Sudden changes in levels of exhaled CO2 (referred to as end tidal or ETCO2) can indicate a number of patient complications such as hyperventilation, hyperthermia, respiratory pathway obstructions, changes in cardiac output and foreign bodies. Measuring CO2 levels in intubated or ventilated patients in the operating room (OR) has long been a standard of care. Recent developments have indicated the use of CO2 monitoring the emergency and pre-hospital settings, but current technologies for doing so are not well suited for the emergency care environment. In many clinical situations, a colorimetric test is used to detect the presence of exhaled carbon dioxide in the respiratory pathway using a pH-sensitive strip of paper implanted in endotracheal tubes and breathing devices. Although this method is inexpensive and simple to use, there are obvious downfalls to these low-resolution results. It gives a qualitative measurement of CO2 but fails to provide quantitative measurements nor does it indicate changes in levels over time.
Studies have shown that accurately measuring CO2 levels (known as “capnography”) has vastly improved endotracheal tube placement success: 0% of endotracheal tubes were misplaced when capnography was utilized, compared to 23% when there was no ETCO2 monitoring. There are alternative solutions to the colorimetric test, which primarily rely on infrared or Raman lasers. Though these methods provide real-time continuous monitoring, the devices remain highly expensive and are limited in their application due to their fragility, power requirements, and size. Thus, Allgene proposes a new method of detecting ETCO2 using a combination of quantitative colorimetric and photoelectric technology, continually monitoring CO2 with results far beyond the capability of 19th century litmus paper technology at a fraction of the price of the gold standard bench top models.
THE PROBLEM: CARBON DIOXIDE DETECTION
The alternative solutions to the colorimetric test provide real-time continuous monitoring. However, they remain highly expensive and are typically confined to areas of high level care, such as the operating room or intensive care unit What Allgene plans to offer is a new device with the power of the bedside detectors in the portable, less costly package of the portable qualitative detector.
The capnography monitoring equipment market in 2006 had revenues of $71.2 million with estimates of $108.4 million in 2013. Market data is currently projected to address $80 million in the disposable analytical unit used in emergency care settings. Aging population, increase in population, and rise in cases of breathing-related illnesses are expanding the current market. Rapidly developing markets including China, India, and Russia among others have begun witnessing above-average growth in their respective markets. While the market is growing, the increasing budget limitations of medical care facilities are driving them to seek lower cost solutions. Additionally, the trend toward providing accurate CO2 monitoring in the pre-hospital and emergency care settings is a recent development and promises to expand this segment of the market at a high rate. SimplyAir Detector functions will address a great medical value that specifically fulfills this desire by the market. The CO2 monitoring market is expanding from principally the hospital/OR setting to emergency medical settings, where CO2 monitoring is needed but not currently used. There are ~60,000 ambulances in the U.S. only. Each of these, and of the rest of the ambulances in the world, is a potential “site” for a SimplyAir device.
SIMPLYAIR: INNOVATIVE SOLUTION
Allgene LLC’s SimplyAir Detector bridges the technology and price gap between the “litmus paper” and high-end but cumbersome and fragile wall-unit. The device provides up to 80% of the information of the wall-unit, with the low cost and high portability of the litmus paper. The device uses a unique colorimetric approach coupled with additional technology that can quantify the color change of the indicator that can then be translated into discrete CO2 measurements. As a result, hospital personnel no longer have to rely on human eye, which can often be inaccurate and subjective. Not only does the device provide quantitative information, it is also completely portable without requiring external power. This allows for uses in emergency medical scenarios where the bench top models may be too delicate, too cumbersome, or too power hungry for fast mobile deployment. Lastly, the device provides CO2 measurements in a matter of milliseconds, which allows for continuous monitoring of patients.
Allgene plans to file a 510(k) with the FDA using the current color changing devices as its predicate. All ISO, IEC and ASTM guidelines will be evaluated and followed where applicable.
