Resorbable Bone Wax and Bone Void Fillers

Resorbable Bone Wax and Bone Void Fillers

While we have been commercializing the CellerateRX business we have also been strategically planning the market launch of products in our pipeline from our Resorbable Orthopedic Products (ROP) subsidiary. ROP plans to file 510ks for resorbable bone wax and bone void filler products in the next few weeks.

  • $1.4 billion worldwide bio materials market
  • Resorbable orthopedic hemostat used to stop blood flow and delivery system for osteogenic / osteoinductive orthopedic products
  • Less than $100k to finalize products to market, filing of 510ks (1H 2011)
  • Assets acquired in Sept. 2009
  • US Patent issued in July 2006 (7,074,425)

Resorbable Orthopedic, LLC is a wholly owned subsidiary of Wound Management Technologies and has the rights to several patented technologies including a resorbable bone wax and a delivery system for orthopedic bone void fillers, among others.


Bone is tissue much the same manner as skin, heart and muscle. As in all tissue, bone tissue is nourished and maintained by a healthy blood supply and when injured, bone bleeds but is also capable of repair. This repair is essential in restoring some degree of strength to the tissue whose principle function is support.

When bone is subjected to surgical trauma it has the potential to bleed as the blood vessels are damaged. Control of the bleeding during surgery is important to:

  • Maintain blood pressure;
  • Reduce blood loss;
  • Keep the surgeons visual surgical field clear;
  • Prevent the formation of adhesions.
Visit BioStructures' website to learn more about bone, how bone heals, about bone grafting, and more!

BioStructures.net

 

On 11/11/11 Wound Management Techonologies and BioStructures released a press release disclosing an agreement for ROP product development. The full release can be read here: 11/11/11 Press Release


 

When bone is compromised during surgery, bleeding is typically controlled via the application of pressure. The product most frequently employed by surgeons to maintain that pressure is bone wax, which physically attaches to the hard tissue.


The majority of the bone wax products available on the market today are capable of controlling the bleeding but because in most cases they are not metabolized away nor resorbed by the body, they form non-resorbable bone wax granuloma and can subsequently delay the healing process.


The Resorbable Orthopedic Products LLC polyethylene glycol (PEG) formulation performs identical to the beeswax used in many of the Bone Wax products available today but is resorbable by the body which creates a significant advantage over its competitors for several reasons;

  • Able to be metabolized by the body
  • Will NOT delay bone healing
  • Reduced risk for post surgical infection

PEG is adherent and water-soluble. This PEG formulation is an excellent delivery system for biomaterials that impact the rate at which bone repair takes place.


Our orthopedic biomaterials product is situated in the $1.4 Billion worldwide bio-materials market. This significant demand is driven by improved patient benefits, a shorter FDA approval cycle and an aging population who are becoming ever more aware of biomaterial benefits.


The product is expected to be available on the market in 2012 pending approval.

 

Resorbable Bone Wax and Bone Fillers