Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities. The company also announced the appointments of three veteran executives to its leadership team to support commercialisation.
Patients treated with Dayspring receive standard of care active compression therapy with a mobility-enabling wearable device. The system includes a low-profile active garment made of soft, breathable mesh using Koya’s proprietary Flexframe technology; a rechargeable, hand-held controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to programme custom treatment options. Koya previously received FDA clearance for Dayspring for the upper extremities in June 2020.
Koya Medical also announced the appointments of additional executive leaders to propel commercialisation plans. As head of sales, Rick Biro will be responsible for building and executing Koya’s go-to-market sales strategy. He joins Koya after serving as area sales director, Central USA at PolarityTE where he was part of the commercial leadership team during the company’s most expansive growth period. Prior to joining PolarityTE, Biro spent more than 15 years in the lymphoedema and wound care space where he held a number of leadership positions with Wright Therapy Products, BSN Medical, and Galaxy Medical Products.
As head of market access and clinical affairs, Liesl Oldstone will work to articulate the clinical value of the company’s highly differentiated product and minimise barriers for patients to access. Her leadership in market access, health economics, and reimbursement has spanned more than two decades in both pharma and the medical device industry for industry-leading companies including ResMed, Bristol-Myers Squibb, Covidien (now Medtronic), Cordis (formerly J&J), and Eli Lilly & Company.
Damian Rippole will join as CFO, and brings more than 20 years of financial leadership experience in both private and public medical technology companies. Rippole was most recently CFO at Ebb Therapeutics (acquired in a private transaction funded by leading global investment firm KKR), maker of an innovative FDA-cleared device for treating insomnia. Prior to that, Rippole was corporate controller for Respironics, a global leader in the sleep and respiratory markets that was acquired by Philips for US$5 billion in 2008. Following the acquisition, Rippole led the global finance integration of Respironics into Philips and served as the group controller for Philips Home Healthcare Solutions business.