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Valion Bio, formerly Tivic Health Systems, reports developments tied to its transformation into a biopharmaceutical company focused on innate-immune therapeutics. Company news centers on Entolimod™, a TLR5 agonist lead candidate for acute radiation syndrome, related gastrointestinal radiation-injury work, broader oncology supportive-care applications, and pipeline depth from Entolasta™.
Updates also cover the company’s wholly owned Velocity Bioworks subsidiary, a full-service CDMO providing analytical testing, process development, and cellular and biologic therapy manufacturing services. Recurring announcements include government and public-health preparedness engagement, nonclinical study agreements, financial results, corporate presentations, leadership changes, and the completed name and ticker change from TIVC to VBIO.
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Tivic Health Systems (Nasdaq: TIVC) announced an expansion of its post-operative pain clinical study to include patients from Otolaryngology and Facial Plastic Surgery. This initiative aims to explore a drug-free alternative to opioids in managing post-surgery pain, amidst the national opioid crisis. With over one million nasal and sinus surgeries performed annually in the U.S., the study signifies a shift towards optimizing pain management practices.
Tivic is collaborating with a leading international hospital and has gained approval to include candidates undergoing rhinoplasty and facial surgeries in addition to functional endoscopic sinus surgeries. The company believes this therapeutic approach can provide a significant option for patients and healthcare providers.
Tivic Health Systems, Inc. (Nasdaq: TIVC) has entered a research collaboration with The Feinstein Institutes for Medical Research to conduct a pilot clinical study on a non-invasive bioelectronic device for vagus nerve stimulation. This collaboration aims to understand the on- and off-target effects of non-invasive vagal stimulation, with a study involving 20 participants and data analysis from the Neural and Data Science Autonomic Nervous System monitoring lab. Tivic's CEO, Jennifer Ernst, expressed optimism about expanding their bioelectronic solutions to include vagus nerve pathways, which could enhance their proprietary offerings in the field. The study represents a strategic step toward validating new treatment approaches for autonomic conditions.
Tivic Health, a health technology company listed on Nasdaq as TIVC, has filed its first patent for Vagus Nerve Stimulation with the U.S. Patent Office. This move expands its intellectual property into new clinical targets, focusing on non-invasive approaches with the potential for superior efficacy. The vagus nerve plays a key role in regulating several vital organs and has shown effectiveness in treating conditions like treatment-resistant depression and epilepsy. Tivic aims to enhance its proprietary footprint in bioelectronic medicine through this innovation. Currently, the company holds five issued U.S. patents and has twenty pending patents. Tivic's first product, ClearUP, is FDA-approved for treating inflammation symptoms.
Tivic Health® Systems, Inc. (Nasdaq: TIVC) reported a 46% increase in revenue for the year ending December 31, 2022, reaching $1.8 million, driven by a 22% unit sales growth and a minor price increase. Direct-to-consumer sales surged by 114% to $1.6 million, while reseller channel revenue fell 32% to $416,000. Gross profit improved significantly to $299,000 from a loss of $38,000 in 2021. However, R&D and marketing expenses rose, totaling $1.7 million and $2.8 million respectively. As of December 31, 2022, cash stood at $3.5 million, free of debt. CEO Jennifer Ernst acknowledged supply chain challenges but expressed optimism for 2023 growth.
Tivic Health Systems, Inc. (Nasdaq: TIVC), a health technology company, announced the completion of supplier qualification and first article inspection with Microart Services, boosting production efficiency. This partnership has led to a 70% reduction in printed circuit board manufacturing costs and 25X increased production capacity. Together with another partner, ALOM, the company expects a 30% decrease in 3PL costs, a 40% reduction in final assembly costs, and an overall 37% reduction in cost of goods sold for 2023, driving scalable growth.
Tivic Health Systems, Inc. (Nasdaq: TIVC) is set to report its financial results for the year ending December 31, 2022, through a pre-recorded conference call and webcast scheduled for March 31, 2023, at 1:30 PM PT / 4:30 PM ET. Shareholders are encouraged to submit questions by March 27, 2023, at 5:00 PM ET. Tivic Health specializes in non-invasive bioelectronic treatments aimed at addressing inflammation and related conditions. The company emphasizes its commitment to enhancing consumer choices in healthcare. Interested parties can access the webcast at the provided link.