because it is not anticipated that patients will receive a second test on the same day in clinical use. While we note significant day-to-day variability when using an earlier model (the algorithm used in the Johns Hopkins Study, Journal of Thoracic Oncology, 2012), repeatability is markedly improved when using a more refined model.

Model

ICC Estimate

Lower Bound

Upper Bound

Model 1b

0.748

0.6

0.787

Model 1b+age

0.958

0.925

0.967

D2dt

0.379

0.284

0.549

Stoddard

0.369

0.186

0.475

PL-209 Study Conclusion

  1. Same-day variability is statistically significant (average second score is 0.0214 points lower), but the clinical impact of this finding is unclear.
  2. Day-to-day variability is impacted by the model (algorithm) chosen. Model 1b+age has an ICC=0.958, indicating it is very repeatable.
  3. Sex and BMI do not affect test performance.
  4. Average test time is 18.5 minutes, with a range of 15-24 minutes.
  5. The test is well tolerated and agreeable to test subjects.

About Lung Cancer

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 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 low-dose CT scan (LDCT) of the chest for high-risk individuals. The screen will amplify this clinical need as up to 24 million patients with IPNs may experience a narrowing treatment window as they wait.

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.

Forward-Looking Statements

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.

For further information, contact:

Andy Robertson | 1-801-503-9231| acr@prolunginc.com
ProLung, Vice President of Business Development
ProLung, Inc.
757 E. South Temple, Suite 150
Salt Lake City, Utah 84102
USA

www.prolunginc.com

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SOURCE: ProLung, Inc.



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