Arthroscopy/Soft Tissue is the second-smallest market segment within the global orthopaedic industry, with 11% share and ~$5 billion in annual product sales. We expect this segment to grow by 5% to 6% this year, and funding activity for the first half of 2017 is at least indicating an interest on the part of the investment community, as well as some larger OEMs. Of the 24 funding announcements that we tracked from orthopaedic companies in 1H17, eight (33%) are arthroscopy/soft tissue-related technologies. We highlight them here for you.
Johnson & Johnson Innovation backed two companies developing cartilage-like products designed to treat joint disease and defects: CartiHeal and Hyalex Orthopaedics.
CartiHeal closed a $18.3 million financing round, supporting the recently-approved Investigational Device Exemption clinical trial of the Agili-C implant in pursuit of a Premarket Approval. The two-year pivotal U.S./ex-U.S. study seeks to demonstrate superiority of Agili-C vs. the surgical standard of care in the treatment of cartilage and osteochondral defects in the joints.
Hyalex Orthopaedics raised $16.0 million in a Series A financing. HYALEX synthetic polymer is designed to mimic hyaline cartilage, to potentially replace only diseased areas while sparing healthy bone. HYALEX was developed with technology licensed from Stanford University.
Also in the cartilage arena, Cartiva secured $8.5 million in a Series E financing. Proceeds will support commercialization of the Synthetic Cartilage Implant (SCI) for treatment of great toe arthritis, as well as general corporate purposes. Cartiva received FDA Premarket Approval for SCI in early 3Q16, representing what is reported to be the first synthetic cartilage device to gain FDA approval. In 1H17, Cartiva also completed enrollment and treatment of 50 patients in a multi-year study evaluating use of SCI in the thumb.
Active Implants and Orthonika both received investments to support development of meniscus implants.
Active Implants completed the first $10.0 million tranche of a $40.0 million Class D Units financing. Funds will support two ongoing clinical trials of the NUsurface Meniscus Implant, a polymer-based investigational treatment for persistent knee pain following medial meniscus surgery. Enrollment for the SUN and VENUS trials is expected to be complete by the end of 2017.
In a 2016 interview with BONEZONE, Adam Klyce, Vice President of Marketing & Communications, U.S. at Active Implants, said that the technology is needed to fill the gap in care for patients who had undergone partial meniscectomy and now have persistent knee pain, but aren’t ready for total or partial knee replacement.
Orthonika closed a £0.7 million (~US $0.9 million) investment round. Funds will support biomechanical testing and a preclinical pilot trial of MenisciKnit, a novel synthetic total knee meniscus replacement, specifically biomechanical testing and a preclinical pilot trial. Orthonika was spun from the Imperial College London in 2015.
Few meniscus implants are on the market or in development. Stryker has an FDA-approved collagen meniscus implant. NovoPedics is developing Meniscofix, a biodegradable polymer, fiber-reinforced scaffold for total meniscal replacement.
Biorez, formerly known as Soft Tissue Regeneration, is the first company to clinically investigate a tissue-engineered scaffold for anterior cruciate ligament (ACL) reconstruction in a human trial. The scaffold facilitates growth of ACL tissue and then fully resorbs, leaving new, functional tissue. The company closed a $1.5 million Series C Financing in 1H17. At the 2017 AAOS meeting, BioRez attended private meetings to share results of a 15-patient safety study that began in 2Q13.
Trice Medical closed a $19.3 million Series C financing led by several investors, including Smith & Nephew, which took a minority stake in the business. Funds will support U.S. marketing and ex-U.S. regulatory approvals for the mi-eye2 system, as well as R&D for a third-generation device. The second-generation of the technology, which can be used in place of MRI to diagnose joint injuries, received FDA 510(k) clearance during 4Q16.
While we classify stem cells under orthobiologics, ASC Biosciences’ news is of interest because its Multipotent Adult Stem Cell platform can differentiate into cartilage, bone, tendon, muscle, ligaments, etc. The company partnered with Stem Cell Development Fund to receive $1.5 million in support of development and marketing of its stem cell platform. ASC’s portfolio includes Chondrofelt, a matrix intended for use with microfracture to repair articular cartilage defects.
We suspect that one or more of these companies or technologies will be acquired in the foreseeable future as larger players seek to build out their portfolios and complement their joint reconstruction lines. View the full list of the funding announcements we've tracked so far this year.
Photo: Cartiva Synthetic Cartilage Implant