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Intelligent Adaptable Surface with Optical Fiber Sensing for Pressure-Tension Relief

Final Report Summary - IASIS (Intelligent Adaptable Surface with Optical Fiber Sensing for Pressure-Tension Relief)

Executive Summary:
Executive Summary of IASiS Project. IASiS addressed the critical clinical problem of pressure ulcer incidence and treatment and developed an Intelligent Adaptable Surface (SMARTsurface) for serving as the skin/machine interface in therapy beds and wheelchair seating systems. This surface is redistributing the pressure, strain and shear applied on the skin i.e. the critical mechanical parameters associated with the onset and deterioration of skin ulceration. This SMARTsurface ought to comprise of self-shaping elements and ought to be responsible for relieving pressure and strain in a timely manner according to the information received by appropriately designed sensing modules. Diagnosis and prevention relies on intelligent optical fiber sensing devices that must identify the values and coordinates of excessive epidermal loadings and must successfully provide feedback information to the adaptable mattress or seat mechanism. A controller optimizes the feedback from the sensors and the surface actuators according to preset “damaging thresholds” thus preventing tissue exposure to prolonged, excessive pressure-shear. This, in turn, must suppress the onset or deterioration of pressure ulcers. To this end, IASiS attempted to develop optical fiber-based two-dimensional pressure/strain/shear sensing elements and tried demonstrated their performance for the first time on rehabilitation applications. The physical components of the integration of the intelligent fiber-based sensing surface could be not materialized for the purpose of a fully functional, durable and flexible SMARTsurface adaptable surface mechanism. Alternative solutions for the pressure feedback were integrated and evaluated for performance through extensive Laboratory and Clinical Trials.
Project Context and Objectives:
WP1. Project Management and Dissemination
WP2: User Needs and Task Analysis (benchmarking), Surface Sensor System Architecture
(Virtual-Actual Prototyping)
# To identify categories of population being susceptible to pressure ulcer development and further analyze information of international prevalence studies from institutions such as the European Pressure Ulcer Advisory Panel, European Wound Management association, National Pressure Ulcer Advisory Panel (NPUAP), European Tissue Repair Society etc.
# To specify and categorize user needs with emphasis on rehabilitation-bed users, wheelchair users, post-operative patients and elderly and disabled people
# To critically review the state of the art regarding interfaces for human skin to bed/seat designs with respect to pressure ulcer prevention
# To develop virtual and actual prototypes of the 2-D sensing surface taking into account interaction dynamics between human skin and bed/seating systems. Objective is expected to be accomplished by the end of M12.
WP3: Fabrication and evaluation of SMF- based and FBG-based optical sensing structures and of 2-D and 3-D sensing pads
WP3 is the bridge between basic science and integration of sensors to the final prototypes i.e. bed and wheelchair surfaces. So some iterative work in this workpackage reiterates depending on the results for final tuning. The main objective of this workpackage are:
# To fabricate and evaluate 1-D multi-point sensing elements by employing cascaded Fiber-Bragg Grating structures with different spectral passbands in a single optical fiber
# To fabricate and evaluate 1-D multi-point sensing elements by employing cascaded Fabry-Perot interferometric cavities with different cavity lengths, formed by in series dual Fiber-Bragg Grating structures.
# To fabricate and evaluate 1-D multi-point sensing elements by employing cascaded Mach-Zehnder interferometric configurations with different cavity lengths, formed by in series dual Long-Period Grating structures.
To develop 2-D elastomeric sensing pads and 2-D and 3-D sensing pads on the basis of nanoimprinted waveguide structures.
# To evaluate the fabricated fiber-based devices as 1-D and 2-D sensing elements and validate their performance in terms of resolution, accuracy, reliability and thermally decoupled operation
WP4: Development and Calibration of the 2-D Optical Fiber- based Sensing Surface
This workpackage is a thorough test of the surfaces with the actual integrated specifications of operation in its optimized interface so that everything is prepared for real-time actual tests.
# To develop and calibrate the 1x1cm2, 2x2cm2 and 4x4cm2 IASiS sensing surfaces
# To evaluate the performance characteristics of the 1x1cm2, 2x2cm2 and 4x4cm2 IASiS surface prototypes.
# To optimize the interface between the IASiS surface and the mechanical pins of the SAFE adaptable mechanism.
# To assembly and integrate the IASiS sensing surface with the SAFE adaptable feedback mattress including the embedded air cushions.This task was redirected to the incorporation of a pressure feedback SMARTsurface alternative as the fiber optics IASiS sensor did not sustain the flexibility, endurance and fatigue tests required by the workpackage. This allowed for a different approach to be implemented so the following workpackages could be completed and the prototype surface to be materialized.
# Monitor and manage the progress of the technical outcomes of this workpackage in accordance with the project work plan.
WP5: Laboratory pilots and Prototype testing with mannequins, dummies and cadavers
Through evaluations the IASiS systems are tested in laboratory conditions for operating ranges under simulated and actual conditions by using ergonomic methodology and experiments that are easily transferable to clinical knowledge and comparison with the existing body of work in pressure interface in human machine interfaces.
# To evaluate the prototype IASiS sensing surfaces in laboratory conditions with mannequins, dummies and cadavers.
# To define Control Case Studies and Protocol Designs for the IASiS prototypes evaluation procedure
# To implement and evaluate IASiS prototype surfaces optimized for mattress-oriented (clinical beds) and seat-oriented (wheelchairs) applications
# To validate the performance of IASiS prototype surfaces in estimating the contact forces between human skin and bed/seat surface and in quantifying normal (compression) and shear force components during lying and seating.
# To compare IASiS prototypes with state of the art clinically available pressure measurement methodologies
# To check the structural/ergonomic characteristics of frame and sensing parts through actual anthropometry parameterization tests.
# To measure ergonomic aspects of prototypes and verify their ergonomic design and maneuverability in a simulated and actual environment.
# Monitor and manage the progress of the technical outcomes of this workpackage in accordance with the project work plan. If iterations are required to a previous stage of the development all necessary actions should be evaluated by the project manager at this stage of the project.
WP6: Clinical Trials, Demonstration User Trials and comparison with state of the art products
The work here pushed the prototypes into real clinical applications and user/demonstration tests, some of which occurred without product familiarization to remove the effect of biasing. The results were disseminated to the clinical and bioengineering world. Ethics Review/Screening Requirements were clearly defined and met.
# To verify the comfort, adjustability, long-term usability and ergonomy of both IASiS bed and seat prototypes in a variety of user tests and different environments (in Hospital bed, during patient transfer, during wheelchair use).
# To provide adequate feedback to the design and development phase as to improvements required by iterating.
# To allow an iterative development of the appropriate user interface.
# To compare with state-of-the-art clinical beds and wheelchairs
# To conduct limited scale short term and long term demonstration trials for validating the prototype interface, verifying ease-of-use and identifying problems, if any, regarding user comfort after some hours of use.
# To disseminate IASiS concept and gain users’ acceptability
# Manage the progress of the technical outcomes of this workpackage in accordance with the project work plan
Project Results:

