Clinical studies TRL 5 Hemostasis

Absorbable Bone Wax

Healda's biodegradable bone wax controls bleeding from cancellous bone during surgery without the long-term drawbacks of traditional waxes.

Key features

  • Absorbed by the body
  • No second operation needed for removal
  • Compatible with bone tissue
Technical overview

About Absorbable Bone Wax

Healda's absorbable bone wax is an innovation in topical hemostats, designed to control bleeding from bone surfaces in invasive surgery. Unlike traditional paraffin-based products that remain in the body permanently as a foreign object, it is made from biocompatible, water-soluble polymers such as polyethylene glycol and its copolymers. This advanced formulation lets the surgeon create a temporary physical barrier over the Haversian canals and cancellous bone, stopping bleeding quickly while leaving a safe path for natural bone healing.

The mechanism is mechanical occlusion of the bone vasculature. Healda's soft, mouldable wax adheres reliably to moist bone surfaces and is shaped easily by hand. Clinically, the key advantage of this biodegradable wax is that it does not interfere with osteoblastic activity: once the critical hemostatic phase has passed, the product gradually dissolves in body fluids and is cleared, so it does not obstruct callus formation or cause non-union. That makes it an ideal choice for demanding spinal and orthopaedic procedures.

Datasheet

Technical specifications

Base material
Biodegradable polymer complex (PEG/Poloxamer)
Complete absorption time
6 to 8 weeks (depending on the placement site)
Sterilisation method
Gamma irradiation
Storage conditions
15–30 °C (no refrigeration required)
Form and packaging
2.5 g pieces in double sterile Tyvek packaging
Biocompatibility
Compliant with ISO 10993 (non-toxic and non-pyrogenic)
Clinical applications

Applications

Cardiac surgery (sternotomy)

Control of bleeding from the sternal edges after a median incision in cardiac surgery.

Spinal surgery

Control of bleeding from bone surfaces in laminectomy and spinal fusion.

Neurosurgery (craniotomy)

Stopping blood leakage from the skull while raising bone flaps.

Orthopaedics and trauma

Hemostasis in hip and knee replacement and open fracture repair.

Maxillofacial surgery

Bleeding management in maxillofacial reconstruction and complex implant procedures.

Compliance

Certification and standards status

The status of national and international certifications for this product.

Certification Description Status
ISO 13485:2016 Quality management system for medical devices In progress
ISO 10993 Biocompatibility evaluation In progress
Pre-clinical studies Animal studies in progress In progress
IRC Iranian Ministry of Health marketing authorisation Planned
FAQ

Common questions about this product

How does this product differ from conventional (paraffin) bone wax?
Unlike traditional paraffin-based waxes that remain in the body for life, Healda's wax is fully absorbed within 6 to 8 weeks and does not obstruct natural bone formation.
Does it need warming or any special preparation before use?
No. The product is formulated to have the right consistency at room temperature and can be applied directly without heating.
Does using this wax increase the risk of infection?
No. Because it is biodegradable and provokes no chronic foreign-body reaction, the risk of infection and granuloma is markedly lower than with non-absorbable products.
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