SOURCE: HeartStitch, Inc.

Heartstitch, Inc.

November 14, 2016 10:49 ET

Dr. Michael Mullen Presents Multi-Center Clinical Data of More Than 100 NobleStitch™ EL Patients at Major U.S. Cardiac Congress

Efficacy of the suture based NobleStitch™ EL for Patent Foramen Ovale (PFO)

WASHINGTON, DC--(Marketwired - November 14, 2016) - Dr. Michael Mullen (Consultant Cardiologist, St. Bartholomew's Heart Hospital, Chief Clinical Officer of HeartStitch) presented preliminary clinical data of PFO closure using the NobleStitch™ EL, in 112 patients, at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) Congress held in Washington, DC.

Attendees from around the world gathered in the Nation's Capital focusing on interventional cardiology therapies. Dr. Michael Mullen presented preliminary data on PFO closure with the suture based closure system NobleStitch EL in 3 separate sessions catching the attention of the structural heart interventionists. Dr. Mullen has extensive experience with the NobleStitch™ EL collaborating with NMT2 on the suture system's evolution. As a renowned Cardiologist and PFO expert, Dr. Mullen has been utilizing the NobleStitch™ EL for 8 years, most recently at St. Bartholomew's Hospital in London. The data presented from centres in the UK, Sweden, Germany, Italy, and Kazakhstan represented the multi-centre experience following commercial release of the NobleStitch EL system in Europe and Asia. In his presentations, to an audience of cardiologists and cardiac specialists from around the world, Dr. Mullen discussed that the NobleStitch™ EL is poised to be the device of choice for PFO closure. Dr. Mullen stated, "The NobleStitch is my first choice for PFO closure, it provides closure rates consistent with umbrella devices without the risks or long-term consequences of leaving leaving prosthetic devices in the heart. The Benefits of the NobleStitch over conventional PFO closure are slef evident. Their is minimal or no risk of complications including device migration, erosion, perforation, nickel allergy or atrial fibrillation. Additionally, the NobleStitch does not require any anti-coagulation, these collective benefits combined with the success we have demonstrated in the multi center data show that the NobleStitch technology is the new choice for PFO closure."

Prof. Anthony Nobles, Chairman, CEO and Chief Clinical Specialist of Nobles Medical Technology commented, "With the renewed interest in PFO closure after the recent ruling of the FDA that PFO closure reduces recurrent stroke we have had a significant increase of interest in our NobleStitch Technology which has led to an increase in sales. The presentation of the multi center data now has given us the ability to show our products performance in a broad range of PFO's. This was the first time we presented our NobleStitch at the TCT, this is a major milestone for our company and we look forward to working with the many US based cardiologists that have approached us to provide the NobleStitch solution for their patients."

The NobleStitch™ EL Suture System is a revolutionary technology in the treatment of structural heart disease of the atrial septum. The suture only system alleviates the need for any implanted device within the heart and therefore greatly reduces side effects associated with the traditional therapies.

About PFO Closure

A PFO is a relatively common heart defect characterized by an unsealed tunnel between the right and left atria of the heart. This defect has been known to be present in anywhere between 27%-38% of people. However, in a number of cases, it is benign.

The PFO is formed as a trace of the fetal circulation. When the chambers of a human heart begin to develop, a tunnel is made between the right and left atria, allowing blood to flow directly from the venous circulation to the arterial circulation, circumventing the non-functioning fetal lungs. Following birth, the pressure differential between the right and left atria changes with newly operational blood flow to the fully functioning lungs. Because of this, the tunnel eventually closes completely within the first few months.

However, in some patients, the foramen ovale fails to seal and stays "patent". In patients with a Patent Foramen Ovale (PFO), the tunnel can reopen under elevated atrial pressure, such as coughing, or straining.

A key issue with PFO is that it gives a pathway for blood clots to pass directly to the arterial circulation without being filtered out by the capillary bed of the lungs. A PFO can also let deoxygenated blood and certain chemicals cross over to the arterial side. The presence of a PFO has been linked to a number of clinical issues, mainly strokes, migraines and chronic fatigue. Developments are being made to solidify the link between PFO and strokes or migraines, and to identify patients that would benefit from PFO closure.

An atrial septal defect (ASD) is a hole in the wall between the two upper chambers of your heart (atria). The condition is present from birth (congenital). Small atrial septal defects may close on their own during infancy or early childhood.

Large and long-standing atrial septal defects can damage your heart and lungs. Small defects may never cause a problem and may be found incidentally. An adult who has had an undetected atrial septal defect for decades may have a shortened life span from heart failure or high blood pressure that affects the arteries in the lungs (pulmonary hypertension). Surgery may be necessary to repair atrial septal defects to prevent complications.

Atrial septal aneurysm is a congenital cardiac abnormality that is characterized by saccular formation of the interatrial septum. Redundant atrial septal tissue results in bulging of the septum into either or both atria during the cardiac cycle. The diagnosis is best established with transesophageal echocardiography (TEE) since it can be easily missed with transthoracic echocardiography. Diagnostic criteria for ASA established by Hanley based on the appearance on echocardiography are: aneurysmal dilatation of the atrial septum protruding at least 1.5 cm beyond the plane of the atrial septum or phasic excursion of the interatrial septum during the cardiac cycle of at least 1.5 cm in total amplitude with a diameter at the base of the aneurysm of at least 1.5 cm. The condition can also be described using the Olivares-Reyes criteria, a classification based on the extent of excursion into each atrium. While the prevalence of ASA based on autopsy studies is <1%, the prevalence on TEE in non-selected patients is higher, in the range of 2% to 10%.

Atrial septal aneurysm is clinically significant because of its association with cryptogenic stroke especially when there is a concurrent PFO. Approximately 70% of patients with ASA also have a PFO, while PFO is present in only 22% of patients without ASA. In one study, the combination of ASA and PFO was associated with a 33-fold higher risk of cryptogenic stroke. A meta-analysis has also found that ASA alone or ASA with PFO is associated with ischemic and cryptogenic strokes in patients <55 years of age. The strongest association is in those patients with both an ASA and a PFO. In patients <45 years of age with ischemic cerebral events, ASA should especially be suspected as a cardioembolic source. Mattioli and colleagues reported that 86% (43 of 50) of such patients had an ASA as the only possible etiology while 97% (42 of 43) of these younger patients with ASA also had a PFO.

Patients with both ASA and PFO who have had a stroke are at substantial risk for recurrent stroke despite aspirin therapy. Mas and colleagues reported that the risk for recurrent stroke was 15% for patients with both PFO and ASA compared with 4.2% for patients with neither abnormality. These patients might benefit from more aggressive therapeutic strategies such as combination antiplatelet drugs, long-term anticoagulation or closure of the PFO.

About Nobles Medical Technology II

Nobles Medical Technology II, Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the PFO, ASD-closure, and vascular-suturing marketplace. The company does business under the name of Nobles Medical II (NMT II). Initial efforts of the company are focused on the innovative suture-based PFO closure system for closing the Patent Foramen Ovale (PFO), a tunnel between the right and left atria of the heart.

The NobleStitch™ is approved for PFO Closure and Cardiovascular suturing in the European Union. The NobleStitch™ EL is FDA cleared for vascular suturing in the United States. NobleStitch™ EL is distributed worldwide by HeartStitch®, Inc. (HeartStitch® is a registered trademark of HeartStitch, Inc.).

NobleStitch™ EL for PFO closure cardiac and vascular suturing.

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.

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