LumiThera Chooses bioaccess.™ as its Regulatory and Market Access Consultant to Sell its Innovative Valeda™ Light Delivery System in Colombia
[Orlando, FL, February 17, 2019] — LumiThera, Inc. has chosen bioaccess.™ as its regulatory and market access partner to obtain marketing authorization and commercialize its innovative Valeda™ Light Delivery System in Colombia. Valeda™ is the first approved treatment for dry age-related macular degeneration using photobiomodulation (PBM). LumiThera is at the forefront of the development of PBM treatments for patients with age-related macular degeneration and other degenerative ocular diseases.
The mechanism of PBM at the cellular level has been ascribed to the activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function and initiation of a signaling cascade, which promotes cellular proliferation and cytoprotection.
PBM works through the absorption of photons by photoacceptors in the targeted tissue. Once absorbed, secondary cellular effects include increases in energy production and changes in signaling modalities such as reactive oxygen species, nitric oxide and cellular calcium. Cellular changes occur through activation of transcription factors leading to modulation in protein synthesis, proliferation and ultimately improved cell survival.
PBM is currently used in physiotherapy, arthritis, wound repair and sports medicine and is increasingly being recognized as a therapy for the treatment of serious, life-threatening disease states.
LumiThera is committed to creating a brighter horizon for patients by developing treatment solutions to improve visual function, stop or slow the progression of debilitating eye diseases and prevent vision loss and blindness. Its team of clinicians, scientists and engineers, well-versed in the benefits of PBM, recognized that no treatment solution existed for the dry AMD patient population and that there are unmet medical needs for other debilitating acute and chronic ocular diseases and disorders.
LumiThera created the award-winning Valeda™ Light Delivery System. Valeda is currently CE Marked in the European Union. Valeda is in clinical trials and not approved for use in the United States. LumiThera was recognized as “The Most Innovative And Promising Medtech & E-Health Company” at the 2017 Biovision Conference in Lyon, France. The Valeda Light Delivery System (LT-300) was awarded the 2016 MD&M West Innovation Prize.
LumiThera is expanding its reach to Latin America and has chosen bioaccess.™ as its regulatory and market access consulting company to obtain market clearance at Colombia's medical device regulatory agency (INVIMA) and to guide the company with is market access strategy in the country.
About LumiThera Inc.
LumiThera (www.lumithera.com) is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry age-related macular degeneration; a leading cause of blindness in adults over 65. The company is a leader in the use of photobiomodulation for treatment of acute and chronic ocular diseases and disorders. The company is developing the office-based LT-300 Light Delivery System to be used by ophthalmologists and other eye specialists as non-invasive medical treatments.
bioaccess.™ (www.bioaccessla.com) is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative life science companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America.
bioaccess.™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210