“He had a severe dilated aortic,” recalled Larry Wood, an Edwards executive. “If that ruptures out of the hospital, the mortality rate is very high.”

But Edwards detected the condition in time.

“He had open-heart surgery in less than a week,” Wood recalled.

The NFL veteran’s potentially fatal condition was discovered during a study by Irvine-based Edwards (NYSE: EW) that included screening 498 retired NFL players and their families for hypertension: 84% were positive, while only 47% had self-reported a history of it.

“You’re talking about people who were elite, world-class athletes,” Wood said. “Generally, they think they’re in good health.

“But more than half the people had hypertension and didn’t know they had it.”

Moreover, of all those in the U.S. who received Edwards’ heart valve replacement to remedy the problem, only 3.9% were African American, while African Americans comprised about 14% of the nation’s population in 2022, according to the Pew Research Center.

“It was shocking to me,” said Wood, who heads Edwards’ unit that developed the valve replacement, known as TAVR, for transcatheter aortic valve replacement. “It highlighted the disparity in care.”

Woods said he doesn’t think African Americans suffer fewer heart problems.

Instead, Jerry Abraham, president the Los Angeles County Medical Association and a board member of the California Black Health Network, cites a lack of access to healthcare.

Along with distrust among African Americans of the medical profession, part of a legacy of the infamous Tuskegee experiment, a 40-year study by U.S. public health agencies in which the effects of untreated syphilis on 399 African American men were studied, with most not given penicillin, even after it was discovered as an effective treatment.

Today, Wood said, “It’s tricky to do a study on Black people. It becomes a lightning rod.”

NFL Alumni

Wood, after talking with his friend, former San Diego Charger kicker Rolf Benirschke, came up with the idea of studying former NFL players, about 60% to 70% of whom are African Americans.

“We realized that by working with the NFL Alumni Association and through this unique network of former players, we might be able to gain a greater understanding of how heart disease is impacting underserved populations, and how education, awareness and simple screening tools can save lives in these communities and in the entire nation as a whole,” Wood said.

Edwards said that more than 80% of those with heart valve disease go undiagnosed or untreated, and the undertreatment rate is significantly higher in underserved communities.

Unlike other progressive diseases, such as cancer, there is no age-mandated screening for heart valve failure, Edwards said.

To expand cardiac screenings and heart treatment in minority communities, Edwards has partnered with the Los Angeles Rams in an outreach program called “Off the Sidelines”.

Severe aortic stenosis, a form of heart valve failure, is the most common type of heart valve disease, affecting as many as 1.6 million older Americans.

Though it is deadly—once heart valve disease progresses to heart valve failure, up to 50% of sufferers die within two years—it is also treatable through open-heart surgery or a transcatheter heart valve replacement procedure.

Huddle Up

Edwards began the study, called Huddle, in 2021 by examining the prevalence of heart disease and associated risk factors among members of the NFL Alumni Association and their families.

Conducted across eight U.S. cities in cooperation with NFL Alumni Health, a subsidiary of the NFL Alumni Association, Huddle was a cross sectional study of NFL alumni and their family members aged 50 years and above. The participants were mostly male, 67%, and African American, 63%.

The study participants self-reported their medical histories and participated in heart health education and screenings that included blood pressure, electrocardiogram (EKG) and echocardiogram.

The noninvasive tests could find problems like heart arrhythmia, an irregular heartbeat caused by electrical problems, and hypertension, which can be early signs of stroke and aneurysms.

One participant went straight from the testing to the hospital, Wood said. Another player, about three days after an event, was on a ladder when he noticed symptoms he learned about and immediately identified it as a stroke.

“We detected early stages of heart failures in half of patients,” Wood said. “We’re glad that our study helped people.”

The study didn’t examine whether the athletes were affected by the notorious misuse of steroids, Wood said, adding that the game was much cleaner by the 1980s.

Besides the hypertension results, of all participants screened and found to have an elevated systolic blood pressure, a surprising 74% were also found to have structural heart changes present on a transthoracic echo sonography (TTE).

“These alarming results are a call to action,” said Dr. Michael Amponsah, an interventional cardiologist at the Banner Boswell Medical Center in Peoria, Ariz. “The disparities highlighted in the cohort involved in the Huddle study point to a significant opportunity to examine a greater role for routine age-based screening, and especially for the expanded use of echocardiogram to better identify undetected or undiagnosed heart disease and heart failure.”

