“Our technology is a completely new paradigm where the physician is empowered to create or adapt the catheter tools in the operating room at the time of the procedure to meet the evolving needs of the patient and procedure.” Bradley Beach, Covellus Founder/CEO.

As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, Emmy Award-winning Journalist Kym McNicholas interviews Covellus Founder/CEO Bradley Beach.  Written by Kym McNocholas.

When an interventional vascular specialist begins an angiogram on a patient’s legs, there are a lot of unknowns in terms of the character, length, and extent of a lesion that’s narrowing flow; no two cases are exactly alike. So, it can be difficult to stock a cath lab’s armamentarium to prepare for every situation – both due to cost and simply shelf space. Having versatile tools on-hand and quickly accessible is incredibly valuable. Sometimes less frequently used tools are kept in other rooms leaving techs running back and forth to seek a different size balloon, wire, and/or catheter. That’s time and money in and of itself. Plus, increased risk for a patient being on the table for an extended period.

What if there was a different way for doctors to use their catheter equipment? Instead of a unique catheter for each feature variation, a physician can adapt their most common catheters by just adding the unique feature when needed…a modular catheter solution? I think doctors would be skeptical that’s possible. But Covellus Founder/CEO Bradley Beach is giving it a shot. He’s taking this modular approach to create more flexible tools to increase efficiency and reduce costs. In our latest Vascular Spotlight, Beach shares his vision to create a paradigm shift in minimally invasive procedures to unblock arteries in the legs.

What is the story behind the technology? Where did it originate?

I found my way to a MedTech startup company in 2005. Prior to that my engineering career was constant motion through a number of different industries. That company lead to another company (Flexible Stenting Solutions) where I was the first employee and inventor of a novel peripheral vascular stent. We had some success with Flexible Stenting and exited to Cordis Corporation in 2013. After the exit, I transitioned to a different kind of role at a contract manufacturer and while I learned a lot in that position, it was not really what I was driven to do and desired to get back to developing product solutions, ideally at a startup. If you have been involved in startups, you know it is just a different world, everything is new, constant learning and offers a unique opportunity to create product solutions that can impact lives. Well, the contract manufacturer and I parted ways, which is a euphemistic way of saying I got fired. A few months later, I was still looking for a new gig without any good prospects and on a walk one day my mind started rattling around an idea that became the Covellus Modular Catheter Paradigm.

The Covellus Modular Catheter Paradigm is a new way to conceptualize how catheter devices can be designed and used. Currently, all device catheters for minimally invasive procedures use an integrated paradigm. Basically, a one-piece unitary construction with a structural, diagnostic or therapeutic element at the distal, the end that goes inside the patient body. Our technology is a completely new paradigm where the physician is empowered to create or adapt the catheter tools in the operating room at the time of the procedure to meet the evolving needs of the patient and procedure. If you look at all other industries, modular and adaptable products are ubiquitous. Industries tend to migrate to modular solutions in some form or fashion as an industry matures because the competitive advantages cannot be ignored.

What need does it address?

As I mentioned, all medical device catheters use an integrated design approach. The good news is integrated catheter designs work. The integrated architecture has been used to create interventional product to meet clinical and therapeutic needs throughout the body. However, the remote nature of interventional procedures and variability in anatomy and clinical condition/disease state, requires many, sometimes hundreds of unique products (SKUs) to make the solution viable. Given the significant design, development, regulatory, manufacturing, and inventory costs of catheter solutions only a limited number can be realistically pursued, limiting device options and access to physicians. This is the bad news.

A modular approach can radically change how all stakeholders think about designing and using catheter products. With modular economies and streamlined development, you can shift the product viability threshold such that many more options are available to physicians to customize treatment options for more patients at a lower cost.

What is the potential for patient impact?

For these vascular interventional procedures, physicians are highly reliant on the device configurations to meet all variations encountered in individual procedures… no two people are alike, and no two procedures are the same. The Covellus Modular Approach has the potential to create many more configuration options for the physician which allows them to tailor their tools for the procedures and therefore create better patient outcomes. More of a personalized approach to catheter device configurations.

Where is the technology in development and what is next for the company?

Covellus is an innovation-focused company. Covellus has patented the Modular Catheter System. We have designed initial products that can be used to customize and configure PTA balloons by the physician. We have met with the FDA to define the regulatory pathway for clearance and understand the expected requirements. We have done substantial prototyping, bench testing and clinical veterinary work to demonstrate the feasibility and robustness of the concept. However, we have no plans to commercialize our Adaptable Catheter products ourselves. That is not the strength of our organization. Instead, we intend to find a strategic partner with the infrastructure, resources, reach, and vision to bring this new, disruptive product category to the market.

How can patients or advocates get involved?

That is a good question. In general, hospitals and cath labs are black boxes to patients. They go in with an idea of the clinic condition and maybe a basic understanding of the procedure but probably know nothing about any of the products that will be inserted into their bodies and used during a minimally invasive vascular procedure. I don’t know, in part because the technology we developed is not typically the way people think of innovation in this industry. Innovation is usually thought of a new therapy. No one thinks of innovation as a new design paradigm. It is understandable because a new therapy drive increases in procedures and more market share for the commercializing company. This is a way to develop more efficient products with more options. For a new therapy, perhaps there is space for patients to demand access to that new therapy and bring market attention to it.

Anything else we should know?

A modular approach to interventional catheter devices can be used to create product solutions that offer physicians the unprecedented ability to safely adapt interventional tools guided by procedural needs and streamline the development pathway of new devices for a manufacturer.