'Dad brain': How becoming a father changes your brain

It's not only mothers who experience profound changes around the birth of a child - fathers also show measurable adjustments in brain structure and hormone balance, according to new research led by psychology professor Darby Saxbe at the University of Southern California.
Results from brain scans show: The cortex, the part of the brain responsible for higher cognitive functions, also changes in fathers, Saxbe explains in the American Psychological Association (APA) podcast Speaking of Psychology.
The changes are more subtle than in mothers, but nevertheless detectable - and they appear to promote the fathers' ability to care.
There are also changes in hormone levels. The testosterone levels of many fathers fall after the birth, something associated with a higher motivation to look after the baby, explains Saxbe.
This means that less testosterone can mean more closeness to the child, as well as a better quality of relationship during the transition to parenthood.
At the same time, it was shown that partners of fathers with lower testosterone reported fewer depressive symptoms - provided the relationship was good.
Poor sleep is a constant companion of young parents. And according to Saxbe's research, lack of sleep is a consequence rather than a cause of brain changes.
Those who are particularly involved in caring for the baby often sleep less well - but the brain seems to want to "remodel" itself precisely for this purpose.
Her research also suggests that fatherhood is a real "development window" for the brain - comparable to adolescence or childhood.
"Every window of change is a window of vulnerability, but it's also a window of opportunity," says the professor.
Anyone who initially feels that they are unable to concentrate like they used to need not worry immediately. This is because children boost their parents' memory: they sharpen their cognitive skills and parents have "more ability to remember and retrieve things" that are related to the child.
Another key finding: fathers who take parental leave also benefit - but mothers benefit even more. They sleep better, are less stressed and show fewer depressive symptoms, her research showed. "It was really the moms that had the biggest benefit."
Parental leave is something that not only benefits fathers, but the whole family. "We know it has benefits for the children. We also know that it's beneficial for the partner. And I think that anything you can do to take the pressure off the family system is also a way of managing stress."
- Darby Saxbe is Professor of Psychology at the University of Southern California in Los Angeles. There she directs the Neuroendocrinology of Social Ties (NEST) Lab, where she studies how close relationships affect health, with a particular focus on the transition to parenthood. Her book "Dad Brain" is due to be published next year.

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UnitedHealth's Rebound: Hidden Strength or Hiding Weakness?

Recently, UnitedHealth Group (UNH, Financial) has been the subject of many headlines because of DOJ probes, kickback accusations in nursing homes, and a shocking departure of its CEO. In addition, the value of its shares has dropped by almost 50%. Yet, underneath the news, the business is still strong. Health insurance remains important and strong throughout economic downturns and doesn't react to changes in global trade. In the aftermath, a clear development can be noticed as Stephen Hemsley was appointed CEO again and bought a large amount of stock which fueled a quick increase in share prices. Warning! GuruFocus has detected 4 Warning Sign with UNH. This is real conviction. UnitedHealth is focusing more on Medicaid-managed care, widening value-based care with Optum, and looking into growing its business in dual-eligible and long-term care. The company's financials confirm the trend since earnings have quadrupled in ten years, cash flow is strong, and insiders are buying in. In short, UnitedHealth is using the uncertainty to its advantage. Long-term investors may find the current price as an attractive chance to enter a company that has shown lasting and solid growth. UnitedHealth Group is the biggest health insurer in the United States and ranks highly internationally in healthcare. Its two key segments, UnitedHealthcare and Optum, give people health benefits, pharmacy services, data analysis, and healthcare. More than 150 million people are helped by this company, which is continuing to expand by combining operations and offering value-based care. The company provides insurance through commercial, Medicare, and Medicaid markets, and Optum sparks new ideas in care coordination and pharmaceutical services. UnitedHealth is smartly diversified. The company is doing well due to managed care growth, making money from healthcare improvements, and strategically serving top segments thanks to Optum doing the main work. Medicaid managed care expansion capturing state-level shifts: The move of Medicaid recipients from fee-for-service to managed care can bring huge benefits to UnitedHealth. According to industry statistics, UNH and four other large insurers cover over 50% of people in Medicaid-managed care across the nation. So, when several hundred thousand