The Silicon Review
Medical device start-up companies must focus on innovation, regulatory compliance, efficient processes and prudent financial management in order to survive. Smart MedTech companies prioritize their funding to only support innovation which will result in new products that fulfill significant unmet clinical needs over the long-term. Thrombolex, a relatively new entrant into the MedTech sector, is a proven, serial innovator that understands this prioritization need. Their experienced leadership team intentionally minimized their direct hiring of staff, opting for careful selection of highly experienced medical device partners for outsourcing their prototype validation & verification testing, manufacturing, clinical trial management and regulatory pathway processes. These strategic and tactical partners helped create an accelerated and financially efficient process which has resulted in a unique and proprietary platform technology and seven (7) new FDA cleared products in a very short time, at very low start-up costs. Their BASHIRTM Endovascular Catheters are a series of pharmaco-mechanical endovascular catheters which physicians are beginning to use to treat their patients suffering from thromboembolic conditions, such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) with excellent clinical outcomes.
At Silicon Review, we know that this type of focus is an intentional, laborious process, but when done right, the payoff for patients and the broader healthcare system may be huge. Thrombolex continues exploring ways to improve both the short and longer term outcomes for patients suffering from arterial and venous thromboembolic disorders. Their goal is to fundamentally improve patient care through efficient innovation. That is why the Silicon Review is proud to have selected Thrombolex as one of the “50 Smartest Companies of 2021”.
We interviewed Michael Cerminaro, President & COO of Thrombolex, who spoke on behalf of their three-person leadership team of Marv Woodall, Chairman & CEO and Brian Firth, MD, Chief Scientific Officer, to learn more about this fast-paced company and its dedication to innovation.
Here are the excerpts from the interview:
Q. Venous thromboembolism (VTE) has been described as a global healthcare crisis. What is VTE and how prevalent is it?
A recent comprehensive scientific review revealed that 10 million cases of venous thromboembolism (VTE) occur annually on a worldwide basis with significant mortality and morbidity. Many VTE-related deaths go largely undocumented, with data predominantly confined to the United States and Europe. In the U.S. alone, VTE accounts for about 180,000 deaths per year. This represents more annual deaths than occur from HIV, breast cancer and all the automobile accidents combined in the United States.
VTE is a blood clotting disorder that includes deep vein thrombosis (DVT) and pulmonary embolism (PE). A DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh, or pelvis. A PE occurs when a clot breaks loose and travels through the bloodstream to the lungs. This disorder is the third most frequent cause of death from cardiovascular disease, behind heart attacks and strokes. While mortality has improved considerably over the past two decades for patients suffering from heart attacks and strokes, mortality for VTE patients has not experienced similar improvements. That is why better, more innovative new technologies are needed to help reduce the burden of this global healthcare crisis related to VTE disorders.
Q. What has Thrombolex done to address this global healthcare crisis caused by VTE disorders?
Thrombolex originated from a serendipitous meeting between Marv Woodall, our Chairman & CEO and Dr. Riyaz Bashir, Professor of Medicine and Director of Vascular and Endovascular Medicine at Temple University Hospital.
Dr. Bashir was seeking help to develop a novel advanced platform technology to treat his patients suffering from VTE. In 2016, Dr. Bashir and Marv, partnered with Nick Green, and me. Nick was a former colleague of Marv’s at J&J who brought a wealth of experience in medical catheter device development and who created our first prototype. Marv and I had been working closely together to source and identify a new, disruptive, early stage MedTech investment opportunity. Together, the four of us co-founded Thrombolex with the intent to reduce Dr. Bashir’s original designs to practice. Shortly, thereafter, Dr. Brian Firth, another of Marv’s former colleagues from J&J, joined us as our Chief Scientific Officer and has been a major contributor to our success while leading our R&D, Clinical and Regulatory programs.
In addition to our unique platform technology, we also have an active research and development pipeline and expect to introduce multiple new innovative products over the next several years.
Q. Why is consistent innovation in the medical device sector so important to patient care?
Medical device innovations have vastly improved the human condition over time. Collectively, new therapies have been some of the greatest contributions to improved mortality and long-term quality of life. However, despite the dramatic life-saving advancements in our area of the healthcare sector, our work is far from done. Innovative companies like Thrombolex, developing new technologies have the capacity to solve major healthcare problems. Developing newer, safer, easier to use medical device technologies is one of the most important steps we can take towards impacting mortality in a positive way and improving our patients’ quality of life.
Q. What experience does the Thrombolex leadership team have in early-stage company development and new medical device innovation?
