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Smart needle that converts conventional syringes into 100% biosafety syringes.

Country of Origin: Spain
Reference Number: TOES20200626001
Publication Date: 26 June 2020

Summary

The company was created in 2017 in Spain, with the aim of carrying out the development of a novel patented technology that breaks into the incipient market of international health safety. Their innovation is a unique retractable needle system that can be assembled to any syringe of the market, whose mechanism is activated fully automatically only few seconds after its single use, making it a 100% safe syringe. The company is looking for a commercial, license or manufacturing agreement.

Description

The founding partners of the company have been working for more than 6 years in the technical optimization of the product and creating a solid family of patents, and it is in 2017 when the company was created to carry out the full development of the product. The last 3 years the company has established collaboration agreements with several leading technology companies who will supply the Spanish company for the product industrialization phase.
The Spanish company is addressing a high-volume market, where 16 billion injections are administered yearly worldwide in hospital environments alone . For each injection, a syringe and a needle are required. Ideally, every injection should occur in a safe environment for the person receiving the injection and for the one administering it. But World Health Organization (WHO) estimates that 40% of those 16 billion injections are made with re-used injection devices.

Health professionals and general users are at risk of exposure to potentially fatal viruses due to accidental needlestick injuries (NSIs), re-use or needle-sharing and unsafe disposal of devices. There is a black market for the resale of used syringes that exceeds 6 billion units each year. Thus, as defined by the WHO, we are facing a Public World Health Problem.
Unfortunately, only a portion of health professionals are mandated by regulations to use safety devices, and most of them do not have access to safety devices due to the high prices. Current technology of safety syringes and needles is not 100% safe, as all of them rely on human interventions. Malpractice and conscious misuse of syringes and needles are causing a huge economic burden on health systems worldwide.

The product of the Spanish SME is within the market segment of safety devices. This segment is expected to grow at a higher CAGR of 9.7% from 2017 to 2022 to reach $6.78 billion by 2022 due to the increasing awareness about the use of safety syringes and the need to reduce accidental needlestick injuries.

Factors such as growing incidence of chronic diseases, ageing of Population, high adoption rate of safety syringes under the influence of the 2010/32/EU Directive brought by European Union for prevention from sharp injuries in the hospital and healthcare sector are driving the growth of the needles market in this region.

With this backdrop, the Spanish SME is looking for a capitalist partner or senior executive of the medical and pharmaceutical sector to collaborate under a commercial agreement with technical assistance; an industrial partner of the medical and pharmaceutical sector to carry out the manufacture and sale of the product under manufacturing agreement; and internationalization companies that commercialise their patent under license agreement.
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Advantages and Innovations

Following the company research and analysis of the factors preventing the mass-utilisation of safety devices as requested by relevant legislation, and recommended by leading organisations (like WHO, UNICEF, Red Cross, etc.), they highlight the main advantages compared to other market solutions for their buyers.
This product is the first ever passive safety system: it is the only system that increases safety without any human action/intervention. Activation, therefore, does not depend on the operator┬┤s will or good faith. Once the injection has finished, there is no possibility to reverse it; the safety mechanism is triggered, fully eliminating human error or malpractice, and consequently avoiding its reuse. They are the only ones in the market that have true passive activation.
It can be coupled to any syringe on the market. Thus, the current manufacturers require minimal adaptations in their production lines to convert their conventional syringes into self-retractable safety system, complying with the national and international legislations.
The product can be used in different medical applications. Initially in Europe, an average of 20 seconds is required for the activation of the self-retracting system, such activation time - programmable during the manufacturing process- depends on the medical protocol where it is applied (emergency, paediatrics, laboratory, vaccination, etc ...), ranging from 5 seconds in Intensive Care Units (ICU) up to 50 seconds in laboratories approximately.

Stage Of Development

Prototype available for demonstration

Stage Of Development Comment

* They are currently in a TRL6 and MRL6
* First-quarter of 2021 they will be in a TRL8 and MRL8
The product has been awarded by various stakeholders including EC through the SME Instrument Phase-1, Neotec program by CDTI and Seals of Excellence by EC through the SME Instrument Phase-2 in the last two calls.

The countries covered by the granted patents are: Canada, USA, Mexico, Brasil, Colombia, India, Indonesia, China, Republic of Korea, Europe (+15 European such as Germany, France, UK, Italy, Portugal, among others).

Requested partner

Currently, the Spanish company is in the pre-industrial development phase of the device that will culminate in the first quarter of 2021 obtaining the final product and a useful pre-series.
For the next industrial phase and large-scale sales, they are looking for:
* A capitalist partner of the medical and pharmaceutical sector that invests in their company (European public institution or private company) and senior executives, brokers and lobbyists specialized in international health business and pharmaceutical sector. They way of collaboration will be under commercial agreement with technical assistance.
* An industrial partner of the medical and pharmaceutical sector to carry out the manufacture and sale of the product (private company or technological and research Centre) to work under a manufacturing agreement for co-development.
* Internationalization companies that commercialise their patent and product via license agreement.

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