It’s estimated that about 40 percent of people who are at risk for colon cancer have never been screened. People avoid the screening process for a number of reasons, including fear, discomfort, and an uncomfortable preparation process leading up to the screening itself.
That's why Yoav Kimchy, Founder and CTO of Check-Cap, launched the company in 2005 with the goal of creating a technology that could make colorectal screenings easier and less invasive for patients.
The company developed a first-of-its-kind technology — the C-Scan ingestible capsule, or C-Scan Cap. In lieu of a traditional colonoscopy procedure, patients can swallow C-Scan Cap just like a normal pill. The capsule then travels naturally along the gastrointestinal tract while scanning the inner lining of the colon.
“The person is free to do whatever he wants while the capsule is traveling naturally, and then it goes out. All the data is recorded and then reconstructed for the physician to look for potential polyps, which are the precursors of colon cancer,” Yoav says.
The goal is to find polyps before they become cancerous, he adds.
Check-Cap received a CE mark in 2018 and the marketing approval was reauthorized in 2021 for another five years.
The company is now focused primarily on getting clearance from FDA for the U.S. market. In May 2022, Check-Cap launched a pivotal trial that will be conducted across 15 clinical sites in the United States, with a goal of enrolling about 1,000 trial participants between the ages of 50 and 75.
Check-Cap is also working with the Centers for Medicare & Medicaid Services to obtain reimbursement for C-Scan.
Yoav says the company is exploring additional products that can use the C-Scan system, too.
“It looks like we have quite a few potential components or potential products that can come out of what we have, which is very exciting as well,” he says.
In this episode of Medsider, Yoav shares how getting early feedback from regulatory professionals can help streamline your development efforts, why you should shift your team’s focus as your company grows, and the importance of knowing when to lead and when to follow.
Yoav Kimchy, Ph.D., has more than 20 years of experience in the development and management of innovative medical device companies. In 2005, he founded Check-Cap, a clinical stage medical diagnostics company that aims to change the colorectal cancer (CRC) screening landscape with its C-Scan ingestible capsule, tracing, and imaging system.
Key Learnings from Yoav's Experiences
- Take every opportunity to get feedback from regulatory professionals. Getting their input, especially early on, can help pinpoint what may or may not work and help to streamline your development initiatives.
- Know when to lead and when to follow. Yoav realized soon after launching Check-Cap that he didn’t want to run the company, so he hired someone to take on the CEO role. It was a good decision, he says, as it allowed him to focus on what he’s good at — R&D — while letting other more experienced people lead the business forward.
- Expand and diversify your team as the company grows. Over time, as you get further into the development process, you’ll need to focus more on logistics and regulation, rather than solely focusing on R&D. Hire people accordingly.
Use Feedback From Regulators To ‘Clean Up Your Act’
Looking back on the early days of Check-Cap, Yoav says he would have interacted with regulators earlier on in the process to better understand the regulatory pathway
Getting input from agencies like FDA can help you pinpoint what may or may not work in your development plans, which is especially crucial as you start testing your product in humans.
Regulatory professionals can essentially help you tidy up your efforts and even point out things you may have missed, Yoav says.
As an example, he adds, Check-Cap just recently learned about FDA’s breakthrough device designation process, which allows device makers to interact with the agency throughout the premarket review phase and prioritizes review of medical devices that qualify for the pathway.
That’s one thing Yoav says he wishes Check-Cap would have known about sooner.
Yoav suggests working with regulatory bodies as soon as possible so you can better understand the landscape, get feedback, and refine your initiatives before heading into human clinical trials.
Know When to Lead and When to Follow
About three years after launching Check-Cap, Yoav began to realize that he did not want to be CEO. Running the company, he says, would not allow him to continue his R&D work.
He hired Guy Neev for the CEO position, and Yoav took on the CTO role in 2009. Guy helped take the company public, with backup support from Yoav.
Alex Ovadia is the company’s current CEO, and has been with Check-Cap since 2013. He served as the Israeli site manager, vice president of R&D, and COOr before being named CEO.
“[It works best] for me to have an experienced person. … [Alex is] running the company as a public entity, and I can do my work in the R&D [function],” Yoav says, emphasizing the company is better with him as CTO, rather than CEO.
He advises medtech startup leaders to check their egos at the door.
“We really have an incredible team of people that are working very hard to get the technology to where it needs to go, to where it can go. So, ego is not something that you can leave on the table there. You need to put it aside and do the actual work,” Yoav says.
Make Sure Your Team Grows and Evolves with the Company
Over time, your company’s focus will start to shift and your hiring needs will change. At the beginning, you’ll want people who are technical experts, but as your work expands, you’ll need people who are more process- and regulation-oriented.
At that point, it’s time to hire more people and focus less on trying to be innovative and more on trying to streamline your processes, Yoav says.
Check-Cap still has a relatively large R&D team that comprises 30 people, but that only accounts for a third of the company’s nearly 90-person staff. The remaining employees are focused on logistics, including manufacturing and quality assurance processes, Yoav says.
“[There’s] a lot of functions that you don’t think of and that you don’t need earlier on, but afterwards, they’re very crucial to the process,” he says.
As your programs evolve, think about your ideal team structure and hire accordingly.
The world of medtech is a complex and interesting space, and there’s room for multiple voices at the table, according to Yoav. The key to success, he adds, is making sure you have the right people in place, and that those people believe in what you do.