In addition to myself, our leadership team consists of Marv Woodall, and Dr. Brian Firth. We have been driving the successful creation of multiple novel medical devices and start-up companies for a long time now. Prior to the inception of Thrombolex, the most notable achievement was the development of the generations of specialty stents, which led to a transformational change in the endovascular treatment of obstructive lesions in the coronary, iliac, renal and carotid arteries. Some of these prior innovations that members of our leadership team were involved with include the Palmaz-Schatz balloon expandable coronary stent and the Cypher drug-eluting coronary stent. Now, our highly experienced leadership team has focused on solutions for the under-recognized and under-treated problems in the arterial and venous circulation, especially PE and DVT.
Q. What types of complications do patients suffering from DVTs and PEs typically encounter?
Without proper treatment, VTE can restrict or block blood flow and oxygen, which can damage the body’s tissue or organs. This can be especially serious in the case of a PE, which blocks blood flow to the lungs, and can cause death acutely or severe long-term disability. Up to one-third of acute PE patients experience post-PE syndrome, such as chronic pulmonary hypertension (CTEPH) and chronic thromboembolic disease (CTED), which can be extremely disabling.
In addition, up to one-half of patients who have a DVT will go on to have long-term complications called post-thrombotic syndrome (PTS). For some people, DVT and PE can become a chronic illness; about one-third of patients who have had a DVT or PE are at risk for another episode within 10 years. New technology like the BASHIR Endovascular Catheters, which are capable of reducing significant thrombus burden with a small caliber device, may have a very positive role to play in improving long term quality of life.
Q. What has been your real-world experience in treating VTE patients and is there any clinical data to support the safety of your novel medical devices?
In real world cases, the BASHIR Endovascular Catheters have been able to restore immediate blood flow, by mechanical expansion of the infusion basket, and significantly reduce thrombus burden using low doses of r-tPA. Some patients have benefited from “on the table” results, short ICU and hospital stays. These beneficial results have been experienced in both arterial and venous vascular beds. The BASHIR Endovascular Catheters have demonstrated an excellent early safety profile. In fact, to date, there have been no major bleeds or adverse events reported during use in real world patients since the start of our commercialization efforts.
Thrombolex successfully completed a first-in-human (FIH) trial in December 2019, treating patients with acute submassive PE. This study met its primary safety and feasibility endpoints and showed a robust reduction in right heart strain as evidenced by a mean reduction in right ventricular to left ventricular (RV/LV) ratio of 37% (P<0.0009), as well as a 37.1% mean reduction (P<0.0005) in pulmonary clot burden, as measured by the Modified Miller Index (MMI) following a mean infusion of only 13.7mg of r-tPA over eight hours.
Q. How has the BASHIR Endovascular Catheter line of products been used to treat COVID-19 patients?
During the COVID-19 pandemic, we learned that the virus does not just cause pneumonia but that it can also create widespread vascular inflammation resulting in hypercoagulation complications. In some COVID patients, blood clots in larger vessels resulted in DVT, PE, stroke, and myocardial infarction. This has been happening even though these patients, in accordance with standard intensive care practice, are placed on anticoagulants like heparin to prevent clots as soon as they are admitted to the ICU.
BASHIR Endovascular Catheters have been used effectively to safely treat COVID-19 patients with VTE disorders with very good clinical outcomes. Hospitals that have seen their ICU resources stretched to the breaking point during the pandemic have experienced short ICU and hospital stays when patients were treated with our devices, which has not only helped to free up limited hospital resources, but has also improved treatment outcomes. Owing to this clinical success, Thrombolex was recently awarded a grant under the U.S. CARES ACT to provide its innovative BASHIR Endovascular Catheters to numerous community hospitals in Pennsylvania.
Q. What’s next for Thrombolex?
The Thrombolex RESCUE clinical trial studies patients with acute submassive PE and is expected to be completed in 2021, which will provide substantial outcome data to support expanded indications for use for our BASHIRTM Endovascular Catheters.
Further, we are developing innovative new devices to further assist physicians to care for their patients with arterial and venous thromboembolic disorders.
The Leadership Team at Thrombolex
Marvin Woodall, Chairman & CEO
Michael Cerminaro, President & COO
Brian Firth, MD, PhD, Chief Scientific Officer
Each team member brings extensive experience and successful records to Thrombolex.
Mr. Woodall has extensive medical device leadership, having led multiple new medical device start-up organizations in both the USA and overseas, within several J&J entities and additional companies.
Mr. Cerminaro has extensive experience in private equity, finance and early-stage company development and oversees the strategic, commercialization and business development aspects of Thrombolex.
Dr. Firth has extensive clinical experience as a cardiologist, in clinical trial organization leadership and R&D, regulatory and health economics and leads all of our scientific, clinical and R&D initiatives.