to millions switch plans, it has a huge effect on the company's finances. Since monthly premiums for complex patients in these states are $600$800, New York, Pennsylvania, and Michigan could add hundreds of millions of dollars to their annual premium earnings. Because of its connections with states, UNH is in a good position to win a major share of this revenue. Value-based care & optum scale turning outcomes into profit: Optum, which drives UNH's value-based approach, recorded $253 billion in revenue in 2024, which was 12% higher than the previous year, and $16.7 billion in operating income. Currently, Optum Health works with close to 4.7 million people in value-based contracts and plans to add another 650k in 2025. Focus on patient care and cost savings are the main aims of these models, and UNH supports this. When Optum grows its care coordination and home services, shared-savings revenue plays a bigger role, already bringing in hundreds of millions and capable of much more. High-Value segments target the dual-eligible and long-term care markets: Instead of raising its volume, UNH is focusing on high-paying customer groups, such as those with both Medicare and Medicaid and patients needing long-term care. Dual-eligibles may receive $2,500 monthly, which means each person will get $30,000 annually. Currently, UNH serves about 500k people, but if it could capture just 2 million of the national enrollments, it could earn $45 billion in annual premiums. Vertical integration with optum: Thanks to Optum, UNH has all its services combined, including pharmacy (over 1.62 billion scripts were handled by OptumRx in 2024), care delivery, data analysis, and provider management. Because of this integration, UNH is ahead in long-term care, managing care effectively, reducing expenses, and boosting results, which other organizations don't have. Overall, UnitedHealth is a leader that is making steady earnings now and is prepared to capture the future of healthcare and population wellness. Now, let's investigate the financial side of UnitedHealth Group. The company had good first-quarter earnings, but it sent a cautious message for the coming months. UnitedHealth Group's quarterly revenue of $109.6 billion was $10 billion higher than the same period last year, showing how much both UnitedHealthcare and Optum are growing. While adjusted EPS of $7.20 surpassed $6.91 from the earlier period, the company adjusted its full-year forecast down to expect adjusted EPS of $26.00 to $26.50. So, what leads to this change of tone? While UnitedHealthcare welcomed 780,000 new members, increased use of health services in Medicare Advantage by its customers caused the company's medical costs to increase above expectations. Because more people needed outpatient and physician care, the medical care ratio rose to 84.8%. For healthcare delivery, this is not necessarily an issue, yet it can still hurt business if prices fall short. Meanwhile, Optum Health experienced challenges with a more diverse member group and reduced payments due to less involvement among members in 2024. Even so, Optum achieved a $63.9 billion revenue thanks to its Rx division, which filled 408 million adjusted scripts. UNH is also operating efficiently, with its operating cost ratio now 12.4%, free cash flow at $5.5 billion, and a high 26.8% return on equity. The company also gave $5 billion back to its shareholders. All in all, UNH's basics are solid, but it has to deal with some short-term problems first. UnitedHealth Group has consistently improved its earnings over the years. In the year 2015, diluted earnings per share was only $6.01. Looking at the trailing twelve months, the number has reached $23.88. Over the past decade, the amount has almost quadrupled. It is even more impressive that the growth has been steady over the years. For many years, UnitedHealth kept increasing its profits, demonstrating the power of its varied businesses and strict management. The only major drop in EPS happened in 2024, with the figure reaching $15.51. Although this was an unusual dip in the company's history, it is on track for a solid recovery in 2025, and first-quarter adjusted EPS was $7.20. Looking into the future, analysts believe the trend will not stop. Even though 2025 is, in some ways, a year of recovery with a projected EPS of $22.59, the company's growth kicks in afterward. By 2026, analysts predict EPS will increase to $26.40, and then keep growing at double-digit rates, aiming for $45.83 by 2030. Source: Author generated based on historical data All in all, despite some occasional setbacks, UnitedHealth's future growth is steady, so patient investors are still in a position to be rewarded. The increase in EPS matches the upward trend in revenue per share. It highlights the company's steady growth and increased success. In the year 2015, the company's revenue per share was $162.47. Now, that figure is $443.16 TTM. That's a 170% jump in ten years, which clearly shows the company is making better use of its growth to help shareholders. What's most promising is that this growth keeps happening consistently. Revenue per share has increased year after year and stayed strong through different economic conditions and impacts on the industry. It is a result of the company attracting