ProLung, Inc.

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Shareholder Update Letter

January 15, 2017

 

Happy New Year from ProLung!

2016 has been a spectacular year.

To achieve our research goals more rapidly, we assembled the most extensive team of clinical investigators of lung cancer in pulmonology.

This speeds the clinical evaluation required for FDA market approval, sets the stage for rapid commercial rollout, insurance reimbursement and commercial growth. The quality of the physician investigators in the US and in Europe is beyond what we could have imagined at this point last year. These clinics, now active in ProLung’s pivotal trial, have choices in what to research. As shareholders, we are deeply grateful for each clinic’s commitment. Today, lung cancer remains the leading cause of cancer death for men and women. With the help from these champion clinicians, a better pathway is just around the corner. 2016 brought the golden age of pulmonology. Here are the clinics that are bringing ProLung and their patients into that age by participating in ProLung research or offering the ProLung test to patients (Europe):

Azienda Ospedaliera Universitaria San Martino di Genova (pulmonology)
Azienda Ospedaliera Universitaria San Martino di Genova (thoracic surgery)
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Azienda Ospedaliero Universitaria Careggi
Chicago Chest Center Interventional Pulmonology and Thoracic Disease
Greater Baltimore Medical Center
Harvard University at Beth Israel Deaconess Hospital
Henry Ford Hospital
Huntsman Cancer Institute at the University of Utah
Intermountain Healthcare
Johns Hopkins School of Medicine
Loyola University, Providence Health Center
Lungenklinik Löwenstein
M D Anderson Cancer Center
Medical University of South Carolina
Northwestern Memorial Hospital
Stanford Healthcare
Università Politecnica della Marche
Universitätsspital Basel
University of California at Los Angeles (pulmonology)
University of California at Los Angeles (radiology)
University of California at San Diego
University of Geneva
University of Minnesota […]

By |15 January 2017|Uncategorized|Comments Off on Shareholder Update Letter|

ProLungdx Unveils its EPN Scan® at the BIO Investor Forum: Long-Awaited Test for those at Risk of Lung Cancer

ProLungdx Unveils its EPN Scan® at the BIO Investor Forum: Long-Awaited Test for those at Risk of Lung Cancer

 Salt Lake City, UT, USA, October 13, 2016 – ProLungdx™ today announced plans to present its leading-edge innovation for patients at risk of lung cancer during the 2016 BIO Investor Forum in San Francisco, California October 18 and 19, 2016.

For the first time in an international biotech investment conference, prospective investors will have the opportunity to review ProLungdx’s Electro Pulmonary Nodule Scan™ or EPN Scan, a device designed to make a difference in time for patients who have the potential for cancer in an indeterminate lung nodule identified by a CT screen or incidental finding. “It is distressing that patients wait months or even years to determine if their lung nodule is cancer,” said Steven Eror, ProLungdx’s CEO. “This waiting time drastically reduces the treatment window for therapy.  The EPN Scan’s purpose is to make a difference in time by reducing or eliminating the wait.”

ProLungdx was selected to present alongside some of the most promising life science companies at the BIO Investor Forum. “The BIO Investor Forum, now in its 15th year, is designed to help biotechnology companies find sources of capital. Attendees have opportunities to learn about the latest investment trends as well as showcase their company to qualified investors,” said Theresa Brady of the BIO Investor Forum.

The EPN Scan is nearing completion of its pivotal work with 14 premier US cancer centers. These represent a consensus of thought leaders seeking to accelerate the assessment of lung cancer risk in pulmonology, radiology, and thoracic surgery. Concern has rapidly increased following this year’s introduction and national reimbursement coverage of the low-dose CT chest screen for lung […]

By |13 October 2016|Uncategorized|Comments Off on ProLungdx Unveils its EPN Scan® at the BIO Investor Forum: Long-Awaited Test for those at Risk of Lung Cancer|

ProLungdx Showcases its EPN Scan® for Lung Cancer at the White Hat Investors Conference

ProLungdx Showcases its EPN Scan® for Lung Cancer at the White Hat Investors Conference

 Salt Lake City, UT, USA, September 7, 2016 – ProLungdx™ today announced plans to present its ground-breaking innovation for lung cancer patients at the AZBIO’s 2016 White Hat Life Science Investors Conference in Phoenix, Arizona September 21 and 22, 2016.

