Regenerative medicine is an emerging market with solutions to not only heal but also grow tissue and bone. Trauma and disease that damage tissue and bones leave a lasting impact that traditional repair methods have failed to address in the long-term. Further, with life expectancy increases and the prevalence of musculoskeletal trauma in active young people, the need is higher than ever for effective, long-term treatments.
U.K.-based startup Renovos is addressing the issue of biological molecule diffusion through a synthetic nanoclay gel technology platform called Renovite. The injectable material stimulates the patient’s stem cells to generate new tissue. With time, it is entirely replaced by the newly-formed tissue at the exact location it was applied.
“Renovite provides an injectable, localized environment conducive to cell attachment and infiltration, acting as a scaffold,” said Agnieszka Janeczek, Ph.D., Founder and CEO of Renovos. “It can also localize and retain therapeutic molecules, which can be used at ultra-low doses.”
Stopping Diffusion in Its Tracks
Though regenerative medicine is on the rise, there are downsides to current biologic solutions, such as Bone Morphogenetic Protein 2 (BMP-2) used in procedures today. The biologic is highly mobile and tends to diffuse; therefore, a high dose needs to be used to achieve clinical efficacy. This can cause serious side effects, such as new bone growing in the wrong place or trapping nerves.
“Renovos’ Renovite nanoclay technology not only ‘tames’ BMP-2, reducing side effects, but also makes the biologic more efficacious at ultra-low doses,” Dr. Janeczek said. “The Renovite platform therefore offers a lower-cost solution for safe delivery of biologics, allowing for their extended use.”
The key advantage of Renovite nanoclay is that it offers superior retention of biologics, and the release is based solely on uptake by the cells infiltrating the material, according to Dr. Janeczek. The versatile nanoclay gels can also deliver, enhance or replace conventional bone fillers, acting as cell scaffolds, as well as add bioactivity to existing materials.
The company’s first product, Renovite BMP-2 gel, offers a safe and rapid application of BMP-2 that reduces the occurrence of failed bone fusion (and associated revision) in spine, ankle and bone defect applications without significantly increasing surgical time. This allows for an attractive price point for the product while taking high costs out of the healthcare system. The decreased risk of ectopic bone formation may allow for access to BMP-2 to higher-risk patients.
“As Renovite is easy to handle and injectable, it can be applied by clinicians with precision and confidence, also for minimally invasive procedures,” Dr. Janeczek said. “This further extends the economic impact to previously unserved patient pools.”
Renovos is not without competition. Many innovative treatments for tissue damage and bone formation incorporate novel biomaterial and cell technologies.
Renovos’ Renovite BMP-2 gel will address the 2.2 million procedures per year that require bone substitutes or orthobiologics. The company will then expand the Renovite platform to other regenerative medicine applications, according to Dr. Janeczek.
“The [Renovite BMP-2 gel] technology is in pre-clinical development, de-risked by various animal proof-of-concept studies. We are currently fundraising to enable clinical trials to start in 2022,” Dr. Janeczek said.
In five years, Dr. Janeczek sees the Renovos Renovite orthobiologics platform deep into a clinical trials program proving the value of the technology both in terms of health economics and improved patient outcomes.
“With the support of expert partners in the field like Orthopaedic Research UK (ORUK), we are rapidly moving towards commercialization and realizing the goal of bringing this regenerative technology to market—and therefore to patients,” she said. “We are happy to discuss collaborations with funding and/or strategic partners that share our vision.”