The results were presented April 7 during a clinical trials session at the American College of Cardiology and published simultaneously in The Journal of the American College of Cardiology.

Wood said the millions of dollars Edwards spent on the study would not have been justified by an expected return on investment for the company.

“If we detect hypertension early, we may stop people from getting our products,” Wood said. “We’re in the business of helping people, not accelerating heart diseases.

“It’s a real passion project for several of us. Part of our responsibility as a successful company is how to use our resources—to be givers, not just takers.”

Edwards and the Rams

The Los Angeles Rams has teamed up with Edwards Lifesciences Corp. for a new community outreach program for heart testing, “Off the Sidelines.”

Edwards was also the official sponsor of the Rams Legends Community for the 2023 season to raise awareness of heart valve disease and make screening for heart valve failure part of the game plan for everyone 65 and older.

“Off the Sidelines” featured heart valve screening events open to Rams Legends, or former players, to determine if they are at risk for heart valve failure. In addition, the Los Angeles Rams and Edwards Lifesciences brought free heart valve screenings into communities across Southern California.

“The partnership is still in the earlier stages,” said Larry Wood, who heads two of Edwards’ biggest units. “They’ve been spectacular partners. We’re contributing our medical know how to figure out how we can make a difference.”

To kick off the partnership last summer, Edwards hosted a screening for the Rams Legends Community in Irvine prior to the Legends’ Day Training Camp practice.

“Our hope is that this partnership with the Legends community will bring awareness to heart valve failure and encourage people, especially those over 65, to take action,” Wood said.

—Peter J. Brennan

Busy Week at Edwards

Edwards Lifesciences Corp. is busy this week.

Mike Mussallem, who retired as chief executive last year, is also leaving his post as chairman. The company’s annual meeting is scheduled for May 7.

He will be succeeded by independent director Nicholas Valeriani, an Edwards board member since 2014, who has more than 40 years of experience in medtech companies, including as an executive vice president at Johnson & Johnson.

The company is also preparing for its eighth annual event that brings together patients from across the country to meet the Edwards teams that designed, and in some cases, hand-sewed the valves that are in their hearts.

The May 9 event will also feature patient advocacy organizations including the American Heart Association, Aortic Hope, Heart Valve Voice US, Global Heart Hub and the Alliance for Aging Research.

Key to Edward’s Fortunes: Larry Wood

Edwards Lifesciences Corp. has been one of Orange County’s most successful publicly traded companies, having grown from a $1 billion market cap in 2000 when it was spun off from Baxter International, to a $52 billion market cap at press time (NYSE: EW).

Playing a key role has been Larry Wood, who has been running Edwards’ Transcatheter Aortic Valve Replacement unit (TAVR) since its inception in 2007.

The unit, Edwards’ biggest, generated $3.9 billion of the company’s $6 billion in sales in 2023.

Longtime Edwards Chief Executive Mike Mussallem, who retired last year, said Wood started the TAVR business from scratch.

Wood has “dedicated 20 years of his career to create probably one of the greatest innovations in cardiovascular medicine, if not more broadly than any of us has seen,”

Mussallem told investors at the company’s annual meeting last year.

A year ago, Wood took on an expanded role as group president, with additional leadership responsibility for Surgical Structural Heart, which reported $1 billion in 2023 sales, and other key company initiatives.

The company on April 25 reported first-quarter sales rose 10% to $1.6 billion. It also boosted its annual forecast for sales to grow at the high end of its prior guidance of 8% to 10%, $6.3 billion to $6.6 billion. Wood’s TAVR unit boosted sales 6% to $1 billion while the Surgical Structural Heart unit was up 7% to $266 million.

“This encouraging start to the year supports our increased 2024 sales guidance,” CEO Bernard Zovighian said in a statement.

The post Edwards, NFL Tackle African American Cardiac Disease appeared first on Orange County Business Journal.

This newest addition to City of Hope’s radiation therapies, MRIdian, combines magnetic resonance imaging (MRI) and linear accelerators (LINAC) to take detailed pictures of soft tissue in a patient’s body.

The device is most often used to treat complex cancers, such as liver and pancreatic tumors, by more precisely targeting cancer cells, avoiding exposing more healthy cells to excessive radiation.

“Those are very sensitive structures that we don’t want to overtake with radiation,” Dr. Percy Lee, the medical director of City of Hope Orange County’s radiation oncology department, told the Business Journal.

