Under the direction of CTO Maria Kristina Bartolo, Orthonika is reimagining the treatment of irreparable meniscal injuries with its total meniscus replacement (TMR) implant. This novel solution addresses a critical gap in orthopedics, offering new hope to patients suffering from knee pain and impaired mobility. By combining innovative design with expert guidance from leading orthopedic surgeons, Orthonika aims to revolutionize joint preservation and enhance patient quality of life.
Orthonika was founded by a dynamic team of innovators at Imperial College London: Mario Alberto Accardi, Seth McCullen, and Dominique Kleyn. Recognizing the critical gap in effective treatments for patients with irreparable meniscal injury in the knee, the founders combined their expertise in biomechanics, biomaterials, and entrepreneurship to develop the TMR solution that forms the backbone of Orthonika today.
After completing her MSc in Biomedical Engineering at Imperial College London, Maria Kristina Bartolo joined the team as the company’s first employee. “From the very start, I knew the TMR was a product that could positively impact patients’ lives, including my immediate family and friends,” she said. Seven years later—and with a PhD under her belt—Bartolo now leads product design and development as Orthonika’s CTO.
Meniscal injuries are among the most common orthopedic injuries, affecting millions of people annually. When repair isn’t possible, the current standard of care involves removing the damaged meniscus (meniscectomy) to alleviate symptoms. While this procedure can provide short-term relief, it often leads to long-term complications.
“Even experienced orthopedic surgeons can repair fewer than 20% of meniscus tears in patients,” Bartolo explained. “Within 1-2 years of meniscectomy, 25% of patients are faced with persistent pain, 50% have a higher risk of osteoarthritis, and 14% eventually require total knee replacement.” Other options, such as partial replacement scaffolds or allograft transplants, face challenges like limited availability, complex surgical requirements, and inconsistent long-term success. This leaves a significant treatment gap for patients who would benefit from a meniscus replacement.
The Orthonika TMR is a synthetic meniscus designed to mimic the structure and function of the native meniscus, enabling patients to regain mobility and reduce pain. Unlike repair-focused treatments, the TMR allows surgeons to completely replace the damaged meniscus with a durable, fully biocompatible alternative.
“The TMR features an anatomical design based on patient MRIs,” Bartolo said. “The implant is made from high-strength, low-wear polymers to minimize cartilage degeneration and is fixed to the bone using a validated method similar to cruciate ligament reconstruction.”
The procedure is minimally invasive and requires minimal rehabilitation time, making it an appealing option for both surgeons and patients. Backed by multiple granted patent families, Orthonika’s novel solution is poised to address a $2.5 billion market opportunity driven by aging populations and rising rates of knee injuries.
Orthonika is in the final stages of preclinical development, having demonstrated positive in vivo data in highly translational models. “This year, we’ll transition from prototypes tested in sheep to final manufactured devices for humans,” Bartolo said, noting that clinical studies are planned for 2027.
The company has optimized its manufacturing processes for scale-up, a critical step toward commercialization. Additionally, Orthonika has secured $3.6 million in equity funding and is currently raising a $4 million Seed round with a first close at $2M to complete preclinical work, including a 12-month animal study and verification and validation testing.
“We will perform first in human studies here in the UK whilst targeting the U.S. market for regulatory approval and product launch, closely followed by UK and EU approvals.
Arthroscopic procedures of the knee, including meniscus repair, are among the most commonly performed orthopedic procedures worldwide. According to LSI’s Global Surgical Procedure Volumes (SPV) database, these are the third most common procedures behind upper and lower extremity fracture repair operations.
In 2024, an estimated 4.05 million knee arthroscopies were performed worldwide. Meniscus repair and partial mensicectomy are some of the most frequently performed arthroscopic procedures of the knee, in addition to ACL reconstruction and other cartilage-based procedures.
Relevant to Orthonika’s mission, nearly 4.0 million knee replacement procedures are performed worldwide. With a sizable number of meniscus injury patients today progressing to knee replacement as a result of limited solutions, access to skilled orthopedic surgeons, and poor outcomes, there is a significant opportunity to improve patient quality of life and reduce the progression to knee replacement. Doing so would significantly reduce surgical invasiveness, pain management, and rehabilitation.
Bartolo has been selected to present at LSI USA ‘25 this March 17-21 in front of hundreds of global medical technology companies. Join us in welcoming Bartolo to the event in Dana Point, CA, where she will share the latest updates on Orthonika’s technology and development.
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