The consortium kicked-off with a lot of enthusiasm and the partners and outside advisors and medical authorities met in a number of meetings several times in the first reporting period. This was necessary to overcome the initial bottlenecks on the design and
functional requirements of the FBG-based sensor pad that were the fundamental challenges in the IASiS project. An all-round user needs analysis on the IASiS bed-mattress was performed (D2.1) based on excessive bibliographical survey, pilot tests and clinical experience from our
hospital partners. A series of e-design, virtual prototypes and modeling studies assisted in defining the overall boundaries of the sensing device and its integration with the SAFE SMARTsurface mechanism. A set of design guidelines covering all major aspects of safety, comfort, usability and costs involved was produced. SAFE and Bioimerosin performed early pilot clinical tests on the IASiS surfaces using existing technological solutions for pressure sensing (D2.1). Based on the user need analysis, technical specifications for the optical fiber-based sensor pads have been defined;
(D2.1). Fujikura Inc., prepared approximately 50 single element fibers with each optical fiber cord bearing a polymer-embedded single element FBG that will undergo a different type of destructive test, to monitor the sensor limitations. Fujikura also provided or loaned equipment to the consortium where specific preliminary tests were necessary and could not be carried out without the help of a manufacturing facility. FORTH set up the fabrication center to implement the multiple element optical fiber cords. Four FBG elements were fabricated on a single patch-cord after several were tested in trial and error paradigms to optimize fabrication. A target of 16 patch-cords was obtained with clear specifications that were reproducible. AUTH designed and implemented the sensor pad fabrication facility, including the molding procedure of the pad and curing of polymer materials. AUTH set up up a sophisticated testbed to evaluate the fabricated fiber-based devices as 1-D and 2-D sensing elements. The testbed validated the performance of the sensor pads in terms of resolution, accuracy, reliability and thermally decoupled operation but the first dissemination effort with the aforementioned work was received by skepticism by the peers. The first 2x2cm2 sensor pad element was also evaluated. We concluded that FBG technology did not match the specification requirements for the development of the sensor pads, as the performance and operational characteristics were not adequately met. In addition, more attention was required in the packaging and fabrication of the individual development stage of the sensor to achieve the operational sustainability, flexibility, rigidity and durability of the sensor under real-life situations. This now became a priority as the plans for fast-track commercialization of the IASiS SMARTsurface required an appropriately calibrated surface to send feedback to the human-machine interface. This task was redirected to the incorporation of a pressure feedback SMARTsurface alternative as the fiber optics IASiS sensor did not sustain the flexibility, endurance and fatigue tests required by the specifications. This allowed for a different approach to be implemented so the benchmarking and evaluation workpackages could be completed and the prototype surface to be materialized.
The consortium established a wide audience as the project was reaching its mid-late-term goals. During the second part and towards the end of the project we participated in a number of fund raising and public appearance forums to attract investors and clients that could potentially take the IASiS products to large scale distribution channels. Since we never overcame the initial bottlenecks on the design and functional requirements of the FBG-based sensor pad that remained the fundamental challenges in the IASiS project we had to creatively assemble a very fast-track methodology to integrate the alternative system with SAFE wheelchair and Mattress/bed system. As part of the closing efforts of the project and finalizing the work of the second period we analyzed more the data collected from early pilot clinical tests on the IASiS new surfaces using existing technological solutions for pressure sensing. Several FBG elements were fabricated and target of 16 patch-cords were introduced to a series of biomechanical tests but assembled benchmarkable pad prototypes were not possible to successfully fabricate and integrate in the IASiS bed of Wheelchair. This last phase reiterated the information of the overall integration requirements with more attention to packaging. AUTH has designed and implemented the sensor pad fabrication facility, including the molding procedure of the pad and curing of polymer materials but none of those techniques delivered appropriate surface pads for integration in the bed/wheelchair prototype. AUTH set up sophisticated testbeds to evaluate the fabricated fiber-based devices as 1-D and 2-D sensing elements but the results could not be converted to the predefined flexibility, rigidity and fatigue specifications. The testbed validated the performance of the sensor pads in terms of resolution, accuracy, reliability and thermally decoupled operation. All results were further discussed and evaluated in the final period of the project. A summarizing peered review publication of the consortium as a whole received wide acceptance and praise demonstrating thousands of citation hits, therefore encouraging our partners to approach EXPO environment and present the alternative integrated solutions of IASiS. The integration of the alternative sensing surface with the SAFE basic bed/Wheelchair unit was then properly implemented. The SAFE surface comprises of a series of bladders at the first level, followed by smaller bladders as we go up in architecture and finally those bladders interact with pin elements that interact with the human body/skin. So there are several layers of interaction that the controller of the interface can interfere with the sensors and the body in contact. A series of phantoms, mannequins and custom made devices were constructed for
in-the-laboratory and in-the-clinic (portable) calibration protocols. FAST-TEST manual calibration test ring device was devised to enable accuracy of calibration using phantoms before actual clinical trials. The summary of our findings as part of this more detailed clinical work on the wheelchair seating system included that: a) It is apparent that the SAFE_IASIS alternative prototype performed better in “static“ and prolonged dynamic seating in all testing configurations; b) Our benchmarking suggested that SAFE_IASIS seat A1 with modified air cushions is an important investment in contrast to the future cost of the patient entailed by an inferior sitting quality; c) The new alternative sensing seating system guarantees anthropometry-based modularity and mobility of the vulnerable pressure sensitive areas; d) In all tests regarding static pressure and prolonged sitting the new seating system with modified
pin-elements and air-cushions performed better than the unmodified air-cushions (AC) and the foam-based seat resulting in considerable reduction of the maximum pressure.
The summary of our findings as part of the mattress/bed clinical work included: a) It is apparent that the SAFE_IASIS prototype performed better in “static“ and prolonged supine rest in all testing configurations; b) The “static” pressure profiles were always better for all the control group and patient trials. The frequency of routine turning and the type of bed had no impact on the Incidence of Stage I ulcer. However the frequency of turning and the type of bed had a significant impact on the development of pressure ulcer lesions (stage II/III/IV); c) It is worth noting that 2 hours between turning on the SAFE_IASIS mattress was almost twice as effective when compared to the Hillrom bed. For the one-hour intervals between turning the SAFE_IASIS mattress in almost five times more effective in preventing pressure ulcer development; d) These findings indicate the ability of the SAFE_IASIS mattress to endure at least a 50% (or more) margin of error in turning frequency without adverse tissue impact. This factor can be significant in reducing pressure ulcer development risks associated with staffing shortages, available staff responding to the emergency needs of other residents negatively impacting on routine turning schedules, resident non-compliance with turning, or residents where the potential for turning is compromised secondary to physical or functional limitations. These findings were brought in an unconsolidated format to several user groups to initiate a follow up for our product line as we move into manufacturing efforts with the partnering SME entities. All the aforementioned work that involved clinical settings was under internal review board approval protocols with all appropriate ethical considerations according to the code of good practice of EC and each partners country-national code of ethics. We hope to continue these interactions, complete the IASiS newly generated patent portfolio as the products reach the market horizon and use the results of IASiS as marketing tool for the branding of our company in the PR campaign to start in the immediate future.

