Latest news with #EthicsCommittee
Yahoo
2 days ago
- Business
- Yahoo
Autonomix Medical, Inc. Granted Approval to Expand Proof-of-Concept Human Clinical Study, Doubling Potential Addressable Market Beyond Pancreatic Cancer Pain
Follow-on study ('PoC 2') builds on initial success in pancreatic cancer pain Ethics committee authorization supports platform expansion into visceral cancer pain for proprietary ablation technology Expansion supports Autonomix's strategy to build long-term value through multi-indication growth Patient enrollment expected to begin in June 2025 THE WOODLANDS, TX, June 05, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) ('Autonomix' or the 'Company'), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced that it has received Ethics Committee authorization from the Ministry of Health of the Republic of Uzbekistan to open the clinical trial site for the follow-on phase to its proof-of-concept human clinical trial ('PoC 2') evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate cancer pain. The Company is on track to commence enrollment in June 2025. 'This next phase of our clinical program represents a meaningful advancement for Autonomix,' said Brad Hauser, CEO of Autonomix. 'With Ethics Committee approval, we can now expand our evaluation beyond severe pancreatic cancer pain to include a broader range of visceral cancers. The initial phase of our study in late-stage pancreatic cancer patients delivered promising results, demonstrating significant pain reduction, substantial decreases in opioid use, and meaningful improvements in quality of life. These outcomes reinforce our belief that Autonomix's technology has the potential to address multiple cancer indications with significant unmet need and transform the standard of care. As we build on this momentum, we see a clear opportunity to create long-term value by unlocking a broader set of impactful clinical applications.' As previously announced, based on the positive results demonstrated in the initial phase of the Company's first-in-human proof-of-concept trial ('PoC 1') in patients with severe pancreatic cancer pain, Autonomix is initiating a follow-on PoC 2 phase in a market expansion opportunity, which has the potential to double the addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain. Autonomix's technology constitutes a platform with the potential to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. The PoC 2 phase will provide a concentrated focus on interventional cancer pain management applications like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence. For more information about the Company's technology, please visit About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company's first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are 'forward-looking statements,' which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the commencement of the PoC 2 phase of the trial. Such forward-looking statements can be identified by the use of words such as 'should,' 'might,' 'may,' 'intends,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'forecasts,' 'expects,' 'plans,' and 'proposes.' Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading 'Risk Factors' and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission ('SEC') on May 31, 2024 and in other filings made by us from time to time with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media ContactJTC Team, LLCJenene Thomas908.824.0775autonomix@ beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
Business Upturn
2 days ago
- Business
- Business Upturn
Autonomix Medical, Inc. Granted Approval to Expand Proof-of-Concept Human Clinical Study, Doubling Potential Addressable Market Beyond Pancreatic Cancer Pain
Follow-on study ('PoC 2') builds on initial success in pancreatic cancer pain Ethics committee authorization supports platform expansion into visceral cancer pain for proprietary ablation technology Expansion supports Autonomix's strategy to build long-term value through multi-indication growth Patient enrollment expected to begin in June 2025 THE WOODLANDS, TX, June 05, 2025 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) ('Autonomix' or the 'Company'), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced that it has received Ethics Committee authorization from the Ministry of Health of the Republic of Uzbekistan to open the clinical trial site for the follow-on phase to its proof-of-concept human clinical trial ('PoC 2') evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate cancer pain. The Company is on track to commence enrollment in June 2025. 'This next phase of our clinical program represents a meaningful advancement for Autonomix,' said Brad Hauser, CEO of Autonomix. 