The latest development in the minimally invasive glaucoma surgical (MIGS) space comes from Glaukos (Laguna Hills, California) as the company has reportedly filed for an initial public offering (IPO) to raise $86 million. The move comes just shy of a month after Ivantis (Irvine, California), another player in the MIGS space, revealed that it had completed enrollment for the HYRDUS IV, a 550-patient study evaluating the firm's solution for MIGS (Medical Device Daily, April 20, 2015) and just a week after Transcend Medical (Menlo Park, California) revealed its intent to file a submission to the FDA seeking approval for CyPass, in the second half of this year (MDD, May 8, 2015).
Glaukos, which was established in 1998, has developed the iStent Trabecular Micro-Bypass Stent system or simply iStent, is the only FDA-approved MIGS solution. The device is inserted through the small corneal incision made during cataract surgery and placed into Schlemm's canal, a circular channel in the eye that collects aqueous humor and delivers it back into the bloodstream. Once inserted, the company said that the iStent improves aqueous humor outflow, while fitting naturally with Schlemm's canal.
In its regulatory filing, Glaukos revealed that its sales for the device "increased from $20.9 million in 2013 to $45.6 million in 2014, and our net losses were $14.2 million and $14.1 million for the years ended Dec. 31, 2013 and 2014, respectively."
In addition the company said these "losses have resulted principally from costs incurred in clinical trials, research and development programs and from general and administrative expenses."
Glaukos has financed its operations primarily through the private placement of its preferred equity securities, debt financing through a credit line and, more recently, sales of the iStent. The company told MDD via e-mail that it would not comment beyond what was presented in the filing.
The iStent received the nod for approval from the FDA in 2012. The technology has also secured CE mark.
What makes the U.S. approval so significant, is that it's the first device in the MIGS space to be green lit by the FDA. Transcend and Aquesys (Irvine, California) are probably going to be the next two companies with devices on the market, according to those close to the space. Larry Haimovitch, president of Haimovitch Medical Technology Consultants (Mill Valley, California), a regular contributor to MDD, said that these products are probably not going to get approval or be on the market until the end of next year.
Haimovitch labeled the space, which has seen an uptick in activity over the last few weeks as "hot."
"The [MIGS] space may be the hottest space in the med-tech sector, and it certainly is the hottest within ophthalmology," Haimovitch, told Medical Device Daily.
If funding is any indication, then venture capitalists seem to be attracted to MIGS companies. According to data compiled from Haimovitch Medical Technology Consultants and published in the May 8th edition of MDD, five of the firms in the MIS space, which includes Glaukos, have raised a total $459 million. The breakdown for funding is as follows: AqueSys $77 million; InnFocus (Miami) $30 million; Ivantis $107 million; Glaukos $156 million; Transcend Medical $89 million.
Glaukos securing an IPO would not only be a first for the MIGS firms, but it would certainly bode well for the space, Haimovitch noted.
"It will cast further positives on this space if Glaukos' IPO goes well," he said. "It is doubtful in my view others will file in the next many months, recall that none of them are expected to be in the U.S. market for another 18-34 months."
In other financings news:
Forbion Capital Partners (FCP) reported an investment in Autonomic Technologies Europe as part of the $38 Million transatlantic series D round raised by Autonomic Technologies (ATI; Redwood City, California), a developer and manufacturer of Pulsante, a microstimulator to treat severe headaches.
ATI has started commercialization of the Pulsante microstimulator in Europe and established Autonomic Technologies Europe GmbH, a wholly owned subsidiary in Germany, to further expand European commercialization. In addition, the company will use proceeds from the financing to fund the ongoing IDE study.