BIOFEST INVEST APPLICANT
Forge Applied Science & Technology
Legal Entity Type: LLC
Company Type: Medical Device
Company Stage: Development
No. of Employees: 4
Desired Financial Amount: $530,000
Forge Applied Science & Technology (“F.A.S.T”) was founded at the height of the global pandemic as a vehicle for development and manufacture of a rapid point-of-care sterilization unit utilizing a novel sensor suite to monitor delivery of germicidal radiation. The device was designed to address a vacancy in spread control that had existed prior to the arrival of SARS-COV-2, and took aim at hard-to-kill Clostridium difficile (“C. diff”). Exploration into the clinical utility of UVGI by John-Paul Bonansinga in the month preceding the lock-down inspired hasty construction of the initial prototype the week of March 20th. The test ready MK 3/4 “Easy-Bake” unit, including first generation firmware, was completed in late May of 2020 . A provisional patent was granted to the John-Paul Bonansinga, then a 4th year medical student at UT Health, on July 1st 2020. Successful preliminary validation for efficacy of the Easy-Bake prototype, at a Dallas based Biosafety Level 3 lab prompted engagement with design for manufacture firms (“DFM”) in North America and Canada. Labor shortages, supply chain disruptions, and advisement by DFM representatives that the unit could not be built on U.S. soil at the desired price point triggered work towards domestic production in earnest. Three full engineering cycles were completed between August 2020 and May 2021. The first minimum viable product could have been made available in December of 2020, with US based production completed by 3 vendors between Dallas, TX and 2 Midwest locations. The Dallas team devised a novel method of production for generating aluminum enclosures, but was limited to 300 units/month as a result of tool/machine limitations. Complete redesign was initiated in January 2021, and culminated in the construction of 22 pre-production MK 1 MOD 0 units. MOD 0 units were equipped with 3rd generation firmware, internal reactors utilizing a proprietary bonding process, and the assembly document was edited in real time as revisions were made. Generation of the MOD 0 enclosure from raw sheet metal occurred 17 miles from final assembly where production units were to be shipped direct from the manufacturers floor. John-Paul Bonansinga returned to UT Health in August 2021 to complete 4th year requirements for graduation, and engaged with Microchem Laboratories in Austin, TX to create a modified ASTM E1153 test procedure in pursuit of 3rd party validation of the MOD 0 sterilization unit. The MOD 0 test unit, featuring gen 2 firmware, achieved >99.9994% reduction of C. diff endospores from 1.6X the standard concentration under intentionally deoptimized conditions in 99 seconds. The MOD 0 also demonstrated orders of magnitude greater efficacy, compared to standard methods of disinfection, against viruses, MRSA, and Pseudomonas aeruginosa. The MOD 0 unit was also validated against Candida Auris, an emerging pan-resistant strain of yeast that has resulted in hundreds of deaths and temporary closing of several hospital units. Hospital acquired infections rose 47% in the 20 months following the lock-down, and contribute to billions in unnecessary costs to the healthcare system. Work continued in the Midwest, as well as Texas, through Spring of 2022 until John-Paul Bonansinga underwent emergency cervical spine decompression surgery in May 2022. Steady progress was made during the 7th month period that the spinal cord injury went undiagnosed, but the decision was made to prioritize recovery following decompression. Internal valuation and reorganization of F.A.S.T began in July 2022. In December 2022, Dr. Bonansinga deemed his recovery sufficient to begin outlining milestones through June 2024 and begin the vetting process for new prospects to fill vacant board positions. 64 individual Texas companies were identified in Fall 2022 as capable of performing one or more production task for F.A.S.T. All production, with the exception of one subassembly, will be shifted to Texas prior to pre-launch of the MOD 1 device.
