Elutia Unveils Breakthrough Publication on EluPro's Effectiveness
Elutia Celebrates Significant Research Breakthrough
EluPro eradicated bacteria commonly associated with cardiac implant-related infections in an established preclinical infection model.
SILVER SPRING, Md. — Elutia Inc. (NASDAQ: ELUT) has recently made a substantial announcement regarding its antibiotic-eluting biologic product, EluPro. As the world’s pioneering antibiotic-eluting biologic envelope approved by the FDA, EluPro displayed remarkable capabilities in combatting bacterial contamination linked to Cardiovascular Implantable Electronic Devices (CIEDs).
Robust Findings in Preclinical Studies
Recent studies published in Frontiers in Drug Delivery highlighted promising data from preclinical research employing an animal model. EluPro showcased its formidable ability to reduce bacterial colonization while keeping systemic antibiotic exposure minimally invasive.
The Path to FDA Clearance
As of mid-2024, EluPro secured FDA clearance for application with CIEDs and now extends its approval to other devices, including those used for pain management, epilepsy, incontinence, and sleep apnea. The first patient implant utilizing EluPro was successfully performed in September 2024.
Expert Insights into EluPro’s Capabilities
Dr. M. Rizwan Sohail from Baylor College of Medicine, a key author in the publication, remarked on EluPro’s potential. “This biologic envelope not only enhances implant stability and mitigates device migration but also addresses bacterial contamination risks, a significant concern in CIED procedures,” he stated. Notably, he underscored that recent clinical findings indicate EluPro’s ability to help minimize scarring and fibrosis around implants, potentially easing reoperation processes.
Preclinical Study Design
The studies employed an established rabbit model for simulating CIED infection. Implants were placed either with EluPro or a non-antibiotic control envelope, followed by the introduction of various bacterial species. Over a week, implant sites were closely monitored for infection signs and bacteria presence. Results made it clear—none of the subjects with EluPro exhibited infection signs, contrasting sharply with the control group that experienced fevers and required additional care.
EluPro: A Step Further in Infection Control
“These findings strongly affirm EluPro’s potential in delivering improved infection control during CIED procedures,” stated Dr. Michelle LeRoux Williams, Elutia's Chief Scientific Officer. “Being the first FDA-cleared biologic antibiotic-eluting envelope, EluPro is poised to revolutionize protection for implantable devices. Following the initial human implant milestone, we are gearing up for EluPro's commercial launch in January 2025.”
Ongoing Commitment to Innovation
Elutia’s dedication extends beyond merely developing advanced products; it aims to forge a future where patients receive better, safer implantable technologies. The company continues to innovate, ensuring that medical devices align with patient needs for maximum compatibility and efficacy.
About Elutia
Elutia focuses on developing and commercializing drug-eluting biomatrix products designed to enhance compatibility between medical devices and patients. Aiming to transform healthcare into a more patient-centric approach, Elutia is committed to humanizing medicine, allowing patients to thrive and experience life without hindrance.
Frequently Asked Questions
What is EluPro?
EluPro is an antibiotic-eluting biologic envelope designed to prevent infections associated with implantable medical devices.
Why is the new study significant?
The study provides strong evidence that EluPro effectively reduces bacterial colonization with minimal antibiotic exposure, which is crucial for improving patient safety.
What types of devices can use EluPro?
EluPro is FDA approved for use with CIEDs, and it is also approved for neuromodulators and neurostimulators for conditions such as pain management and epilepsy.
When is EluPro’s commercial launch planned?
Elutia plans to launch EluPro commercially in January 2025, following successful initial human implants.
Who is involved in EluPro's research?
Experts like Dr. M. Rizwan Sohail from Baylor College of Medicine contribute to the research, along with Elutia’s dedicated scientific team led by Dr. Michelle LeRoux Williams.
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