Cresilon, a New York-based medtech company, specializes in developing hemostatic technology. Its co-founder and CEO, Joe Landolina, created a plant-based hemostatic gel that can stop bleeding very rapidly when applied to a wound. Landolin developed the gel when he was just seventeen, and has spent the years since building the company to bring it and similar technologies to market.
At present, Cresilon’s technology is sold under the name Vetigel for use by veterinarians for bleeds that occur during surgery or dental work, or those caused by trauma. However, the company has recently submitted the technology to the FDA for 510(k) clearance. If approved, the product could be very useful in stopping bleeds in human patients.
Current approaches for hemostasis require the application of pressure or the administration of clotting agents, and both techniques have their drawbacks, including a wait time of several minutes until bleeding stops. This new technology aims to provide extremely rapid cessation of bleeding and acts as a mechanical barrier over the bleeding site.
Here’s a short video introducing the product:
Medgadget had the opportunity to speak with Joe Landolina about this technology and his plans for the future.
Conn Hastings, Medgadget: Please give us an overview of the need for point-of-care hemostatic therapies.
Joe Landolina, Cresilon: There is a strong need for a broad indication hemostatic device that works quickly, effectively, and across multiple types of bleeds. Existing technologies currently on the market require long periods of manual pressure, are difficult to apply, and are poorly suited to work on all types of bleeds.
For greater perspective on the need for point-of-care hemostatic therapies, consider these research reports and studies:
- More than half of people with traumatic injuries, including hemorrhaging, die within minutes of the accident or injury, according to a report from Baylor University Medical Center.
- Approximately 313 million surgical procedures are performed worldwide each year, according to a report published by the British Journal of Surgery. The report concludes that perioperative bleeding remains a major risk during and after surgery, and is associated with a high rate of death, complications, and healthcare resource use.
- Nearly 2 million people worldwide die from hemorrhaging (or blood loss) each year, per a review published by the New England Journal of Medicine.
- According to the National Association of Emergency Medical Technicians, hemorrhage from extremity wounds is one of the most common causes of preventable death on the battlefield.
Medgadget: How is hemostasis most commonly achieved at present, and what are the limitations of these approaches?
Joe Landolina: Present hemostatic technologies typically work through one of two mechanisms of action. The first type is mechanical in nature (like impregnated gauzes and sponges) and functions by absorbing blood and physically stopping the flow of bleeding at the wound surface. These technologies typically require at least five minutes of manual pressure and cannot be applied to bleeds in areas not conducive to applying pressure (called “noncompressible hemorrhage”).
The second type is biochemical in nature, employing an active ingredient (like thrombin or fibrin) to quickly clot the blood at the site of injury. These technologies work faster (in two or three minutes), but still require pressure to hold them in place while they are creating the clot. Furthermore, these technologies typically require special preparation and storage conditions which make them difficult or impossible to be used point-of-care.
Our approach to the bleed is instantaneous stoppage and on that point alone this becomes a game changer.
Medgadget: What inspired you to develop this technology, and how did the idea for it come about?
Joe Landolina: My grandfather was a retired chemist who owned a vineyard in Upstate New York, and I would work alongside him in his winery laboratory every single day after school from a very young age. During that time, I developed a strong love for chemistry, especially plant-based chemistries from ingredients found in nature around me.
Once I was in high school, I was able to enroll in a number of university summer programs on tissue engineering research. This piqued my interest in the application of plant-based materials into wound healing and tissue engineering, and I brought that interest back to my winery lab. At the age of 17, I was experimenting with polymers extracted from the cell walls of algae and discovered a matrix that would instantly bond to living tissue. I had the idea to apply this concept to a traumatic bleeding wound, being able to inject this gel into an actively bleeding wound to create a temporary seal. I entered this idea into New York University’s business plan competition as a freshman in 2010 and began building Cresilon from there.
Medgadget: Please give us an overview of the technology and how it works.
Joe Landolina: Cresilon’s technology is a blend of two plant-based polysaccharides that form a viscous gel capable of stopping bleeding on contact without the need to apply manual pressure. The gel forms an instant mechanical barrier over the source of bleeding, stopping anything from a small cut to traumatic arterial bleeding.
Once the bleeding is stopped, our gel allows the patient to create their own fibrin clot and can be removed easily without disturbing the underlying clot or left in the body to resorb. Cresilon’s technology offers a fast and effective way to control bleeding both at the point-of-care and in the operating room without pressure, preparation, or special storage conditions.
Medgadget: What are the next steps for the technology? When do you anticipate that it might be available?
Joe Landolina: Cresilon’s technology is currently available to veterinarians under the brand name VETIGEL® for surgical, traumatic, and dental bleeds. Cresilon also recently submitted our technology to the U.S. Food and Drug Administration for use in humans under the brand name CHG, which will expand our mission of saving lives from pets to include humans.
As Cresilon grows, we envision that this technology will be able to be used in any place where there is bleeding, from surgeries and trauma to first aid and consumer use.
Medgadget: Do you have any plans for other medical technologies? How do you see Cresilon developing?
Joe Landolina: Cresilon is well-positioned to use our technology as a jumping off point to revolutionize the standard of care for wound care. Our goal is to continue developing technologies that carry out our mission of saving lives in the area of hemostasis, wound healing, therapeutic delivery, tissue regeneration, and more.
Link: Cresilon homepage…