Competition drives innovation, efficiency, and improvement across various fields and endeavors. Look at Google and Apple, there is a need and room for both in the smartphone industry; innovation begets innovation. The same is true for infection prevention—the more competition, the better the solutions.
Hylomorph, a clinical-stage medical device company, has developed one such solution that has the potential to minimize post-surgical complications greatly. Designed to prevent rather than treat, Hylomorph's innovative drug-eluting envelope used with surgical implants promotes 'functional' healing while delivering antibiotics (as well as other drugs in the future).
Post-surgical infections pose severe risks to patient health. The infection rates for surgeries involving implants are even higher than for other surgeries. Approximately two million people worldwide and 500,000 in the United States receive cardiology-tech implantable electronic devices (pacemakers, defibrillators, etc.) annually. The infection rate on these implant surgeries is 1 in 18 for high-risk individuals.
This increased risk is due to several factors, including the presence of a foreign object in the body, which can serve as a surface for bacterial colonization and complicate the immune response. Infections associated with implantable medical devices lead to pain, prolonged hospitalization, increased mortality and higher healthcare costs.
Traditional approaches to managing these infections are insufficient, often requiring drastic measures like full extraction of the implant, which itself carries high risks. Minimizing infection rates is the answer to improving patient outcomes, minimizing costs and improving hospital rankings.
CEO Simone Bottan shares, "That is why we have developed a modular, bio-resorbable antibiotic-eluting envelope (B.A.E.E.) that wraps around the implant. It comes ready-to-use off the shelf and can be swiftly implanted using a proprietary applicator, taking just about a minute. This envelope releases antibiotics rapidly, reaching effective concentrations within 1–2 hours and maintaining them for 7–10 days, effectively eradicating infection-onsetting bacteria. Over three months, the envelope is absorbed into the tissue, while tissues heal and the implant is stabilized. We call this 'functional' healing. This approach has been demonstrated to significantly reduce the incidence of infection in large-scale clinical trials."
What gives Hylomorph's solution a competitive advantage over others like Medtronic is it more flexibly allows for future adaptability, enabling the incorporation of novel therapeutics for antimicrobial resistance and treatments for other complications, such as hematomas.
Bottan explains, "We see that the field will continue to evolve. There will be a need for different therapies because antibiotic resistance is a big issue. So you don't want to stick to the same drug forever. There will be a need to move into new drugs. And so that's one thing, one main point."
"And the second is that there will be a need to address other complications like hematoma. Patients with implants in contact with their bloodstream typically require anticoagulant drugs, which increase the risk of bleeding during surgery. This can lead to hematoma formation around the implant site. Research shows that hematomas can significantly amplify (by 10 times) the risk of infection. Therefore, effective infection treatment should also address hematoma management, which necessitates additional medications. Future healthcare demands will require expanded therapeutic options. Our solution will facilitate the integration of new therapies and enhance our ability to meet evolving healthcare needs effectively."
Hylomorph's innovative approach has earned them multiple accolades in its early stages, including the European Heart Rhythm Association Innovation Award 2019 and a number of Swiss awards for leadership and innovation.
Just as Google and Apple push each other to innovate, Hylomorph is driving impactful change in the medical device industry. Positioned alongside other industry leaders, Hylomorph is taking a leading role in addressing surgical infections in cardiology and beyond. By focusing on both current and future surgical needs, the team at Hylomorph aims to not only tackle today's challenges but also anticipate tomorrow's.
To learn more about Hylomorph's cutting-edge solution, visit www.hylomorph-medical.com.
Join the Conversation