Why Medcura’s LifeGel™ Is the Backbone of a Surgery Revolution

The $2.8B surgical bleeding control market is ripe for disruption.

At Medcura, we believe we are poised to do just that.

As we stand on the threshold of a new healthcare frontier, I am reflecting on the work that has led us to this point. And I am looking forward to what is ahead as the Medcura team works to make a new standard of surgical bleeding control available to surgeons and their patients across the globe.

FDA Breakthrough Designation

December 2022 marked a major milestone. That is when the U.S. Food and Drug Administration (FDA) granted a Breakthrough Designation to LifeGel™ — Medcura’s first flowable, absorbable surgical hemostatic technology. LifeGel is the first and only surgical hemostatic agent the FDA has recognized with a Breakthrough Designation, a strong testament to its innovation and potential.

A ‘Breakthrough Designation’ is the FDA’s way of prioritizing the development and review process, potentially reducing LifeGel’s time to market as compared to other devices in the same class. Only technologies that appear capable of markedly improving upon the current standard of care get a Breakthrough Designation from FDA. They must show promise for enhanced therapeutic benefits (safety or efficacy), lower costs, or both.

LifeGel has the potential for both. Other hemostatic agents in Medcura’s pipeline, all leveraging the same core biochemistry innovation, show similar promise.

Beyond the Surface: New Surgical Uses for a Proven Hemostatic Agent

LifeGel, which is designed to control bleeding during spinal surgeries without swelling, is a polysaccharide-based technology derived from a molecular modification of chitosan, a complex carbohydrate that comes from shellfish exoskeletons.

Chemists discovered chitosan’s strong bleeding control properties in the 19th century, and hemostatic dressings that contain raw chitosan have been used to control bleeding in combat and trauma for more than 40 years.

While chitosan-derived polysaccharides are a proven hemostatic base, they can also pose challenges that include high endotoxin levels, long resorption times, foreign body reaction, inflammatory response, and formulation of granulomas in healing tissues. Up until now, due to these challenges, chitosan-based hemostatic agents in the U.S. have been for external and trauma use only. The biochemistry discoveries driving LifeGel make chitosan safe for internal use, offering excellent biocompatibility and resorption into the body — without sacrificing the strong hemostatic properties of raw, unmodified chitosan that have made it so effective for external use in challenging trauma and combat bleeding situations.

Medcura’s hydrophobically modified chitosan, the component in LifeGel contributing to its hemostatic mechanism of action, makes for a highly effective hemostatic agent because it achieves hemostasis by mechanical means, coating the bleeding site via the process of mucoadhesion. Once applied, LifeGel interacts with itself, blood, and tissue to create a robust network of millions of noncovalent bonds, resulting in stable attachment to the bleeding site.

It is noteworthy that LifeGel controls surgical bleeding without swelling, which sets it apart from other currently available hemostatic agents, which do swell. When operating in the confined spaces of spinal surgery, swelling adjacent to nerve roots and the cord itself can cause neurological deficits and even paralysis. Because LifeGel doesn’t swell, it potentially mitigates the risk of complications associated with swelling hemostatic agents.

LifeGel offers additional benefits, including being highly cost-effective, immediately ready to use, and complete with the antimicrobial properties of its base, chemically inert biopolymer.

The Completely Novel Polymer That Can

To make LifeGel and other hemostatic agents that are suitable for internal use, we remove the proteins that trigger shellfish allergies and create a concentrated powder. This is the same raw powder used in topical applications.

What comes next is the breakthrough.

In reactors at our headquarters in Maryland, we dissolve the raw powder in a solvent and add a proprietary recipe of fatty acids and other proprietary copolymers. We mix the ingredients at a proprietary speed, temperature, and duration until it is cured, and then remove the base solvent to create a completely novel molecule.

The Medcura process neutralizes toxicity obstacles that have limited the raw polysaccharide to external applications up to now.

We now have a novel biopolymer that surgeons can use inside the body to control bleeding during surgeries.

Spine Surgery Solution

The novel polymer we have created has multiple surgical uses. We have started with spine surgery because it is a $1.1B market segment, the largest in the $2.8B surgical bleeding control market.

