Signum Surgical Appoints Carol Burns as CEO to Lead Commercialization of BioHealx®
Signum Surgical (‘Signum’ or ‘the Company’), a medical technology company developing innovative solutions for colorectal diseases, has announced the appointment of Ms. Carol Burns as Chief Executive Officer. This significant leadership change marks a transformative period for the company as it moves forward with the commercialization of BioHealx®, an innovative medical device designed to treat anal fistula, a painful and often debilitating colorectal condition that affects approximately one in 5,000 people worldwide.
Carol Burns brings more than 25 years of experience in the medical device industry, with an exceptional track record of leading and commercializing breakthrough therapies. Her appointment is expected to accelerate the company’s mission to redefine the surgical management of fistula-in-ano, a condition that has long posed challenges for both patients and healthcare providers.
A New Era for Signum Surgical: Commercializing BioHealx®
The appointment of Ms. Burns comes at a pivotal time for Signum Surgical, as the company transitions from product development to commercialization. This follows the landmark U.S. Food and Drug Administration (FDA) De Novo clearance for BioHealx® in 2024. BioHealx® is a first-of-its-kind, bioabsorbable implant that provides a minimally invasive solution for safely closing anal fistulas. By promoting primary healing through tissue apposition, BioHealx® eliminates the need for repeat surgeries, which are often costly and can result in complications such as incontinence.
Anal fistulas have historically been challenging to treat, with many patients enduring multiple surgical procedures that carry risks of infection, recurrence, and damage to sphincter muscle function. BioHealx® represents a groundbreaking advancement by addressing these concerns with a bioabsorbable, patient-friendly approach that preserves fecal continence while promoting effective healing. With this technology, Signum Surgical aims to establish a new standard of care for fistula-in-ano treatment.
Carol Burns: A Proven Leader in Medical Device Innovation
With decades of experience in the medical technology sector, Carol Burns has a well-established history of bringing innovative medical solutions to market. She co-founded and served as CEO of both Cagent Vascular and Intact Vascular, leading the development and commercialization of transformative vascular therapies. Throughout her career, she has played an instrumental role in pioneering advancements such as serration angioplasty, endovascular abdominal aortic aneurysm repair, and endoscopic vein harvesting.
In addition to her leadership roles at Cagent Vascular and Intact Vascular, Ms. Burns has held senior positions at prominent medical device companies, including:
- Embrella Cardiovascular (acquired by Edwards Lifesciences)
- Animas Corporation (acquired by Johnson & Johnson)
- Ventrica (acquired by Medtronic)
- Guidant Corporation
Her extensive experience in launching and scaling medical technologies will be instrumental in guiding Signum Surgical through its next phase of growth and product adoption.
Expressing her enthusiasm for joining the company, Ms. Burns stated:
“I am delighted to join the Signum Surgical team to lead its next phase of growth. This innovative technology is the first treatment for fistula-in-ano that directly closes the fistula tract by tissue apposition without sacrificing sphincter muscle function. We believe this technology will become the standard of care for the management of fistula-in-ano while also preserving fecal continence.”
Clinical Validation and Future Market Expansion
A key element in Signum Surgical’s commercialization strategy is ensuring robust clinical validation of BioHealx®. The First-in-Human (FIH) study results, which will be published later this year, have already demonstrated promising outcomes. The study reported excellent primary healing rates with no recurrence at 12+ months, reinforcing BioHealx® as a viable and effective treatment for fistula-in-ano.
To further build upon this evidence, Signum Surgical is implementing a Post Market Surveillance Study to gather additional real-world data following its initial commercialization. This approach aims to provide long-term insights into BioHealx®’s effectiveness and safety, further supporting its adoption among colorectal surgeons and healthcare providers globally.
Strengthening Leadership to Drive Growth
Carol Burns’ appointment has been met with strong support from Signum Surgical’s leadership team, who recognize her expertise as a crucial asset for the company’s growth.
Eoin Bambury, Co-Founder and Chief Technology Officer of Signum Surgical, shared his confidence in Ms. Burns’ ability to lead the commercialization of BioHealx®:
“With a proven track record of introducing innovative technologies, commercializing products in highly specialized fields, and driving strategic growth, Carol is an ideal fit to lead the commercialization of BioHealx® and our next phase of development.”
Moshe Zilversmit, Co-Founder and Chief Innovation Officer, echoed this sentiment:
“Carol’s deep expertise in the medical device industry and unwavering dedication to improving patient outcomes align perfectly with our mission to revolutionize the surgical management of fistula-in-ano. We are delighted to have her on board.”
The Future of BioHealx® and Signum Surgical’s Impact
The commercialization of BioHealx® is expected to significantly impact both patient care and the healthcare system at large. Traditionally, fistula-in-ano treatment has been associated with lengthy recovery periods, high recurrence rates, and substantial healthcare costs. By introducing a minimally invasive, bioabsorbable solution, Signum Surgical aims to alleviate these burdens and enhance the overall quality of life for affected individuals.
From a market perspective, BioHealx® presents a strong commercial opportunity in the field of colorectal surgery. With an increasing focus on improving surgical outcomes and reducing hospital readmissions, healthcare providers are actively seeking innovative solutions that optimize efficiency and patient well-being. As BioHealx® gains traction in clinical practice, Signum Surgical is positioned to play a leading role in shaping the future of colorectal disease treatment.
Looking Ahead: A Transformational Period for Signum Surgical
Under Carol Burns’ leadership, Signum Surgical is entering an exciting phase of rapid growth. The company’s immediate priorities include:
- Scaling Commercial Operations: Establishing strong distribution channels and partnerships to ensure widespread access to BioHealx®.
- Expanding Clinical Evidence: Building upon the First-in-Human study results with further research and Post Market Surveillance.
- Driving Physician Adoption: Educating colorectal surgeons on the benefits of BioHealx® through targeted training and engagement programs.
By capitalizing on these initiatives, Signum Surgical is poised to solidify its position as a leader in the medical device industry, setting new standards in the treatment of fistula-in-ano.