John-Paul Bonansinga MD: Dr. Bonansinga is a former United States Army Ranger and Dept. of Defense Foreign Service Officer with extensive leadership experience both on the battlefield and in the civilian sector. As a medical doctor, he is an expert in human physiology and biological sciences. He has a B.S in in neuroscience, and conducted undergraduate research in the field of neuroimmunology with a focus on cytokinetic processes contributing to neurodegenerative diseases. He possesses advanced knowledge in the field of genetics, developmental biology, and neuroscience. Dr. Bonansinga elected to enroll at UTSA during 2022 rehabilitation, and completed advanced coursework in Lean Manufacturing and Artificial Intelligence. Dr. Bonansinga is a self-taught gun smith, electronics engineer, and musician. Hobbyist pursuits have resulted in the generation of a novel phosphating process, proprietary 1911 ignition geometry, an estimated 200 guitar effects circuits, custom controls in his instruments, and the restoration of a 1937 Rickenbacker Model B lap steel. As a firm believer in “Gemba”, he elected to work afternoons on an assembly line to improve his technical documentation in F.A.S.T’s infancy. Dr. Bonansinga is an experienced project manager, who has developed working knowledge of the necessary aspects of design, engineering, production, assembly, and compliance to direct F.A.S.T towards interim goals. Nick Hardy: Nick works as a Program Manager in the field of Industrial Engineering / Manufacturing. He is a seasoned leader with 17 years in the United States Army and currently serves as an Infantry First Sergeant (E8) reservist. Nick’s involvement in F.A.S.T projects began in June 2021, and he has continuously expanded his skillset to meet the needs of the company. Nick earned a B.S. in Project Management from Colorado State University in 2020 and is currently attending University of Arkansas School of Engineering studying for Master of Science in Operations Management. Nick currently holds the following certifications; Certified Six Sigma Black Belt (CSSBB) and Certified Lean Practitioner (CLP). As part of the CSSBB certification process, candidates must design and implement a new practice that results in a savings of $50,000 or more. Nick’s lean implementation initiative resulted in a savings of $1,000,000 for his company. Thomas Nuessen: Thomas is a highly skilled mechanical engineer with 10+ years of experience. He has a successful track record of creating and improving component designs, increasing assembly efficiencies, and minimizing re-engineering. His excellent communications skills have allowed him to engage cross-functional team members to drive product development. Thomas began working with F.A.S.T in December 2020, and was instrumental in the rapid redesign of the MOD 0 sterilizer unit. He has an eclectic engineering background with experience ranging from medical devices and aerospace to HVAC systems. Thomas’s modification to the MOD 0 assembly process resulted in a 60% reduction in assembly time. Key skills include Design Engineering, Solidworks, Sheet Metal, 3D Printing, Product Analysis & Inspection, Prototyping, Technical Documentation, Computer Hardware, and Customer Service. He updated CAD capabilities for his family’s operations which resulted in a 75% decrease in quoting time and allowed for handling larger weldments on complex assemblies. Winner of 2012 CATI Solidworks Rollout Speed CAD Modeling Competition. He currently holds 10 professional certifications and is a Certified Solidworks Professional. Crystal Maldonado, MSN, APRN, CPNP-PC, FNP-C: Crystal has 15 years of clinical/hospital experience primarily in the acute and emergency care setting. She holds 3 degrees including a Masters of Science in Nursing for pediatric primary care and a Family Nurse Practitioner Post Master’s Certificate. She served as a Chairwoman on the Pediatrics Committee from 2012 to 2016 while at University Health Systems. Her comprehensive understanding of the dynamics associated with patient care have influenced aspects of the device design direction as well as the proposed implementation guidance. She has worked almost exclusively as a contracted emergency response provider since Fall of 2020, with experience in austere and low resource settings. Crystal’s extensive work history in San Antonio, TX contributes to a large network of health care providers as well as hospital administrators. Her general tenacity and ability to learn quickly have allowed her to fill gaps in team knowledge ranging from technical documentation translation compliance to infection control protocols. Crystal has developed high level knowledge in spread control and is a key collaborator for experimental design initiatives meant for the hospital environments.
Board of directors
John-Paul Bonansinga MD, Nick Hardy, and Crystal Maldonado act as CEO/CVO, COO, and Interim CFO currently. Additional members are being vetted to fill vacant board positions. Former Board Members/Stakeholders: Derek Sandler: Derek was the Company’s CFO from June 2020 to April 2022, but transitioned out of an active role during reorganization to focus on personal goals. Derek penned all original filings, non-disclosure agreements, service agreements, and co-authored the first draft of the MOD 0 user manual. Derek attended Tufts University where he received his BA in Political Science. Subsequently, he graduated from Villanova with his JD/MBA. He is licensed to practice law in Texas and Pennsylvania. He represented entrepreneurs and Fortune Five Hundred companies alike, has transactional as well as litigation experience, and has closed in excess of $10B in construction loans. Derek will be available in mid 2024, and is interested in returning to an active role. Ryan Pyffer: Ryan acted as COO of Forge until November of 2021, and had an active role in the project beginning in April 2020. Ryan was the co-founder of Tierney and Pyffer Constuction which was recently purchased by a national construction corporation developing next generation tools for design. In addition to charge of millwork, he is the brain tasked with training the Artificial Intelligence during supervised learning trials as it builds directories. Ryan generated the method of production for the first enclosures, which was reminiscent of origami. The process involved light scouring of .030″ aluminum on a 3 axis CNC machine, and subsequent folding on custom table brakes designed and built for the purpose. Though the method was ultimately scrapped for limits to scalability and expense, it was completed in 5 months with a single consult from a mechanical engineer. Though Ryan is not formally trained in engineering or scientific research, He applies the scientific method to aspects of carpentry and construction tasks. He is an adept project manager who has successfully completed large scale projects across the continental US including luxury hotels, retail store chains, and restaurants. Ryan has expressed interest in returning to an active role when there is an opening suited to his skillset.