The technology is part of a trio of advanced machines that City of Hope has installed to tailor radiation therapy to individual patients. They are in the Lennar Foundation Cancer Center’s radiation oncology department.

“If a patient has all of those options under one roof, it’s really amazing because the patient won’t have to go anywhere else for it,” President Annette Walker told the Business Journal.

Donations

City of Hope in 2022 opened its 190,000-square-foot outpatient cancer center within its growing $1.5 billion Irvine campus at the Great Park Neighborhoods.

At the end of next year, a 164,000-square-foot cancer hospital will be opening next door to the center after three years of construction. Hospital executives say it will be Orange County’s only hospital dedicated exclusively to treating and curing cancer.

The six-story facility will be connected to the adjacent outpatient center and equipped with 73 beds, four operating rooms, an advanced imaging lab and a blood bank. As with the cancer center, the hospital will be designed with elements of feng shui in mind for inclusivity, such as the absence of a fourth floor, Walker said.

The nonprofit has received several large donations in recent years, including $25 million from the Argryos family and $50 million from the Lennar Foundation, the charitable arm of real estate developer Lennar Corp.

City of Hope topped the Business Journal’s list of recipients of Largest Charitable Gifts of 2023 with a $100 million donation from Andrew and Peggy Cherng, co-founders and co-CEOs of the Rosemead-based restaurant chain Panda Express.

The Cherng family’s donation is going toward the creation of what the hospital says is a novel, oncology program that combines Eastern and Western practices. It’s the largest-ever gift in the cancer hospital’s century-long history.

With these contributions, City of Hope is aiming to create the most advanced cancer care network in OC, according to its website.

Founded in 1913, City of Hope’s headquarters in Duarte has grown into one of the largest cancer research and treatment organizations in the U.S. The company’s OC cancer care network includes regional clinics in Newport Beach, Huntington Beach and Irvine.

City of Hope opened its first Orange County location in Newport Beach in 2020.

City of Hope now has about 600 physicians and more than 1,000 researchers and scientists focusing solely on cancer in Orange County.

Experienced Director

The cancer center has recruited national experts in areas such as radiology, pathology and anesthesiology.

One of them is Lee, who Walker calls is “one of the best in the nation.”

Lee, who earned his doctorate from Harvard Medical School, has written over 350 publications about the benefits of advanced radiation technology.

In August 2022, he helped launch the radiation oncology department, which has since grown from eight employees to about 50.

“When you have technology that’s so sophisticated, you need sophisticated operators running it and directing care,” Walker said.

To be sure, there have been bumps in the road. The radiation oncology department began using its MRIdian last Thanksgiving, just a few months after Denver-based ViewRay Inc., the company that created the technology, filed for Chapter 11 bankruptcy in July.

But ViewRay said it planned to sell some or all its assets and received $6 million in financing from MidCap Financial Services to maintain MRIdian systems at customer sites.

The MRIdian’s combination of magnetic resonance imaging (MRI) and linear accelerators (LINAC) spots soft tissue, which most tumors are made of, better than a traditional computed tomography (CT) scan, Lee said.

While inside the machine, music plays and patients wear glasses that let them see on a screen what’s happening.

“Patients say that really helps with claustrophobia because it’s more of an interactive experience,” he said.

Lee said they prioritize patient comfort. The radiation oncology floor has natural light and some rooms have blanket warmer machines for patients undergoing radiation treatment.

“That may sound like a small thing, but it makes a difference,” Lee said.

Ethos, TrueBeam

The radiation oncology department also houses the TrueBeam and Ethos radiotherapy systems, both made by Varian Medical Systems in Palo Alto.

Lee calls the TrueBeam a work horse, typically used for longer course treatments, such as breast cancer. The machine can rotate in different directions to deliver radiation from many angles.

Ethos, on the other hand, uses an adaptive approach to radiation therapy that changes daily to match the patient’s body, like the MRIdian, except it’s CT-based.

City of Hope officials said the Lennar Foundation Cancer Center is the only cancer center in the world doing adaptive therapy using both machines under one roof.

Doctors will determine which machine best suits patients, based on the movement of the tumors, Lee said.

“The body changes all the time,” Lee said. “In the past, we would just deliver radiation because we couldn’t see these changes, but now, we can adjust treatment plans.”

The post New City of Hope Cancer Killer Spares Healthy Cells appeared first on Orange County Business Journal.

