Shawn Fojtik, CEO of Control Medical
Shawn Fojtik brings a wealth of knowledge and experience in to Utah’s Life Science Industry. With over 20 years of sales and marketing management, product development, and general management experience (General Electric Medical Systems, Boston Scientific, Black & Decker), Shawn founded Pinyons, his own medical device company in 2006. And in just over 2 years, he sold it. Since then, he has founded two more Utah-based medical device companies. We recently caught up with Shawn to learn more about his ventures and the medical device community in Utah.
Silicon Slopes: Your background includes management roles in some major corporations including GE, Boston Scientific and Black & Decker. What inspired you move from the established corporate world to the startup world?
Shawn Fojtik: I am grateful for the large company experience. I particularly thank to Boston Scientific and those that managed me. They taught “product development 101” with unbending patient safety ethics and gave me the ability to work with Lazar Greenfield MD and other thought leaders. Start-ups attracted me as they allowed me to focus on innovation and rapid commercialization. Plus, start-ups allow you to learn and operate daily in all functional areas of the company.
Silicon Slopes: You founded a very successful medical device company, Pinyons, in 2006. Can you tell us more about the foundation for this company and how it came about?
Shawn Fojtik: Pinyons was born out of necessity to commercialize one of my first patent applications. After applying for the patent, I approached a number of companies to commercialize the platform. As usual, some companies liked it and some passed. But, having worked for large companies, I know that it is difficult to get them to focus on new product commercialization as they have a warehouse full of projects that need sustaining engineering and other support. It became clear that the only way to commercialize Pinyons platform with speed was to do it on our own. So, we partnered with a strategic distributor in Japan, funded Pinyons, and quickly built the company.
Silicon Slopes: Looking back on that venture, what accomplishment are you most proud of?
Shawn Fojtik: Three things: speed, safety, and clinical relevance.
Regarding speed, within 26 months of funding, we earned a US patent, applied for five additional patents, froze product design, used the system in live studies, published performance data, received two FDA approvals, won a global 2008 Medical Design Excellence Award, and sold the company to one of the largest medical device companies.
As for safety and clinical relevance, we discovered early that our device was not just another nice-to-have or “better mousetrap” product. By staying close to clinicians, we built the platform to achieve major patient and safety improvements in image quality, reducing contrast media delivery (to prevent kidney complications), empower the use of low profile catheters, and reduce high-dose x-ray exposure. Best of all, our device was simple and allowed the physician to control the procedure with tactile feel and responsiveness.
Silicon Slopes: You sold Pinyons just over two years after it was founded. Can you tell us about the sale of the company and the story behind such a quick exit?
Shawn Fojtik: The quick exit goes back to how Pinyons executed their plan. Pinyons began talking to large companies about distribution and acquisition after our first working prototypes were made. We told potential partners our upcoming milestones then successively achieved our plans while the big companies watched. I believe it gave the potential acquiring companies the chance to watch us “grow up” and be part of our development. It also created a sense of urgency for potential acquiring companies to see that we were hitting our milestones and we will likely move on without them if they did not come on board. This resulted in a number of companies being interested in the deal.
We also had a perfect storm of clinical drivers that led to a fast exit. Contrast induced nephropathy (CIN), or poisoning of the kidneys with too much contrast media, was a clinical topic at most cardiology meetings 2006-2008. Physicians also talked about the need to use smaller diameter catheters to reduce access site complications to enable faster patient recovery. Also, as the medical device world has become more complicated, our platform was a simple mid-tech and cost-effective solution among a field of complicated high-tech expensive competitors.
Our system was in a good place to meet these new evolving clinical drivers with simplified commercialization strategy. As a company we “de-risked” the deal for acquisition as we had issued patents, freedom to operate, proven in-vivo data, and FDA approval.
Silicon Slopes: You don’t seem to be sitting gathering dust having recently launched two more companies. Tell us about Control Medical and traction you have already had with this new venture?
Shawn Fojtik: Control Medical is a unique start-up medical device company as we already have issued patents, new notice of allowance on new patents, FDA approval, established reimbursement, and an intuitive product platform.
Control’s devices serve three areas: thrombus (blood clot) removal, rotational vacuum assisted breast biopsy, and tissue resection with a common device platform. Our thrombus aspiration catheters use novel technology to improve aspiration force, control, and speed. Our breast biopsy platform will be the world’s first 100% disposable vacuum-assisted rotational system to improve diagnostic confidence and reduce patient complications. Our tissue resection system will help physicians perform autologous stem cell harvesting, spinal disc decompression, and other procedures where increased aspiration force, control, speed, and volume is needed.
Silicon Slopes: Similarly, tell us about CIRCA.
Shawn Fojtik: CIRCA Scientific will commercialize devices that serve the cardiac electrophysiology space. Our first device will be the CIRCA Sensor. Esophageal fistula is a rare complication during/after atrial fibrillation ablation reported only about 100 times per year. But, most esophageal fistulas are fatal. CIRCA’s technology will allow the physicians to see the esophagus, sense the temperature in a large geographic area, physically move the esophagus, and cool it.
Silicon Slopes: What are some of the advantages of developing and growing a life science company in Utah, compared to other regions?
Shawn Fojtik:The Utah medical device community is innovative, entrepreneurial and committed to patient care. We see innovation in Utah’s clinicians working at the University and private institutions; Utah’s private and public University system, and in the state’s established and developing device companies. Last, most important, I believe Utah medical device companies are grounded in a firm commitment to improving patient care, accomplishing something bigger than ourselves. We also need to recognize that the State of Utah is committed to life sciences at all levels from Governor Huntsman to the innovative USTAR initiative.
Utah also has a talented professional network for companies to work with. Our patent law firms are among the best in the nation. Pinyons, Control and CIRCA’s intellectual property is prosecuted by TraskBritt Law. There are other world-class patent law firms including Workman Nydegger, Stoel Rives, Bateman, and others.
Our general counsel is led by Michael O’Brien and Karen O’Brien at Vancott Law. There are numerous other Utah firms that provide excellent representation including Jones Waldo, Parsons Bailey, Snell & Wilmer, and others.
Another Utah advantage is our access to recreation. It is much easier to get an out of town associate, professional advisor, or customer to visit Utah in the winter than most any other state :).
