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Devices Interventional Cardiology Product Launch

 News Release - May 2, 2018

Nobles Medical Launches Sales of its NobleStitch(TM) EL for PFO Closure in Spain

NOBLES MEDICAL TECHNOLOGIES II, INC. (NMT2) CONTINUES TO EXPAND SALES OF NOBLESTITCH EL WITH ITS FIRST CENTERS IN BARCELONA, SPAIN

BARCELONA, Spain, May 2, 2018 -- (Healthcare Sales & Marketing Network) -- NMT2 announces the further expansion of the NobleStitch™ EL with the addition of Hospitals in Barcelona, the first to perform PFO closure cases in Spain has been Vall Hebron Hospital. Dr. Gerard Marti, Consultant in Interventional Cardiology and Structural Heart disease at the Hospital Vall Hebron was the first in Spain to perform the NobleStitch™ procedure using the suture-based closure system.

Dr. Marti commented, "We are delighted to be the first center in Spain to do PFO closure cases with the NobleStitch™ suture technique. We treated successfully six patients in a couple of sessions. Despite we thought it would be a technically demanding procedure we quickly realized that it was more user-friendly than expected. In fact, in our second session we were able to treat three patients in no more than three hours. Moreover, we could test the technique in non-selected anatomies including long tunnel, large PFO and fatty septum, a procedure that I would not use an umbrella in, and we were impressed of the complete closure rate achieved. The best perception of this technique came the day after when we discharged all six patients with no fear about erosion, embolization, clot formation and mostly new onset atrial fibrillation."

Dr. Bruno Garcia, Chief of the Hospital's Interventional Cardiology Department stated, "I was not a fan of PFO closure because I did not like to place the traditional devices, but after seeing this smart technique and their initial results in our patients I think NobleStitch™ should be used as first row therapy instead of an umbrella device".

Josep Jorba, Principal of Cardiolink, distributor of NobleStitch™ in Spain commented; "It has been wonderful to attend these initial cases as we are launching sales of this exciting new product in Spain. We were surprised how simple the device was and how incredible Prof. Nobles was as a proctor. We feel that we will make this the PFO closure system in Spain. After reviewing the recent published peer reviewed data in EuroIntervention (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.htm) and sharing these results showing the benefits of NobleStitch™ over traditional umbrella occluders we expect good growth in Spain. We look forward to the upcoming meeting at Euro PCR in Paris (https://www.pcronline.com/Courses /EuroPCR/EuroPCR-2018) where we will have the ability to show the NobleStitch™ to a broad range of customers in one meeting."

Professor Anthony Nobles, Inventor of the NobleStitch™ EL and Chairman, CEO and Chief Clinical Officer of NMT2 was on hand to proctor Dr. Marti and commented, "I am thrilled at every opportunity to present our technology to physicians, Spain is one of our strategic sales territories and critical to our global expansion. It is so rewarding to watch physicians respond to our suturing system positively after their very first cases. As we continue to train at each new center around the world we are seeing similar reactions, both the physicians and their staff are thrilled with the ease of use of our devices as well as having a safer and less invasive option of closure for their patients. Both Dr. Garcia and Dr. Marti are exceptional operators and passionate about finding innovative technologies that help their patients, moreover their skill at the table is first rate. I look forward to building our experience in Spain and expect that Vall Hebron under the direction of Dr. Garcia will be a key center and Dr. Marti will be a key proctor for NobleStitch in Spain."

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 communication 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 communication eventually closes completely within the first few months.

However, in some patients, the foramen ovale fails to seal and remains "patent". In patients with a Patent Foramen Ovale (PFO), the communication 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 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 cardiovascular-suturing marketplace. The company does business under the name of Nobles Medical II (NMT II). Initial efforts of the company have been focused in Europe 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 and Cardiovascular suturing in the United States. Further information including warnings and precautions can be found in the instructions for use.

NobleStitch™ EL is distributed worldwide by HeartStitch®, Inc. (HeartStitch® is a registered trademark of HeartStitch, Inc.).

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.

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.

For more on Nobles Medical Technologies II visit http://www.noblesmed2.com.


Source: Nobles Medical Technology II

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