Nexvena
Date of Foundation
2024

Nexvena

Nexvena creates bidirectional cannulas to prevent limb ischemia during ECLS.

The Idea origin story

Nexvena aims to redefine extracorporeal life support by developing a bidirectional cannula that curbs limb ischemia, a common side effect due to restricted blood flow. Despite critical care advancements, current devices fail to protect the limb. Our innovative cannula assures full systemic support while preserving distal perfusion. In essence, it's one device promoting whole body support and limb protection.

The Mission

Our vision is to make life support safer and more humane, eliminating limb loss. Our mission involves innovating cannulations to maximize patient safety during ECLS and ECMO.

Clients

PitchBob’s recommendation: Our customers include cardiac surgery centers, ICU departments, medical device integrators, hospital administrators, and defense medicine units.

Problems we solve

Client’s problem

Our product addresses limb ischemia during femoral cannulation in ECLS or ECMO. Currently, standard single-lumen femoral cannulas block blood flow to the lower limb, resulting often in serious and preventable complications.

Confirmation of problem

The problem is serious because it's common with high morbidity, severe consequences, substantial costs, widespread lack of solutions; it profoundly affects patient survival.

Solution

Our solution is a bidirectional femoral arterial cannula. It ensures continuous blood flow during ECLS and cardiac surgery, reducing the chance of limb ischemia significantly.

Our technologies

This solution is based on technologies

How it works

We are still developing a prototype

Value for the client

We revolutionize ECLS safety, preventing limb ischemia with our bidirectional cannula, thus saving lives and reducing healthcare costs.

Market and strategy

Market size

The global femoral cannula market is valued at ~$41 billion (2023) and projected to reach ~$77 billion annually by 2032 — with Nexvena’s target arterial segment worth about $18–20 billion per year.

mln/year

We estimate the market size for which our solution is designed in monetary terms as follows

Market share goal

In the initial launch phase (first 3 years), Nexvena targets ~1% market share within the arterial femoral cannula segment — equivalent to ≈ $180 million in annual revenue potential across EU early-adopter hospitals.

% of the market

Is our goal in the next 3 years

Team

My name’s

Dmitriy Gudovskiy

My key role in the product

"My key role is CBDO, responsible for fundraising, liaising with investors & leading business development initiatives."

Team size and key members

"Our team: Dr. Skrypnik, 18 years in Vascular Surgery; D. Potyagaylo, PhD with 13 years in Software development & R&D; N. Mazein, a PhD holder with 20 years experience in M&A and Strategic Planning."

Competitors

Competitors

Our main competitors are traditional cannula manufacturers like Medtronic and Abbott Laboratories. While they offer single protection devices, we at Nexvena provide a first-in-class dual-protection device to prevent limb ischemia during ECLS procedures.

Our Advantages

Nexvena's femoral cannula stands out through its unique bidirectional flow feature solving the prevalent issue of limb ischemia. Its user-friendly design necessitates no additional training or equipment and aligns seamlessly with existing ECMO and CPB circuits. Our patented technology also ensures optimal laminar flow avoiding any turbulence, which is a game-changer in extracorporeal care.

Business model

Our revenue comes from selling our single-use cannulas that reduce complications and costs. Moreover, we offer optional training packages for comprehensive integration in medical facilities.

Traction

Over the past six months, we've made significant strides in our cannula's design and prototyping, confirmed its superior flow via testing, secured provisional patent rights for it in Germany, prepared for pre-clinical validation through partnerships with German cardiac centers and are also shortlisted for two MedTech accelerator opportunities.

We will have a CE-ready design, validated through animal testing. We'll also establish partnerships with hospitals, expand our IP internationally and prepare for further investment as we present a clear commercial roadmap.

Metrics

PitchBob’s recommendation: We track important metrics such as flow performance and limb perfusion efficiency. The trend shows stable systemic support, reduced ischemia risk, predictable hemodynamics, and improved design & handling in comparison to market alternatives.

PitchBob’s recommendation: Currently, Nexvena is pre-revenue focusing on research & development along with prototyping. We also initiated IP filing and MDR preparation by maintaining a lean structure funded by founders and early grants. Our primary expected revenue would be through hospital programs post-approval.

Incorporation

Our company incorporated in

Germany

Key risks

PitchBob’s recommendation: Our startup could potentially face regulatory hurdles, clinical validation and manufacturing challenges, slow adoption by hospitals due to conservative procedures, fundraising for multi-stage developments as well as competition from established brands.

Investments

$

100000

We raised investments

Our Investors

founders, 25% each

Rising Investments

$

40000

Currently, we are raising investments

$

2000000

Estimated pre-investment valuation of the company

We’re looking for a co-founders

My startup, Nexvena, is actively seeking a versatile co-founder brightened by entrepreneurial zeal and shares in our vision to revolutionize extracorporeal life support. We're developing a bidirectional cannula that aims to prevent limb ischemia - a common but severe and costly complication during ECLS and ECMO procedures. Our mission calls for innovating cannulation methods to maximize patient safety and quality of life. Earning an impressive ~$180 million in potential revenue by capturing just 1% of the $18 billion arterial femoral cannula market, potential for growth in our startup is significant. Our team, made up of experts with a significant track record in vascular surgery, software development, and strategic planning, is positioned to face the competition head-on. However, we are missing a strategic co-founder who can complement our strengths and address our weaknesses. Our ideal co-founder will be experienced in the med-tech field with a focus on product development, FDA regulatory pathways, and clinical trials

Open positions

We're seeking a dedicated Biomedical Engineer to join our dynamic startup, Nexvena. Our mission is to redefine Extracorporeal Life Support (ECLS) safety by developing an innovative bidirectional cannula that mitigates limb ischemia, acommon adverse effect of present ECLS procedures. The ideal candidate will possess a deep understanding of medical/device design and development with an emphasis on ECLS procedures. Key responsibilities shall include: - Lead Prototype Design: Participate actively in designing, developing, and refining our bidirectional cannula. - Manage Validation Process: Conduct and manage pre-clinical trial validation of our prototype. - Collaborate with our cross-functional team of experts consisting of vascular surgeons, R&D software developers, and strategic planning professionals. Required qualifications: - Bachelor’s degree (or higher) in Biomedical Engineering. - Proven experience in medical device development, ideally in the cardiovascular field. - Deep understanding of ECLS procedures and complications. - Exceptional collaboration skills, able to thrive

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