Tivic Health Names Biotech Industry Veteran Michael K. Handley to Executive Leadership Team
Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today that Michael K. Handley, formerly Chief Executive Officer, President and Chairman of Statera Biopharma, Inc., has joined Tivic Health as the President of Tivic Biopharma, a newly formed division of Tivic Health. Additionally, he will assume the role of Chief Operating Officer of Tivic Health and will work closely with the CEO and other leadership team members to develop and operationalize company-wide strategies.
His key responsibilities will include building and leading Tivic's Biopharma team, advancing Tivic's recently licensed, late-stage product candidate, Entolimod™, through manufacturing validation, regulatory approval processes and commercialization, and directing pipeline development activity.
'Mike brings to Tivic a rare blend of device and pharmaceutical background, as well as proven operational, business and scientific experience that sets Tivic up for a smooth and successful expansion into drug development,' stated Tivic Health Chief Executive Officer, Jennifer Ernst.
'With our recent licensing of the late-stage TLR5 agonist, Entolimod, from Statera Biopharma, and Mike's deep experience in immunology and biotech, we believe that he is the ideal leader to establish Tivic's biopharmaceutical capabilities and advance our therapeutics pipeline. In tandem, we continue to pursue the development and exciting promise of our non-invasive bioelectronic vagus nerve stimulation, creating a portfolio of device and drug therapeutics from which to build shareholder value,' added Ernst.
Over the course of his career, Michael has successfully led or assisted in the global commercialization of 17 drugs and devices that represented ~$7 billion in annual sales. Additionally, he served as part of the management teams of successful exits to Johnson & Johnson and Boston Scientific. He has successfully led teams in a variety of capacities in high growth organizations. As CEO, President and Chairman of the Board of Statera, Michael created and executed the company's growth strategy, advanced clinical development and intellectual property strategies, and spearheaded the company's business development and financing activities.
'This is an exciting and critical time at Tivic Health, and I am thrilled to join the Tivic leadership team to continue the essential work of advancing Entolimod towards potential commercialization,' stated Handley. 'With compelling evidence of preventing death following a potential lethal dose of radiation and the opportunity to expand to adjacent indications in radiation toxicity and immune system dysregulation, I believe that Entolimod serves as a great foundation on which to build and potentially expand Tivic Health's biopharma pipeline.'
Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
In connection with, and as a material inducement to, the hiring and appointment of Michael as Chief Operating Officer of Tivic Health and President of Tivic Biopharma, Tivic agreed to grant Michael 600,000 restricted stock units (RSUs), which shall vest over four years, with one fourth of the RSUs vesting on the one-year anniversary of the date of grant and the remaining RSUs vesting in 12 equal quarterly installments thereafter until fully vested. The vesting of shares of common stock underlying the RSUs will be subject to Michael's continuous service with Tivic through each applicable vesting date.
The foregoing RSU grant was unanimously approved by Tivic's board of directors and the compensation committee of the board, and such grants were inducements material to Michael entering into employment with Tivic, in accordance with Nasdaq Listing Rule 5635(c)(4). The foregoing equity grant was made outside of Tivic's Amended and Restated 2021 Equity Incentive Plan or any other equity incentive plan of the company.
About Tivic Health
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health takes a multi-pronged approach to treating diseases caused by immune and autonomic nervous system dysregulation. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches. Tivic Health's first FDA approved product ClearUP™ is clinically proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com.
Forward-Looking Statements
This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate.
Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding Tivic Health's development and advancement of Entolimod for the treatment of acute radiation syndrome (ARS) and any other indications that it may elect to license from Statera in the future; the future development of ncVNS treatment, Tivic Health's ability to commercialize products arising out of the license from Statera and Tivic Health's ncVNS treatment; the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing Entolimod, including for the treatment of ARS and/or any other indications it may elect to license in the future, and its ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; the timing and success of clinical studies and trials; market and other conditions; macroeconomic factors; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading 'Risk Factors'; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
Hanover International, Inc.
SOURCE: Tivic Health Systems, Inc.
Copyright Business Wire 2025.