Additional commends of SAFE and IASiS project Coordinator to Ms. Vraila and Technical reviewers of IASiS project,

This document serves as an additional final administrative and overall review of the IASiS project to accompany the second and final periodic report. It is an effort to explain the extensive administrative delays in IASiS given the opportunity that EC is offering our company and the SAFE executives to revive IASiS and present the overall history of events from our perspective.

Some of the document accompanying the present report have excessive file size and we could not -despite very helpful assistance form the EC help desk- reduced them further. So we have delivered them by a series of emails directly to Ms. Vraila.

I will start with some background information on the formation of the idea and consortium to support the IASiS project. SAFE was formed as part of Diogenes Incubator mechanism of University of Cyprus; I, as the original founder contributed in kind, with capital and in the form of patents and existing equipment that I owned an equivalent of a multiple of the capital investment received from Diogenes. The business plan was originally to join European and International consortia in the human machine interfaces market (Rehabilitation beds, wheelchairs, advanced prothesis, diagnostic software associated with pressure ulcers) to promote our products. We had already identified partnerships with previous contacts we had in Europe and the US before we formed the present consortium. Before IASiS, I personally had established non-tenured positions and external associations (non-academic) with incubators associated with Academia in UWM Biomedical Incubator in Milwaukee US and New jersey Institute of Technology (NJIT) Incubator in New Jersey US and Katholieke Universiteit Leuven Belgium (this was clearly stated in the IASiS proposal). SAFE, had therefore, produced a path to obtain a large investment round A expected in 2012. The first seed funding effort with University of Cyprus Incubator and the results from the IASiS project were critical requirements for the next round of financing to our company. IASiS was the innovative wedge-project whose outcome was critical for the final due diligence of our investment-related fund raising.
One of the challenges we had as a company, and still the Holy Grail of skin science to date, was that we could not effectively associate our SMARTsurface bed and amputee SMARTsocket products (both existing products of SAFE before IASiS) with the damages occurring due to shear stress at the human skin during prolonged bed rehabilitation and during the skin-stump compression of above knee amputees (see EXHIBIT_1_2009_ORS_Program.pdf -search keyword "Papaioannou"-in which the SAFE team completing a US based incubation grant publishes on the peered-reviewed Orthopedic Research Society (ORS) 2009 International conference several papers confirming the body of work SAFE demonstrated before the IASIS project: e.g. Paper No. 346, "Assessing Residual Bone-Stump-Skin-Socket interface kinematics of Above Knee Amputees with High Accuracy Biplane Dynamic Roentgen Stereogrammetric Analysis" by George Papaioannou, Christos Mitrogiannis, George Nianios, Goeran Fiedler and Poster No. 1987, "A new method for assessing residual limb skin-tissue strain during above-knee amputee high-speed movement" by George Papaioannou, et, al.,) and "Comparison of several seating solutions designed for prolonged sitting and car driving with transportation-oriented wheelchairs" by George Papaioannou (2009) (Computer Science), "Buttock and back pressure distribution tests on seats of mobile agricultural machinery" by George Papaioannou et. al., Applied Ergonomics 32 (2001) 347–355. My personal international involvement with multiple projects at the time was clearly started in the IASiS DoW. I am presenting this, and could provide you with much more evidence-(see list of Papers published by SAFE team before and during the IASiS project in EXHIBIT_7_SAFEpublications.docx) to demonstrate our team's established research track in both US and Europe (I had participated as Ph.D student in two EC Marie Curie grants from 1996 onwards and in many research projects in the Biomedical device arena as technical manager and principal investigator/Professor of the institution I resided as Researcher or Professor in Europe between the years 1990-2008 including the EC projects CAMARN 1 and 2 , BIOMED2, GAIT/GAIT2, TRANSWHEEL, SAFEGUARD among others; all of these projects were never late and were always completed with high praise by the EC).
Also, this preamble is here to stress the timing of events that led to IASiS. It all started when I was introduced to then post-doctoral student Dr. Pleros early in 2007 as he was preparing to assume his new Assistant Professor position at AUTH. I mentioned to him our shear detection problem and he was very enthusiastic in directing our attention to fiber optics sensors (see EXHIBIT_2_Confirmation for attendance of negotiations for IASIS proposal 232479.docx in which he replies with his post doc email from Athens Metsovion Polytechnic). He ended up forming the Fiber optics expert consortium that became the IASiS photonics team and recommended a call that fitted the idea and his expertise. Dr. Pleros requested that I coordinate those proposals because I was the most senior and experienced person in the group with SAFE being an appropriate vehicle for the SME type of proposals and calls.
While we were negotiating the IASiS grant we identified some engineers from the team that studied in Dr. Plero's supervisor's Laboratory in Athens (i.e. Prof. Avramopoulos;s NUTH Laboratory) that could produce preliminary work to support our hypothesis. Therefore, SAFE and I invited Mr. Kanelos (end of 2008) (who was associated with the laboratories that Dr. Pleros was working for or building towards) as a researcher in the US MOVE center incubation environment that SAFE participated in (subcontractor-see proof at the respective part of SAFE's financial report for 2007-2008: EXHIBIT_4_FinRe_SAFE_S1+2_v3_FINAL_01-08-2008.pdf) to demonstrate some of the early functionality of the fiber sensors in our applications (EXHIBIT_3_KANELOS_postdoc_letter_febr2009.doc). Dr. Kanelos would become a pivoting member of Dr. Plero's laboratory in IASiS and many other projects after that.
Another significant milestone in this timeline is the IASiS kick-off meeting at ITE in Crete the home of one of the most significant IASiS RTD performers- FORTH (invited to this consortium by Dr. Pleros) on the 12-14 of January 2009. At this time and as the project evolves in the preliminary background work, SAFE is preparing the second set of major prototypes for this project (see EXHIBIT_5_SAFEbed+WHEELCHAIRFABRICATION.pdf) the wheelchair and bed prototypes based on the new specifications we receive from the fiber optics IASiS experts. It is important to stress this since the fiber optics team's new specifications changed completely our bed and wheelchair system architecture with significant and very expensive changes in the final prototype (see EXHIBIT_10_SAFEbedFABRICATIONwithoutphotonicSENSOR.pdf)that burdened only SAFE and myself personally as there was no budget allocated for this in IASiS.

