Newport Beach-based Alliance HealthCare Services Inc. executives recently gave shareholders an overview of the recent change in majority ownership and several other matters.
Alliance provides diagnostic radiology, interventional radiology, and pain management and radiation oncology through fixed and mobile sites.
The company said late last month that Fujian Thai Hot Investment Co. was buying 5.5 million shares of Alliance for $102.5 million to become its majority shareholder. Thai Hot is based in Fuzhou, China.
“The recent news regarding a change in ownership for [about] 51.5% of the company’s shares does not imply a change in strategic direction or financial outlook for the company,” Chief Executive Percy “Tom” Tomlinson said.
He spent some time discussing Thai Hot and how it decided to invest in Alliance.
Thai Hot has assets totaling more than $1 billion, including investments in biomedicine and healthcare.
The investor “performed extensive due diligence” and “confirmed their strong support” for Alliance’s direction and leadership, Tomlinson said.
“We made our strategic investment in Alliance primarily because of our assessment of the strong growth opportunities present in the U.S. healthcare market,” said Thai Hot founder Kisum Wong, who will join Alliance’s board.
The healthcare provider, which has about 1,000 hospital customer relationships, “is uniquely positioned to capitalize on the growth,” Wong said.
Yong Ge, Thai Hot’s deputy general manager, and Tao Zhang will also be appointed to Alliance’s board. The Chinese trio will replace Michael Harmon, Curtis Lane and Aaron Bendickson.
ReVision Nears Trial End
Lake Forest-based ReVision Optics Inc. said late last month that it submitted to the Food and Drug Administration the fourth and final module of a premarket approval application for its Raindrop Near Vision inlay for correcting presbyopia.
The form of farsightedness commonly occurs in people 45 or older. Raindrop is a microscopic hydrogel inlay that’s implanted in a patient’s nondominant eye in a minimally invasive procedure.
ReVision said the fourth module of its application has clinical data from more than 300 subjects who’ve been followed for at least 24 months after receiving Rainbow.
Chief Executive John Kilcoyne called completing the submission “clearly our most significant milestone to date in advancing the Raindrop toward FDA approval and expanding our commercial footprint into the U.S. market.”
The FDA already accepted and closed two modules of ReVision’s application, and the company is anticipating closure of the third module, which involves manufacturing, this year, Kilcoyne said.
Timing “would suggest a Raindrop approval in the second half of 2016,” he added.
The company received $55 million in equity funding in 2013 from several investors, including Johnson & Johnson Development Corp., the venture capital arm of New Brunswick, N.J.-based Johnson & Johnson.
Sironis Gets FDA Warning Letter
Newport Beach-based Sironis Inc., in other FDA news concerning OC device makers, recently received a warning letter from the agency on clinical trial issues.
The FDA said in the letter that Sironis failed to ask for or win an investigational device exemption approval for a clinical study of its LIR closed-loop fluid administration device.
“Your firm began an investigation of a significant risk device on November 15, 2012, and failed to submit an IDE application to FDA,” the agency said in the letter, which was dated March 15 and made public in late September.
In December 2013, Sironis “published findings in a medical journal from a study in which your unapproved device was used,” the FDA said.
The FDA noted that Sironis’ clinical trial sites had enrolled 66 subjects, according to the company and a letter to the agency from the University of California-Irvine Office of the Vice Chancellor for Research, and added that the company’s failure to obtain FDA approval prior to enrollment “may have placed study subjects at increased risk of harm.”
“Please do not conduct any further investigations of your device until you have obtained the appropriate FDA approval,” the agency told Sironis in the letter.
Sironis also failed to inform an institutional review board about changes to the trial, failed to adequately describe the risks of the trial, and didn’t reveal the existence of alternative treatments, as required, the FDA said.
Sironis “worked closely with the site visitor to understand the FDA’s concerns and positions. Our full response to the warning letter (including our steps to address each concern and to bring Sironis into compliance) went back to the FDA earlier this year and the investigation has been subsequently closed,” said Dr. Joseph Rinehart, Sironis’ president and co-founder.
