Matthew Perry

F e dM a t ri x -H e a l t hc a r e & Li f e Sci e nc e s Metabo Lite Opioid BioMEMS (Stomach) CWW1Q` FedMatrix-HLS’s Portfolio of Designs of SMART Devices & IOT Ecosystems " Me di c a l S c i e n c e A i ms Wil li am J. at The May o , Tr ut h, M. D . The Wh o l e Tr ut h. " - ) Introduction to FedMatrix-HLS’s Portfolio of SMART Devices & IOT Ecosystems BioMEMS, (i.e. “biomedical/biological, microelectromechanical systems ” a/k/a “Biological Micro-Machines”) is a vast and burgeoning area of biomedical engineering and biomedical device R&D and manufacturing with a TAM of $100B+. Biosensors are devices that consist of a biological recognition system, called the bioreceptor, and a transducer. The interaction of the analyte with the bioreceptor causes an effect that the transducer can convert into a measurement, such as an electrical signal. The most common bioreceptors used in biosensing are based on antibody–antigen interactions, nucleic acid interactions, enzymatic interactions, cellular interactions, and interactions using biomimetic materials. Common transducer techniques include mechanical detection, electrical detection, and optical detection 1).Biosensors (Nanobiosensors): The SOBER Solution consists of their SMARTMetabo Lite Opioid IOT Ecosystem. This platform consists of 3 main components, 1).the SMARTMetaboLite Opioid Implantable Biosensor IOT, 2). the SMARTMetabo Lite Opioid Ingestible Biosensor IOT and 3). the SMARTMetaboLite Opioid IOT Ecosystem, which together formulate an impenetrable system of SMART in vivo diagnostic tools, data analytics and visualization applications, interventions, alerts and maintenance solutions all in real-time so that the patient and provider both can focus on and commit to 100% medication/treatment adherence, trust that they have a secure fail-safe system that will result in 100% compliance to treatment programs/facilities. FedMatrixHLS is thoroughly invested in R&D involving BioMEMS with applications envisioned for healthcare, security and other markets. Our senior subject matter expertise includes biomedical microelectron systems or “BioMEMS” and the design, development and strategic implementation of BioMEMS that address a variety of needs. Through our nimble R&D rapid proto-typing infrastructure and process, we produce smart solutions, including design and efficient integration strategies that may Confidential involve software, hardware, platforms and foundational models encompassing multiple disciplines, markets and opportunities. We have established a pipeline of proprietary IP/designs for novel systems and methods that will be introduced by and through an expanding federated matrix of systems, companies and networks. Figure 1-Diagram for Classification/Types of BioMEMS Systems and Devices Introduction to the SOBER Method™ & IOT Ecosystem for Recovery FedMatrix-HLS is working to complete our novel designs for the “SOBER Method™ & IOT Ecosystem”. Our SOBER Method is a Smart Medically Assisted Treatment Solution for opioid addiction. “SOBER” stands for: “SMARTMetaboLite Opioid Biosensor & (360°) Ecosystem for Recovery”. The SOBER Method™ & IOT Ecosystem for Recovery is a smart new approach to addiction treatment and recovery that will enable stakeholders to efficiently and cost effectively solve the seemingly intractable problems of opioid addiction and relapse. The SOBER Method™ & IOT Ecosystem includes an advanced technology platform that is designed for 24-hour, persistent, remote patient biomonitoring and biosurveillance. It also includes novel features and functionality to meet the particular challenges associated with the effective treatment of opioid addicted individuals. Imagine nothing more than a tiny implantable chip easily inserted just under the skin of every patient at risk of opioid addiction, relapse and/or overdose. Our unique Implantable SMARTMetabo Lite Opioid Biosensor and SOBER Method ™ Ecosystem will include Predictive Analytics & modeling, complex events processing, Clinical Decision Support, etc. Once in place, our SMARTMetaboLite Opioid Biosensor and SOBER Method™ Ecosystem will serve as a discrete, highly efficient and highly cost-effective holistic solution with a virtually failsafe 24/7 surveillance and alert system that constantly monitors an individual’s internal system for the presence of opioids. The detection of opioids in a patient being treated with our SMART implantable chip will immediately and automatically trigger an emergency text communication to be sent to the patient’s treating physician and possibly other appropriate