Remon’s implant, which requires no antenna, battery or connecting leads, contains a pressure monitoring system that measures the pressure inside the artery and wirelessly transmits this information to an external computer based system.Hezi Himelfarb, CEO of Remon Medical Technologies, wants to make sure he has made his point.
“Our device communicates wirelessly from inside the body, to an external operator,” he says for the third or fourth time in the hour-long interview.
He is right, however, it is an important statement to make, since the real strength of Remon’s implantable intravascual telemetric communication system, which is being designed for patients suffering Abdominal Aortic Aneurysm (AAA), and Congestive Heart Failure (CHF), is that it does not need to be connected to any kind of wire or lead in order to communicate vital information about the state of a patient’s health from deep within the body.
“There is no limit to the depth or distance of the implant device to the surface of the skin,” explains Himelfarb enthusiastically. “They can go absolutely anywhere in the body. The uniqueness of this technology defines us from the other technologies now being developed.”
Remon’s implants are a new generation of monitoring tools designed to help a variety of patients. The company’s first product Remon ImPressure, which is now undergoing initial clinical trials, is aimed at patients suffering from AAA. This disease affects the aorta. The wall of the artery becomes thinner and due to internal pressure and the flow of blood, the artery begins to balloon in size. If nothing is done to stop the pressure, the balloon gets bigger and there is a danger that it will pop. Ninety percent of patients who suffer such a rupture die.
Today about 1.5 million people suffer from AAA in the US. There are two treatments for this disease. The first is a highly invasive surgical procedure where a small pipe made of Dacron is inserted into the artery to allow the blood to flow freely without putting pressure on the artery wall. The surgery has high success rates, but has a mortality rate of 6%, because of the severity of the operation.
The second solution is to insert a stent graft into the diseased artery to release the pressure and act as a pipe. This process is gradually becoming more popular than the first since it is far less invasive. The stent graft can be inserted in a cathartisation in the leg. The only problem with this treatment is that sometimes leakages of blood continue to feed the aneurysm, and it carries on growing.
At present, the only way to check the condition of an aneurysm is to undergo a CT scan. This is expensive – each scan costs $1,500 – and harmful to the patient because it involves radiation and X-rays. During the first year after receiving a stent graft, the FDA recommends that patients undergo four CT scans, if all is well, this is reduced to one or two in the following years.
Himelfarb believes that Remon’s device is a cheaper and safer alternative to CT scans. The implant, which requires no antenna, battery or connecting leads, contains a pressure monitoring system that measures the pressure inside the artery and wirelessly transmits this information to an external computer based system. The doctor can then use this knowledge to decide if there is a problem that requires re-intervention. If there is no leakage to the aneurysm then pressure in the artery will remain low, if a leakage occurs then pressure begins to build.
The tiny implant is designed to be sutured to the stent graft so that it can be inserted into the body without an additional procedure. The checks can be undertaken at a doctor’s office, and patients are recommended to carry out the test every one or two months. Unlike CT scans, the system is based on ultrasound, and is therefore not harmful to the patient.
In February 2002, Remon signed an agreement with $2.7 billion US company Guidant Corp., a specialist in endovascular treatments, to mount the implant on Guidant’s Ancure Endograft system and run clinical trials. Guidant later backed out because of unrelated problems with the FDA.
Instead, the FDA gave Caesarea-based Remon special approval to carry out clinical trials on eight high-risk patients from the Mount Sinai Medical Center in New York. Prior to the procedure, the ImPressure device was attached to a polyester endovascual stent graft, and together these were implanted into patients. Himelfarb says the trial is a success.
“In two patients we already detected changes that were dangerous, and these were afterwards confirmed by CT scans,” says Himelfarb.
The main goal of these trials, says Himelfarb, is to prove the efficacy of the product. Remon is now negotiating with other large partners in this arena and once an agreement is signed, the company will have to take part in clinical trials with its new partner. If all goes well, Remon hopes the product will reach the market in 2004.
Remon is also working on another product for CHF, a heart disease that affects about 5.5m. people in the US, and some 15m. people worldwide. Every year, 500,000 patients are diagnosed with this disease, and some 200,000 die from the consequences of it. If the market for AAA is estimated at close to $1 billion by 2008, CHF is considered to be much larger.
There are four classes of CHF patients, each increasing in severity. By class four, patients are normally unable to move from their homes. They cannot walk further than 100 meters, and cannot climb the stairs. They also have breathing problems. These patients are usually waiting for a heart transplant. While there are treatments that can help a patient before a problem emerges, doctors have no way of knowing if the health of a patient is deteriorating until after the deterioration has taken place.
Remon’s wireless implant, RemonCHF, is designed to act as an early warning system, giving doctors prior notice before something happens. The device, which will be a stand-alone unit, monitors the filling pressure of the heart. By observing pressure changes, the doctor or patient will be able to receive an indication that something is wrong, before the event occurs.
Unlike the external AAA unit, the CHF one is to be operated by the patient himself and will therefore be small and simple to use. The test should be carried out every day, and if there is a problem the patient should call his doctor immediately. The device will be implanted in the pulmonary artery using a special anchoring system developed by Remon. The implantation will occur when a patient is undergoing a simple vein catheterization procedure. The CHF unit is still only in animal experiments and clinical trials should begin in 2004.
Remon, which today employs 46 people, was founded in 1997 by three physicists who had worked previously in the field of submarines, ultrasound and sonars, for the Israel Defense Force and for Rafael Armaments.
Remon’s real target in the years ahead is to complete the clinical trials of both products, and to develop its marketing network. Remon must find a partner for its AAA device, so that clinical trials can go ahead without delay. The CHF device does not require a partner, because it is a stand-alone product, but Himelfarb says the company may look for a distribution partner at a later stage.
The company’s next step is to complete a fund-raising round, and then open a business development and marketing office in Boston, later this year. The company is also exploring future applications, but Himelfarb does not want to discuss details. Himelfarb hopes that sales will begin in 2004, and that the company will break even in 2006, when the CHF implant goes on the market.
While Himelfarb insists that Remon’s devices are unique, the company does face competition, and some of it is serious. In the field of AAA, Remon’s most serious rival is US company, Cardiomems, which is developing a similar solution using different technology. Himelfarb believes that Remon is more advanced than Cardiomems, because the US company has not yet started clinical trials.
The RemonCHF will be up against stiffer competition. There are several companies in this sector and the most significant competitor is medical devices giant, Medtronic, which has developed a pressure sensor connected to a lead and wire. The device is already in clinical trials in humans in Europe and the US. Himelfarb adds, however, that Medtronic has shown a lot of interest in Remon’s device.
“We feel very positive about our future,” says Himelfarb.