For the first time in an investment opportunity conference, prospective investors will be able to get a glimpse of ProLungdx’s Electro Pulmonary Nodule Scan™ or EPN Scan, a device designed to bridge the gap in the current standard of care between the detection of indeterminate pulmonary nodules and the risk of malignancy.  “It is distressing that patients wait months or even years to determine if their lung nodule is cancer. This waiting time drastically reduces the treatment window for therapy.  The EPN Scan’s purpose is to make a difference in time by reducing or eliminating the wait,” says Steven Eror, ProLungdx’s CEO.

The selection of ProLungdx to present alongside the most innovative life science companies at White Hat 2016 is significant.  It highlights the rapidly accelerating concern following the introduction and reimbursement of the low-dose CT chest screen for lung cancer, which has been shown to have a 96% false positive rate for cancer.  Leading medical experts universally agree that advances in lung cancer management present the largest opportunity to reduce cancer mortality.

“The Rocky Mountain Southwest Region is home to a wide range of exciting life science companies and diagnostics is one of our strongest areas,” shared Joan Koerber-Walker, president and CEO of AZBio and part of the organizing committee for White Hat 2016. “Companies from across the region competed to be selected for one of the 32 presentation slots and were scored […]

By |7 September 2016|Uncategorized|Comments Off on ProLungdx Showcases its EPN Scan® for Lung Cancer at the White Hat Investors Conference|

University of Liverpool Lung Cancer Research

Lung cancer survival rate increases by 73% if caught early
A major lung cancer screening trial, conducted by experts at the University of Liverpool, has found
that patients with a high risk of
developing lung cancer can be identified
with early stage disease and have up to a
73% chance of surviving five years or
more.
The UK Lung Cancer Screening Trial
(UKLS) was undertaken in partnership
with Liverpool Heart & Chest
Hospital, Papworth Hospital and the Royal Brampton & Harefield Hospital with the aim of
highlighting the need for a screening programme to help benefit people who are at risk of developing
lung cancer.
The Chief Investigator of the UKLS trial is Progessor Jogn Field, who is based in the University’s
Institute of Translational Medicine.
Identifying those at risk
Lung cancer kills more people than any other cancer. The number of deaths in 2012 in the UK
was 35,370, making lung cancer the commonest cause of cancer death in the UK for both
men and women.
The main reasons why lung cancer outcomes are so poor, are that approximately 70% of
patients first present to specialist care with incurable advanced disease and current
treatment at this late stage has very little effect on mortality.
However, if a patient’s lung cancer is identified at an early stage, then the clinical outcome is
greatly improved. Individuals with very early stage disease have up to a 73% chance of
surviving for five years or more and over 80% have had surgical interventions. As a result
there is a major national and international focus on CT screening trials.
National screening programme
The results of the UKLS trial provide further evidence for the UK National Screening
Committee (UKNSC) to consider when making a decision whether to implement a national
screening programme in the UK in the future.
Funded by the NIHR Health Technology Assessment Programme the trial was the first and
only lung cancer screening trial to take […]

By |3 June 2016|Uncategorized|Comments Off on University of Liverpool Lung Cancer Research|

ProLungdx Board Names Dr. John C. Ruckdeschel as Newest Board Memeber

Salt Lake City, Utah, May 25, 2016 – The Board of Directors of Fresh Medical Laboratories Inc., doing business as ProLungdx, today announced the appointment of Dr. John C. Ruckdeschel, M.D. to serve as a Director on the Company’s Board of Directors.  Dr. Ruckdeschel is a renowned oncologist with a career-long focus on thoracic malignancies and lung cancer.  Dr. Ruckdeschel formerly served as the Medical Director of Clinical Oncology at Intermountain Healthcare in Salt Lake City, Utah, the CEO of Moffitt Cancer Center and is a current member of the Medical Advisory Board of Prolungdx.

“ProLungdx will benefit immensely from the experience Dr. Ruckdeschel offers,” said Steven Eror, President and CEO of ProLungdx.  “We are pleased to expand his involvement to our Board of Directors, and we are confident his expertise will help bring our novel technology to those who need it most.”

