Innovative Approach: A Simple Percutaneous, Non-Surgical, Non-Drug Solution
iCHOR utilizes a proven surgical concept – the Fogarty balloon sweep – and is reinventing it as a percutaneous, non-surgical procedure. This novel approach offers clinicians a familiar and proven mechanism of action to remove blood clots, but in a much less invasive procedure compared to traditional thrombectomy methods. By transforming a surgical technique into a minimally invasive procedure, iCHOR aims to eliminate surgical and drug complications, reduce costly patient and hospital ICU time, eliminate blood loss associated with aspiration tools, and bring down the costs related to skyrocketing thrombectomy treatment algorithms.
The Fogarty sweep, traditionally used in open surgeries, involves using a balloon catheter to clear blocked arteries or veins. iCHOR’s groundbreaking approach adapts this concept into a percutaneous (through the skin) method, eliminating the need for invasive surgery while maintaining the same effectiveness of clot removal we get from surgical options. This novel solution stands apart from current surgical or drug-based options, as well as metal dragging / aspiration-based treatments, offering a safer, faster, and a more affordable alternative.
Addressing Shortcomings of Existing Solutions
Current thrombectomy methods are typically borrowed from other parts of the body and therefore have limitations. Traditional gold standard procedures can be highly invasive with blood loss, bleeding complications and lengthy recovery times. More recent metal scraping tools and aspiration technologies that were borrowed from stroke and pulmonary embolism continue to have significant blood loss, vessel damage or scarring, and distal embolization issues that go unreported. iCHOR’s technology addresses these issues head-on.
The company’s product minimizes blood loss by arresting flow, reduces the potential for vessel damage with a proven balloon sweep, and equally aims to lower the high costs associated with existing thrombectomy treatments. By using a proven mechanism of action that is familiar to vascular surgeons and interventionalists, iCHOR believes they can make thrombectomy procedures safer, less traumatic for patients, and more efficient
Ease of Use and Workflow Integration
One of the most significant advantages of iCHOR’s solution is its ease of use. iCHOR has designed its product to be intuitive and straightforward, ensuring that it seamlessly integrates into existing clinical workflows. The product comes packaged in a single kit that can be quickly deployed without requiring additional capital equipment or complex setups. Open the iCHOR kit, and treat the patient!
The simplicity of the solution means that healthcare providers can implement it with minimal training, making it an accessible option for hospitals and clinics anywhere in the world at any time of night. By reducing the need for specialized equipment or technical expertise, iCHOR’s solution can streamline the thrombectomy process, making it both faster and more efficient for clinicians and patients alike. “We use a proven surgical technique that all vascular surgeons trust, and we implement interventional elements that are well understood and intuitive to today’s physicians and technical staff. We wanted the low volume users with traveling techs to open a single package and intuitively understand how to use the product.” says Dr Troy Long the inventor and co-founder of the iCHOR Vascular Thrombectomy / Embolectomy system.
Health Economics Considerations
As the cost of healthcare continues to rise, hospitals and healthcare systems are under increasing pressure to manage their budgets effectively. iCHOR is actively addressing this concern by offering a more cost-effective thrombectomy solution to combat the skyrocketing costs of peripheral vascular disease. By providing a less invasive and simpler approach to clot removal, iCHOR aims to reduce both procedural costs and patient recovery times.
The company’s focus on improving the cost-efficiency of thrombectomy procedures ensures that its solution is not only clinically effective but also financially viable for healthcare providers in the US but also OUS (outside the US) where economics are a bigger factor. This focus on health economics is crucial in today’s healthcare landscape, where value-based care is becoming a significant factor in decision-making.
Regulatory Approach and FDA Engagement
Navigating the complex regulatory landscape is a key challenge for any medical device company, and iCHOR has embraced this challenge with a hands-on, collaborative approach. The company has worked early and often with the FDA to guarantee the safety and efficacy of its thrombectomy solution through rigorous testing and clinical trials.
iCHOR’s proactive engagement with the FDA demonstrates the company’s commitment to meeting regulatory requirements and bringing a safe, effective product to market. iCHOR has successfully brought 2 products through the US FDA regulatory gauntlet and is starting to shift into real-world utility and data through a deliberate limited market release (LMR). iCHOR believes the LMR promotes market validation while allowing for quick market feedback to fuel immediate iterative elements that further refine and perfect the technology in months not years.
Overcoming Challenges: Resilience in Adversity
The path to success in the medical device industry is rarely smooth, and iCHOR has had its share of obstacles to overcome. From navigating the challenges brought about by the COVID-19 pandemic to addressing the difficult fundraising environment, the company has demonstrated remarkable resilience and adaptability, hitting their regulatory and development milestones time and time again.
The COVID-19 pandemic disrupted supply chains, delayed testing, and created uncertainty in the healthcare market. Despite these challenges, iCHOR remained committed to its mission and continued to make significant progress with minimal budgets and resources during a crazy moment in history. The company’s ability to overcome these hurdles speaks to the strength of its leadership team, their efficient development model, and its unwavering focus and passion for improving lives and in some cases saving lives.
“We were stocking PTFE liners and prebuilding nitinol baskets in 2022-3 because we saw our suppliers drifting on their turn around times (TAT). We never ran short on materials because we have tight controls on our supplier lists with constant oversight on (TAT) trends,” notes Craig Berky, COO.
