Highlight

February 3, 2022

2021 Year End Review

news end of year

The past year was a landmark year for Paige’s growth and evolution as we solidified our position as the global leader in AI-based diagnostic software in pathology.

From landmark regulatory and product milestones to commencing new industry partnerships and presenting new clinical evidence, we’re excited to share some of our recent highlights below and look forward to building on this momentum into 2022.

“We’re proud to usher in a new era of implementing AI in digital pathology particularly with the FDA approval of Paige Prostate,” said Andy Moye, Ph.D., Chief Executive Officer at Paige. “We look forward to taking Paige to the next level in 2022 with the same commitment to delivering products that help pathologists and oncologists make informed and efficient diagnoses and empowering life science companies to pursue more targeted therapies for patients.”

Regulatory Achievements

Paige achieved an industry-first in 2021 with the U.S. Food and Drug Administration (FDA) de novo marketing authorization for Paige Prostate, a first of its kind approval for any AI product in digital pathology, in September 2021.

Additionally, the U.K.’s National Institute for Health and Care Excellence (NICE) published a Medtech Innovation Briefing (MIB) on Paige Prostate, in December 2021 – a first-ever MIB review for a digital pathology product, which will help bring systems like ours into real-world clinical use to fully realize their potential.

Financing Updates

We continued to enhance our financial profile, closing a $125 million Series C financing round led by prominent investors and industry giants such as Casdin Capital, Johnson & Johnson Innovation – JJDC, Inc. and KKR.

Leadership Appointments

Over the past year, we’re proud to have built out a strong bench of leaders with commercial, business development and clinical expertise. These include:

Andy Moye, Ph.D., named CEO in January 2022; Dr. Moye joined Paige in 2021 as Chief Commercial Officer

Jill Stefanelli, Ph.D., named President + Chief Business Officer in January 2022; Dr. Stefanelli joined Paige in 2021 as Chief Precision Medicine Officer

Peter Hamilton, Ph.D., FRCPath (hon), named Chief Operating Officer in January 2022; Dr. Hamilton joined as Chief of Staff and European Director in May 2021

David Klimstra, M.D., named Chief Medical Officer in June 2021

Juan Retamero, M.D., named Medical Director in March 2021

Strategic Partnerships

Our industry partnerships in 2021 expanded Paige’s footprint in the U.S. and U.K., with Paige Prostate and the Paige Platform being utilized at various institutions.

In June 2021, Paige, Oxford University and National Health Service (NHS) regional partners in the U.K. won a Phase 4 Artificial Intelligence in Health and Care award from the NHS Accelerated Access Collaborative to study Paige Prostate prospectively in a real-world cancer laboratory setting. The award funded the founding of a new multidisciplinary research organization called ARTICULATE PRO (Artificial Intelligence for Cellular Pathology Transformation in Prostate Practice).

We initiated partnerships with Epredia and Leica to expand compatibility with scanner platforms to streamline the adoption to digital pathology technology. We also commenced partnerships to implement Paige software and accelerate adoption of digital pathology workflows at renowned commercial laboratories including Quest Diagnosticsand Inform Diagnostics.

Furthermore, our partnerships with Perspectum, Flagship Biosciences and Agendia to offer robust products, decentralize laboratories, and enable these laboratories and hospitals to provide an expanded set of services are a testament to the versatility of Paige’s platform to work with other industry standards.

Product Deployments

In April 2021, Paige completed the deployment of Paige FullFocus™ and Paige Prostate at Grupo Oncoclinicas, the largest private provider of cancer care in Latin America. Additionally, we announced an agreement with the University of Louisville Health to deploy a full suite of Paige AI-enabled digital pathology software in December.

Corporate Recognitions

Paige was recognized by CB Insights in their third annual Digital Health 150 in December, which showcases the 150 most promising private digital health companies in the world. We were also named to Fierce Medtech’s 2020 Fierce 15 list of companies in March, designating Paige as one of the most promising private companies in the industry.

Clinical Evidence Highlights

Further clinical data supporting Paige’s portfolio of digital diagnostics was published in peer-reviewed medical journals and presented at preeminent scientific conferences around the world in 2021, providing further validation of our foundational technology.

Research publications: Published original research in Journal of Pathology  and Modern Pathology demonstrating high specificity and sensitivity of Paige Prostate.

Scientific posters: Paige presented a number of podium talks and exhibited posters with additional evidence on Paige Prostate and Paige Breast at a number of global medical conferences. Additional poster topics included an overview of Paige’s approach to building pathologist-centric AI-based digital diagnostics and a poster presentation by University College London collaborators who used AI to aid macrodissection for prostate cancer “omics” studies.

Rounding out the year, Paige presented two spotlight poster discussions focused on the performance of Paige Breast “Beta” in detecting various forms of breast cancer and highlighted the accuracy of a new AI-based system that detects invasive lobular carcinoma (ILC) at the San Antonio Breast Cancer Symposium in December.

As we look toward the rest of 2022, we are excited to elevate our AI capabilities for life sciences and drug development with a significant focus initially on immuno-oncology, while commencing new partnerships and strengthening our portfolio of digital diagnostics. We will also continue to offer an open technology platform to enable researchers to reimagine what’s possible for AI in digital pathology. Now more than ever, we are embracing the same spirit of innovation that our founders brought to Paige and remain committed to the promise that Paige “can ultimately save lives.”