Year: 2023

U.S. annual market opportunity increases based on real world adoption and strength of long-term BeAT-HF data MINNEAPOLIS, Dec. 26, 2023 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today that the U.S. Food and Drug Administration (FDA) has approved revised Instructions For Use (IFU) for Barostim incorporating key long-term clinical data from the BeAT-HF randomized clinical trial. “We are very pleased to receive this important validation from FDA of the long-term results of the post-market phase of the BeAT-HF clinical trial and excited we can now share this data with physicians and patients,” said Nadim Yared, President and CEO of CVRx. “We remain grateful to all patients, investigators, research teams, the executive steering committee and FDA personnel, for supporting...

electroCore Granted Two New U.S. Patents ROCKAWAY, N.J., Dec. 26, 2023 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that it has received patent issue notifications from the United States Patent and Trademark Office (USPTO). The two patents were issued on December 26, 2023, and relate to electroCore’s non-invasive vagus nerve stimulation (nVNS) technology:US Patent No. 11,850,056 entitled “Devices and Methods for Remote Therapy and Patient Monitoring” generally relates to systems and methods for treating medical conditions that include delivering an nVNS therapy regimen, detecting a heart rate variability (HRV) of the patient, and comparing the HRV with data related to parameters of the therapy regimen. US Patent No. 11,854,695 entitled “Medical...

Key findings from prospective evaluation of 200 prenatal samples:Optical genome mapping (OGM) detected pathogenic structural variants (SVs) in 20.5% of samples (41/200); combination of chromosomal microarray analysis (CMA) and karyotyping (KT) detected pathogenic SVs in 19.5% of samples (39/200) Compared to CMA and KT combined in this prospective cohort, OGM had the following performance:Sensitivity: 97.4% Specificity: 100% Positive Predictive Value (PPV): 100% Negative Predictive Value (NPV): 99.4%For 8 copy number variants (CNVs) detected by CMA, OGM defined their location and orientation and revealed that they were 6 tandem duplications and 2 unbalanced cryptic translocations In 4% of samples (8/200), OGM identified D4Z4 repeat contractions on the permissive 4qA haplotype that may indicate facioscapulohumeral muscular dystrophy...

$5 million at closing and up to $7 million of additional committed funding SAN DIEGO, Dec. 26, 2023 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has entered into a royalty-backed financing agreement that provides Daré with $5 million at closing and up to an additional $7 million through three tranches over time at Daré’s option. The financing structure entitles the investor to a percentage of the royalties and milestones to be received by Daré under its global license agreement for XACIATO™ with Organon only until the investor achieves a targeted return on investment. “This advance against a percentage of future net payments we receive under our license agreement for XACIATO provides us with capital at an opportune time to drive shareholder value through...

Proceeds expected to extend cash runway into H2 2027 VANCOUVER, British Columbia, Dec. 26, 2023 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biopharmaceutical company developing novel, multifunctional biotherapeutics, today announced that it had entered into a securities purchase agreement with funds affiliated with EcoR1 Capital, LLC (“EcoR1 Capital”), for the sale of an aggregate of 5,086,521 pre-funded warrants to purchase 5,086,521 shares of common stock, $0.00001 par value per share, in a private placement. Each pre-funded warrant will be exercisable at an exercise price equal to $0.0001 per share, subject to adjustments as provided under the terms of the pre-funded warrant and will be exercisable at any time on or after the closing date, subject to a post-exercise beneficial ownership limitation of 19.99%. “We...

NEW YORK, Dec. 26, 2023 (GLOBE NEWSWIRE) — Inspired Entertainment, Inc. (“Inspired” or the “Company”) (NASDAQ: INSE), a leading B2B provider of gaming content, technology, hardware and services, today announced that Marilyn Jentzen has been appointed Interim CFO and principal accounting officer, upon the Company’s acceptance of Stewart F.B. Baker’s resignation from his role as CFO and principal accounting officer effective December 20, 2023. Ms. Jentzen brings over three decades of financial and accounting experience to Inspired. She is an accounting and auditing expert, strong leader and strategic thinker. Ms. Jentzen will be responsible for the Company’s financial policies, overseeing the finance and accounting functions, and ensuring compliance with financial and accounting regulations. The Board of Directors has initiated a...