Medgadget recently reported that Gecko Biomedical, a biomedical start-up based in Paris, France received CE mark approval for their SETALUM Surgical sealant. The bioinspired polymer sealant is cured on-demand using light and can supplement conventional sutures during vascular surgery. The material is biodegradable, bioresorbable, and biocompatible, can be delivered minimally invasively and is conceived for use in wet and challenging environments, such as vascular tissues. Now, Gecko intends to expand its family of polymer therapeutics, using the same type of polymer materials to create a barrier between different tissues, act as a filler material for tissue defects, or act as a scaffolding material.
To help develop and deploy this new portfolio of therapeutic products, Gecko has established an Innovation Hub to address the challenge of developing multiple products simultaneously. Their goal is to move from concept development to first-in-human trials in under two years.
Medgadget had the opportunity to ask Christophe Bancel, Gecko Biomedical CEO and cofounder, some questions about the SETALUM sealant and the company’s plans for a new family of therapeutics.
Conn Hastings, Medgadget: Can you tell us what first attracted you to this technology?
Christophe Bancel, Gecko Biomedical: This technology was developed at MIT by Robert Langer and Jeffrey Karp, both of whom are co-founders, and Maria Pereira, now our Chief Innovation Officer, leading our Innovation Hub. The aim was to develop a versatile technology that could close internal wounds and allow tissue reconstruction before it is resorbed. Such requirements implied a need to design a family of polymers that could adhere on demand, in a wet environment. The team there developed a tunable platform that encompassed all these properties and that became the gateway of a breadth of innovative solutions for tissue reconstruction.
Medgadget: What are the advantages of the SETALUM polymer sealant? Can you tell us how it was initially conceived and how it works?
Christophe Bancel: Besides being highly biocompatible and bio-resorbable, the viscosity and hydrophobicity of the material allows effective and consistent applications of the product onto the surgical site. More importantly, because the polymer is activated by a specific light, it only polymerizes when the surgeon decides. The polymer is dispensed from a prefilled syringe onto the wound with a specific adapter, then a specific visible blue light allows the polymerization from its liquid viscous state into a solid yet flexible state forming a leak proof closure onto the anastomosis.
Medgadget: Please tell us about this new family of polymer therapeutics and the disease states they could address.
Christophe Bancel: We have demonstrated that, depending on the formulation, our family of polymers can be used for different functions, such as a sealant, an adhesive, a filler, a 3D tissue guide or a localized drug release vehicle, and on different tissue types including vascular, cardiac, nerve, bone, and tissues in other areas of medicine including ophthalmology and urology. In addition, the right polymer is always associated to a specific device to facilitate its delivery and application, allowing specific surgical procedures, in open or in minimally invasive settings.
Medgadget: Will the new products use the same polymer formula and delivery devices as the SETALUM sealant, or will these designs be customized for each new application?
Christophe Bancel: We have designed and industrialized a set of formulations so that depending on the tissue we are targeting we can match the right technical requirements, elements such as adhesion and mechanical properties, to the needs of the tissue. However, we believe that the right solution is the combination of specific formulation and a specific delivery accessory, so the surgeon has a very effective and tailored solution for the surgical procedure being performed. We believe in specificity and design for a purpose.
Medgadget: Are all the new materials conceived as curable in the body, or will some be pre-formed before implantation, using techniques such as 3D printing?
Christophe Bancel: The polymers were first designed to be cured or “printed” onto the tissue during the surgical procedure. However, due to the fact that the polymer is light activated, we have adapted it so that it can be 3D printed through DLP technics allowing a flexible, bioresorbable medical device, with extremely fine resolution (down to 25 microns). This opens up a new area of applications.
Medgadget: When do you envisage that the new materials will be available?
Christophe Bancel: We received the CE mark in July 2017 for our SETALUM sealant for vascular reconstruction.
We are currently scaling up our manufacturing capabilities in order to go commercial in late 2018/ early 2019.
In parallel, we have streamlined our innovation capabilities to speed up the design of new solutions by leveraging existing formulations that have been industrialized and combining them with the right activation device. This has allowed us to expend in orthopedic and nerve reconstruction, with advance prototypes being currently tested.
See the story behind the glue here:
See how the glue could be used for vascular surgery here:
Link: Gecko Biomedical…