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When a healthy heart does its thing in the human body, it uses what’s called a pulsatile flow to rhythmically move blood through the cardiovascular system.

When the heart is offline during certain types of surgery, a pump provides laminar flow — constant smooth movement — to keep the patient alive during the procedure.

A startup Pelham company believes pulsatile flow during surgery is a better option for a patient, so it is developing what it says is the world’s first pump to deliver a life-like pulse for use during cardiac-related surgery.

VentriFlo is currently in the process of seeking federal Food and Drug Administration (FDA) approval, and raising needed capital to bring its products to the medical market.

Doug Vincent, president and CEO of VentriFlo, which he founded in 2002, said his True Pulse Pump is like a vehicle that requires fuel.

“The vehicle that we’ve built is almost finished, but not fully, but the money is the fuel,” he said. “We have raised and spent $17.5 million, all from angels. We think we need another $3 million to get to our initial FDA clearance, and then double that again, another $3 million beyond that to build the initial set of systems that could be placed.”

The pump is designed to change the standard of care for patients of cardiac surgeons and cardiologists.

According to Vincent, true pulsatile flow pushes and then relaxes. By delivering this heart-like flow, the True Pulse Pump can better help patients who have their heart stopped for surgery or those who have a weakened heart recover faster, in a much more biologic fashion, he said.

In Vincent’s estimation, one problem with continuous flow pumps currently in use (called temporary mechanical circulatory support) is that the capillary function of exchanging oxygen and carbon dioxide is affected, with kidney failure as a risk.

“It’s not super healthy, and the longer you’re on it, the more it’s a problem,” he said.

The True Pulse Pump is designed to recreate the human heartbeat outside of the body.

Vincent has drawn education, experience and inspiration from a variety of institutions and people over the years.

His mechanical engineer education started at the Massachusetts Institute of Technology (MIT), to where he transferred from the University of Massachusetts. He said he’d always been into engine repair, and a robotics class at MIT with Woodie Flowers, known for his innovative approach to engineering education, gave Vincent a whole new insight into another world of machines.

Past work at DEKA Research & Development and Abiomed gave him insight to certain aspects of medical equipment technology.

DEKA, founded by technology innovator and entrepreneur Dean Kamen in Manchester, has devised advanced mobility systems, bionics and diabetes management systems to name a few. Vincent started at DEKA in 1989 when there were just a handful of people, and he was the lead engineer in the development of a ground-breaking bedside home peritoneal dialysis machine.

Abiomed is a medical device company headquartered in Danvers, Mass. Now part of Johnson & Johnson’s MedTech Segment, it develops and manufactures devices for circulatory support, including the Impella heart pump, which is designed to enable the heart to rest and recover. Vincent worked at Abiomed for two years as a product development manager.

He also drew some inspiration for his work from a conversation he had while skiing with a friend, who was the acoustic director for Bose, known for its innovative designs and manufacture of audio equipment.

“A lot that I’d learned at Abiomed had haunted me … that I really felt two things that the industry had concluded were wrong,” said Vincent in an On Pump podcast in May. “Number one, that pulsatile flow was not important or a differentiator, and number two, it was too hard to manage and so they kind of turned away from it really for engineering reasons not for clinically relevant reasons.”

In overcoming the engineering hurdle, he started working with Bose engineers on the applications of a linear motor, which produces straight-line motion, as opposed to rotary motion. Like an acoustic speaker, such as a subwoofer, which converts electrical energy into linear motion, VentriFlo’s motor moves back and forth but instead of producing sound waves, blood is propelled beat-by-beat into the cardiac patient with physiologic stroke volumes and at a natural rhythm.

“A speaker, of course, goes up and down in air at high frequency, but our idea was to just slow it down and use it to mechanically push and pull on a diaphragm and therefore recreate the human heartbeat outside of the body,” he said on the podcast.

His scientific team is an impressive roster of doctors who specialize in cardiology.

One of them is Nader Moazami, a professor of cardiothoracic surgery and surgical director, heart transplantation and mechanical circulatory support, at the New York University Langone Medical Center.

“There are these smart amazing scientists who’ve done single organ perfusion models and have actually shown that pulsatile flow improves renal function and increases urinary production, reduces the number of hormones that are bad for the kidneys compared to continuous flow,” Moazami said in a VentriFlo-supplied video.

Another member of the team, Jack Copeland said in a separate video, “I think it could change the way that all cardiac surgeons and cardiologists look at what they’re doing today.” He is a retired cardiac surgeon, having done more than 10,000 open-heart procedures and 850 heart transplants in his career.

Vincent sees three applications for the True Pulse Pump. One is to provide that heart-like flow during a procedure when the heart is offline. Another is using the pump to help cardiac patients repair weakened or malfunctioning hearts. A third application is the post-mortem harvesting of organs for transplant; and the procedure “has shown that you get more of the organs and better quality when you do this,” said Vincent.

With the workable model done, Vincent said the VentriFlo team is “crossing the t’s and dotting the i’s” toward its FDA clearance. It has some internal and third party testing to do — software, the electricals, and sterility, to name a few.

“You have to do a lot of different tests to prove to them that you’re not only a clever approach — in fact, they care less about that — but more that you are going to be safe and effective,” said Vincent.

Once submitted for clearance, Vincent expects the process with the FDA to take about six months. With approval, the pumps will get real world testing in cardiac clinics selected to provide what Vincent described as the “human data” to then go forward with mass production and sales.

Vincent is also president and CEO of Design Mentor, founded in 2000 as an engineering services company to assist medical device manufacturers with their product development, with a particular focus on medical pumps and systems engineering.

According to Vincent, VentriFlo grew out of Design Mentor in what he described as a “nights and weekends” effort starting in 2002 and becoming more dominant as an effort by 2013. In 2019, he said, with a reincorporation, VentriFlo took its first major investment of more than $6 million.

Design Mentor still exists and occasionally does some work for legacy clients, but Vincent said it “is not our active focus.”

His current team, which can ebb and flow as work demands and funding allows, runs at about 30 people, made up of regular employees, consultants, and a growing group of what he called “angel consultants.” Those consultants, he said, have largely retired but not fully, so they work on an investment basis, submitting monthly/quarterly invoices, which are converted into investment notes, the value of which depends on how well the company does down the road.

PELHAM, N.H. —

Computers and phone lines in the Pelham School District are down after a cyberattack this week, school officials said.

Superintendent Chip McGee said the district will be offline for the next two weeks while an investigation continues into what happened and workers get everything back online.

"Yesterday morning, we found out about an employee that was having trouble with his computer," McGee said. "We put our incident response plan in place."

McGee said the attack has cut the school off from the internet, phone lines and email.

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"We are very intense with technology in Pelham," he said. "And so, kids don't have access to their Chromebooks. They aren't connected to the internet because the school district's not. Teachers don't have access to their Google Drive or email."

Learning at the district will continue, he said, but it will just be offline for a little while.

Hacks targeting schools are nothing new, said cybersecurity export Gary Miliefsky.

"Schools are a great target for hackers for one reason," he said. "Kids are a great target because their data is clean and unused."

Miliefsky said it's a growing and costly problem.

"The financial impacts by year end, we're looking at a $1.2 trillion to $1.5 trillion cost of cybercrime globally," he said. "Identities are stolen, crimes are committed, and money is made."

McGee said it's too early in the investigation to know whether teachers' or students' private information was stolen.