Startup Transcend to submit PMA in second half for glaucoma micro-stent after positive pivotal data
|Transcend Medical's CyPass Micro-Stent|
Venture-backed startup Transcend Medical is expecting to submit a PMA for its novel minimally invasive glaucoma surgical implant during the next half of the year. The move comes after the company garnered positive pivotal data, which it has just released.
The pivotal COMPASS study met it primary endpoint, finding that implantation of the company's CyPass Micro-Stent as part of cataract surgery provided a 20% or greater reduction in intraocular pressure from baseline in a significantly higher proportion of eyes compared to cataract surgery alone at one-year and two-year postoperative exams.
"The CyPass Micro-Stent represents the next wave of innovation in the minimally invasive glaucoma surgical category," said Dr. Steven Vold, president of Vold Vision in Fayetteville, AR; chair of the COMPASS steering Committee; and one of the lead investigators for the study, in a statement.
"With an elegant, straightforward implantation procedure coupled with these positive clinical outcomes, the CyPass Micro-Stent is positioned to provide a valuable new therapeutic option for ophthalmologists treating their cataract patients suffering from glaucoma," he added.
The COMPASS study was a prospective, randomized, controlled trial conducted at more than 20 U.S. sites in more than 500 patient with mild-to-moderate glaucoma undergoing cataract surgery. Patients were randomized to receive the CyPass Micro-Stent after cataract surgery or undergo no further intervention.
The CyPass Micro-Stent is the first minimally invasive glaucoma stent designed to reduce intraocular pressure by enhancing aqueous outflow to the suprachoroidal space. The device is implanted in a procedure that enables it to avoid the trabecular meshwork and Schlemm's canal--a drainage pathway that is believed to be compromised in glaucoma patients. The device has already received a CE mark.
The startup garnered a $22 million Series C round in April 2014 to support this pivotal trial; prior to that it got a whopping $51 million in July 2011. Its investors include Morgenthaler Ventures, Split Rock Partners, Canaan Partners, Investor Growth Capital, Technology Partners, HLM Venture Partners, Latterell Venture Partners, Kaiser Permanente Ventures, Finistere Ventures and the undisclosed corporate investor.
"We are very pleased with the results of the COMPASS trial," said Brian Walsh, president and CEO of Transcend Medical, in a statement. "We believe the CyPass technology has the potential to help the millions of patients who suffer from glaucoma worldwide, and we look forward to FDA's review of our PMA submission."
- here is the release
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