8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (date of earliest event reported): August 7, 2019

ProLung, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-38362	20-1922768
(State or other jurisdiction of	(Commission	(IRS Employer
incorporation or organization)	File Number)	Identification No.)

350 W. 800 N. Suite 214
Salt Lake City, Utah	84103
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s Telephone Number, Including Area Code:

(801) 736-0729

N/A

(Former name, former address, and formal fiscal year, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)
[  ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

Item 7.01. Regulation FD Disclosure.

On October 3, 2019, the Company issued a press release, entitled “ProLung, Inc. Announces Large Clinical Validation Trial Results of 84% sensitivity and 74% specificity” related to the announcement of clinical trial results, a copy of which is filed as Exhibit 99.1 to this Current Report.

The information contained in this Item 7.01 and in the attached Exhibit 99 is being furnished and shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not deemed incorporated by reference by any general statements incorporating by reference this Current Report or future filings into any filings under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates the information by reference. By filing this Current Report and furnishing this information, the Company makes no admission or statement as to the materiality of any information in this Current Report that is required to be disclosed solely by reason of Regulation FD.

Item 8.01 Other Events

On October 3, 2019, ProLung, Inc. (“ProLung” or the “Company”) and its long-time partner ProLung China (a Delaware, USA-based company), both whom are focused on reducing the time to diagnosis for lung cancer patients, proudly announced today the results of a large clinical validation trial on its ProLung Test™ led by Professor Chunxue Bai at Fudan University. The study was sponsored by ProLung China and executed by its subsidiary, ProLung Biotech Wuxi, under the supervision of a Clinical Research Organization (CRO). In the study of 486 subjects with 418 effective, the ProLung Test returned results of 84% sensitivity, 74% specificity, 79% Positive Predictive Value (PPV) and 81% Negative Predictive Value (NPV).

The ProLung Test’s performance from this clinical trial are the highest combined sensitivity and specificity values for a truly non-invasive solution that is pursuing FDA clearance for a lung cancer diagnostic that the Company is aware of. Furthermore, the ProLung Test is the only predictive analytic utilizing bioconductance in lung cancer. These trial results, along with the results of a soon to be started repeatability study, will underpin a future FDA de novo submission.

Item 9.01. Exhibits.

(d) Exhibits

ProLung, Inc. Press Release dated [October 3, 2019], exhibit 99.1

SIGNATURES

Pursuant to the requirements of the Securities Exchange of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	ProLung, Inc.
Dated: October 3, 2019	By:	/s/ Jared Bauer
		Jared Bauer, interim Chief Executive Officer

EX-99.1

PRESS RELEASE

FOR IMMEDIATE RELEASE

ProLung, Inc. Announces Large Clinical Validation Trial Results of 84% sensitivity and 74% specificity

Salt Lake City, UT, October 3, 2019 – ProLung, Inc. (“ProLung” or the “Company”) and its long-time partner ProLung China (a Delaware, USA-based company), both whom are focused on reducing the time to diagnosis for lung cancer patients, proudly announced today the results of a large clinical validation trial on its ProLung Test™ led by Professor Chunxue Bai at Fudan University. The study was sponsored by ProLung China and executed by its subsidiary, ProLung Biotech Wuxi, under the supervision of a Clinical Research Organization (CRO). In the study of 486 subjects with 418 effective, the ProLung Test returned results of 84% sensitivity, 74% specificity, 79% Positive Predictive Value (PPV) and 81% Negative Predictive Value (NPV).

The ProLung Test’s performance from this clinical trial are the highest combined sensitivity and specificity values for a truly non-invasive solution that is pursuing FDA clearance for a lung cancer diagnostic that the Company is aware of. Furthermore, the ProLung Test is the only predictive analytic utilizing bioconductance in lung cancer. These trial results, along with the results of a soon to be started repeatability study, will underpin a future FDA de novo submission.

Highlights from the trial include:

● Large clinical trial with 486 enrolled subjects

● Uniformly high performance across all cancer stages, including very early stages of lung cancer

● ProLung Test performance was effective across a wide range of lesion sizes ranging from 4-50mm

● ProLung Test performance was outstanding in small lesions ranging from 4-8mm

● ProLung Test was effective across a wide age range of 20-80 years

● ProLung Test performance was effective in both male and female subjects

Additional highlights, details and analysis are likely to be included in a future peer-reviewed publication.

Mr. Jared Bauer, ProLung CEO, stated, “ProLung, Inc. in the USA and ProLung China have been partners for more than six years, which formally began when we licensed the ProLung Test™ to them for the China market. Through ProLung China’s own experiments, they made a number of modifications to the methodology of our ProLung System. The ProLung Test’s performance from this validation study are the highest combined sensitivity and specificity values for a truly non-invasive solution that is pursuing FDA clearance for a lung cancer diagnostic that we’re aware of – not to mention the only predictive analytic test utilizing bioconductance in lung cancer. We plan to use these validation study results along with the future results of a soon to be started repeatability study in a future FDA de novo submission. We are grateful to Mr. Ning Zhou and his team for their efforts and collaboration.”

Mr. Ning Zhou, ProLung China CEO, stated, “I have believed in the ProLung Test for many years and the results of this clinical trial are not surprising. With key modifications to the ProLung System protocol, the trial produced actionable clinical results that can help physicians in both the USA and China diagnose lung cancer in the earliest and most-treatable stages of the disease. China has the highest mortality rate from lung cancer globally. I expect this non-invasive and cost-effective medical device will make a tremendous difference for lung cancer patients in both urban and rural areas. Now that the strategic objectives of ProLung China and ProLung, Inc. are formally aligned, both companies are already benefiting from one another’s hard work. With the combined resources of the two companies, we are poised for greater success.”

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 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 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 adults, which was based in part on a 2013 recommendation by the US Preventive Services Task Force (USPSTF). 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 a 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 is engaged in developing, testing and commercializing 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

Statements contained in this release which are not purely historical, including, without limitation statements regarding ProLung’s future performance and goals, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in the ProLung’s Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties include inherent risks and uncertainties relating to ProLung’s ability to meet its funding requirements for its operations and other commitments and to obtain successful test results and regulatory approvals for its products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections.

For further information, contact:

Andy Robertson | 1-801-503-9231| acr@prolunginc.com

ProLung, Vice President of Business Development

ProLung, Inc.

350 W. 800 N., Suite 150

Salt Lake City, Utah 84103

USA

www.prolunginc.com

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