Dr. Pedro Martinez-Clark —a renowned Harvard-trained Colombian cardiologist— receives funding to develop and market an innovative medical device based on the revolutionary TransCaval Access technique

Dr. Pedro Martinez-Clark, a renowned Colombian-born interventional cardiologist trained at Harvard, is developing an innovative medical device based on the revolutionary TransCaval Access (TCA) technique —co-developed with his research team in Cali, Colombia—, to treat patients with severely clogged arteries. The technique won the Best of the Best Abstract Award at The Society for Cardiovascular Angiography and Interventions (SCAI)'s 2014 meeting. Dr. Martinez-Clark obtained funding from private investors to develop and market his medical device to treat over 154,000 patients annually who cannot be treated with conventional technical devices, thus creating a $ 2.2 billion market opportunity in 2020.

Miami, FL, October 3, 2015 - Dr. Pedro Martinez-Clark, —a renowned Harvard-trained Colombian cardiologist based in Miami, FL, and co-founder & chief medical officer of Interventional Concepts, Inc.— co-developed along with members of his clinical research team in Cali, Colombia, a novel and ingenious technique that approaches the size and elasticity of the main veins of the body and make possible to perform minimally invasive aortic valve replacement in patients whose arteries are too clogged with plaque and prevent the passage and use of large catheters. Dr. Martinez-Clark's research team —which includes the world-renowned cardiologist Dr. William W. O'Neill— has officially presented the TransCaval Access (TCA) technique at The Society for Cardiovascular Angiography and Interventions (SCAI)'s 2014 meeting,  and was awarded the 2014 Best Abstract Award.

Generally, arteries are used in cardiovascular procedures such as angioplasties and transcatheter aortic valve replacements (TAVR) to access the left side of the heart, while veins are used in procedures such as ablation for arrhythmias and interventricular septum repairs to access the right side of the heart. The innovative TCA technique uses veins to access the aorta to perform TAVR using the CoreValve system in order to repair a calcified aortic valve malfunctioning in patients who lack other treatment options.

With the TCA technique, the flexible wires and devices typically used in the TAVR procedure are inserted through a puncture in the femoral vein in the groin —rather than the traditional point of access through the femoral artery. Dr. Martinez-Clark and his team performed the first procedure using the TCA technique in July 2013 and has since been used successfully —without fatalities— in over 100 TAVR procedures in 12 different cardiovascular centers around the world. The medical community has recognized that the TCA technique is undoubtedly successful, but it is difficult to perform and causes blood loss in patients due to the lack of closure devices in the market that are suitable to perform it —nor accessories to support the technique. It is estimated that over 30% of patients requiring TAVR are not suitable for the TAVR procedure using transfemoral access. This represents over 154,000 annual patients around the world and a great $2.2 billion market opportunity to sell specialized closure devices to be used with the TCA technique in 2020. 

The first medical device that Dr. Martinez-Clark and his team will develop will be a special TCA closure device developed under a startup company called TransCaval Solutions, Inc.. This will be followed by the development of complementary support devices. The new closure device has been conceived and designed exclusively for use with the TCA technique and has many clinical advantages over the current off-label closure devices commonly available on the market. This new closure device makes the TSA technique easy and fast to perform and eliminates the bleeding that occurs in patients with the closure devices currently available on the market.

The funding that Dr. Martinez-Clark and his team received will allow them to complete a near final clinical design and successful in-vivo study within 12 months as a preparation for a commercial-ready device to be used in a first-in-man clinical trial. The market analysis conducted by Dr. Martinez-Clark and his team predicts that in 2020 the new TCA closure device, and its accessories, will reach sales of at least $ 385 million and $ 62 million respectively.


About Pedro Martinez-Clark, MD: Dr. Pedro Martinez-Clark was born in Barranquilla, Colombia, he trained as a cardiologist at Harvard Medical School's Beth Israel Deaconess Medical Center, is the director of the catheterization lab at Mercy Hospital in Miami, FL, and is the co-founder and chief medical officer for TransCaval Solutions, Inc. Read more at www.transcavalsolutions.com.

About bioaccess.™: bioaccess.™is based in Orlando, FL, and it helps medical innovators develop their ideas from clinical development to commercialization. The company partners with innovative pharma, medtech & biotech startup companies in the US, Europe and Asia develop their medical products by inviting them to conduct their clinical trials in Colombia. The company has signed a historic alliance with the Government of Colombia to promote the country's excellent clinical research capabilities: fast regulatory approval, ample patient access, and very competitive costs. Read more: www.bioaccessla.com

Press contact: Julio G. Martinez-Clark, CEO, bioaccess.™ | jmclark@bioaccessla.com - +1 (954) 903-7210.