BIOFEST INVEST APPLICANT
Legal Entity Type: LLC
Company Type: Medical Device
Company Stage: Development
No. of Employees: 2
Desired Financial Amount: 1.5 million
Airway compromise is the second leading cause of potentially survivable battlefield deaths. When assessing a casualty, combat medics have a few precious seconds to assess the oral cavity to determine if the airway is blocked. Once unblocked via suction, the medic must maintain a clear airway to assure passage of air and access for additional intervention. In better equipped settings such as hospitals, providers use powerful, permanent building suction to clear obstructions and determine damage. However, the available “portable” electrically powered systems are not powerful enough to remove thick vomit or blood. Marketing surveys show they are simply left behind. Furthermore, many medical settings require suction for other lifesaving indications such as chest tubes or wound VACs. We have previously developed high-powered portable suction units for use by combat medics and propose to expand this design to encompass a broader capability that addresses the needs of DoD and civilian end-users including GST damage control surgery, enroute care, and prolonged field care. Our objective is to create a compact, highly portable, and flexibly powered suction device to address these needs. Potential Benefit: Successful completion of the proposed project will produce a minimum viable product (MVP) design at a readiness level to begin FDA review and approval. The intended clinical application is to provide a compact, highly portable, and powerful suction unit for military and civilian first responders. This device would allow them to have powerful suction to efficiently clear the airways of the wounded. The system could also be adapted to operate at variable pressures for related applications such as removing air trapped in the chest outside the lungs (collapsed lungs) or suctioning wounds to improve caregiver access and view. Other concepts include a hands-free face mask allowing protracted placement of a suction catheter while leaving medics both hands available. The risks involved with the proposal are minimal, as this is a proven technology being refined and updated.
Robert De Lorenzo, MD, Co-Founder CEO, President – Clinical A retired combat medical officer, and board certified in emergency medicine and fellowship trained in EMS/prehospital care and research. His focus is on airway medical device research and development and his experience includes several DoD-funded clinical trials and serves as an emergency medicine subject matter expert for the DoD. Lyle Hood, PhD, Co-Founder CFO, Vice-President – Engineering Assistant Professor in the Department of Mechanical Engineering at the University of Texas at San Antonio. His research focuses on development of novel medical technologies with an emphasis on new platforms for airway management. He has published more than 10 manuscripts and patents on the design, prototyping, characterization, and field analysis for innovative portable oropharyngeal suction devices, endotracheal tubes, and alternatives to the laryngoscope. Each of these projects was developed with military and civilian first responders in mind. Zachary Fallon, BSME, BS, Operations Manager – Operations Product development engineer focused on product design, development, rapid prototyping, market competition analysis, and business modeling for entrepreneurial commercialization. Prior experience includes sole proprietorship and founder for six small enterprises; recent projects include the AirSINC and AirSEQURE suite of advanced endotracheal tubes; Stimson shoulder dislocation-reduction facilitator; SmartShade drone-powered dynamic sun blocking; and TurboWing microturbine fixed wing powerplant.
Board of directors
Our Board consists of members from the following organizations: Venture Mentor Services (VMS) –UTHealth, and Technology Commercialization Center of SW Texas SBDC. Jane C. Andrews, Ph.D., Founder & CEO of Cell Bridge Therapies Dr. Andrews is a recognized leader in Life Sciences, Regenerative Medicine and Cell Therapy, with a deep understanding of the technology, markets and operational aspects of these industries, and how they will grow for biomedical advancement. The Cell Bridge Strategies team, under Jane’s leadership, helps companies match their strengths with market opportunities by bridging the gap between Science and Business. Dr. Andrews has built a global network of Life Science and Regenerative Medicine experts that can be tapped into to aid Cell Bridge Strategies clients. Mike