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Linshom Respiratory Monitoring Device receives FDA 510 (k) clearance
Linshom Management LLC
Contact:
Ronen Feldman
(410) 480-
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFO Magazine
Published: February 17, 2020
CEOCFO: Dr. Feldman, what is the vision behind Linshom Management LLC?
Dr. Feldman: Thank you for your time. What we have developed is a respiratory monitor that is capable of detecting both respiratory rate and tidal volume in patients who are breathing spontaneously and do not have a breathing tube inserted. Linshom is a respiratory monitor that is noninvasive, inexpensive, robust, and does not suffer from motion artifact. Although our current FDA indications for use are for hospital settings and Oxygen mask, we plan in the near future to request additional clearances for use, outside of a hospital setting such as by medics, home use and military applications and for nasal cannula, because Linshom is so practical, small and is incredibly accurate and robust.
CEOCFO: What is it about your monitor that is different?
Dr. Feldman: That is a very good question. What we have done is create a monitor that really does not currently exist. It is one thing to make a better vehicle, a better iPhone, a better watch: something of that nature. However, what we have done is we have gone from black and white TV to hi def color TV with Dolby Digital. We are able to provide more information about the patient’s respiratory condition than other available devices, and we can do it in an environment that does not require high end technology nor high end medical knowledge for people to utilize it.
CEOCFO: What can you tell us about the technology?
Mr. Feldman: Based on the concept that if you can monitor the changes in temperature in close proximity to the mouth and/or nose, then you can accurately detect respiration. Linshom has the ability to monitor minute changes in temperature as a person breathes. During respiration, a person inhales and exhales, and this causes heating and cooling of the micro environment around their mouth and their nose. We have a very sophisticated thermal sensor that is able to control that microenvironment and determine what the respiratory signature looks like. From that respiratory signature, we are able to derive respiratory rate, relative tidal volume and seconds since last breath.
CEOCFO: Has a similar approach been tried in the past?
Mr. Feldman: There have been people who have tried to use thermal sensors before, like thermistors for instance, or thermocouples, but they were not successful, because there is another part to the equation which they did not figure out. As an example, if you place a thermistor within a mask, initially the thermistor would detect respiration. However, the ambient temperature within the mask quickly rises and reaches equilibrium with the temperature of the face and the exhaled breath. At that point the thermistor gets saturated and the “signal to noise” becomes so small that it’s difficult to extract the signature of the respiration. We are able to overcome that by controlling the temperature of the thermal sensor continuously through proprietary algorithms and electronics in order to accurately detect both respiratory rate, seconds since last breath, and relative tidal volume in real time.
CEOCFO: Would you tell us about the device? Is it a piece of equipment and a disposable?
Mr. Feldman: We have two pieces of equipment. We have electronics that control the system and we have a sensor. The sensor itself would fit into a mask or into a nasal cannula. It will be composed of two parts; a disposable and a non-
The electronics are relatively simple and straightforward. Basically, all of the electronics are housed in a footprint that is the size of a smartphone and is thus portable. It is also not expensive to manufacture. As opposed to some of the competition, for instance capnography, which does not provide as much information as we do such as tidal volume, we do not need pumps, gas analyzers, etc.
CEOCFO: Linshom recently received an FDA clearance. What are your next steps?
Mr. Feldman: The FDA has validated and accepted our claims that we monitor respiratory rate, versus the current Gold Standard, which is capnography. The FDA also validated our claim that we accurately monitor relative tidal volume. Tidal volume is not something that other monitors can provide easily and noninvasively in non-
Dr. Feldman: What I would like to emphasize is that there are other devices on the market that are able to provide respiratory rate. However, they are not able to easily and reliability provide you with a tidal volume. The tidal volume really completes the picture of how that patient is doing. Two individuals might breathe at the same rate. You could breathe at a respiratory rate of twenty breaths per minute and I could be breathing at a rate of 20 breaths per minute. However, I might be suffering from broncospasm (asthma) while you are breathing just fine. Our respiratory rate might be the same, but the quality of our respiration is different, and tidal volume tells the difference. We are able to provide this data through our device and that is what makes us very special.
CEOCFO: What has been the response from the medical community that is aware of what you have developed?
Dr. Feldman: Up to this point we have conducted third party validations at Harvard; Brigham and Women’s Hospital (Boston, MA) Department of Anesthesiology, at the Cleveland Clinic department of gastroenterology, at the University of Mississippi department of anesthesiology and at Einstein Philadelphia department of emergency medicine. All the results from those different studies have been spectacular, to be honest with you. The medical staff, the PI’s that conducted the study and observed the Linshom device and studied the results, were very enthusiastic, and some of them actually asked us if they could invest in Linshom, because they were so impressed with our technology. We have also presented Linshom to KOLs (Key Opinion Leaders), who looked at this technology and were also very enthusiastic and told us that once this is a commercially available product that they would strongly support the Linshom device being purchased and implemented at their institutions.
