PRODUCTS & PROGRAMS
AcuFocus Inc. of Irvine is preparing to launch its small aperture intraocular lens for the treatment of cataracts in the U.S.
The company recently submitted its pre-market approval application to the Food and Drug Administration for its IC-8 lens and is hiring a salesforce ahead of its anticipated U.S. market approval in late 2021.
The IC-8 uses the small aperture mechanism of action (channeling light through a small opening) to essentially create a new pupil that extends depth of vision and may reduce visual disturbances, Chief Executive Al Waterhouse said.
The product is expected to “address diverse unmet needs and help patients achieve best personal vision,” he said.
Waterhouse joined AcuFocus from Abbott Medical Optics in 2015 and was appointed to his current post in 2016. He sold the company’s former flagship product, the KAMRA small aperture inlay corneal implant, and transitioned its focus to the development of the IC-8.
AcuFocus is looking forward to taking advantage of the well-established IOL market, with about 5 million procedures performed annually in the U.S., Waterhouse said.
The company, which has raised more than $200 million since its 2001 inception, is also actively pursuing studies of the IC-8 that could lead to approvals for treatment of cataracts in eyes with corneal irregularities.
Prodoscore, a workforce productivity software platform, is teaming up with Michelle Wax and The American Happiness Project to host free online motivational workshops for businesses.
The Irvine-based firm said its workshops will address positive mindsets, reinforcing habits, generating energy, and harnessing stress for productivity amid remote work and social distancing.
Upcoming workshops with interactive components are scheduled for April 7, April 22 and May 5 at 1 p.m.
Prodoscore had its first full-year of generating revenue in 2020, with growth coming from existing customers adding more employees to its platform as well as new customers joining the platform, the company said.
Other milestones in 2020 included completing platform integrations with LinkedIn, Slack and others, expanding channel partnership agreements, and launching a research council to produce insights on remote workforce behaviors.
NEW HIRES
JenaValve Technology Inc. has named Jane Metcalf its vice president of regulatory affairs and quality.
The Irvine-based firm is the developer of transcatheter aortic valve replacement (TAVR) device that is designed for the minimally invasive treatment of both severe aortic regurgitation and stenosis.
Metcalf was most recently vice president of regulatory affairs and quality at Laguna Hills-based root canal device maker Sonendo. She previously held positions in regulatory affairs at Interventional Spine, Rebound Therapeutics, and Viseon Spine, all based in Irvine.
Metcalf “has a strong track record of successfully developing strategies for worldwide regulatory approvals of innovative devices,” Chief Executive John Kilcoyne said.
“I am excited Jane is joining us at this pivotal time as we continue to enroll patients into our ALIGN-AR clinical trial and move forward in our efforts to commercialize our TrilogyTM heart valve for the treatment of aortic regurgitation.”
JenaValve raised a $50 million round of financing led by Bain Capital Life Sciences last February. Additional investors include Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.
ACQUISITION
CenExel Clinical Research Inc. of Salt Lake City recently acquired CITrials.
Terms of the deal were undisclosed.
CITrials is a clinical research firm with a mix of outpatient clinics and inpatient facilities in Santa Ana, Riverside, and Los Angeles. It conducts Phase I to Phase IV clinical studies with a focus on mental health and neurological disorders such as Alzheimer’s disease, depression, PTSD, schizophrenia and others.
“Our mission and performance are ideal complements to the CenExel’s operating culture, and we see this as an important means of serving our clients with more single- and multi-site studies,” Debra Hoffmeyer, founder and CEO of CITrials said.
CenExel was founded in 2018 to bring together services in clinical trial design, execution and analysis.
It has grown through multiple acquisitions and now has a total of eight facilities across five states including Anaheim Clinical Trials, a 30,000-square-foot, 90-bed research facility in Anaheim.
INCUBATORS
EvoNexus Orange County has closed its startup incubator in Irvine.
The organization said it did not renew its lease at UCI Research Park at the end of last year because only five or six individuals were using the coworking space on a routine basis.
“We received a strong response from our local and highly valued mentors and selection committee members, as well as the local investor community and the many entrepreneurs and startup companies that applied to EvoNexus,” Managing Director Bob Genthert said of EvoNexus’ time in OC.
“I truly appreciate the hard work, volunteerism, and dedication by everyone who made EvoNexus Orange County a special place for the local startup community to thrive.”
Genthert said the one area that EvoNexus Orange County struggled to gain support was in sponsorship dollars, except for funds from the Irvine Co., Blizzard Entertainment and Extel Technologies.
EvoNexus started in San Diego and expanded to Irvine in 2015. The technology-focused incubator has provided crucial support to several established companies, including artificial intelligence-powered chipmaker Syntiant and Swift Health Systems, the developer of invisible braces that sit behind the teeth.
Current portfolio companies are now in the process of moving to EvoNexus’ newly launched virtual incubator.
Westcliff University, a privately held institution based in Irvine, recently launched its Innovation Hub and startup incubator inside of its main campus at the Intercept office complex.
The innovation center “is already giving startup companies the benefits of access to multiple cohorts of diverse students educated with the latest business curriculum,” Chief Executive Anthony Lee said.
“The incubator was developed to help accelerate business growth while concurrently giving students the hands-on, real-world business experience employers desire.”
The first companies to join the incubator include:
•Seekr z.com, an online trading platform for pre-owned luxury streetwear.
• Research-based game developer Brain Leap Technologies, which is making “gaze-driven” games to help children improve their attention skills and learning outcomes.
• Fyncom, a nanopayment platform that offers micro-financial rewards to drive user engagement. The company’s flagship product, KarmaCall, incentives more than 10,000 users to block and report robocalls.
• Semiconductor company AONDevices, which specializes in application-specific edge artificial intelligence processors to improve smart devices. It was previously a portfolio company of EvoNexus Orange County.
