Stellartech Research Corporation — Furthering innovation in healthcare by creating state-of-the-art medical devices

Technological innovation is revolutionizing healthcare. The future of healthcare is shaping up in front of our very eyes with pioneering advances in healthcare technologies such as gene therapy, 3D-printing, nanotechnology, therapeutic energy delivery and robotics. To stay current, we need to familiarize ourselves with these rapidly developing, advanced medical technologies and systems.

Stellartech Research Corporation is a company that throughout its history, has strived to contribute to the advancement of healthcare by developing state-of-the-art, precision-made, medical devices. Today Stellartech Research Corporation is a global leader in the design, development and contract manufacturing of technologically advanced medical systems that use radiofrequency, ultrasound and other complex energy sources to deliver breakthrough therapies.

Recently, The Silicon Review sat down to talk with Roger A. Stern, Ph.D., the President, CEO, and Founder of Stellartech Research Corporation. The following are excerpts from this conversation.

Q. What were the circumstances that led to the founding of Stellartech Research Corporation?

Stellartech was founded to develop innovative medical device solutions for challenging clinical applications in partnership with medical device startups and venture capitalists.

In 1989, we were approached by one of our first clients, EP Technologies, a small startup company in the emerging field of ablation for cardiac arrhythmias. Despite the limited body of knowledge about therapeutic radiofrequency (RF) energy delivery for ablation available at the time, Stellartech developed the first temperature-controlled cardiac ablation system for EP Technologies and helped the company get PMA approval. After launching the system in the mid-1990s, EP Technologies quickly became the market leader in cardiac ablation.

Building on this early success, Stellartech went on to expand and deepen its expertise in the field of therapeutic energy delivery.

Setbacks, roadblocks, and learning lessons that helped Stellartech grow.

1. In the early years after our founding, we focused solely on design and development, outsourcing the manufacturing of the devices we designed to a contract manufacturer. However, we quickly learned that if we could control the design transfer to manufacturing as well as ongoing manufacturing engineering, we could produce a higher-quality product for our customers. Additionally, expanding into manufacturing made us a stronger, more balanced company and resulted in a significantly higher revenue stream.
2. We are dedicated to innovation, and one of the primary roadblocks to medical device innovation is funding for startup companies. Finding ourselves presented with several high-potential companies having difficulty securing funding, we decided to develop a capital-efficient model to “incubate” some of these companies at Stellartech on a very selective basis.

The Stellartech incubation model minimizes an emerging company’s capital requirements. At the same time, it helps them achieve speed to market by leveraging Stellartech’s infrastructure, engineering expertise and its manufacturing capabilities. Importantly companies do not have to undertake the costly and complex process of developing a quality assurance system that meets regulatory requirements but can operate under Stellartech’s QSR/ISO quality system. Both BARRX^TM and Thermage^®, two of our biggest success stories, were incubated at Stellartech.

Q. As a world leader in the design, development, and manufacture of sophisticated medical systems, what are Stellartech’s key focus areas?

Stellartech’s strategy is to provide complete design, development, and manufacturing services to our customers, from initial concept through commercialization. Our goal is to ensure delivery of the highest-performance, highest-quality product throughout all stages of the product life cycle. We have developed comprehensive in-house capabilities that allow us to maintain this standard of excellence.

Stellartech’s capabilities include extensive R&D services, electronic, mechanical, and software engineering, regulatory assistance, industrial design, and commercial manufacturing with ongoing sustaining engineering and product servicing. Although we design and manufacture many types of complex devices, our special focus is on therapeutic energy delivery systems.

We excel at “lesion science,” the science of the interaction of energy with tissue. We utilize advanced knowledge of applied physics in our design process, varying a complex array of parameters to achieve the desired therapeutic effect. We have designed safe and effective systems to create highly controlled therapeutic lesions in depths ranging from 700 microns to ablate the thin epithelium of the esophagus to treating malignant liver tumors up to several centimeters in diameter. We have experience with a wide range of energy modalities, including radiofrequency (RF), cooled RF, pulsed field RF, microwave, high-intensity focused ultrasound (HIFU), cryogen, vapor, and high-voltage X-ray. Our energy delivery systems have provided solutions in a variety of clinical applications, such as cardiology, oncology, gastroenterology, pulmonology, and urology.

Q. What are the factors influencing the pricing of your products?

We focus on innovating for our customers, but true innovation takes time and is costly. To address this, we have developed advanced platform technology that accelerates the development process while keeping costs down. This frees up funds to devote resources to the more innovative aspects of a product’s design while ensuring the basic technology is “state of the art.” Our goal is to help our customers develop innovative systems with the potential to change the practice of medicine.

An example is Stellartech’s SURF, our energy delivery platform. SURF offers multiple energy delivery modes with multi-channel temperature feedback and control including the option of seamless integration of fluid cooling. We call our SURF system “ultra-configurable” because it can be rapidly configured to a customer’s specification, allowing selection from a wide range of energy modalities. Customers get the benefit of high- performance modular hardware and software, pre-validated manufacturing processes and agency approved configurations that facilitate an expedited market launch.