'With Ethics Committee approval, we can now expand our evaluation beyond severe pancreatic cancer pain to include a broader range of visceral cancers. The initial phase of our study in late-stage pancreatic cancer patients delivered promising results, demonstrating significant pain reduction, substantial decreases in opioid use, and meaningful improvements in quality of life. These outcomes reinforce our belief that Autonomix's technology has the potential to address multiple cancer indications with significant unmet need and transform the standard of care. As we build on this momentum, we see a clear opportunity to create long-term value by unlocking a broader set of impactful clinical applications.' As previously announced, based on the positive results demonstrated in the initial phase of the Company's first-in-human proof-of-concept trial ('PoC 1') in patients with severe pancreatic cancer pain, Autonomix is initiating a follow-on PoC 2 phase in a market expansion opportunity, which has the potential to double the addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain. Autonomix's technology constitutes a platform with the potential to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. The PoC 2 phase will provide a concentrated focus on interventional cancer pain management applications like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence. For more information about the Company's technology, please visit About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company's first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are 'forward-looking statements,' which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the commencement of the PoC 2 phase of the trial. Such forward-looking statements can be identified by the use of words such as 'should,' 'might,' 'may,' 'intends,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'forecasts,' 'expects,' 'plans,' and 'proposes.' Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading 'Risk Factors' and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission ('SEC') on May 31, 2024 and in other filings made by us from time to time with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media ContactJTC Team, LLCJenene Thomas908.824.0775 [email protected]
Yahoo
30-05-2025
- Business
- Yahoo
Report alleges Cherfilus-McCormick may have accepted campaign contributions ‘linked to an official action'
An official report outlining potential ethics violations by U.S. Rep. Sheila Cherfilus-McCormick, D-Fla., said there was probable cause to believe that she 'accepted campaign contributions linked to an official action.' If proven, the allegation contained in a document released Thursday by the House Ethics Committee could be a violation of House rules, standards of conduct and federal law. The Office of Congressional Conduct determined in May 2024 that the matter warranted review by the Congressional Ethics Committee, which said it has been reviewing the allegation for the last year. The official document provided no details, just a total of three sentences in two different places. It was one of five alleged violations. The board of the Office of Congressional Conduct recommended further review of three and dismissal of two. The document was released one year after the conduct office, which reviews allegations of misconduct against members, referred the case to the committee, which investigates and adjudicates alleged violations of House rules and related laws. In a joint statement accompanying the release of the referral, the Republican chair and top Democrat on the Ethics Committee said that 'the mere fact of a continued investigation into these allegations does not itself indicate that any violation has occurred.' For the three violations it said warranted further investigation, the congressional conduct office said Cherfilus-McCormick 'may have' taken actions that, if substantiated, mean 'she may have violated House rules and standards of conduct.' For two of the allegations, it said violations may have violated federal law. Besides the allegation about 'campaign contributions linked to an official action,' the office said she may have requested community project funding that would be directed to a for-profit entity. It also said her congressional office may have 'made payments to an entity in violation of' the rules or 'alternatively, that her campaign may have accepted and failed to report in-kind (campaign) contributions that may have exceeded applicable limits.' In each of the three allegations, the conduct office's board voted 6-0 to recommend further review by the Ethics Committee. The board voted 5-1 to recommend dismissal of the allegation that she 'may have dispensed favors or privileges to friends' in connection with official requests for community project funding. It voted 6-0 to recommend dismissal of an allegation that her campaign misrepresented the source of a campaign contribution or accepted a contribution made by one person in the name of another. In both dismissal recommendations, the board found there was 'not substantial reason to believe' the allegations. In a statement provided by her communications director, Cherfilus-McCormick said, 'The Committee on Ethics has not yet concluded its review of the allegations, and no decision has been made at this time. As outlined in the Committee's public statement, the referral for further review does not imply that any violation has occurred. I fully respect the process and remain committed to cooperating with the Committee as it works to bring this inquiry to a close.' In 2023, the Ethics Committee received an earlier referral. A limited summary was released in 2024 — similar to the one put out Thursday. In January, 576 pages of materials were released. In the earlier case, which has not been publicly resolved, the Office of Congressional Conduct said there was 'substantial reason to believe' four allegations including that she 'made