PCCN book - AACN Progressive Critical Care Nursing Updated: 2024

Understanding diabetes today requires holding two conflicting realities in your head simultaneously.

First, diabetes therapy has been revolutionized by a world of new drugs that have become available since the turn of the century—most notably, drugs of the same class as Wegovy and Ozempic that began their existence as diabetes medications and are now hailed as wonder drugs for treating obesity. These drugs do the best job yet of controlling blood sugar and, of course, body weight, which is critical for those Type 2 diabetes, the common form of the disease that constitutes over 90 percent of cases and is associated with age and obesity. For type 1 diabetes, the acute condition that typically strikes in childhood and adolescence, new devices—continuous blood sugar monitors and automated insulin delivery systems—make blood sugar control easier than ever. Still more advanced devices and better drugs are in the pipeline.

But then there’s the flip-side. It’s why the pharmaceutical industry has invested so heavily in new therapies: Once a relatively rare condition, diabetes is now so common that drugstores dedicate entire aisles to it and television commercials for diabetic medications are common fare. In 1960, when the first concerted federal surveys were quantifying prevalence, two million Americans were living with a diabetes diagnosis. Today that number is 30 million; almost nine million more have diabetes but don’t yet know it. Each year, 1.4 million new cases are diagnosed and at ever younger ages.  

Diabetes puts all of these individuals at increased risk of heart disease, strokes, cancer, blindness, kidney failure, nerve damage, gangrene, and lower limb amputation. It increases cognitive impairment and dementia risk as patients age. Living with diabetes still comes with a decrease in life expectancy of six years.

For those with Type 1 diabetes, despite the remarkable new drugs and devices, blood sugar control is seemingly getting worse, on average, not better. As of 2018, fewer than one in five individuals diagnosed with Type 1 diabetes were achieving even the relatively generous blood-sugar goals set by the American Diabetes Association (ADA); this was a smaller proportion than a decade earlier.

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Despite the remarkable advances in therapy, both Type 1 and Type 2 diabetes are still considered progressive chronic diseases, meaning the patient’s condition is expected inevitably to deteriorate as they live with the disease. The greatest challenge to better therapy, as one exact analysis suggested, is the hesitation of physicians to continue prescribing more or newer drugs and increasing dosages as the diseases progress.

All of this comes with a staggering financial burden. In November, the ADA estimated that the total annual cost of diabetes in the U.S. is over $400 billion; over $300 billion is direct medical costs. This was up $80 billion from 2017 when an editorial commenting on a similar accounting characterized these costs as the “elephant in the room” of the diabetes epidemic. Patients with diabetes are likely to spend over $12,000 a year just for medical care, almost three times that of healthy individuals of equivalent age. It does not help that the drugs themselves—whether insulin or Ozempic and its ilk —are expensive, costing many thousands of dollars a year. One in every four health care dollars spent in America goes to treating diabetic patients.

And the U.S. is by no means unique. The World Health Organization estimates that diabetes prevalence worldwide increased four-fold between 1980 and 2014, from 108 million to over 400 million, with the greatest rise coming, paradoxically, in the poorest countries. In 2016, Margaret Chan, then WHO director general, described the situation as a “slow-motion disaster” and predicted with near absolute certainty that these numbers would only get worse. They have.  

So how do we reconcile these conflicting realities: Unprecedented advances in medical therapies for an out-of-control disease epidemic in which patients, at least in general, are doing poorly and can expect to do worse as time goes on? Confronted with such a dismal state of affairs shouldn’t we be asking how we got to this point? Were mistakes made in how we think about this disease? Were questionable assumptions treated as facts, and could those assumptions be wrong?

Asking the Right Questions

These are the kinds of questions you would hope health organizations worldwide would be asking, but surprisingly they have no mechanisms or protocols to do so. Diabetes associations like the ADA will regularly convene expert panels to address revisions in the latest standard of care guidelines to accommodate the latest research, but not whether the guiding principles underlying those guidelines should be rethought entirely. Independent investigators are not recruited to analyze and to provide an unbiased assessment of where progress might have gone off the rails. That job instead has been left to physicians in their clinics, those confronted with ever more diabetic patients and willing to take the risk of thinking independently, and to investigative journalists like myself, whose obligation when confronted with such conflicting realities is to ask just these kinds of questions.

Among the revolutions that changed medical practice over the past half century, one in particular is very relevant here. Beginning in the 1970s, health-care analysts began to confront quite how little physicians really knew about the risks and benefits of what they were doing for their patients. Not only had clinical trials demonstrated that some standard medical practices resulted in far more harm than good—the surgical procedure known as a radical mastectomy, most infamously, for breast cancer—but researchers were documenting wide variations in medical practices from physician to physician, hospital to hospital and state to state. This, in turn, resulted in a wide variation of benefits, harms and costs to the patients, depending on which physicians they might visit, and so which treatments they might get.

