바이오스펙테이터

by Changmin Shin

Core Product for Revenue Expansion Expected in 2Q: Targeting July Launch Differentiation in Safety, Price, and Convenience Compared to Medtronic’s Competitor Clinical Trials for Pain Embolization Also

▲Young-Kuk Ko, CEO of ENGAIN

ENGAIN is awaiting the results of the pivotal clinical trial for “VENOCCLO,” a varicose vein treatment medical device expected to form the foundation of the company’s growth. As a specialized medical device developer utilizing polymer-based materials, ENGAIN currently holds the largest market share in Korea’s hepatocellular carcinoma (HCC) embolization market, demonstrating recognized technological capabilities. The company plans to complete the pivotal trial by June and aims for a product launch in July.

CEO Young-Kuk Ko stated, “VENOCCLO is a third-generation technology that overcomes limitations of existing surgical and laser treatments. It treats varicose veins by occluding refluxing vessels using an adhesive substance. Compared to Medtronic’s competing product, it offers similar efficacy but is differentiated in treatment convenience and pricing.”

He added, “VENOCCLO incorporates our proprietary R&D not only in the NBCA (N-butyl cyanoacrylate) adhesive chemical technology but also in the injector system. This allows precise delivery control of the adhesive—a critical factor—which gives us a competitive edge in usability.”

He continued, “Once VENOCCLO is launched, we are confident it will capture a high market share thanks to its differentiated pricing compared to Medtronic’s product.”

Following VENOCCLO, ENGAIN is conducting clinical trials for another major pipeline product, “KIPZA,” an embolic agent designed for the treatment of musculoskeletal pain. KIPZA works by occluding microvessels that cause inflammation, offering a novel approach not yet commercialized. “This concept was initially proposed in the 2010s by Japanese physician Yuji Okuno, and is now being explored globally,” Ko said. “A key aspect of this technology is controlling the degradation time of the embolic agent in the body. Inadequate degradation can lead to secondary pain or complications.”

Ko further stated, “We’ve developed KIPZA, an embolic agent that eliminates problematic abnormal micro vessels and ensure predicable degradation within hours. We are leading the field and, earlier this year, became the first in the world to initiate a randomized controlled trial (RCT) comparing this approach with conventional pain treatments.” He expressed expectations that, if the trial proves successful, KIPZA could be approved as a treatment for pain, introducing a groundbreaking pain management solution to the market.

Founded in December 2011, ENGAIN has been developing and marketing specialized medical devices based on polymer chemistry and proprietary device manufacturing technology. In August 2016, five years after its founding, the company launched its first product: EGgel, an embolic agent for liver cancer, which now holds the top domestic market share.

As a follow-up product to EGgel, ENGAIN launched “EGglue,” a medical adhesive, in 2022. Medical adhesives are used across various medical fields—surgery, plastic and orthopedic surgery, and dentistry—for purposes such as wound closure, hemostasis, and infection prevention. EGglue is a fast-acting adhesive that polymerizes on contact with skin moisture and close the wound. Now in its fourth year on the market, EGglue has recently expanded its indications across multiple departments including orthopedics (OS), interventional radiology (IR), obstetrics and gynecology (OBGY), and otolaryngology (ENT).

CEO Ko said, “EGglue is Korea’s first domestically developed medical adhesive and is expected to become the fourth such product in the world to obtain European marketing approval. We anticipate obtaining the approval this summer.” He added, “We’re currently undergoing review under the CE MDR (Medical Device Regulation) framework, which has stricter standards than the conventional CE MDD system. If approved, EGglue will become the first medical adhesive to be certified under CE MDR, and we anticipate annual sales exceeding KRW 10 billion.”

Looking beyond EGgel and EGglue, ENGAIN is now focusing on the clinical development and commercializing its varicose vein device and pain embolization therapy, both of which are expected to drive rapid revenue growth. In alignment with this, the company is preparing for an initial public offering (IPO) targeted for late this year or early next year. ENGAIN’s revenue in the previous fiscal year reached KRW 1.756 billion, a 13.4% increase year-on-year, with EGgel accounting for approximately 75% of total sales.

Varicose Vein Treatment Device Nearing Launch Milestone

ENGAIN is currently focused on the development of two key pipeline products. Among them, the varicose vein treatment device “VENOCCLO” began its pivotal clinical trial in 2023 and is approaching data evaluation for regulatory approval in Korea by the end of this June. The company aims to obtain approval from the Ministry of Food and Drug Safety (MFDS) and launch the product in July.

In the clinical trial, ENGAIN is comparing VENOCCLO with Medtronic’s varicose vein treatment device “VenaSeal,” which received FDA approval in 2015 and MFDS approval in 2017.

Medtronic, the global leader in medical device, offers VenaSeal as the only third-generation varicose vein treatment using NBCA (N-butyl cyanoacrylate). The procedure involves real-time ultrasound imaging to identify the target vessel, followed by injecting NBCA through a gun-shaped catheter and compressing the vessel to achieve permanent closure.

CEO Ko emphasizes that VENOCCLO demonstrates comparable or superior efficacy to VenaSeal, while offering competitive advantages in safety, procedural convenience, and price. Notably, in ENGAIN’s clinical trial, no cases of phlebitis-like abnormal reaction (PLAR)—a common side effect seen in 4–20% of VenaSeal patients—have been observed.

