MacroPore Biosurgery Completes Clinical Evaluation of New Polymer Implant System

Strategic Insights -

MacroPore Biosurgery Inc, a San Diego-based company, has completed a 12-month clinical evaluation of its new faster resorbing polymer (FRP) bioresorbable implant system. The product, cleared by the US Food and Drug Administration (FDA) for craniofacial and neurosurgical applications, has shown comparable safety and efficacy to the company's existing craniomaxillofacial (CMF) and neurosurgical fixation systems. The successful trial will result in a $5 million payment from Medtronic Inc, which acquired MacroPore's CMF/neurosurgical business unit in a deal valued at up to $21 million. MacroPore is also expecting an additional $2 million milestone payment once the transfer of manufacturing know-how is completed, which will allow the company to recognize up to $10 million on the sale of CMF/N assets currently held on its balance sheet as deferred gain.

Key Takeaways:

  • MacroPore Biosurgery Inc has completed a 12-month clinical evaluation of its new faster resorbing polymer (FRP) bioresorbable implant system.
  • The FRP system, cleared by the US FDA for craniofacial and neurosurgical applications, has shown comparable safety and efficacy to MacroPore's existing CMF and neurosurgical fixation systems.
  • The successful trial will result in a $5 million payment from Medtronic Inc, which acquired MacroPore's CMF/neurosurgical business unit in a deal valued at up to $21 million.
  • MacroPore is also expecting an additional $2 million milestone payment once the transfer of manufacturing know-how is completed.
  • The company is working with Medtronic to meet the final condition of the sale agreement and will recognize up to $10 million on the sale of CMF/N assets as deferred gain once the payment is received.
  • MacroPore develops bioresorbable polymer implants for use in various surgical applications, including spine, neurosurgical, and musculoskeletal surgeries.
  • The company is also working in the field of regenerative medicine using adult stem cells derived from a patient's own adipose tissue.
  • MacroPore's products are distributed through a variety of channels, including Medtronic, the company's own direct US sales force, and an international distribution network.

Statistics:

  • MacroPore Biosurgery Inc has developed 20-patient, 12-month clinical evaluation of the new FRP bioresorbable implant system.
  • The FDA has cleared the FRP system for craniofacial and neurosurgical applications.
  • The deal with Medtronic Inc, valued at up to $21 million, includes a $5 million payment related to the sale of the CMF/N business unit.
  • MacroPore is expecting an additional $2 million milestone payment once the transfer of manufacturing know-how is completed.
  • The company is traded on the Frankfurt Stock Exchange in Germany.
  • MacroPore has a direct US sales force and an international distribution network for its products.

Sources:

  • MacroPore Biosurgery Inc press release, December 2003.
  • Medtronic Inc, "MacroPore Biosurgery Completes Clinical Evaluation of New Polymer Implant System," [www.medtronic.com](http://www.medtronic.com), December 2003.
  • "MacroPore Biosurgery Inc Completes Clinical Evaluation of New Polymer Implant System," BioSpace, December 2003.