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Friday, Sep 30, 2022

OC Gets Heart: Medtronic, Edwards Report Trial Updates

Orange County’s reputation as one of the country’s top medical device hubs is well-deserved, and its cardiovascular disease-focused device makers are buzzing with activity.

Irvine-based Edwards Lifesciences Corp. (NYSE: EW), the largest publicly traded local company, with a nearly $29 billion market cap, recently announced positive outcomes from several trials, including one-year outcomes of self-expanding transcatheter heart valve Centera, and comparison data for expanding the use of Sapien 3 valve for intermediate risk-patients with severe aortic stenosis.

Centera received European CE Mark approval in February. It hasn’t been cleared by the Food and Drug Administration in the U.S.

Medtronic PLC (NYSE: MDT) recently announced it started a clinical study in the U.S. to assess the safety and efficacy of Resolute Onyx Drug-Eluting stent for the treatment of coronary bifurcation lesions, which occur at or near a major coronary artery. The multicenter study will enroll 250 patients at 30 sites in the U.S. and Europe.

The stent, which received FDA approval last year, is the first and only coronary stent to use core wire technology enabling thinner struts while maintaining structural strength, according to a company press release.

The release said the technology will provide doctors with stent sizes of 4.5 and 5 millimeters to treat patients with large coronary arteries.

The medical device company’s tax residence is in Dublin, Ireland, and has operational headquarters in Fridley, Minn. Its local operations are in Santa Ana, primarily for manufacturing surgical heart valves.

Last month Medtronic’s Covidien Neurovascular unit signed one of the biggest office leases of the year in the county, consolidating operations into 102,000 square feet at UCI Research Park in Irvine. Its heart valve and neurovascular operations employ about 1,700 here.

Last week, Hancock Jaffe Laboratories Inc. raised $8 million by offering 1.5 million shares at $5 each.

The Irvine-based medical device maker develops bioprosthetic implants designed to treat chronic deep-vein insufficiency and heart valve conditions, and coronary bypass grafts.

In December the company said it planned to price nearly 1.9 million shares at $6 to $8 apiece, which would have generated approximately $13.1 million in gross proceeds at the midpoint. In another filing, Hancock said it would price roughly 1.1 million shares in the same price range for gross proceeds of $6.9 million to $9.1 million. It ultimately raised $8 million but had to offer an upsized number of shares to make up for the $5 apiece price, below its targeted $6 to $8 range. Shares would trade on the Nasdaq under the symbol HJLI.

Hancock sold its ProCol vascular bioprosthesis in 2016 to Burlington, Mass.-based LeMaitre Vascular Inc. (Nasdaq: LMAT) for $665,000 in upfront payments, plus a three-year royalty of up to $5 million. It’s developing a bioprosthetic porcine heart valve for pediatric patients that it hopes to start a first-in-human study on next year.

Hancock still has quite a while to go to attain regulatory approval. Its other two products, CoreoGraft and VenoValve, are in preclinical studies.

Dry Eye

Aliso Viejo-based Visionary Ventures Fund LP and Sioux Falls, S.D.-based Bluestem Capital led an $8.5 million series B preferred stock funding to provide growth capital to Tear Film Innovations Inc.

“We continue to see the value in [Tear Film Innovations] and fully support the company’s leadership team in bringing this important dry eye treatment option to the eye care market,” said Visionary Venture Managing Partner Jeffry Weinhuff.

The San Diego-based ophthalmic device maker develops the iLux system, a portable hand-held device that uses light energy to warm meibomian glands—which are responsible for producing meibum, an oily substance that keeps tears from evaporating. The device applies localized heat and pressure therapy to the upper or lower eyelid. It comes with a single-use disposable smart tip and precision temperature sensors to continually monitor inner eyelid temperature.

It’s not a first-time investment for Visionary Ventures. The ophthalmic-focused venture capital firm, which is affiliated with local accelerator OCTANe, also led a $9 million series A preferred stock funding for Tear Film in November. San Diego-based seed-stage investment firm and incubator Tigris Ventures was also a lead investor.

Tear Film received FDA clearance for its device in December. It introduced the therapy to ophthalmologists at this year’s annual meeting of the American Society for Cataract and Refractive Surgery in April.

Bits & Pieces

Irvine-based Quality Systems Inc. (Nasdaq: QSII), known to its clients as NextGen Healthcare, promoted Betty Rabinowitz to chief medical officer, reporting to Chief Executive Rusty Frantz. She joined the company in August, following her roles as a founder and chief executive of EagleDream Health, the cloud-based analytics and population health management software that’s now NextGen Population Health.


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