dimecres, 29 de juny del 2016

Avita taps IMS for BARDA economics study of ReCell

Avita MedicalAvita Medical (ASX:AVH) said today it tapped health economics group IMS Health to join in an study of its ReCell regenerative medical device to evaluate its economic benefits when used at U.S. burn centers.

The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the company said.

“We have data to show that ReCell is safe, and very effective in treating burns. What we must also demonstrate is how our approach, in conjunction with other treatments, can save public health bodies money, by getting patients out of hospital faster, and improving their outcomes. The IMS study will generate standard budget impact metrics vital to driving discussions on reimbursement and access,” Avita CEO Adam Kelliher said in a press release.

The study is being funded by BARDA through a $61.9m development and procurement contract, the company said, and is expected to take 6 to 8 months as it evaluates the potential cost savings from major interventions for burn treatments, including wound bed preparation, grafting and scar management.

“Burns remain the 4th most common trauma in the international community, and cause 1% of non-fatal injuries in the US. Although burn fatalities have fallen over time, effectively managing burns remains a challenge, with significant morbidity and mortality among burn patients. Potential effects include shock, infection, electrolyte imbalance, respiratory distress, incapacitation, disfigurement, pain, and psychological complications due to scarring and deformity,” IMS said in a prepared release.

IMS said that burns cost the U.S. medical system more than $1.5 billion annually, and that the costs could “increase significantly if there was armed conflict or a mass casualty event.”

This week, Avita Medical said that the U.S. Department of Health and Human Services extended its contract with the company to the tune of an extra $8 million to support the U.S. market approval and launch of its ReCell autologous cell harvesting device.

The company said the additional funds will support the company’s premarket approval application for ReCell, as well as for funding new initiatives to explore the benefits of ReCell for treating burns at U.S. burn centers under the company’s investigational device exemption.

Funds will also be used to bolster personnel at the company’s Northridge, Calif.-based location, with staff focused on regulatory, supply chain, quality systems, clinical support and reimbursement.

The post Avita taps IMS for BARDA economics study of ReCell appeared first on MassDevice.



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