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Theranova |
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March 27, 2017 Issue |
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CEOCFO MAGAZINE |
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Medical Device Developer With a History of Successfully Bringing Products to Market that Improve Health and Reduce Cost of Care from an Implantable Battery Powered Device to a Urine Sensing System |
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Chief Executive Officer
Theranova
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 27, 2017
CEOCFO: What is the vision behind Theranova? Mr. Burnett: The vision behind Theranova is related to what we call our triple aim. It is the focus of all of our efforts to improving outcomes in healthcare, reducing the cost of healthcare and expanding access to healthcare. If you hit on all three of those cylinders, you develop technologies that are a win/win for all the different sectors of the healthcare system.
CEOCFO: Where are you focusing your efforts? Mr. Burnett: Our niche is regulated medical products. We are not interested in direct to consumer technologies that may have some health benefits, because the expertise that we have developed over the last fifteen years largely relates to the medical device industry and the art of bringing the technology to commercialization. It is an art. There are regulatory considerations, reimbursement considerations. You also have a quality system that you need to function under and then there is the R&D design history file and a variety of other factors that factor into medical device design that are not nearly as prevalent in consumer products.
CEOCFO: What have you learned over time on how to do it well? Mr. Burnett: On different fronts, there are different things to learn. For regulatory, I have learned that you should engage the FDA as early as possible as soon as you have some semblance of a plan. It waxes and wanes but right now the FDA is very collaborative and when you get in front of them, you can start to build a plan that will work for both parties. For reimbursement, engaging the payers early is important, as well. We have brought in house counsel for in house support for intellectual property and regulatory matters, simply because these two are so critical. The main thing is being able to see the entire picture, regulatory reimbursement, patent protection and how the whole landscape fits together and whether that is going to be an opportunity that will hit on our triple aim and resonate with investors.
CEOCFO: What are some products you have worked on and what is in the forefront now?
Mr. Burnett:
We have a technology that is an intragastric therapy for obesity, being
developed by a Theranova spinout called BAROnova®. I also invented a
technology that is on the market in Europe now. It is an implantable pump to
treat fluid accumulation with liver failure, being developed by another
spinout called Sequana Medical. We have also spun out companies developing
technologies in therapeutic hypothermia, migraines, overactive bladder,
abnormal uterine bleeding, and congestive heart failure management. I am
currently the CEO of Potrero Medical, where we are developing an ICU
monitoring technology that utilizes existing bladder access to guide patient
care. CEOCFO: Is there a strategic plan to work in different areas or is there some connection amongst some of these products? Mr. Burnett: I would say the main connection is all the technologies that we are developing and continuing to develop and will develop, achieve the triple aim that I mentioned earlier. The only real connection is that they are focused on improving outcomes, reducing costs and expanding access to care. What those needs are and what technologies we use to satisfy those needs vary quite a bit.
CEOCFO: What do you look at that might not be obvious to less experienced people as to whether something has a good shot? Mr. Burnett: I was in venture capital for a couple of years and our process is very similar to the venture capital process. When we look at a company and we are either starting internally or bringing in from the outside, we will perform a pretty thorough diligence and look at every facet such as the intellectual property, regulatory, reimbursement, and feasibility of the technological solution. If there are not any black balls on any of those, then we will typically move forward and try to generate proof of principle on the technology. If we can generate proof of principle, then we carry it forward to investors and try to raise money for the concept.
CEOCFO: Do you have a group of people that is available more easily for investment than companies that are starting with one product and do not know where to turn? Is it a hard sell every time? Mr. Burnett: In my first three companies, I drew from completely different pools of investors each time. Each of those times it was more like reinventing the wheel and it was a hard sell. Since my fourth company, EMKinetics was founded, I have started to develop stronger relationships with some groups in Dallas and San Antonio. There are repeat investors in several of my last endeavors. Those repeat investors start from a position of trust because they know me really well and I know them really well, so a decent bit of the management diligence process is taken care of.
CEOCFO: Are the potential changes to the medical landscape meaningful for you? Mr. Burnett: There is a lot of angst any time there is change and the thought of repealing the Affordable Care Act has people a little squirrelly. The fact of the matter is, though, I do not think there will be an administration that would resist the concepts of improving health funds, reducing costs and expanding access to care. The Trump administration recently stated that Americans are going to get better care and it is going to cost less. This sounded like a bold statement at the time, but we at Theranova agree that that is possible with the right innovation. I do not think anyone would argue that the more expensive care or worse care or less access to care makes sense.
CEOCFO: What are you working on today? Mr. Burnett: Right now my biggest push is with Potrero Medical, which is a urinary catheter from which we can derive a variety of vital signs and unique parameters that we use to guide patient care. The catheter is currently cleared by the FDA to report intraabdominal pressure, urine output and temperature. We are exploring what other parameters we can derive from our catheter because we know there are quite a few more. The plan is to use those parameters to help predict and detect illness earlier in the ICU.
CEOCFO: Would that mean a worsening of the condition of someone in the ICU? What are the uses? Mr. Burnett: The patient would have to be sick enough to already have a catheter. That is our first market. They are already in the ICU, but there are a whole slew of illnesses that happen to patients that are already in the ICU such as acute kidney injury, ventilator-associated pneumonia, sepsis, etc.. We are developing algorithms to drive the predictive analytics to help detect those diseases earlier.
CEOCFO: How do you deal with working on things that can really make a difference but can be somewhat of an arduous process even when you know what you are doing? Mr. Burnett: You have to be committed to that first part of making a difference for people. If all you wanted to do was make money, then there are much easier and more rapid ways to do that in my mind than in the medical industry where there is regulation and some baked in delays and risks that are not in other industries. The key for me is the commitment to the whole double bottom line concept. To that end, we have started a nonprofit to commercialize Theranova Technologies in low resource areas, as well.
CEOCFO: Why pay attention to Theranova? Mr. Burnett: It is solving real world medical problems. It is helping payers by reducing costs, helping patients by improving their health and broadening access to superior, affordable care to more people. That is Theranova in a nutshell and how we do it varies from the implantable battery powered device that we have on the market in Europe, to a urinary catheter that we have on the market here, to elegant sensors in a home use device. |
“…helping payers by reducing costs, helping patients by improving their health and broadening access to superior, affordable care to more people. That is Theranova in a nutshell…”- Dr. Daniel Burnett, M.D.
Theranova
Contact: Kenna Sylliassen 415-926-8616
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Dr.
Daniel Burnett, M.D.