more members and expanding its main businesses, UnitedHealthcare and Optum. Once more, this trend keeps happening in the future. Revenue forecasts keep going up from $449.81 billion in 2025 to more than $591 billion by 2030. Minor changes in growth do not stop the company from expanding and creating more value for its shareholders. Source: Author generated based on historical data UnitedHealth Group's free cash flow per share is a reliable sign of how well the company is financially and operationally. The amount of free cash flow per share in 2015 was $8.46. Afterward, the company increased this number, reaching $26.82 for the TTM, which is more than three times higher than its value a decade back. What stands out about this growth is that it follows closely in line with the company's earnings trajectory. Therefore, we see that UnitedHealth's profits are being turned into cash that can be used to strengthen the business, cut debt, or be given back to its shareholders. Being that efficient is not common in an industry that relies heavily on capital like healthcare. UnitedHealth Group gives investors a good dividend since the dividend yield is 2.92% and the payout ratio is only 30%, which suggests that dividends could increase in the future. It's worth noting that over the past 5 years, the company has seen a 14.6% growth in its dividend, which tops inflation and profits long-term investors. Through ten years of constant raises, the yield on cost increases to 15.38%. Although UNH is offering a high yield now, low buybacks mean most capital is shared through dividends. UnitedHealth Group looks deeply undervalued right now. According to GuruFocus, the stock is trading about half its worth, as the fair value is $633.16 but it is currently trading at $303.22. There is a massive disconnect here, and it's very unusual for a company as stable as UNH to deviate so much from its fair value estimate. Valuation multiples are also telling the same story. The forward P/E of this stock is 13.42, which is much lower than the average of 17.66, giving a discount of 23.98%. The company's forward EV/EBITDA of 9.61 is better than the sector's ratio of 11.79. On a price-to-sales ratio, UNH is trading at 0.61 times its projected sales, while the healthcare industry is pricing in at 3.43xa discount of 82%. All in all, UNH gives you both quality and value. Almost all of the valuation measures suggest that the company is undervalued in terms of its earnings, sales, and cash flow. Even though the stock is built on solid foundations and pays out more in dividends each year, it still trades at a lower price than its competitors. As a result, long-term investors can take advantage of acquiring a leader in healthcare at a much lower price than its actual value. When measured against companies like Humana (HUM, Financial) and HealthEquity (HQY, Financial), UnitedHealth Group is still a good buy. Because its forward P/E is lower than HUM's 14.1 times and much lower than HQY's 30 times, it attracts those who want to invest for growth as well as value. Considering price-to-sales, UNH trades at 0.68 times, making it more valuable than HQY's 7.8 while being slightly higher than HUM's very low 0.23. On the EV/EBITDA ratio, UNH stands at 9.6x forward, quite similar to HUM's 9.2x and much less than HQY's 19.2x. All in all, UNH is well-balanced by giving investors scale, profits, dividend growth, and a reasonably attractive price. HUM also does well in various areas, especially when it comes to managing expenses and the way the company works. But in the long run, investors admire UNH for its consistent results and potential to increase. Source: Author generated based on data Going forward, I feel UnitedHealth Group (NYSE:UNH) is well-positioned to achieve a price target of $395$410 in the next year and possibly surpass $525$550 by 2027. Despite the stock's recent volatility, the numbers, the company's health, and the outlook seem to fit together nicely. Let's begin our discussion with the short term. Despite many years of increasing earnings and a high rate of cash conversion, UNH is only valued at 13.4 times its future earnings when the stock is trading at $303. Healthcare companies, on the other hand, have a forward P/E of about 17.6, and UNH has generally had a forward P/E between 18x and 20x during calm times. If UNH is valued at just 17 times the expected FY2025 EPS of $22.59, the price would come to $384. At 18x, If stability comes back and the new leaders reassure everyone, the stock could increase to $406. The story gets even better as you look further into the future. Analysts are predicting that EPS will rise to $45.83 by 2030, meaning it will be about double the current earnings in just five years. Multiply the earnings by 15, and the share price comes out to $687. But, let's narrow our focus to conservatism, and for 2027, the predicted EPS is about $34.50. At this multiple of 15x, the price comes out to $517if the market recovers, shares could climb to $550 or more due to the 16x or 17x rating. If the DOJ investigation ends well and Hemsley's efforts to cut costs are successful, the company should do well over the next few quarters. We are not just discussing theory here. Since 2015, UNH's free cash flow per share has more than tripled, its