Westwood-based Sensydia Corp., which is developing a non-invasive cardiac assessment platform, has received a $3 million grant from the National Institutes of Health for clinical testing of its artificial intelligence algorithms.
That follows the company’s announcement last month that it had raised $8 million from investors, led by Orlando, Florida-based Orlando Health Ventures.
Sensydia was founded in 2015 to apply rapidly emerging technologies in the field of artificial intelligence to deliver non-invasive heart assessments with much more detail than the echocardiogram technology that’s been around for decades. Traditionally, echocardiograms give a general picture; if a problem is indicated, often the cardiology team must proceed to another more detailed test. Currently, the most common additional test is obtained through inserting a catheter, an invasive procedure that requires a hospital setting.
Drawing upon a combination of expertise in clinical cardiology, biomedical engineering and machine learning, the Sensydia team developed a platform that uses biosensors and artificial intelligence algorithms to provide clinicians with rapid, non-invasive measurement of ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure in a handheld device – without the need for in-hospital catheterization.
The goal of all this is to more effectively, more rapidly, and less expensively deliver information on key heart metrics than can indicate heart disease – both heart failure and high pulmonary blood pressure – and the need for various types of intervention, including surgery.
“Non-invasive and real-time cardiac function measures will lead to early diagnosis and personalized care for heart disease,” said Farhan Khawaja, president of the Orlando Health Heart & Vascular Institute, an affiliate of Orlando Health Ventures, which is a principal investor in Sensydia. “This technology has the potential to vastly improve patient lives by enabling faster and more affordable disease management, moving health care from the hospital setting into the patient’s home.”
In 2018, Sensydia received clearance from the Food and Drug Administration for non-invasive measurement-of-ejection fraction, which is a measurement of the percentage of blood leaving the heart each time the heart muscle contracts. If the fraction or ratio is below 40%, it generally points to damaged heart muscle.
In January of last year, Sensydia’s device and technology platform was granted “breakthrough device designation” by the FDA to measure three additional key cardiac metrics: cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure.
The NIH grant award, which Sensydia announced on June 5, was through the Fast-Track Small Business grant program from the National Heart, Lung, and Blood Institute, one of the component parts of the National Institutes of Health. This program supports small businesses with early-stage capital for creating innovative technologies to improve human health.
The award provides Sensydia with non-dilutive funding for the development and clinical testing of the machine-learning algorithms for the company’s technology platform, which it calls the Cardiac Performance System. It’s designed to enable earlier detection and therapy guidance for patients with heart failure and pulmonary hypertension.
The grant is actually being awarded in two phases: Phase I is budgeted for approximately $600,000, and Phase II for $2.4 million, following successful completion of Phase I milestones.
“We are honored to be a recipient of this competitive award from the NIH/NHLBI and look forward to unlocking the capabilities of AI-based cardiac assessment to provide personalized care to patients suffering from heart disease,” said Aman Mahajan, Sensydia’s chief medical officer.
Meanwhile, the $8 million in funding was announced on May 9; this tranche of funding brings the total raised to $17.5 million, excluding the aforementioned NIH grant award. Orlando Health Ventures, a previous investor, led the funding round. As part of its funding arrangement, Orlando Health Ventures’ chief administrative officer, Erick Hawkins, is joining Sensydia’s board.
New York-based Colle Capital, another returning investor from previous rounds, and Boulder, Colorado-based Frontier Venture Capital participated in this latest funding round.
The funding will enable the company to finalize the development of the CPS platform and submit it again to the FDA, this time for prioritized review as part of the agency’s Breakthrough Devices Program; that submission is now slated for next year.
“We are thrilled to have the support of investors who share our vision for transforming heart-failure management,” Anthony Arnold, Sensydia’s chief executive, said in the funding round announcement. “This funding will enable us to accelerate our march to commercialization by expanding development and operations for our CPS platform.”
