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Open Stent Solution develops the Cornelis™ Valve, the world’s first valvular implant employing RIBBON VALVE technology for non-surgical heart valve replacement, targeting mitral and tricuspid valve regurgitation, to restore heart valve continence and to TREAT heart valve dysfunction. This innovative method offers a less invasive alternative, promising faster recovery and reduced risk compared to traditional surgery.

50 remaining days
156 investors
Investment achieved
484.460€
Target
500.000€
Invested
96.9%
100% COMMITTED ? Amount of committed pre-campaign investments in the form of reservations or signed letters of intent.
COMMITTED : 14.500,00
484.460
96.9% INVESTED
Maturity

Prototype/preclinical

Premoney valuation

7.500.000

Estimated exit

2027

Sector

Medical devices

Equity offered

6.25%

Minimum investment

500

FR based flag
Equity L
Tax deduction L
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Overview: Open Stent Solution

Valuation 7.500.000
Estimated return x19
% Offered 6.25%
Estimated exit 2027
The company

Open Stent Solution (OSS) stands at the forefront of minimally invasive heart valve replacement technology, with its groundbreaking Ribbon Valve technology aimed at treating heart valve diseases. Specializing in transcatheter valve replacement, OSS is dedicated to providing innovative, patient-adaptive solutions with the Cornelis valve device, aimed at a wide patient demographic.

Currently, OSS is advancing towards finalizing the Cornelis Valve™ design and moving into the verification, validation, and preclinical trial phases by the third quarter of 2024. The Cornelis™ Valve, designed as a direct replacement for failing heart valves, has demonstrated promising hemodynamic performance and integration within the anatomical heart structures in animal trials, aiming to halt disease progression, enhance quality of life, and extend patient longevity.

With mitral regurgitation—a condition affecting a significant portion of the elderly population—remaining largely untreated due to surgical limitations, OSS targets a potential $18 billion TMVR market by 2032. The company’s innovative approach overcomes the design and anatomical limitations of current technologies, offering a solution for a broader patient base.

OSS’s strategy involves finalizing its product design, engaging with regulatory bodies like the FDA, and initiating clinical trials to achieve global regulatory approvals. Through strategic partnerships with leading heart valve specialists and MedTech companies worldwide, OSS is well-positioned to expedite its market entry and adoption.

Focused on developing treatments for both mitral and tricuspid valve diseases, OSS is committed to expanding access to its technologies, leveraging its expertise to bring these much-needed solutions to patients. With significant seed funding, prestigious awards, and a growing team of experts, OSS is poised to make substantial contributions to the field of heart valve replacement, revolutionizing patient care with its unique, adaptable valve technology.

Why is Capital Cell investing in this company?

Open Stent is a game-changer for heart health, targeting a common heart condition that affects 7 million older adults in Europe, the United States, and China. Currently, many patients do not receive the best treatment because traditional heart surgery is too risky for them, and existing heart devices do not fit well for most people, putting their safety at risk.

Open Stent's innovative solution: a unique heart valve that can be adjusted for any patient, designed to be placed through a simple procedure from the groin, and without open-heart surgery. This new design can match any blood vessel size and heart movement of the patient, promising better outcomes. With successful early animal tests and plans for more studies starting in 2025, Open Stent is on track to meet a significant need in heart care.

Led by a team of expert cardiac surgeons, Open Stent arises to meet a clear medical need drawn directly from the experiences of doctors and patients.

Minimum investment: 500
Type of exit expected: M&A
Drag-along rights
Tag-along rights
Tax deductions
Our company is qualify for French investors with 30% taxe incentives
Main risks

Regulatory hurdles could delay or restrict Open Stent's market access, with the outcome of human clinical trials being a crucial turning point.

Moreover, although there is currently no known competitor with an approach as innovative as Open Stent's to address this significant unmet medical need, new competitors with similar features may emerge.

More information

The Cornelis Valve™ is a game-changer, transcending conventional boundaries in transcatheter mitral valve replacement (TMVR). Its unparalleled ability to increase patient eligibility not only enhances patient care but also positions us to capture a significant 25% market share within just 5 years of commercialization.

Ribbon Valve Technology: The standout feature is the Ribbon Valve Technology, allowing easy loading into a low-profile delivery system. This technology significantly broadens eligibility criteria, making it suitable for a wider range of patients.

