Diality Company Profile

Background

Company Overview

Diality Inc., founded in 2015 and headquartered in Irvine, California, is a privately held medical device company dedicated to developing innovative solutions for individuals affected by kidney disease. The company's mission is to enhance the quality of life for patients by providing versatile and user-friendly hemodialysis systems that can be utilized across various healthcare settings. Diality's flagship product, the Moda-flx Hemodialysis System™, exemplifies this commitment by offering a flexible and mobile dialysis solution designed to meet the diverse needs of both patients and healthcare providers.

Key Strategic Focus

Core Objectives and Specialization

Diality's strategic focus centers on addressing the unmet needs within the dialysis industry by developing a hemodialysis system that combines the prescription capabilities of in-center treatments with the ease of use required for home and alternative care settings. The Moda-flx Hemodialysis System is engineered to deliver a broad range of dialysis prescriptions, accommodating both low-dose extended treatments and high-dose in-center treatments. This versatility allows healthcare providers to tailor treatments to individual patient requirements, thereby improving outcomes and expanding access to care.

Key Technologies and Target Markets

The Moda-flx system incorporates advanced features such as variable flow rate ranges, integrated reverse osmosis filtration, and an intuitive graphical user interface. Its compact and mobile design facilitates deployment in diverse environments, including hospitals, skilled nursing facilities, dialysis centers, and home settings. By offering a system that is both adaptable and user-friendly, Diality aims to serve a total addressable market estimated at over $7 billion in the United States alone.

Financials and Funding

Funding History and Utilization

Diality has successfully secured multiple funding rounds to support its development and commercialization efforts:

Series B2 Funding (March 2022): Raised $24 million to support regulatory clearance activities, prepare for home clinical studies, and build a U.S. commercial organization.

Series C Funding (August 2023): Secured $28 million to support 510(k) filing, pre-commercialization activities, and initiation of U.S. home hemodialysis clinical trials.

These investments have been instrumental in advancing the Moda-flx Hemodialysis System toward regulatory approval and market entry.

Pipeline Development

Product Development and Clinical Trials

The Moda-flx Hemodialysis System has achieved significant milestones:

FDA 510(k) Clearance (August 2024): Received clearance for use in patients with acute and chronic renal failure across various care settings.

First Patient Treatment (Date Not Specified): Successfully completed the first patient treatment with the Moda-flx system in collaboration with the North America Research Institute at Ontario-Holt Dialysis Center in Ontario, California.

These developments position Diality to commence broader clinical adoption and commercialization efforts.

Technological Platform and Innovation

Proprietary Technologies and Scientific Methodologies

The Moda-flx Hemodialysis System distinguishes itself through several innovative features:

Variable Flow Rate Ranges: Allows customization of dialysis treatments to meet individual patient needs.

Integrated Reverse Osmosis Filtration: Ensures high-quality dialysis fluid without the need for external water treatment systems.

Intuitive Graphical User Interface: Simplifies operation for healthcare providers and patients, reducing training time and potential for user error.

These technologies collectively enhance the system's adaptability and ease of use across multiple care environments.

Leadership Team

Executive Profiles

Osman Khawar, MD – Chief Executive Officer: A board-certified nephrologist with extensive experience in clinical research and dialysis operations. Dr. Khawar holds an MD from the University of Glasgow and an MPH from Johns Hopkins University.

Daniel Guthrie, MBA – Chief Business Officer: Brings over 20 years of experience in the medical device and pharmaceutical industries, with previous roles at Neuronetics, Zimmer Biomet, and Medtronic. Mr. Guthrie earned his MBA from Southern Illinois University at Carbondale.

Jahnavi Lokre, MS, MBA – Chief Operating Officer: An experienced product developer with a background in electromechanical and software medical devices. Ms. Lokre holds an MS from Texas A&M and an MBA from UCLA.

Blaine Murakami – Chief Technology Officer: Over a decade of engineering leadership experience, with prior roles at Becton Dickinson and Vyaire. Mr. Murakami earned his BS in Electrical Engineering from the University of Hawaii.

Clayton Poppe, MS, MBA – Chief Strategy Officer: Experienced in systems engineering and technical management, with a focus on home hemodialysis machines. Mr. Poppe holds an MS in Systems Engineering and an MBA from MIT.

Craig Ross – Chief Financial Officer: Over 15 years of experience as a CFO and operational leader in technology companies. Mr. Ross received his BS from the University of Vermont.

Board Members

Dr. Allen R. Nissenson, FACP, FASN, FNKF: Emeritus Professor of Medicine at UCLA and former Chief Medical Officer for DaVita Kidney Care. Dr. Nissenson has authored over 700 publications in nephrology and dialysis.

Robert Funari: Nearly 50 years in the healthcare industry, with leadership roles at Syncor International, Crescent Healthcare, and as chairman of NxStage Medical. Mr. Funari joined Diality's board in May 2023.

Leadership Changes

Recent Appointments

Robert Funari – Board Member (May 2023): Appointed to the board, bringing extensive experience in healthcare services and medical devices.

Competitor Profile

Market Insights and Dynamics

The hemodialysis market is experiencing significant transformation, driven by the decentralization of dialysis delivery and the increasing demand for home-based treatments. The U.S. market alone is estimated to be over $7 billion, presenting substantial opportunities for innovation and growth.

Competitor Analysis

Key competitors in the hemodialysis space include:

DaVita Inc.: A leading provider of dialysis services, operating numerous outpatient dialysis centers across the United States.

Fresenius Medical Care: A global leader in dialysis products and services, offering a comprehensive range of hemodialysis machines and related equipment.

NxStage Medical (acquired by Fresenius): Specialized in home hemodialysis solutions, providing portable systems designed for patient use outside traditional clinical settings.

Diality differentiates itself by offering a system that combines the flexibility of home dialysis with the capabilities of in-center treatments, addressing a gap in the current market offerings.

Strategic Collaborations and Partnerships

Key Alliances

Paramit Corporation (March 2022): Established a partnership for the manufacture of the Moda-flx Hemodialysis System, leveraging Paramit's expertise in complex electromechanical and fluidic systems.

Kidney Care Partners (August 2024): Joined this leading kidney care coalition to advocate for patient-centered care and innovation within the kidney care sector.

Operational Insights

Strategic Considerations

Diality's strategic positioning focuses on providing a hemodialysis system that is both versatile and user-friendly, catering to the evolving needs of the dialysis market. By offering a device suitable for multiple care settings and capable of delivering a wide range of dialysis prescriptions, Diality aims to enhance patient outcomes and expand access to quality care.