The R&D Tax Credit Aspects of Heart Disease Technology Advancements



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Heart-Disease     
        Heart disease  is a serious condition that affects numerous individuals around the world. With new advancements in technology for heart disease, scientists and researchers have the ability to diagnose patients more efficiently and are provided with the resources to create new treatments. New methods and improved treatments are significant in the process of providing the best options for patients. Throughout the vast amount of research that is conducted, university research plays a large role in developing new insights and technology for heart disease.


The R&D Tax Credit

        Enacted in 1981, the Federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

  • New or improved products, processes, or software
  • Technological in nature
  • Elimination of uncertainty
  • Process of experimentation
       
        Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent. On December 18, 2015 President Obama signed the bill making the R&D Tax Credit permanent.  Beginning in 2016, the R&D credit can be used to offset Alternative Minimum tax and startup businesses can utilize the credit against $250,000 per year in payroll taxes.


Heart Disease

        In the United States, approximately 610,000 people die each year due to heart disease. Heart disease is the highest cause of death for both men and women. Annually, 735,000 people suffer from heart attacks and about 370,000 people alone pass away due to Coronary Heart Disease (CHD).  It is imperative that early action is taken in order to prevent a significant amount of damage that may occur to an individual with heart disease.

        There are certain warning signs people should be aware of to determine if they are having a heart attack. If someone is experiencing chest pain, shortness of breath, nausea, cold sweats or upper body pain he or she should be taken to the hospital immediately. There are also certain medical conditions and lifestyle activities which can result in a higher risk of obtaining heart disease.

        Diabetes , obesity, high blood pressure, high cholesterol, smoking and low physical activity are all significant risk factors. To solve the condition of heart disease and take preventative measures, there are various treatments available for patients.

 

Treatments

TAVR Procedure
        One of the many treatments offered to patients who are diagnosed with heart disease is known as a Transcatheter Aortic Valve Replacement (TAVR). TAVR is a minimally invasive procedure that has already been FDA approved.  This is an alternative available to patients who don’t have the option of open heart surgery due to certain physical conditions.

        The TAVR procedure consists of positioning a catheter and valve through an artery in the leg that connects to the heart. The device has to be placed in the correct position otherwise it can move out of place. The surgery takes only ninety minutes compared to a four hour open heart surgery procedure. Benefits of the TAVR are that it provides patients with a faster procedure, decreased blood loss and a quicker recovery rate.






Medtronic’s Evolut R TAVR
        Medtronic has developed a new system known as the Evolut R transcatheter aortic valve replacement. The system has been approved by the U.S. Food and Drug Administration (FDA). Last year, the company created the CoreValve which consists of valves that can expand on its own and is available in several sizes. So far, CoreValve has supported approximately 75,000 patients.  

        The newer Evolut R system is an improved version of the CoreValve system that provides an increase in flexibility. The most beneficial aspect of this technology is it can be repositioned during the procedure. This feature reduces the number of complications that may occur from d
evices that are placed in the wrong position. With the new design and improvement of the CoreValve, the TAVR procedure has become a practical alternative and offers a higher level of reliability.   

IOWA Approach
        IOWA Approach is a startup from Iowa City, Iowa, who is developing a catheter ablation treatment.  This treatment is particularly meant for individuals who have atrial fibrillation, which causes fatigue and affects the daily activities of an individual. Around 200,000 new individuals obtain this disease each year mainly due to aging.

        The company has recently established an equity financing with Boston Scientific Corporation, which will assist in funding further activities for their atrial fibrillation ablation technology. IOWA Approach will use the money to improve their products and conduct pre-clinical activities. This startup has the goal of creating a simple and cheaper treatment that is available to everyone who suffers from atrial fibrillation.

Mobile Applications

Circle of Health
        A cardiologist, Valentin Fuster, worked on developing a mobile application  with the Icahn School of Medicine at Mount Sinai in New York and the Fundacion Pro CNIC in Spain. The application is called Circle of Health and is free for any individual to use. It provides users with the assessment and tracking of their cardiovascular health.  The application educates people about the main risk factors of developing heart disease and how they can prevent these risks from occurring. Primarily, a user takes a questionnaire which assesses and determines what level his or her health is at. Video, audio, and educational images are used in the app to reach out to people and educate them about staying healthy.

