New York Society For The Relief Of The Ruptured And Crippled, Maintaining The Hospital For

FDA Approves Hyalex Orthopaedics' IDE Supplement for Pivotal Trial of Freestyle Knee Implant

4 days ago

• The FDA has approved Hyalex Orthopaedics' supplemental IDE application, allowing expansion of their Early Feasibility Study into a pivotal clinical trial for the Freestyle Knee Implant. • The novel implant technology targets patients with cartilage damage and early osteoarthritis of the femoral condyle, addressing an estimated $2 billion market in the US with limited current treatment options. • Early clinical evaluations have shown promising results in mimicking natural joint mechanics and helping patients return to active lifestyles, according to principal investigator Dr. Sabrina Strickland.

Certolizumab Therapy Shows Breakthrough Results for High-Risk Pregnancies in Antiphospholipid Syndrome

a month ago

• The IMPACT trial demonstrates that certolizumab pegol significantly reduces adverse pregnancy outcomes in women with antiphospholipid syndrome, with complication rates dropping from 69-79% to just 20%. • Women treated with certolizumab alongside standard therapy experienced dramatically improved pregnancy duration, averaging 36.5 weeks compared to 24 weeks in their previous pregnancies. • The groundbreaking study reveals that targeting inflammation rather than blood clotting alone may be key to preventing pregnancy complications in APS, with 93% of participants successfully delivering healthy babies.

FDA Approves Elute's BonVie+: A Novel Resorbable Bone Void Filler Addressing Limitations of Current Options

2 months ago

• Elute, Inc. has received FDA clearance for BonVie+, a calcium-salt resorbable bone void filler designed to overcome limitations of traditional bone cement and calcium sulfate-based alternatives. • The novel implant features controlled resorption technology that allows natural bone replacement over time, eliminating the need for additional removal surgeries common with non-biodegradable options. • BonVie+ represents over a decade of innovation in bone restoration technology and includes a kit system enabling surgeons to select appropriate granule sizes based on patient-specific anatomy in real time.

Lipogems Completes Patient Enrollment in Pivotal FDA Trial for Knee Osteoarthritis Treatment

3 months ago

• Lipogems has completed enrollment of 173 patients across 16 U.S. sites in the ARISE II clinical trial, evaluating MicroFat injections for knee osteoarthritis treatment. • The double-blinded, randomized controlled trial will assess pain reduction and functional improvement at 6 months post-injection, with results expected in late 2025. • The company is pursuing a modular Premarket Approval Application (PMA) with the FDA, aiming to secure specific indication for knee OA and expand treatment accessibility through reimbursement.