Dwyer, President and CEO of Vida Medical Devices Inc. Mr. Dwyer is an experienced executive with a demonstrated history of working in the biotechnology industry. His is skilled in Medical Devices, Clinical Trials, Data Management, Biotechnology, Regulatory Requirements as well as Finance. He is currently the President & CEO, Vida Medical Devices, Inc, and the Director, Vice President & Member of the Investment Committee for the San Antonio Economic Development Corporation. He has previously help positions as: President – MTD Associates, LLC; President & CEO – Azaya Therapeutics, Inc; Executive Vice President, Ilex Oncology, Senior VP Quintiles Translational; Partner – Arthur Anderson Bijo Matthew, Ph.D., Director of Technology Commercialization Center of SW Texas SBDC Bijo Matthew serves as Founding Director to the Technology Commercialization Center of the South-West Texas Border Small Business Development Center (SBDC) Lead Network at The University of Texas at San Antonio (UTSA) In this role he is responsible for developing the regional strategy and provide Texas at San Antonio (UTSA). In this role he is responsible for developing the regional strategy and providing executive direction to programs created to enhance innovation, access to groundbreaking, high-impact, high risk funding for applied and translational research opportunities, applied entrepreneurial education curriculum, and promotion of science and technology-drive entrepreneurial capacity. The SBDC Technology Commercialization Center is part of the Institute for Economic Development Programs and Centers at UTSA. Sean Thompson, MS, MBA, CLP, Co-Director Tech Novum, Operations Manager VMS UT Health Sean Thompson is a biomedical business leader skilled at deriving value from bioscience-related technologies and transforming novel technologies into commercialized products. A self-motivated and driven visionary with a broad and practically useful set of skills; an analytical, evidence-based decision-maker. Creative and resourceful with an established track record of building trusting working relationships and motivating and leading diverse teams of subject matter experts to achieve goals on time and on budget. Experience spans multiple sectors: pharmaceuticals, medical devices, and regenerative medicine, including human tissue (allografts), blood products, and cell-based and cell-derived therapeutics.
Product / Service
disease area / application
Next Gen Airway Management – Prehospital care, Prolonged field care, Enroute care
product / Service
Airway compromise is the second leading cause of potentially survivable battlefield deaths. When assessing a casualty, combat medics have a few precious seconds to assess the oral cavity to determine if the airway is blocked. Once unblocked via suction, the medic must maintain a clear airway to assure passage of air and access for additional intervention. In better equipped settings such as hospitals, providers use powerful, permanent building suction to clear obstructions and determine damage. However, the available “portable” electrically powered systems are not powerful enough to remove thick vomit or blood. Our marketing surveys show they are simply left behind. Furthermore, many medical settings require suction for other lifesaving indications such as chest tubes or wound VACs. We have previously developed high-powered portable suction units for use by combat medics and propose to expand this design to encompass a broader capability that addresses the needs of AF end-users including GST damage control surgery, enroute care, and prolonged field care. Our objective is to create a compact, multimodal, highly portable, and flexibly powered suction device to address these needs.
technology / ip
Intellectual Property: 1) PCT/US2019/057008 Methods, Apparatuses, and Systems for Aspirating Airways, 2) PCT/US2017/031164 Airway Suction Device, and 3) PCT/US2020/056090 Endotracheal Tube. All patents held by the University of Texas Board of Regents. As employees of the University and co-inventors on the patent, the principals in this proposal have the appropriate rights to use this patent. Our airway technology has orientation independent tech that allows EMS personnel to not be concerned with the orientation of the device upon operation. Throw the device onto the ground, turn on and begin procedures.
DoD and private sector purchasing channels. Purchasing manager’s through EMS care companies, and hospital systems. Purchasing managers through DoD commands such as CCATT and General Surgical Team(GST) through the Air Force, Army, Navy medical services and beyond.
