NaviGate Cardiac Structures Inc. (“NCSI”) reports GATE™ bioprosthesis as the first transcatheter valve replacement in Canada to treat tricuspid regurgitation

The patient, a 79-year old male, was deemed at high-risk for standard cardiac surgery and unable to withstand cardiopulmonary external circulation. A compassionate plea on his behalf was made by the Heart Team of the Institute. Dr. Rodés-Cabau, who has performed multiple procedures for atrioventricular valve dysfunction using various repair devices, said: “The NaviGate bioprosthesis is the only transcatheter device in development that has been used to completely replace the native tricuspid valve and restore its function in the human.” Dr. Rodés-Cabau proposed the NCSI GATE™ as the only viable treatment option for this patient. The replacement procedure, performed in less than 30 minutes after the patient was prepared, minimized fluoroscopic exposure to both patient and operator, as well as contrast imaging media quantity known to be deleterious to the patient’s kidney.

There were no immediate complications and an excellent result was obtained, which allowed the patient to be discharged within a few days after a satisfactory recovery from the procedure. As this was the first catheter-guided tricuspid valve replacement in the country, the Institute’s Heart Team and patient were interviewed by the Canadian media. At the onset of the interview, the patient told the journalist how, for a long time before this procedure, he had experienced loss of balance and generalized weakness. Now, with feelings of relief a few days after the procedure, he felt much better and all was returning to normal.

In three of ten previously treated patients, the GATE™ bioprostheses were implanted through the jugular vein of the neck through a tiny puncture. “Because the patient’s anatomy did not allow jugular access to the tricuspid valve,” Dr. François Dagenais explained, “we chose an alternate path. Fortunately, with a small incision between a pair of right ribs, a direct path for the catheter led to quick implantation of the replacement valve. We must understand that the technology will evolve and soon the great majority of patients will receive their replacement valve through the neck veins,” he concluded.

Dr. Élisabeth Bédard, the cardiologist aiding the navigation through imaging, explained: “We see these patients continuously, showing edema of their lower limbs, shortness of breath and their chests full of liquid. We give them medications to relieve them of some fluid but in a short time come to an end where we cannot help them anymore. Suddenly, we see a superb new technology that may help our patients.”

Concluding the interview, the journalist asked the patient if he felt he would be able to return to his normal activities. He said: “I would love to,” and added, “I always loved to dance. Years before this condition, I danced and danced.” The journalist said you will and probably live to 100 years of age. He replied: “You think I deserve it?” and the answer was, “You really deserve it.”

“NaviGate Cardiac Structures Inc. is very pleased to have helped the Canadian patient by correction of tricuspid regurgitation,” said Dr. R. C. Quijano, President and CEO of NCSI. “We would like so much to hear when he resumes his dancing, thanks to the superb team at the Institute. Canada is now another country where NCSI has a patient whose severe-to-torrential TR conditions was treated by the bioprosthesis, and it happened at the most progressive research center in the country.” This patient now joins a very interesting cohort of 10 patients, seven patients with valves functioning over 5 months, and he joins in two weeks a cohort of three patients with well-functioning GATE™ bioprostheses that has reached greater than 30 days.

Tricuspid regurgitation is a lethal condition and is not self-repairable. Medical treatment alone only prolongs the descent into right heart failure but cannot prevent the outcome that is reached earlier rather than later. Efforts to reproduce by catheter guidance the surgical repair methods have not given satisfactory and durable TR correction as invariably there is residual TR that returns to the moderate-to-severe stage, as TR generates TR. Estimates of patients in severe-to-torrential TR in the USA and Europe quantify the totals over a million, and lesser-than-severe stages bring the total to more than 7 million. The unfortunate fact of this harbinger of death is that progression to the lethal end stages must be arrested and current repair devices allow residuals that permit the vicious cycle to continue. Valve replacement may provide the stop, and NaviGate Cardiac Structures Inc. will continue the effort to validate this alternative. To that end, the Company is gathering data that will allow entry into an early feasibility clinical trial in the USA and some countries abroad to investigate the safety and efficacy of the GATE™ tricuspid valved-stent bioprosthesis.

The valve replacement system is developed at NaviGate Cardiac Structures Inc. and includes novel technology on tissue dehydration that extracts toxic fixative glutaraldehyde. That technology licensed from Cleveland Clinic Foundation’s original research and was co-licensed to Edwards Lifesciences from NCSI for fees and royalties. It is believed that such technology may have potential to increase the longevity of the tissue valvular mechanism.

About NaviGate

NaviGate Cardiac Structures Inc. (www.navigatecsi.com) is an early-stage company focused on the development of catheter-guided correction of tricuspid regurgitation. The NaviGate valve-based technology was initially licensed from the Cleveland Clinic and later modified by NaviGate Cardiac Structures Inc.

NOTE: The GATE™ atrioventricular valved stent is not approved for use in the USA. The patient implants described in this news release were performed under compassionate pleas sanctioned by Health Canada, European Health agencies and US FDA.