The Memo: Marine Biomedical Turning Mother of Pearl Into the Next Generation of Bone Grafts

Under the direction of CEO Rolee Kumar, Marine Biomedical is advancing a novel approach to bone regeneration by transforming mother of pearl from Western Australia’s pearling industry into a biomaterial designed to support natural bone healing. Built on research originating at the University of Western Australia, the company has developed PearlBone™, a marine-derived bone graft substitute that combines the consistency and scalability of manufactured materials with the biological architecture found in nature. With an FDA 510(k) submission under review, a planned clinical trial on the horizon, and manufacturing operations established in Broome, Marine Biomedical is working to bring an entirely new category of regenerative biomaterials to orthopedic surgeons.

Origin Story

Marine Biomedical’s roots can be traced back to the University of Western Australia and the work of regenerative medicine pioneer Professor Ming Hao Zheng, who recently received the Member of the Order of Australia for his contributions to the field. Alongside orthopedic surgeon Dr. Rui (Chris) Ruan, Zheng began exploring a deceptively simple question: Could nature provide a better blueprint for bone repair?

The answer emerged from an unlikely source.

Located in Western Australia, the company sits within one of the world’s most renowned pearling regions. For generations, the industry has harvested some of the world’s highest-quality pearls. Yet the oyster shells that house those pearls remained an underutilized byproduct.

“They came together, and the idea was, why don’t we look at nature to solve the problem with bone grafts?” Kumar explained. “They looked at the architecture of a pearl shell, and it mimics a lot of what natural bone does.”

The founders discovered that nacre, also known as mother of pearl, shares structural characteristics with human trabecular bone. After millions of years of natural evolution, the material had developed a complex architecture that appeared uniquely suited to supporting bone regeneration.

That concept eventually led to the formation of Marine Biomedical in 2021 and the development of PearlBone, the company’s platform technology built around marine-derived regenerative biomaterials.

The Current Landscape

The global bone grafts and bone graft substitutes market is estimated at approximately US$3–4 billion today and is projected to exceed US$5.5–6.0 billion by 2032–2033, driven by increasing fracture rates, aging populations, spinal fusion procedures, and demand for advanced regenerative biomaterials.

Yet existing solutions come with significant tradeoffs.

Autografts, which use the patient’s own bone, remain the clinical gold standard. However, harvesting that material requires a second surgical site, increasing procedure complexity, recovery burden, and surgical time.

“You are actually increasing the burden of recovery for the patient because you’re creating another site of injury,” Kumar said.

Alternatives such as allografts and xenografts can avoid that additional surgery, but they introduce challenges related to supply, variability, cost, and patient acceptance.

As a result, many companies have focused on synthetic bone graft materials that offer manufacturing consistency and reliable supply chains. The challenge is that these products often struggle to match the biological performance of natural bone.

“This is the opportunity that PearlBone is trying to capture,” Kumar said. “You’re kind of marrying the worlds of being able to produce something and have the consistency of supply and manufacturing it, but also being able to marry it up with a biological performance.”

The need is only expected to grow. Aging populations, increasing rates of osteoporosis, and rising demand for orthopedic procedures continue to drive interest in new approaches to bone regeneration.

Inside the Innovation

At the center of Marine Biomedical’s platform is PearlBone, a marine-derived calcium carbonate biomaterial developed from pearl oyster shell.

According to the company, the material is engineered into a porous, biocompatible scaffold designed to fill bone voids and defects, support new bone formation, and integrate with the body’s natural bone matrix. Over time, the scaffold is gradually resorbed and replaced by native bone as healing progresses.

Marine Biomedical’s manufacturing process begins with sustainably sourced oyster shells from Western Australia’s pearling industry. Through proprietary processing methods, the company isolates and refines nacre’s regenerative structure before converting it into a sterile, clinically engineered biomaterial.

The initial application is focused on orthopedic trauma, specifically bone defects associated with tibial plateau fractures.

From a surgeon’s perspective, ease of use has been a key design consideration.

“The PearlBone itself is a granule, which can be made into a putty,” Kumar said. “You can make it either using the patient’s blood or saline, and you mix it up and make it into a putty, which a surgeon can mould to fill a bone void.” 

That flexibility allows surgeons to conform the material to irregular defects and fracture voids.

“PearlBone fills the defect and provides a scaffold that supports bone healing,” Kumar explained. “It remains in place for as long as it’s needed, then gradually disappears as new bone forms.”

Preclinical studies have generated encouraging results. Using the FDA-accepted Rabbit Critical Defect Model, Marine Biomedical evaluated PearlBone against a commercially available predicate.

"Compared with the predicate device, PearlBone demonstrated greater bone regeneration and significantly faster remodelling over time. By 26 weeks, the material was almost fully resorbed and replaced by new bone, resulting in more complete bone formation and trabecular architecture than the predicate in this model," Kumar said.

By the end of the study period, the material had largely resorbed, leaving behind regenerated bone.

“At 26 weeks, there’s hardly any PearlBone left, so you just see this beautiful bone structure that’s formed,” she said.

Progress and Milestones

Marine Biomedical has entered what may be the most consequential period in its history.

The company recently submitted its FDA 510(k) application for PearlBone, positioning the United States as its initial commercial market. The strategy reflects both the size of the U.S. orthopedic market and the regulatory pathway available for bone graft products.

At the same time, the company is preparing for a clinical trial expected to begin early next year while continuing to scale manufacturing operations in Broome.

Even establishing those operations represented a significant milestone.

“Setting up a manufacturing facility in Broome is quite a pioneering thing to do,” Kumar said. “Broome’s not known for a medtech industry at all.”

Today, Marine Biomedical operates a GMP manufacturing facility in the region and is preparing for the next phase of growth, including production scale-up, clinical validation, and eventual commercialization.

The company is also implementing an electronic quality management system and laying the operational foundation required to support future expansion into additional indications such as spine and dental applications.

To support those efforts, Marine Biomedical is actively raising capital ahead of its next phase of growth. The company is seeking approximately US$3.5 million to fund clinical studies, manufacturing scale-up, and preparation for commercial launch.

For Kumar, the focus remains clear.

“The company is at a very exciting and really pivotal stage,” she said. “The 510(k) is going to be very important for us. We are working very hard to see if we can get that approval by the end of this year, preparing ourselves for the human clinical trials, and scaling up our manufacturing.”

If successful, Marine Biomedical could demonstrate that one of the world’s oldest natural materials still has new lessons to teach modern medicine. By turning a sustainable byproduct of the pearling industry into a regenerative scaffold for bone repair, the company is seeking to bridge biology, manufacturing, and sustainability in a way few bone graft technologies have before.

Join Us at LSI Asia ‘26

Kumar has been selected to present at LSI Asia '26, June 30th–July 3rd, in front of hundreds of global medical technology companies. Join us in welcoming her to the event in Singapore, where she will share the latest updates on Marine Biomedical’s technology and development.