SOURCE: HeartStitch, Inc.

Heartstitch, Inc.

November 29, 2016 09:48 ET

HeartStitch® Presents Progressive Multi Center Data at Three Consecutive Clinical Congresses

HeartStitch® Receives Rave Reviews During Three Consecutive Clinical Congresses Presenting Multi-Center Data and Performing Live Cases

FOUNTAIN VALLEY, CA--(Marketwired - November 29, 2016) - HeartStitch® continues to increase its presence in Interventional Cardiology with additional successful cases worldwide. Recent Multi-Center clinical data presented at the TCT, CSI and GISE meetings in the US and Europe occurring between June and November. Presentations have consecutively shown increased patient data at each meeting with the most recent data presented at the TCT (Transcatheter Cardiovascular Terapeutics), showing the successful results in a 113 patient study which reaffirms the safety and efficacy of the NobleStitch™ EL in repairing septal defects including PFO, ASD and ASA's.

This ongoing study is expected to reach more than 250 patients in Q1, 2017. At the CSI (Catheter Interventions in Congenital and Structural Heart Disease) and GISE (Italian Studies Group of Hemodynamics and Interventional Cardiology) meetings, the NobleStitch™ EL was performed live during the congress and received overwhelming positive reviews and has substantially raised the request for product. This has led Heartstitch® Inc. to increase production to meet the supply and to meet the need generated by the increased awareness of its suture based septal repair system for Patent Foramen Ovale (PFO) as well as Repair of Atrial Septal Aneurysm's (ASA) and Closure of small Atrial Septal Defects (ASD) The NobleStitch™ EL uses its proprietary suture based technology to create a surgical solution in a percutaneous approach without the complications associated with the large metal umbrella type prosthesis.

Dirk Segers, Vice President of World Wide Sales and Marketing for HeartStitch® stated, "We continue to see rapid uptake of our product in the international markets. We have had to increase production to meet the better than expected response by key opinion leaders and customers, the recent live cases at CSI and GISE created significant requests for our products. We are expecting in 2017 to increase production dramatically to meet our new goal of opening a new country each month. Currently we are servicing Italy, Germany, England, Sweden and Kazakhstan with the NobleStitch™ EL. We will enter several new markets beginning in January while increasing our clinical staff and professional proctor's to continue our growth. For me personally this is the best product I have ever had the pleasure of bringing to market."

Roberto Riva, Director of Sales for Kardia, Distributor of HeartStitch® in Italy stated, "After 20 years in the interventional cardiology field the NobleStitch™ is the first real revolutionary product I have introduced to the market. Its fantastic to see the physicians surprise every time they try the NobleStitch™ for the first time when they see a complete closure without a leak and without a metal device left behind. We have also not had a product with this level of clinical uptake and success; every center we have opened has continued to request more product at a level that has had us adjust our forecast every month. I have asked HeartStitch® to increase production to meet the needs of our hospitals. We are excited to be partners with HeartStitch® as do our physicians who regularly publish their own article, press release and clinical data of the NobleStitch™."

Prof. Anthony Nobles, Chairman, CEO and Chief Clinical Specialist of HeartStitch stated, "In my close to 30 years in this business I have not had a product that has been as well received by physicians across the world. We have had positive acceptance of our technology in every hospital we have proctored. The incredible response of doctors and patients has been fantastic. The NobleStitch™ has become the primary or "first choice" of treatment for many of our physicians which is unprecedented in my experience for a new technology. Physicians have attributed this to the simple and intuitive suture based system that provides immediate closure without the complications associated with umbrella plug systems.

I have also been amazed at how we are already seeing patient referrals to many of our physicians, given are recent growth we are already having patients refer their friends and relatives who require closure to have a NobleStitch. Giving patients the highest quality of care both in-procedure and post-recovery along with providing Doctors the ability to have a system with ease-of-use with the highest of success rates is our continuing goal at HeartStitch on a daily basis."

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.

About HeartStitch®

HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures.

The HeartStitch® TA and HeartStitch® MR are FDA cleared for vascular suturing in the United States. HeartStitch® manufactures and markets the NobleStitch™ EL under exclusive license from Nobles Medical technologies II, Inc. NobleStitch™ EL is FDA cleared for vascular suturing in the United States and CE Marked for cardio-vascular suturing and PFO closure in the European Union and the Republic of Kazakhstan, respectively.

HeartStitch® is a registered trademark of HeartStitch, Inc.

HeartStitch® TA for cardiac suturing and transapical access and closure

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, 8348962, 8469975, 8496676, and 8709020.

HeartStitch® MR for suturing an anatomical valve

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, 8348962, 8469975, 8496676, 8709020, and 8771296.

NobleStitch™ EL for PFO closure

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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