Of the 104 total patients targeted for the VENOCCLO trial, 75 have completed six-month follow-ups. To date, there have been no reports of PLAR or serious adverse events (SAEs) in the VENOCCLO group. “Our safety profile is showing superior data compared to competitors,” Ko noted.

Ko attributes the improved safety profile of VENOCCLO to two main factors: material property optimization of the cyanoacrylate adhesive and enhanced procedural convenience for medical professionals. ENGAIN has focused on refining both the physical properties of the adhesive and the device itself to make the procedure easier and more efficient. According to Ko, improving procedural convenience allows doctors to perform surgeries more quickly and easily, which leads to better patient outcomes.

He explained, “Cyanoacrylate adhesives must solidify within three minutes after injection into the vein. If it doesn’t solidify in time and remains in the body longer, it’s believed to trigger inflammation. This is a key limitation of competing products. In contrast, VENOCCLO’s chemical technology ensures rapid solidification of the adhesive—an essential differentiator.”

He also emphasized the importance of precise dosing in cyanoacrylate-based varicose vein treatments, which requires fine-tuning the adhesive’s physical properties. “If the adhesive is too thin, it flows uncontrollably through the catheter; if it’s too thick, it cannot be injected accurately in the required amount,” he said. “Competitors struggle with this, and clinicians frequently cite it as a drawback. We developed VENOCCLO through continuous dialogue with doctors to address these specific issues.”

Ko also pointed out the superiority of VENOCCLO’s device technology. “In third-generation NBCA-based systems, the device is just as critical as the adhesive. VENOCCLO incorporates a gear mechanism to control dosage and a reflux-prevention valve that ensures the liquid doesn’t flow backward—something that’s not available in VenaSeal,” he explained. “When the procedure becomes faster and smoother, not only does it improve patient outcomes, but it also reduces the likelihood of inflammatory side effects—making these enhancements vital from a clinician’s standpoint.”

Lastly, Ko shared ENGAIN’s pricing strategy for VENOCCLO, aiming to set it apart from competitors with more affordable pricing. Third-generation adhesive-based devices for varicose vein treatment do not require tumescent anesthesia and offer less pain, quicker recovery, and eliminate the need for compression stockings—features that appeal strongly to patients. However, high device costs remain a barrier.

Ko explained, “Medtronic’s third-generation product is expensive, so patients often resort to second-generation treatments like radiofrequency or laser procedures. In Korea, the varicose vein treatment market is valued at approximately KRW 180 billion, with radiofrequency and laser procedures accounting for KRW 120 billion.” He added, “If we price our product closer to radiofrequency treatment, we can capture not only the third-generation segment but also expand into the radiofrequency market, gaining a strong competitive edge.”

ENGAIN plans to complete six-month follow-up evaluations for all clinical trial participants by June to secure MFDS approval. The company will continue follow-up evaluations up to 12 months post-procedure to assess long-term safety and efficacy, with final analysis expected by December 2025.

Global First-in-Class Launch Planned for Pain Embolization

Following VENOCCLO, ENGAIN is pursuing a second major pipeline project: KIPZA, a gelatin-based embolic agent for treating musculoskeletal chronic pain. KIPZA is designed for use in transcatheter arterial micro-embolization (TAME), targeting abnormal microvessels responsible for pain and inflammation.

The concept of TAME is based on the understanding that chronic musculoskeletal is sustained by the formation of abnormal microvessles. By embolizing and eliminating these vessels, inflammation and pain can be reduced. The method was first introduced by Dr. Yuji Okuno in Japan through small-scale clinical studies, where he used crystalline forms of imipenem mixed with a contrast agent. However, due to concerns about antibiotic resistance, the method faced hurdles for regulatory approval.

Ko noted that while global efforts are underway to develop safe embolic agents for pain treatment, a key challenge has been finding a material that fully degrades within 24 hours. Incomplete degradation may lead prolonged pain or ischemic necrosis.

To overcome these limitations, ENGAIN leveraged its gelatin-based, biodegradable embolic technology, adjusting the crosslinking degree of gelatin to develop KIPZA, which degrades completely within 24 hours. The company’s existing EGgel product, also gelatin-based, degradess in 4–6 weeks, but KIPZA is optimized to resorb in just 2 to 6 hours through tailored crosslinking.

As no products for pain embolization are currently available in the market, ENGAIN expects this novel approach to qualify for designation as a “new medical technology.” The company is currently conducting a randomized controlled trial (RCT) of KIPZA in patients with knee osteoarthritis who have not responded to at least three months of conservative treatment. The trial, which includes 96 patients, is being conducted at Kunkuk University Medical Center.

Ko emphasized, “This is the first global RCT to directly compare a pain embolic agent with conservative treatments in a 1:1 design. We are ahead of any competitor in this field, and to our knowledge, no other company is currently developing a biodegradable embolic agent.”

ENGAIN aims to complete the RCT by the end of 2026 or early 2027 and launch the product soon after. If successful, the company projects annual sales of KRW 100 to 300 billion.