revenue per share has nearly tripled too, and it still has some of the top dividend growth rates in healthcare. Such consistency, size, and under-valuation are hard to find in one company. Let's look at how Wall Street views this area. Looking at the chart, analysts foresee that the price of Apple shares might rise by 26.2% to $382.80 in the next 12 months. It is estimated that the cost can fall anywhere from $270 to $677. To conclude, although there may be short-term ups and downs, it looks like disciplined, patient investors will find more favorable long-term conditions. When Andrew Witty suddenly left his CEO post in May because of profit problems and dropped 2025 guidance, UNH shares fell over 12% to their lowest point in five years and wiped out more than $250 billion in market value. As a consequence, the board brought back former CEO Stephen Hemsley (who headed the company from 2006 to 2017). Within only a few days, Hemsley made a big step by buying nearly 86,700 shares worth about $25 million for $288.60 per share. Hemsley, together with the CFO and several directors, voted to keep the company's value high, and shares rose by about 8% the following trading day. What does it imply? It is clear that the management views the falling share price of UNH as a good time to purchase. The fact that Hemsley has invested his money shows how much he believes in the company after all it has achieved. Yet, this is not a case of blind faith: the company is dealing with an ongoing investigation, higher medical costs in Medicare Advantage, and a cyberattack it suffered recently. From a strategic point of view, all this buying in UNH suggests that the company's leaders believe the worst has passed and risks for the stock are low. The guru trading chart has an interesting narrative. Although UnitedHealth's stock has gone down recently, gurus have been buying it more frequently. Many green bars are appearing, both early in 2024 and again later in 2025, showing that some informed investors are looking at the dip as an opportunity to buy instead of a warning sign. This trend can be seen in the investor's stock portfolio. Vanguard is still the biggest shareholder, but it slightly reduced its holdings. I'm also paying attention to Ken Fisher (Trades, Portfolio) , who bought much more, a solid 52%, and Jeremy Grantham (Trades, Portfolio) , who increased his holding by over 7%. Though there is selling and shares are reduced as well, institutions tend to be cautiously upbeat. Even though UnitedHealth's future looks bright, investors should still pay attention to the risks in the near term. The DOJ is currently investigating the business for possible Medicare Advantage fraud, such as upcoding and billing errors, which is a very serious matter that could result in being fined or charged in court. At the same moment, Washington is paying more attention to supervision. Should reforms reduce the inflation of risk scores or Medicare allowance for nurse practitioners, it could affect the profitability of Medicare Advantage. Q1 faced some issues because the higher use of medical services caused the medical loss ratio to increase to around 85%, and Optum is still learning to handle CMS's updated risk model. Because of these pressures, there could be more budget reductions for guidance. However, the bad news appears to be mostly factored into share prices. For careful investors who believe the company will survive, this could present an opportunity to buy long-term. The headlines can be very tempting, but stepping back, it appears that UnitedHealth is still a powerhouse lurking in plain sight. It is the same old stuff but with a different sentiment. The long-term story is still in place with the reinstatement of Stephen Hemsley, a recent insider purchase, and a long history of expertise in Medicaid-managed care and the Optum platform in value-based care. Most of that bad news, including the increases in care costs, and regulatory noise, appears to be reflected in price. Sentiment can change at any minute as long as we hear a resolution to the DOJ investigation, a slowdown in the trend of rising Medicare costs, or upbeat guidance in coming quarters. Any of those may be the spark. In the meantime, the stock is currently trading at one of the most attractive valuations it has seen in years, and the set-up is of the sort long-term investors tend to reflect back on with gratitude. If you are waiting to have a clear picture, you may miss the opportunity. However, to the patient and longer-term investors, this may be one of those times when interceding in soreness results in actual payoff. In other words, this just might be a smart time to lean in and buy the stock. This article first appeared on GuruFocus. Effettua l'accesso per consultare il tuo portafoglio

Yahoo

an hour ago

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NurExone Advances U.S. Growth Strategy with Acceptance into Prestigious ARMI HealthTech Hub Accelerator and Provides Corporate Update