Lower Complication Rates: The low-profile delivery system reduces vascular access complications and bleeding during procedures, contributing to better patient experiences and faster recoveries

The primary advantage of the Cornelis Valve™ is its ability to expand patient eligibility for transcatheter mitral valve replacement (TMVR). By accommodating a broader range of patients who were previously considered ineligible for this procedure, the market potential significantly increases.

Our experts say

It is a highly innovative project that focuses on a very specific area that currently lacks an effective solution. The team has deep knowledge in this area and understands the critical need they are addressing.

Raschid Stoffel

EIC Accelerator Expert Evaluator

Open Stent technology appears to overcome the limitations of current devices. If proven to work with accuracy and a low failure rate, the solution could be a real breakthrough.

Dr. Stephan Hecking

CFO

Technology in an early stage of development, however, the potential is great with a solid team.

Andreu Schönenberger

Senior Statistician at SOTIO | Research, Data Analysis

The final rating

APPROVED: This company has successfully passed a rigorous legal and financial analysis.

Approved by
The BioExpert Network is an independent and exclusive network of experts in the life science industry and investment. Only proposals that receive positive evaluations in innovation, science, finance... make it successfully through to the funding campaign stage of Capital Cell.
Team
79%
Science
74%
Innovation
72%
Business
74%
Approved by
Alira Health is an international consultancy that provides a suite of integrated services designed to help companies in the healthcare and life sciences sectors.
Market access
70%
Regulatory
70.1%
Approved by
Elion is an intellectual property (IP) agency, which helps biotech and medtech start-ups with their protection strategies, patent drafting and prosecution, as well as freedom-to-operate studies.
Intellectual Property
83%

The project

Your support extends beyond funding a device; it catalyzes a transformative shift in healthcare.

Open Stent Solution (OSS) is pioneering advancements in the field of transcatheter (percutaneous) heart valve replacement with its innovative Ribbon Valve technology, designed to address and to treat heart valve disease. Our objective for the Cornelis Valve device is to provide a less invasive (percutaneous) alternative for heart valve replacement, offering a solution that conforms to the patient’s anatomy, with the goal of benefiting a broad patient population.

We aim to finalize the design and initiate the verification and validation phase, including preclinical trials, in the third quarter of 2024. Our implant has already shown excellent hemodynamic performance and good integration within the anatomical environment during prior chronic animal trials.

Our product, the Cornelis TM Valve, is a valvular implant which, once implanted in place of the failing heart valve, ensures perfect valve function and continence. This halts the progression of the disease towards heart failure and death, improves quality of life and increases longevity.

Mitral regurgitation affects 10% of the world’s population aged over 75 years.  Millions of patients today remain without any effective treatment option, as surgery is the only effective treatment and can only be offered to 20% of these patients.  The potential market for transcatheter mitral valve replacement (TMVR) is expected to reach $18 billion by 2032. 

Current transcatheter mitral valve replacement technologies are limited, serving only 15% of potential patients due to design and anatomical mismatches.  

                                                         

Cornelis Valve™

The success of The Cornelis Valve™  technology is the result of a paradigm shift and the creation of a new design that incorporates multiple fundamental technological innovations designed to meet the challenges of a universally deployable valve solution: a) The ribbon stent’s open configuration removes the necessity for the radial compression that is generally required to fit an implant into its delivery system (the device that delivers the valve to its deployment location). This feature simplifies the implant’s insertion into even the smallest of delivery systems, regardless of the implant’s sizes. b) The low-profile delivery system minimizes vascular access complications and bleeding. c) The prosthetic valve is engineered for optimal hemodynamic performance. d) The dual-frame design enhances adaptability to various anatomical characteristics while preserving the cylindrical configuration of the valve support. e) Bulb shape for enhance the anchoring and sealing.

             

The helical configuration facilitates introduction into a small, single catheter, independently of the valve size, an essential feature given that the valves in such conditions can exceed diameters of 60 mm or even more. It is therefore important to be able to implant a valve of any size using a small catheter and avoid complications related to the size of the catheter.  Our novel design, in addition to its ability to implant any valve, also meets all the challenges, in particular its ability to adapt to different types of anatomy and therefore to extend to the widest possible range of patients.   

In simple terms, our device, thanks to its unique and patented design, can be delivered and adjusted for every patient, expanding its use and seizing a major portion of the market.

In Vitro Testing: Extensive in vitro testing has been conducted to validate the Cornelis Valve™’s performance. A series of tests evaluated its crimping capabilities, valve function, and hemodynamic properties. Durability test (repeated opening and closing) of a heart valve prosthesis under accelerated conditions has reached 300M cycle, equivalent to 7 years.