stakeholders. The alert will indicate that opioids were detected in a patient’s system and will record when opioids were detected, thereby enabling immediate, timely and potentially life-saving intervention in ways that have never been possible or available until now. Confidential The SOBER Method a/k/a SMARTMetaboLite Opioid IOT Ecosystem is an advanced tech system and network that consists of 3 main components: 1. SMARTMetabo Lite Opioid Implantable Biosensor IOT; and, 2. SMARTMetabo Lite Opioid IOT Health Ecosystem. Together, these two (2) core components are designed to create a comprehensive and virtually undefeatable technology ecosystem containing SMART in-vivo diagnostic tools, data analytics and visualization applications, interventions, alerts and maintenance solutions. Our holistic IOT ecosystem is designed to operate in real-time so that patients, providers and other stakeholders can commit to achieve unprecedented levels of discrete surveillance, medication/treatment adherence and superior positive outcomes through a secure, virtually fail-safe ecosystem that will result in near 100% compliance with/in treatment programs/facilities. SMART & Timely Opioid Detection and Intervention That Will Save Lives Our SMART MetaboLite Opioid Biosensor is designed to be able to include a dose of Narcan, for example, that can dispense as needed to reverse an overdose from excessive ingestion of opioids so as to create an entirely new method to further protect vulnerable individuals who suffer from opioid addiction. Our revolutionary approach will enable Pain Management Professionals and other stakeholders to finally bring the opioid crisis under control for the benefit of patients, their families and others who are adversely affected by the negative and costly consequences of opioid addiction. How the SOBER Method ™ & IOT Ecosystem Works The design of the SMART MetaboLite Opioid Biosensor & IOT Ecosystem includes a novel next-generation Implantable Biosensor. The biosensor is complemented by an Integrated IOT Ecosystem that is designed to support the SOBER Method™ & IOT Ecosystem. The SOBER Method™ & IOT Ecosystem includes SMART Software Platforms, Applications, Tools, Workflows (Engines) and (Applications (web/mobile/ desktop-laptop) that, when integrated, form a unique 360° ecosystem. The IOT Ecosystem will enable, generate and facilitate 100% patient-provider accountability/continuity, medication adherence and addiction/alcoholism/substance abuse, pain and rehabilitation program/treatment compliance and emergent intervention as appropriate in individual cases. Once in place, the SOBER Method™ & IOT Ecosystem and the critical 24/7 biosurveillance capabilities it enables will generate significant new data, new treatment insights and new benefits for multiple beneficiaries and will positively empower Pain Management Professionals and other stakeholders to: 1. Accurately and instantly detect when a patient in the SOBER Method ™ & IOT Ecosystem has ingested/absorbed controlled substances (i.e. opiates); 2. Instantly alert authorized parties, including doctors to take appropriate interventional action as needed on a real-time/near-real time basis, and; 3. Optionally pre-deliver doses of selected medications such as, for example, Narcan, Naltrexone, Buprenorphine, Endocannabinoids and/or others that can be available on stand-by as needed to reverse overdoses due to opioid ingestion based on patient-specific risks and needs. Confidential Key Features & Benefits of the SOBER Method SMARTMetabo Lite 1). 100% patient medication adherence and opioid abuse disorder treatment program compliance (via utilization of 24-hour, continuous patient opioid ingestion/absorption/metabolism biosurveillance/biomonitoring, real-time clinical analytics/data processing, complex events processing engine, predictive analytics, big data analytics dashboard, clinical decision support engine, opioid abuse/overdose/intervention guidelines/EBM) etc. 2). Effective design for development and utilization of (liposome) nanocarrier drug delivery system, which gives prescribing physician the ability to offer, deliver and manage multiple opioid blocking agents (i.e. both Naltrexone and Buprenorphine HCL) as well as opioid interventional (anti-opioid) agents (i.e. Narcan/Naloxone) and more choices for patient therapeutics i.e. if patient is a legitimate nociceptive pain sufferer with real pathology, the nanocarrier-based drug delivery system can be triggered by the prescribing physician to release endocannabinoid (mu-opioid receptor, g protein, nocioceptive pain inhibiting drug). 