RESEARCH TRIANGLE PARK – Durham-based global orthobiologic company Bioventus and nonprofit Edison, NJ-based MTF Biologics, the largest tissue bank in the world, are betting that placental tissue from the birth of newborns can inject new life into the aching knees of older adults suffering from osteoarthritis (OA).
The two companies recently announced a strategic collaboration through which they will develop next generation orthobiologics – likely injectables – for knee joints to reduce pain, promote healing and provide better alternatives to current therapies.
Orthobiologics are products made from substances already found in the body used by orthopedic surgeons to promote faster healing and reduce pain from musculoskeletal injuries and disease processes. They have come into greater use in the last two decades due to technical advances and demand for reduced or no hospital stays and minimally invasive treatments for musculoskeletal issues. They are an emerging and significant sector of regenerative medicine and cellular therapies.
“The placental tissues have growth factors that accelerate healing and reduce inflammation in knee OA that would be promoting the formation of healthier and more durable cartilage based on what a patient already has in their joints,” said Thomas Hill, Bioventus director of corporate communications.
Data Monitor Healthcare reports that there are 23.5 million knee OA patients age 45 and older in the U.S. this year. That number is only projected to grow as the U.S. and worldwide population ages, more experience obesity, which stresses knee joints, and more Baby Boomers and older adults expect and continue to remain active, compared to previous generations.
The Arthritis Foundation estimates that one in two adults will develop symptoms of knee OA during their lives. Other risk factors are previous joint injuries, repetitive wear on the joints over time, weak thigh muscles and genes.
OA is a result of the cartilage, which cushions the joint where the leg bones meet, breaks down. This causes pain, swelling and difficulty moving the joint. Over time, as OA worsens, bits of bone or cartilage chip off and float around the joint (causing that crunchy sound when going up stairs), or the bones may develop growths, called spurs. The body has an inflammatory response, and cytokines (proteins) and enzymes develop, which further damage the cartilage. In the final stages of OA, all cartilage wears away and bone rubs against bone, which causes more joint damage and pain.
Bioventus already has three injectable knee OA products using hyaluronic acid (HA), which is a natural substance already found in joint tissues. HA acts like a lubricant or shock absorber in the synovial fluid, which resides in the knee joint. These products supplement the HA already in the joint to increase the cushion and to relieve pain.
The collaboration with MTF Biologics gives Bioventus access to placental tissues. Hill said the term broadly includes placenta, amniotic fluid, membranes and the umbilical cord. These are donated by birth mothers for research and other medical purposes. Bioventus has been ramping up for this collaboration with the addition of lab space in downtown Durham. The company does not expect to add more employees or manufacture the new products under development in North Carolina.
According to Hill, based upon encounters with the FDA later in 2019 as part of the Biologics License Application process, they expect to fine-tune their timeline for coming to market with a product out of this collaboration. For now, they are projecting sometime in 2024.
Other firms also are working with placental tissues on orthobiologics. According to MarketWatch, the total worldwide industry for orthobiologics, of which treatments for knee OA is a subset, is projected to grow from the current $4 billion to $10 billion by 2025.
Bioventus formed in 2012 when Smith & Nephew, a global medical technology business, spun out its biologics division in Durham in partnership with Essex Woodlands, a health care growth equity firm, and other investors. It has more than 700 employees worldwide, 135 in Durham. It has sales and production offices in Memphis and in Canada. The international headquarters is in Hoofddorp, The Netherlands. The company registered for an initial public offering in 2017 but elected to remain privately held. Smith & Nephew has a 49% stake and the other 51% is private equity. Other orthobiologic products by Bioventus include offerings for surgical and non-surgical bone healing.
About MTF Biologics
MTF Biologics is also known as the Musculoskeletal Transplant Foundation. It is a consortium comprised of leading organ procurement organizations, tissue recovery organizations and academic medical institutions, and governed by a board of surgeons who are leading experts in tissue transplantation. Since its inception in 1987, the organization has received tissue from more than 132,000 donors and distributed more than 8.6 million grafts for transplantation. Through its IIAM subsidiary, it has placed more than 58,000 non-transplantable organs for research. Through its Statline subsidiary, it has managed more than 11.3 million donor referrals.
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