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INTERview





Digital Health Company AFFIRMATIVhealth delivers Personalized Treatment Plans for Alzheimer’s disease and other forms of Dementia


Denise M Kalos

President & CEO


AFFIRMATIVhealth

www.AFFIRMATIVhealth.com


Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine


Published – August 24, 2020


CEOCFO: Ms. Kalos, MS, what is the concept behind AFFIRMATIVhealth? Where are you today?

Ms. Kalos: AFFIRMATIVhealth is a digital therapeutic company. We enable physicians to deliver precision medicine treatment plans to their patients at risk or living with Alzheimer’s disease or other types of dementias. To date, we have developed a piece of technology that digests a person’s genetics, blood biomarkers and medical history and then the software identifies underpinning causes of memory loss. It then generates a personalized treatment plan to address the specific issues within a person’s body chemistry that may contribute to memory loss.    

 

CEOCFO: Is it well accepted science that the biomarkers can pinpoint the problem? Are all doctors onboard or is that somewhat newer or not as well accepted? How do we know that what you are doing works?

Ms. Kalos: It is becoming more common practice and accepted that there are alternative treatments for Alzheimer’s disease and memory loss. There is a great deal of published research that addresses very specific, single markers that affect memory. We reviewed the wealth of published science and we realized, “This is a lot of information and not everybody can do everything.”

 

We examine an individual’s biomarkers, or a person’s body chemistry, to understand specific deficiencies with that person and apply the relative science. When we optimize a person’s body chemistry and we see improvement.  

 

CEOCFO: What are a couple of the biomarkers? What are you looking at and what do they indicate?

Ms. Kalos: We are looking for things like inflammation, hormone imbalance, vitamin deficiency, metal toxicity; we are looking at 40 different biomarkers. What we are looking to do is optimize a person’s body chemistry, moving people toward an optimal range, so that their body and mind is functioning efficiently.


CEOCFO: How does the RE:mind™ program work?  

Ms. Kalos: We deliver our program in a few different ways. There is an immersion experience where people come and join us for four days and we take them through the entire foundation of our process, including a one-on-one consultations with a doctor, dietitian and physical therapist, group lectures, and learn by doing exercises, and then follow up using telehealth for 3 more months. We also have a one hundred percent telehealth platform, so we do everything online and on the telephone. We also, recently opened an in-person research clinic. What is consistent, regardless of process, is that you receive the same comprehensive examination of cognitive health including, genetic testing, blood tests, and very detailed medical history, and the patients walks away with a personalized, one-size-fits-one therapeutic plan; one-on-one consultations with a physician, with a dietician and with a physical therapist are always part of the process. Consultations are designed to educate and refine the personal therapeutic plan, so they walk away understanding exactly what needs to be done to improve their cognition. In this way, we take all individual recommendations, applying scientific studies, and create a plan for each patient that is unique to them and easy to follow. We follow up on a monthly basis to confirm that they are adhering to the program. We know the key to improving cognition is adherence to the personal therapeutic plan. This is not a cure for Alzheimer’s disease. It is a therapy that requires long term behavioral change in order to be effective.

CEOCFO: When you are putting in a person’s information and medical and the technology is working, does a clear-cut plan come out? Is there a range where if someone shows between this and that, then this is what they need? Is there a human element to developing the program before you talk with the person and refine it? How does that basic plan get in place?

Ms. Kalos: The computer generates a very specific plan. However, it is always reviewed by a physician who looks for anomalies. Ninety-five percent of the time, the plan is extremely accurate. The physician is reviewing to identify other abnormalities that potentially need to be addressed prior to focusing on cognition. What we do is so extensive that we typically identify other health concerns that can then be addressed by their primary care provider 

 

CEOCFO: Would you give us an example of what a program might be for an individual? What are you going to ask someone to do every day, every week, twice a day?

Ms. Kalos: Absolutely! We treat using lifestyle medicine. We do not prescribe medications that you might typically think about when you think about treating for Alzheimer’s disease. We use diet, exercise, supplements, stress management, and sleep.


People always ask what supplements they should be taking. What we are looking for are specific deficiencies related to Alzheimer’s disease. We prioritize them and then develop a supplement regimen specific to each person. We start with those that are most critical and add in others over time.  In this way we don’t overwhelm the individual.


We would also recommend certain types of exercise. We consider a person’s medical history, current daily practices and customize an exercise program is appropriate for their age and their physical ability.


Diet is the most important part of the program. Our preference is that people get their nutrition through a balanced, healthy diet. We consider allergies, likes and dislikes, where the person lives and what is accessible to them, so that we are designing nutritional programs that can be accommodated by the individual’s lifestyle.


We also look at stress. We make recommendations about how to reduce stress. Educating participant on meditation, resilience and deep belly breathing.