The Irvine-based clinical-stage company (NYSE: AEON) said its ABP-450 treatment for the prevention of chronic migraine did no better than placebo in a Phase 2 trial.

Aeon’s stock quickly fell to about $1.60 per share in intraday trading, down 90% from its all-time closing high of $15.75 on March 15.

The company was “surprised and disappointed that ABP-450 did not demonstrate statistically significant superiority over placebo in this interim readout,” Marc Forth, Aeon’s president and chief executive, said in a statement.

“We are conducting additional analyses of the interim data to understand the highly abnormal and unexpected placebo effect and further evaluate the results of this study to determine the best path forward.”

Aeon’s stock has been on a roller coaster since it went public last July.

The firm has been developing its proprietary botulinum toxin complex to treat migraines, which affect about 1 billion people worldwide, making it the third-most prevalent illness in the world.

Aeon is also studying medication to treat cervical dystonia, where the neck and shoulders have painful twisting movements. Aeon spun off in 2020 from Newport Beach-based Alphaeon, owned by local entrepreneur Robert Grant.

Aeon licenses ABP-450, a toxin, from Daewoong Pharmaceutical Co., a South Korean-based pharmaceutical manufacturer that has invested tens of millions of dollars and has 17% of the shares. Aeon uses the same ABP-450 toxin as Newport Beach-based Evolus Inc., whose flagship neurotoxin product, Jeuveau, competes with Allergan’s Botox in the aesthetics industry.

After Aeon went public through a special purpose acquisition company, also known as a SPAC, last July, the shares began trading around $10 before falling to around $3.37 a month later. Then it started a slow climb, boosted by a January announcement of positive clinical data for its medication that treats cervical dystonia and post-traumatic stress disorder.

By March 18, Aeon reached an all-time high of $17.17 in intraday trading.

The Ride Down

Then the bottom began falling out:

• On March 18, Aeon announced a “productive end-of-Phase 2 meeting.” The Food and Drug Administration meeting followed the Phase 2 data in episodic migraine that had been released in October, and which supported advancing ABP-450 injection into the proposed pivotal Phase 3 program.

As part of the updated development plan, the company said it was conducting an interim analysis of the ongoing Phase 2 study of ABP-450 for the preventive treatment of chronic migraine and anticipates releasing the data in this year’s second quarter.

• That same day, it announced an agreement for a private placement of $15 million in senior secured convertible notes with Daewoong. Proceeds from the private placement will be used to support the late-stage clinical development of ABP-450 and for general working capital purposes.

• On March 29, it reported a fourth-quarter loss of $26.2 million, narrower than the $34.6 million loss in the same period a year before. It also showed that its cash fell to $5.2 million, more than a two-thirds drop from $16.2 million on Sept. 30.

• Also on that day, the company said it would redeem all its outstanding public warrants in exchange for shares. When it went public, it issued 9.2 million public warrants, which gives the owner a right to buy the stock under certain conditions. Exactly how many shares will be issued to warrant holders haven’t yet been disclosed. The company reported 37.2 million common shares as of Dec. 31.

After those four announcements, the stock began a dive, reaching as low as $3.80 by April 25.

Then the bottom completely fell out on May 3 when Aeon released the result of that interim analysis when it reported its Phase 2 trial to treat migraines on ABP-450 didn’t meet its primary endpoint.

The primary endpoint of mean reduction in migraine days over a 13-to-24-week period in 325 patients randomized across three arms showed a reduction of 8.5 days in one case, 7.7 days in a second case while the placebo case showed an 8.4-day reduction.

The post Aeon’s Migraine: Stock Plummets as Drug Test Fails appeared first on Orange County Business Journal.

The post Aeon Biopharma Plunges on Phase 2 Results appeared first on Orange County Business Journal.

Since the April 15 announcement, the stock has risen about 7%.

Keel, most recently the CEO of British engineering company Smiths Group PLC, has also held leadership positions at 3M, General Electric, McKinsey & Company and General Mills.

He is to join the $3.4 billion-valued Brea-based maker of dental products (NYSE: NVST) as both CEO and a board member on May 1.

He’s succeeding Amir Aghdaei, who is stepping down, but will stay on through the transition as a senior adviser, the company said

“After nearly 10 years leading Danaher’s dental platform and the Envista team,” he said in a statement, “it is now time to focus on the next phase of building a world-class dental company.”

Keel joins Envista two months after the company said it was launching a search for a new CEO to succeed Aghdaei. At the time, its stock price had fallen to about $23 a share from about $38 a share 10 months earlier. On April 26, it was trading at about $20.47 a share.

