ThermoTek, in Collaboration with WRS, Among Winners in FDA's Opioid Innovation Challenge
FDA Looks to Industry Leaders to Recommend Solutions in the Opioid Crisis
Jan 15, 2019, 08:45 ET
FLOWER MOUND, Texas and ANN ARBOR, Mich., Jan. 15, 2019 /PRNewswire/ -- ThermoTek, a leading manufacturer of cold compression therapy devices, is thrilled to announce they have been selected in the FDA's Opioid Innovation Challenge. ThermoTek partnered with WRS, a musculoskeletal healing company, to submit the application, given their national scope of operations and experience collecting outcome data.
The FDA called for applications from industry leaders to present solutions to address the abuse of heavy-duty painkillers in what has been considered a public health emergency. More than 250 companies submitted applications in the FDA's Opioid Innovation Challenge and ThermoTek is among the eight selected to accelerate the development of their products and address the opioid crisis.
"The opioid epidemic is at the forefront of our healthcare crisis and we're honored to be selected and recognized," said Sam McSpadden, CEO of ThermoTek. "We intend to work together with WRS and the FDA to expand the VascuTherm's indications for use, resulting in broader acceptance of and accessibility to our cold compression therapy products."
ThermoTek's VascuTherm technology was chosen as an effective alternative to highly addictive opioid therapies to treat and manage post-surgical, traumatic, and chronic pain. Selected applicants will now work directly with the FDA to accelerate the development and expedite marketing application review of innovative products, similar to what occurs under the Breakthrough Devices Program. With this support, ThermoTek can pursue more expeditiously the required clinical evidence to support an opioid-free alternative therapy market clearance as well as a mechanism to provide more complete insurance coverage for these alternative therapies.
More about ThermoTek
ThermoTek has been a leader in the medical device industry for more than 25 years. ThermoTek VascuTherm devices help post-surgical orthopedic patients heal more quickly, more naturally, and more comfortably, while dramatically reducing their consumption of opioids. They are committed to providing the most streamlined, cost-effective, and sustainable user-friendly devices available. To learn more, visit https://www.thermotekusa.com/.
More about WRS
As a national provider of world-class cold-compression therapy and point of care dispensing, WRS is focused on developing innovative programs that make patient recovery more efficient and effective, without driving up the cost to the payors. Their multi-modal approach to pain management combats the runaway opioid epidemic head on, and helps drive consistently better outcomes for patients. To learn more, visit http://www.wrspecialists.com/.
Lynch Communications Group, LLC
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