More importantly, spine surgery needs transformational hemostatic technology. A hemostatic agent that doesn’t swell is especially beneficial for spine surgery because swelling in such a bony, confined area can lead to adverse outcomes such as neurological deficits and paralysis. Unlike other hemostatic agents available for spine surgery currently, LifeGel is fully hydrated and does not swell.

Spine Surgeons Speak

Once we had secured FDA’s Breakthrough Designation for LifeGel, we decided to bring top neurosurgeons and orthopedic spine surgeons from around the country to get their direct feedback. We wanted to know how spine surgeons viewed LifeGel’s potential compared to the surgical bleeding control options that had been available to them over the past 25 years.

What happened next, we did not plan for. I have never seen it happen in my 30-year medtech career.

“May we invest?” the spine surgeons asked.

LifeGel captivated spine surgeons in our lab that day because it:

• Controls bleeding without swelling, potentially mitigating spinal surgery risks associated with swelling hemostatic agents such as paralysis and vessel compression;
• Is ready to use without the need to mix prior to surgery, which means less time spent and less unused product going to waste;
• Is cost-effective;
• Mucoadheres to inverted and vertical tissues (unlike other flowables), which makes it a better option for spine surgery;
• Is more transparent than other hemostatic flowables, which allows the surgeon to see the bleeding lesion and clot formation more clearly;
• Retains the antimicrobial properties of its base biopolymer, chitosan; and
• Can be stored at room temperature.

After seeking out legal counsel, we decided to allow for limited participation from surgeon investors during the next round of financing. In March 2024, Medcura closed $22.4M in financing. Almost $8M of that amount came from surgeon investors and spine surgery industry executives. Leading neurosurgical practices have also invested, as well as top sales distribution teams.

The voice of LifeGel’s market has spoken loudly. Few companies that face the clinical and regulatory hurdles we still face in our future can raise that amount of money. It has humbled us—and encouraged us—to see the extent to which North America’s leading spine surgeons have chosen to participate in this round of financing and offer their thought-leading support.

Many of these surgeon investors have joined Medcura’s advisory board. Medcura will announce their new spine advisory board members later this year.

View from the Beachhead

To grow a company like Medcura, you need a great product like LifeGel. To create value, you need a great platform.

Because the biopolymer we are working with is quite versatile, we believe we are well on our way to building this platform. LifeGel is our beachhead product. The same biopolymer that makes LifeGel possible has surgical bleeding control possibilities far beyond the beachhead.

Also in the pipeline, all leveraging the same core biopolymer, and all positioned for their high efficacy, high safety and low cost of goods (high margin potential) are:

• Other uses for LifeGel beyond spine surgery, such as cardiac, minimally invasive and GI endoscopic and laparoscopic surgery.
• LifeCoat™ (for future FDA evaluation): A powdered version of Medcura’s hydrophobically modified chitosan, LifeCoat can be delivered by a bellows applicator during surgical procedures to control moderate surgical bleeding. LifeCoat will be a high efficacy, less expensive alternative to more costly, market-leading hemostatic powders.
• LifeSheet™ and LifeFib™ (in development): These electrospun sheets of varying size and thickness are composed of Medcura’s hydrophobically modified chitosan, for use as absorbable surgical hemostatic gauze.
• LifePatch™ (in feasibility): This lyophilized patch composed of hydrophobically modified chitosan is designed to be used in minimally invasive and open surgical procedures as an absorbable hemostatic patch.
• Additional formats in feasibility include LifeFoam™ and LifeFilm™.

The Power to Lower Healthcare Costs

Safety and effectiveness are key, but just as important to us is the potential to lower the costs for surgeons, patients, and health systems, all while increasing margins for the selling entities.

In addition to low production costs, which should permit savings opportunities, there are user advantages that lead to simpler storage, less prep time, and less product waste.

Together, these factors create a tremendous economic advantage that parallels the safety and effectiveness advantages we hope to demonstrate in upcoming trials.

Playbook for a Life Tech Market Disruption

As seismic as this moment is, there is some déjà vu for me.