CEOCFO: Are you seeking funding, investment or partnerships at this time?
Mr. Feldman: Yes, we are. We are currently in the final stages of a pre-
CEOCFO: In addition to hospitals, where are the most promising areas for use?
Dr. Feldman: This device could really be ubiquitous in the medical field. One use that is self-
Additionally, EMTs that have to run up three and four flights of stairs to treat patients in an apartment as an example, and then transport them in an ambulance where there is the issue of motion artifact, changes in temperature, and limitations of space could benefit from Linshom. Once they arrive at the emergency room, Linshom could help the staff at the emergency room triage those patients. There are about one hundred and fifty million visits to the ER in the United States every year. Therefore, Linshom will be a very nice tool to help diagnose monitor and treat patients during this most vulnerable time. If the patient then gets transported, for instance, to radiology, how do you know that they are still breathing when they are away from a central monitoring location? Linshom could also be utilized on ER patients that are admitted to the hospital and need respiratory monitoring on the floor. In our opinion, Linshom could and should be utilized from when a patient is first contacted by EMT’s out in the field to locations within the hospital site.
Mr. Feldman: One thing that I would like to add, is that we feel that our technology is also very well suited to under-
Dr. Feldman: Just one additional thing is that we are currently in discussions with the United States Air force, who is looking at our device for different applications as well; whether they be for medics in the field during war fighting operations as well as response to manmade and natural disasters and in military hospitals. We recently applied for an SBIR grant from them, to explore having this type of technology in the armed forces as well.
CEOCFO: With so much potential opportunity how do you decide where to focus?
Mr. Feldman: Clearly, we are a small company. As a startup, we cannot be all things to all applications. Our market research as well as conversations with multiple physicians and chief medical officers indicates that the best penetration point for us is the emergency room
CEOCFO: What type of mask is used-
Mr. Feldman: Our device will be integrated into a standard oxygen mask such that currently exist.
CEOCFO: What changed in your approach from the original concept to where you are today with an FDA cleared product?
Mr. Feldman: We realized the great need for respiratory monitoring and, that a device such as ours is necessary. It was also apparent that many of the big companies, the medical manufacturers, were working towards this solution.
In house, we have fabricated and tested multiple iterations of our device. We have learned what works, does not work and what needs improvement. We have been working on Linshom now for about ten years and over that time, both the electronics and the software have evolved to where we are today and what was submitted to the FDA for clearance. We have certainly learned much over the years!
CEOCFO: What do we see a year from now? What are some of the benchmarks you expect to go through?
Mr. Feldman: We anticipate that will have our first generation monitor that will be fielded in hospital settings.
CEOCFO: Do you feel that as the concept is easy to understand Linshom can attract investors more easily?
Dr. Feldman: Let me try to field that question first. Many individuals do not realize how little respiratory monitoring actually occurs, even in sophisticated hospital settings. For example, people that undergo a colonoscopy assume that they have respiratory monitoring while they are sedated and that is usually not the case. They might have their saturation monitored with a pulse oximeter, but pulse oximetry is a lagging indicator and becomes inaccurate when supplemental oxygen is provided. The clinician, a gastroenterologist who is providing you with a narcotic and a Benzodiazepine, turns off the light in the room, applies a pulse oximeter, gives you oxygen, and then all they are really doing is looking at video monitor displaying images of the colonoscopy. No one really knows if you are breathing or not until it might be a little too late.
The reason there is not a lot of respiratory monitoring is not because the medical community is unaware of the need. It is just that they do not have technology that provides the information accurately, reliably and in real time. Capnography has not proven to be effective in this regard and proof positive of that is that capnography has been around for thirty plus years, but it barely got out of the operating room. It should have taken over the world by now. The fact that so many companies are trying so hard to come up with different solutions also tells you that we do not have one good solution. When many different people are working on the same problem, there is not one good solution. We think we came up with a solution that works very, very well. An elegant solution for a huge market in the many billions of dollars. There is legislation coming down the pike to demand more monitoring, but at the same time, we have less individuals, less nurses, clinicians that are able to really keep an eye on the patient. The medical community is stretched thin, so having such a monitor can be of great economic value and improve the healthcare of patients. We appreciate the time that you have given us and that you have contacted us and hopefully, within the not too distant future, Linshom will be used throughout the medical community and beyond!
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“The Linshom Respiratory Monitor improves patient safety by providing continuous, uninterrupted, critical respiratory information through innovative monitoring technology. Linshom is safe, reliable, noninvasive, simple to apply to the patient and answers a critical unmet medical need. Linshom is patented in the U.S, and internationally. FDA 510(k) cleared”-
Ronen Feldman
President
Doron Feldman
Chief Medical Officer