I must also bring to your attention that SAFE and I personally have always worked with consortia and grant programs that are associated with healthcare calls and Medical devices. This consortium was a unique and a first-time experience for me as a coordinator in a call that was predominantly in the fiber optics domain and somewhat displaced from the core work that SAFE has its expertise. Therefore, I and SAFE had to rely mainly on our RTD performers that were responsible for the sensor development and particularly FORTH, AUTH and FUJIKURA. Based on their previous reputation it was easy to trust their feedback, up to date background review of state of the art in fiber optics sensing, and after the visit in FORTH I was reassured that they could fabricate and deliver the sensor to fit our newly designed bed and wheelchair prototypes. This was in detail described at the DoW by the fiber optics team of IASiS.

In the first IASiS period, before 2011, SAFE and I realized that, from the dissemination level of the fiber optics RTD performers, we were coming closer to reaching the sensor specifications in a standalone photonics pad without the bed or wheelchair interface. We, at the medical devices side, were reassured before the clinical demonstration, that this would be a bendable, flexible photonics shear sensing pad which was now tested in the laboratory environment and could be significantly improved in the second and third iteration. The fiber optics group publications confirmed these findings but SAFE had not physically seen this sensor working independently as part of an integrated bed surface. The confidence of the fiber optics expertise team within IASiS was keeping the spirits up as we were approaching the end of 2010 and fast moving into 2011. As the internal and first period periodic report suggest however, there were some delays on the final fabrication of the complete functional, durable, robust and ready-to-integrate in the bed, IASiS shear-sensor. Our managerial intervention was always defended by the IASiS fiber optic group that was so encouraging about the initial laboratory results that invited us to participate in the Marie Curie training grant titled: "Intelligent amputee sockets employing real time advanced photonic sensors for optimum fit and pressure relief through active controls". The fiber optic community was very engaging and as our fiber optics partner in IASiS were disseminating the IASiS results, we found ourselves to win the Marie Curie proposal in 2010-2011. The main IASiS consortium continued at the new grant: AUTH continued in the Marie Curie proposal as CERTH, MEDCOM was also a continuing partner and FORTH was replaced by Belgium's Free University of Brussels (VUB), a photonics research authoritative addition to our new consortium that strengthen SAFE's due diligence for the positive outcome of these projects. For SAFE this made sense since IASiS had already spent a significant amount on equipment and instrumentation towards the fiber optics part of the IASIS consortium. It should be noted that although practically this instrumentation belongs to SAFE it has not yet been returned to SAFE from the two major fiber optics RTD's in IASiS. In addition, the Marie Curie project was a path to train some of our new technical people and also employ our previous work on above knee amputee prosthesis to the below knee amputee prosthesis. The further miniaturization of the IASiS shear sensor could really revolutionize the way feedback is given from and to the patient for optimal real-time intervention of the pressure ulcer problem that significantly limits their autonomy. The timing was reassuring and SAFE really trusted the expertise of our RTD partners in the fiber optics domain in a way that SAFE presented the shear sensor as part of a large due diligence effort in major investment Venture Capital groups in both US and Europe. This round of financing past the seed investment of Diogenes UoC was very positively received and brought offers by major investors to the table with a highly likely investment horizon in 2013-2014; the validation coming from the IASiS and Marie Curie grants would be critical to the outcome of those negotiations (see our SAFE report for round A fund raising and participation in fundraising forums at EXHIBIT_6_SAFE-AseriesFUNDING.docx)

To our sincere disappointment and despite the positive and successful financial audit that SAFE underwent by EC instructions just after the first period in IASiS with the supervision of our then EC officer Mr. Antonio Loredan and EC appointed auditor Mr. Fabrizio Gravino (see EXHIBIT_8_Letter of conclusionIASISaudit2011.pdf) the integrated shear sensor was never materialized by our fiber optics group within IASiS. As IASiS project was fast drawing closer to the particular milestones that related to clinical trials and demonstration workpackages, SAFE went into panic mode and followed plan B. Plan B aimed to integrate an existing commercially available pressure sensor (non-shear) in hope of completing its deliverables and its commercialization targets and product closures, but most importantly complete its contractual responsibilities with the EC. As SAFE went above and beyond its resources to repair this project, the IASIS bed now required: a) a major re-customization to fit the new sensor and b) a new laborious calibration workpackage to even attempt to utilize the new commercially available sensor; This means that workpackages WP3, WP4 and WP5 were left in the disposal of SAFE to manage from scratch. Note that at this stage there was no time to pursue another amendment or predispose the consortium and EC to more administrative delays after the most recent audit; in addition SAFE is pursuing investment due diligence with its international investment partners.
Namely, the workpackage W3 (LEADERS: FORTH, AUTH, FUJIKURA) and its relevant subtasks i.e. "Fabrication and evaluation of SMF- based and FBG-based optical sensing structures and of 2-D and 3-D sensing pads" has never actually produced a physical integration-ready photonic sensor deliverable. Similarly the workpackage W4, namely " Development and Calibration of the 2-D Optical Fiber-based Sensing Surface" and its associated subtasks have never produced a physical testbed with repeatable objective methods and a physical deliverable of a stable 2-D surface that can be demonstrated even as a research prototype.

The photonics group (AUTH, FORTH, FUJIKURA) within IASiS has failed to deliver clearly on each and every of the following aspects of the DoW: I) the microstructured or standard FBG fibers do not exhibit sufficient sensitivity as promised by the DoW; II) the aspect of portability was not even possible as the response of embedded micro-structured FBGs required highly sensitive read-out equipment with picometer wavelength measurement accuracy; this is huge and very expensive equipment that cannot be made portable/wearable or can be used at the bedside according to the know-how of the IASiS or current -2020- state of the art. The same stands for optional wearability of such a sensor; III) the complexity of the fabrication and packaging process and its evolution from 2D to 3D curved shapes was never proved in the laboratory or in a working sensor prototype in IASiS; IV) a polyurethane liner-type structure could never result in a tangible output as promised by the Dow; furthermore that promise was already based on falsehood and experimental impossibility that the fiber optics partners of IASiS ought to know; we have reasons to believe they did know and cantankerously pushed through the project(s) while keeping this facts to themselves during the negotiation phase before the start of the project and during the project.

