Oraya Therapeutics (Newark, California), a company developing radiosurgical treatments for eye diseases, said it has raised $42 million in Series C financing. Oraya said it would use the financing to expand its clinical trials with two independent international studies to support worldwide regulatory approval and commercial efforts for its treatment of wet age-related macular degeneration (AMD).
Scale Venture Partners (Foster City, California) and Domain Associates (Princeton, New Jersey and Laguna Niguel, California) led the round; current investors Essex Woodlands Health Ventures and Synergy Life Partners also participated. Mark Brooks, a managing director with ScaleVP, and Brian Halak, a partner with Domain Associates, have joined the board.
Michael Gertner, MD, founder and CEO of Oraya, told Medical Device Daily that the financing would be used to complete the company's trials for regulatory approvals. He said the company will be seeking a CE mark, FDA approval, and also reimbursement approval in other countries.
"We made good progress on the development side and our feasibility study is going well, it is time to test it and go for regulatory approval," Gertner said.
Oraya is developing the IRay system, designed to deliver a highly localized dose of low-energy X-ray radiation non-invasively to the macula using a robotic positioning system, targeting algorithm and a device for eye stabilization. Its procedure can be performed quickly in the doctor's office under a topical anesthetic (Medical Device Daily, Jan. 28, 2009).
"We've developed a way to apply very highly localized X-ray beams to the eye and because of the way we do it it's only the eye," Gertner told MDD. "It's a customized X-ray delivery system for the eye, that's what's unique about it and because of that we think we have optimized it for safety."
To date Oraya has raised, with this financing, $64 million since its inception.
"We are very pleased to welcome Mark and Brian to the board at a critical stage for the company," Gertner said. "We believe our approach to treating AMD will result in a paradigm shift, and are seeing encouraging data from our current trials. We are eager to continue trials of the IRay system both in the U.S. and internationally."
According to Oraya, the IRay is a "first-in-class" system that is customized for the disease and physician segment and as a result, can be placed in almost any medical setting.
"Age-related macular degeneration is a leading cause of vision loss in Americans 60 years and older, and current solutions are difficult to endure for patients who need treatment," Brooks said in a company statement. "Oraya has developed a promising and easy-to-administer solution, and the data from the IRay system trials are very encouraging. I'm looking forward to working closely with Michael and the team to help move the product through trials in a timely way and into the market."
"Oraya's novel treatment for AMD has the potential to provide significant benefits to patients, physicians, and payors," Halak said in the same company statement. "I look forward to working with the company to help it realize this potential."
In other financing activity:
• BeneChill (San Diego) – a private device company that concentrates on developing products in the therapeutic hypothermia arena with a focus on rapid, non-invasive cooling for use in the field – reported it has closed a $13.5 million Series C financing. New investor HealthCap (Stockholm) led the financing. Series A and B investors MedVenture Associates, NGN Capital, and the Solon Foundation also participated, BeneChill noted. The company said proceeds would be used to fund early commercialization of its RhinoChill device.
Concurrent with the Series C financing, Johan Christenson of HealthCap joined the BeneChill board.
BeneChill has recently completed its randomized PRINCE (Pre-Resuscitation Intra-Nasal Cooling Effectiveness) study of the RhinoChill device in cardiac arrest patients. This study will determine whether the addition of intra-nasal cooling during resuscitation improves outcome following cardiac arrest over hospital-based cooling alone. Results of the PRINCE trial will be reported at the American Heart Association's (AHA; Dallas) scientific sessions in Orlando, Florida in November.
According to the company, the RhinoChill device is non-invasive, portable, easy-to-use and does not require an external source of power for cooling. The device consists of a nasal catheter which delivers an inert coolant to the nasopharynx in patients requiring hypothermia. The company received a CE mark for the RhinoChill device in 2007.
• NICO (Indianapolis) reported raising $10 million in venture capital. NICO, a company that makes a device used for the removal of brain and spine tumors through open or minimally invasive surgery, said the funding came from Indiana-based Clarian Health Ventures, Twilight Venture Partners and the Halo Group and River City Capital (Cincinnati). Other investors also were involved, the company noted.
The company said its NICO Myriad system has been used in about 80 patients at facilities including the University of Pittsburgh Medical Center and at St. Vincent Health and Methodist Hospital (Indianapolis).
• Addus HomeCare said it has filed a registration statement on Form S-1 with the Securities and Exchange Commission relating to a proposed initial public offering of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined, Addus said. All of the shares in the proposed offering will be offered by the company.
Jefferies & Co. is acting as sole book-running manager and Robert W. Baird & Co. is acting as co-lead manager of the offering.
Addus says it provides a "broad range" of social and medical services in the home. Its services include personal care and assistance with activities of daily living, skilled nursing and rehabilitative therapies, and adult day care.