HILLEL'S TECH CORNER: Append Medical works to take unknown out of strokes

The company has developed a minimally invasive medical device, called the Appligator™ that aims to reduce stroke risk in patients suffering from atrial fibrillation (AF).

Append Medical (photo credit: Courtesy)
Append Medical
(photo credit: Courtesy)
One of the most frightening aspects of medical conditions, at least for me, is the unknown. What I mean is that there is so much technology being developed for early detection of many conditions. I have covered many examples in previous articles.
But then you hear a story of a friend who went to the doctor for a standard checkup or a stomachache only to be told that they are suffering from a very serious illness. When I think of that unknown that frightens me so much, two things come to mind: aneurysms and strokes.
Append Medical, a company established in 2016 and based in Or Yehuda, is taking on the latter, strokes.
The company has developed a minimally invasive medical device, called the Appligator™ that aims to reduce stroke risk in patients suffering from atrial fibrillation (AF). Append Medical’s technology was invented by Dr. Leonid Sternik, director of the Sheba Medical Center Department of Cardiac Surgery.
AF is a common condition in which the upper chambers of the heart, or atria, fibrillate. This means that they beat very fast and irregularly, which results in a lack of sufficient blood flow to the rest of the body.
AF can increase the risk of stroke by five times and, over time, often leads to heart failure.
So how many people suffer from strokes? How serious is this problem and what are the current solutions?
Each year, 33 million people worldwide suffer a stroke, 20% of which are caused by AF. In the United States, stroke is the fifth leading cause of death and a leading cause of disability for those who survive it. A major part of the stroke risk for AF patients is related to a small sock-like structure attached to the wall of the left atrium of the heart: the left atrial appendage (LAA).
This structure becomes a breeding ground for blood clots for people with AF. If one of these blood clots escapes and makes it to the brain, that’s when a stroke can hit. In fact, 90% of strokes in AF patients are caused by migration of these clots from the LAA to the brain.
There are a few different approaches to treating AF in an effort to minimize stroke risk. The first intervention is pharmaceutical: anticoagulants like Warfarin (Coumadin) are often prescribed to AF patients, and they are quite successful – except when they are not.
For some people, a drug like Warfarin also comes with the increased risk of internal bleeding, ruling out this standard treatment for some patients. For others, taking a daily medication is simply hard, and compliance to the medication regimen is low. A study presented at the 2016 American Heart Association (AHA) Scientific Sessions found that 25% of patients stopped taking their anticoagulant within the first three months.
For this reason, major medical device companies have developed alternate approaches. One approach to this LAA problem is to just close up the LAA. By blocking off the opening, clots won’t be able to escape. So, when medication isn’t an option, many AF patients will opt to have a metal implant surgically inserted to plug up the LAA opening.
WHILE THIS might sound simple, like plugging a bathtub, each person’s LAA is shaped differently. The opening is a different size, so finding the right “plug” can be tough.
Due to the LAA’s complex structure, it becomes difficult to close it completely using the current marketed devices and blood clots can still leak to the brain. Another risk of these devices is device-related thromboembolism, the potential formation of clots on the closure device itself, which can then escape to the brain and cause stroke. Worse, though rare, the device itself can dislodge and enter the heart. I don’t need to tell you the consequences if that happens.
Append Medical has taken a completely different approach which leaves no metal implant behind. The procedure is designed to prevent blood clot leakage by achieving complete LAA closure, avoid device-related thromboembolism by leaving minimal foreign material at the closure site, and offer a simple procedure with fewer LAA pre-procedure measurement requirements (measuring the unique size of the LAA opening of the patient before surgery).
How does it do this? The Appligator device enters the heart through a standard, minimally invasive transcatheter procedure. The device forms a vacuum over the opening of the LAA, sucks the LAA in on itself, manipulating the tissue to close the opening. All that is left behind is a simple suture at the surgical site. This approach to LAA closure is protected by three patent families.
The LAA closure market is the second-fastest growing segment of the medical device market, estimated to reach $958 million by 2025, according to Energias Market Research.
Append Medical is a member of MEDX Xelerator, a med-tech incubator formed as a collaboration between Boston Scientific, Intellectual Ventures, MEDX Ventures and Sheba Medical Center. Append’s funding so far has come through MEDX Xelerator, with Boston Scientific, MEDX Ventures, Intellectual Ventures and the company’s founder and CEO, Zachi Berger, all invested in the company.
Zachi Berger, PhD, MBA, is a seasoned executive in the healthcare field, with over 30 years of experience as an entrepreneur, manager and venture capitalist. Before founding Append, Berger established four companies with one exit (XTL, Peptor, Quantomix, Endopix) and at Star Ventures, he led investments in five companies with exits.
The company recently announced two successful clinical trials for its device. Dr. Leonid Sternik, co-inventor of the Appligator device, performed the procedures in open heart surgery on two patients, both of whom suffered from AF, in clinical safety trials. In follow-up after three years and one year, respectively, each patient is healthy and the invaginated LAA has been successfully absorbed into the surrounding tissue of the left atrium wall.
In December 2019, Append was selected from among hundreds of start-ups as a finalist for the ICI Innovation Award Competition, and despite the company’s early stage, it is being noticed by industry analysts. The company is also supported by a strong scientific advisory board, including some well-known key opinion leaders in the cardiac world, including Dr. Leonid Sternik, Prof. Amir Halkin of Tel Aviv Medical Center and Professor Horst Sievert, Director and Founder of the CardioVascular Centre in Frankfurt who specializes in internal medicine, cardiology and angiology.
While the company is relatively small as far as team members and funding, at $1 million to date, the technology is mature and shows promise of truly bringing an innovative product to a much needed and widespread global health risk.