So WP4 could not be completed as it depended on the physical photonics sensor deliverable from WP3. We at SAFE had seen data and pictures but never a finalized prototype that could robustly be integrated at the bed surface. Nor did the responsible photonics partners ever produced a multitude of photonic sensor pads to fit the whole physical dimension of a hospital bed that WP4 and WP5 required for the completion of the remaining demonstration and clinical trials related workpackages. The consortium was conveniently not informed with respect to the power requirements of the photonics equipment to receive readings from those test beds. As we discovered later (see next paragraphs and EXHIBIT_10_SAFEbedFABRICATIONwithoutphotonicSENSOR.pdf) an entire laboratory worth of apparatus was required to capture photonics data; this makes the portability of this system impossible, a fact that was kept silent from the clinical consortium of IASiS and SAFE both at the level of the DoW initially and during the respective work-packages within the project. Yet the publications told a different story to SAFE and the rest of the research world. (see EXHIBIT_7_SAFEpublications.docx).
An indirect consequence of the above lack of deliverables was that the execution and timing of the clinical trials was now impossible to be complete by the clinical partners of this IASiS consortium and that SAFE had to complete this work with significant delays and additional budget never accounted for in IASiS.
Again, at this point, SAFE risking a failure in its technological audit with its IASiS critical project facing potential premature termination, turned into plan B that employed a very extensive and expensive calibration procedure of the new pressure sensor. The SAFE bed that was fabricated especially for the photonics shear sensor did not fit the commercial new sensor employed in plan B. SAFE was then burdened with more costly and time consuming customizations of yet another NEW bed to complete this work package. I am stressing here that additional re-customization of the bed/wheelchair to receive the commercial pressure sensor was also not available in the IASiS or Marie Curie project budget. In the meantime, the IASiS fiber optics team was always requesting more time for that fiber optics shear sensor deliverable claiming that between the two projects the shear sensor target would be met. The results were not what SAFE was expecting according to the DoW from this consortium and the additional costs to customize the bed, wheelchair and socket prototypes (customizations occurring for at least three times in the same projects) almost depleted the R&D resources of SAFE; Nonetheless, SAFE with significant effort delivered a secondary solution to the IASiS project and disseminated the results. In addition, SAFE completed the diagnostics pressure ulcer detection software (vision-based inspection of ulcer treatment) with a different objective; we altered its outcome which initially was to read the photonics shear sensor data and dynamically adjust the pressure readings within the bed bladders that supporting the weight of the patient.

We are at this point, well into 2012 and with the Marie Curie project to not even being able to begin without the photonics sensor, as its main aim is to address the skin shear problem within the below knee amputee socket. You can see this in the spasmodic actions by the AUTH-CERTH personnel to move man-months allocated to their workpackages earlier in the Marie Curie project, a strange phenomenon which coincides with their fear of the incapacity to deliver what those projects had contractually promised to EC and SAFE. A preamble of discouraging-to-almost hostile actions, cold communications and very distant/indifferent approach to previously enthusiastic engagements were received by the AUTH towards the end of this period. Were they already preparing an exit from the projects as they had threatened us repeatedly? We soon found out.
The IASiS shear sensor deliverable/product was to produce a technological translation between the two projects and the two different applications; IASiS fiber optics experts failing to deliver this shear sensor had a significant and highly negative affect on SAFE's growth, its commercialization portfolio and the credibility and careers of its members both executive and technical personnel.

I personally attribute the direction that the IASiS project took, in the flair of the Consortium RTD performers which was dominated by academic research groups that miscalculated the product development nature of SME projects with the outcomes expected by R&D projects. This unfair assumption by our academic partners totally destroyed our value proposition and its activation window that for a small enterprise is of paramount importance. Our RTD consortium did not realize in time that SAFE's team is not part of the academic tenured-truck safety-net and without tangible SME-type product deliverables it can get wiped out in its efforts to move into a full commercialization phase with new products roll-out and imminent financing rounds at stake.

As we were trying to pick up a next wave of efforts and make the best of these projects collectively while commercializing the alternative "plan B solution", the SAFE team found evidence that the IASiS fiber optics shear sensor was not a new novel idea in the EC fiber optics sensing arena. To our TOTAL disappointment and while we were between IASiS project wrap up, Marie Curie Project kick off and its first period review meeting we received word by the new Fiber optics expert at our consortium (VUB) that the work proposed was not only unoriginal but it had recently and just before IASiS been attempted with a different consortium that was much more powerful than the IASiS consortium. A leader of the PHOFOS pan European consortium and partner in our Marie Curie project, Prof. Francis Berghmans clearly stresses in this email on the 30th of March of 2012 that an EC project before IASiS concluded that the proposed IASiS approach to shear sensing is beyond the state of the art and impossible to integrate into a portable solution. I include here, the unabridged email I received from the internationally authoritative consortium PHOSFOS by his leader Prof. Berghmans, our new partner in the Marie Curie (Smartsocket) Consortium:

"On Fri, Mar 30, 2012 at 7:55 AM, Francis Berghmans wrote:
Dear George,

as promised and after a week of discussions here, please find below
the items (shortly explained without too much background) that we
would like to discuss during our Skype call of 17h00 (CET) today.

1) Update on results achieved by the SAFE secondees

2) Lessons learned so far and progress by VUB compared to the DoW
- From our work performed so far for smartsocket we can conclude that
we will not be able to achieve the required specs (neither for
pressure, nor for shear)
a) the microstructured fibers do not exhibit sufficient sensitivity,
although we managed to increase it significantly
b) the response of embedded micro-structured FBGs therefore requires
highly sensitive read-out equipment with picometer wavelength
measurement accuracy that cannot be made portable/wearable
- Lessons learned during the last period of PHOSFOS also demonstrate
that it will not be feasible for us to comply with Task 2.2 for
several reasons
a) the complexity of the fabrication and packaging process in going
from planar systems to curved shapes
b) the inability to package the read-out electronics and to create a
wearable system
c) the need for lots of additional experiments to identify the
required sensor density in view of the complex response of the sensors
and hence doubtful results so far for Task 2.1
d) a possibility to use standard FBGs instead of micro-structured
FBGs could still be envisaged, but considering the work of Nikos
Pleros and team on this we do not think that VUB can offer added value
for that
e) assembling a single sensor in a polyurethane liner-type structure
would not result in a tangible output and is likely to be perceived as
a hoax by the review team
f) even if a more tangible result would come out (which would only
be possible if we would have more capacities offered by another
project), we do not see how SAFE or the consortium would have the
capacity to transfer it to a sensible product for the target
application on the longer term and therefore how VUB could benefit
from IPR transfer

3) Impact on reporting, on project and on DoW
- The conclusions above should be conveyed in a fair manner to the review team
- Considering the above and the unassessed need for VUB to continue
the work, we believe that it wouldn't serve any technical purpose to
have a second secondment (with little to no impact) of Sanne Sulejmani
to SAFE. We believe that re-orienting this secondment (backed up by an
ammended DoW) would provide a possibility to enhance the more natural
collaboration between SAFE and CERTH and provide more consistency to
the project.
- Therefore and for sake of consistency and credibility of the
project, we would appreciate it if you could consider that VUB leaves
the project once that it has fullfilled its obligations with respect
to the two secondments from SAFE to VUB that are still running. We
will gladly continue to support these two guys.

