Levisonics Inc. Market Research Report

Background

Overview

Levisonics Inc. is a biotechnology company specializing in the development of innovative medical devices for blood coagulation analysis and fluid rheological measurement. Founded in 2016, the company is headquartered in Fishers, Indiana, with additional operations in New Orleans, Louisiana. Levisonics' mission is to revolutionize coagulation testing by providing safe, fast, and reliable assessments of bleeding and thrombotic risks across all patient demographics. Their proprietary technology, known as "acoustic tweezing rheometry," enables non-contact analysis using minimal blood samples, enhancing patient comfort and diagnostic efficiency.

Mission and Vision

Levisonics aims to transform coagulation testing by introducing a non-invasive, rapid, and comprehensive diagnostic tool that can be utilized in various healthcare settings, including point-of-care environments. Their vision is to improve patient outcomes through innovative technology that simplifies and accelerates the assessment of bleeding and thrombotic risks.

Industry Significance

In the medical device industry, particularly within the diagnostics sector, Levisonics stands out by addressing the critical need for efficient and patient-friendly coagulation testing methods. Their technology has the potential to streamline clinical workflows and enhance the accuracy of diagnostics, thereby contributing to better patient care and management.

Key Strategic Focus

Core Objectives

Levisonics is focused on developing a point-of-care coagulation analyzer that delivers comprehensive diagnostic information about bleeding and thrombotic risks using a single drop of blood. This approach aims to provide rapid and reliable assessments, facilitating timely medical interventions.

Areas of Specialization

The company specializes in blood coagulation analysis, fluid rheological measurement, and the development of medical devices that utilize acoustic tweezing technology for non-contact analysis.

Key Technologies Utilized

Levisonics employs "acoustic tweezing rheometry," a unique containerless approach for fluid analysis that requires only a drop of fluid sample per test. This technology enables safe, fast, and reliable assessments of bleeding and thrombotic risks in patients.

Primary Markets Targeted

The primary markets targeted by Levisonics include neonatal, pediatric, and adult patients requiring coagulation assessments, as well as healthcare facilities seeking efficient point-of-care diagnostic solutions.

Financials and Funding

Funding History

Levisonics has secured multiple grants to support its research and development efforts:

• National Institutes of Health (NIH) Phase I SBIR Grant (2021): $225,177 to develop a home-use coagulation monitoring platform.

• National Science Foundation (NSF) Phase II SBIR Grant (2022): $998,857 to advance a minimal marketable prototype for small-volume blood coagulation testing.

• Department of Defense (DoD) Grant (2024): $4.3 million for the project titled "Point-of-Care Diagnosis and Management of Trauma Patients by Acoustic Tweezing Coagulometry."

Notable Investors

Levisonics has received support from various organizations, including the NIH, NSF, and the DoD. Additionally, the company has been featured in the Entrepreneurship Indiana Yearbook by the Indiana Economic Development Corporation, highlighting its role in the state's entrepreneurial growth.

Utilization of Capital

The funds raised are primarily allocated towards the development and refinement of Levisonics' coagulation analysis technology, including prototype development, clinical testing, and regulatory approvals. The capital also supports strategic initiatives aimed at expanding the company's market presence and operational capabilities.

Pipeline Development

Key Pipeline Candidates

Levisonics is advancing a point-of-care coagulation analyzer designed to provide comprehensive diagnostic information from a single drop of blood. This device is intended for use in various healthcare settings, including hospitals, clinics, and home care environments.

Stages of Development

The company has progressed through several stages of development:

• Prototype Development: Completion of a minimal viable prototype funded by the NSF Phase I STTR grant.

• Clinical Testing: Ongoing validation of the prototype using clinical samples in collaboration with Tulane University.

• Regulatory Approval: Preparation for FDA approval to bring the device to market.

Target Conditions

The device targets conditions related to bleeding and thrombotic risks, including hemophilia, trauma-induced coagulopathy, and other coagulation disorders.

Anticipated Milestones

Levisonics aims to achieve the following milestones:

• Prototype Refinement: Finalize the design based on clinical testing feedback.

• Regulatory Submission: Submit the device for FDA approval.

• Market Launch: Introduce the device to healthcare providers and patients.

Technological Platform and Innovation

Proprietary Technologies

Levisonics' proprietary technology, "acoustic tweezing rheometry," allows for non-contact analysis of blood coagulation and fluid rheology using minimal sample volumes. This technology is particularly beneficial for real-time monitoring in critically ill patients and those with coagulation disorders.

Significant Scientific Methods

The company employs photo-optical and viscoelastic measurement techniques to assess coagulation and fibrinolysis stages, providing a comprehensive diagnostic profile from a single test.

Leadership Team

Key Executives

• Dr. Nithya Kasireddy: Chief Executive Officer. Dr. Kasireddy is an entrepreneur, engineer, clinical research scientist, and inventor with a background in biomedical engineering. She has been instrumental in leading Levisonics' strategic direction and technological development.

• Dr. Damir Khismatullin: Co-Founder, President, and Chief Scientific Officer. Dr. Khismatullin is a tenured associate professor of biomedical engineering at Tulane University and has been pivotal in the scientific research and development of Levisonics' technology.

• Dr. R. Glynn Holt: Co-Founder and Chief Technology Officer. Dr. Holt is a tenured associate professor of mechanical engineering at Boston University and has contributed significantly to the technological advancements of Levisonics.

Competitor Profile

Market Insights and Dynamics

The medical device industry, particularly in the diagnostics sector, is experiencing growth driven by the increasing prevalence of coagulation disorders and the demand for efficient point-of-care testing solutions. Levisonics' innovative approach positions it to address these market needs effectively.

Competitor Analysis

Levisonics faces competition from companies such as Helena Laboratories, which manufactures electrophoresis and point-of-care hemostasis products. However, Levisonics' unique non-contact analysis technology differentiates it in the market.

Strategic Collaborations and Partnerships

Levisonics has established collaborations with academic institutions like Tulane University and Boston University, leveraging their expertise in biomedical and mechanical engineering to advance its technology. Additionally, the company has engaged with organizations such as the Indiana Economic Development Corporation and the Midwest Pediatric Device Consortium, securing grants and support to further its mission.

Operational Insights

Levisonics' strategic focus on non-contact, low-volume blood analysis positions it uniquely in the diagnostics market, offering a competitive advantage over traditional methods that require larger blood samples and more invasive procedures.

Strategic Opportunities and Future Directions

Strategic Roadmap

Levisonics plans to continue refining its coagulation analyzer prototype, conduct extensive clinical testing, and navigate the regulatory approval process to bring its device to market. The company also aims to expand its product offerings to address a broader range of coagulation-related conditions.

Future Business Directions

Levisonics is exploring opportunities to integrate its technology with the Internet of Things (IoT) to enhance connectivity and data sharing capabilities, thereby improving patient monitoring and care.

Opportunities for Expansion

The company is considering partnerships with healthcare providers and medical device distributors to expand its market reach and accelerate the adoption of its technology.

Contact Information

Levisonics Inc.

Official Website:

Social Media:

Headquarters:

Note: Specific contact details such as email addresses and phone numbers are not publicly disclosed.