News & Insights

VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a clinical-stage healthcare company dedicated to people living with chronic autoimmune diseases, today announced late-breaking data from the RESET-RA study presented at the American College of Rheumatology (ACR) Convergence 2024, the largest global gathering of rheumatologists. New clinical trial results support the SetPoint System's potential as a first-of-its-kind neuroimmune modulation treatment for adults living with moderate-to-severe rh

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no FDA approved treatments. Arrowhead also intends to submit applications for approval of investigational plozasiran for the treatment of patients with FCS to a

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced new results from the Phase 3 PALISADE study and the open-label extension from the Phase 2 MUIR and SHASTA-2 studies of investigational plozasiran. These data were presented in two oral presentations at the American Heart Association Scientific Sessions 2024 (AHA24) and PALISADE data was simultaneously published in the AHA journal, Circulation. “In the Phase 3 PALISADE study in patients with and wit

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company” or “Adagio”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today announced, today provided business updates for third quarter ended September 30, 2024. Recent Business Highlights: Reported total company revenue of $185 thousand in the third quarter of 2024, compared to $41 thousand in the third quarter of 2023. In September 2024, secured CMS coverage (

BEVERLY HILLS, Calif.--(BUSINESS WIRE)--GordonMD® Global Investments LP announced today that its portfolio company, Flare Therapeutics Inc., has entered into a strategic discovery collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY). Flare will lead discovery and preclinical activities targeting multiple transcription factor targets in oncology, while Roche will pursue the further preclinical and clinical development and commercialization of potential products from the collaboration, leveragin

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced that its management will participate in the Jefferies London Healthcare Conference on Thursday, November 21, 2024 at 8:30 a.m. GMT. A live webcast of the presentation will be available on the Masimo website at www.masimo.com. A replay of the webcast will be available following the live presentation. About Masimo Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-l

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Prof. Dr. Laura van 't Veer, co-founder of Agendia, pioneer in personalized cancer care and co-developer of the MammaPrint® genomic breast cancer recurrence test, will be honored in November and December at three prestigious breast cancer symposia in Italy, the Netherlands and the U.S. for her pioneering work in molecular cancer diagnostics and breast cancer research over the past 30 years. MammaPrint was developed in 2002 and approved by the FDA in

IRVINE, Calif.--(BUSINESS WIRE)--TAE Life Sciences (TLS), a leader in developing boron neutron capture therapy (BNCT) technology and associated innovative boron target drugs, and Stella Pharma, the pioneering developer of boronophenylalanine (BPA) under the product name Steboronine® for BNCT, are pleased to announce a strategic collaboration focused on the development, commercialization and expansion of BNCT using BPA in the United States and European markets. Stella Pharma’s BPA drug is the wo

IRVINE, Calif.--(BUSINESS WIRE)-- #InvestorRelations--SBC Medical Group Holdings Incorporated (“SBC Medical”, or the “Company”), a global owner, operator and provider of management services and products to cosmetic treatment centers, today announced its unaudited financial results for the third quarter ended September 30, 2024. Third Quarter 2024 Highlights Total revenues for the three months ended September 30, 2024 were $53 million, representing an increase of 12% from $47 million in the same quarter of 2023. Tot

THOUSAND OAKS, Calif.--(BUSINESS WIRE)---- $ATRA #CART--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that Cokey Nguyen, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Stifel 2024 Healthcare Conference on Monday, November 18, 2024 at 6:10 a.m. PST / 9:10 a.m. EST. A

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced that its management will participate in the Stifel 2024 Healthcare Conference on Monday, November 18, 2024 at 11:30 a.m. Eastern Time. A live webcast of the presentation will be available on the Masimo website at www.masimo.com. A replay of the webcast will be available following the live presentation. About Masimo Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industr

LANCASTER, Calif.--(BUSINESS WIRE)--Simulations Plus, in partnership with the University of Connecticut, was awarded a new FDA grant to investigate additional LAI product technologies.

LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL™) for myopia, astigmatism and presbyopia, invites investors and the general public to listen to a webcast fireside chat with STAAR Management at the upcoming Stephens Annual Investment Conference, which will be held in Nashville, TN. Event: Stephens Annual Investment Conference (NASH2024) Management Attendee: Patri

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ, a leader in endoscopic imaging and operating room (OR) integration, is proud to announce that the IMAGE1 S® CONNECT II camera control unit has earned certification to UL 2900-2-1 through the UL Cybersecurity Assurance Program. UL 2900-2-1 is a national consensus standard published by the American National Standards Institute and recognized by the FDA as a path to fulfilling the agency’s cybersecurity testing recommendations for medical devices. “

IRVINE, Calif.--(BUSINESS WIRE)-- #EpilepsyCare--Nihon Kohden, a global leader in medical device innovation for high-precision patient monitoring and diagnostics, today announced the acquisition of a 71.4% stake in NeuroAdvanced Corp., the parent company of Ad-Tech Medical Instrument Corporation (Ad-Tech), a trusted provider of specialized electrodes for epilepsy treatment and neurodiagnostic procedures. The move further solidifies Nihon Kohden's position as an industry leader by combining its established expe

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Sonendo, Inc. (“Sonendo” or the “Company”) (OTCQX: SONX), a leading dental technology company and developer of the GentleWave® System, today reported financial results for the third quarter ended September 30, 2024. Recent Highlights Generated $8.0 million total revenue for the third quarter of 2024 and carried over a double-digit console backlog for the third straight quarter; Drove substantial increases in GAAP gross margin and adjusted gross margins (no

THOUSAND OAKS, Calif.--(BUSINESS WIRE)---- $ATRA #CART--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the third quarter 2024, recent business highlights, and key upcoming milestones. “With the first patient now enrolled in our Phase 1 NHL trial of ATA3219, we have taken an important ste

SOUTH SAN FRANCISCO & LOS ANGELES & SAN DIEGO--(BUSINESS WIRE)--Biocom California, the association representing the California life science industry, today announced that it appointed Kathryn Lowell, group vice president of global government affairs at BioMarin; Stephen Hatke, vice president of operations and site head for Takeda; and Tina Self, senior vice president, biologics manufacturing capacity cluster leader and Berkeley site head at Bayer, to its board of governors. “With deep knowledge

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Sonendo, Inc. (“Sonendo”) (OTCQX: SONX), a leading dental technology company and developer of the GentleWave® System, today announced that management will postpone the third quarter 2024 conference call that was previously scheduled for after the market close on Tuesday, November 12th, 2024. The Company intends to issue a press release disclosing third quarter 2024 financial results and will file its quarterly report on Form 10-Q on November 12th, 2024. Ab

RIVERSIDE, Calif.--(BUSINESS WIRE)-- #ClinicalResearch--The Heart & Kidney Health Screening offers no-cost Lp(a) testing as well as screenings for other related metabolism and kidney risks.

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that its management is scheduled to participate in the following upcoming investor conferences: Stifel Healthcare Conference on Tuesday, November 19, 2024, at 12:40 p.m. ET in New York City, NY Stephens Annual Investment Conference on Wednesday, Novembe

EL MONTE, Calif.--(BUSINESS WIRE)--Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent,” or the “Company”), a technology-based company with a well-established laboratory services business and a therapeutic development business, today announced financial results for its third quarter ended September 30, 2024. Third Quarter 2024 Results: Total Revenue of $71.7 million Core Revenue1 grew 9% year-over-year to $71.7 million GAAP loss of $14.6 million, or ($0.48) per share Non-GAAP income of $9.4 million

LOS ANGELES--(BUSINESS WIRE)--On Nov. 7, Puma Biotechnology issued its earnings results for 3Q-2024 and hosted a conference call to discuss the details.

IRVINE, Calif.--(BUSINESS WIRE)--Axonics, Inc. (Nasdaq: AXNX), a medical technology company that develops, manufactures and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction, today reported financial results for the three months ended September 30, 2024. “Axonics continued to execute at a high level in the third quarter, generating revenue growth of 25% year over year,” said Raymond W. Cohen, chief executive officer. “Revenue growth for both sacral

LOS ANGELES--(BUSINESS WIRE)---- $CDXC #ChromaDex--ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research with a focus on healthy aging, today announced the nationwide rollout of its pharmaceutical-grade nicotinamide riboside chloride (NRC) products, Niagen® IV, now accessible at over 200 Restore Hyper Wellness locations across the United States. This represents a major milestone, making Niagen IV—a significant advancement in intravenous NAD+ therapy—more widely acc

