Regeneration, Reimagined
Transforming bone healing through precisely controlled biologic delivery
Transforming bone healing through precisely controlled biologic delivery
A $1bn-$2bn opportunity in bone growth factors
A high-margin market ready for disruption
The US bone graft substitute market is valued at approximately $2.3 billion. Growth factor products represent nearly 40% of that total, dominated by Medtronic’s Infuse—which alone is estimated to generate more than $650 million annually despite persistent concerns around safety, handling, and cost. This has left the door open for next-generation solutions.
The strategic shift towards biologics
Leading spine companies have been openly seeking innovative biologics to fill portfolio gaps. High-margin, low-SKU products such as recombinant human Bone Morphogenetic Proteins (rhBMPs) offer a path away from commoditized, inventory investment-heavy hardware—driving improved outcomes and stronger differentiation.
Locate Bio’s LD Graft
LD Graft: reshaping BMP-2 perspectives
Locate Bio’s LDGraft is a breakthrough bone graft substitute designed to deliver the same high efficacy as Infuse, but with improved handling, safety, and cost efficiency. By precisely controlling BMP-2 delivery, LDGraft is reshaping how bone repair is achieved.
- Avoids “too much, too soon”: Through encapsulation, LDGraft provides critical dose shielding to prevent early BMP-2 presentation during the peak inflammatory period of bone healing. Surface-attached products have consistently shown that premature exposure leads to compounding inflammation and adverse events.
- Timed for natural healing: In humans, anabolic growth factors such as BMP-2 and TGF-β peak after the inflammatory phase subsides — during the repair phase of bone healing. LDGraft mimics this natural biology, aligning growth factor delivery with the body’s regenerative timeline.
- Controlled release: Polymer-controlled BMP-2 release prevents the premature protein stripping by cells or serum proteins suffered by the surface attached products. LDGraft uniquely achieves a linear, five-week release profile—dose shielding during inflammation and releasing the majority of BMP-2 during the repair phase.
- Excellent handling: LDGraft is a room-temperature stable dry powder with the protein fully encapsulated. Upon rehydration with saline at point of use, it instantly forms a familiar putty, ready for implantation—eliminating the 15-minute soak time required by Infuse.
- Future proof platform potential: Using the same encapsulation platform, Locate Bio’s solid-dose formats maintain the same controlled-release and dose-timing profiles, yet can be printed down to the thickness of a human hair. This opens possibilities for point-of-use BMP-2 integration with medical devices and ultra-minimally invasive procedures.
Proven performance
LD Graft is making steady progress towards approval, already having achieved:
- Largest sheep study in the field: All three doses were equivalent to the gold standard in terms of efficacy. Uniquely, LDGraft is the only BMP-2 product tested in sheep that has shown no adverse events—underscoring the importance of dose shielding during the inflammatory phase.
- Global KOL advocacy: backed by leading clinical voices.
- Human trials underway: active pilot study in both the US and Australia.
- FDA recognition: multiple Breakthrough Device Designations.
- Pivotal study next: preparing for full-scale human trials.
About Locate Bio
Locate Bio is a UK-based MedTech innovator with world-class expertise in drug delivery and tissue scaffolds. The team is lean, expert-led, and experienced in scaling and exiting orthobiologics businesses. With in-house manufacturing and cleanroom facilities, the company controls quality and cost from end to end.
The company’s IP portfolio is strong, and its clinical data, manufacturing know-how, and strategic engagement set it apart from competitors. LDGraft has been described by strategics as “once in a generation” and “in a class of its own.”
Why Locate Bio?
- Large unmet need: Addresses a $1bn+ market segment underserved by current solutions.
- Clinical validation: Robust preclinical data, strong KOL endorsement, and imminent human data.
- Regulatory momentum: Multiple FDA Breakthrough Device Designations and innovative trial design.
- Scalable platform: Potential for expansion into additional indications and geographies.
- Experienced team: Proven leadership with deep regulatory, clinical, and commercial expertise.
- Strategic fit: Fills biologics gaps for acquirors, complements hardware portfolios, and offers a differentiated, cost-effective solution.
Locate Bio’s LDGraft is reshaping BMP-2 perspectives by aligning BMP-2 release with the body’s natural healing timeline. With Breakthrough Device Designation, first-in-human trials underway, and strong strategic interest, Locate Bio is excited to be preparing for pivotal trials and ultimately commercialisation.
Get in touch
If you would like more information about Locate Bio or would like to meet up at NASS in Denver (November 14-16), please email us to get in touch.