We realize that the way it is put here is a little abrupt, but we
truly believe that the continuation of the project and the credibility
of what we propose to the reviewers for the second term may strongly
benefit from a couple of clear-cut decisions on how to go on.

Looking forward to hearing you later today.

With best regards,

Francis Berghmans
Vrije Universiteit Brussel
Brussels Photonics Team B-PHOT
Pleinlaan 2, B-1050 Brussels, Belgium
T: +32 2 6293453
F: +32 2 6293450

The email was communicated to the SAFE board and caused a confusion and an instant freezing of SAFE leadership decision making along with a very negative effect on its credibility. The Diogenes administrative support, somewhat understandably, started to weaken until it evaporated. What followed was even worse as SAFE immediately suffered gradual loss of trust from its supporters and got penalized by vendors, its personnel, the local academic authorities, the international academic authorities.
To this date, even the most updated review of current state of the art in photonics sensors in biomedical applications (2018) concludes the same main conclusions with Prof. Berghmans (EXHIBIT_9_Correia_2018_J._Opt._20_073003.pdf)

The questions that everyone around me, as, the SAFE leading executive, I was responsible for bringing this consortium and idea together, would pose were:

a) Why our internal IASiS partners failed to protect us during the conceptualization of IASiS and Marie Curie projects? How could those leaders not considered the PHOSFOS lessons and failed to inform SAFE in time?
b) FORTH and AUTH in particular were in the cutting edge of innovation in the fiber optics consortia in a pan-European level. Why did they not warn us during the conceptualization of the specifications for the shear sensors from the most certain exposure to the PHOSFOS experience, the PHOSFOS being one of the most important consortia in EC framework associated with interface sensors like the ones proposed in IASiS? Why did they let us risk the IASiS effort being considered as a "hoax" per Prof. Berghmans's characterization and only when a different project came into picture a new partner stood up with a clear warning? Why were there so hostile when we tried to amend the situation?

c) PHOSFOS as a large-scale long-term R&D project with multimillion Euro funding and major participants from all technologically advanced member states had set the standards for what to expect for at least a number of years to come from the state of the art in pressure and shear-flexible, portable, non-obtrusive fiber optics sensors. How could our leading RTD performers in this field confused and misinformed us with respect to the SME project IASIS and requirements of a tangible, functional shear-sensor? How could anyone in their scientific risk-to-cost benefit evaluation miss this huge gap for a ready to commercialize product for a small medical device company whose success heavily depended on the very sensor specifications. Why did nobody from the IASiS fiber optic consortium warn us instead of confusing us?

d)Why didn't our fiber optics partners stop the project when it was time with a clear statement of incapacity to deliver the one single most important deliverable of both the IASiS and Marie Curie projects and instead let SAFE bleed technologically, administratively and financially.

SAFE went from a prosperous high potential SME to a confused misdirected company trying to defend itself from a state of affairs that were originated by its partners.
One of the worst consequences was the loss of technological credibility for the innovation niche that SAFE had advertised and marketed. Credit was lost in the eyes of investors, advisors and lobbyists that removed themselves from the negotiation table of which SAFE had worked so hard to bring together and promote. SAFE lost its ability to complete the gap with new projects and was almost irreversibly financially wounded.

To our losses in resources one must add the loss of personal credibility and removal of any new job replenishment opportunities for both executives and technical personnel at SAFE. To this day, the we are writing this, the consequences echo in our small steps to recovery.

I will add here, and I admit that I shared this information confidentially with our Officer, Ms. Vraila, that a tragedy in my family in the years post-IASiS almost brought a complete end to our efforts. I will like this information to be treated with outmost confidentiality, but I want the officers and reviewers to take it into consideration because it is legally considered "force majeure" and beyond the control of the SAFE leadership and myself in particular.

SAFE leadership underwent severe depression and withdrawal symptoms of loss which for some of us meant serious health consequences. We were suddenly left without prospects and jobless for almost two years.

Diogenes incubation closed a couple of years after the unofficial end of IASiS-end of 2013. SAFE structured support mechanisms disappeared along with the eminent economic crash that occurred from 2013 onwards in Cyprus. Personally, these events raised an additional "force Majeure" as I was incapacitated in administering my duties from the period of mid 2012-2015. In Cyprus, capitol control "shaved" all savings above a certain limit ($100,000) for a period of years during the economic crash. The basic partners in the SAFE team decided to continue to pursue our chances in the environments away from Cyprus and where our previous reputation had never been associated with unclear outcomes or incomplete projects.
I, personally, as a coordinator had never experienced anything like this in my career in both sides of the Atlantic. I felt at the end of 2012 a huge responsibility, for many of the IASiS collaborators and scientific personnel that were outside the academic grid, had their kids born within the duration of the IASiS project; failure to complete these projects meant that new young families would be left unsupported. It still holds a heavy irreversible dark stigma in my mind.

SAFE's international investment efforts tried to rescue the round A opportunity but everything was on hold until I was able to return and retold the true story of IASiS to the parties involved.
I tried to save the DIOGENES incubator directive and complete the due diligence for round A but without the technological audit of the shear sensors and with constantly diminishing resources we found ourselves moving the commercialization target further away; SAFE eventually under the economic crash in south-eastern Europe missed the early growth window and went into pause mode.
SAFE, because of the IASiS "hoax" scenario also failed to submit continuation clauses to its Intellectual Property portfolio and lost deadlines for new patent securement and existing patent support. We have not valuated exactly the cost of those losses but they are highly significant for us.
Without DIOGENES incubator's administrative support and without even access to our administrative back-ups, this task was almost impossible. After trying to collect the broken pieces for almost two years now, we still hope that we can recover and rebuilt what was a healthy and fast-growing company. This document, although it started as an objective representation of facts from SAFE's perspective with respect to IASiS, to my own surprise it has become a personal struggle to refrain from pointing fingers to irresponsible parties that let us down in the worse possible way. I would feel better if we at SAFE, and I in particular, were convinced that this was a null hypothesis project that disproved itself and I could then accept that the outcome was fair. This was not the case as I feel some of our partners knew that the outcome would only be a scratch in the surface of the research questions and not a tangible product that an SME type of project ought to aim for. It is also an exercise for situations and bottlenecks like this that can occur under the EC umbrella and hopefully can be addressed without the need for time consuming and costly litigation.