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today reported financial results for the third quarter ended September 30, 2024, and provided a business update. “Our third quarter results underscore the momentum we’ve been building throughout the year,” said David Moatazedi, President and Chief Executive Officer. “We continue to deliver growth at multiples above the market, vali

PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today reported financial results for the third quarter ended September 30, 2024 and provided a review of recent business and clinical-stage program updates. “In September, we provided updates across our clinical pipeline of XmAb® bispecific T-cell engagers in oncology and introduced our new autoimmune p

LANCASTER, Calif.--(BUSINESS WIRE)--Shawn O'Connor, CEO, will participate in a fireside chat at the Stephens Annual Investment Conference on Wednesday, November 20, 2024 at 12:00pm ET.

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on November 4, 2024, the Compensation Committee of Puma’s Board of Directors approved the grant of an inducement restricted stock unit award covering 5,625 shares of Puma common stock to one new non-executive employee. The award was granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity award

IRVINE, Calif.--(BUSINESS WIRE)--Masimo Corporation (Nasdaq: MASI) today announced its financial results for the third quarter ended September 28, 2024. Third Quarter 2024 Results Consolidated revenue was $504.6 million, comprised of healthcare revenue of $343.3 million and non-healthcare revenue of $161.3 million. Shipments of noninvasive technology boards and instruments were 60,500. GAAP operating income was $30.1 million and non-GAAP(1) operating income was $80.8 million. GAAP net income wa

THOUSAND OAKS, Calif.--(BUSINESS WIRE)---- $ATRA #CART--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the Company will release third quarter 2024 financial results after market close on Tuesday, Nov 12, 2024. About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to dev

IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced the final 36-month results of the DETOUR2 Study. The DETOUR System offers a unique approach to treating complex peripheral arterial disease (PAD), enabling physicians to percutaneously bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to res

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), will share 18 presentations, including six oral presentations, demonstrating the strength of its CAR T-cell therapy portfolio across a spectrum of blood cancers during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition (December 7-10). “Our data underscore our commitment to helping people with blood cancers live longer and demonstrate the benefit of CAR T-cell therapy as a mainstay of blood ca

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) today announced that it will host a webcast and conference call on November 26, 2024, at 4:30 p.m. ET to discuss its financial results for the 2024 fiscal year ended September 30, 2024. Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced financial results for the third quarter ended September 30, 2024. Key highlights for the third quarter of 2024 include: Record net sales of $96.7 million increased 24% year-over-year. Glaucoma record net sales of $76.0 million increased 30% year-over-ye

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today announced that its CEO & President, Olav Bergheim, will present at the Stifel 2024 Healthcare Conference on Monday, November 18, at 9:45 a.m. Eastern Time in New York, NY at the Lotte New York Palace Hotel. A live audio webcast and replay of the presentation may be accessed on the “Investors” sec

IRVINE, Calif.--(BUSINESS WIRE)-- #animalhealth--Immunis, Inc., a clinical-stage biotech developing novel secretomes for age-related diseases and immune dysfunction, has initiated non-terminal safety studies with VetBio Partners, LLC for canine muscle atrophy. With the preclinical success of Immunis’ investigational secretome (IMM01-STEM, previously IMMUNA) in aged mouse models and the rapidly advancing clinical testing in its STEM-MYO and STEM-META programs, Immunis is pursuing a parallel STEM-K9 program in d

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events: 15th Annual American Conference on Pharmacometrics (ACoP 2024) – November 10-13, 2024 Title: Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemia Presenter: Jack Shi Session: Poster Title: Population K-PD Modeling of Plozasiran (ARO-APOC3), a

PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today announced that it has initiated dosing of healthy volunteers in the first-in-human study of XmAb®942, an investigational high-potency extended half-life anti-TL1A antibody. Xencor continues to expect initial data from the ongoing study during the first half of 2025. “An anti-TL1A antibody enginee

IRVINE, Calif.--(BUSINESS WIRE)-- #RespiratoryCare--Nihon Kohden, a global leader in medical technology, today announced the introduction of the industry’s first ventilators to receive Authority to Operate (ATO) certification under the Department of Defense’s (DoD) Risk Management Framework (RMF) eMASS #3389. This rigorous cybersecurity certification ensures Nihon Kohden’s ventilators meet the highest standards for data protection and operational security in healthcare settings. “Our ATO-certified ventilators rep

IRVINE, Calif.--(BUSINESS WIRE)-- #HearingLoss--InnoCaption acquires CaptionMate, expanding footprint and multilingual capabilities.

