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Unique multi-curve active catheter for complex endovascular navigation

Periodic Reporting for period 1 - MULTICURVE (Unique multi-curve active catheter for complex endovascular navigation)

Reporting period: 2018-02-01 to 2018-07-31

The endovascular technique, less invasive than open surgery, involves passing through the vascular system to perform a therapeutic action. In short, the practitioner is guided by advanced medical imagery, introduces a catheter through a patient’s leg or arm artery, and then pushes it along a guide up to the area to diagnose and/or treat. This procedure allows the access to the targeted area.

While endovascular procedures have become the therapeutic references of many pathologies, notably in neurology (e.g. for strokes), current solutions are limited to the use of passive catheters navigated on flexible guides, all presenting a strong performance issue. Indeed, due to tortuous and sometimes highly complex anatomies, it is estimated that 20 to 25% of procedures require the use of alternative techniques, costly in time and equipment (use of multiple catheters, complex procedures…) and with no guarantee of ultimate success. To improve these therapeutics, a few new technologies have emerged, based on the use of active catheters, however they all present to date limitations regarding cost, bulkiness and actual usability in clinical routine. As a consequence, they are not used at this stage by medical practitioners.

In this context, the demand for new, safe, efficient and cost-effective solutions is very high, even more so as endovascular procedures are often used for highly critical, very frequent medical conditions. Typically, strokes currently represents the second cause of death at world level, i.e. around 6 million casualties a year and 17 million people affecting with a stroke (World Health Organisation). In France, it is also the first national cause of acquired handicap in adults (French Health Ministry).

There is therefore a true health public issue to be addressed at the global level, to which Basecamp Vascular (BCV), a French SME created in 2016, contributes to bring a high level medical and scientific answer.

BCV develops a breakthrough medical device (MULTICURVE) combining electronics and precision mechanics: a new type of active catheter-guide, adjustable on demand, which can adapt to individual anatomical variations of each patient, thus allowing a safer, faster and more efficient action compared to current techniques. Such device fits fully with the personalised medicine ambition, without entailing a crippling cost or bulkiness, allowing for its daily use in clinical routine in the operating room.

To date, a first version of this device has been achieved and will soon enter in a regulatory and clinical step for the obtaining of EC marking and subsequent commercialisation (planned for 2021).

In this frame, the SME-Instrument phase 1 has been important to support us in the refinement of our business strategy, notably regarding the market access, the positioning of the MULTICURVE device, and the overall commercial strategy to implement (model, pricing, distribution, production, communication…).

Notably, it contributed to a fundraise of 2 million euros that was realised in July 2018, right after the achievement of the project, through bringing us with relevant and realistic technical and financial roadmaps and forecasts, needed for our investors.
Four tasks were performed during the project:

1) Market study, with the objective to refine our market roadmap,
2) Regulatory markings preparation, to implement upstream steps and best anticipate the future regulatory markings demands,
3) Clinical study preparation, to best anticipate the future clinical study necessary for validating the device before any commercialisation,
4) Elaboration of a detailed business plan.

Main results achieved are synthesised below.

First, regarding the market study performed, the following results were achieved (no details are given due to confidentiality reasons):

- a promising scenario in terms of potential margin generation has been selected regarding the industrialisation step of the MULTICURVE device,
- the maximum cost production of the device determined as acceptable has been established,
- the distribution model has been determined,
- the market segments to address first have been identified,
- the timing for commercialisation has been adjusted.

Second, regarding the regulatory markings preparation, the following results were achieved:

- the Quality Management System plan has been established,
- a Gap Analysis has been performed.

Third, the following results were achieved regarding the clinical study preparation:

- the clinical evaluation report has been prepared (for the parts not dependent upon the study implementation itself),
- contacts and exchanges with the ANSM (French regulatory authority) have been established,
- the clinical studies timing has been determined.

Finally, a new, detailed business plan was elaborated, notably based on results obtained in other tasks. Details of this business plan remains fully confidential at this stage.
In short, BCV MULTICURVE is a breakthrough medical device applicable to all cases of endovascular navigation for access to cerebral vessels, including the most complex ones, which are currently not tackled by passive catheters (state-of-the-art).

The MULTICURVE device is:

- Highly innovative, relying on an original, patented manufacturing process and protected by four other patents to date,
- Universal, allowing to perform procedures at an efficiency level never achieved to date in any kind of human anatomy (even the most tortuous ones),
- Affordable, allowing to perform procedures in a highly secured way and at a cost (human and material) lower than current state-of-the-art solutions,
- Thought for clinical use: its affordable price and ergonomics have been designed from the very beginning to be used in the operating room in clinical routine, so as to avoid any commercial failure.

Thus, the MULTICURVE device represents a unique value proposal on the endovascular procedures market, with the planned following impacts:

- For hospital practitioners i.e. device end-users (neuroradiologists, interventional radiologists, endovascular surgeons…): complete answer to their technical and medical needs and expectations in terms of safety and performance, with an easy-to-manipulate device presenting higher technical performances and safe for all procedures even the most complex ones,
- For buyers of public / private hospitals: answer to their economic constraints with a total planned price for the full kit lower than the total cost of using several passive catheters for a single procedure (necessary for complex procedures),
- For patients: improved medical care, leading to better survival chances, less risks of remaining handicap, and enhanced care quality,
- For society as a whole: better treatment for critical pathologies such as stroke (2nd leading cause of death at world level).
Illustration of the MULTICURVE device