4 January 2022

LungLife AI, Inc.
(the “Company” or “LungLife”)

 

CPT® Code granted by American Medical Association

Successful grant marks first step facilitating commercial reimbursement

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer announces it has been granted a CPT® Proprietary Laboratory Analyses (PLA) code for its LungLB^® test by the American Medical Association (AMA). The new code has been approved and published by the AMA Editorial Panel and is scheduled to become effective on 1 April 2022.

 

Reimbursement in the US is comprised of three components: code, price, and coverage. CPT® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT® code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers. The successful granting of a CPT® code marks the first step on the path for commercial reimbursement.

 

Paul Pagano, Chief Executive Officer, LungLife AI said: “A CPT® code is fundamental in the commercialisation of the LungLB® test. We were delighted with the AMA’s decision as this will facilitate access to LungLB® for patients with indeterminate pulmonary nodules who are at-risk for lung cancer.”

 

For the full announcement please click HERE.

19 November 2021

LungLife AI, Inc.
(the “Company” or “LungLife”)

 

LungLife AI Clinical Laboratory achieves CAP accreditation

Independent inspection confirms highest standard of care for laboratory patients

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that its clinical laboratory in Thousand Oaks, California has been awarded accreditation by the College of American Pathologists (CAP). The Company, whose clinical laboratory is already CLIA certified, voluntarily sought the accreditation as part of its on-going commitment to maintaining best in class quality systems.

 

The Company’s laboratory processes have been independently assessed by the CAP, the world’s largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes, during a recent on-site inspection designed to ensure the highest standard of care for all laboratory patients.

 

As part of this process, the inspectors examine a laboratory’s records and quality control procedures, as well as laboratory staff qualifications, equipment, facilities, safety programme and overall management. The U.S. federal government recognises the CAP Laboratory Accreditation Program as being equal-to or more-stringent than the government’s own inspection programme, and the Centers for Medicare and Medicaid Services (CMS) have granted the CAP Laboratory Accreditation Program “deeming authority,” which allows for CAP accreditation in lieu of a CMS inspection.

 

Lara Baden, VP Clinical Operations, LungLife AI, commented: “We are proud of the recognition of our quality by the College of American Pathologists through receiving this accreditation, which reflects our commitment to maintaining the highest standards of excellence in laboratory testing for patients and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide ordering physicians and patients a further degree of confidence in the results they are receiving for our LungLB® test as well as for future products.”

For the full announcement, please click here. 

 

10 November 2021

LungLife AI, Inc.

("LungLife" or the "Company")

Block Listing Application

 

LungLife AI (AIM: LLAI), the developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that a block listing application (the “Block Admission”) has been made to the London Stock Exchange for up to 1,356,139 common shares of US $0.0001 each (the “Block Listing Shares”) to be admitted to trading on AIM (“Admission”).

 

The common shares that are being reserved under this block listing application will be issued by the Company, as required, in order to satisfy the exercise of share options and vested awards pursuant to the terms of the following share plans (the “Schemes”):

 

Scheme	No. of common shares under block listing application
2010 Stock Incentive Plan	480,775
2020 Stock Incentive Plan	201,374
2021 Omnibus Long-Term Incentive Plan	673,990

 

The Block Listing Shares will, upon issue, rank equally with all other common shares of US $0.0001 each in the capital of the Company that are then in issue. The Block Listing Admission is expected to become effective on 15 November 2021.

 

For the full announcement, please click here.

12 October 2021

 

LungLife AI, Inc.
(the “Company” or “LungLife”) 

PLA Code application submitted in first step in reimbursement process

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces it has submitted its application for a Proprietary Laboratory Analysis (PLA) code to the American Medical Association.

 

Reimbursement in the US is comprised of three components: code, price, and coverage. The code is the mechanism by which clinical laboratories can more specifically identify their tests when billing Medicare and commercial insurers. If LungLife’s application for a PLA code is granted, the code will be priced for Medicare by the Centers for Medicare & Medicaid Services (CMS) in 2022. PLA code applications can be made at four times in the year.

 

Click HERE for the full announcement.

9 September 2021

LungLife AI, Inc.
(the “Company” or “LungLife”)

Half-year Report

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for the early detection of lung cancer enhanced by artificial intelligence, announces its maiden unaudited half-year report for the six months ended 30 June 2021 following admission to trading on AIM on 8 July 2021.

LungLife, based in California, USA, is a developer of clinical diagnostic solutions for the early detection of lung cancer from a simple blood draw, enhanced by artificial intelligence (“AI”). Lung cancer is one of the most lethal cancers, accounting for nearly a quarter of all cancer-related deaths in the US, and its global incidence has increased by 37% from 2007-2017.

Summary and Highlights:

• H1 2021 Revenues of $107k which entirely relates to resale of FISH probes to the licensee of the LungLB technology in China
• Loss before tax of $4.57m, after charging IPO costs of $2.1m. Adjusted EBITDA¹ loss of $2.23m.
• Admission to AIM & successful £17m (gross) fundraising at an issue price of 176p on 8 July 2021
• Net proceeds to be used to complete its multi-centre pivotal validation studies and support progress towards regulatory authorisation and reimbursement
• Since IPO:
  • CRO for clinical studies has been engaged
  • Actively seeking our first new hires: Directors of R&D and Quality and a Clinical Laboratory Scientist
  • On track for PLA code application
• Targeting commercialisation of LungLB® in 2023

Commenting on outlook, Paul Pagano, Chief Executive Officer of LungLife, said: “Early detection is absolutely key to ensure better outcomes for people with lung cancer and we believe our LungLB® test will give physicians the additional information needed to identify this disease earlier and reduce its impact.

“The funding provided through our AIM IPO allows us to proceed to a larger multi-centre pivotal validation study and secure regulatory authorisation and reimbursement support.  We are now laying the groundwork for successful implementation of our clinical programmes.”

 Notes:

1. Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional item and other operating income

 Please click here to view the full announcement. 

3 September 2021

LungLife AI, Inc.
(the “Company” or “LungLife”)

Notice of Results

Investor Presentation

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that its maiden unaudited half-year report for the six months ended 30 June 2021 will be announced on Thursday 9 September 2021.

Investor presentation

Paul Pagano, Chief Executive Officer, and David Anderson, Chief Financial Officer, will be hosting a live online presentation relating to the half-year report via the Investor Meet Company platform at 4.30pm (BST) on Thursday 9 September 2021. The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and register for the presentation here:

https://www.investormeetcompany.com/lunglife-ai-inc/register-investor

Investors who already follow LungLife on the Investor Meet Company platform will automatically be invited.

Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the "Ask a Question" function.  Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation, a PDF of the slides used, and responses to the Q&A session will be available on the Investor Meet Company platform afterwards.

Click here to read the full announcement.

LungLife AI plc - TR-1 (28.07.21)

TR-1 Lunglife AI Inc (12.07.21) [PDF]

TR-1 Lunglife AI Inc (09.07.21) [PDF]

TR1-Notification of Major Interest in LungLife AI Inc - (08.07.2021) [PDF]