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October 16, 2017 Issue

CEOCFO MAGAZINE

 

Q&A with Sonal Tambe, Co-Founder and CEO of NimbleHeart, Inc. patient-friendly Wireless, No Gel, Dry ECG Electrode Based Device for Monitoring Cardiac Risk in the Home, Office or the Gym During Activity

 

 

Sonal Tambe

Co-Founder & Chief Executive Officer

 

NimbleHeart, Inc.

www.nimbleheart.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – October 16, 2017

 

CEOCFO: Ms. Tambe,, what is the vision behind NimbleHeart?

Ms. Tambe: NimbleHeart’s vision is to empower people with cardiac risks to be monitored long term in all the settings like office, home or gym or alternate care centers in a clinical way and during activity. This is intended to help them and their physicians better manage their cardiac health and overall fitness.

 

CEOCFO: Would you explain what your device looks like and how it works?

Ms. Tambe: Most of the ECG monitors including the recent patch type devices require some skin preparation, because the electrodes that detect the electrical signals from the heart need to stick to the body. This involves shaving for men and skin abrasion for both men and women. We have made a breakthrough using dry electrode technology. There has been a great deal of research going on in this area, but NimbleHeart has the first product that is able to work without any gels or skin preparation or shaving. NimbleHeart Physiotrace is a very lightweight harness that can be wrapped around the torso and works very well on the anatomy of women, as well as men. In addition, it can give clinical ECG data, even during activity. Physiotrace is easy to integrate into people’s lives; something that people with risk of cardiac events can wear inside or under their exercise or regular clothing, and can be monitored wirelessly and comfortably. Another advantage of Physiotrace over the other devices on the market is that it can be cleaned very easily with water and alcohol.

 

CEOCFO: How does the Physiotrace™ Smart work? How are you able to do it without the gel? What is the science behind it?

Ms. Tambe: We have a patented technology for patient-friendly dry ECG electrode based monitoring. The fundamental science is having good conductive contact with the skin and more importantly ensuring that contact with the skin during movement to avoid artifacts. Our technology ensures a very good contact with the help of gold plated metal electrodes, whose geometry has been designed to get the best signal from the body without causing any reaction or without degrading the quality of that signal over time. In addition we have the design of the whole wearable system that provides the localized force on the electrodes to maintain the body contact during movement.

 

CEOCFO: Who typically would be using the device? What conditions are being monitored?

Ms. Tambe: Physiotrace Smart is a prescription device for use by adults with known cardiac risk. It is for people who attend a structured outpatient or home based program called Cardiac Rehabilitation after undergoing a surgery or a procedure like CABG (Coronary Artery Bypass Grafting), angioplasty or stent or have certain cases of CHF (Congestive Heart failure). Such people are given exercise prescriptions based on their risk level after the surgery or procedure and perform monitored exercises during Cardiac Rehabilitation. The goal is proactive monitoring for any abnormal heart rhythm symptoms and improving cardiac fitness in the long term. Physiotrace is safe for such patient population that is likely to have implanted cardiac devices. All the people undergoing Cardiac rehabilitation can continue using Physiotrace Smart at home while maintaining their fitness routine.

 

In addition people living with conditions like AFIB (Atrial fibrillation) or those with other cardiac related risks such as hypertension or diabetes can also be monitored using Physiotrace.

 

Physiotrace will also be used on the research subjects as part of various institutional clinical or academic research programs.

 

CEOCFO: You received FDA clearance for the Physiotrace™ Smart just last month. What is the strategy for the next few months to one year, to move from development to commercialization?

Ms. Tambe: I am excited that we are moving to the commercialization phase at this time. Our goal is to bring the product to the US market by the beginning of the next year. We are also planning to enter some other countries that accept the FDA regulation.

 

CEOCFO: How are you getting attention from the medical community?

Ms. Tambe: We performed clinical studies during the R&D phase, as well as during the FDA clearance process and got exposure to the medical community through those. Our pilot clinical study in the US was performed at Henry Ford Hospital in Michigan at three different Cardiac Rehabilitation sites. Another extensive study was administered by the staff from Palo Alto Medical Foundation and Good Samaritan Hospital in California.

 

CEOCFO: Are you seeking funding, partnerships and investors as you move forward?

Ms. Tambe: Yes. We are seeking funding for the next steps through platforms like AngelList, traditional investors as well as strategic partners. Our product can be put to the best use when there is a synergistic partnership with bigger medical device vendors/ service providers. We are already talking to some of them.

 

CEOCFO: Is there any competition at this point for a product with similar capabilities?

Ms. Tambe: I do not know of any FDA approved product that has the same capabilities and can be used in the same way at this time. However, I am sure people are working on those. We did not start with any invention or technology that was looking for a market; we were focused on a big unmet need of patient-friendly long-term home-usable monitoring, and developed technology and product to address that. That is why we have always been practical in our approach, and targeted on satisfying the end user – the patient and the providers.

 

CEOCFO: What surprised you through the process of developing and getting approval for your product?

Ms. Tambe: I would say there were challenges rather than surprises. Most of the entrepreneurs get a kick out of handling new challenges by the way. When you design an innovative medical product, you may also have to think of innovative ways of testing how it works. We had to creatively come up with the tests to prove to the FDA that our technology is safe and effective in comparison to the products and technologies in the market.

 

CEOCFO: Put it together for our readers as well as members of the medical community. Why is NimbleHeart a company to watch?

Ms. Tambe: A big part of the medical community, whether they are cardiologists or working on treating some other diseases/ symptoms, need to monitor the condition of the patient’s heart. Our technology is going to make long term or frequent monitoring so easy that the physicians will be able to use the data generated by our device as an important input to make better and more proactive clinical decisions. The comfort, wear-ability and ease of maintenance of Physiotrace product will no-doubt invite patient compliance during monitoring.


 

“We did not start with any invention or technology that was looking for a market; we were focused on a big unmet need of patient-friendly long-term home-usable monitoring, and developed technology and product to address that.”- Sonal Tambe


 

NimbleHeart, Inc.

www.nimbleheart.com

 

Contact:

Sonal Tambe

408-475-7630

sonal@nimbleheart.com



 


 

 



 

 


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