PUB: 02/24/2025 08:15 AM/DISC: 02/24/2025 08:15 AM
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
18 minutes ago
- Business Wire
Sammons Financial Group Employees Direct $175,000 to Iowa Charities
WEST DES MOINES, Iowa--(BUSINESS WIRE)-- Sammons ® Financial Group, Inc. announced the results of its 2025 Community Outreach Program. Sammons Financial Group employees selected 25 organizations to receive a total of $175,000 in financial support. Recipient charities were invited to the company's West Des Moines headquarters to further connect with employees about their organization and mission. The initiative, started in 2018, empowers employees to nominate their favorite local charities to be considered for a financial grant from Sammons Financial Group. The employees who choose to make nominations are given the opportunity to educate their coworkers on the mission of the organization and why they are passionate about it. Employees then vote for the organizations they would like the company to support financially. 'Our employees selected this year's recipients because of the excellent work they do in our community,' said Casey Decker, West Des Moines site leader and Chief Operating Officer at Sammons Financial Group. 'We're proud to support these organizations elevating the quality of life in Central Iowa.' The following organizations received funding from the 2025 Community Outreach Program: Aheinz57 American Cancer Society (Iowa Chapter) American Lung Association of Iowa American Parkinson Association Iowa Chapter Animal Rescue League of Iowa Building Brave Teams Camp Fire of Iowa Combat Vets Motorcycle Association Iowa Chapter 39-1 Des Moines Refugee Support Focuss Four Oaks Foster and Adoption Support Great Plains Pointer Rescue Hope Ministries Iowa Donor's Network Iowa Jobs for America's Graduates Kid Hope USA Leukemia and Lymphoma Society of Iowa Mason's Lighthouse Peace Creek Animal Sanctuary and Rescue SEEDS Shriner's Children's Hospital in partnership with Blank Children's Hospital Sleep in Heavenly Peace The Supply Hive Urban Bicycle Food Ministry Waypoint Resources The Community Outreach Program is one part of Sammons Financial Group's longstanding commitment to its communities. In 2024, the company donated $4.7 million to local charities through its various charitable giving programs. West Des Moines is home to about 1,000 on-site and remote employees. A similar program is held each year in the Sioux Falls office, which has 600 employees. About Sammons ® Financial Group, Inc. Sammons Financial Group ® helps families and businesses by empowering futures and changing lives. Sammons Financial Group is employee owned with member companies that are among the most enduring and stable in the financial services industry. Our member companies include Midland National ® Life Insurance Company (including Sammons ® Corporate Markets); North American Company for Life and Health Insurance ®; Sammons Institutional Group ® (including Midland Retirement Distributors ® and Sammons Retirement Solutions ®) and Sammons Wealth Management Group. Committed to our communities, Sammons Financial Group is Midwest-based, with offices in Iowa, Illinois, Minnesota, North Dakota, Ohio, and South Dakota.
Business Wire
18 minutes ago
- Business Wire
Accenture Acquires The Highlands Consulting Group
NEW YORK & SACRAMENTO, Calif.--(BUSINESS WIRE)--Accenture (NYSE: ACN) has acquired The Highlands Consulting Group, a leading management consulting provider with extensive experience in healthcare, transportation, social services and environmental solutions. This move enhances Accenture's capabilities, particularly in the State of California, where Highlands Consulting has a strong presence and a proven track record of delivering high-impact strategy and consulting services. Ryan Oakes, global Health & Public Services industry practices chair at Accenture, said: 'Highlands Consulting's strong relationships and credentials with state agencies will help us better serve our clients and unlock new opportunities for reinvention that drives growth and innovation. We are confident that this acquisition will deliver greater outcomes for our clients in the State of California and beyond.' Highlands Consulting, founded in 2002 and headquartered in Sacramento, CA, brings a team of professionals with decades of hands-on experience in strategic business and digital planning, organizational and process change, and IT planning and analysis. The combination of Accenture and Highlands Consulting will offer clients an expanded range of services and a deeper pool of talent to address their most pressing challenges. This move underscores Accenture's commitment to growing its presence and service offerings, leveraging Highlands Consulting's established relationships and credentials with key agencies in California. 'This deal is a natural fit for both organizations. We are joining forces to deliver even more value to our clients,' added Mike Cappelluti, President of Highlands Consulting. 'Accenture's scale and resources will enable us to expand our services and capabilities, while our local expertise and long-standing client relationships will provide a solid foundation for Accenture's growth in the State of California.' Highlands Consulting's knowledge of areas like Health & Human Services, transportation and organizational change management will help Accenture further support long-term growth plans for clients. This acquisition aligns with Accenture's broader strategic goals to enhance service offerings in critical sectors and ensure a smooth transition to deliver immediate value to clients. Financial terms of the transaction were not disclosed. Forward-Looking Statements Except for the historical information and discussions contained herein, statements in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'may,' 'will,' 'should,' 'likely,' 'anticipates,' 'aspires,' 'expects,' 'intends,' 'plans,' 'projects,' 'believes,' 'estimates,' 'positioned,' 'outlook,' 'goal,' 'target' and similar expressions are used to identify these forward-looking statements. These statements are not guarantees of future performance nor promises that goals or targets will be met, and involve a number of risks, uncertainties and other factors that are difficult to predict and could cause actual results to differ materially from those expressed or implied. These risks include, without limitation, risks that: the transaction might not achieve the anticipated benefits for