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Ultra Legionella Inmunoanalysis System for Early Sensing

Periodic Reporting for period 1 - ULISENS (Ultra Legionella Inmunoanalysis System for Early Sensing)

Reporting period: 2015-02-01 to 2015-07-31

"ULISENS project is focused on the commercial development and further commercialization of an automatic early warning system able to detect and quantify Legionella species in water. The system integrates an innovative and patented fast detection test certified by AOAC-RI in an automatic module able to carry out “in situ” the analysis of Legionella spp in real-time.
The specific objectives of the ULISENS project accomplished during the SME INSTRUMENT PHASE 1 were the following:

-To develop the business and exploitation plan, including the assessment of the cost‐effectiveness and exploitation potential of the envisaged solution.
BIOTICA’s commercial product will be addressed at the beginning (LEGIOLAB version) to the manufacturers of cooling towers, going afterwards towards other facilities at risk (hotels, SPAs, Hospitals…) with other product versions, according to the characterization of the market size and segmentation. Our market analysis carried out during Phase 1 indicates we have two different segments that are defined by their analytical requirements of stakeholders:
- One analysis per batch, which in turn could be divided in the following market segments attending to sampling requirement:
- Buildings, considering both area of Health (hospitals...) and Leissure (hotels, spas...). ULISENS Product for Health Area (H version) could have a market size of 247,079 units and ULISENS Product for Leissure Area (L version) could have a market size of 491,508 units.
- Industry, considering risk facilities at water using companies, mainly cooling towers. ULISENS Product for cooling towers (called LEGIOLAB) could have a market size of 501,700 units
- Several analyses per batch, which comprises the Legionella testing laboratories, mainly those that are accredited by ISO 17025. ULISENS Product for Laboratory (Lab version) could have a market size of 2,133 units (33,786,720 analyses per year)
These figures are very promising because BIOTICA will specialise in the own production of testing consumables and additionally we will receive a royalty per each physical system sold.

-To tackle the main bottlenecks and barriers for the full commercialization of the innovative technologies, mainly related to legislative and regulatory aspects in each country.
BIOTICA has investigated the regulatory issues not only in EU but also in (USA, Canada, Japan…) and all the product versions will be certified

-To widely disseminate project outcomes to stakeholders and end‐users, strengthening synergies with other initiatives and platforms to reach the maximum impact.
BIOTICA has organised meetings not only with the main Cooling tower OEMs (like EWK) but also with risk facilities owners to disseminate the project outcomes. The following list is a not exhaustive summary of the meetings:
- Manufacturing companies (SPX, Baltimore Aircoil , Cofely, Eurovent, Evapco, Jaeggi, KTK…)
- End customers (Iberdrola, Endesa, Mercadona, El corte ingles)
- Lab equipment (MERck, Hach, Pool ID)
- Buiding maintenance (Humiclima, ISS, Magontec…)
-To analyse market and business strategies in the sector in order to find the best combination of external agents and international entities to develop cooperation strategies for market exploitation and further products commercialization.
BIOTICA has achieved an initial exploitation agreement with several stakeholders to produce the dispositive and commercialise each solution:
-ULISENS –H, L versions will be designed for the Building environment. The production of the physical systems will be carried out by our partner Humiclima. Customer service will be developed by our partner ISS and Consumables will be distributed by BIOTICA.
- LEGIOLAB version is designed for the industry environments (mainly cooling towers) and it will be manufactured by EWK. Customer service and consumable sales will be similar to the previous case.
- ULISENS-LAB will be specifically designed for water testing labs. This segment is significantly different from the others, therefore we have an agreement with Hach to manufacture this product version and we will have the Merck support for the commercialisation.

Therefore, during phase 2, BIOTICA will specialise in the production of the patented consumables which are the technology core and it will support the OEM with its engineering department for the market replication of the different versions.
According to the concept of ""Technology Readiness Levels"" (TRL), ULISENS is currently situated in TRL 6-7. The product concept was integrated in a laboratory version of the prototype that has been validated under controlled conditions. In the last six months BIOTICA has assembled a more advanced ULISENS version for the cooling towers market niche. It has been called LEGIOLAB and this has been introduced to show the concept to potential stakeholders.

Testing was performed to compare the Legiolab with ISO 11731 method for the enumeration of Legionella spp. in naturally contaminated water samples with three different contamination levels (102, 103,and 104). Five replicate test portions per level were tested for each method, covering the whole range of interest. The performance of Legiolab was found to be comparable to the reference method. No significant difference, based on t-test, was detected between the Legiolab mean and ISO 11731 reference method mean. The method comparison evaluations of the Legilab demonstrated that this method is equivalent to the ISO 11731 reference method for detection of Legionella spp

"The first stage of the project was the ""TECHNICAL ASSESSMENT AND FEASIBILITY OF THE CONCEPT"".
BIOTICA has developed a repository of product design modifications to adapt the system not only to specific industrial environments but also to end user real needs. In this sense, BIOTICA has conducted surveys to determine key specifications of the future commercial versions.
These surveys we carried out not only visiting potential stakeholders but also organising different workshops at BIOTICA or potential distributor’s facilities. The study harvested information about: i) the satisfaction of customers with LEGIONELLA detection systems available on the market; ii) the customer product evaluation; iii) Additional functionalities which could include the system; iv) Customer intention to buy the ULISENS system; v)Maximum price that they would pay to acquire the proposed system.
The main conclusions are the following:
- Our main strengths are related to our patented detection technology. Customers feel safe using a certified product. Furthermore, our quicker results and high detection capability are also part of our competitive edge.
- Customers and stakeholders indicate us that original design of the lab version must be revised, we need to improve the robustness in the commercial versions (mechanical and environmental resistance)
- Different product versions are necessary for each market niche (towers, hospitals, fountains…) because the needs of cooling tower sectors are different from hot water networks. We have to implement a modular design to adapt the system to each application.
- Taking into account the price of each laboratory test, customers think that an investment around 25.000€ in a system like ULISENS for cooling towers (Legiolab) is adequate.