As of February 2012 a provisional patent has been filed with the USPTO. This provides a twelve-month window to file a Patent Cooperation Treaty (PCT) application with the USPTO protecting our international IP rights. Once the PCT is filed, we then have eighteen months to determine the specific countries/markets in which we desire patent protection. This will be determined by additional market research and the availability of funds, since each market/country requires a separate fee above and beyond the PCT, which can quickly become cost prohibitive to an unfunded company.
IMPLEMENTATION AND NEXT STEPS
The provisional patent for the SimplyAir Detector was submitted in February of 2012. The next step is the purchase of the necessary equipment and materials to create proof of concept prototypes of the Simply Air. A facility on the outskirts of the Raleigh-Durham area has been agreed upon, and once the laboratory is equipped, it will take three to four months to complete this phase of development. As previously mentioned, the base technology is well understood, but the application and the geometry of our application is novel. The proof-of-concept work will concentrate on the optimization of the mixtures and coatings, and the physical geometry of the presentation of the reagents to the exhaled gas stream. This work will be completed by the end of the summer 2012.
At that stage, an Alpha device will be created, with parallel creation and submission of a 510K substantial equivalence application to the Center for Devices and Radiological Health division of the U.S. Food and Drug Administration by the end of 2012.
Our experimental laboratory is located in the physical plant of a local electronics manufacturing plant in which some of the principles have already developed a working relationship. Thusly the transition from experimental technology to Alpha and Beta units to marketable device can be accomplished entirely in house. As this progression proceeds, we will begin negotiating with several of the larger medical device manufacturers to determine the most appropriate arrangement for a business model. The most two likely scenarios will be either an exclusive arrangement/”buy out” arrangement with a company like GE or Mallinckrodt. The other scenario is the development of a mutual interest agreement where we arrange distribution rights with a distributor like King Systems, 3M or Johnson and Johnson, and retain manufacturing rights and control within Allgene. We will be actively producing and marketing this device, or have sold the exclusive rights, by the end of 2013.
FUNDING NEEDS FOR COMPANY EXIT
The company foresees a need for the following:
The company will enter into significant negotiations with strategic partners as its Alpha prototypes are available and will enter into commercial arrangements with one or more of these companies at that time. This will reduce the market risk of commercializing the product and may, in fact, be a point at which the technology is sold or licensed exclusively to an outside organization, reducing or eliminating the need for additional capital.
The SimplyAir team is composed entirely of experienced professionals. The core group listed below has worked together in the past and is currently commercializing another medical device targeted at the anesthesia equipment market (www.an-alarm.com).
· Dr. Allan Shang is an anesthesiologist in private practice, owner and co-founder of Allgene, LLC, and an entrepreneur and inventor in the medical devices space. Formerly on the faculty of the Department of Anesthesiology at Duke for ten years, he is President and co-founder of the medical device company An-Alarm and serves as an Assistant Adjunct Professor of Biomedical Engineering at Duke University in addition to being Outreach Program Director at The Fitzpatrick Institute for Photonics.
· Dr. Gene Moretti, MD, MHSc, of Duke Anesthesiology and Critical Care will act as the Chief Medical Officer for the company.
· Ed Fadel, a serial entrepreneur and an engineering alumni of Duke University, will lead the company on a day to day basis
· Rob Wood has his degree in Chemical Engineering is an experienced, senior commercialization engineer with more than 40 patents in his name. Rob will lead the product development and commercialization efforts.
· The Duke Student consultant team working with Allgene, LLC is composed of driven graduate and undergraduate students concentrated on engineering, business, and public policy. These students include Matteo Caporrella, Lydia Lim, Kartik Pawar, Cameron Setzer, and Alice Yen.
NEED FOR DUKE START-UP CHALLENGE SUPPORT
The Duke Start-Up Challenge funds and support would be timely in that they would be used for the development of the proof-of-concept prototypes and to cover the cost of the FDA 510(K) application.
The SimplyAir product concept was developed by anesthesiologists with a first-hand knowledge of the market need for the device. The team that has assembled to commercialize the device includes the necessary skill-sets to develop the product and the business and has worked together in the past on other medical devices. With a team specialized in engineering, business, and public policy, SimplyAir is fully equipped to take on the capnography market and save lives.
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