payments to a state political action committee in connection with her campaign and failed to report these payments as contributions to her campaign' and that her campaign campaign committee 'accepted and failed to report contributions exceeding contribution limits.' Cherfilus-McCormick was first elected in a January 2022 special election in the Broward-Palm Beach county 20th Congressional District. A Democrat, she was elected to a full term in November 2022. No Democratic primary challenger or Republican general election challenger came forward to run against Cherfilus-McCormick in 2024, making her the only one of Florida's 28 members of Congress returned to office without facing a primary or general election. A young Democratic activist, Elijah Manley, who has run unsuccessfully for office before, is challenging Cherfilus-McCormick in the 2026 Democratic primary. 'The people of Florida are sick and tired of political corruption, ethical scandals, and the legal maneuvers the wealthy and powerful use to escape accountability,' Manley said in a statement, adding that in his view the information released by the Ethics Committee shows the incumbent's 'inability to serve the people of Florida's 20th District with honesty and transparency.' Congressional ethics investigations move slowly, and the system is byzantine to outsiders. The Office of Congressional Conduct has its own staff and is governed by a bipartisan board of private citizens who aren't members of Congress and don't work for the federal government. Half the members are chosen by the House speaker and half by the minority party leader. Currently there are only four members instead of the six members and four alternates. Another change: Until January, it was called the Office of Congressional Ethics. This year 'conduct' was substituted for 'ethics' in the name. The House Ethics Committee includes equal numbers of Republican and Democratic members, which is unusual. The majority party has a majority of spots on all other committees. The panel conducts its business behind closed doors and is circumspect about its activities. The joint statement Thursday from U.S. Rep. Michael Guest, a Mississippi Republican and committee chair, and U.S. Rep. Mark DeSaulnier of California, the top Democrat on the panel, was the usual, brief format, totaling four paragraphs. 'No other public comment will be made on this matter except in accordance with Committee rules,' Guest and DeSaulnier said. In cases — such as this one — in which the committee hasn't finished its investigation within a year receiving a referral from the Office of Congressional Conduct, House rules require the release of the referral. The referral contains some details, but the supporting materials the committee gets at the same time, which can be voluminous, aren't included. Two pages were released Thursday, but pages 3 to 17 were not. If there has been no resolution of the investigation and at least one year has passed, all the supporting documents are publicly released at the end of the two-year session of Congress. In this case, that would be January 2027. Currently the matter is in the hands of an investigative subcommittee of the Ethics Committee, which is still considering the earlier ethics referral. Separately, a lawsuit involving Cherfilus-McCormick's former company, Trinity Health Care Services, has been settled. In December, the Florida Division of Emergency Management sued Trinity to recover what it said was $5.8 million in overpayments. Before she was elected to Congress, Cherfilus-McCormick was the CEO of the family-owned company. The case involved the company, not Cherfilus-McCormick. Her brother, Edwin Cherfilus, is vice president of operations, according to his LinkedIn page. In 2021, the emergency management agency hired Trinity to administer COVID-19 vaccinations and employ canvassers to sign people up to get vaccinated. In its lawsuit, the state said that on June 28, 2021, the emergency management division sent Trinity an 'overpayment of $5,057,050.00' instead of the $50,578.50 it actually owed 'due to a clerical error.' It later discovered 'several' additional overpayments, totaling $5.78 million. The Leon County Circuit Clerk's Office website shows the case is closed. The most recent filing, from an attorney representing the Division of Emergency Management, said there was 'an executed settlement agreement in the matter,' and that both the state agency and Trinity Healthcare Services would each pay their own attorneys' fees. Trinity did not admit any wrongdoing in the settlement, and it agreed to repay $5.62 million. Though the total repayment is almost as much as the state wanted, it is effectively much less because it is being repaid over many years without interest. Under the terms of the settlement Trinity agreed to pay $25,000 in April and $15,000 in May. Starting in 2026, the company agreed to repay $92,910.99 each quarter, which works out to $371,644 a year. The repayments last 15 years, which means the final payment would be made in the fourth quarter of 2040. _____
Yahoo
29-05-2025
- Business
- Yahoo
Official report alleges Cherfilus-McCormick may have accepted campaign contributions ‘linked to an official action'
