Functional Fluidics Company Profile

Background

Functional Fluidics, founded in 2014, is a biotechnology company specializing in red blood cell (RBC) health. The company's mission is to establish itself as the gold standard in RBC health, beginning with sickle cell disease (SCD). By offering a suite of proprietary blood function assays, Functional Fluidics provides valuable insights into RBC health, addressing the need for reliable biomarkers to monitor these cells' well-being. The company operates a high-complexity, CLIA-certified diagnostic laboratory, serving clinical providers, pharmaceutical companies, academic institutions, and biotech partners to support drug development and patient care.

Key Strategic Focus

Functional Fluidics focuses on:

Proprietary Assays: Developing and offering unique diagnostic platforms that assess RBC health.

Clinical Trial Support: Providing contract research services to pharmaceutical, biotech, and academic research companies, facilitating large-scale validation studies and personalized medical applications.

Global Expansion: Establishing operations in sub-Saharan Africa, starting with Nigeria, to broaden access to RBC health insights and support the development of therapies for SCD.

Financials and Funding

Functional Fluidics has secured funding through various channels:

Seed Round: Completed on January 5, 2021.

Later Stage Venture Capital: Secured on December 30, 2022, and December 7, 2023.

Investors: The company has attracted investments from entities such as Michigan Rise, NYBC Ventures, CB3 Holdings, Invest Detroit Ventures, and Michigan Capital Network Ventures.

Pipeline Development

Functional Fluidics offers a suite of proprietary assays, including:

Flow Adhesion Assay: Evaluates the adhesion properties of RBCs under simulated physiological conditions.

Dynamic Sickling Assay: Assesses the propensity of RBCs to undergo sickling under hypoxic conditions.

Mechanical Fragility Assay: Measures the susceptibility of RBCs to hemolysis under mechanical stress.

These assays are utilized to monitor the effects of drugs on blood function over time, supporting clinical studies and trials.

Technological Platform and Innovation

Functional Fluidics distinguishes itself through:

Proprietary Technologies: Developing unique diagnostic platforms that assess RBC health.

Scientific Methodologies: Utilizing assays such as Flow Adhesion, Dynamic Sickling, and Mechanical Fragility to provide comprehensive insights into RBC function.

Global Patient Registry: Partnering with Ripple Science to build a global registry of sickle cell patient biomarker data, enhancing the speed, cost, and success rate of bringing therapies to patients.

Leadership Team

Dr. Patrick Hines: Founder and CEO. As an ICU physician, Dr. Hines has treated patients with serious health conditions resulting from abnormal RBC function. His mission is to develop diagnostic tools to predict problems, treat illnesses, and monitor therapy responses in patients.

Dr. Nnamdi Okeke: Vice President, Head of Global and Medical Affairs. Dr. Okeke managed the buildout of the Nigeria facility, aiming to improve the lives of individuals living with SCD in Nigeria and globally.

Leadership Changes

In June 2024, Functional Fluidics officially opened its clinical research center and laboratory in Awka, Nigeria, marking a significant milestone in the company's global expansion efforts.

Competitor Profile

Market Insights and Dynamics

Sickle cell disease affects approximately 25 million people worldwide, with a significant prevalence in sub-Saharan Africa. The demand for reliable biomarkers to monitor RBC health is critical, driving the need for innovative diagnostic solutions.

Competitor Analysis

While specific competitors are not detailed in the available information, companies operating in the RBC health diagnostics and SCD therapeutic development space may include:

Global Blood Therapeutics: Focuses on developing therapeutics for SCD.

Emmaus Life Sciences: Develops treatments for rare diseases, including SCD.

Novartis: Engages in SCD research and treatment development.

These companies contribute to the competitive landscape by offering various approaches to SCD treatment and diagnostics.

Strategic Collaborations and Partnerships

Functional Fluidics has established significant collaborations to enhance its capabilities:

Ripple Science: Adopted Ripple's cloud platform to build a global registry of sickle cell patient biomarker data, initially deploying at sites in the United States and sub-Saharan Africa.

Operational Insights

Functional Fluidics' strategic expansion into Nigeria positions the company to address the high prevalence of SCD in sub-Saharan Africa. By establishing a clinical research center and laboratory in Awka, Nigeria, the company aims to support clinical trials and improve access to innovative therapies in regions most affected by SCD.

Strategic Opportunities and Future Directions

Functional Fluidics is poised to:

Expand Global Reach: Continue its expansion into regions with high SCD prevalence to support clinical trials and patient care.

Enhance Diagnostic Platforms: Further develop and validate its suite of proprietary assays to become the gold standard in RBC health diagnostics.

Foster Collaborations: Strengthen partnerships with pharmaceutical, biotech, and academic institutions to accelerate the development of life-changing therapies for SCD and other RBC-related conditions.