Emergency Medical Interventional Technologies...where minutes translate into life or death.
Company Overview:
EMIT Corporation is a commercial stage company focused on the design, development, manufacture, and sale of devices and related products for the treatment and prevention of hypothermia caused by traumatic, environmental, and procedure related occurrences. The company was incorporated in January 2009 based on technology exclusively licensed from The University of Texas Health Science Center at Houston and The University of Texas at Austin. The United States Army Telemedicine and Advanced Technology Research Center provided initial research and development funding for the technology.
Market Problem/Opportunity:
The market for warming of blood products/infusion fluids exceeds $1 billion with an initial $300+ million target market opportunity for the EMIT’s HypothermX® HX100 and LG product lines and room for further expansion. Market expansion is driven by the portability, transferability from one care setting to the next, lightweight, use longevity, small size/form-factor, and negligible power consumption/needs. In addition, the unique ability for the HypothermX® to operate in a closed-loop heating mode, whereby the patient’s own blood is extracted, heated, and re-infused, appealing to a much larger market audience and allowing for entrance into new market segments.
Solution:
HypothermX® HX100 and LG are patented, FDA-cleared, CE-marked, fast, simple, portable, compact, light, fully-disposable, and long-term use IV fluid and blood warming systems fueled with Isobutane/Propane, eliminating the need for generated power to operate, and utilizes a flameless hydrocarbon combustion process for heating. StayWarmTM, a patent protected convective warm air blowing system utilizing the same flameless hydrocarbon combustions process and has also been designed for use in medical, recreational, and military applications. ETeslaTM, a patent protected high flow centrifugal pump, used in the conjunction with the HypothermX® to accelerate the infusion and warming processes, has several other ancillary benefits that make it useful for other medical applications. Several other temperature management systems are being developed to meet specific U.S. military Special Operations needs.
Business Model:
With a succinct regulatory strategy, controlled product rollout plan, and highly qualified team in place, EMIT has successfully obtained FDA 510(k) clearance and CE-Mark for the HypothermX® HX100/LG product lines; obtained ISO 13485:2003/EN ISO 13485:2012 Quality System certification; completed Military Airworthiness, User, & Environmental Testing in accordance with the Joint En-route Care Test System (funded by the Marine Corps System Command); and conducted a limited product market release. EMIT outsources clean-room manufacturing; however, it procures, inspects, & inventories raw materials; builds non-sterile sub- assemblies & final assemblies; labels, packages, inventories & distributes its products directly. A combination of direct sales to high- end military customers coupled and select-direct/distributor model for the domestic and OUS markets is utilized by EMIT. Strategic Partnerships and M&A transactions will be sought as additional milestones are achieved.
Competitive Advantages:
The HypothermX® is the first truly lightweight (HX100 < 3.0 lbs, LG 1 lb), portable, long-term use solution (HX100 > 4 hours & LG > 2 hours) offering actual therapeutic warming in the field. The HypothermX® is capable of warming up to: HX100 - 5 liters of saline infused at 15° C and 15 units of packed red blood cells infused at 5° C to 38° C ± 3° C with an infusion rate between 50 ml/min and 200 ml/min; and LG - 2 liters of saline infused at 15° C or 2 units of packed red blood cells infused at 5° C to 38° C ± 3° C with an infusion rate between 50 ml/min and 100 ml/min. Ambient conditions between 0° C and 40° C. The systems have all of the requisite safety features and provide alarm-silencing capability to accommodate operational needs.