Strong Track Record

Keel was named CEO of Smiths in 2021 and left the post in less than three years.
Smiths last month said that Keel was stepping down to return to the U.S. where most of his family is reportedly based.

Smiths is a $7 billion company with 15,000 employees globally.

“The considerable momentum that makes it so hard to walk away from Smiths right now, also makes this an ideal time to pass the baton,” Keel said in a LinkedIn post last month.
During his tenure, Smiths’ medical division was acquired by ICU Medical Inc. for $2.4 billion in 2022.

Smiths’ medical business includes syringe and ambulatory infusion devices, vascular access and other vital care products.

“Paul’s strong track record as CEO of a public, diversified, global innovation company makes him the right leader for Envista at this stage in our growth journey,” Envista Chairman Scott Huennekens said in a statement.

Keel’s appointment at Envista also marks a return to oral care in his career.

He spent 16 years at global industrial products firm 3M, including three years as president of the company’s orthodontic business.

At 3M, Keel is credited with increasing digitization efforts and overseeing four acquisitions of companies such as Dallas-based Lingualcare Inc., known for its customizable lingual braces called iBraces.

His education includes Carleton College and an MBA from Harvard Business School.

Ex-Danaher Dental Unit

Envista is a legacy business of Beckman Coulter Diagnostics, which was spun off by Danaher Corp., shortly after it acquired Beckman.

Ormco and Nobel Biocare Services make up the company’s specialty products and technologies unit, while its equipment and consumables division are under KaVo Kerr.
Since the IPO, Envista sold its KaVo Kerr business to dental equipment manufacturer Planmeca for $455 million in 2021.

Envista is currently valued at $3.4 billion and reported $645.6 million in fourth-quarter revenue, down 2% from the year prior.

The post Envista Taps Former Smiths Chief Keel as New CEO appeared first on Orange County Business Journal.

Ostrom has ambitious goals for building on the school’s recent rise in reputation from its start a decade ago.

“My vision is that we are a top 50 pharmacy school and top 25 in research funding,” Ostrom told the Business Journal.

The U.S. News & World Report’s most recent ranking rated the pharmacy school at No. 80, up from No. 99 four years ago.

Chapman launched the school in 2013, stating its mission is to inspire students to create new medicines, as well as to meet the demand for pharmacists by local hospitals, drug stores and pharmaceutical companies, both well-established ones like Johnson & Johnson and startups.

Chapman has the 18th highest rate of passing licensing exams out of the nation’s 140 pharmacy schools, he said.

It currently has about 250 students, with enrollment expected to expand by about 20% in coming years. The school offers high school graduates a program to earn a Doctor of Pharmacy degree in five years, rather than the typical eight years.

It has 47 full-time faculty members, with plans to add more. Ostrom said he also aims to double the school’s annual research budget from its annual level around $3.5 million to $5 million.

“Some faculty members are starting their own companies,” Ostrom said. “Their research is generating patentable discoveries.”

Teacher Passion

Ostrom, a fifth-generation Californian, was raised in Chico where his parents were teachers at Chico State University.

He earned his Ph.D. in pharmacology and toxicology from the University of California, Irvine, and was a postdoctoral fellow and research faculty member at the University of California, San Diego School of Medicine.

Why did he pick pharmacy as a profession?

“What I love is trying to discover how drugs work and find new research,” Ostrom said. “It’s like putting together a puzzle that you cannot see.”

In 2003, he joined the University of Tennessee College of Medicine, becoming a professor and then director of the Integrated Biomedical Sciences Program. When Chapman came calling, he was intrigued because of its emphasis on teaching.

“I’ve always loved teaching,” he said. “When you’re a successful researcher at a big research institution, you’re not encouraged to teach and instead to bring in the research dollars. Chapman has a tightly held belief that teaching excellence is the most important.”

Ostrom, who joined Chapman in 2016, has authored or co-authored more than 160 peer-reviewed articles and published abstracts, the school said.

The post Chapman Appoints New Pharmacy School Dean appeared first on Orange County Business Journal.

With cash flow hampered by slow reimbursements from Medi-Cal, Goodman has branched out into taking commercial insurance.

“So, we’ve contracted with about 13 insurance plans in California that we’re now accepting services for, which we weren’t last year,” Goodman said.