Accenture; Accenture's results of operations have been, and may in the future be, adversely affected by volatile, negative or uncertain economic and geopolitical conditions and the effects of these conditions on the company's clients' businesses and levels of business activity; Accenture's business depends on generating and maintaining client demand for the company's services and solutions including through the adaptation and expansion of its services and solutions in response to ongoing changes in technology and offerings, and a significant reduction in such demand or an inability to respond to the evolving technological environment could materially affect the company's results of operations; risks and uncertainties related to the development and use of AI could harm the company's business, damage its reputation or give rise to legal or regulatory action; if Accenture is unable to match people and their skills with client demand around the world and attract and retain professionals with strong leadership skills, the company's business, the utilization rate of the company's professionals and the company's results of operations may be materially adversely affected; Accenture faces legal, reputational and financial risks from any failure to protect client and/or company data from security incidents or cyberattacks; the markets in which Accenture operates are highly competitive, and Accenture might not be able to compete effectively; Accenture's ability to attract and retain business and employees may depend on its reputation in the marketplace; if Accenture does not successfully manage and develop its relationships with key ecosystem partners or fails to anticipate and establish new alliances in new technologies, the company's results of operations could be adversely affected; Accenture's profitability could materially suffer due to pricing pressure, if the company is unable to remain competitive, if its cost-management strategies are unsuccessful or if it experiences delivery inefficiencies or fail to satisfy certain agreed-upon targets or specific service levels; changes in Accenture's level of taxes, as well as audits, investigations and tax proceedings, or changes in tax laws or in their interpretation or enforcement, could have a material adverse effect on the company's effective tax rate, results of operations, cash flows and financial condition; Accenture's results of operations could be materially adversely affected by fluctuations in foreign currency exchange rates; Accenture's debt obligations could adversely affect its business and financial condition; changes to accounting standards or in the estimates and assumptions Accenture makes in connection with the preparation of its consolidated financial statements could adversely affect its financial results; as a result of Accenture's geographically diverse operations and strategy to continue to grow in key markets around the world, the company is more susceptible to certain risks; if Accenture is unable to manage the organizational challenges associated with its size, the company might be unable to achieve its business objectives; Accenture might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses; Accenture's business could be materially adversely affected if the company incurs legal liability; Accenture's work with government clients exposes the company to additional risks inherent in the government contracting environment; Accenture's global operations expose the company to numerous and sometimes conflicting legal and regulatory requirements; if Accenture is unable to protect or enforce its intellectual property rights or if Accenture's services or solutions infringe upon the intellectual property rights of others or the company loses its ability to utilize the intellectual property of others, its business could be adversely affected; Accenture may be subject to criticism and negative publicity related to its incorporation in Ireland; as well as the risks, uncertainties and other factors discussed under the 'Risk Factors' heading in Accenture plc's most recent Annual Report on Form 10-K, as updated in Item 1A, 'Risk Factors' in its Quarterly Report on Form 10-Q for the second quarter of fiscal 2025, and other documents filed with or furnished to the Securities and Exchange Commission. Statements in this news release speak only as of the date they were made, and Accenture undertakes no duty to update any forward-looking statements made in this news release or to conform such statements to actual results or changes in Accenture's expectations. About Accenture Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world's leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities. Visit us at
USA Today
18 minutes ago
- USA Today
New NFL crocs look cozy but have have 1 major flaw
The NFL has announced a multiyear licensing deal with the footwear company Crocs, which should allow for some comfortable Sunday viewing sessions. Many sports fans and players, including Dallas Wings rookie Paige Bueckers, enjoy wearing Crocs. Earlier this year, Las Vegas Raiders rookie Ashton Jeanty showed up to the 2025 NFL Draft wearing the crystal-covered clogs. 'The Crocs brand has made a significant impact on footwear culture with their shoes becoming synonymous with ease and comfort,' said Ryan Samuelson, vice president of consumer products at the NFL. 'Collaborating with Crocs allows us to give fans expanded gameday options that will keep them stylishly comfortable for gameday and every day.' The original release, which will drop on September 18 for $84.99, will feature 14 NFL teams. The initial line includes the Kansas City Chiefs, Philadelphia Eagles, Detroit Lions, San Francisco 49ers, Pittsburgh Steelers, Chicago Bears, Buffalo Bills, Las Vegas Raiders, Dallas Cowboys, Miami Dolphins, Minnesota Vikings, Cincinnati Bengals, Houston Texans, and Denver Broncos. Many of them look normal and inoffensive and seem perfectly suited for a casual hang: Some of them, like the pair for the Cowboys, look fairly normal. But the attached Jibbitz™ charms for the Bears, Bills, and Vikings are a bit more odd. These shoes should not have horns! Aside from aesthetic issues, that would make it quite difficult to walk. Similarly, the shoes for the Bears should not have claws. That was a bold decision that isn't working. If these are detachable, there's less of an issue. But if this is a permanent part of the shoe, it's a glaring problem for anyone who hopes to take themselves seriously.
