Bench2Bedside:
Surgical adhesions affect most patients who undergo abdominal or pelvic surgery, and yet they are rarely part of the preoperative conversation. How significant is the clinical burden that adhesions create — and why, despite decades of awareness and a handful of approved products, does the problem remain so largely unsolved?

Chris Springate:
Surgical adhesions are unwanted, abnormal scars that form between tissues inside the body after common surgeries. Surgical adhesions are a significant clinical burden; they cause pain and suffering, immobility, infertility, bowel obstruction, and the need for expensive re-operations.

Approximately 3 million patients undergo arthroscopic or arthroplasty orthopedic knee or shoulder surgery in the US every year and more than 5% of these patients have such stiff joints and immobility due to adhesions that they require an expensive and painful, subsequent procedure to cut or break apart the adhesions. No products are approved in the US for the prevention of orthopedic joint surgical adhesions and this unmet clinical need provides a “greenfield” opportunity for ARC.

Approximately 6 million patients undergo laparoscopic or open gynecologic or abdominal surgery in the US annually and more than 30% of patients form adhesions. Due to surgical adhesions, approximately 5% of these patients end up in the emergency room, take pain medications including opioids, become infertile, and/or undergo a subsequent surgery to cut apart the adhesions. The two top selling products for abdominopelvic surgical adhesion reduction in the US are Seprafilm® (Baxter) and Interceed® film (J&J MedTech). Both medical devices were approved over 30 years ago. These films are approximately the size of a Post-It® note. Following placement in the abdominopelvic cavity at the end of a surgery, these films provide a physical barrier that only reduces adhesions where they are placed. The lack of coverage of the larger, remaining surface area in the abdominopelvic cavity results in films failing to prevent up to 75% of adhesions.

The problem of surgical adhesions remains largely unresolved because no company has figured out how, following a joint or abdominopelvic surgery, to cover the entire surgical cavity with an effective adhesion barrier. ARC’s JOCOAT™ and IPCOAT™ liquid adhesion barrier medical devices, in clinical development for orthopedic and abdominopelvic surgeries, respectively, are designed to flow and provide a temporary physical barrier that prevents adhesions throughout the entire surgical cavity.

Bench2Bedside:
ARC’s clinical program is generating some striking early signals — including long-term data showing meaningful improvements in range of motion for orthopedic patients, and an expanded access case in endometriosis surgery where ultrasound at six weeks showed no new adhesions and no reformed adhesions after a three-hour procedure. What do those results tell you about what JOCOAT™ and IPCOAT™ are doing at the tissue level, and how do they shape the way you think about the pivotal trials now underway?

Chris Springate:
Yes, initial data from the current clinical trial for JOCOAT™ in orthopedic knee anterior cruciate ligament (ACL) reconstruction surgery patients suggest that the use of JOCOAT™ results in an improvement in long term range of motion and a reduction of subsequent surgeries to cut apart adhesions. Separately, results from the use of JOCOAT™ in a total of 20 knee and shoulder re-operation patients, under expanded access authorizations, demonstrate long term improvements in range of motion compared with prior to surgery and JOCOAT™ treatment. The use of IPCOAT™ in a complex, gynecologic endometriosis and adhesiolysis surgery patient, under expanded access authorization, remarkably show no new adhesions and no reformation adhesions as determined by ultrasound at 6 weeks after the surgery. In addition, the safety of ARC’s medical devices was demonstrated in a safety clinical trial in which IPCOAT™ or blinded, placebo control solution was applied into the abdominopelvic cavity in 76 healthy volunteers.

Multiple preclinical studies provided ARC with a high level of confidence regarding the mechanism of action, efficacy and safety of JOCOAT™ and IPCOAT™ as the company headed into the clinic. First, we were able to see that, following application of our liquid medical devices into the surgical area, our devices flowed and provided a temporary physical barrier between all the tissues throughout the entire surgical cavity. Second, head-to-head efficacy comparison studies against currently marketed film and gel devices in a well-accepted model of surgical adhesions showed that ARC’s liquid adhesion barrier medical devices prevented adhesions throughout the entire surgical cavity, while the competitors’ films and gels were limited to only the local area they covered; that is, the film and gel devices failed to prevent adhesions throughout the larger, remaining surgical cavity. As a result of the mechanism of action of ARC’s devices, we demonstrated superior efficacy compared with the competitors’ films and gels.

Our current clinical trials for JOCOAT™ and IPCOAT™ are confirmatory trials, designed to provide the additional “proof of concept” mechanism of action, efficacy, safety, and ease and speed of use clinical data that surgeons, clinics, regulators and payors are looking for (see our response to Q4 below).

