Koya Medical Receives FDA 510(k) Clearance for Active Compression Therapy System

Koya Medical, a healthcare company focused on developing breakthrough treatments for lymphedema and venous diseases, has received Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphedema and venous diseases that impact lymphatic flow in lower extremities.
 
The company also announced the appointments of three veteran executives to its leadership team to support commercialization: Rick Biro, Head of Sales; Liesl Oldstone, head of market access and clinical affairs; and Damian Rippole, chief financial officer.
 
New Indication for Lymphedema in Lower Extremities
An estimated 20 million Americans live with lymphedema, a progressive, incurable condition where a buildup of protein rich fluid causes painful swelling in the arm, leg and/or other regions of the body.¹
 
“Lymphedema can be physically and emotionally debilitating for patients, so a daily treatment option that enables mobility and allows them to receive treatment while continuing their daily life activities is a significant breakthrough,” said Andy Doraiswamy, Ph.D., Koya founder, President and CEO. “We are excited about this new indication and milestone, as well as the addition of three new esteemed executive leaders. Rick, Liesl and Damian bring a wealth of highly relevant experience building successful medical technology companies and will be invaluable in supporting Koya as it transforms lymphatic and vein care by providing access to our innovative products to patients all over the world.”
 
Patients treated with Dayspring receive standard of care active compression therapy with a mobility-enabling wearable device designed with real life demands in mind. The Dayspring system includes a low-profile active garment made of soft, breathable mesh using Koya’s proprietary Flexframe technology; a smart, rechargeable, hand-held controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to program custom treatment options.
 
Koya previously received FDA clearance for Dayspring for upper extremities in June 2020.
 
Appointments of Additional Executive Leaders
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 US 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 lymphedema 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 minimize 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 is a strategic and operationally-focused CFO who 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 $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.
 
Reference:
¹ Dean, S. M., Valenti, E., Hock, K., Leffler, J., Compston, A., & Abraham, W. T. (2020). The clinical characteristics of lower extremity lymphedema in 440 patients. Journal of Vascular Surgery: Venous and Lymphatic Disorders, 8(5), 851–859.https://doi.org/10.1016/j.jvsv.2019.11.014