In this interview, we explore the world of surgical adhesion prevention with Dr. Chris Springate, CEO of ARC Medical, diving deep into ARC’s groundbreaking clinical trials and innovations. As Chris unpacks the complexities, challenges, and potential of their medical devices, we get a firsthand glimpse into the intricacies of clinical trials, regulatory pathways, and the pivotal role of patient-centric strategies in ARC Medical’s mission.
Moe Alsumidaie: Chris, let’s begin by understanding the medical needs your product addresses. Can you give us a comprehensive view of its mechanism and the potential impact?
Chris Springate: Surgical adhesions are a prevalent post-operative issue, often leading to complications and further surgeries. ARC Medical’s solution, a liquid polysaccharide, is easily and rapidly applied into the surgical site at the end of a surgery. The solution flows and the polysaccharide forms a physical barrier film between tissues throughout the entire surgical area, preventing tissues and organs from sticking together. It’s a medical device as the mechanism of action is from the physical barrier film; and not from any drug effect. Since the polysaccharide is hydrophilic, over time it’s absorbed and later excreted by the kidneys. This approach is both innovative and straightforward, and provides a tool which surgeons and hospitals can use to dramatically reduce post-operative complications due to surgical adhesion.
Moe Alsumidaie: The regulatory landscape can be intricate. How has ARC’s product been positioned within this, and what factors influenced its classification?
Chris Springate: ARC’s journey with regulatory bodies like the US FDA and Japanese PMDA has been insightful. Given our product’s primary mechanical function, it’s appropriately classified as a medical device. We’ve had clear discussions with the FDA and PMDA, especially regarding the gynecological and abdominal indications, and are now in discussions with the FDA regarding orthopedic indications. Our comprehensive regulatory strategy, including several in vivo, radiolabel mechanism of actions studies, further fortifies our regulatory positioning.
Moe Alsumidaie: Clinical trials are the heart of medical innovation. Can you elaborate on the methodologies ARC Medical has adopted and the outcomes you’ve derived?
Chris Springate: Our initial pilot clinical trial with 76 healthy volunteers was safety-centric and involved a transabdominal injection under ultrasound guidance into the abdominopelvic cavity. In our subsequent trials involving surgical patients, we will delve into both safety and efficacy. For gynecological surgeries, we focus on tangible outcomes such as whether a patient is completely adhesion free or not. This direct approach provides quantifiable data, which are vital for regulatory approvals. For orthopedic surgeries, we focus on function related, patient reported outcome tools and range of motion measurements. We’re also considering adaptive design pivotal clinical trials, including looking at phased approaches and safety & efficacy assessments at different stages.
Moe Alsumidaie: With the diverse nature of surgeries, ensuring consistent application seems challenging. How does ARC Medical manage this?
Chris Springate: Our device’s fluidity ensures uniform application. Regardless of where in the surgical area our solution is applied by the surgeon, our numerous preclinical mechanism of action and efficacy studies clearly demonstrate that our solution flows and forms a physical barrier film throughout the entire surgical area. The application of our solution is straightforward using a standard syringe and off-the shelf applicator, whether in an open surgery such as a total knee replacement surgery, an arthroscopic surgery like a shoulder rotator cuff repair, or a laparoscopic gynecological or abdominal surgery. Surgeons already use liquids in various procedures; our products seamlessly integrate into their workflow.
Moe Alsumidaie: The mention of laparoscopic surgeries caught my attention. How has ARC adapted its research for these unique procedures?
Chris Springate: Laparoscopic procedures are intricate and offer a fascinating research perspective. We designed our liquid device to be easily introduced into the surgical cavity through a trocar, ensuring its efficacy remains consistent across surgical settings. This ensures that irrespective of the surgical technique, the device’s effectiveness remains uncompromised.
Moe Alsumidaie: Intellectual property is the bedrock of innovation. Could you elaborate on ARC’s patent strategy and its significance?
Chris Springate: ARC’s proactive patent strategy has led us to file seven distinct patent families, now recognized globally. This vast patent coverage provides exclusivity for our innovations through 2039 and beyond. It’s been a significant investment and one which ensures our products’ longevity in the market.
Moe Alsumidaie: Chris, as we look forward, what’s on the horizon for ARC and its product?
Chris Springate: Our products are going to be #1 in preventing gynecological & abdominal and knee & shoulder surgical adhesions. ARC is at an exciting juncture. Our next inflection point is to obtain proof of concept efficacy data in human surgical patients. We are running a systematic, dual-track process to complete a financing to fund clinical trials and approvals in the USA and to partner for clinical trials and approvals in Europe, Japan and China. Our vision is to make surgical recoveries safer and complication-free for patients, and every step we take is towards that goal.
Moe Alsumidaie: Before we wrap up, do you have any final insights for our clinical researchers?
Chris Springate: The journey at ARC is a testament to the transformative potential of patient-centric clinical research. A key insight is that persistence in ensuring the quality of your protocols and in working with the best clinical researchers and clinical sites, results in the best quality data. Our commitment to enhancing post-operative outcomes is unwavering. As we navigate the challenges, collaborations, and innovations, we invite the clinical research community to engage with us. Together, we can shape the future of surgical care, making it safer and more effective.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.