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S.E.A. Medical Systems, Inc.
Medical Devices & Tech
3350 Scott Boulevard, Bldg. 33
Santa Clara, CA 95054 United States
phone:650-218-1840
fax:408-987-0673
Symbol Private
Founded 2008
Employees 12
www.seamedical.com
Research Sector Medical Devices & Tech
Summary Description
Technologies for safe delivery and disposal of liquid drugs
Management
Michael J. Weickert, Ph.D., CEO and President; James W. Bennett, COO; Leo Matsiev, Ph.D., CTO; David W. Bates, M.D., Board of Directors; David A. Kvancz, MS, RPh, FASHP, Board of Directors
Keywords
IV technology, IV check, smart iv, disposable, sensor, inexpensive, intravenous, IV preparation, administration, waste disposal, diversion detection, auto IV, IV Waste, IV management, smart pump, consumable, IV manufacturing, IV drug, Diagnostics, Drug Delivery, Drug Sensors, Wireless Information Transmittal, Drug Errors

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Updated: May 10, 2012

Description
S.E.A. Medical Systems Inc. is a private healthtech company that pioneers smart solutions for the safe manufacture, preparation, delivery, and disposal of intravenous and other liquid medications. The Company’s medical devices catch life-threatening IV drug errors before they harm patients. While IV drug delivery is the most powerful route to administer drugs, the most devastating consequences occur when things go wrong. It is estimated that 7,000 people are killed in U.S. hospitals each year when they receive the wrong medicine or wrong dosage, and such incidents cost large hospitals up to $5.6M per year; 61% of these errors are IV-related. S.E.A. Medical’s unique technology identifies drugs, concentrations, and diluents in IV fluids, and simultaneously measures flow rate and cumulative dose during IV administration. The Company’s products include touch-screen electronic devices, consumables containing sensor chips, drug recognition software, and drug library modules. This later-stage medical device company has numerous patents pending on its technology and products.
Products / Services
Four product families are in development to insure the “five rights” of medication administration. S.E.A. Medical plans to introduce the first commercial product, IV Check, at the ASHP meeting in New Orleans in December of 2011. IV Check catches errors made preparing IVs. Smart IV instantaneously reports drug, concentration, and flow rate in IV lines during drug administration to patients, alerting healthcare providers to errors which injure or kill hundreds of thousands of patients per year. Auto IV controls IV administration automatically by recognizing the fluid being delivered and matching it to safe delivery parameters and/or patient’s electronic medical records. IV Waste automatically measures and seggregates hazardous liquid pharmaceutical waste, documenting EPA compliance and detects diversion of scheduled IV medications to meet DEA regulations. IV Check and IV Waste are not subject to FDA regulation as neither has patient contact nor is involved in therapeutic decisions. Other products would be subject to the 510(k) regulatory approval process. The company has successfully completed tests of working IV Check and Smart IV prototypes on 36 “high alert” medications, including narcotics, cytotoxics, insulin and heparin, in several leading US hospitals including Brigham and Women’s, UCSF and Cleveland Clinic. S.E.A. Medical Systems is likely to partner with one or more companies to integrate this technology into Pharmaceutical and IV manufacturing, dispensing robots and other IV systems.
Technology / Differentiation
S.E.A. Medical has developed a disruptive technology, a proprietary version of admittance spectroscopy, to rapidly measure multiple parameters of the IV fluid to identify the drug, concentration and diluent. This proprietary, multiparametric sensing technology generates rapid and consistent fluid fingerprints and matches them to a library of fingerprints of drugs in IV fluids generated by S.E.A. Medical. Product prototypes have been used to recognize the top 36 “high alert” medications so far, those most likely to cause injury or death, including insulin, heparin, narcotics and opioids, chemotherapeutics, neuromuscular blockers, electrolytes, sedatives, cardiovascular medications and antibiotics. The technology also recognizes drug combinations, like Fentanyl and Bupivicaine, commonly used together in epidurals. IV drug fingerprint libraries will eventually include hundreds of drugs and drug combinations. So far, there have been no IV drugs the technology could not be used to recognize. Unlike optical approaches, the Smart IV technology is sensitive to electrolytes, a class of compounds used routinely in patients and where mistakes happen frequently with severe consequences. The sensor is a disposable product that can be sterilized by conventional methods typical for IV equipment. Sensors are made by conventional, commercial micro-lithography, which ensures highly reproducible, large volume, cost effective manufacturing. Measurements do not perturb the IV fluid and are performed almost instantaneously. For adminstration, one sensor would be used with each IV set for the duration the set is used (typically 2-3 days) then discarded when the IV set is removed. One Smart IV sensor will recognize all of the drugs or combinations being administered that are present in the signature library - there are no separate sensors for each drug.