ASCVD Risk Estimator

        The American College of Cardiology and the American Heart Association have partnered together to create a mobile application which determines an individual’s risk for heart disease. The development of the ASCVD Risk Estimator app was to assist in preventing and decreasing the risk of a patient experiencing a heart attack or stroke.  The application gathers information about a patient and analyzes it in the app to calculate someone’s overall risk. The data that is collected includes information such as a patient’s age, sex, race, cholesterol and blood pressure.

        The ASCVD Risk Estimator is an application that lets doctors know a patient’s status so they can decide if any further actions need to be taken. The tool is mainly used to analyze an individual’s risk for heart disease within a period of 10 years as well as their entire lifetime. Utilizing this mobile application gives patients and doctors a better perception of a patient’s status and helps determine if any preventative measures should be taken.


University Research

UC Berkeley
        Scientists from UC Berkeley have dedicated a large amount of their time to develop a special device, referred to as the “heart-on-a-chip.” The device was developed as a new method to model human heart tissue. Scientists hope to use this technology as an alternative to experimenting on animals  in order to test new cardiac disease medications. In order to fully develop a drug, it costs approximately $5 billion where 60% of this total cost is generated from research and development expenses.  

        The heart-on-a-chip is created into a 3-D structure that replicates the formation and functions of the heart. The device is able to mimic how tissue in the heart would react when medicine is taken by an individual. This process allows researchers to analyze the heart-on-a-chip device to see if a drug has positive or negative effects on the heart and determine if the drug needs to be modified.

University of Buffalo
        Researchers from the University of Buffalo have been experimenting with creating a pacemaker which doesn’t require batteries in order to function. The overall goal of the project is to create a device that is powered by an individual’s heart, but at the same time is able to regulate a person’s heart as well. The battery has to be changed every few years, which results in a decrease of expenses and required procedures.  

        Researc
hers discovered that this type of technology is a functional alternative for pacemakers by utilizing a method known as the piezoelectric system. This system utilizes a person’s heartbeats to create vibrations which are transformed into electricity to power the device. Currently, scientists are working to develop prototypes and expect to undergo human trials within the next few years.






University of Michigan

        Scientists from the University of Michigan may have developed a solution by utilizing nanotechnology in order to prevent heart attacks or strokes from occurring.  Nanotechnology  would be used to locate and destroy particular cells that cause these conditions. Studies have been conducted on mice and sheep where it was discovered that this method was successful in getting rid of cells that were damaging.

        Researchers release nanoparticles into a subject that contains a particular chemical combined with an amino acid based peptide. Only the harmful cells are drawn to the nanoparticles, which allow scientists to determine which cells should be targeted.  A low level red light is used to destroy the targeted cells and leave the surrounding cells alone.  The team working on this procedure believes that the next stage of development will be ready to be tested on human studies in the near future.  

Washington University in St. Louis
        A team of biomedical engineers and scientists have utilized 3D printing technology  to develop a cardiac device that will be able to convey accurate information about a patient’s heart and predict when a heart attack may occur. The 3D model is created from flexible silicon, which allows the material to contour to the shape of an individual’s heart.

        Specifically, using MRI or CT scans, researchers can create a 3D model of a patient’s heart and develop a mold of the device based on the 3D model of the heart. This aspect is beneficial for patients because current technology is only 2D and requires additional components to fully function. The 2D devices aren’t as reliable and efficient compared to new 3D technology.

        Once the base of the model is developed, small sensors are printed onto the silicon material, which are used for functions such as measuring an individual’s temperature and delivering electrical pulses to the heart.  This device will assist doctors in the process of assessing and determining what diagnosis should be given to a patient.


Conclusion

        Heart disease is an issue that many people suffer from. A vast amount of research is being conducted by universities to create new developments and many mobile applications are being created to assess the risks and conditions of an individual. Companies who are involved with creating new developments and improvements in technology for heart disease are eligible to receive R&D tax credits.

Article Citation List

   


Authors

Charles R Goulding Attorney/CPA, is the President of R&D Tax Savers.

Lauren Chin is a Tax Analyst at R&D Tax Savers.