May 11, 2016 10:57am
Favorable outcomes reported in Critical Limb Ischemia (CLI) study in New Delhi, India
Follow-up data from a compassionate use initiative to treat six patients with late-stage CLI using KOOL’s SergWerks showed favorable outcomes in lifestyle and pain reduction.
The procedures, conducted by Dr. Suhail Bukhari of the Fortis Escorts Heart Institute and Research Center in New Delhi, India showed patients’ pain scores fell from an average of 7.6 before treatment to 0.67, with four of the six patients reporting no pain. Foot ulcers and open wounds appearing on five of the six original patients healed, while five of the six were amputation-free after six months.
CLI is a late-stage form of peripheral artery disease that can result in severe non-healing ulcers and potential loss of limb due to the lack of blood circulation. Approximately 70 K patients undergo major limb amputation as a result of CLI each year in the U.S. alone. Further 135 K patients undergo minor amputation that results in a significant decrease in quality of life.
The Bottom Line: KOOL has received approval from the U.S. FDA for a pivotal trial for CLI using its SurgWerks System, and is preparing to submit an IDE supplement for review.
KOOL closed UP $0.01 Tuesday at $2.26 and is DOWN -$0.01 at $2.25 on51.1 K share volume (3-month average = 22.3 K shares).