Bench2Bedside:
The adhesion barrier market has existing players — Seprafilm®, hyaluronic acid-based gels, and others — and yet none of them address orthopedic surgery in any meaningful way, and none work across the full abdominopelvic cavity in both open and laparoscopic settings. JOCOAT™ and IPCOAT™ are liquid adhesion barrier devices — a meaningful departure from the films and gels that have historically defined this space. What does the liquid format make possible that a film like Seprafilm® or a gel-based barrier simply cannot achieve, and why is the ability to flow throughout an entire cavity so critical to preventing adhesions rather than just reducing them locally? Where does ARC Medical fit in a competitive landscape that appears to have significant gaps, and how does the liquid format reframe what a surgeon can realistically do in the final moments of a procedure?

Chris Springate:
For orthopedic joint surgeries, as outlined above, no products are approved in the US for the prevention of surgical adhesions and this provides a “greenfield” opportunity for ARC’s JOCOAT™.

For abdominal and gynecologic surgeries, Seprafilm® (Baxter), Interceed® film (J&J MedTech), and gels reduce adhesions solely where they are placed, providing only limited coverage of the abdominopelvic cavity. The challenges with the films are threefold: 1) films (and gels) only cover a small portion of the surface area in the abdominopelvic cavity and thus fail to prevent up to 75% of adhesions; 2) films are time consuming to apply and the application time results in significant, additional operating room time costs to clinics; and 3) films are challenging to apply, which means that technical training and a learning curve are required to adopt films.

As an alternative, application of JOCOAT™ or IPCOAT™ in the surgical cavity results in three positive differentiators 1) ARC’s liquid adhesion barrier medical devices flow, provide a temporary physical barrier, and prevent adhesions throughout the entire surgical cavity; 2) as liquid devices, JOCOAT™ is applied in only 30 seconds and IPCOAT™ in less than 2 minutes; and 3) ARC’s liquid devices are easily applied during arthroscopy, arthroplasty, laparoscopy and open surgeries. We are not aware of any other products that share ARC’s superior mechanism of action and efficacy.

Bench2Bedside:
ARC is approaching two major data readouts — topline efficacy data from the GLAD-04 orthopedic knee ACL reconstruction trial by December 2026, and from the GLAD-02 gynecologic endometriosis surgery trial by mid-2027. You have been clear that clinical data are the primary value drivers and the gateway to strategic partnerships. What will those datasets need to show to move the needle with regulators, potential partners, and the surgeons who will ultimately determine adoption?

Chris Springate:
Our current JOCOAT™ knee ACL reconstruction surgery clinical trial (N=74) aims to further confirm safety and demonstrate an efficacy trend towards patients having 1) greater mobility; and 2) a reduction in the number of subsequent procedures to cut or break apart adhesions that otherwise cause a stiff joint.

ARC’s current IPCOAT™ gynecologic endometriosis surgery clinical trial (N=33) aims to further confirm safety and demonstrate an efficacy trend towards 1) an increase in the number of patients that are completely adhesion free; and 2) a reduction in the average number of adhesions per patient.

In our experience, in addition to safety and efficacy clinical data, ease and speed of use will also drive adoption of ARC’s medical devices. As outlined above, deployment of JOCOAT™ and IPCOAT™ introduce almost no additional time or workflow for operating room staff.

Bench2Bedside:
If the clinical program unfolds as you hope, where does ARC Medical stand five years from now — and beyond the commercial and regulatory milestones, what does success look like for the patients who are today recovering from surgery without any protection against the adhesions that may define the quality of their recovery?

Chris Springate:
For regulatory and commercial milestones, success five years from now means, following the PMA approvals of JOCOAT™ for orthopedic surgeries and IPCOAT™ for gynecologic surgeries, both medical devices have become the standard of care for use in these surgeries.

For orthopedic patients undergoing a knee, shoulder or other joint surgery, successful treatment with JOCOAT™ means a better surgical outcome for patients, including that patients have less pain and discomfort when undergoing physiotherapy, patients enjoy a greater range of motion (for example, be able to ride a bike and run), and we will have eliminated additional surgeries that otherwise would be required to cut apart adhesions to rescue a stiff joint.

For patients undergoing a gynecologic or abdominal surgery, successful treatment with IPCOAT™ means a better surgical outcome for patients, including that patients have less pain and discomfort from adhesions, patients have a reduction in the incidence of surgical complications caused by adhesions including infertility in female patients and bowel obstruction in all patients, and we will have eliminated additional surgeries that otherwise would be required to cut apart adhesions to rescue ovaries or a small bowel strangulated by adhesions.