Medi-Cal required that Mountain View transition to health plans. That’s what caused the slow Medi-Cal payments—the transition and delay while contracting with the plans.

Goodman, rescued by doctors from a life-threatening health condition as a teenager, now palpably delights in the feeling of providing for those in need, while running a profitable business.

“I’m more concerned about the impact we’re making in our community than the bottom line,” he said.

His Newport Beach-based Mountain View sells and delivers food and medical supplies to about 500 homes for developmentally disabled adults and children, homeless shelters, residences for the elderly, home care facilities, hospices, nonprofits and schools.

His products also include personal care items, nutritional supplements and janitorial supplies.

Over the last year, he’s added customers from Kaiser Permanente, Blue Shield of California Promise and IEHP, among others.

“We’re talking about expansion and growth,” he told the Business Journal recently.

Obstacles

To be sure, Goodman’s challenges have not disappeared.

He said the company is “struggling,” due to a lag in payments from Medi-Cal, California’s Medicaid healthcare program.

“Right now, we’re in a little bit of struggle the last four months because the new MCP’s (managed care plans) haven’t been paying us,” he said. “Once the new health plans start paying again, we will be” on solid footing.

Newport Beach HQ

Since Mountain View Services launched in 1988, it has grown to about 55 employees, with revenue now at about $20 million, Goodman said, in part on the strength of delivering both groceries and medical supplies on the same truck.

Six executives of the management team work at company headquarters in Newport Beach, with the majority of the staff in distribution centers in Redlands and San Bernardino, he said.

The post Mountain View Has Expanded Its Opportunities appeared first on Orange County Business Journal.

About 225 employees of Glaukos Corp. (NYSE: GKOS) peer into microscopes, constructing daily hundreds of eye stent devices that are smaller than the dot in this “j.”

“We make micro-scale implants for the treatment of glaucoma,” Matt Young, senior vice president of Global Operations, told the Business Journal during a tour of the facilities.

“We’ve been told it’s the smallest device ever approved by the FDA.”

Microscopic in size, the company’s products, dubbed the iStent, are often used in conjunction with cataract surgery for the reduction of intraocular pressure.

While small in size, the success of its product is emblematic of big developments for the growth of Aliso Viejo-based Glaukos, whose market value is approaching $5 billion, making it the most valuable public company in Orange County’s expansive ophthalmology industry, a sector that includes scores of device makers, drug companies and artificial lens manufacturers with operations here.

Glaukos’ shares are up nearly 100% from year-ago levels, and not too far off their all-time high.

There’s room for more growth, according to analysts.

“Our checks indicate commercial iDose procedures began as recently as last week and—despite strong recent outperformance by the stock—we argue further upside in GKOS shares exists from current levels,” Stifel analyst Thomas Stephan wrote in a February note to investors, boosting his target price to $110 with a buy rating.

Glaukos ranks No. 13 on this week’s Business Journal list of OC’s largest medical device makers, by local employee count (see list, page 18).

About 454 of its 949 employees work at its facilities in Orange County.

MIGS Pioneer

Founded in 1998, Glaukos pioneered the now well-established microinvasive glaucoma surgery (MIGS) marketplace.

Tom Burns, its chief executive since 2002, was, in the 1990s, general manager of Chiron Vision Corp., founded by the well-known local ophthalmology investor Bill Link. After joining Glaukos as a director in 2001, Link served 20 years before retiring as its chairman in 2021 and was replaced by Burns.

Trials on the iStent began in 2005 and it won Food and Drug Administration approval in 2011, followed by a smaller iStent in 2017.

“The analogy would be cardiovascular stenting but for the eye,” Young said. “These are placed in the trabecular meshwork, and they open that meshwork to get fluid flowing through the eye and that helps to reduce pressure, which is what glaucoma is.

“We do our best to minimize footprint of the product and placement in the eye.”

Medication Delivery

About 15 years ago, Burns asked his scientists if they could invent a device like iStent, to deliver medication.

About 80 million patients worldwide suffer from glaucoma, with 5 million having lost their vision. Research shows 90% of patients are non-compliant with topical medication use and 50% purposely discontinue their medication within six months. Worse, only about 7% of eyedrops can reach the affected area.

“There’s a high rate of non-compliance—it’s a complex dosage,” Glaukos Chief Development Officer Tomas Navratil told the Business Journal earlier this year.

“These topical eyedrops have host of disadvantages.”

