BIOFEST INVEST APPLICANT

Forge Applied Science & Technology LLC

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  • What is the problem that your company will solve?

    F.A.S.T is targeting hospital acquired infections which is a leading cause of preventable death in the USA resulting in 100,000 deaths per year. 2.2 million more patients experience prolonged suffering, increased length of hospital stay, and/or permanent disability. The estimated direct cost to the Health Care System is estimated to be $22-$28Bil annually with indirect costs estimated at an additional $12-$20Bil.

  • What is your solution and how does it solve the problem?

    F.A.S.T has developed several technologies to enhance 6/7 strategies to prevent hospital acquired infections. We intend to launch Rushlight Infection Control Systems- a comprehensive service customized to client needs which will include site evaluation, contract custodial services, custom formulated antimicrobial agents, routine environmental testing, maintenance of site specific genetic libraries, source tracing assistance, materials/surface retrofit using an AI project planning program, installation of environmental/hand hygiene technologies, validation of current infection control consumables, and purchase of infection control expendables.
    Additional technology plans include near real time cloud based monitoring to analyze foot traffic to facilitate constant improvement initiatives using Lean Six Sigma principles for the Healthcare Environment.
    FAST-5CAST, a primordial machine learning algorithm, will have capabilities expanded to automatically handle scheduling of asynchronous disinfection of high risk surfaces. FAST-5CAST may eventually be able to predict genetic drift resulting in antimicrobial/antibiotic resistance in time to initiate preventative measures.
    Textile solutions have also been explored, and are on the agenda for further development.

    RLX is intended to be a unified multi-modal initiative for synergistic and systematic reduction of hospital acquired infections.

  • Describe any proof of concept or testing you have completed so far.

    The UV-C RSS-1 (rapid surface sterilizer) was 3rd party validated in January of 2022 against pathogens of concern in the hospital. It achieved 99.994% reduction of Clostridium Difficile at the surface of least exposure in less than 1 minute while loaded improperly with obstructions in place using Gen 2 firmware. It was validated against Candida Auris during the same trial and achieved 99.995% reduction under the same conditions using maximum exposure cycle. Gen 4 firmware is now in use. 11 pre-production prototypes were manufactured, entirely on US soil, 17 miles from fabrication of the enclosure to final assembly in MAY of 2021. The technology is ready for commercialization and firmware can be integrated into other closed systems using other photon irradiation for a variety of purposes.
    FAST Formula 3 is a restorable antimicrobial hard-coat that has had preliminary validation against gram negative and gram positive organisms.
    FAST Formula 4 is a food safe polymer coating that has had preliminary validation against biofilm formation.
    Photon Coil is a modular air disinfection system, currently at TRL 2-3, that can be installed in ducts or floor standing filters.
    FAST-5CAST is a machine learning algorithm developed in FALL of 2022. It has proven reliable in prediction/prompting of 45 day buy/sell cycles for NoS components and items with cyclic scarcity. It’s application in the healthcare environment is currently confidential.

  • Describe your market opportunity, i.e., size, competition.

    Market growth for infection control is at 5.7-6.5% CAGR and estimated at $47Bil per year in North America as of 2022. 70% of the market share is in consumables, which we intend to handle the purchase/sale of for our clients following our independent validation of their utility. The UV disinfection Market is estimated at $2Bil in North America with a 14-16%CAGR, with UV-C technology making up 40% of the market share. Services make up the remaining market.

    APIC, MasVida Health Care Solutions, PDI Healthcare, SafetySpect, TMG Health Technologies, and Xstream Infection Control offer multimodal infection control approaches and/or consulting services. Several advertise UV-C technologies to augment their other initiatives- none have published 3rd party validation studies. None of these companies offer more than 3 applications aimed at infection control, nor do any offer source tracing assistance, genetic testing, or onsite staff. Companies like 3M, Steris, and BD are not considered competitors. Many of their products may find utility in the RLX initiative.

    RLX will be the only company offering a comprehensive multimodal infection prevention service under unified direction.

  • Describe your sales strategy, including reimbursement plan, sales channel (distributors, direct), location.

    Initial sales strategy will target hospitals that have historically performed in the bottom quartile for rates of Hospital Acquire Infections and been subject to fines and reduction in CMS reimbursement. In Texas, there are 15 hospitals that have been fined 5 or more times since CMS started fining in 2016. An additional 10 have been fined 4 times. 1 Texas Hospital has been fined all 8 years.

    Our objective for the next phase is to secure one of those hospitals for implementation and refinement of the pilot program. RLX will begin with site evaluation and subsequently assume all custodial duties.

    Reimbursement will come through yearly subscription (based on personnel requirement, custodial payroll, number of devices in service, and expected volume of testing), client purchasing of infection control consumables, and performance based bonuses for reduction in number of infections at 50% of cost savings. Performance bonuses at 50% of reimbursement reductions avoided for each year of fines prior to implementation of RLX.

    Manufacturing of all devices will be done by, or through, F.A.S.T as a separate entity with preference for Texas based contract manufacturing companies.

  • What is your regulatory strategy?
  • Describe your management team.

    JP Bonansinga MD CEO & Founder: Doctor of Medicine, Bachelors of Neuroscience with special interest in developmental neurobiology, undergraduate research in neuroimmunology, research into antimicrobial beginning in 2012, research self taught electronics engineer, former US Army special operator with extensive leadership experience.

    Crystal Maldonado MSN, APRN, CPNP-PC, FNP-C Interim CFO & Founder: 15 years of critical care and emergency medicine experience. Versed in technical and medical documentation. Key collaborator.

    Nicholas Hardy: Certified Six Sigma Black Belt, Certified Lean Practitioner. Major project management experience with a manufacturing company doing $7Bil in sales annually. Extremely capable engineer. Combat veteran, now E8 (First Sergeant) in Army Reserve.

    Thomas Nuessen: Holds 10 professional engineering certifications, winner of CADI Speed Rollout competition. Experience in industries ranging from HVAC to Aerospace engineering.

  • How much funding have you received since your company was founded and what types (grants, investors, friends/family, etc.)?

    >$400,000 in liquid investment from founders. Additional value added services, facilities, prototypes estimated at $1,000,000.

    2 proprietary manufacturing methods, novel exposure projection algorithms, optical flat manufacturing advantage, and technology ready for immediate commercialization at the consumer level.

  • Do you currently have an open round of funding? If yes, how much is the round, how much have you raised so far, and when will the round close?

    No current open round. Fundraising has been on hold following complications from spinal hardware malfunction.

  • How many pitch competitions have you entered in the last 12 months, and how many have you won?

    1 pitch, 0 wins. Numerous invites.

  • Check the box(es) for your IP situation (licensed or company-owned)
    Provisional patent pending, Non-provisional patent pending, Trade secret
  • If patent applications, please list foundational patent application numbers and application dates

    S. Patent Application No. 18/092,701, Filed January 3, 2023, METHODS, SYSTEMS, AND APPARATUSES FOR DISINFECTING AND SANITIZING MATERIALS, John-Paul Bonansinga

    PCT Patent Application No. PCT/US2021/040205, filed on July 1, 2021, METHODS, SYSTEMS, AND APPARATUSES FOR DISINFECTING AND SANITIZING MATERIALS, John-Paul Bonansinga

    US Provisional Patent Application Serial Number 63/047,138, Filed July 1, 2020; “Device, Systems and Methods for Disinfecting and Sanitizing Materials”, John-Paul Bonansinga

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