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Concept Medical

Concept Medical

Tampa, United States· Est. 1999

Headquartered in Tampa, Florida, Concept Medical is a leader in developing innovative solutions for cardiovascular diseases, focusing on unmet clinical needs in coronary and peripheral artery disease. The company's mission, 'Converting Concepts into Reality,' is powered by its patented Nanolute, Nanoactive, and Envisolution technologies. With a vast clinical trial portfolio including the world's largest RCT on diabetic patients and multiple ongoing IDE studies in the US, Concept Medical is positioned at the forefront of the drug-coated balloon and stent market.

conceptmedical.com

Private Company

Total funding raised: $17.5M

AI Company Overview

Headquartered in Tampa, Florida, Concept Medical is a leader in developing innovative solutions for cardiovascular diseases, focusing on unmet clinical needs in coronary and peripheral artery disease. The company's mission, 'Converting Concepts into Reality,' is powered by its patented Nanolute, Nanoactive, and Envisolution technologies. With a vast clinical trial portfolio including the world's largest RCT on diabetic patients and multiple ongoing IDE studies in the US, Concept Medical is positioned at the forefront of the drug-coated balloon and stent market.

CardiovascularPeripheral Vascular DiseaseCoronary Artery Disease

Technology Platform

Proprietary nanotechnology-based drug delivery platforms (Nanolute, Nanoactive, Envisolution) for coating balloons and stents with sirolimus, designed to optimize drug transfer and tissue bioavailability in vascular interventions.

Funding History

2
Total raised:$17.5M
Series A$15MMar 15, 2020
Seed$2.5MJun 15, 2018

Opportunities

Major growth opportunity lies in successful US FDA approval via the MAGICAL IDE trials, unlocking the world's largest medical device market.
Expansion of sirolimus-coated balloon indications and leveraging extensive diabetes clinical data to capture a high-need patient segment present significant potential.
Further geographic expansion and potential platform technology licensing are additional avenues.

Risk Factors

Primary risks include failure of pivotal US clinical trials (MAGICAL ISR/SV) to meet endpoints, resulting in delayed or denied FDA approval.
The company faces intense competition from large, established medtech corporations with greater resources.
Market adoption challenges and securing favorable reimbursement in key markets also pose significant commercial risks.

Competitive Landscape

Competes against major players like Boston Scientific, Medtronic, and BD in the DCB/DES space. Key differentiation includes a focus on sirolimus (vs. common paclitaxel), proprietary nanotechnology drug-delivery platforms (Nanolute), and owning the world's largest RCT dataset for DCB/DES in diabetic patients, a critically important population.