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today, on FCS Awareness Day, announced the launch of a new disease awareness campaign, 'We'll Get There Soon,' to bring hope to the rare disease community affected by Familial Chylomicronemia Syndrome (FCS). The campaign seeks to raise awareness about FCS, a severe and rare condition marked by persistently high triglyceride levels despite standard treatment, which can lead to serious and potentially life-threateni

LOS ANGELES--(BUSINESS WIRE)---- $CDXC #ChromaDex--ChromaDex Corp. (NASDAQ:CDXC) today announced financial results for the third quarter of 2024. Third Quarter 2024 Financial and Recent Operational Highlights Total net sales were $25.6 million, with $18.1 million from Tru Niagen®, up 31%, and 4%, respectively, from the prior year quarter. Total Niagen® ingredient sales, including food-grade and pharmaceutical-grade, reached $6.7 million, up 368% YoY. Delivered strong gross margin of 63.5%, up 210 basis points from

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced the EU Medical Device Regulation (MDR) certification was received for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme® (pronounced “esteem”), branded as Evolysse™ in the U.S. market. This certification marks a key regulatory milestone for Evolus, enabling it to commercially enter the der

CLAREMONT, Calif.--(BUSINESS WIRE)--Synedgen Announces $2.2 Million JWMRP Award for MIIST305 For Use as a Prophylactic Radiation Medical Countermeasure

HAWTHORNE, Calif.--(BUSINESS WIRE)--OSI Systems, Inc. (the “Company” or “OSI Systems”) (NASDAQ: OSIS) today announced that its Optoelectronics and Manufacturing division has received an order for approximately $6 million from a leading healthcare original equipment manufacturer (OEM) to provide optical sensors for use in its patient care devices. OSI Systems’ Chairman and Chief Executive Officer, Deepak Chopra, stated, “We are pleased to receive this order and look forward to supporting this lo

EL MONTE, Calif.--(BUSINESS WIRE)--Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent,” or the “Company”), a technology-based company with a well-established laboratory services business and a therapeutic development business, today announced it has been awarded a five-year contract by the U.S. Department of Veterans Affairs (VA) to provide hereditary cancer, pharmacogenetic and other genetic testing to Veterans. A leader in clinical molecular diagnostic testing, Fulgent has been periodically prov

LAKE FOREST, Calif.--(BUSINESS WIRE)--The end of the paragraph after bullets in the "Outlook" section of release should read: APAC sales growth of 5% (prior outlook was 7%), including approximately 2% growth in China (prior outlook was 10%) and all other APAC countries approximately 10-20% growth (prior outlook was flat). (Instead of: APAC sales growth of 4% (prior outlook was 7%), including approximately 2% growth in China (prior outlook was 10%). The updated release reads:  STAAR SURGICAL REP

IRVINE, Calif.--(BUSINESS WIRE)--Today, TIME reveals its annual list of the Best Inventions, which features 200 extraordinary innovations changing our lives. Normatec Elite, Hyperice’s latest technology in dynamic air compression devices, was among the 2024 honorees. “The launch of Normatec Elite was a tentpole moment for both the Hyperice brand and Normatec product line. This innovative product delivers our most premium and versatile experience to date, while enhancing power and performance,”

HAWTHORNE, Calif.--(BUSINESS WIRE)--OSI Systems, Inc. (the “Company” or “OSI Systems”) (NASDAQ: OSIS) today announced that its Healthcare division, Spacelabs Healthcare®, has received an order valued at approximately $6 million to provide patient monitoring solutions and related supplies and accessories to a U.S. based hospital system. The Company expects to provide a range of patient monitoring tools, including Xhibit® Central Stations, Xprezzon bedside monitors, Qube® portable patient monitor