BioDevek, a medtech company based in Cambridge, Massachusetts, has developed a biomaterial adhesive that acts to seal internal wounds and incisions. The material is designed to be sprayed through a catheter, and the primary application for the technology so far is to act as a sealant following colonic polyp resection.
At present, following polyp resection, surgeons can use polyp clips to seal the resection site, which can hamper wound healing, or use no sealant at all, leading to an open wound that comes with a risk of bleeding or other complications. This can lead to additional surgeries to correct the issue and is inconvenient for patient and clinician alike.
To address this, these researchers have fine-tuned this biomaterial to form an instant seal over the site of a resected polyp immediately after being discharged from a catheter. The sealant has been optimized to provide the correct mix of mechanical properties and biocompatibility for this application, but it can be modified for use at other sites in the body.
BioDevek was recently listed as a finalist in the 2021 MedTech Innovator Global competition.
See a video about the company’s technology:
Medgadget had the opportunity to speak with Natalie Artzi, co-founder of BioDevek, about the technology.
Conn Hastings, Medgadget: Please give us an overview of the difficulties involved in sealing wounds or incisions following internal surgeries.
Natalie Artzi, BioDevek: Any material that gets inside our body will immediately be recognized as foreign. Therefore, material formulation is critically important in mounting the ‘right’ biological response. Adhesive sealants are inherently designed to chemically and physically interact with tissue surfaces, making it even more challenging to obtain the right tissue response.
Adhesive sealants have to match the mechanical properties of the underlying tissues in order to enable proper tissue function. At the same time, the sealant must remain attached to the tissue to prevent leakage from the suture line following internal surgeries.
Commercially available adhesive materials have either high mechanical properties or adequate biocompatibility, forcing physicians to choose between the two. BioDevek is working to solve this problem by designing smart materials that will fulfill both properties. We believe that the development of such materials will increase the penetration of adhesive materials into the market, which has been limited so far due to the suboptimal performance of existing products.
Medgadget: What consequences can suboptimal wound sealing have for patients?
Natalie Artzi: Inadequate wound closure can result in leakage, such as bleeding following vascular surgeries, gut-content leakage following gastrointestinal surgeries, and air leakage following lung surgeries in up to 30% of the patients undergoing internal surgeries. This leakage may result in the need for additional procedures and even emergency surgery, increasing the risk of potential infection and compromising overall wound healing time. Eliminating these complications and enabling the natural healing of the body to take place allows for less hospitalization time and decreased cost for patients and providers.
Medgadget: What commercial solutions are currently available for such applications? How are they suboptimal?
Natalie Artzi: Aside from sutures and staples, there are currently no commercially available biomaterial-based solutions for wound closure following internal surgeries. In the past few years, we have seen a significant need for better wound closure techniques. For example, the incidence of bleeding following polyp resection in the colon has increased. Polyp resection clips are applied when the polyps are smaller than two centimeters, however they may fall off prematurely and impede wound healing as they exert high mechanical stress to the tissue. For polyps larger than two centimeters, the clips are too small to be applied and so patients are sent home with an open wound. This puts the patients at a high risk of experiencing delayed bleeding and increases the potential need for reoperation and a potential blood transfusion.
Medgadget: Please give us an overview of the sealant developed by BioDevek.
Natalie Artzi: BioDevek’s adhesive sealant is designed to be sprayed through a catheter from one of the existing ports of colonoscopy equipment currently in use, to coat and protect the patient’s tissue following polyp resection. It is an easy and rapid process as the material is designed to gel instantaneously upon contact with the tissue. As no two patients are exactly alike, our material is designed to interact with each tissue uniquely to maximize its performance. We have also developed an injectable solution that can coat the anastomotic line between tissue and graft following cardiovascular surgeries.
Medgadget: How long does the sealant remain in place? Is it possible to fine tune the degradation and mechanical properties of the gel for different applications?
Natalie Artzi: The material is designed to stay in place for about a week post-polyp resection, but its residence time can be fine-tuned for each application by controlling its formulation. The degradation time can be programmed to match the rate of tissue healing. This way, the material will provide protection while the tissue is still ‘compromised’ and will fall off when the tissue is fully healed.
Medgadget: Was it difficult to develop a formulation that could be delivered through a catheter?
Natalie Artzi: Developing the ideal adhesive sealant that can be delivered through a catheter has been a learning experience. The processes of delivering the sealant must happen very fast and must occur in less than one second. The material should have a viscosity low enough to flow easily through a catheter of only a few millimeters in diameter, however once sprayed it should form a gel instantaneously without flowing or dripping. While the gel solidifies, it needs to interact with the tissue and at the same time interact with itself to form a strong cohesive solid gel. We are in the process of refining our solution, but we believe we are on the right track towards providing an innovative option for patients that undergo internal surgeries.
Medgadget: Congratulations on being a finalist in this year’s MedTech Innovator Global competition. How did you find the program?
Natalie Artzi: We are thrilled that BioDevek has been recognized as a finalist in this year’s MedTech Innovator global competition, and we look forward to accelerating our development timeline with the prize money we have earned. A truly priceless part of this journey has been the mentorship that we have received from company sponsors of the program such as Gore & Associates, Olympus Medical Systems, and Jabil Healthcare, among many others. These conversations have helped shape the direction of our company moving forward. We have sincerely enjoyed our time in the accelerator, and we look forward to using what we have learned from the program to provide better solutions for patients that undergo internal surgeries.
Link: BioDevek homepage…