Experienced Team and Background
iCHOR, a Delaware C-Corp was actually founded in 2014 and is today based in South Florida. A key factor behind ICHOR’s success is its experienced leadership team. The core executive team brings over 100 years of combined expertise in the medical device industry, shaping the company’s strategic vision and approach.
Timothy Blair, the CEO, leads with his 20-year Sales and Marketing background combined with 10 years in Clinical research / Regulatory to provide strong leadership and extensive industry knowledge and networks. Troy Long, MD, the Inventor and Chief Medical Officer (CMO), is fellowship trained at Miami Cardiovascular Institute under Barry Katzen and Jim Benenati and brings deep clinical insights as a vascular interventional radiologist and innovator. Craig Berky, the Chief Operating Officer (COO), leads with 30+ years in R&D, Engineering and Manufacturing to ensure smooth operations with his vast experience in managing complex systems and optimal designs for manufacturing. The team has recently brough Liz Lieber on board to lead Sales and Clinical with 15 years of sales experience and recent direct experience in thrombectomy and distribution sales management.
Together, this team’s backgrounds in engineering, regulatory affairs, marketing, and clinical development equip iCHOR to navigate the complexities of medical device development into early-stage commercialization. Their deep expertise across many disciplines has enabled an innovative approach to thrombectomy that mitigates many of the pitfalls startups face. The iCHOR leadership is driven and focused on a mission to revolutionize the thrombectomy space through simplicity.
Future Outlook and Milestones
The company is excited about the recent 510(k) US market clearance and the ability to bring their groundbreaking thrombectomy solution to the market. The team will continue to focus on gathering real-world feedback in 2025 that enables technology and technique improvements, which will be critical in fine-tuning the product and ensuring it meets the needs of healthcare providers and patients alike.
In addition to the limited market release activities, iCHOR has also achieved other key milestones vital to iCHOR’s value creation. The company has successfully developed working prototypes to further the platform into dialysis graft and fistula managment, closed on a Series A, and engaged in several distribution opportunities in preparation for scaling the business when the timing is right. These achievements demonstrate iCHOR’s passion and will to make significant progress even during some challenging economics.
The team at iCHOR is excited to continue building this momentum, with plans to expand the real world clinical data through registries and single center studies that become a foundation for eventual commercialization. As the company moves closer to scalable commercialization, iCHOR remains committed to its goal of transforming the thrombectomy landscape by improving patient outcomes and bringing value to our healthcare system in the process.
Improving Lives, One Patient at a Time
Peripheral vascular occlusions are a serious health issue, and these patients are a rather heavy burden on our healthcare system. iCHOR aims to offer physicians and patients tools that can improve the lives of patients, get them home sooner, and cut the cost to treat by more than 30%.
The surgical Fogarty balloon sweep is arguably the greatest vascular tool ever invented, such that 60 years later we are still using that very same mechanism of action today as a surgical procedure. iCHOR’s thrombectomy / embolectomy device has
further revolutionized vascular care by replicating that proven mechanism of action to make procedures simpler, safer, and more accessible. It is not just about improving medical techniques; it is about improving patient lives.
By focusing on simplicity, efficiency, and accessibility, iCHOR is changing the way vascular occlusions can be treated. The company’s commitment to innovation and patient care is paving the way for better outcomes and a brighter future for patients around the world.
With its continued focus on advancing medical technology and improving care, iCHOR is set to lead the next wave of transformation in vascular health care.
“We built the iCHOR reperfusion system to treat peripheral vascular issues more efficiently. A single packaged system that is completely intuitive and has no capital equipment enables many patients to be treated in non-hospital settings such as office-based labs (OBLs) and ambulatory surgery centers (ASCs). This same thesis of efficiency and simplicity applies to the rest of the world (ROW) where costs are bigger drivers of healthcare.” stated Tim Blair, CEO.
A Bright Future for iCHOR’s Innovation
iCHOR’s innovative approach to thrombectomy, combined with its commitment to reducing healthcare costs, improving patient outcomes, and simplifying clinical workflows, positions the company as a potential market leader in peripheral vascular clot management.
As iCHOR continues to refine its products, gather valuable feedback from real-world applications, and expand the platform, the future is bright. iCHOR is poised to revolutionize the peripheral thrombectomy space by evolutionizing a proven technique, aimed at making a lasting impact on the healthcare industry.
CONNECT, DISCOVER, INVEST
iCHOR Vascular shares updates, achievements, and insights on its social channels. Follow the team on their website at www.ichorvascular.com and LinkedIn at https://www.linkedin.com/company/ichor-vascular-inc/ to learn more about their work and vision.
If you are interested in investing, iCHOR welcomes discussions. They are always open to exploring funding opportunities and structured deals that support product acceleration. These include support for clinical evidence, building the sales and marketing channels, or advancing the platform. iCHOR is supported by a strong board and works with investors who share their mission to improve vascular care and to make a positive impact in people’s lives.
iCHOR is a culture aimed at creating solutions to improve lives. The products work in the real world, and they are getting better every iteration. We encourage others to be a part of this culture as iCHOR builds out their sales and marketing footprint in 2025.
