Sanuwave gets regulatory approval for dermaPACE system in Mexico
The dermaPACE System is designed to treat diabetic foot ulcers, venous and arterial ulcers, and post-traumatic and post-surgical wounds.
SANUWAVE Health, a non-invasive medical technology firm, has received the regulatory approval to market its dermaPACE System for chronic wounds, in Mexico.
The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) has approved the device for various chronic wounds, including diabetic foot ulcers (DFUs), venous and arterial ulcers, and post-traumatic and post-surgical wounds.
The company has developed the Pulsed Acoustic Cellular Expression (PACE) Technology, which was first used in the dermaPACE System for wound treatment.
SANUWAVE Health chairman and chief executive officer Kevin A Richardson, II said: “COFEPRIS clearance to market dermaPACE in Mexico is a key achievement in our global expansion strategy and represents our second distribution agreement in the Latin America region.
“We look forward to working with MEDSTENT to bring our non-invasive shockwave technology to the millions of patients across Mexico who suffer with unhealing, chronic wounds.
DermaPACE System is designed to deliver shockwave technology
The dermaPACE System is designed to deploy shockwave technology, which has been used in lithotripsy procedures and in orthopedic treatments since many years.
The company claimed that its dermaPACE System is the first and only FDA approved system to deliver electrohydraulic shockwave technology, to treat diabetic foot ulcers (DFU).
The device has been granted CE Mark approval in Europe for advanced wound care indications and a Health Canada Medical Device class II License in Canada.
Furthermore, the dermaPACE System is currently approved for advanced wound care indications in Brazil, Mexico and other countries around the world.
Sanuwave, MEDSTENT joint venture will market the device in Mexico
In addition to the regulatory approval, the company has also established a joint venture with Mexican biomedical firm MEDSTENT.
The joint venture allows MEDSTENT to exclusively market and distribute the company’s dermaPACE System for chronic and acute wounds in Mexico, on a profit sharing basis.
Established in 1995, MEDSTENT is engaged in providing biomedical products and service in Mexico.
MEDSTENT chief executive officer Daniel Capuano said: “Incorporating SANUWAVE’s dermaPACE System into MEDSTENT medical products portfolio allows us to leverage our experience in the vascular surgery markets in Mexico.
“We are creating a wound care specialty within our vascular expertise and this joint venture with SANUWAVE provides us with a broad offering for vascular surgeons, who also treat these recalcitrant, chronic wounds.
“We look forward to partnering with SANUWAVE and expect a successful launch of this end-to-end wound care offering in Mexico, where limited effective treatment options can often lead to lower limb amputations.”