Novel Materials and Manifacturing Process Enabling Wristed Micro-Instruments: Business Feasibility Of Surgical Applications

Project Information

MicroInstrmntsBP

Grant agreement ID: 663776

DOI

10.3030/663776

Project closed

EC signature date 28 January 2015

Start date 1 January 2015

End date 31 May 2015

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

MEDRA SRL
Italy

Periodic Reporting for period 1 - MicroInstrmntsBP (Novel Materials and Manifacturing Process Enabling Wristed Micro-Instruments: Business Feasibility Of Surgical Applications)

Reporting period: 2015-01-01 to 2015-05-31

Summary of the context and overall objectives of the project

MicroInstrmntsBP aimed at planning the best business approach to the commercialization of micro-surgical instruments with the same dexterity of state-of-the-art instruments but smaller in size. The reduction in size allows the instruments to be introduced and used in smaller surgical fields and opens up robotic micro-surgery and endoscopic applications, that are currently beyond the capabilities of state-of-the-art products and have an estimated market size 10x the current 2014 market size for wristed surgical instruments (0.5 Billion USD).
Micro-wristed instruments are enabled by a proprietary, integrated design and a proprietary manufacturing process. Medra's design and manufacturing process for 3D micro-parts allows parts to mate together with high precision. Current manufacturing technologies are limited in the fabrication of small 3D parts, especially parts for assemblies, by limits on the achievable geometry of the parts and their tolerances. We have overcome such limitations and are able produce very precise small parts in very hard and high yield strength materials. Such an approach allows to counter the weakening of the parts due to the scaling down of the dimensions.
MicroInstrmntsBP had identified the following objectives:
1. Selection of first target procedures and exact indications
2. Definition of an international IP strategy including ‘Freedom To Operate’
3. Preparation of Business Plan for funding the company with Business Angels or private Institutional Investors.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The MicroInstrmntsBP project has resulted in the identification of a key step common to a majority of microsurgical procedures, namely the re-joining of sub-millimeter diameter arteries, veins and nerves, and the ideation of a compelling product vision based on our robotic micro-instruments that could revolutionize this step.
The rejoining of blood vessels (anastomosis) is the decisive step for positive outcomes of autologous reconstructive surgery after cancer removal, in limb reattachment and wound closure. It is recognized as extremely difficult to perform, success rates decrease dramatically with vessel diameter, allowing only few micro-surgeons worldwide to offer the best possible treatment. Our large worldwide survey of micro-surgeons has identified robotics as the enabler technology for scaling down and stabilizing their surgical gestures under the microscope.
Our robotic micro-instruments have the same dexterity of state-of-the-art laparoscopic robotic instruments but are smaller in size, thanks to our proprietary micro-fabrication process and miniature instrument articulation design. They offer a marked advantage when working in the small field of view of a surgical microscope. The overall small size of the micro-instruments also leads to a markedly innovative microsurgical robotic product that makes surgeons enthusiastic about its compactness and manageability.
The target market identified is composed of an aggregate of several surgical procedures that share the same microsurgical step of anastomosis. Importantly, the expected clinical impact of our product can be tested convincingly for efficacy before first human use.
A quantitative business analysis has been carried out to value the business opportunity together with investors. Finally, a specific IP strategy for the entire product protection has been planned, including freedom to operate analysis.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The importance of one’s physical integrity is increasingly recognized as being paramount to an individual’s physical and psychological wellbeing. Hence the attempts to offer high quality surgical reconstructions to individuals after tumor removal, after traumatic injuries or with congenital malformations are increasing. The impact of such a reconstruction is unmatched for a patient. A successful replantation can restore an individual’s ability to return to the workplace and have an autonomous lifestyle. Similarly, reconstructions post-tumor or of congenital malformations such as cleft palate are important in restoring physical function as well as ease of an individual in social settings. For example, microsurgical autologous flaps in breast reconstruction after mastectomy has multiple advantages and has become the Gold Standard in therapeutic plastic surgery.
The product envisioned by MicroInstrmntsBP can help more surgeons to offer to more patients advanced reconstructive procedures, while reducing both costs of complications to hospitals and general societal costs.
The SME Instrument Phase I grant has given our Company exceptional visibility and as been decisive to secure the first round of Angel investment. It has been key for our decision of applying for a SME Instrument Phase II to finance the two core years of product development and get the momentum further financing.

Results of survey of 50 Microsurgeons, identifing small caliber anastomosis as best target