We think that our system has to be addressed to Cooling Towers, Hot water networks (hotels, public buildings, etc.), SPAs and laboratories .Therefore, our competitor benchmarking analysis has been focused on these niches. We have not found commercial devices that could be ULISENS direct competitors because automated systems are still in the development stage.
The prototypes we have found are the following:
A)POSEIDON PROJECT- H2020-ICT-2014-1 ( ). The detection platform is implemented as a prototype in which water and air samples are sequentially concentrated, injected into a microfluidic system, and delivered to the SPR sensor for analysis. The system will be designed to allow for its future integration in water distribution and HVAC (heating, ventilation and air conditioning) for prevention of L. pneumophila outbreaks. The system is not finished.
B)GLOBAL-TEST ( . We have found some press releases about the development of an automated system by RCA . They indicate that the system combines the latest chemical and telecommunications technologies and enables real time and remotely, to have all the information required by law for the proper maintenance facilities with risk of proliferation of the dreaded bacteria such as the cooling towers, evaporative condensers, humidification, ornamental fountains, sprinkler systems, fire water systems, cooling elements, etc. However we have not found any technical specification or product reference. However, this system is not addressed to direct determination of Legionella spp.

Therefore, at the present moment we have no competitors that offer a finished system for automated online analysis at owners risk facilities and we have technical competitive advantage because we have unique specifications that differentiate our product from our traditional competitors (Emlab, Safewater solutions…):
•1-4 analysis per hour (multipoint)
•Range of 10 analyses per batch.
•Adjustable sample volume (and Limit of Detection)
•Remote control of the device using APP: remote command to begin the analysis.
•Cloud data storage.
•Control over external device (pumps for biocide dosage, other, …)
•Validated and certified technique used as basis of the automated equipments

In addition, one of our most relevant strength is our commercialisation strategy. As explained before BIOTICA plans to exploit the ULISENS test consumables by means of own commercialisation. But the different physical equipment’s versions will be manufactured by allied enterprises that have sufficient scale economy for massive production. The product will be distributed using a prestigious network integrated by the main manufacturers of the facilities at risk (cooling towers, hot water networks…) combined with our global distributor network.
Finally we will have a complementary network of authorised partners for the customer service. BIOTICA will study the potential creation of a new company in our group for the global supply chain division, maintaining Biotica as technological partner and manufacturer of the reagents in order to maximize market opportunities, profits and, ultimately, shareholder value.
The final commercial agreement is near to be signed with all the involved agents, the final product price could be fixed around 25.000€ per expert system and BIOTICA will receive a royalty of 2.500€/system sold. The consumable set price would be fixed around 25€ and this set enables to carry out 10 tests.

Users and public authorities need to prevent bacterium infections from cooling towers and water networks at global level. Water quality policies on Legionella control are a strategic outcome to be achieved by WHO (Water Quality and Health Strategy 2013-2020). Every year 5,500 legionella cases are reported annually only in EU and since 2008, an increasing proportion of cases with known outcome or place of residence has been reported. 75% of the population has ever suffered infection with the Helicobacter Pylori bacterium. And other bacteria like Escherichia coli, Salmonella and aspergillus cause a hospitalization cost of billions of euros each year.

Biotica value proposition is based on control the concentration of bacteria in these facilities in order to prevent infections. We think to have timely information is the key for successful prevention. Two-three days could be enough to achieve infective level in a facility initially tested as negative for Legionella. Therefore, using ULISENS technology, more than A BILLION risk facilities can be controlled to prevent the negative impact of the above mentioned bacteria.

Our product will improve protection of public health by reducing the incidence of the disease and its associated cost (patient treatment) and the penalties for the owner of the facility (around 100.000€). But other additional benefits can be achieved:
-Significant reduction of the control and prevention costs in risk facilities. Now they have to stop the facility for maintenance purposes but ULISENS will enable the internal set up operations stopping only the affected lines. The system will trigger an alarm as soon as the level of this pathogen differs from a pre-defined level and, hence, will allow the operator to supervise it and react properly, if necessary. Significant reduction of the downtime cost could be expected.
-Significant increase in the energy efficiency. EWK has indicated us Evaporative traditional cooling towers are more efficient than adiabatic towers, but they are likely to be infected by legionella. Therefore traditional towers have lost market share. With the help of LEGIOLAB system and its continuous monitoring strategy, our partner EWK thinks evaporative towers could be reintroduced in the market.

In order to fulfil the expected demand BIOTICA consumable production pilot plant will be developed during phase 2 and it is expected to fulfil a global demand up to 650.000 consumable units per year. Replication of production cells in defined areas will allows the growth of the activity, reporting to headquarter at BIOTICA.

The initial scenario consists on introducing the solution in in large companies from three different segments, in the next list is summarised our first contacts with clients of each one:
•Laboratories: Eurofins, ALS, EXOVA
•Facility maintenance companies: General Electric, Veolia, ISS facility services.
•Risk facility owners: Hotel chains, Shipping companies, Energy industries. MARRRIOT, HYATT, NALCO.