Dr. Ruckdeschel received his B.S. degree in Biology from Rensselaer Polytechnic Institute and his MD from Albany Medical College in New York.  He trained as an intern at John Hopkins Medical Center, fulfilled a residency at Boston’s Beth Israel Hospital and completed a fellowship at the National Cancer Institute in Washington D.C.  He is a fellow of the American College of Physicians as well as the American College of Chest Physicians.  Dr. Ruckdeschel is also a well accomplished writer and presenter.  He has written and co-written more than 350 publications, book chapters and abstracts and has given more than 250 invited presentations.

Dr. Ruckdeschel served on the staff at Albany Medical College for a decade beginning in 1991, before he assumed the role of CEO and Director of the Moffitt Cancer Center in Tampa, FL.  In 2001, he became CEO and Director of Karmanos […]

By |25 May 2016|Uncategorized|Comments Off on ProLungdx Board Names Dr. John C. Ruckdeschel as Newest Board Memeber|

ProLungdx Announces Todd Morgan as Chairman of the Board

Salt Lake City, Utah, May 19, 2016 – Fresh Medical Laboratories, Inc, doing business as ProLungdx™, announced today that its board has appointed Todd Morgan as Chairman of the Board of Directors.  Mr. Morgan succeeds Clark Campbell, who served as the Chairman from 2012 to 2016.  Todd Morgan has been a Director since 2014 and begins his role as Chairman while ProLungdx markets its Electro Pulmonary Nodule Scanner (EPN Scan)â in Europe and seeks FDA approval in the US.

“Todd Morgan is an extraordinarily successful entrepreneur. He brings senior management ability with business and banking board experience,” said Steven Eror, President and CEO of ProLungdx.  “His leadership will help guide ProLungdx through our next period of growth and expansion.”

Mr. Morgan is a successful and widely respected businessman.  He began his career with The West Bend Company in the sales department and served as the District Manager.  He started Morgan Industries, an asphalt paving and maintenance business, growing it from one employee to 150 employees with offices in Utah and Arizona, and contracting in seven western states.  Mr. Morgan also started NuRock, a company which manufactures asphalt maintenance products.  He formed MPM Investment Group LP and currently serves as general partner and manager.  Mr. Morgan served on the Board of Directors of America West Bank and is a current member of the Board of Directors of Ellison Ranching Company.

About ProLungdx

ProLungdx is a privately held, US-based medical technology company that develops, manufactures and sells non-invasive medical technology to aid in the early detection and diagnosis of lung cancer.  The EPN Scan is approved for sale in the European Economic Area and is for investigational use only in the US.

For more information, contact:

C. Lindsay McSweeney

801-308-8861

info@prolungdx.com

By |19 May 2016|Uncategorized|Comments Off on ProLungdx Announces Todd Morgan as Chairman of the Board|

ProLungdx EPN Scan® Confirms Performance in Early Lung Cancer Risk Assessment

Salt Lake City, Utah, USA, May 18, 2016 – Fresh Medical Laboratories, Inc., doing business as ProLungdx™, today announced the initial results of its ongoing European Lung Cancer Registry.  When the Electro Pulmonary Nodule (EPN) Scan was administered to patients with lung nodules suspicious for cancer, the scan demonstrated results consistent with earlier research performed at Johns Hopkins and published in the Journal of Thoracic Oncology.  The non-invasive test correctly identified 23 out of 27, or 85% of patients where malignancy was confirmed by tissue biopsy.  More results are expected soon, as the EPN Scan has been administered to more than 170 patients in Europe and over 100 of these are enrolled in the registry.  Other research is underway at eight cancer centers in the US and four in Asia.

“The key to improved survival is understanding the risk associated with a suspicious pulmonary nodule.  It’s heartening to see such positive results coming from leading European interventional pulmonologists.  They are pioneers focused on immediate evaluation of indeterminate lung nodules.  Compared with the standard of care, we believe that the EPN Scan can increase the time available for treatment and may ultimately save lives,” said Steven Eror, President and CEO of ProLungdx.

The EPN Scan uses its novel mass averaging bioconductance technology to evaluate patients who discover lung nodules incidentally or by lung cancer screening.  As the low-dose computed tomography (LDCT) screen becomes widespread, risk stratification tools, such as ProLungdx’s EPN Scan, will be essential to aiding physicians to evaluate the risk of cancer while treatment options are still available.

