Kinetic’s Prevena Cleared by FDA – Analyst Blog

Kinetic Concepts Inc. (KCI) recently received approval from the US Food and Drug Administration (FDA) for its negative pressure wound therapy (NPWT) product, Prevena Incision Management System. It is the first and only powered negative pressure product designed specifically for management of surgically closed incisions. The product is expected to be accessible to the hospitals in early July.

 

Prevena embodies a prospective billion-dollar, global market opportunity for the treatment of millions of patients worldwide. The system, designed for single-patient use, is indicated for application over clean, closed incisions that continue to drain following sutured or stapled closure. Prevena includes a single dressing for the duration of therapy, which acts as a barrier to external infectious sources.

 

The Prevena system is already available in Europe and Canada since March 2010. The surgeons gave a positive response for the system, as it met all unmet requirements in the surgical suite.

 

Prevena’s launch in the US is an important milestone in strengthening the worldwide NPWT product portfolio, specifically designed for the surgical suite. The launch further diversifies Kinetic’s Active Healing Solutions (AHS) portfolio, which offers advanced wound healing and tissue repair systems using its Negative Pressure Technology Platform to meet the needs of specific care settings and wound or patient requirements.

 

Kinetic engages in the design, manufacture, marketing and service of wound care and therapeutic products in the United States and internationally. Its products are used in wound healing and tissue repair, pulmonary care in the intensive care unit, bariatric care, and wound treatment and prevention.

 

In the first quarter of 2010, AHS’ worldwide revenue increased 6% over the first quarter of 2009. Kinetic’s long-term goal includes the development and commercialization of new, next-generation products in NPWT for the treatment of chronic wounds and hard tissue defects. We expect the Prevena launch to provide further boost to the top line in the coming months.