TORONTO and HAIFA, Israel, June 20, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) ('NurExone' or the 'Company'), a biotech company developing exosome-based therapies for central nervous system injuries, announced today that it has been accepted into the HealthTech Hub ('HTH') Accelerator Program. Based in Boston, Massachusetts, home to more than 1,000 biotech companies1, HTH is operated by the Advanced Regenerative Manufacturing Institute ('ARMI') and its BioFabUSA initiative. NurExone's acceptance into the prestigious HTH Accelerator Program will support the Company's expansion into the U.S. market following the establishment of Exo-top Inc. ('Exo-TOP'), the Company's wholly owned U.S. subsidiary dedicated to GMP-compliant exosome manufacturing for clinical development and commercial scale-up. HTH, co-led by ARMI and Mass General Brigham, is a competitive accelerator program supported by the U.S. Department of Health and Human Services and Israel's Ministry of Health. The HTH Accelerator Program selects a limited number of innovative companies each year to help them validate U.S. clinical relevance, strengthen commercialization strategies, and build meaningful collaborations with key stakeholders across the U.S. HealthTech landscape. The program is funded by HTH at no cost to participants. Dr. Lior Shaltiel, CEO of NurExone, commented: 'The HTH Acceleration Program offers the kind of U.S.-based insight and guidance needed at this stage of our growth. As we establish Exo-TOP to manufacture clinical-grade exosomes in the U.S., the HTH will help us sharpen our regulatory and scale-up strategies and pursue meaningful commercial collaboration opportunities. This is a timely and strategic opportunity to accelerate our commercialization pathway in the world's largest healthcare market 2.' NurExone's participation in the HTH Accelerator Program is expected to enhance its visibility within the U.S. regenerative medicine ecosystem and to support its mission to bring novel exosome-based therapeutics to patients with unmet needs. Omnibus Plan Approval The Company is pleased to announce that, further to its press release dated June 4, 2025, at the Company's annual general and special meeting held on June 18, 2025 (the 'Meeting'), disinterested shareholders ratified and approved the amended and restated omnibus incentive plan (the 'Omnibus Plan'), a copy of which is available under the Company's SEDAR+ profile at The Omnibus Plan is a hybrid plan that provides flexibility to grant-equity incentive awards in the form of stock options ('Options'), restricted shares ('Restricted Shares') and restricted share units ('RSUs'). The Omnibus Plan is a hybrid 10% rolling and 10% fixed share-based compensation plan that amends and restates the Company's previous equity incentive plan approved by shareholders on June 4, 2024 (the 'Previous Plan'). The Previous Plan was a 20% fixed share-based compensation plan whereby the maximum number of common shares in the capital of the Company ('Common Shares') reserved for issuance was set at 13,166,085, representing 20% of the issued and outstanding Common Shares as of the effective date. The Omnibus Plan now includes (i) a 10% 'rolling' Option component that shall not exceed 10% of the Company's total issued and outstanding Common Shares from time to time; and (ii) a 10% fixed component permitting up to 7,800,781 RSUs and Restricted Shares in the aggregate. Additionally, the Omnibus Plan was amended to increase the number of securities issuable to insiders of the Company. The Previous Plan provided, that unless approved by disinterested shareholders, (i) the maximum number of securities issuable to insiders collectively would not exceed 10% of the Company's securities at any time and (ii) the maximum number of securities issuable to insiders collectively in any twelve-month period would not exceed 10% of the Company's total issued and outstanding securities as at the date any award was granted to an insider. Now, the Omnibus Plan provides the following that (i) the maximum number of the Company's securities issuable to insiders collectively shall not exceed 20% of the Company's total issued and outstanding Common Shares at any point in time and (ii) the maximum number of the Company's securities issuable to insiders collectively, in any 12-month period, when combined with all of the Company's other share compensation arrangements, shall not exceed 20% of the Company's total issued and outstanding securities, calculated as at the date any award is granted or issued to any insider. RSU Grants In addition, the Company announced that it has granted an aggregate of 1,125,000 RSUs to certain officers and directors of the Company pursuant to the terms and conditions of the Omnibus Plan. Each RSU vests on the one-year anniversary of the grant date and may be settled, upon their vesting, into one Common Share. The RSUs and underlying Common Shares are subject to the Exchange Hold Period (as such term is defined under the policies of the TSX Venture Exchange ('TSXV')). About NurExone NurExone Biologic Inc. is a TSXV, OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsi. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy. For additional information and a brief interview, please watch Who is NurExone?, visit or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube. For more information, please contact: Dr. Lior ShaltielChief Executive Officer and DirectorPhone: +972-52-4803034Email: info@ Dr. Eva ReuterInvestor Relations – GermanyPhone: +49-69-1532-5857Email: Allele Capital PartnersInvestor Relations – +1 978-857-5075Email: aeriksen@ press release contains certain 'forward-looking statements' that reflect the Company's current expectations and projections about its future results. Wherever possible, words such as 'may', 'will', 'should', 'could', 'expect', 'plan', 'intend', 'anticipate', 'believe', 'estimate', 'predict' or 'potential' or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the; the Company's acceptance into the prestigious HTH Accelerator Program will support the Company's expansion into the U.S. market; the Company's participation in the HTH Accelerator Program is expected to enhance its visibility within the U.S. regenerative medicine ecosystem and support its mission as discussed herein; each RSU will be settled into one Common Share; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: the Company's acceptance into the prestigious HTH Accelerator Program will allow it to support the Company's expansion into the U.S. market; the Company's participation in the HTH Accelerator Program will give the Company the ability to enhance its visibility within the U.S. regenerative medicine ecosystem and support its mission as discussed herein; each RSU will be settled into one Common Share; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company's early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; dependence on the Company's strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the inability to obtain adequate financing; the inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; risks that the Company's intellectual property and technology won't have the intended impact on the Company and/or its business; the Company's inability to carry out its pre-clinical trials and realize upon the stated benefits of the pre-clinical trials; the inability of the Company to realize on the benefits of exosomes; the inability of the Company to produce and/or supply exosomes for a wide range of applications; the inability of the Company's products to be used for patient treatment; there not being broader adoption in the field and/or cell therapy applications; the inability of the Company to fulfill its intended future plans and expectations; there not being growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the Company's inability to realize upon the stated potential for exosome-loaded drugs in regenerating or repairing damaged nerves; the Company's inability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and/or cell therapy applications; the Company's inability to expand into further studies; the Company will not receive all required regulatory approvals; the Company will not have clinical and/or commercial breakthroughs in regenerative medicine; the Company will be unable to enhance its presence in key markets; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; the Company will not realize its future development plans, operational initiatives, and strategic objectives; the Company will not advance its therapeutic programs and clinical milestones; the Company will not engage with regulatory agencies; the Company's acceptance into the prestigious HTH Accelerator Program will not support the Company's expansion into the U.S. market; the Company's participation in the HTH Accelerator Program will not enhance its visibility within the U.S. regenerative medicine ecosystem and will not support its mission as discussed herein; each RSU will not be settled into one Common Share; and the risks discussed under the heading 'Risk Factors' on pages 44 to 51 of the Company's Annual Information Form dated August 27, 2024, a copy of which is available under the Company's SEDAR+ profile at These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law. Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. i Spinal cord injury, Glaucoma 1

Medscape

2 hours ago

• Medscape

ACC Revises Obesity Control Strategies in Heart Failure

A new Scientific Statement from the American College of Cardiology (ACC) has named two anti-obesity drugs as options for symptom control in patients with heart failure. The benefit for these incretin mimics, semaglutide and tirzepatide, is attributed to symptom control, according to the statement. The document, published on June 13 in the Journal of the American College of Cardiology , states that each medication has the potential to reduce cardiovascular (CV) events related to heart failure, but neither has yet done so on the basis of level 1 evidence. The new recommendation appl ies only to heart failure with preserved ejection fraction (HFpEF). The safety and efficacy of these drugs has yet to be established for heart failure with reduced ejection fraction (HFrEF), according to the ACC statement. The new anti-obesity drugs were approved initially for type 2 diabetes. On the basis of substantial weight loss and their relative safety, the FDA subsequently granted indications for obesity alone in patients with at least one additional obesity-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea. Current Indications for Incretin Mimetics Semaglutide has an indication for patients with CV disease, but not heart failure specifically, and obesity on the basis of the 2023 SELECT trial. Tirzepatide has an indication for patients with sleep apnea and obesity in the