Product / Service
disease area / application
Hospital acquired infections, infection control, rapid high level sterilization at the point of use for handheld items
product / Service
Hospital acquired infections (“HAI’s”) have a direct cost to the healthcare system of $28-$45Bil and indirect costs estimated at $13Bil per year. These costs are in 2010 dollars and unadjusted for inflation. Policies have been established by third party payers, such as Medicare, to shift more of the financial burden to the hospitals. HAI’s are the 5th leading cause of death in the acute care settings, and contribute to nearly 100,000 potentially avoidable patient deaths per year. Instituting new standard operating procedures (SOP’s) for disinfection/sterilization of equipment such as stethoscopes, smartphones, pens, clipboards, and ultrasound transducers which are carried from one patient to the next is a logical countermeasure. In a single site study spanning 18 months, an ultrasound gel bottle was identified as the source of 40 HAI’s resulting in an estimated 1.6Mil in additional costs to that hospital. The rate of HAI’s increased by 47% in the 20 months following the lockdown. Though central guidance has recommended that more stringent practices be instituted for disinfecting handheld equipment, reports suggest that 85% of healthcare facilities either do not enforce or have not instituted SOP’s addresses this vacancy in spread control. Current practice is provider driven, and disinfection is generally attempted with the application of antimicrobial wipes which require 2 minutes of continuous wet time. Antimicrobial wipes are expensive, and contribute to additional waste in addition to being ineffective. The main ingredient in most wipes has been identified as contributing to increased bacterial resistance to antibiotics which are concentration dependent. Large investments have been made to further research and development of UVGI systems since the NIH published its comprehensive review of UV technology in late 2020. New technologies on the market, such as the Pearl Surface 24G9, are limited in the items they propose to disinfect and have cycle times ranging from 20-30 minutes. The majority of these systems are not 3rd party validated, and those that have conducted testing have not done so to ASTM or ISO standards. The Rushlight MK 1 MOD 0 has been 3rd party validated, under deoptimized conditions, against MRSA, P. aeruginosa, C. difficile, MS2 phage, and Candida Auris for sterilization in accordance with both CDC and ASTM standards. It achieves supplemental sterilization (99.99% reduction) of handhelds to all surfaces simultaneously in as little as 16.88 seconds. Items can be disinfected to the same level as the hands that hold them between each patient encounter without disrupting work flow. C. difficile cannot be killed by any mechanism currently available. The MOD 0 has been 3rd party validated to achieve a reduction of >99.9994% from 1.6X the initial concentration required by ASTM/CDC testing when loaded improperly. With institution of SOP’s the device may also serve as a tool for source tracing. Future development of the unit could be used to augment local antibiograms as part of service agreements.
technology / ip
Intellectual property protection has focused on the novel sensor suite that was generating to monitor and project real time exposure at the delivery sites. The algorithms produced circumnavigate sources of error resultant from variations in output due to a variety of factors. The sensor suite guarantees at least a minimum exposure level to all surfaces simultaneously. It has been developed with complete understanding of the limitations of the chosen wavelength and extends protection to combination systems. The sensor suite, and its associated firmware, can be modified to monitor other UVGI systems such as those being fielded in airports and HVAC systems. The MOD 0 sterilizer design is meant to facilitate ease of cleaning and a 3rd party validated technical coating employing silver/zinc ion technology offers continuous antimicrobial activity against all pathogens of concern so the unit itself will not become a source of spread. The MOD 0 requires very little training to operate, and still achieves sufficient disinfection when used improperly. No timers are used nor estimates made. Delivery of a lethal payload of UVGI occurs regardless of ambient conditions and component life cycle. Provisional Patent: Granted 01JUL2020 North American PCT: Submitted 02JAN2023
A direct sales force will be responsible for early sales targeting 2 major healthcare systems in separate cities. Establishing a market in Dallas, Austin, Houston, and San Antonio will allow a small team to cover a large area. Final adjustments to manufacturing/assembly and considerations for maintenance and technical support can be proofed with less burden of transportation. Devices will be made to order, with shipment direct from the manufacturer preferred. VAR’s may be considered.
The global ultraviolet disinfection equipment market size was estimated at USD 3.74 billion in 2021 and expected to expand at a CAGR of 5.7% from 2022 to 2030. Products developed for the healthcare industry are expected to drive market growth with UV-C technology dominating the revenue share. North America dominates the market due to rising incidence of hospital-acquired infections, better healthcare infrastructure, and awareness of efficacy by key decision makers. The clinical UVGI deployments have been growing steadily since 2010 and have increased dramatically since the start of the COVID-19 pandemic. Compounded annual growth rates are forecasted between 5.7% and 23.6% for the 2023-2030 with market value assessed at $964mil USD for 2021.