SAFE offers a recommendation to the partners and the EC with the hope that we can remedy and move toward the recuperation of our company.

It should be noted that AUTH and FORTH have been benefitted from using machinery and instrumentation from the IASiS project (never returned to SAFE) that was designed to built long term capacity in their laboratories instead of focusing on the tangible short term aims of the IASiS project.

For this unfair and inflexible singularity outcome we request that for aforementioned incomplete R&D workpackages the IASiS RTD partners (AUTH, FORTH, FUJIKURA) did not complete the requirements of the IASiS programmatic work and SAFE does not recognize or approve the respective financial claims presented to the EC funding body.

SAFE does not officially recognize and cannot see how SAFE or the consortium would have the
capacity to transfer any knowledge produced by the three RTD performers (AUTH, FORTH, FUJIKURA) to a sensible product for the IASiS target application on the longer term and therefore how we could benefit from IPR transfer; All the collective budget allocated in period 1 to these partners has produced additional know how and more value for them but for projects outside the field of use of IASiS and SAFE: this is clearly in direct contradiction with the traditional SME EC project aims.

We hope that the upcoming technical audit by EC reviewers will strengthen our position and a major litigation action can be prevented. We are however, prepared and we will pursue any action necessary in the effort to clear our collective reputation as SAFE executives and scientists with a transparent and successful history before IASiS, SAFE and 6th-7th Framework involvement.

