What is the structure of Micropulse Systems?

  • MicroPulse Systems is incorporated as a Minnesota Corporation.

What resources and IP does Micropulse Systems have?

  • Two new patents have been granted for pad construction (US8051516, US8196239).
  • MicroPulse Systems has pad prototypes faithful to the new patent in a small format.
  • MicroPulse Systems has 300 complete original controllers
  • New controller design has additional potential Intellectual Property and can expand to mobile care with battery operated unit.

What differentiates the Micropulse System from existing preventions and treatments?

  • The Micropulse System is thin and stable enough for use, (approx 1⁄2” thick). All other alternating pressure options have very large cells (9” thick) that do not provide sufficient patient stability.
  • The Micropulse System does not need to be deflated to perform CPR like large cell alternating pressure pads.
  • The Micropulse System does not vent air like low-air loss systems.
  • The Micropulse System requires much less power consumption than large cell alternating pressure systems.
  • The Micropulse System has been proven effective in two clinical studies.

Why did the previous commercialization of Micropulse cease operations?

  • Hospital developed injuries were still reimbursed by Medicare prior to 2008 so there was no incentive for prevention.
  • Sales were Lease/rental only which was not appealing to care facilities who wanted to avoid recurring costs.
  • Quality issues with pad construction.
  • Current CMS reimbursement to hospitals at $600/month/patient for pressure ulcer therapy (capped at 10 months) was not available.

What investment was made in the previous commercialization?

  • Privately held Company formed in 1996 as a Delaware Corporation.
  • Invested over $7 million in initial research and development.
  • Completed clinical studies proving safety and efficacy.
  • Approval CE rated.
  • Filed IP; initial patent issued Oct. 11 1989. What FDA requirements exist for manufacturing?
  • FDA 510k file 880.5550 from the previous commercialization is attached to Micropulse Systems.
  • The device class is exempt from 510K under CFRxxx.9 where xxx refers to parts 862 – 892.
  • FDA requires a letter of intent to manufacture and quality controls for GMP (good manufacturing practice)
  • An ISO certified manufacturing facility has been identified to meet FDA requirements.

Are there any opportunities for purchase orders for development units?

  • Canadian health care officials stated that they have 221,000 patients at risk, and have expressed interest in purchasing units.
  • 5 local hospital/care centers, have expressed interest in purchasing development units.
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Aronovich Study, Russell 2002 Study, pressure sore, pressure ulcer, decubitus ulcer, alternating pressure mattress, mattress overlay, small cells, operating room ulcer prevention, pressure ulcer prevention, decubitus ulcer prevention, Medicare, Medicaid

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