                             

In vitro test results demonstrated good hemodynamic performance and valve td function, meeting the requirements of the standards.

In vivo tests were performed on animal models to assess safety and efficacy. These tests included implantation procedures, post-implantation monitoring, and assessment of valve functionality.

                     

The results of the animal implantation demonstrated perfect integration of the implant in the anatomical environment, good valve function and absence of leakage surrounding the implant. 

Comparative Analysis: A comparative analysis demonstrates the advantages of the Cornelis Valve™ over conventional TMVR devices. It highlights reduced LVOT obstruction risk, fewer vascular access complications, and improved patient eligibility.

                     

Comparative Analysis

Our plan includes finishing the design of the Cornelis Valve™, meeting with the FDA to outline our preclinical and verification testing plans, starting tests and studies to check the safety and effectiveness of the valve, and beginning clinical trials in both the EU and US. All these steps are to help us get the necessary approvals to sell our product in the coming years.

               

Looking ahead, our objectives include finalizing the Cornelis Valve™ design, engaging with the FDA for a pre-submission meeting, starting the Validation & Verification Phase with a preclinical study, and launching feasibility clinical trials in the EU and US, all aimed at obtaining CE mark and FDA approval in the forthcoming years.

Open Stent Solution has established important partnerships with leading heart valve specialists in France, Europe, Canada, and the USA, a move that’s essential for leading clinical trials and sharing findings at significant medical conferences. These institutions are key early adopters, playing a critical role in the initial testing stages and serving as benchmarks for broader implementation, offering guidance and training to other centers. Our strategy is focused on ensuring our technology quickly reaches the market through these partnerships. In addition, we have established relationships with several of the most important MedTech companies. 

Open Stent Solution’s strategic direction is built upon two foundational pillars: a) prioritizing the internal development of our premiere offering tailored for the mitral valve, and b) launching a new vertical that leverages the mitral design to innovate treatments for the tricuspid valve.

Our team is devoted to expanding access to these advanced treatments for a broader patient base. We are assembling all the necessary expertise to drive this project to success. Our commitment is to ensure that our medical innovations provide substantial health advantages for individuals afflicted with heart valve diseases, thus widening the range of patients who can benefit from such essential care.

Open Stent Solution has made significant advancements. Joining the EURASANTE Bio-Incubator in 2021, we’ve successfully raised €5 million in seed funding from reputable investors, such as business angels, angel networks, and through public non-dilutive grants. This financial support has accelerated our development from initial concept to detailed design, enabling us to create a successful implant and delivery system, and conduct animal testing. Our team has expanded to include 10 dedicated professionals, from engineers and technicians to assembly experts.

Winning the prestigious I Nov prize was a milestone, bringing in an additional €1.6 million to boost our research and development, speeding up the advancement and launch of advanced heart valve technologies.

Conclusion:The Cornelis Valve™ is built upon robust scientific and technological principles, validated through extensive in vitro and in vivo testing. Its innovative design offers substantial advantages over existing TMVR technologies, making it a promising solution for mitral valve replacement.

 

Our team

Open Stent Solution is powered by a diverse 10-member team of engineers and experts, including a specialist in numerical simulation. Ideally suited to the project, together, we've turned the innovative concept of Ribbon valve into a tangible, high-quality product. Backed by an experienced advisory board and equipped with advanced testing tools, our unique blend of skills and knowledge sets us apart in delivering this unique innovation.

Management team

Doron CARMI MD , Founder and CEO
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Doron Carmi, MD, MSc - Founder and CEO

  - Experience:

    -       Cardiac Surgeon; Over 20 years in heart valve diseases and cardiology device development.

    -       Inventor of the Cornelis Valve™ technology, revolutionizing cardiac care.

    -       Extensive background as a cardiac surgeon for two decades, with a deep understanding of the medical  device field, supported by a Master's degree in bioengineering.

  - Achievements:

    -       Co-founded "Laboratoire Invalv" in 2012, focusing on unmet needs in cardiac care with transapical transcatheter solutions.

-       Demonstrated foresight in identifying and addressing emerging trends in cardiac care, leading to market-leading solutions.

  - Business Skills:

    -       Skilled in managing intellectual property and negotiating complex contracts.

    -       Proficient in strategic financial planning and budget management, crucial for navigating through challenging financial situations.

