Medcura Files for IPO Following $22.4M Funding Round for FDA-Designated Breakthrough Hemostatic Agent LifeGel™

In surgical and wound care, hemostasis is an essential component. Among various hemostatic agents, absorbable hemostatic materials are gaining increasing favor due to their advantages, including absorption by human tissues, elimination of the need for secondary surgical removal, reduction of postoperative complications, and shortening of recovery time.

According to Zhiyan Qianzhan statistics, the market size of China's absorbable hemostatic materials industry was RMB 11.619 billion in 2019, and reached RMB 3.565 billion in the first quarter of 2024, representing a year-on-year increase of 4.28%.

However, absorbable hemostatic materials have long faced numerous challenges in practical applications. For instance, water absorption and subsequent swelling may cause compression of nerves and blood vessels; the limited forms of hemostatic agents fail to accommodate diverse clinical scenarios; they are not ready for immediate use; and the need for advance preparation leads to material waste.

To address the aforementioned pain points, Medcura, a U.S.-based wound care product developer founded in 2007, has introduced innovative solutions. The company has developed LifeGel, an innovative biopolymer technology platform, and leveraged it to create a range of novel hemostatic products in various forms. Utilizing naturally derived hydrophobically modified biomaterials, these products are designed to control mild to moderate surgical bleeding. Characterized by strong adhesive encapsulation, resistance to moisture-induced swelling, ready-to-use convenience, and scalability, they provide safe, effective, and cost-efficient bleeding management solutions for medical, military, and home settings.

For decades, chitosan-based technologies have been used in the United States for ex vivo hemostasis, trauma care, and military applications. This is due to the abundant availability and low cost of chitosan, as well as its inherent antimicrobial properties. Most importantly, chitosan can form a mechanical barrier through an adhesion process that supports blood coagulation, thereby rapidly controlling bleeding.

Although chitosan-derived polysaccharides serve as an effective hemostatic matrix, they are associated with certain risks and side effects, such as high endotoxin levels, prolonged absorption time, foreign body reactions, inflammatory responses, and granuloma formation in healing tissues. Consequently, chitosan-based absorbable hemostatic agents have not previously received FDA approval for use in non-traumatic surgical applications within the body.

Medcura’s hydrophobic modification process for chitosan has unlocked its potential to address the challenge of internal bleeding. Through rigorous biochemical research, Medcura’s experts have developed a biopolymer that is safely absorbed in vivo, with a matrix composed of self-assembled hydrophobically modified chitosan, fatty acids, and other inert, well-characterized agents.This biopolymer matrix base material exhibits high biocompatibility, elicits minimal foreign body reaction in tissues, is absorbed within approximately 8–12 weeks, does not require thrombin, and does not cause coagulopathy due to protein sensitivity.

Medcura’s LifeGel absorbable hemostatic gel leverages the mucoadhesive properties of its base materials to firmly adhere to moist biological tissues. Upon application, the hydrophobic non-covalent bonds within the gel temporarily break, allowing it to flow easily into the bleeding site. After application, these modified biopolymers form a network comprising millions of non-covalent bonds, creating a mechanical barrier at the bleeding site to prevent further hemorrhage.

Meanwhile, it promotes clot formation by immobilizing blood, causing platelets and red blood cells to accumulate on the gel and tissue surfaces. At the interface between the gel and the tissue, as well as within the gel itself, the high concentration of red blood cells and platelets forms a stable hemostatic plug that effectively controls bleeding and facilitates wound healing.

For a long time, the high risk associated with hemostatic agents swelling upon exposure to moisture has remained a difficult problem to solve.

Since 1996, the FDA has received more than 110 adverse event reports related to absorbable hemostatic agents. Among these, 11 cases resulted in paralysis or other neurological deficits. The last reported case of paralysis occurred in October 2003. The common contributing factor in these 11 cases was the use of absorbable hemostatic agents placed in or near bone or neural spaces and left in the patient’s body. This material expands upon exposure to moisture, exerting pressure on the spinal cord or other neural structures, leading to pain, numbness, or paralysis. In some instances, blood accumulates behind the implanted absorbable hemostatic agent, forming a hematoma that compresses neural tissue and causes a range of neurological dysfunctions. Although such events are rare, their consequences are extremely severe.

Unlike other flowable hemostatic agents,Medcura's LifeGel absorbable hemostatic gel is fully hydrated and ready to use, with no expansion.LIFEGEL™ undergoes complete hydration during manufacturing, enabling immediate efficacy upon application without the need to wait for water absorption and expansion. This design facilitates rapid and effective hemorrhage control, which is particularly critical in emergency situations.

December 20, 2022,Medcura’s LifeGel Flowable Technology Receives FDA Breakthrough Device Designation,This technology can control bleeding during surgery and is suitable for procedures where expansion of hemostatic agents is not tolerated.It is the only absorbable surgical hemostatic technology to receive FDA Breakthrough Device Designation due to its “non-expansile” properties.

Meanwhile, LifeGel can also reduce the waste rate of hemostatic agents.

A survey conducted in late 2014 on “Whether Advance Preparation Wastes Absorbable Hemostatic Agents,” which polled 200 registered nurses in the United States, found that 62% of respondents prepared absorbable hemostatic agents before being requested by surgeons to avoid intraoperative delays. However, many of these hemostatic agents went unused. Overall, nurses reported product waste in 68% of all cases. The data indicate that using absorbable hemostatic agents that do not require advance preparation can significantly reduce product waste and costs. Unlike current flowable hemostatic agents, LifeGel is a ready-to-use product that requires no reconstitution or mixing. Furthermore, it can be stored at room temperature, effectively reducing the waste of unused products in the operating room.