We also examine sleep patterns. If we suspect sleep issues related to sleep apnea we ask that they consult with a specialist.


We also educate on socialization, meditation, and brain stimulation.


In general, we are looking at overall behaviors and designing a program that fits into their lifestyle.


CEOCFO: How do you measure the results?

Ms. Kalos: We do cognitive testing on the front end, as well as test the blood biomarkers. It typically takes three to four months to see dramatic change in a person’s body chemistry, so we retest the blood biomarkers and cognitive test after three or four months. We also ask subjective questions. Most people who go through this experience actually feel better! They feel like they are thinking more clearly! They are remembering things in a way that they had not in recent history. This is often reflected in their cognitive testing. Therefore, there are three ways that we actually look at success.  

 

CEOCFO: If a person without Alzheimer’s starts working on their stress, diet and starts working on exercise, are they not likely to feel better as well? You mentioned the biomarkers, but how else might you distinguish? What is the social effect of improving one’s lifestyle?  

Ms. Kalos: You are absolutely right! “Healthy body, healthy mind!” When we look to improve cognition we always start in the gut. We try and get their gut in order, because we want their body to be able to absorb the nutrition and the supplements that are being fed into the body in a healthier way. However, the real “risk” at going through our program is that overall, they become healthier. There is no way to get the brain functioning better without improving the entire health of the body.

 

CEOCFO: Are patients looking for this type of program? Is it caregivers, perhaps, that would be the first to look at it? How are you introducing it to physicians? How are you introducing it to patients?

Ms. Kalos: Both patients and caregivers are looking for help. Everyone keeps hearing that there is no cure, but what they are finding if they do the research, is that there are alternatives treatments for Alzheimer’s disease and other types of dementias. When they look online, they are reading a lot about how to improve their body chemistry. The problem is that it is just too much information. Not everyone can do everything that is recommended in the research and not everyone has to do everything that is recommended in the research. What happens is that people try it and then they give up. It is just too much, and they don’t see results.


The patients and caregivers are really their own advocates in this process. They are the ones introducing this program to their physicians. More and more physicians are hearing about alternative approaches to Alzheimer’s and so there are some who seek us out. Word of mouth is very powerful, and the way we currently get most of our referrals. 


CEOCFO: Where does cost come into play?

Ms. Kalos: We give people options in terms of how to participate. For our immersion program, where they are coming and they are visiting with us and they are staying in a resort and they are going through the process, it is obviously more money. It is a cash pay experience that is seven thousand five hundred dollars, not including testing. However, if we use telehealth to deliver our services, it is much less expensive. It is two thousand five hundred dollars and the cost is the same if you walk into our research clinic.

 

We received our credentials from Medicare. Medicare is critical if we want to bring this type of program to the masses. At AFFIRMATIVhealth, our goal is not to offer services to only those who can afford it. We want everyone to be able to have access to this type of treatment. Also, with the new rules around Medicare, we are hoping to be able to use Medicare with our telehealth delivery option. In this way we hope to reach everyone being touched by this disease.

 

CEOCFO: Are you seeking funding, partnership or investment as you move forward?

Ms. Kalos: Yes we are! We are seeking investment to complete the build out of our care management platform. This will allow us to reach physicians interested using our program to provide care to their patients. We at AFFIRMATIVhealth cannot do it all ourselves. We need primary care physicians, neurologists, functional medicine physicians . . . really all providers . . . to be able to treat their patients. What we want to do is put our solution in the hands of those physicians, so that they can continue to own that patient relationship, as well as the care management for their patients.  Investment will also allow us to establish a longitudinal data base to further the research so needed in this field.

 

CEOCFO: What has been the response from the medical community as well as the investment community? Do they understand?

Ms. Kalos: It has been a long road. We have known for the past five years that this type of program will help people. However, the scientific community wants to see the research, which is why we focused the better part of the last two years in conducting a research study and delivering our results. That is not to say that our research study is the “be all, end all.” We know that it requires more study and we need a larger study group. However, we wanted put it out there in the scientific community and for the consumer to read and understand that there are viable alternative treatments for memory loss.  

 

CEOCFO: What is the takeaway for our readers? We reach many people in healthcare, we reach the investment community and we people in general?

Ms. Kalos: There is hope. A diagnosis of mild cognitive impairment or Alzheimer’s disease is not a death sentence. There are things that people can do to maintain their cognitive health, and improve cognition. What is important is that they start early, they do not wait.

 

It is much harder to bring someone back to “typical” if they progress to a point where they are not functional. If we can catch people in the early stages and put them on our program, there is no reason to believe that they cannot maintain their cognitive and physical health for the rest of their long-lived lives!


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“If we can catch people in the early stages and put them on our program, there is no reason to believe that they cannot maintain their cognitive and physical health for the rest of their long-lived lives!” Denise M Kalos


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