ARC Presents Positive IPCOAT™ GLAD-01 Clinical Safety Data and Nonclinical Data at AAGL 2025
Key IPCOAT Data and Conclusions
• The GLAD-01 clinical data showed that IPCOAT was safe, well tolerated and accepted at up to and including 3 mL/kg without or with enoxaparin sodium.
• The GLAD-01 Independent Data and Safety Monitoring Committee and ARC’s Clinical Steering Committee recommend IPCOAT for future gynecologic, obstetric and abdominal surgery clinical trials at 2 to 3 mL/kg.
• The nonclinical efficacy & safety studies demonstrated that IPCOAT is safe and effective at preventing de novo and reformation surgical adhesions throughout the entire abdominopelvic cavity at 2 mL/kg body weight.
• The nonclinical mechanism of action studies showed that, following the application of IPCOAT into the surgical site, the liquid medical device flowed and provided a temporary, physical barrier that mechanically separated the tissues and prevented adhesions throughout the entire abdominopelvic cavity.
• ARC is now initiating a clinical trial with IPCOAT at 2 mL/kg in gynecologic endometriosis surgery patients, based on the results of the IPCOAT data.
“The IPCOAT clinical and nonclinical data milestones presented at AAGL continue to validate our mission to improve the care, recovery and outcomes for women undergoing gynecologic or obstetric surgery and for all patients undergoing abdominal surgery” stated Dr. Chris Springate, Chief Executive Officer of ARC. “Internal adhesions are the largest complication following common surgeries, even with perfect surgical technique. The nonclinical data presented at AAGL demonstrate that IPCOAT flows and provides a liquid surgical adhesion barrier medical device that, in addition to being easy and rapid to apply in a laparoscopic or open surgery, safely prevents surgical adhesions throughout the entire abdominopelvic cavity.”
Prof. Dr. Robert Litchfield, Chief Medical Officer of ARC, noted “The nonclinical data in head-to-head comparisons showed that IPCOAT outperforms conventional, locally applied films and gels, which only cover a fraction of the tissue in the abdominopelvic cavity. IPCOAT provides comparable protection where the films and gels are locally applied and IPCOAT provides superior coverage throughout the larger, remaining surface area of the abdominopelvic cavity where the films and gels are not present and cannot prevent surgical adhesions.”
CLICK HERE to view the details of the IPCOAT GLAD-01 clinical trial and multiples series of nonclinical studies presented at AAGL.
Why the Prevention of Surgical Adhesions Matters
Surgical adhesions are bands of scar tissue that form between internal organs and tissues after surgery, causing them to stick together. They are the most common postoperative complication, contributing to chronic pelvic pain, infertility, bowel obstruction, and challenging reoperations to cut apart adhesions after they form. Despite advances in minimally invasive surgery techniques, surgical adhesion formation remains a significant risk, including following gynecologic procedures such as endometriosis excision, obstetric procedures including Caesarean section, and abdominal procedures such as colectomy. Following a gynecologic, obstetric or abdominal surgery, 31% or more of these surgery patients form adhesions, yet effective and easily and rapidly applied adhesion prevention options remain limited.
About IPCOAT
IPCOAT liquid surgical adhesion barrier device is surgeon friendly: easily and rapidly applied into the abdominopelvic cavity at the end of a gynecologic, obstetric or abdominal surgery in laparoscopic and open procedures. IPCOAT then flows and provides a temporary, physical barrier that mechanically separates the tissues and prevents or reduces surgical adhesions throughout the entire abdominopelvic cavity.
About ARC Medical Inc.
ARC Medical is a privately held medical device company advancing next generation, liquid adhesion barrier medical devices to prevent surgical adhesions. Surgical adhesions are internal scars comprised of fibrous tissue, that form after common surgeries and can cause serious complications including infertility, chronic pain, bowel obstruction, and immobility. ARC’s lead devices are in clinical development for the prevention of surgical adhesions and include JOCOAT™ for orthopedic (including knee and shoulder) surgeries and IPCOAT™ for gynecologic, obstetric and abdominal surgeries.
Media Contact
Chris Springate, CEO of ARC Medical, Inc
ARC Medical, Inc
cspringate@arcmedinc.com
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