-       Proven ability to lead the company towards sustainable growth and profitability in the competitive medtech industry.

  - Leadership Qualities:

    -       Combines clinical expertise with entrepreneurial acumen.

    -       Adept at fostering an environment for continuous advancement in medical technology.

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Hikmat HOJEIBANE , CTO
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- Hikmat Hojeibane, MSc, BSc: Chief Technology Officer in the United States.

  - Experience:

    - Over 25 years in the development of medical devices for cardiovascular diseases.

    - Led R&D initiatives, guiding products from concept through to commercialization.

  - Career Highlights:

    - Significant roles at Cryocath (Canada), acquired by Medtronic for USD 380 million.

    - Contributed to Stentys (France), Orchestra Biomed (US), and Cryotherapeutics (Belgium).

    - Developed stents and cardiovascular devices at Johnson & Johnson.

  - Innovations:

    - Launched some of the earliest flexible stent designs.

    - Holds over 30 U.S. patents and 70 international patents.

  - Expertise:

    - Specializes in the design and development of complex medical devices.

    - Experienced in conducting clinical and animal trials for IDE/PMA and 510(k) approvals.

    - Managed U.S. and EU regulatory submissions and approvals.

    - Proficient in design verification in accordance with ISO 13485 standards.

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Key team members

Stig Visti Andersen
Chairman Strategic Board
Olivier Pierron
Member of the Strategic Board
Michel Finance
Member of the Strategic Board
Louis Labrousse MD
Membre of the Scientific Advisory Board
Thomas Modine MD
Membre of the Scientific Advisory Board
Leroy Matthieu
Delivery System Project Manager
Mehdi Bordji
FEA Project Manager
Eloise Kerignard
Valvular component project Manager
Alexandre Hadir
Implant Project Manager

The problem

The mitral valve is important for keeping blood flowing in the right direction in the heart. If it doesn’t work properly, it can lead to a condition where blood flows backward, known as mitral regurgitation. This problem is common in about 10% of people older than 75 and can be very serious, with half of those affected risking death within 4 years if not treated. However, 80% of those who need treatment don’t have good options because surgery is too risky for them, or less invasive methods don’t work well for their situation. As a result, a lot of patients, 80% in fact, end up without a way to effectively fix their heart valve problem.

Open Stent Solution is offering a revolutionary non-surgical valve replacement device to fill this critical treatment gap. This minimally invasive alternative is designed to meet the needs of a wide range of patients who are unsuitable for traditional surgery.

The solution

Open Stent Solution’s Cornelis™ valve the first-ever heart valve to use RIBBON VALVE technology for non-surgical heart valve replacement, a groundbreaking approach allows for a simpler, less invasive way to implant the valve through the femoral (groin) vein.

This technology is the cornerstone of our unique valvular implant that addresses many of the challenges of percutaneous valve replacement to date.

This valve implant can adapt to all anatomical shapes of heart valves and ensure proper valve function.  

Our differentiating solution is set to capture a significant market share by offering a solution that meets a wide range of patient needs in an as-yet untapped market.

Our differentiation

The primary challenge with current technologies lies in the high rate of patient ineligibility, stemming from a mismatch between patients’ anatomical characteristics and implant designs. Remarkably, over 80% of patients are deemed unsuitable for transcatheter procedures.

The Cornelis Valve™ stands out as a transcatheter mitral valve replacement (TMVR) system that offers a game-changing solution. It allows for the prosthetic valve to be seamlessly crimped into a standard low-profile delivery system, regardless of its size. This groundbreaking feature significantly expands the eligibility criteria for TMVR procedures, drastically reducing the risk of screen failure and thus enabling a greater number of patients to benefit from this technology.

Moreover, the Cornelis Valve™ is the sole TMVR system that effectively mitigates the problem of a substantial protrusion of the prosthetic valve into the left ventricle, consequently minimizing the risk of left ventricular outflow tract (LVOT) obstruction. This enhancement in clinical outcomes goes hand in hand with a notable reduction in vascular access complications, bleeding incidents, and post-procedural iatrogenic atrial septum defects, all thanks to its low-profile delivery system.

Furthermore, the Cornelis valve, with its dual-frame design, enhances its adaptability to a wide range of patients. In essence, the Cornelis Valve™ is well-equipped to accommodate even the largest prosthetic valves, making it suitable for both TMVR and transcatheter tricuspid valve replacement (TTVR) therapies.