test in a wrap
Taking a page from exercise stress testing, NimbleHeart has come out with a unique remote cardiac monitoring device that ECG´s the heart when it´s at its most active and its function easiest to follow. The concept has earned the start-up NASA´s stamp of approval.
By Gergana Koleva
In the world of remote cardiac monitoring, where experienced medtech innovators are surpassing each other with ever smarter designs and features, NimbleHeart has turned founders Sonal Tambe and Dr. Pramod Deshmukh’s passion to help at risk individuals to manage their cardiac fitness exercises at home, into a niche success. When Tambe, an electronics engineer at Apple was pursuing her executive MBA at UCLA, she met and heard Dr. Kathy Maggliato (also a UCLA MBA Alumna) speak about womens’ heart health. That inspired Tambe to use cutting edge wireless technology for patient focussed heart monitoring.
After jumping into a new start-up venture by quitting Apple in 2012, she ran a proof-of-concept clinical study in 2013 in her native India to validate the feasibility of an ECG body harness using dry electrodes.
Out of that clinical study in India and a subsequent test of the technology´s usability in space flight conditions, carried out in collaboration with NASA scientists, emerged NimbleHeart´s current product: Physiotrace Smart, a single-lead dry electrode-based ECG device aimed at monitoring the heart health of pre-diagnostic and post-surgery patients.
NimbleHeart still defines itself as a start-up, although its humble beginnings belie a grand mission: to bring to market a home-usable and consumer-friendly, but clinical-grade, long-term cardiac monitoring device for preventive care. A tall order, even by Silicon Valley medical engineering standards.
A passion project
This patch was created by NASA AMES research center team to honor NimbleHeart's partnership. NimbleHeart delivered second version of Male and Female ECG harnesses to NASA.
Having received FDA 510(k) clearance in 2017 and commercially available by prescription since late 2018, NimbleHeart´s Physiotrace Smart device is its flagship product – but not the only one. The company is planning on FDA clearance to market the Physiotrace Multi, a 3-lead harness that uses the same Bluetooth Low Energy interface as the Smart to transmit the heart´s electrical signal to the cloud-based portal for analysis.
In addition, NimbleHeart´s 12-lead Physiotrace Snap NimbleHeart continues to undergo tests and improvements on how its technology can be deployed to monitor the heart health of NASA space flight crew members.
“Who would have imagined that we would be working with NASA on this?” As Tambe excitedly explains the origins of that partnership, she recalls coming across a research paper by NASA scientists that piqued her curiosity during the early brainstorming stages of the start-up, so she reached out to the authors to compare notes about the then existing electrode technologies in the market. That was in 2013; and after the scientists explained that NASA too was looking for a solution to a particular problem, they invited her to call them when NimbleHeart had a working prototype.
“So next year we just checked in with them and said ´We have something working, do you want to see it?` We went down to NASA Ames Research Center and they were amazed and said literally in those words, ´We couldn´t have imagined a small start-up could bring such a product to us.` They are a whole team of pretty smart scientists and engineers and clinicians, and they know exactly what this technology means,” says Tambe.
Soft-spoken and confident about the value NimbleHeart´s products bring to the wearable ECG telemetry space, Tambe highlights as an important moment in the company´s journey the decision to set up its own manufacturing facility in Sunnyvale. “Manufacturing and performance are very critical for any clinical product and we wanted to control the quality of such a device that requires multiple manufacturing skills. We might use electronics from overseas, but we actually manufacture the final product on our own in California,” she says.
Since settling in its new home, NimbleHeart has been marketing the Physiotrace Smart harness and has participated in pilot projects with Henry Ford Hospital and several other U.S.- and India-based hospitals for Cardiac Rehabilitation. While it simultaneously perseveres with its goal to become the cardiac telemetry brand of choice for NASA, it is also pressing ahead with yet another, more earthly but no less lofty ambition: to facilitate a true and really long term remote ECG monitoring program for primary and secondary prevention of Cardiac events. With increasing awareness about the impact of cardiovascular disease and the urgency to reduce hospitalizations and health deterioration in people who already live with the condition, the start-up sees a role for itself in serving as a bridge between care teams and patients
And thanks to a recent introduction by the Centers for Medicaid and Medicare Services (CMS) of a billing code for reimbursing telemonitoring services for several chronic conditions, which gives physicians the green light to follow their patients remotely, it seems to be walking in lockstep with the coming new era of preventive care.
Pipeline and space dreams
Control over manufacturing
The Physiotrace Smart invention follows the logic of a treadmill test by monitoring electrocardiac function when the heart is under physical stress and potential anomalies are more likely to surface compared to a resting state. As such, the battery-charged, sensor-equipped harness is clinically prescribed to be worn during exercise or other periods of increased physical activity. It captures clinical ECG data, displays it instantaneously on a mobile application for the user’s benefit using its patented Bluetooth Low Energy technology and sends it over internet to a cloud-based platform to be viewed by the patient´s physician. It also alerts the users immediately based on a low or high threshold of their safe heart rate limits as prescribed by the Physician.
Thanks to the harness´s one-strap design, which makes its use completely hands-free, and its composition of special materials that optimizes the transmission of electrical heart signals without requiring the application of gel or conductive paste or most importantly needing skin shaving or abrasion, the NimbleHeart device is demonstrably patient-friendly.
“The requirement for an ECG monitor is that it makes really good contact with the patient´s skin and all the latest innovations in the ECG space, which are patch devices, require skin preparation or adhesives of some kind to make this happen. This limits how long they can be used,” Tambe says, noting the added difficulty some patients experience with shaving their chest area at home, as well as the rashes and skin discomfort that can accompany the process. “Patches are really good for short term use. However they have the practical limitations due to use of an adhesive on the skin, and ours is designed for a different market. It is about preventive monitoring for long term regular long term use during exercise for many months.
Driving home the point that the company prioritizes user-centered design, Tambe also emphasizes the special care taken to offer different sizes of the 12-lead harness to suit both men and women, as well as different body types. She references research showing that women´s heart conditions are not given as much attention as men´s despite the fact that more women die of heart disease than of breast cancer and that heart diseases in women manifest differently than they do in men. (NB: Historically, new drugs and medical devices have been developed and tested envisioning an average male user).
“I´m proud to say that all of our products are designed to work on and tested on women of all sizes – including the NASA 12-lead product,” she says.
So next year we just checked in with them and said ´We have something working, do you want to see it?` We went down to NASA Ames Research Center and they were amazed and said literally in those words, ´We couldn´t have imagined a small start-up could bring such a product to us.` They are a whole team of pretty smart scientists and engineers and clinicians, and they know exactly what this technology means,
Sonal Tambe, Co-founder and Chief Executive Officer