It’s estimated that about 40 percent of people who are at risk for colon cancer have never been screened. People avoid the screening process for a number of reasons, including fear, discomfort, and an uncomfortable preparation process leading up to the screening itself.
That's why Yoav Kimchy, Founder and CTO of Check-Cap, launched the company in 2005 with the goal of creating a technology that could make colorectal screenings easier and less invasive for patients.
The company developed a first-of-its-kind technology — the C-Scan ingestible capsule, or C-Scan Cap. In lieu of a traditional colonoscopy procedure, patients can swallow C-Scan Cap just like a normal pill. The capsule then travels naturally along the gastrointestinal tract while scanning the inner lining of the colon.
“The person is free to do whatever he wants while the capsule is traveling naturally, and then it goes out. All the data is recorded and then reconstructed for the physician to look for potential polyps, which are the precursors of colon cancer,” Yoav says.
The goal is to find polyps before they become cancerous, he adds.
Check-Cap received a CE mark in 2018 and the marketing approval was reauthorized in 2021 for another five years.
The company is now focused primarily on getting clearance from FDA for the U.S. market. In May 2022, Check-Cap launched a pivotal trial that will be conducted across 15 clinical sites in the United States, with a goal of enrolling about 1,000 trial participants between the ages of 50 and 75.
Check-Cap is also working with the Centers for Medicare & Medicaid Services to obtain reimbursement for C-Scan.
Yoav says the company is exploring additional products that can use the C-Scan system, too.
“It looks like we have quite a few potential components or potential products that can come out of what we have, which is very exciting as well,” he says.
In this episode of Medsider, Yoav shares how getting early feedback from regulatory professionals can help streamline your development efforts, why you should shift your team’s focus as your company grows, and the importance of knowing when to lead and when to follow.
Yoav Kimchy, Ph.D., has more than 20 years of experience in the development and management of innovative medical device companies. In 2005, he founded Check-Cap, a clinical stage medical diagnostics company that aims to change the colorectal cancer (CRC) screening landscape with its C-Scan ingestible capsule, tracing, and imaging system.
Key Learnings from Yoav's Experiences
- Take every opportunity to get feedback from regulatory professionals. Getting their input, especially early on, can help pinpoint what may or may not work and help to streamline your development initiatives.
- Know when to lead and when to follow. Yoav realized soon after launching Check-Cap that he didn’t want to run the company, so he hired someone to take on the CEO role. It was a good decision, he says, as it allowed him to focus on what he’s good at — R&D — while letting other more experienced people lead the business forward.
- Expand and diversify your team as the company grows. Over time, as you get further into the development process, you’ll need to focus more on logistics and regulation, rather than solely focusing on R&D. Hire people accordingly.
Use Feedback From Regulators To ‘Clean Up Your Act’
Looking back on the early days of Check-Cap, Yoav says he would have interacted with regulators earlier on in the process to better understand the regulatory pathway
Getting input from agencies like FDA can help you pinpoint what may or may not work in your development plans, which is especially crucial as you start testing your product in humans.
Regulatory professionals can essentially help you tidy up your efforts and even point out things you may have missed, Yoav says.
As an example, he adds, Check-Cap just recently learned about FDA’s breakthrough device designation process, which allows device makers to interact with the agency throughout the premarket review phase and prioritizes review of medical devices that qualify for the pathway.
That’s one thing Yoav says he wishes Check-Cap would have known about sooner.
Yoav suggests working with regulatory bodies as soon as possible so you can better understand the landscape, get feedback, and refine your initiatives before heading into human clinical trials.
Know When to Lead and When to Follow
About three years after launching Check-Cap, Yoav began to realize that he did not want to be CEO. Running the company, he says, would not allow him to continue his R&D work.
He hired Guy Neev for the CEO position, and Yoav took on the CTO role in 2009. Guy helped take the company public, with backup support from Yoav.
Alex Ovadia is the company’s current CEO, and has been with Check-Cap since 2013. He served as the Israeli site manager, vice president of R&D, and COOr before being named CEO.
“[It works best] for me to have an experienced person. … [Alex is] running the company as a public entity, and I can do my work in the R&D [function],” Yoav says, emphasizing the company is better with him as CTO, rather than CEO.
He advises medtech startup leaders to check their egos at the door.
“We really have an incredible team of people that are working very hard to get the technology to where it needs to go, to where it can go. So, ego is not something that you can leave on the table there. You need to put it aside and do the actual work,” Yoav says.
Make Sure Your Team Grows and Evolves with the Company
Over time, your company’s focus will start to shift and your hiring needs will change. At the beginning, you’ll want people who are technical experts, but as your work expands, you’ll need people who are more process- and regulation-oriented.
At that point, it’s time to hire more people and focus less on trying to be innovative and more on trying to streamline your processes, Yoav says.
Check-Cap still has a relatively large R&D team that comprises 30 people, but that only accounts for a third of the company’s nearly 90-person staff. The remaining employees are focused on logistics, including manufacturing and quality assurance processes, Yoav says.
“[There’s] a lot of functions that you don’t think of and that you don’t need earlier on, but afterwards, they’re very crucial to the process,” he says.
As your programs evolve, think about your ideal team structure and hire accordingly.
The world of medtech is a complex and interesting space, and there’s room for multiple voices at the table, according to Yoav. The key to success, he adds, is making sure you have the right people in place, and that those people believe in what you do.