In 2012, Glaukos began a decade of clinical trials on what it now calls iDose TR, an ocular implant designed to treat open-angle glaucoma and ocular hypertension.

Doctors implant the iDose, which is made from medical-grade titanium and is about half-a-millimeter wide and 1.8 millimeters long. Once implanted, 75 micrograms of a proprietary formulation called travoprost continuously elutes into the anterior chamber via membrane-controlled diffusion.

Travoprost is 25,000 times more concentrated than a typical glaucoma medication.

Hence, instead of a typical thousands of eyedrops administered per eye over a several-year period, a patient only needs to receive “one administration” of iDose with its formula that is secreted into the affected area 24/7 for up to three years.

Glaukos estimates the potential U.S. market is 1 million eyes.

A big moment occurred on Dec. 14 when the FDA approved iDose TR. Shares jumped 25% that day.

“The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago,” Burns said in a statement.

“We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension.”

Glaukos on Feb. 21 reaffirmed its 2024 forecast that revenue will rise 13% to 17% to $350 million to $360 million. It has a compounded annual growth rate topping 30% in the past decade. It plans to release first quarter results on May 1.

Expanding Facilities

Since 2018, Glaukos Corp. (NYSE: GKOS) has spent more than $600 million on research and development on iDose TR and other innovations, representing more than 30% of its revenue.

Altogether, it has built out 134,000 square feet for iDose TR manufacturing. Part of that was a new, 64,000-square-feet building at its San Clemente complex, which totals about 210,000 square feet.

Glaukos has another 160,000 square feet at its Aliso Viejo headquarters campus, where it moved to in 2022.

Matt Young, senior vice president of Global Operations, who has worked in medical devices his entire career, including at Irvine-based Edwards Lifesciences Corp., showed the Business Journal a two-minute video that condensed a yearlong construction process that was completed last year.

The buildings contain ISO Class 7 and Class 8 clean rooms, which are a couple steps below the Class 5 used to make semiconductors.

The new building, which has massive air conditioning units, has several measures to keep it clean such as air-lock pass boxes to ship finished products out the door. One passageway has an airlock where passersby wait until large sliding doors are open to maintain a consistent air pressure; employees have nicknamed it the “Star Trek doors.”

Many employees take off their street clothes to wear clean scrubs. They often spend hours looking at microscopes and have machines that can weigh travoprost drops that last up to three years in an eye. Much of the machinery was designed in-house.

The company is gearing up for iDose shipments by training surgeons in the first half this year, receiving procurement codes and accelerating its marketing to be at full speed by the end of this year. It’s also developing 14 products to treat areas like dry eye, keratoconus and presbyopia.

The San Clemente facility plans to hire another 30 employes in the coming year.

“There’s a lot going on,” Young said.

The post Glaukos’ Tiny Medical Devices Fuel Expansion for Ophthalmology appeared first on Orange County Business Journal.

The Lake Forest-based maker of implantable lenses for myopia, astigmatism and presbyopia (Nasdaq: STAA) on April 4 reported preliminary first-quarter revenue would top $77 million, when analysts were expecting $72 million.

Importantly, U.S. sales were expected to be $5 million, the company’s highest quarterly Implantable Collamer Lens (ICL) sales in the U.S. since it obtained Food and Drug Administration approval two years ago for its newest ICL product, called EVO.

“U.S. ICL sales were up approximately 20% sequentially to $5 million in the first quarter, which reflects early signs of our increased market focus,” Chief Executive Tom Frinzi said in a statement.

Frinzi also noted European sales climbed 11% while Asia-Pacific sales—by far its largest market—were up 9%. Frinzi said the company expects 2024 net sales at the higher end of a previously announced outlook range of $335 million to $340 million, implying a 3.9% to 5.5% growth rate.

Shares in Staar climbed 34% in the subsequent week to around $50 and a $2.4 billion market cap.

The company ranks No. 23 on this week’s list of Orange County’s largest medical device makers, with an estimated local base of 102 workers (see list, page 18).

Fortune Reversal

The April projections stand in stark contrast to last November, when company executives said initial U.S. growth would be slower than expected and the shares dropped 17% on one day alone. About 58% of Staar’s 2023 revenue of $322.4 million were in China while the U.S. accounted for about 5%.

Jefferies analyst Young Li is forecasting sales will accelerate 17% to $396 million in 2025 and another 19% to $469.3 million in 2026.

He increased his target price from $50 to $60 a share, implying a valuation of seven times 2025 sales.

