ALAPPUZHA: Malayali scientist has played a pivotal role in the development of an innovative non-invasive medical technology that has reached a major milestone in knee treatment in the United States.
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for the clinical trial of the SOLA-2 alternating magnetic field (AMF) system, developed by Dallas, Texas-based medical device company Solenic Medical Inc.
Dr Bibin Prasad, a native of Haripad and an alumnus of TKM College of Engineering, where he completed his MTech in 2011, is one of the key persons behind the technology.
He currently serves as the director of research and development at Solenic Medical, leading the development of advanced computational models and scientific simulations that support medical device design and patient-specific treatment planning.
Dr Bibin began working on SOLA-2 during his postdoctoral fellowship at the University of Texas Southwestern Medical Center, where he collaborated with Prof Dr Rajiv Chopra, co-founder and chief technology officer of Solenic Medical. Since then, he has played a central role in advancing the technology from early-stage research to human-clinical evaluation.
Commending his contributions, Prof Chopra said Bibin led the development and validation of sophisticated electromagnetic and thermal simulation models that were critical for device design, preclinical studies and human-safety assessments.
He added that Bibin’s research has received recognition from several international scientific organisations and was instrumental in generating the scientific and engineering evidence required for the FDA’s IDE approval.
The FDA clearance paves the way for Solenic Medical to launch a pivotal multicentre clinical trial across leading orthopaedic hospitals and academic medical centres in the US. Patient enrolment is expected to begin in the second half of 2026, Bibin said.
The study will evaluate the safety and effectiveness of the SOLA-2 AMF system in treating infected artificial joint implants.
If successful, the technology could become one of the world’s first non-invasive treatment options capable of preserving infected prosthetic joints without removing the implant, potentially eliminating the need for complex revision surgeries and significantly improving patient outcomes.
Bibin hails from Kuravuthara in Karthikappally.
He is the son of Rajendra Prasad, former manager of the Kerala State Drugs and Pharmaceuticals (KSDP), Kalavoor; and Prof Sheela, former head of the department of botany at TKMM College, Nangiarkulangara.
Cutting-edge tech
US Food and Drug Administration has granted investigational device exemption (IDE) approval for the clinical trial of the SOLA-2 alternating magnetic field system, developed by Dallas, Texas-based medical device company Solenic Medical Inc
Dr Bibin Prasad, a key figure behind the technology, led the development of sophisticated electromagnetic and thermal simulation models that were critical for device design, preclinical studies and human-safety assessments