Q. Can you provide us with one or two success stories?

Over the years, Stellartech has pioneered many energy-based therapies.

Thermage^®:

One of these innovative therapies is a cooled RF Energy System for aesthetic tissue remodeling for our customer Thermage^®. The physician entrepreneur who partnered with us wanted to develop a non-invasive skin-tightening system that could be used in a physician’s office using minimal anesthesia, allowing a patient to return to work immediately afterward. Shrinking skin collagen at the proper level to achieve the desired cosmetic effect without causing superficial tissue destruction and pain was challenging.

Our solution was an innovative cooled ablation system that disperses high levels of RF energy to deeper tissue areas through an insulated tip that permits capacitive coupling — achieved by protecting the skin tissue with a cooling cryogen spray. The system is powered by a high-frequency RF generator embedded with patented microchip and sensor technology that constantly monitors tissue parameters and controls the energy delivery algorithm. The immediate result is renewed youthfulness of the skin, with additional tightening over time.

BARRX^TM:

Some years ago, two physicians approached Stellartech with the clinical need to endoscopically remove Barrett’s pre-cancerous esophageal tissue in a rapid outpatient procedure. The goal was to reduce a patient’s chances of developing deadly esophageal cancer. At the time, patients with Barrett’s were required to have esophageal biopsies at least every two years to remove small sections of their esophagus to be analyzed for malignancy. A diagnosis of esophageal cancer was a virtual death sentence, as the survival rate at 5 years was ~7%.

Stellartech’s challenge was to design a system capable of precisely ablating the superficial lining of the esophagus while simultaneously preserving underlying tissue. Stellartech’s solution, the BARRX^TM System, is comprised of a high-frequency RF energy generator, a sizing balloon, and an ablation balloon. To ensure reliable tissue contact, a one-size-fits-all sizing balloon automatically sizes the esophagus, and the correct therapeutic balloon catheter size is displayed on the energy generator. The generator delivers a rapid burst of radiofrequency (RF) energy to a bipolar electrode band mounted on the correctly sized balloon catheter.

With this system, therapeutic RF energy removes the pre-malignant epithelium of the esophagus in just seconds and allows it to be replaced by normal tissue.

Acquired by Medtronic, the BARRX^TM system is the standard of care for the treatment of Barrett’s metaplasia and dysplasia. Today, this system dominates with ~95% market share. But most importantly, clinical studies show it to be associated with a high rate of complete eradication of pre-cancerous tissue and a reduced rate of progression to esophageal cancer. For the invention and development of this device, Stellartech received a Gold Medical Device Excellence Award.

Charting new territory; plans for transformation.

We plan to remain at the forefront of innovation by ensuring the devices we design for our customers take advantage of the very latest technology. Advances in technology will drive capabilities up, prices down, and deliver results faster; we are committed to leveraging these benefits in the medical devices we design for our customers.

With the increased prevalence of chronic disease as the population ages, therapeutic energy delivered in minimally invasive applications will be in increased demand. Energy-based therapies offer many advantages over conventional surgery, including reduced pain and faster recovery times. In addition, discoveries in medicine are yielding a deeper understanding of the body and the parameters that lead to disease. These discovery pathways are leading to new applications for therapeutic energy delivery, such as the treatment of complex arrhythmias, hypertension, type 2 diabetes and cancer. Research studies project the market for energy-based therapies to be over $12 billion by 2029, growing at a CAGR of almost 6%.

Stellartech has built a team that excels at the design, development, and manufacturing of therapeutic energy devices. We have always been at the forefront of this field and are looking forward to developing the next generation of clinical solutions for our customers and patients.

Q. What is your final message to The Silicon Review readers, your current and future clients, and partners?

Our aim is to go above and beyond in speeding up the discovery and development of innovative medical device technology for medical device startups, investors, and OEMs. Our track record includes many successful products developed for startup companies that have gone on to become public or have been acquired by large multinational companies. This includes many “first of its kind” products, such as the first cardiac ablation system approved by the FDA and the first Barrett’s esophagus ablation system. These systems have changed the standard of care in medicine. We intend to continue this track record of innovation.  

About the President, CEO, and Founder

Roger A. Stern, Ph.D., is President, CEO, and Founder of Stellartech Research Corporation. Roger is recognized as an expert in the application of radiofrequency, ultrasound, and other directed energy sources for therapeutic applications, including ablation and electrosurgery. Over the past 35 years, he has developed key technology for more than 40 medical device start-up companies.

Roger received a BSEE from Syracuse University and a Masters and Ph.D. in Electrical Engineering from Stanford University, where he specialized in medical imaging systems. He currently serves on the board of directors of five medical device companies. Roger has been recognized as one of the Medical Device and Diagnostic Industry’s 100 Notable People. 

“Stellartech excels in the ability to take your product idea and your requirements and turn them into a successful clinical application.”

“Stellartech functions as your business partner through every stage of the product development process.”