Myopia Vision

Staar makes implantable eye lenses that compete with LASIK and lessen or eliminate the need for glasses or contact lenses.

Its key product is EVO ICL, which is a single-piece foldable phakic intraocular lens designed to correct myopia. The implant procedure typically takes 20 to 30 minutes per eye; Staar says it has quick recovery and little downtime typically.

Staar said myopia, also known as nearsightedness, is the most common ocular disorder worldwide. The constant staring at cellphones and computers may cause a rise in myopia from 28% of the global population to 50% by 2050, Staar has predicted.

Staar on April 2 said it has sold 3 million lenses since its founding more than 30 years ago.

The company has told investors it wants to boost that number to 6 million in 2026. It estimated the total addressable market is 180 million eyes.

Staar, which has its principal manufacturing facility in Monrovia, is expecting its Lake Forest headquarters will also serve as a future manufacturing site for its Evo Viva lenses, which assists certain patients by eliminating the need for reading glasses or frequent replacement contact lenses.

The post Staar’s Surge: US Sales Surprises Investors appeared first on Orange County Business Journal.

Despite the turmoil, local employment has continued to grow, albeit slowing down in recent years.

The 25 companies on the Business Journal’s list of medical device makers reported 23,092 employees, a 1.1% increase from a year ago. A year ago, employment growth was 2.1%.

The list includes companies with at least 100 employees in Orange County.

Topping the list once again was Edwards Lifesciences Corp. (NYSE: EW) with 5,033 employees, a 3.5% increase from a year ago.

Its employee count may fall next year as Edwards plans to spin off its Critical Care unit into an independent publicly traded company. Separation of the unit, which makes a variety of patient monitoring products for hospital settings, is set to be completed near the end of this year.

“The planned spinoff of our Critical Care product group will enable Edwards to completely focus on structural heart disease, allowing more agility and increased speed of innovation, and we are excited to see what they will accomplish as an independent company,” Chief Executive Bernard Zovighian said in this year’s annual report.

The spinoff is Zovighian’s biggest move since he became CEO last May, replacing Mike Mussallem, who built Edwards into the second most valuable public company in Orange County with a market cap of $54 billion.

Mussallem last month said that he was retiring as executive chairman, effective at the next shareholder meeting on May 7.

Masimo’s Moves

Another possible spinoff comes from Irvine’s Masimo Corp. (Nasdaq: MASI), which is best known for its monitoring products used at hospitals.

Masimo on March 22 announced a potential separation of its consumer business that would include the Stork baby monitor, Freedom smartwatch and hearing aids the company is currently working on.

The company recently said that it was considering a possible joint venture and has already “been approached by a potential partner,” according to the Wall Street Journal.

Masimo saw its local headcount drop 15% to 788 employees. Companywide, its headcount also decreased 8.3% to 9,000 employees.

Boston Scientific Buy

Another big move is taking place at Axonics Inc. (Nasdaq: AXNX), which is being bought by Boston Scientific Corp. for $3.7 billion.

The Irvine-based medical device maker of products to treat incontinence grew its OC headcount by 12% to 331 employees. It is expected to keep its local operations intact after the sale.

The sale is expected to close in the first half of this year, according to Boston Scientific.

“Our team is looking forward to the global impact we can make as part of Boston Scientific as we endeavor to bring these life-changing therapies to more patients than ever before,” CEO Raymond Cohen said in a statement.

Largest Growers

For the second year in a row, the biggest increase on the list, by percentage, was No. 18 Aliso Viejo-based RxSight Inc. (Nasdaq: RXST), whose employee count jumped 44% to 203.

The company, which touts the world’s first adjustable eye lens after cataract surgery, reported revenue increased 82% to $89 million in 2023.

“Since all our products are made in Aliso Viejo, this revenue growth led to a significant expansion of our workforce in Orange County, especially in the manufacturing sector,” Anisa Nammar, associate director of marketing communications, told the Business Journal.

RxSight now offers two lenses in its Light Adjustable Lens (LAL) product line. The company at the beginning of the month announced the commercial launch of LAL+, a new eye lens designed to slightly extend the depth of focus.

The next largest local jump came from Santa Ana’s Medtronic Heart Valves, which climbed 20% to 724 employees, followed by a 20% increase to 454 employees at Aliso Viejo-based Glaukos Corp.

The post Changes Abound for Top Medical Device Makers appeared first on Orange County Business Journal.