Kind regards,
George Papaioannou IASiS project coordinator

Potential Impact:
The consortium aimed all through its operational period for an expanded network of alliances to help support research activities of our four European SMEs (SAFE, BIOIMEROSIN, Comitech and MEDCOM). Their success depends on their ability to operate on the highest level of excellence. Steps towards enabling the impact of this project include actions to keep our consortium in the forefront of exploratory research, development and market horizon. Our strategy was and continues to be to pursue participation in major EXPOs and workshops that bring user groups and large bodies of beneficiaries together at a European and International Level.
In this prospect, IASiS industrial partner Fujikura Inc. has hosted/mentioned the IASiS products at her booth in Medical/CompaMed 2011/12. Medica/CompaMed is the largest trade fair for medical devices and components in Europe and is the best advocate for our products and target customers. The project brought a lot of discussions and attention and Fujikura has expended its invitation to the IASiS techology for exhibiting again in 2012/13. IASis approach to fabrication and system integration also attracted positive feedback in the largest international "Digital Manufacturing" EXPO in the US. SAFE brought the IASiS results with the alternative pressure SMART surface bed and wheelchair prototypes to international investment related forums such as the 2011 New YOrk Venture Summit and the 2014 medical devices RSNA EXPO in Chicago MI US.
• We continued to send our data and results from benchmarking studies to all the National Pressure ulcer related databases and to marketing engineering companies such as Frost and Sullivan and the world health organization. Some of our public deliverables are disseminated at large user group bodies such as those related to Diabetic cohorts of caregivers, orthopedic research groups and dermatological conventions. Our clinical evaluation sites (the two hospitals in our consortium) have a large network of collaborators (other hospitals and care-giving facilities, elderly homes) that will be in close proximity and function as our advocates.
• Our consortium of partnerships has organized an updated and clear etiological classification and identification of the rehabilitation hazards and care-giving performance limitation factors that relate to problems of pressure ulcer management of the Elderly and Disabled of Europe/USA. Based on that, the SAFE technology aims to be marketed as a reliable but also cost-effective and modular methodology to assess the health impact of a new surface system to several sub-groups of pressure related pathologies. Allowing a wider product and marketing base (replacement mattresses, bedding systems, advanced hospital beds, bariatric beds, 2D, 3D sensors, advanced sensing pads, variable size sensing pads) this methodology and accompanying tools will be discerned in several different versions of products and a multitude of alternative sensor devices. Our partnerships, such as that with Fujikura Inc, one of the largest fiber optics company in the world and basic research accommodated at the internationally recognized ITE institute will warrant reliability levels from 90% to 95%. We aimed to reach the market with marginal subsequent production costs for our sensor components in the range of 1-2.5 kEuro for our sensing devices which can eventually be functional with the SAFE products and other SMARTsurface and mattress/seating systems or very high advanced (i.e. bariatric) mattresses for the severely affected patient. A strategic impact is the offering for the first time of an optimum concept surface system, with advanced comfort of at least 90%, easily adaptable to the user’s specific anthropometric needs, for patients undergoing the different rehabilitation progressive steps with an affordable price of less than 1 kEuro (1k$) (for the wheelchair seat cushion application). An equivalent solution will be offered for the bedding mattress replacement market with a unique technological advantage of shear tracking. The new concept bed mattress system, with advanced comfort of at least 90%, easily adaptable to the user’s specific anthropometric needs, for patients undergoing the different rehabilitation progressive steps with an affordable price of less than 20 kEuro for each bed type is also going to have a significant impact to the pressure ulcer therapy and prevention world.
Our consortium has an already excessive network with links to the major payers in the market. Increasing this interaction through meetings, demos and workshops had a significant influence in how our consortium and strategic alliances will target their market segments. As an example SAFE’s CEO and IASiS project coordinator and members of the board of the company have recently represented SAFE and IASiS in international commercialization and exploitation meetings with intention to advocate towards investment for the production capacity necessary for SAFE to bring some of the products of IASiS to the market. The company and IASiS innovations were presented in workshops organized by leading companies in rehabilitation. Among the participants included representatives from Kinetic Concepts, Inc., Pegasus Airwave Inc., Plexus Medical Inc., Sunrise Medical Continuing Care Inc.
At a local level SAFE is now accredited to participate in national hospital bidding efforts in hoping of generating early sales.
In brief, the IASiS consortium was represented through SAFE LLC presentation at:
• the NEW ENGLAND VENTURE SUMMIT “Where Innovation Meets Capital” DECEMBER 14, 2011, HILTON, BOSTON DEDHAM, organized by Young Startup Ltd.
• the NEW YORK VENTURE SUMMIT, July, 2011, in New York, Manhattan, at Digital Corner organized by Young Startup Ltd.
the Life Sciences & Healthcare Venture Summit March 28, 2012 in Hilton Boston, with presence of the largest investors and major players in the following sectors:
o Biotech/Pharma
o Diagnostics
o Drug Discovery
o Healthcare
o Healthcare IT
o Medical Devices
The meetings were a great exposure of the IASiS product line and innovation and have already resulted in several invitations for pitching our products in large investing funds and major players in the HMI environment. These further meetings lead to further financing necessary to improve the production capacity of SAFE LLC with respect to the SMARTsurface and HMI product line.
These meetings further helped all our partners and the IASiS products to come closer to the marketing horizon. These meetings enabled us:
• To work towards establishing clear guidelines with regards to pressure ulcer related problems and draft standards on how to protect the rehabilitated patient.
• To provide a designer’s checklist to promote the application of those guidelines to the maximum extent to different types of existing bed systems or biosensors.
• To stem the aforementioned work to several other biomedical applications (Surgical table surface, tissue histology, etc.) and other comfort related industries including the transportation industry
(vehicle comfort/safety research) and find synergies for faster market penetration.
• Understand how to approach the market position without loossing too much equity in our effort to stop outsourcing and control most of the manufacturing of our products.
Main Publications of IASiS. (our effort to use the electronic dissemination templates to import these was not conclusive since a lot of peer reviewed publications have no DOI. We could not locate how to import these publication details without the DOI so we add them here for the reviewers and public readership.
Additionally the dissemination activities of the project include the publications of the knowledge generated through IASIS to the following scientific journals and conferences:
• G., Papaioannou et al, "3D Fiber Optic Pressure Sensor for Application in Rehabilitation" ELEMBIO
2010, 4th National Conference of the Hellenic Society of Biomechanics, University of Ioannina, GREECE, 4 - 6 June 2010.
• G. Papaioannou et al, (2010). "Validation of a novel Adaptive Smart Surface bed with Integrated Decubitus Prophylaxis Sensors". Proceedings of the 56th Annual Meeting Orthopaedic Research Society, New Orleans, Louisiana, March 6-9.
• G. Papaioannou et al, (2010). "Validation of a new Optical Fiber Sensor for novel amputee socket designs". Proceedings of the 56th Annual Meeting Orthopaedic Research Society New Orleans, Louisiana, March 6-9.
• G. Papaioannou et al, (2010). "Flexible strain sensing surface based on fiber optic sensors for application in orthopedic biomechanics and rehabilitation". Proceedings of the HFM SYMPOSIUM on «Use of Advanced Technologies and new Procedures in Medical Field Operations», Essen, Germany, 19-21 April.
• G.T. Kanellos et al (2009). "High spatial resolution FBG-array based strain sensor". Proceedings of the International Commission for Optics (ICO) Topical Meeting on "Emerging Trends and Novel Materials in Photonics", Delphi, Greece, October 7-9.
• Fiedler, G. et al, (2009). "Development of a new Bed System With Improved Decubitus Prophylaxis
For Bed-Ridden Patients ". Proceedings of the 9th International Conference on Information Technology and Applications in Biomedicine, Larnaca, Cyprus, November 5-7.
SAFE BOOTH PRESENTATION IN INTERNATIONAL EXPO: Papaioannou G. Participation in Digital Manufacturing workshop. International Manufacturing
Technology Show, 14-18 September 2010. McCormick Place, 2301 South Lake Shore Drive, Chicago, IL 60616 US
• Dimitris Tsiokos, George T. Kanellos, George Papaioannou and Stavros Pissadakis., (2012) “Fiber Optic–Based Pressure Sensing Surface for Skin Health Management in Prosthetic and Rehabilitation Interventions”, INTECH editions., Chapter 11.,in Biomedical Engineering - Technical Applications in Medicine, ISBN: 978-953-51-0733-0.
• Alessandro Candiani, Michele Sozzi, Annamaria Cucinotta, Member, IEEE, Stefano Selleri, Senior Member, IEEE, Rosanna Veneziano, Roberto Corradini, Rosangela Marchelli, Paul Childs, and Stavros Pissadakis. (2011) “Optical Fiber Ring Cavity Sensor for Label-Free DNA Detection” IEEE JOURNAL OF SELECTED TOPICS IN QUANTUM ELECTRONICS. pp1-8.
• Michele Sozzi, Aashia Rahman, and Stavros Pissadakis. “Non-monotonous refractive index changes recorded in a phosphate glass optical fibre using 248nm, 500fs laser radiation”. May 2011 /Vol. 1, No. 1 / OPTICAL MATERIALS EXPRESS, pp. 121-127.
• A. Candiani, W. Margulis, C. Sterner, M. Konstantaki, and S. Pissadakis. “Phase-shifted Bragg microstructured optical fiber gratings utilizing infiltrated ferrofluids”. OPTICS LETTERS / Vol. 36, No. 13 / July 1, 2011
• Paul Childs, Alessandro Candiani, and Stavros Pissadakis. “Optical Fiber Cladding Ring Magnetic Field Sensor”, IEEE PHOTONICS TECHNOLOGY LETTERS, VOL. 23, NO. 13, JULY 1, 2011 929-932.
• Stavros Pissadakis, Alessandro Candiani, Maria Konstantaki, Carola Sterner, and Walter Margulis, “Microstructured optical fiber gratings for magnetofluidic sensors and actuators”, SPIE
• Stavros Pissadakis, “Lighting the way-Sensing the way and going FORTH”,
selected invited presentation in European Commission Biophotonics media channel
The IASIS project official website was maintained and updated. The Website address of IASIS is: with and additional wiki page with constantly updated content at
Knowledge management activities
During the development of the project, a substantial know-how and original intellectual property (IP) has been generated. The consortium is using all possible means to protect generated IP with focus on post-project commercial exploitation as suggested by FP7 rules. An IPR council has been established comprising one person appointed by each IASIS beneficiary. The role of this IPR council is to continuously monitor the newly generated knowledge in the respective IASIS fields world-wide and to ensure that IPR protection strategies will be activated before publishing.
SAFE Ltd is in the process of defending two patents related to the IASiS product cluster.
These are:
Summary: Embodiments of the present invention provide an adaptable surface that measures the pressure distribution between a person and the surface and is able to conform to the user’s unique body morphology by adapting to distribute pressure across the human-cushion interface. By so adapting, the surface reduces the maximum pressure, increases comfort, and prevents skin maceration and the development of pressure ulcers.
Attorney Docket No. 025369-9002
Summary: Various embodiments of the invention provide camera-based systems and methods for capturing digital wound data and calculating wound statistics including area, volume, depth, and color. The system uses this digital skin mapping, these statistics and other patient data to evaluate existing wounds and determine the risk of developing new wounds. Because the system is camera-based, the system and methods of the invention are minimally invasive and reduce the discomfort and risk of infection to the patient.
List of Websites: