Infection risks associated with medical implants present a significant challenge within healthcare. Post-surgical infections, particularly those related to implants, not only jeopardize patient health and survival but also impose a considerable economic strain on hospitals and the healthcare system at large. Reducing these infection rates is crucial for enhancing patient outcomes, minimizing healthcare costs, and upholding high standards of care.

Cardiac implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter defibrillators, are vital for managing serious heart conditions. However, these devices come with inherent infection risks. Statistically, about 2 million people globally receive CIEDs annually, with 500,000 in the U.S. alone. In high-risk patients, the infection rate can be as high as 1 in 18. Alarmingly, recent Medicare data indicates that 80% of these infections go undetected or untreated, exacerbating the risks for patients and the costs involved.

Despite advances in medical technology, the prevention of post-operative infections remains under addressed. Current infection statistics reveal a significant gap between the incidence of infections and the effectiveness of the preventive measures. Hospitals face numerous challenges in managing these infections, which often involve complex and costly interventions. The focus of medical treatment has traditionally been on responding to infections rather than preventing them. But that is changing, and with the growing emphasis on preventative medicine, solutions like those developed by Hylomorph are right on time. 

A pioneering health tech company, Hylomorph has devised an innovative envelope that is designed to encase cardiac implants and deliver antibiotics directly to the surgical site, subsequently minimizing post-surgical infections in cardiac patients. Hylomorph’s bioresorbable envelope is applied by cardiologists or electrophysiologists around the implant, where it delivers the antibiotics for several days and is fully resorbed over a period of up to three months.

The benefits of Hylomorph’s envelope are substantial. By delivering a high concentration of antibiotics in the immediate postoperative period, the envelope aims to significantly reduce infection rates. CEO Simone Bottan shares, “Our approach not only enhances patient safety and quality of life but also has the potential to decrease hospital readmissions and improve hospital performance rankings.”

One in 10 people in the Western world will need an implant of some variety in their lifetime, contributing to a market exceeding $10 billion annually. Each year, over 10 million implants are at risk of infection, creating a significant demand for advanced prevention methods like those proposed by Hylomorph. Approximately 2 million of these implants are cardiac implantable electronic devices (CIEDs), a critical area in which Hylomorph’s innovative solutions are particularly relevant.

Additionally, there are around 500,000 neurostimulators — a rapidly growing market expected to either match or surpass the CIED market in the coming years. Hylomorph’s focus on minimizing infection in cardiac devices has the potential to address a broader range of implants and conditions, magnifying the company’s role in a lucrative, expanding, and life-saving market.

“We have created a modular solution, so we’re able to load the antibiotics in the envelope in a modular way which will allow us to move more flexibly into new drugs, new compounds, new antibiotics, or other conditions to be treated,” explains Bottan.

Bottan continues, “As antibiotic resistance grows, there’s a pressing need to move beyond existing drugs to new antibiotics and address other complications, such as hematoma. Hematomas are a significant concern and the next big complication in this field. They are particularly frequent in these patients who are undergoing anticoagulant therapy. Studies have shown that hematomas can increase the incidence of infections tenfold.”

The risk of infection associated with medical implants due to contamination during surgery poses significant health and economic challenges. Infections can lead to severe complications, prolonged recovery, and increased mortality, as well as higher healthcare costs from extended hospital stays and additional treatments. Hylomorph’s solution is pivotal in addressing these issues.

Bottan shares, “We are at the tip of the iceberg. ‘Advanced infection prevention’ will become a standard of care in the next one to two decades. With CIED being the start, more implants and indications are going to be addressed and more antimicrobial drugs deployed.”

By preventing infections before they start, Hylomorph offers a crucial advancement in patient care and cost management.