IPGDx, LLC

PrognostiCheck^® is our patented biometric scoring system that is based on results (phase angle) from an FDA approved Class II medical device.  PA measures the ability of the cell membranes to hold an electrical charge and illustrates disease presence and trajectory and measures prognosis (remission or prognosis) in patients with chronic diseases.

Michaeal G. Singer's background is in Emergency Medicine (as an EMT, Paramedic and Instructor), Nursing (LPN and RN) and as a Physician Assistant with specialty training in Oncology, Surgery and Internal Medicine.  In the middle 1980's Michaeal started doing Family Practice treating patients with heart failure and high blood pressure who were being treated with diuretics; nearly half the patients seemed to have renal stress indicators and signs of impaired hydration.  Many of these patients had heart failure and high blood pressure and were all on diuretics.  Nearly half of these patients seemed to have elevated renal stress indicators and signs of impaired hydration. 

 

This led Michaeal to measuring their body water to see if they were volume expanded; the quantification of extra cellular fluid volume would be a good indicator of whether diuretic therapy or therapies to reduce the resistance within the circulatory system would be more effective in these patients as diuretics would lower their blood pressure but over time injure their kidneys if they were not volume expanded.

 

As Michaeal continued his research he found publications from Jan Nyboer, M.D.; a professor emeritus of cardiology at Wayne state in Detroit who had publications about using impedance plethysmography for measuring circulatory resistance the other component of blood pressure as well as the estimate of body water using the same technique. He met and worked with Nyboer using the equipment and was referred to a device manufacturer in Detroit and he purchased a device for a retail cost of almost $6,000. It worked!

 

Over time Michaeal noticed the changes of phase angle in sicker patients and the higher values in healthier subjects.  He was interested in body water, its distribution intra and extra cellularly as well as the changes in phase angle.  Michaeal invested in his first patent on the use of the measured impedance values for clinical practice; phase angle for prognosis, resistance for extra-cellular water and reactance for nutrition status. It was/is a methods patent, independent of the instrument.

 

In the late 90's Michaeal started his own company and a subsequent company was formed IPGDx at which time he was joined by John D. Kutzko, Pharm D, a clinical pharmacist with experience in providing home infusion therapies to patients with cancer, hepatitis C, HIV/AIDS, infectious disease, chronic intractable pain and many other chronic diseases in SW FL.  To date Singer & Kutzko together have invested more than $1.3 million in IP, business development, instrument development, scientific trails and research.  In the interim others have joined the company for support.

 

So overall it is our clinical roots, entrepreneurial infestation and a belief that we can do more through our companies for people than seeing patients one at a time. 

 

Michaeal and john designed disease management treatment guidelines, clinical criteria and guidelines for use and comprehensive regimen specific treatment algorithms and protocols for specialty pharmacy firms, payers and healthcare systems in the areas of HBV, HCV, HIV/AIDS, oncology, rheumatoid arthritis, multiple sclerosis, hemophilia A and B, growth hormone, solid organ transplant, depression and osteoporosis.  They have supported the development of IP and regulatory filings for foreign companies essentially doing whatever was necessary to move our projects and company forward to where it is today.

 

 

PrognostiCheck® has two additional registered trademarks; the first is the If Sick How Sick® web platform and results in the third trademark, the Vitality Index®. The primary revenue will be derived from the consumers, from selling the device ($300) as well a subscription to the ISHS E-Health platform model, which facilitates personalized information from their individual profile and measures that against a broader dataset for the Vitality Index®, a metric of their trajectory as it relates to other people with similar conditions and treatments.

 

Patients would use the device and the output of phase angle as well as other pertinent medical and demographic information would be entered into their profile at the website ifsickhowsick.com. The individual could track their own results and outputs, and use a customized printout for their provider-patient interactions...all creating their "Vitality Index®."

 

The "Vitality Index®" measures the course of the disease, the specific treatments that the individual patient/consumer is experiencing, generating a personalized assessment warranting an ongoing but affordable monthly cost. Vitality Index® can be positive, neutral or negative and illustrates the trajectory of the disease process that the individual patient is experiencing answering the question of "How am I doing?" By comparing various treatments effectiveness over time the site will have invaluable comparative data points to guide, patients, families, providers and industry to improved treatment decisions.

 

An additional revenue stream would be directly from the provider community, particularly chronic and terminal disease specialists who are interested in population subgroups for specific diseases and the treatment responsiveness.  This aggregated data would be de-identified, protecting the confidentiality of the individual patients, yet provide invaluable information to providers and researchers seeking to answer complex questions about patients, treatment, and disease progression. PrognostiCheck® will place the ‘professional' device in several key areas, oncology, critical care, hospital admission, surgery, nursing homes to be used as references points for sales and to generate awareness and adoption among the healthcare community.

The competitive advantage of PrognostiCheck® is that as a FDA Class II noninvasive medical device it clearly and objectively provides accurate and sensitive prognostic data in any disease state, using a single biometric measure from a patient. 

 

Additionally:

• The consumer device is non-invasive and easy to use at the household level
• The data can be uploaded onto a website that provides contextual information and resources based on that disease, the individuals' treatment plan, and population-based health data
• The technology and its interpretation harnesses existing evidence-based, peer-reviewed, clinically sound evidence that exists, tailors it to an individual, and equips them to navigate their treatment and disease trajectory in a personalized way
• The objective yet personalized data generated from the device can be used in patient self-advocacy with the clinical provider
• The information will be relevant at multiple levels:

                the individual level (health),

                the household level (stress, expense),

                the clinical level (improving decision-making),

                and public health and industry level

               (comparative effectiveness and outcomes research)