absence of diabetes on the basis of the 2024 SURMOUNT-OSA trial. In the 2023 STEP-HFpEF trial with semaglutide and the 2025 SUMMIT trial with tirzepatide, each agent was associated with a reduction in symptoms of heart failure in patients with HFpEF. However, the study designs and outcomes differed. For one, the HFpEF entry criterion was a left ventricular ejection fraction ≥ 45% in STEP-HFpEF but ≥ 50% in the SUMMIT trial. In dual primary endpoints, both included changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ), but the first of the two trials evaluated weight change, while the second evaluated a composite endpoint of CV death and heart failure-related events. By listing semaglutide and tirzepatide as options within a comprehensive review of the treatment of obesity in heart failure, the new document steps in front of current regulatory guidance. In a table that juxtaposed FDA-approved indications for these drugs to evidence-based benefits as defined by the statement, only the latter identifies a role in heart failure. 'The intent of the Writing Committee in including this table was to highlight that there are no FDA-approved heart failure indications for the use of incretin-based anti-obesity medications to date,' said Michelle M. Kittleson, MD, PhD, director of Heart Failure Research at Cedars-Sinai Medical Center in Los Angeles, who chaired the committee. 'While clinicians might identify individuals with heart failure who meet the standard FDA-approved indications, it is important to also identify which of those patients also meet inclusion criteria for th e heart failure trials were benefit was shown,' Kittleson said. Semaglutide acts on the GLP-1 receptor alone. Tirzepatide is an agonist of both the GLP-1 receptor and glucose-dependent insulinotropic polypeptide. Both drugs are associated with strong signals of CV benefit overall and in heart failure specifically, even if the evidence in HFpEF is 'stronger,' according to the statement. Incretin drugs mimic hormones that downregulate appetite. They are considered third-generation anti-obesity agents on the basis of their targeted mechanism and a low relative risk for adverse events. More than a dozen such agents are now in various stages of development, according to the ACC statement. Semaglutide and Tirzepatide Trials Differ In the STEP-HFpEF trial, which like SUMMIT trial, was placebo controlled, the 7.8-point gain ( P <.0001) in the KCCQ on active therapy vs placebo was statistically significant, as was the percent body weight loss (-13.3% vs -2.6%; P < .001). The SUMMIT trial found a 6.9-point gain in the KCCQ score ( P < .001) relative to placebo, while the rate the composite event endpoint of CV death from events associated with heart failure was lower (9.9% vs 15.3%; P = .026), but CV deaths occurred in only 13 patients. Heart failure events were observed in 81 patients over 2 years of follow-up. In both studies, significant gains in the secondary endpoints of physical and exercise function were associated with the assigned weight-loss drug. On the evidence so far, the authors of the ACC statement concluded that despite the marginal benefit observed in the SUMMIT trial, no firm conclusions can be made about the ability of incretin therapies to protect patients with HFpEF against hard endpoints, Kittleson said. Until more data are available, she cautioned against the risk for 'indication creep,' the willingness to offer these drugs for potential benefits that have yet to be confirmed. Still, she added, 'the goal of the writing group was to strike a tone of cautious optimism guided by the available data.' Part of this optimism has been fueled by the 2023 SELECT trial, which enrolled more than 17,000 patients with overweight with CV disease but no diabetes. Relative to placebo, semaglutide was associated with a 20% reduction ( P < .001) in the composite primary endpoint of CV death, nonfatal myocardial infarction, and nonfatal stroke. Only 24% of patients in this study had heart failure, but the risk reduction in this group was consistent with that of the study population as a whole. Obesity is listed in most guidelines, including a 2024 ACC Expert Consensus Decision Pathway for Treatment of HFrEF, as a common comorbidity of heart failure and potentially treatable risk factor for symptoms and progression of the condition. However, the new statement differs from prior guidelines. Typically, lifestyle modifications are identified as a first step toward weight loss. 'Patients should not be required to try and fail lifestyle changes prior to initiating pharmacotherapy,' according to Olivia Gilbert, MD, a cardiologist specializing in advanced heart failure and transplantation at Atrium Wake Forest Baptist Medical Center, in Wake Forest, North Carolina. Although Gilbert was not part of the writing committee for the new document, she has been involved in developing clinical guidance statements for the ACC. The incretin therapies are more effective than lifestyle medications and safer than procedure-based weight-loss interventions, Gilbert said, providing a basis for suggesting they can be considered first line therapy for patients with symptomatic HFpEF. 'Lifestyle interventions should always be offered in conjunction with obesity medications,' she said.