3). Significant senior in-house Drug Discovery, Development (Biotech/Translational Bioinformaticist), Nanoscience/Materials-Biomaterials and overall STEM knowledge and expertise, laboratory science/R&D expertise. 4). Additional/Expanded Network Access to local/regional/national treatment program provider/facilities, academic medical centers/teaching hospitals/clinical research institutions. 5). Additional/Expanded Network Access to other SMART technology/tangential advanced technologies/solutions partners. 6). An experienced team that possesses world class HW/SW/BioMEMS/Biosensors and biomedical subject matter expertise and a demonstrable ability to innovate. 7). A proprietary design for our Cloud/SaaS-based, Recovery oriented, Coordinated Care EHR platform for Behavioral Health Facilities. 8). The proprietary design for our CloudEHR has 4 Main Modules consisting of: a). Clinical Systems; b). Revenue Cycle Management; c). Practice Management; and, d). Integrated Workflow Automation and Business Process Management. 9). Our CloudEHR also includes a library of forms designed to address virtually every conceivable type of encounter with the patient. Our dynamic library includes an intelligent forms process automation suite with terms for goals and objectives that provide support to the clinician during the evaluation process and will help to streamline the clinical documentation process. Sample forms from our extensive library of designs to populate the system include: Confidential ! ! ! ! ! Assessments and Intake Treatment Plan Psychiatric Evaluation Progress Note Discharge Summaries 10). The ability to create large patient Big Data sets that will be able to be modeled and stored for prescribing physician/institutions via The SOBER Method & IOT Ecosystem. 11). Significant in-house senior level expertise/experience with clinical trials data management, clinical dataset creation, storage, modeling etc. as well as publishing of clinical trials results/outcome data etc. 12). Significant in-house senior level experience/expertise designing global/national pricing models/schemas for healthcare-life sciences bundled industry solutions (SW, HW, IOT, AI/Data Sci). FedMatrix also has other BioMEMS systems, devices and tools in their upcoming R&D pipeline. The following are other classes of BioMEMS that are in high demand within the global healthcare and life sciences industry: 2). Microfluidic (Nanofluidic) Lab-on-Chip (LOC’s or BioChip’s): is a device that integrates one or several laboratory functions on a single integrated circuit (mm to cm) to achieve automation and high-throughput screening. LOCs may use microfluidics, the physics, manipulation and study of minute amounts of fluids. However, strictly regarded "lab-on-a-chip" indicates generally the scaling of single or multiple lab processes down to chip-format. The interdisciplinary nature of bio-MEMS combines material sciences, clinical sciences, medicine, surgery, electrical engineering, mechanical engineering, optical engineering, chemical engineering, and biomedical engineering. Some of its major applications include genomics, proteomics, molecular diagnostics, point-of-care diagnostics , tissue engineering, single cell analysis and implantable microdevices (such as the FedMatrix SMART Opioid Implantable Biosensor IOT). 3). Diagnostic BioMEMS: Genomic and Proteomic Microarrays are to make high-throughput genome analysis faster and cheaper, as well as identify activated genes and their sequences.There are many different types of biological entities used in microarrays, but in general the microarray consists of an ordered collection of microspots each containing a single defined molecular species that interacts with the analyte for simultaneous testing of thousands of parameters in a single experiment. Some applications of genomic and proteomic microarrays are neonatal screening, identifying disease risk, and predicting therapy efficacy for Personalized, P4 Medicine (which FedMatrixHLS has built a proprietary P4Medicine platform that combines Diagnostic BioMEMS (Omics) with microfluidics, as well as, predictive analytics and collective medical intelligence and cognitive computing/neuromapping) 4). Point-of-Care Diagnostic BioMEMS: The ability to perform medical diagnosis at the bedside or at the point-of-care is important in health care, especially Confidential in developing countries where access to centralized hospitals is limited and prohibitively expensive. To this end, point-of-care diagnostic bio-MEMS have been developed to take saliva, blood, or urine samples and in an integrated approach perform sample preconditioning, sample fractionation, signal amplification, analyte detection, data analysis, and result display. In particular, blood is a very common biological sample because it cycles through the body every few minutes and its contents can indicate many aspects of health. 