Avedro is a Waltham, MA–based ophthalmic pharmaceutical and medical device company led by CEO Reza Zadno, PhD. The company has developed a patented corneal cross-linking technology that includes drug formulations and medical devices, which is approved for sale in numerous countries. Avedro is developing proprietary corneal remodeling products to treat keratoconus, corneal ectasia and to provide refractive correction as an alternative to contacts and eyeglasses. It secured $25M in financing to support its programs. The company plans to use the funds for product development, clinical studies and commercial efforts, including expansion of sales and reimbursement support. Avedro’s board gained Hongbo Lu, PhD, as a representative of the lead investor in connection with the financing. Avedro develops and commercializes corneal cross-linking pharmaceutical and device therapies, including FDA‑approved Photrexa Viscous, Photrexa and the KXL System. The company sells additional capital equipment and formulations outside the U.S., such as UV‑X devices, the KXL and Mosaic Systems, and VibeX and MedioCROSS. Avedro announced a combined $42 million equity and debt financing to support commercial expansion and pipeline and clinical development programs. It has opened a new manufacturing facility in Burlington, Massachusetts, near its Waltham headquarters, to increase production capacity and support a global supply chain. The facility employs 5S, Lean and Six Sigma methodologies and will accommodate an anticipated year‑over‑year increase in large capital equipment production in 2017. Avedro is also expanding its corporate team to support growth and broader commercialization efforts. Avedro develops corneal cross-linking platforms and related pharmaceuticals, including the KXL and Mosaic systems and formulations such as VibeX and MedioCROSS. Its Mosaic System performs the PiXL procedure, intended to deliver non-surgical correction of myopia and improve cataract surgery outcomes. The company distributes products outside the United States through a network of ophthalmic medical device distributors; its products are not approved for sale in the United States. Avedro has re-submitted an NDA to the U.S. FDA for its corneal cross-linking technology and anticipates a PDUFA action date in April 2016. Proceeds from recent financing are intended to strengthen the balance sheet, expand global distribution of KXL, commence commercialization of Mosaic outside the U.S., and support potential U.S. commercialization if FDA approval is received. The company describes its work as advancing the science and technology of corneal cross-linking and refractive correction. Avedro develops corneal crosslinking capital equipment and related pharmaceutical (riboflavin) products used to treat multiple corneal pathologies and to improve LASIK outcomes via its Lasik Xtra procedure. The company’s products have received CE Mark and have been commercially launched in 32 countries outside the United States; Avedro’s products are not for sale in the U.S. It reports that nearly 50,000 Lasik Xtra procedures were performed worldwide in 2012. Avedro is preparing to launch a new device platform that it says will open significant new procedure opportunities previously demonstrated in early trials. Its technology is being evaluated in three Phase III clinical studies in the U.S. involving more than 100 sites. The company plans to pursue U.S. FDA approval and expand applications of corneal crosslinking into cataract and refractive surgery. Avedro is a privately held ophthalmic device and pharmaceutical company based in Waltham, MA developing systems and procedures to biomechanically strengthen and modify the cornea. The company produces and sells the KXL System for performing Lasik Xtra and Accelerated Cross-linking and the Vedera System for performing Keraflex, an incisionless thermal procedure to flatten the cornea. Both devices are CE Marked and commercially available outside the United States. Avedro positions KXL as a way to enhance the LASIK market by offering patients added security and Vedera as able to induce refractive change without removing tissue. The company completed a $25 million Series C and plans to use the proceeds to expand commercial operations of the Vedera and KXL Systems outside the United States and to seek U.S. FDA clearance.

Total raised

$167M

Funding rounds

6

Latest round

Equity

Latest activity

May 2018