Fluid overload caused by congestive heart failure and chronic kidney disease is a major clinical problem, placing a heavy burden on healthcare budgets and representing the leading cause for frequent re-hospitalization of the elderly.
Sometimes coined the “unluckiest frequent flyers,” approximately 1.2 million heart-failure patients are admitted to American hospitals every year, with 90% of those hospitalizations related to fluid overload and 20% of patients re-admitted monthly for necessary treatment.
Yet nearly a third of patients have developed diuretic resistance and therefore do not respond to current medication, leading to frequent re-hospitalizations costing the US healthcare system approximately $17 billion annually – more than half of all heart failure-related costs.
Aiming to break the costly hospitalization cycle for eight million heart failure patients worldwide, Nazareth-based Paragate Medical has developed a fully-implantable medical device offering a 24/7 out-of-hospital solution to actively prevent painful fluid overload.
Paragate co-founder and medical director of Dr. Yair Feld (L), and CEO and co-founder Nitai Hanani (Credit: Courtesy)
“If we can find a chronic solution for this fluid accumulation, we can prevent the hospitalization, and it will be an enormous benefit for both the patient and the health system,” Dr. Yair Feld, founder and medical director of Paragate, told The Jerusalem Post.
“Each hospitalization is a major life event, shortening the patient’s life expectancy and [leading to] kidney function not returning to its baseline. Preventing hospitalization is one of the major goals for all the big companies, and it’s a primary end point for any heart failure treatment.”
Paragate’s Implantable Peritoneal Ultrafiltration device is a minimally invasive, implanted system serving as a mechanical bypass of the kidneys. Peritoneal refers to the serous membrane, which forms the lining of the abdominal cavity and secretes a fluid that fills body cavities.
By inducing negative hydrostatic pressure in the device, extracellular systemic fluid is drawn through the peritoneal membranes into the device’s absorption chamber toward the urinary system.
The company expects to commence clinical tests later this year in Wroclaw, Poland, in collaboration with leading cardiology specialist Prof. Piotr Ponikowsky.
“We cannot replace the kidney entirely, but we can at least relieve congestion, reduce the cardiac filling pressure and high blood pressure, and relieve the flood that hits all internal organs and leads eventually to the deterioration of the patient,” Paragate CEO and co-founder Nitai Hanani told the Post.
“The implantable device has a smart control unit that the patient recharges wirelessly on a weekly basis. After the device is implanted and the patient has stabilized, we believe the patient may only need to visit a physician every three months.”
The device has already received backing from a number of high-profile medical experts, including Dr. Maria Rosa Costanzo, Prof. Uri Elkayam and Rambam Medical Center director-general Prof. Rafael Beyar.
“The method of Paragate to remove body fluids is an amazing, groundbreaking technology,” said Beyar.
“Once proven in clinical trials, it has a chance to disrupt the way congestive heart failure patients are being managed today. Both patients and healthcare providers can benefit dramatically by changing the setting of the treatment from frequent hospital admissions to continuous care at home.”
Paragate is one of over a dozen life science and medical device start-ups working with Nazareth-based incubator and early-stage investment entity NGT³ (Next Generation Technology).
“The incubator not only focuses on life sciences but also integrates a very important mission into their work,” said Hanani.
“It has a social agenda based on promoting partnerships between different sectors of Israeli society, integrating Jews, Arabs, Christians and Muslims all together at work.”