5). BioMEMS for Stem Cell Nanbioengineering: The goal of stem cell engineering is to be able to control the differentiation and self-renewal of pluripotency stem cells for cell therapy. Differentiation in stem cells is dependent on many factors, including soluble and biochemical factors, fluid shear stress, cell-ECM interactions, cell-cell interactions, as well as embryoid body formation and organization. Bio-MEMS have been used to research how to optimize the culture and growth conditions of stem cells by controlling these factors. Assaying stem cells and their differentiated progeny is done with microarrays for studying how transcription factors and miRNAs determine cell fate, how epigenetic modifications between stem cells and their daughter cells affect phenotypes, as well as measuring and sorting stem cells by their protein expression. 6). BioMEMS SMART Nanodrug Delivery Systems: Microneedles, formulation systems, and implantable systems are bio-MEMS applicable to drug delivery. Microneedles of approximately 100µm can penetrate the skin barrier and deliver drugs to the underlying cells and interstitial fluid with reduced tissue damage, reduced pain, and no bleeding. Microneedles can also be integrated with microfluidics for automated drug loading or multiplexing. From the user standpoint, microneedles can be incorporated into a patch format for self-administration, and do not constitute a sharp waste biohazard (if the material is polymeric). Drug delivery by microneedles include coating the surface with therapeutic agents, loading drugs into porous or hollow microneedles for maximum drug loading. Microneedles for blood extraction, and gene delivery are also being developed. 6).BioMEMS for SMART Nanosurgical Devices: Bio-MEMS for surgical applications can improve existing functionality, add new capabilities for surgeons to develop new techniques and procedures, and improve surgical outcomes by lowering risk and providing real-time feedback during the operation.Micromachined surgical tools such as tiny forceps, microneedle arrays and tissue debriders have been made possible by metal and ceramic layer-by-layer microfabrication techniques for minimally invasive surgery and robotic surgery. Incorporation of sensors onto surgical tools also allows tactile feedback for the surgeon, identification of tissue type via strain and density during cutting operations, and diagnostic catheterization to measure blood flows, pressures, temperatures , oxygen content, and chemical concentrations. For physical product security needs, we have expertise in product authentication, track and trace, etc. Through Spectrum Dynamix, Inc., founded by Russell Case, we offer world class physical product security solutions www.SpectrumDynamix.com. SDI has been awarded had a contract with the provides undefeatable quantum-physics-based anti-counterfeit, product authentication, and anti-diversion technology and related services. Originally licensed through DuPont, Spectrum Confidential Dynamix chemists, designers and engineers have significantly improved and advanced our authentication technologies and developed new technologies that are opening up new and exciting channels for our solutions across multiple industries. Our primary authentication products and services, named SpectraSure(TM), allows product manufacturers, pharmaceutical companies, semiconductor manufacturers, central banks, chemical companies, and many others to "tag" or mark their products and other valued items and track them through the supply chain and in other contexts so as to thwart counterfeiters and defeat product pirates and other wrongdoers. About FedMatrix-HLS FedMatrix-HLS is a next-generation disruptive/exponential technologies designer and incubator and reverse systems engineering and STEM-oriented consultancy based in the Greater Tampa, Florida area. We utilize an evolutionary R&D modeling process that, in turn, results in unique strategies and selected curated technologies that we align and apply to circumstances so as to generate significant value for intended beneficiaries and stakeholders. Contact For more information, please contact Thaddeus Marshall at- or by email at-or through LinkedIn at https://www.linkedin.com/in/thomasthaddeusmarshallesquire. Confidential