My prior experiences spurred Larry Tiffany , Medcura’s Co-Founder and Executive Chairman to seek me out, initially as a board member in 2018 and as CEO since 2022.

Earlier in my career, I was Vice President of Marketing and Business Development at Closure Medical, a Raleigh, North Carolina-based company that developed a synthetic sealant and adhesive. Closure’s foundational innovation back then foreshadowed Medcura’s innovation today.

As a startup, Closure found ways to adapt a substance that had previously been suitable for external uses only so that it could be an internal solution as well. We successfully gained European regulatory approval and soon thereafter sold the company to Johnson & Johnson’s Ethicon division for $370M in 2005.

I am on the quest at Medcura for a similar win. My biosurgery platform leadership experience at Closure Medical has provided a playbook for bringing a life tech gamechanger to the market.

A Team with All the Right Moves

Even a winning playbook won't get you far unless you have a talented team to execute it.

I am privileged to work alongside a uniquely strong and inspired Medcura team, which is guided by the intellect, experience, and leadership of people like:

• Matthew Dowling , Co-Founder and Chief Scientific Officer: Trained as a chemical engineer, Matthew founded a wound care technology company prior to spearheading the scientific innovations that are Medcura’s foundation.
• Kenneth Renkens, M.D. , Chief Medical Officer: A neurosurgeon, Dr. Renkens co-founded the Indiana Spine Group and has been involved in more hemostatic agent clinical studies than any other spine surgeon.
• John Barry , Chief Operations Officer: With a strong background in Research & Development, John drives our product roadmaps.
• Steven Ford , Senior Vice President of Business Development and Marketing: Steve has launched more hemostatic agents globally than any other business executive.
• Rachel Hoffman , Senior Vice President of Clinical and Regulatory Affairs, Head of Translational Research: A biomedical engineer, Rachel leads our efforts to apply laboratory discoveries to clinical practice and patient care.

Together, the Medcura team has achieved:

• 5 FDA clearances;
• 2 FDA Breakthrough Device Designations;
• 28 issued patents; and
• More than 10 peer-reviewed articles in high-impact, peer-reviewed scientific journals.

I look forward to continuing to work with the Medcura team as we shepherd our initial innovations and accomplishments into human clinical trials and commercial launch.

Watch this space for an upcoming press release that describes the world-class spinal advisory group we have assembled. I invite you to follow our progress as we work together to create better surgical bleeding control options for doctors and their patients.

LifeGel™ and its application tips are currently in development. All intended uses and/or indications for use for this medical device and its application tips have not been cleared or approved by the FDA.

References

• https://www.fdanews.com/articles/210821-medcura-receives-breakthrough-device-designation-for-lifegel-to-manage-surgical-bleeding?v=preview
• Arista ® AH Absorbable Hemostatic Particles, Instructions for Use,; Warnings. Davol Inc. Subsidiary of C. R. Bard, Inc., Warwick, RI; 2015, Arista-AH
• Gelfoam ® absorbable gelatin compressed sponge, USP, Instructions for Use; Warnings.  Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022
• Gelfoam ® absorbable gelatin powder from absorbable gelatin sponge, USP, Instructions for Use; Warnings.  Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022
• PerClot ® Polysaccharide Hemostatic System, Instructions for Use, Warnings. Starch Medical Inc., San Jose, CA, Uploaded 2019, PerClot-IFU
• Surgicel ® Powder, Absorbable Hemostatic Powder, Instructions for Use, Contraindications. Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2017
• Surgicel ® SNoW Absorbable Hemostatic, Instructions for Use, Contraindications; Adverse Events.  Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2013
• SurgifloTM Hemostatic Matrix Kit, Essential Product Information, Warnings; Precautions. Ethicon Johnson and Johnson Surgical Technologies; 2022, SURGIFLO-Hemostatic-Matrix-Brochure
• SurgicelTM Original/ Surgicel NU-KNIT/ Surgicel Fibrillar Absorbable Hemostats, Instructions for Use, Contraindications; Adverse Events. Ethicon, Neuchâtel, Switzerland; 06/2013

‍