Market / Customers
The IV equipment market including IV pumps and consumable sets, was over $6B in 2010. An estimated 450 million IV consumable smart pump infusion sets were used in 2010; this is expected to grow to 630 million by 2016. S.E.A. Medical’s products are expected to become an important part of this market due to the emphasis on patient and provider safety, and the economic pressures of not reimbursing medical errors (“never events”) and litigation and settlements when errors occur. Product revenue comes from multiple sources; i) sales of the electronic devices, ii) sales of the software modules for detecting different families of drugs, iii) sales of consumable fluid sensors and iv) service contracts. The S.E.A. Medical products are expected to be very affordable, with consumables costing in the low single digit dollars. With billions of IVs prepared and administered worldwide, the market for these products is extremely large.
Competitors / Substitutes / Alternatives
Current “chain of control” approaches to reducing ADEs include computerized physician order entry, bar codes, automated medication preparation and dispensing, and smart pumps. Despite utilization of these technologies, serious errors frequently occur. Wrong dose is the most common for IVs. Chain of control systems typically cost millions of dollars to implement and months of staff training to effectively use. These costs are not reimbursed. Hospitals recoup the investment through savings from avoided ADEs. The Smart IV, Auto IV, IV Check and IV Waste products offer real verification of the IV and compliment other technologies whether integrated into other equipment or as stand alone products. Several companies have developed sensors for IV fluids. ValiMed by CDEX allows the user to test IV fluid samples for 40 drugs at preset concentrations and diluents. The device costs $70-80,000 and uses an optical spectroscopy technology that is unable to recognize electrolytes and non-fluorescing drugs. The user must select the drug, concentration and diluent to be verified and the device reports a verified/not verified response only in 15-45 seconds. Dynalabs’ Dynalyzer, with capabilities similar to the ValiMed system, is in beta testing. Sensors by Moog/Zevex recognize air and blood in the IV line but cannot recognize drugs. Issys has a MEMS sensor measuring fluid specific gravity to help monitor delivery of drugs, but it was only approved by the FDA as a flow sensor (Feb. 2006). Gravimetric and photographic verification of IV preparations are other approachs to improve IV drug saftey. Baxa has commercialized a system called DoseEdge. The DoseEdge Pharmacy Workflow Manager, formerly IntelliFlowRx Workload Management Software, is a system designed to track and manage intravenous (IV) medication dosages prepared by pharmacy personnel in a clean room environment. When followed as designed, barcode scanning and the photo image of the medications drawn to the appropriate dose are used to insure safety potentially by remote parmacist examination. Robotic IV preparation systems like Robotic IV Automation (RIVA), offer another approach to IV drug safety. Verification of drug preparations is gravimetric (weighing the completed dose) with stock solutions verified by specific gravity before loading into the device. Many solutions have the same specific gravity and measurements are difficult so this is not ideal. RIVA and systems like this are very expensive costing ~$1M each. No competitors on the market or in development have the capabilities of S.E.A. Medical’s technology to instantly and reliably identify, empirically, IV drug, concentration, and diluent in which they are prepared, independent of the label, bar code, or other information, including during delivery to patients. S.E.A. Medical has introduced its technology to all the major companies in the IV delivery equipment field and all are interested in applying this technology despite their existing solutions.
Funding
Company has been privately funded and completed a Series A in 2010.
Status
S.E.A. Medical Systems’ disruptive alternative to the “chain of control” is creating products that instantaneously and continuously recognize the drug(s) in the intravenous fluid as well as their dose(s), empirically and independently, and provide real-time alerts to serious errors and thus unprecedented IV medication safety. Product families in development reflect a continuum of increasing technology complexity and corresponding increasing patient safety, from checking samples in the pharmacy (IV Check) to monitoring IV administration (Smart IV) to controlling IV administration (Auto IV), and also include management of IV manufacturing and disposal as well as diversion detection of schedule drugs like fentanyl and morphine (IV Check, IV Waste). IV Check: Prototype stage, tested in hospitals, introduction planned ASHP, Dec. 2011 with sales in 2012. No regulatory approval required. Smart IV: Prototype stage, tested in hospitals, approval filing planned 2012 with sales in 2013. IV Waste: in development, introduction planned in 2012. No regulatory approval required. Auto IV: in development, partnerships being considered.