BioPoly® Knee FDA-Approved Clinical Study is Now Published on ClinicalTrials.gov

FORT WAYNE, IN – April 23, 2025 – BioPoly LLC, an innovator in orthopedic implant biomaterial technology, is pleased to announce that patient recruitment has commenced for its clinical study, BioPoly Partial Resurfacing Knee Implant IDE, now officially listed on ClinicalTrials.gov, the world’s leading clinical trial database.

This FDA-approved randomized controlled trial aims to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant. Specifically designed to address cartilage defects of the distal femur of the knee, this implant is intended for adult patients experiencing persistent knee pain and symptoms who require surgical intervention.

The BioPoly® knee implant utilizes a proprietary biomaterial that closely replicates natural cartilage function, providing more natural joint motion. Unlike traditional metal implants, the BioPoly® material reduces wear and eliminates issues related to metal sensitivity or allergies. Additionally, compared to biological treatments, BioPoly® offers enhanced durability, predictability, and immediate structural support without requiring the patient to have robust biology, which many older patients lack.

“Listing our IDE clinical study and patient recruitment through ClinicalTrials.gov underscores BioPoly’s commitment to transparency, scientific rigor, and patient care,” said Dr. Herb Schwartz, CEO of BioPoly LLC. “With our first site up and running, this milestone brings us closer to providing a novel, less invasive treatment option that preserves the natural anatomy of the knee and significantly enhances patient outcomes.”

Long term clinical outcomes from earlier studies conducted in Europe have already demonstrated promising results, reinforcing the potential benefits of this innovative treatment. These findings have been published and can be reviewed here:

• BioPoly Knee Implant Provides Beneficial Clinical Outcomes at 5 Years (JBJS)
• European Prospective Study Demonstrates Patient Improvement at an Average 6.3-Year
  Follow-up

Additional information about the current U.S. study, including comprehensive details on trial design, outcome measures, and patient eligibility criteria, can be found at:

BioPoly Knee Study (clinicaltrials.gov)

This recruitment announcement marks another significant advancement for BioPoly as it continues its mission to improve patient care through innovative orthopedic solutions.

About BioPoly LLC
BioPoly LLC specializes in developing and commercializing next-generation orthopedic implants utilizing proprietary biomaterials designed to mimic natural cartilage and tissue function. BioPoly products aim to deliver superior outcomes through minimally invasive solutions that enhance patient quality of life.

Partial Resurfacing Knee Implant is an investigational device and is limited by United States law to investigational use. It is not yet available for commercial sale or use in the U.S