January was a busy month for Irvine-based patient monitoring device maker Masimo Corp., which announced Food and Drug Administration approval of two devices. Its latest news—it received FDA clearance for its next-generation SedLine brain-function monitoring device—moved up company shares nearly 3% trading to $94 on Jan. 29 following that announcement.
The device monitors the brain’s state under anesthesia by measuring changes in electrical activity. The newest version includes an enhanced patient state index and better EEG data display. It can be used with O3 regional oximetry, which helps clinicians monitor oxygen in the brain.
Shares of Masimo currently trade at $84 for a $4.3 billion market cap.
Masimo also got an FDA nod last month for home use of its Rad-97 Pulse CO-Oximeter. The device takes the patient monitoring company’s flagship capabilities, such as blood oxygen and carbon dioxide level metrics, and puts them into “a compact new design, which will allow broader applications in many new settings, including low-resource countries and homes,” said Chief Executive and Chairman Joe Kiani in a company press release.
Rad-97, which got FDA clearance in September, also features a multitouch display, built-in Wi-Fi and Bluetooth wireless connections, in addition to an optional camera that allows clinicians to remotely interact with patients over live audio and video.
Masimo also secured approval to market its RD Rainbow Lite SET sensors in Europe.
Separately, it announced it’s studying whether oxygen reserve in the blood can provide early warning of exercise-induced hypoxemia in obese patients.
Kiani is also chief executive of Cercacor Laboratories Inc. in Irvine, which makes a noninvasive monitoring device targeting endurance athletes. In December, it introduced an Android version of the app, which previously was available only on iPhones. It also added a parameter last month, allowing users to measure and monitor dysfunctional hemoglobins unable to carry oxygen from the lungs to cells.
Botox Contender
Botox continues its reign as the top grosser for Allergan PLC, as more than one company is hoping to take a slice of the market share. Irvine-based Evolus Inc. plans to raise approximately $65 million by offering $5 million shares at $12 to $14. It plans to list on the Nasdaq under the symbol EOLS.
Cantor Fitzgerald and Mizuho Securities are the joint bookrunners.
Evolus has finished all clinical studies of its neurotoxin, a Botox biosimilar to be used in facial aesthetic procedures. It submitted data for European CE Mark and the FDA for approval, according to a Securities and Exchange Commission filing. Evolus licensed the compound from Daewoong Pharmaceutical Co. Ltd. in Seoul.
It had filed for an initial public offering of up to $75 million, according to the filing. It said proceeds would be used to provide “financial flexibility,” including fulfilling payments due to Daewoong and others. Proceeds remaining, according to the filing, would go toward building a sales force and commercial infrastructure upon approval of the drug.
Evolus is a subsidiary of Alphaeon Corp. in Irvine, which is an affiliate of Newport Beach-based investment firm Strathspey Crown Holdings LLC. Strathspey changed its name in April to SCH-AEON LLC to reflect its core focus on Alphaeon.
The Business Journal reported last week on Bonti’s expansion of therapeutic Botox.
Bits & Pieces
Rancho Santa Margarita-based True Wearables Inc. won the iF Design Award, which is given by Hannover, Germany-based design firm iF International Forum Design GmbH. True Wearables makes Oxxiom, a wireless device that monitors blood pulse and oxygen. The single-use, disposable device operates continuously for 24 hours. It’s not yet cleared by the FDA for clinical use as a medical device. … Mission Hospital and Children’s Hospital Orange County at Mission Hospital received verification from the American College of Surgeons as level two trauma centers for adult and pediatric trauma services. CHOC at Mission Hospital is comprised of 54 beds on the fifth floor. Mission Hospital, a 552-bed medical center in Mission Viejo, is part of Renton, Wash.-based Providence St. Joseph Health’s 50-hospital network. … Newport Beach-based Hoag Memorial Hospital Presbyterian was named one of America’s best hospitals for heart care and obstetrics via the 2018 Women’s Choice Award. The award, its fifth since 2014, placed Hoag in the top 9% and 17%, respectively, of U.S. hospitals offering heart care and obstetrics services.