The markets available for defense commercialization are vast but, the CRUSH has a broad civilian healthcare market applicability, including prehospital Emergency Medical Services (EMS), critical care transport, the emergency department, the intensive care unit, the operating room and other procedural areas. Currently the global suction device market is valued at USD 3,093.6 million and is expected to reach USD 3,851.2 million by the year 2023, at a Compound Annual Growth Rate (CAGR) of 7.57%. Emergency Clinics are popping up around the country leading to more personnel with EMS, driving the need for more suction devices. The suction device market contains not just oropharyngeal suction but also oral-nasal tracheal suction, dental suction, surgical suction, abdominal drainage, nasal gastric drainage, duodenal drainage, wound drainage, pleural drainage, and sump drainage. Versatility was an important goal to cover all the HCW’s suction requirements. CRUSH can be deployed in combat to evacuate vomitus solution from the airway from point of injury or utilized when a patient is en route to the intensive care unit on a transportable gurney. Long-term commercial solutions are needed to meet global demand now, in months ahead and when international combative confrontations arise. Global 2015 data from 74 World Health Organization (WHO) member countries estimated over 200M intubation procedures in a non-pandemic environment. This data supports a market opportunity of $1.85B in the US and $3.1B globally. Additional usage could be driven by at-home and nursing home care for neurodegenerative diseases requiring wound or oral suction. The customers for CRUSH will expect a target price range of $250-300 for commercial pre-hospital, emergency service, hospital, nursing home, and at-home care. A more robust design intended for military service is in transit for a price point of $500. Our market strategy takes advantage of the CRUSH’s versatile features and affordability in the current market. The CRUSH addresses the limited space in combat medics pack while also addressing the vast applications for multiple procedures. Airway management being the 2nd leading cause of preventable battlefield deaths underlines the value proposition in bringing to market a device that addresses the HCW’s demands. Speed to market will be a critical factor to gain traction and rapidly expand market access and penetration. Market entry will initially be US direct sales to targeted hospital and EMS accounts, driving maximum adoption, and generating evidence to support wider US and global market expansion that will expand direct sales and include a specialty distributor to rapidly increase market penetration. Forecasted sales revenue for the first full year is $9M with a less than 1% market penetration. Full third year revenue is forecasted at $70M with a less than 3% market penetration Currently, we are utilizing internal expertise and social media to promote CRUSH. As development continues, we are continuing to expand our network by contacting distribution partners, vendors, intensive care purchasing managers, and chief financial officers. After a successful pilot program with our military partners, we intend to hire a Senior Director/VP level marketing and sales resource(s) to lead all marketing and sales initiatives and activities, from prelaunch through post-launch surveillance.
Current Competition: A search of the major airway management or medical device companies revealed similar products in basic functionality, but CRUSH is superior. These specifications include but are not limited to improved portability, greater suction power, reduced footprint, and most importantly versatile control systems for multiple applications, a feature that is not seen on current commercial suction devices. To name a few (Table 3), Ambu ResCue, Zoll 330, and Laerdal Compact Suction units do not provide sufficient care. Reasons being, the units are heavy and bulky for first responders, leading to widespread non-use. Suction capability is inadequate and unable to clear the airway. Devices are not orientation independent, resulting in the medic having to maintain the device upright when every second is crucial. Current devices are unimodal and unable to be safely used for multiple procedures whereas CRUSH will have multiple modes for different procedures ranging from airway suction, wound suction, and chest drainage. Moreover, CRUSH will be single use, preventing transmission of disease, omitting the costly practices of sterilization, and reprocessing. Airway suction, wound drainage, and chest suction are common indications in medical care. Laerdal, Ambu, and Impact are the primary competitors for airway suction and will be our poster child’s for comparative testing. However, CRUSH will be superior in capability and disrupt this segment by offering multiple indications not available in the competition. The price point for devices on the market range from $50 for Ambu Res-Cue which has insufficient suction and $600 for Laerdal Compact Suction Unit which is the top competitor. CRUSH intends to enter the market with a civilian price point of $300 and a robust, impact resistance military CRUSH price point of $500. Competitors lack key design elements of the CRUSH, including the combination of being lightweight, powerful, reliable, disposable, cheap and lastly multimodal. Improving basic specifications such as weight, footprint, suction power, and orientation independency immediately put CRUSH ahead of the competition but the added value of switching the device to various modes for different suction scenarios is the key distinguishing factor. The Impact 326/326M (price point $1600) is the current model available in military role 2&3 units, however, these devices do not meet End-User Requirements based on customer feedback. The Zoll 330 is the current civilian model, but does not meet DoD end-user requirements, either. No devices currently include all major modes of suction, bringing to market the first universal suction machine. Reducing the footprint of 5 different machines into a universal unit makes the device irreplaceable.
Desired financial amount
$50,000 SAMMI (San Antonio Military Medical Institute Fund) provided assistance in producing a Proof of Concept (V1)and Design for manufacturability device (V2) $1.25 MIllion Direct to Phase II Air Force Contract
Burn rate is engineering dependent. We have $10k in the bank, have sources of funding SBIR AFWERX (awaiting reply). We have a group of passionate individuals dedicated to the problem willing to bend backs and make this reach fruition for the sake of improved prehospital care, enroute care and prolonged field care.
Pour it into the company for engineering development. Another round of listening to the customers. Round 3, Version 3 of the device and move onto FDA approval. Hire an FDA consultant (aint cheap) and move forward. Engineering development and FDA expertise.
Zero revenue. Presales.
Our options are open. We recognize a need, our end users on the DoD and private sector are very responsive and acknowledging of the need. Our options are open.