An official report outlining potential ethics violations by U.S. Rep. Sheila Cherfilus-McCormick said there was probable cause to believe that she 'accepted campaign contributions linked to an official action.' If proven, the allegation contained in a document released Thursday by the House Ethics Committee could be a violation of House rules, standards of conduct and federal law. The Office of Congressional Conduct determined in May 2024 that the matter warranted review by the Congressional Ethics Committee, which said it has been reviewing the allegation for the last year. The official document provided no details, just a total of three sentences in two different places. It was one of five alleged violations. The board of the Office of Congressional Conduct recommended further review of three and dismissal of two. The document was released one year after the conduct office, which reviews allegations of misconduct against members, referred the case to the committee, which investigates and adjudicates alleged violations of House rules and related laws. In a joint statement accompanying the release of the referral, the Republican chair and top Democrat on the Ethics Committee said that 'the mere fact of a continued investigation into these allegations does not itself indicate that any violation has occurred.' For the three violations it said warranted further investigation, the congressional conduct office said Cherfilus-McCormick 'may have' taken actions that, if substantiated, mean 'she may have violated House rules and standards of conduct.' For two of the allegations, it said violations may have violated federal law. Besides the allegation about 'campaign contributions linked to an official action,' the office said she may have requested community project funding that would be directed to a for-profit entity. It also said her congressional office may have 'made payments to an entity in violation of' the rules or 'alternatively, that her campaign may have accepted and failed to report in-kind (campaign) contributions that may have exceeded applicable limits.' In each of the three allegations, the conduct office's board voted 6-0 to recommend further review by the Ethics Committee. The board voted 5-1 to recommend dismissal of the allegation that she 'may have dispensed favors or privileges to friends' in connection with official requests for community project funding. It voted 6-0 to recommend dismissal of an allegation that her campaign misrepresented the source of a campaign contribution or accepted a contribution made by one person in the name of another. In both dismissal recommendations, the board found there was 'not substantial reason to believe' the allegations. In a statement provided by her communications director, Cherfilus-McCormick said, 'The Committee on Ethics has not yet concluded its review of the allegations, and no decision has been made at this time. As outlined in the Committee's public statement, the referral for further review does not imply that any violation has occurred. I fully respect the process and remain committed to cooperating with the Committee as it works to bring this inquiry to a close.' In 2023, the Ethics Committee received an earlier referral. A limited summary was released in 2024 — similar to the one put out Thursday. In January, 576 pages of materials were released. In the earlier case, which has not been publicly resolved, the Office of Congressional Conduct said there was 'substantial reason to believe' four allegations including that she 'made payments to a state political action committee in connection with her campaign and failed to report these payments as contributions to her campaign' and that her campaign campaign committee 'accepted and failed to report contributions exceeding contribution limits.' Challenger raises 18 times as much campaign money as Congresswoman Sheila Cherfilus-McCormick ICE pushes back, says congresswomen arrived at Broward facility with 'hostile intentions' Seeking answers about death at Broward ICE center, congresswomen say they encounter 'hostility and evasiveness' As many Congress members avoid anger-filled town halls, a few still take place Health care company says it didn't refuse to return $5.8 million demanded by state Ethics report details allegations of campaign violations by Cherfilus-McCormick Cherfilus-McCormick was first elected in a January 2022 special election in the Broward-Palm Beach county 20th Congressional District. A Democrat, she was elected to a full term in November 2022. No Democratic primary challenger or Republican general election challenger came forward to run against Cherfilus-McCormick in 2024, making her the only one of Florida's 28 members of Congress returned to office without facing a primary or general election. A young Democratic activist, Elijah Manley, who has run unsuccessfully for office before, is challenging Cherfilus-McCormick in the 2026 Democratic primary. 