Angel Medical Systems Credits NOL Program with Critical Support to Help Reach FDA Approval
The AngelMed Guardian® System recently received FDA approval.
TRENTON, N.J. (June 21, 2018) – Cardiac patients are one step closer to obtaining a medical device that can alert them to a potential Acute Coronary Syndrome (ACS) event (including a heart attack) whether they experience symptoms or not, following recent U.S. Food and Drug Administration (FDA) approval of the AngelMed Guardian® System. Considered Monmouth County-based Angel Medical Systems’ flagship product, the AngelMed Guardian System is the world’s first implantable cardiac monitor and patient alerting system for ACS.
Nicknamed “the Guardian,” the implant is designed to identify changes in the heart’s electrical signals indicative of a potential ACS, including heart attacks or episodes of unstable angina, alert patients to seek urgent medical attention, and store electrocardiogram data for later review by emergency room physicians. Angel Medical Systems executives say that in its clinical trials, the Guardian demonstrated that it fills an unmet medical need by providing more effective diagnosis of a life-threatening condition when compared to patient symptoms alone.
Angel Medical Systems plans to bring the Guardian to market in 2019. The company is currently ramping up its staff and recently began leasing 9,000 square feet of space in Tinton Falls.
While FDA approval brings renewed optimism to Angel Medical Systems, Chief Operating Officer David Keenan says the company would likely have folded were it not for funding it received through New Jersey’s Technology Business Tax Certificate Transfer Program, also commonly referred to as the Net Operating Loss (NOL) Program. The New Jersey Economic Development Authority (EDA) and the New Jersey Department of Treasury’s Division of Taxation administer the program.
After executing clinical trials at 100 medical centers throughout the country, including four here in New Jersey, the company had to complete an extensive review process as it pursued FDA approval of the Guardian. As a result, the company made the tough, but strategic, decision to reduce its overhead by shuttering its physical space in Shrewsbury and allowing its ten employees to work remotely.
“Companies like ours often go through peaks and valleys on their way to commercialization,” Keenan said. “We are very fortunate that the NOL Program was in place when we were going through unprofitable times and were in need of capital.”
The NOL Program enables eligible technology and life sciences businesses to sell New Jersey net operating losses and unused research and development (R&D) tax credits to unrelated profitable corporations for cash. The money can be used for working capital or to fund research. Qualified New Jersey technology and life sciences companies have until June 30 to apply for this year. The online application can be found at https://www.njeda.gov/nol.
“Young, growing companies are the lifeblood of an innovation-centered economy, and we are thrilled that the NOL program helped Angel Medical Systems progress toward this key milestone,” EDA Chief Executive Officer (CEO) Tim Sullivan said. “We are excited to begin reviewing new applications this summer for the next crop of Garden State success stories that can utilize this important tool to finance their growth.”
@NewJerseyEDA spoke with Keenan about his company’s experience in New Jersey and its plans for the future:
Why did you choose to grow your company in the Garden State?
The founder and CEO of the company, David Fischell, is a resident of Little Silver, and has long ties to the rich technical resources and employees that can be found in Monmouth County, having previously worked at AT&T Bell Laboratories. Much of the R&D for the Guardian was performed by former Bell Labs employees.
What would you say was the single greatest benefit of the NOL Program?
The greatest benefit was that the money enabled the company to stay the course and ultimately achieve FDA approval for the device. It is very difficult to raise additional capital at that juncture in the life of a medical device company – the risk is highest at that point – so the NOL Program was very useful in filling that need.
It is gratifying when you see a government program in action that truly serves the intended need. This program got it right.
What advice do you have for companies considering applying to the NOL Program?
I would advise them to look into the NOL Program and see if it might help their particular scenario. In our case, it definitely helped very much, so we are very glad we looked into it.
To learn about the multitude of resources available to help technology and life sciences companies thrive, visit https://www.njeda.gov/tls and follow @NewJerseyEDA on Facebook, Twitter and LinkedIn.