About ProLungdx

ProLungdx is a privately held, US-based medical technology company that develops, manufactures and sells non-invasive medical technology to aid in the early detection and diagnosis of lung […]

By |18 May 2016|Press|Comments Off on ProLungdx EPN Scan® Confirms Performance in Early Lung Cancer Risk Assessment|

In March 2016, ProLungdx was featured on Rai 3, the 3rd largest National news source in the market in Italy.

By |13 April 2016|Uncategorized|Comments Off on In March 2016, ProLungdx was featured on Rai 3, the 3rd largest National news source in the market in Italy.|

ProLung study presented at IASLC 2015 Conference

September 22, 2015, Salt Lake City, Utah – A study comparing results from the ProLung EPN scan to the results of PET scans was presented at the 16th World Conference on Lung Cancer in Denver, CO 2015.  The results from this study were also published  in the Journal of Thoracic Oncology, concluding that the “EPN Scan performed favorably versus PET, especially in evaluating smaller or PET-indeterminate lesions.”  Below is the abstract of the published data:
       

  
Bioconductance Compared to 18FDG-PET in Evaluating CT-Detected Lung Lesions
Rex Yung1, Jeff O’Driscoll2, Michael Garff3, Ming Ying Zeng4

1Pulmonology, Greater Baltimore Medical Center, Townson/MD/United States of America, 2Emergency Medicine, Intermountain Health Care, Salt Lake City/UT/United States of America, 3Prolung, Salt Lake City/UT/United States of America, 4Pulmonology, Johns Hopkins School of Medicine, Baltimore/MD/United States of America

 Background: Lung cancer (LC) is the leading cause of cancer mortality. Computed tomographic (CT) screening detects LC at earlier stages but also results in finding many more smaller, benign nodules. Positron-Emission-Tomography (PET) is commonly used to evaluate suspicious lesions prior to invasive biopsies. However, PET accuracy is confounded by various factors including size, inflammation and tumor metabolic activity. Another potential biomarker of cancerous tissue is a non-invasive measure of transcutaneous bioconductance. This study compares Electro Pulmonary Nodule (EPN), a tissue bioconductance scan, to 18FDG-PET in evaluating CT detected suspicious lung lesions.

Methods: Cohort- 27 patients with suspicious nodules evaluated with both PET and EPN scanning (IRB approved protocol) prior to biopsy or long-term radiologic follow-up. An EPN Scan measuring bioconductance was performed on bilateral anatomic skin sites and results were scored as either positive or negative dependent on a defined cut-off point. The PET results were interpreted as positive, negative or indeterminate.

Results: There were 18 LCs (16 non-small […]

By |22 September 2015|Uncategorized|Comments Off on ProLung study presented at IASLC 2015 Conference|

Dr. Jeffrey S. O’Driscoll joins Board of Directors

August 20, 2015, Salt Lake City Utah – The Board of Directors of the Company appointed Jeffrey S. O’Driscoll as a director of the Company.  Dr. O’Driscoll has practiced as an emergency physician since 1992.  He started with Salt Lake Emergency Physicians and then with Utah Emergency Physicians, LLC, when Salt Lake Emergency Physicians merged with Wasatch Emergency Physicians to form the new group.   Since 2004, he has served as an Assistant Adjunct Professor at the University of Utah College of Medicine.  Since 2008, Jeffrey has served as the Medical Director of the Valley Emergency Communication Center – the 911 Call Center for Salt Lake Valley. From 2010 to 2013, he was the Chairman and CEO of Dolor Technologies, LLC, which markets and sells a device co-invented by Dr, O’Driscoll for treating severe aches.  Jeff has served as a member of the medical advisory board of the Company since 2013.   He earned a B.S. in Microbiology from Brigham Young University and an M.D. from the University of Utah College of Medicine.  He has written and presented extensively on professional and religious topics.
For additional information contact:

Chelsey Keeler
801 736 0729 (office)
info@prolungdx.com

By |21 August 2015|Uncategorized|Comments Off on Dr. Jeffrey S. O’Driscoll joins Board of Directors|