NaviGate Cardiac Structures Inc. (“NCSI”) reports “excellent valvular function” at 1-year follow-up of first patient to receive GATE™ tricuspid valved stent via transjugular access

This first transjugular implantation of the GATE ™ tricuspid valved stent occurred at the Cleveland Clinic in April 2017. At one year, the valvular bioprosthesis is demonstrating excellent leaflet mobility and valve function. In the patient’s own words, “I could not walk from one end of my house to the other before the valve was implanted. Now, it feels great to go everywhere.” Dr. Samir Kapadia and Dr. José Navia, the implanting Cardiac Team at Cleveland Clinic, explained that the patient has no more fluid build-up (ascites and edema), which accounts in large part for the patient’s loss of nearly 20 Kg (about 40 lbs.) in weight.

Columbia Presbyterian Hospital in New York has treated the largest number of patients with the GATE^TM tricuspid bioprosthesis to date, with all patients in good condition at 7, 4 and 2 months post-procedure. The first two Columbia Presbyterian Hospital implants, now at 7 months, are a 92-year-old woman and a 94-year-old man who are now enjoying good mobility and are quite active.

In addition, a total of 4 patients have been successfully treated with the device at the Cleveland Clinic under compassionate use basis, with no 30-day mortality. Of these, a patient undergoing intervention in the last two months demonstrated the possibility that the GATE^TM tricuspid bioprosthesis can be implanted in patients with pacemaker leads traversing their tricuspid valve. This patient, a 79-year-old female, was released with a well-functioning 52mm valve and seemingly improved QoL and has since returned from her distant home state for valvular function and clinical condition assessment more than a month post-intervention. Also, a 77-year-old female having undergone an intervention at Cleveland Clinic on the day prior with a 48mm GATE™, was released on day 5 after her massive TR+5 was corrected to a trace incompetence. Reassessment of this patient at one month provided evidence of excellent valvular function.

In Canada, NCSI has recently reported on a 78-year-old male patient with torrential TR who received a 40mm GATE^TMtricuspid bioprosthesis at Quebec Heart and Lung Institute in early February 2018. This patient, the first to receive NCSI’s tricuspid valved stent in Canada, remembers a love for dance from decades ago and has rekindled his desire to live until ago 100.

In Padua, Italy, a 66-year-old male who received a 52mm diameter (the largest developed for this purpose) GATE^TM tricuspid bioprosthesis in July 2017 to treat a failing tricuspid valve from his heart transplant that had been performed 20 years earlier is also doing well. This patient drives himself from a neighboring city for periodic follow-up assessments that extend now to almost 11 months. This interesting result was published this month by Colli et al (“Transcatheter tricuspid valve replacement with a self-expanding bioprosthesis”) in the Journal of Thoracic and Cardiovascular Surgery.

Furthermore, in Frankfurt, Germany, two patients were treated with the GATE^TM tricuspid bioprosthesis in January 2018. Both patients, one of whom had pacemaker leads through his tricuspid valve, are doing well.

Since the beginning of this calendar year, a total of eight (8) additional patients have received the GATE^TM tricuspid valved stent in response to compassionate pleas to find a therapy to alleviate symptoms resulting from tricuspid valvular incompetence. NCSI is currently in the process of gathering requisite information supporting initiation of clinical feasibility trials to assess the safety and effectiveness of the GATE^TM System for dysfunctional tricuspid valve therapy. Presently, NCSI’s catheter-guided GATE bioprosthesis is the only orthotopic transcatheter valve replacement under development to treat severe tricuspid regurgitation.

“NCSI is working diligently to move into a feasibility clinical trial to initiate Safety and Effectiveness research of the tricuspid bioprosthesis,” said Dr. R. Quijano, CEO of NCSI. “These compassionate plea patient implants are instructive and obviously are good for the patients who have no other recourse, although we find several who cannot be helped by the valve since their ventricular function is beyond repair and their postoperative course would be troubled. Careful patient selection is imperative to obtain proof of what the GATE^TM tricuspid valved stent bioprosthesis can or cannot do, and that requires a well-controlled clinical trial to obtain such evidence, which we hope to start later in the year. Until then, we have requests from many centers in Europe, the U.S. and Canada to do both: more compassionate cases and a full trial.”

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 U.S. 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 U.S. 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 NCSI

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. (“NCSI”).

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