Aquisense: The PealSurface 24G9 made up of 3 x 3-inch square modules that can be operated individually for disinfection or combined into large arrays to fit other applications. Strengths: Modern aesthetics in rendering. UVGI delivery uniformity by report. Use of LED’s limits risk of mercury exposure. Weaknesses: Long cycle time of 20 mins, lacks of 3rd party validation, limited capacity, dedicated fixture requirement for items, expensive LED modules UVC Concepts: Uvenclosure automated, no-touch UV-C enclosure designed to improve the standard of manual cleaning and disinfection of large portable medical equipment (PME). Strengths: UVbadge, UVtags, and UVdatacloud automatically record badged users and cycle history to UVdatacloud. “60 second flat” cycle time. Management team experienced in marketing and sales. Weaknesses: 60 second timed cycle does not account for variability in electronics, lifecycle of electronics, or ambient conditions. Claims to inactivate >99.99% of microorganisms on solid surfaces but lacks 3rd party or in-house validation. No device specifications available. No renderings or pre-production unit photographs available. American Ultraviolet: UVC Blade handheld unit Strengths: Patent pending technology from an industry leader. Shatterproof lamp Weaknesses: Insufficient shielding likely to result in dangerous exposures to users. Inefficient Aluminum reflector surfaces. Treatment of surfaces requires specially trained or dedicated crew and protective equipment. Confirmation of lethal payload requires additional expendables. Offerings from 3B Medical, UVO care, Tangshan UMG Medical Instruments, Phillips and others Strengths: Branding. Price points. Weaknesses: Timed cycles, single source directional germicidal radiation, durability, lack of 3rd party validation, limited capacity, unsuitable for professional or commercial environment, unsuitable technical materials. Intellego Technologies: Launched a colorimetric dose indicator in September 2022. The UVCLED-QCC, to color-indicate UV-C doses when exposed to 260-280 nm of UV-C. A visible checkmark develops on the indicator as it is subjected to UV-C light, indicating that germicidal irradiation has been successfully administered. – Included to bring awareness to the market for confirmation of lethal irradiation. EnergyWare: Launched the Olympia Disinfection Lighting System in March 2022, capable of air and surface disinfection. The system is equipped with “cutting-edge” disinfection UVGI devices that have been shown to eliminate 99.9% germs, mold, and viruses like COVID-19. – Claims such as those made by EnergyWare are the standard for the UVGI industry. Elimination of 99.9% of germs, mold, and viruses does not meet minimum CDC standards to be considered supplemental disinfection. Competitor device claims and material selection are based on poor research which has been carried forward for decades without re-confirmation studies. Designs do not account for the limitations of UV-C radiation which include lack of penetration, low transmissivity, low reflectivity, and variability in output based on ambient conditions. The MOD 0 device is purpose built to reliably and repeatedly deliver germicidal radiation to the minimum threshold to all surfaces simultaneously. The MOD 0 has been validated against specific pathogens of concern by 3rd party using ASTM guidelines.
Desired financial amount
~$300,000 cash from founders for direct R&D costs including ~$450,000 in professional and value added services from members/contractors for legal filings, IP, graphic design, website/SEO, and engineering ~$140,000 in travel, facilities use, shipping/tariffs, expendables, and monthly services
Forge was put on standby in May 2022 when Dr. Bonansinga underwent emergency surgery to decompress his spinal cord. Forge’s current burn rate is <$300.00, which pays for secure email, secure cloud, website hosting, Adobe Pro, and other professional subscriptions. Monthly expenses are covered by Dr. Bonansinga and Crystal Maldonado. $20,000 legal fees due by 01 JUNE 2023 Estimated value of component inventory: CMD arrays: ~$27,000 Dot matrices: ~$1,800 UV bulbs: ~$16,000 UV Drivers: ~$11,000 Electronics components: ~$18,000 Non-proprietary equipment: $15,000-$25,000 22 MK 1.0 MOD 0 Reactors: MSRP $7999.99/ea
– Retain Marketing/PR expert x12 months – Part time salaries for employees – Minor engineering cycle for aesthetics and improved safety – Relocate terminal assembly to Texas – Gen 4 firmware – Class II (special controls) FDA Pre-market notification – Pre-launch – Train small sales force – Pre-orders
Reimbursement: N/A Revenue Model: Hybridized Fixed term equipment lease w/ regular maintenance plan vs. Purchase w/ recurring yearly fee for maintenance plan
The Rushlight sterilization devices will be rebranded and launched using a tradename. Sale of the brand/tradename/product line with licensing/sale of the IP will be explored when the UV product line has expanded to include consumer level offerings. Early designs of consumer level devices will be re-evaluated following successful sale and delivery of 500 compliant medical grade units.