On the other hand, its non-expanding property makes LifeGel more stable and predictable in controlling bleeding, as it does not change its volume or position within the wound due to expansion, thereby ensuring effective hemostasis and avoiding additional pressure on surrounding tissues.

LifeGel has goodAntibacterial Properties, its proprietary matrix material retains the inherent antimicrobial properties of chitosan, reducing bacterial colonization that may lead to infection. Moreover, the formulation of LifeGel is visuallyRelatively transparent, allowing physicians to more clearly observe bleeding lesions and clot formation during use, thereby enabling more effective hemostasis. Furthermore, LifeGel possessesMucosal Adhesiveness, capable of adhering to inverted and vertical tissues, and providing effective hemostasis for tissues in non-horizontal positions.

LifeGel’s hemostatic matrix has been meticulously engineered in its research, development, and manufacturing to ensure cost-effectiveness and sustainable production capacity, holding the promise of reducing costs incurred by healthcare providers through strategic procurement opportunities.

Medcura’s base hemostatic material has been hydrophobically modified to offer unique adaptability and scalability. It can be customized into various shapes across multiple product formats, representing a first-in-class innovation that provides novel hemostatic solutions for diverse types of bleeding and clinical scenarios. By utilizing the same base hemostatic material across multiple product formats, Medcura can accelerate product development and reduce regulatory timelines for product line extensions.

Its patented biochemical matrix can be expanded into various hemostatic product forms, including gels, powders, and foams. Leveraging the LifeGel technology platform, Medcura has developed hemostatic powders for local and diffuse bleeding, as well as sheet-style hemostatic gauze, fibrous hemostatic gauze, and hemostatic patches for cardiovascular, abdominal, and minimally invasive surgeries. Meanwhile, the company is exploring additional hemostatic products, such as transparent hemostatic films for staple and suture line bleeding, expandable hemostatic foams for trauma, abdominal, orthopedic, and plastic surgeries, and moldable hemostatic pastes for bone bleeding in cardiothoracic and orthopedic procedures, gradually forming a comprehensive portfolio of surgical hemostatic products.

Currently, LifeGel has been applied in scenarios such as spinal surgery, cardiac surgery, and minimally invasive surgery.

Spinal SurgeryThis is a key application scenario that the company highly values. Currently, some popular hemostatic agents on the market may expand after application, potentially causing serious adverse events when used in areas with bony stenosis. In this field, the risk of expansion associated with hemostatic agents is the highest, and so is the market opportunity, whileLifeGel’s non-expansive property enables it to excel in this application scenario.。

InCardiovascular SurgeryIn China, surgeons face the challenge of surgical site infections before and after cardiac surgery. From the sternal edges to pacemaker pockets, cardiovascular surgical sites are susceptible to mycobacterial colonization, leading to potentially life-threatening complications. LifeGel offers unique suitability for cardiovascular surgeries; itCan firmly grasp and adhere to dynamic, vertical, and inverted bleeding sites, whereas most other flowable hemostatic agents are unable to achieve this function. Furthermore, itsInherent Antibacterial PropertiesThis also makes it an ideal product for controlling bleeding during cardiovascular surgery, demonstrating excellent performance in managing suture lines, ePTFE grafts, and diffuse epicardial bleeding.

InMinimally Invasive SurgeryIn minimally invasive procedures performed through tiny incisions under camera guidance, any bleeding can rapidly obscure the surgical field and hinder the procedure. At this point, LifeGel’sRelative Transparencybecomes particularly important, offering optimal visibility and ease of use during minimally invasive surgery (MIS).LifeGel achieves rapid hemostasis and is easy to remove, regardless of the angle or direction of application. Its ability to be delivered via small catheters and applicators is particularly beneficial for radical prostatectomy and partial nephrectomy.

Medcura Surgical Hemostasis Products

LifeGel’s innovative technology has provided Medcura with abundant opportunities to expand its product pipeline across multiple disciplines and professional fields, enabling its products to extend into the military and consumer retail sectors.

To address the challenge of uncontrollable hemorrhage in military settings, Medcura has published a feasibility study and secured funding from the U.S. government to develop new products that meet this significant unmet market need. The company has currently developed self-expanding injectables and self-expanding hemostatic powders for non-compressible wounds, as well as ready-to-use, moldable, and absorbable pastes. Notably, LifeFoam™ has received FDA Breakthrough Device designation, and recent publications have highlighted its substantial potential to save lives in military combat environments.

Medcura Military Hemostatic Products

In the consumer retail sector, Medcura products are currently available at major retailers across the United States for home wound care, including products for both humans and pets.

Medcura Consumer Hemostatic Products

On April 3, 2024, Medcura announced the completion of a private placement, raising a total of $22.4 million (approximately RMB 163 million) in convertible debt. The company plans to use the proceeds from this offering to accelerate the development of its flagship surgical product, LifeGel, an absorbable hemostatic gel. Medcura will complete its preclinical testing and file an Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) for LifeGel, in support of a global clinical study focused on hemostasis in spinal surgery.

Next, Medcura will further advance critical clinical trials and the global commercialization of its platform-led product, LifeGel, which is expected to receive initial approval for use in spinal surgery.