Liberate Medical, a local medical device maker, gets sales green light

A Louisville area medical device company has received clearance to sell its core product on the open market.

Liberate Medical LLC has received the “CE mark” or certification mark from a European Union regulatory body that allows device makers to sell their products.

Angus McLachlan, CEO of Crestwood, Ky.-based Liberate Medical, said in an interview it will start to sell its VentFree device to distributors, rather than going directly to hospitals.

“We’re transitioning from a clinical stage company into a commercial stage company; it’s a pretty big milestone and a lot of work went into getting us here,” McLachlan said. “It’s been a long road to get here.”

The VentFree device stimulates the respiratory muscles of patients who are on mechanical ventilators for more than four days. When a ventilator helps a patient breathe, the respiratory muscles begin to rapidly deteriorate because they are not being used. VentFree stimulates the muscles, impacting atrophy and allows for quicker rehab from mechanical ventilators.

The effort to commercialize the product will launch at the beginning of 2020. The company is starting with a soft launch in a limited number of countries and then will expand throughout the entirety of the EU. The company is establishing its manufacturing to prep for sales.

“This means more patients will be able to benefit from the device and that’s a great thing as well,” McLachlan said.

Because the company will sell directly to distributors, who will in turn sell to providers, Liberate Medical will be able to maintain a smaller salesforce during the commercialization process.

McLachlan declined to specify the company’s sales goals in the early days. But he added that the focus early on will work on refining how it markets and trains people on the use of VentFree.

The company was founded in 2013. It was spun off of Crestwood-based Apellis Pharmaceuticals. In May, it closed a $1.35 million fundraising round to help it prep for the final steps of approval in Europe and start the regulator review process in the U.S. with the Food and Drug Administration.

Liberate Medical is in the pre-submission phase of FDA medical device review. The company was granted the Breakthrough Device designation for VentFree in January. That means that the FDA has certified that VentFree provides “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The company is working with the FDA to establish the best pathway for possible review and approval. McLachlan said the company intends to submit its application to the FDA in 2021.

https://www.bizjournals.com/louisville/news/2019/10/29/liberate-medical-a-local-medical-device-maker-gets.html