CorInnova, Inc. Market Research Report

Background

Overview

CorInnova, Inc., founded in 2004, is a Houston-based medical device company specializing in the development of innovative cardiac assist technologies aimed at treating acute heart failure. The company's flagship product, the EpicHeart™ device, is a minimally invasive, non-blood-contacting soft robotic system designed to enhance cardiac output and promote heart recovery. This technology represents a significant advancement over traditional left ventricular assist devices (LVADs) by reducing complications associated with blood contact and invasive procedures.

Mission and Vision

CorInnova's mission is to revolutionize heart failure treatment by providing a safer, more effective alternative to existing cardiac assist devices. The company's vision is to expand the eligibility for cardiac assist therapies, potentially tripling or quadrupling the number of patients who could benefit from such treatments.

Primary Area of Focus

The company's primary focus is on developing and commercializing the EpicHeart™ device, which aims to address the limitations of current heart failure treatments by offering a less invasive and more patient-friendly option.

Industry Significance

Heart failure affects millions globally, with a significant number of patients being ineligible for existing assist devices due to their invasive nature and associated risks. CorInnova's technology has the potential to transform the treatment landscape by providing a viable option for a broader patient population, thereby addressing a substantial unmet medical need.

Key Strategic Focus

Core Objectives

• Innovation in Cardiac Assist Devices: Developing a non-blood-contacting, minimally invasive device to improve cardiac output and promote heart recovery.

• Market Expansion: Increasing the number of patients eligible for cardiac assist therapies by offering a safer and more accessible treatment option.

Specific Areas of Specialization

• Soft Robotic Technology: Utilizing soft robotics to create a device that gently compresses the heart, enhancing its function without direct blood contact.

• Minimally Invasive Procedures: Designing a device that can be implanted through a minimally invasive procedure, reducing patient recovery time and associated risks.

Key Technologies Utilized

• Pneumatic Actuation: Employing air inflation to actuate the device in synchrony with the heartbeat, providing gentle cardiac compression.

• Collapsible and Self-Expanding Design: Ensuring easy delivery and rapid deployment within the pericardial sac.

Primary Markets Targeted

• Short-Term Cardiac Assist: Addressing the acute heart failure market, particularly for patients unsuitable for existing devices.

• Global Heart Failure Treatment: Expanding the addressable market by offering a device suitable for a broader patient demographic.

Financials and Funding

Funding History

CorInnova has secured multiple funding rounds to support its development efforts:

• 2006: Received a $500,000 award from the Texas Emerging Technology Fund.

• 2017: Secured a $6.1 million investment from the Wellcome Trust.

• 2019: Awarded a grant from the National Science Foundation.

Total Funds Raised

The company has raised a total of approximately $6.1 million across several funding rounds.

Notable Investors

• Wellcome Trust: A UK-based global charitable foundation that has provided significant funding to support CorInnova's development.

• National Science Foundation (NSF): Provided grants to support the company's research and development efforts.

Intended Utilization of Capital

The funds have been utilized for:

• Product Development: Advancing the design and functionality of the EpicHeart™ device.

• Clinical Research: Conducting preclinical and clinical studies to validate the device's safety and efficacy.

• Regulatory Approvals: Navigating the regulatory pathways to achieve necessary approvals for human use.

Pipeline Development

Key Pipeline Candidates

• EpicHeart™ Device: A non-blood-contacting, soft robotic cardiac assist device designed to treat acute heart failure.

Stages of Development

• Preclinical Studies: Conducted to assess the device's safety and efficacy in animal models.

• Clinical Trials: Plans for future human clinical trials to further evaluate the device's performance.

Target Conditions

• Acute Heart Failure: Focusing on patients who are ineligible for existing cardiac assist devices due to their invasive nature.

Anticipated Milestones

• Regulatory Approval: Seeking approval from regulatory bodies for human clinical trials.

• Market Launch: Aiming to introduce the device to the market upon successful clinical validation.

Technological Platform and Innovation

Proprietary Technologies

• Soft Robotic Cardiac Assist Device: A collapsible, self-expanding device that gently compresses the heart to enhance cardiac output without direct blood contact.

Significant Scientific Methods

• Pneumatic Actuation: Utilizing air inflation to actuate the device in synchrony with the heartbeat, providing gentle cardiac compression.

• Minimally Invasive Delivery: Employing a delivery system that allows for rapid deployment within the pericardial sac through a minimally invasive procedure.

Leadership Team

Key Executives

• William Altman: CEO

• Professional Background: Extensive experience in medical device development and commercialization.

• Contributions: Led the strategic direction and funding initiatives for CorInnova.

• John C. Criscione: Co-Founder and CTO

• Professional Background: Professor in the Department of Biomedical Engineering at Texas A&M University.

• Contributions: Developed the foundational technology for the EpicHeart™ device.

• Clarice Motter: Vice President & CFO

• Professional Background: Background in finance and operations within the medical device industry.

• Contributions: Oversees financial strategy and operations for the company.

• Boris Leschinsky: Vice President of Product Development

• Professional Background: Experience in product development and engineering within the medical device sector.

• Contributions: Leads the development and refinement of the EpicHeart™ device.

Competitor Profile

Market Insights and Dynamics

The heart failure treatment market is substantial, with a significant number of patients being ineligible for existing assist devices due to their invasive nature and associated risks. CorInnova's technology has the potential to address this unmet need by providing a safer and more accessible treatment option.

Competitor Analysis

• Brainlab: Develops software and integrated solutions for surgical and radiotherapy applications.

• PROCEPT BioRobotics: Specializes in robotic waterjet systems for prostate tissue removal.

• Auris Health: Focuses on robotic microsurgical systems for endoscopy.

• Intuitive Surgical: Known for robotic-assisted surgical systems for minimally invasive procedures.

• Medical Microinstruments: Provides a robotic platform for microsurgery with scaled instruments.

Strategic Collaborations and Partnerships

CorInnova has established key partnerships to advance its technology:

• Wellcome Trust: Provided significant funding to support the development of the EpicHeart™ device.

• National Science Foundation (NSF): Awarded grants to support the company's research and development efforts.

• Johnson & Johnson Innovation JLABS @ TMC: Offered a residency to CorInnova, providing access to resources and expertise to further develop the EpicHeart™ technology.

Operational Insights

Strategic Considerations

CorInnova's strategic focus on developing a minimally invasive, non-blood-contacting cardiac assist device positions it uniquely in the market. By addressing the limitations of existing devices, the company aims to expand the patient population eligible for cardiac assist therapies, thereby increasing market share and impact.

Competitive Advantages

• Innovative Technology: The EpicHeart™ device's soft robotic design and non-blood-contacting approach differentiate it from traditional LVADs and other assist devices.

• Minimally Invasive Deployment: The collapsible and self-expanding nature of the device enables easier implantation with reduced risk and faster recovery.

• Broader Patient Eligibility: By mitigating typical complications of blood-contacting devices, CorInnova targets a larger market demographic.

Challenges and Considerations

• Regulatory Approval Process: Moving from preclinical to clinical stages involves rigorous validation and regulatory scrutiny.

• Market Entrenchment of Competitors: Established devices and companies have strong presences in cardiac assist markets, requiring CorInnova to demonstrate clear advantages.

• Clinical Validation Needs: Comprehensive trials are necessary to prove safety, efficacy, and long-term benefits.

Market Trends

• Increasing prevalence of heart failure worldwide is driving demand for novel, less invasive assistive technologies.

• Growing interest in soft robotics and minimally invasive medical devices supports innovation in this segment.

• Healthcare providers seek solutions that reduce complications and shorten hospital stays.