Digistain® Company Profile

Background

Overview

Founded in 2019, Digistain® is a UK-based medical device company specializing in digital solutions for cancer diagnostics. The company's mission is to revolutionize cancer grading and prognosis by providing rapid, cost-effective, and accurate diagnostic tools. By integrating advanced imaging technologies with artificial intelligence, Digistain® aims to eliminate subjectivity in cancer diagnosis, ensuring patients receive appropriate treatments.

Industry Significance

Operating within the diagnostic equipment sector, Digistain® addresses critical challenges in oncology diagnostics. Traditional methods often involve subjective assessments, leading to variability in diagnoses. Digistain®'s technology offers a standardized, objective approach, enhancing diagnostic accuracy and potentially improving patient outcomes.

Key Strategic Focus

Core Objectives

• Enhance Diagnostic Accuracy: Develop technologies that provide precise and reproducible cancer grading.

• Reduce Diagnostic Time and Costs: Offer solutions that streamline the diagnostic process, making it faster and more affordable.

• Integrate with Existing Clinical Workflows: Ensure that new technologies can be seamlessly adopted within current medical practices.

Areas of Specialization

Digistain® focuses on breast cancer diagnostics, particularly for hormone receptor-positive patients. Their technology assesses the necessity of chemotherapy, aiding clinicians in making informed treatment decisions.

Key Technologies Utilized

• Mid-Infrared Imaging: Utilized to map chemical changes in tissue samples, identifying cancerous transformations.

• Artificial Intelligence and Machine Learning: Employed to analyze imaging data, providing objective risk assessments.

Primary Markets Targeted

The company primarily serves healthcare institutions, including hospitals and diagnostic laboratories, aiming to enhance their oncology diagnostic capabilities.

Financials and Funding

Funding History

Digistain® has secured funding through multiple rounds:

• Pre-Seed Round (January 2021): Raised approximately $125,000.

• Seed Round (August 2022): Secured around $1 million.

• Grant (January 2023): Received an undisclosed amount to support ongoing research and development.

• Later Stage VC (January 2024): Obtained additional funding to scale operations and expand market reach.

Notable Investors

• Y Combinator: Participated in the pre-seed funding round.

• Gaingels Syndicate: Invested during the seed round.

• Sofia Angels Ventures: Also contributed to the seed funding.

Utilization of Capital

The funds have been allocated towards:

• Research and Development: Advancing the Digistain® technology and expanding its applications.

• Regulatory Approvals: Securing necessary certifications for market entry.

• Market Expansion: Building partnerships with healthcare institutions and expanding the company's presence in the diagnostic market.

Pipeline Development

Key Pipeline Candidates

• DIGISTAIN® Diagnostic Test: A patented risk profiling test for hormone receptor-positive breast cancer patients.

Stages of Development

• Clinical Validation: Conducted double-blind clinical pilot trials demonstrating the technology's reliability in grading cancer severity.

• Regulatory Approval: Received approval from the UK's Medicines & Healthcare products Regulatory Agency (MHRA).

Target Conditions

Primarily focused on breast cancer diagnostics, with potential applications across various cancer types due to the technology's ability to measure the nuclear-to-cytoplasmic ratio, a common biomarker in multiple cancers.

Anticipated Milestones

• Market Launch: Introduction of the DIGISTAIN® test into clinical settings.

• Expansion of Applications: Research into applying the technology to other cancer types.

Technological Platform and Innovation

Proprietary Technologies

• DIGISTAIN® Imaging System: Utilizes mid-infrared light to capture chemical changes in tissue samples, providing a quantitative 'Digistain index' (DI) score that correlates with cancer severity.

Significant Scientific Methods

• Mid-Infrared Imaging: Maps out chemical changes signaling cancer onset.

• Machine Learning Algorithms: Analyze imaging data to compute risk scores, reducing human subjectivity in diagnosis.

Leadership Team

• Dr. Hemmel Amrania: Co-Founder and Chief Executive Officer. Brings expertise in medical imaging and diagnostics.

• Dr. Christopher Phillips: Co-Founder and Chief Scientific Officer. A professor at Imperial College London, specializing in biomedical optics.

• Sabrina Ali: Chief Operating Officer. Oversees operational strategies and business development.