'The people of Florida are sick and tired of political corruption, ethical scandals, and the legal maneuvers the wealthy and powerful use to escape accountability,' Manley said in a statement, adding that in his view the information released by the Ethics Committee shows the incumbent's 'inability to serve the people of Florida's 20th District with honesty and transparency.' Congressional ethics investigations move slowly and the system is byzantine to outsiders. The Office of Congressional Conduct has its own staff and is governed by a bipartisan board of private citizens who aren't members of Congress and don't work for the federal government. Half the members are chosen by the House speaker and half by the minority party leader. Currently there are only four members instead of the six members and four alternates. Another change: Until January, it was called the Office of Congressional Ethics. This year 'conduct' was substituted for 'ethics' in the name. The House Ethics Committee includes equal numbers of Republican and Democratic members, which is unusual. The majority party has a majority of spots on all other committees. The panel conducts its business behind closed doors and is circumspect about its activities. The joint statement Thursday from U.S. Rep. Michael Guest, a Mississippi Republican and committee chair, and U.S. Rep. Mark DeSaulnier of California, the top Democrat on the panel, was the usual, brief format, totaling four paragraphs. 'No other public comment will be made on this matter except in accordance with Committee rules,' Guest and DeSaulnier said. In cases — such as this one — in which the committee hasn't finished its investigation within a year receiving a referral from the Office of Congressional Conduct, House rules require the release of the referral. The referral contains some details, but the supporting materials the committee gets at the same time, which can be voluminous, aren't included. Two pages were released Thursday, but pages 3 to 17 were not. If there has been no resolution of the investigation and at least one year has passed, all the supporting documents are publicly released at the end of the two-year session of Congress. In this case, that would be January 2027. Currently the matter is in the hands of an investigative subcommittee of the Ethics Committee, which is still considering the earlier ethics referral. Separately, a lawsuit involving Cherfilus-McCormick's former company, Trinity Health Care Services, has been settled. In December, the Florida Division of Emergency Management sued Trinity to recover what it said was $5.8 million in overpayments. Before she was elected to Congress, Cherfilus-McCormick was the CEO of the family-owned company. The case involved the company, not Cherfilus-McCormick. Her brother, Edwin Cherfilus, is vice president of operations, according to his LinkedIn page. In 2021, the emergency management agency hired Trinity to administer COVID-19 vaccinations and employ canvassers to sign people up to get vaccinated. In its lawsuit, the state said that on June 28, 2021, the emergency management division sent Trinity an 'overpayment of $5,057,050.00' instead of the $50,578.50 it actually owed 'due to a clerical error.' It later discovered 'several' additional overpayments, totaling $5.78 million. The Leon County Circuit Clerk's Office website shows the case is closed. The most recent filing, from an attorney representing the Division of Emergency Management, said there was 'an executed settlement agreement in the matter,' and that both the state agency and Trinity Healthcare Services would each pay their own attorneys' fees. Trinity did not admit any wrongdoing in the settlement, and it agreed to repay $5.62 million. Though the total repayment is almost as much as the state wanted, it is effectively much less because it is being repaid over many years without interest. Under the terms of the settlement Trinity agreed to pay $25,000 in April and $15,000 in May. Starting in 2026, the company agreed to repay $92,910.99 each quarter, which works out to $371,644 a year. The repayments last 15 years, which means the final payment would be made in the fourth quarter of 2040. Anthony Man can be reached at aman@ and can be found @browardpolitics on Bluesky, Threads, Facebook and Mastodon.
Rakyat Post
16-05-2025
- Sport
- Rakyat Post
Malaysian Parusuraman Subramaniam Retains Deputy Chairperson Role In FIFA
Subscribe to our FREE The Fédération Internationale de Football Association, or more commonly known by its acronym FIFA, has voted on the The lineup should excite Malaysian football fans because Parusuraman Subramaniam still holds the position as the Deputy Chairperson of the Investigatory chamber of the Ethics Committee, making him the first and only Malaysian to hold a position in FIFA to date. He was selected out of 209 representatives from other countries. If the name sounds familiar it's because SAC Parusuraman is currently the head of the Sarawak Police's Crime Prevention and Community Safety Department. He garnered 139 votes during the 2021 FIFA Congress in Zurich, Switzerland previously, resulting in him serving as the Deputy Chairperson from Part of his duties as the Deputy Chairperson is to hear and decide cases relating to ethical violations by any football official or player following FIFA legislation. His peers in the police force have extended their warmest congratulations, noting that his new role is a great recognition and a source of pride for Malaysians. FIFA president Gianni Infantino confirmed that the 76th FIFA Congress will take place on 30 April 2026 in Vancouver, Canada. JUST ANNOUNCED! Vancouver, Canada, will host the 76th FIFA Congress on April 30, 2026. 🇨🇦 — Canada Soccer (@CanadaSoccerEN) Share your thoughts with us via TRP's . Get more stories like this to your inbox by signing up for our newsletter.