Read More: Should We End Obesity?

The revolution that followed became known as the Evidence-Based Medicine (EBM) movement, founded on the principle that medical interventions should be rigorously tested in clinical trials— double-blind, randomized, placebo-controlled—before they be used or prescribed. This would be necessary whenever physicians were faced with a choice between multiple options, and whenever the harms of an intervention might outweigh the benefits. David Sackett of McMaster University, a founder of the movement, would describe the EBM process as beginning with the fact that half of what aspiring doctors learn in medical school is “dead wrong,” and then trying to establish thoughtfully and critically which half that is. David Eddy of Duke University, another EBM pioneer, later described his motivation and that of his colleagues as the revelation that “medical decision making was not built on a bedrock of evidence or formal analysis, but was standing on Jell-O.”

It would be nice to think that this situation has been widely resolved by evidence-based guidelines, but that’s not the case. Journalists or physicians looking for the evidence base in decision making about diabetes therapies, will likely find themselves, as I did, with the same revelation. Clearly it, too, was standing on Jello-O in the 1970s, but the problem neither began nor ended there. A remarkable history emerges, with three clear observations.

First, we’ve been here before. We have had miracle drugs for diabetes. Most notably, the hormone insulin itself, when University of Toronto researchers led by Frederick Banting and Charles Best purified it and put it to use in 1922 treating patients with severe cases of diabetes. We then had better insulins, slower-acting and longer-lasting, and then, in the post-World War 2 years, drugs (oral hypoglycemic agents) that could lower blood sugar without having to be injected, as insulin did. We have had revolutionary advances in diabetes technology, beginning in the 1970s with devices that allowed patients to monitor their own blood sugar, and then insulin pumps that automated the process of insulin therapy. All contributed to easing the day-to-day burden of diabetes. None had any influence in controlling the epidemic, nor did they eradicate or meaningfully reduce the long-term complications of the disease. Put simply: diabetes plus drug therapy and devices, even the best drug therapy and devices, does not equate to health.

Secondly, diabetes researchers have not been averse to testing their fundamental assumptions. They‘ve done so in ever more ambitious clinical trials. But a disconcerting proportion of those trials failed to confirm the assumptions, despite the fact that it was these assumptions that constituted the rationale for therapeutic approaches. The $200 million Look AHEAD Trial, for example, tested a foundational belief in the field: that weight loss in those with Type 2 diabetes would lengthen lives. The trial was ended for “futility” in 2012. ”We have to have an adult conversation about this,” as David Nathan, a Harvard diabetes specialist, said to The New York Times. The 10,000-patient ACCORD trial had also been ended prematurely just four years earlier. “Halted After Deaths,” in the words of The New York Times headline. “Medical experts were stunned,” the 2008 article said. ACCORD was one of three trials testing the assumption that intensive blood sugar control by medications would reduce the macrovascular complications of Type 2 diabetes—particularly heart disease—and premature death. All three trials failed to confirm it.

Third, the remarkable aspect of all these trials is that they all assumed an approach to dietary therapy that itself had never been tested. This is the “standing on Jell-O” problem. For well over a century, diabetes textbooks and chapters in medical texts invariably included some variation on the statement that diet is the cornerstone of treatment. The most exact guidelines from the ADA refer to dieting as “medical nutrition therapy” (MNT) and say MNT is “integral” to therapy.

But what constitutes MNT—the dietary advice given—has been determined not by any meaningful research comparing different dietary approaches. Rather it has been assumed that individuals with diabetes should eat the same “healthful eating pattern” that health organizations recommend for all of us—“non-starchy vegetables, fruits, legumes, dairy, lean sources of protein… nuts, seeds, and whole grains”—albeit with the expectation, if weight control is necessary, that they should eat fewer calories.

Read More: Are Weight Loss Drugs From Compounding Pharmacies Safe?

Controlling the symptoms and complications of the disease is left to insulin and the pharmacopeia of drugs that work to maintain blood sugar levels near enough normal that the specter of diabetic complications may be reduced as well. Diabetes associations have assumed that this approach is easiest on the patients, allowing them to balance the burden of insulin injections or multi-drug therapy, against the joy of eating as their non-diabetic friends and family do. But this assumption has never been tested to see if it is true, nor whether a better approach exists that might truly minimize the disease burden of diabetes, extend lives and make the trade-off of restrictive eating vs. health worthwhile.

History of Diet and Diabetes

This is where understanding the history of the diet-diabetes relationship can be vitally important. What has been known for certain about diabetes since the 19^th century is that it is characterized by the inability to safely metabolize the carbohydrates in our diet. This observation led to two divergent approaches/philosophies to dietary therapy. Beginning in 1797, when a British physician named John Rollo wrote about curing a diabetic patient using a diet of fatty (rancid) meat and green vegetables, through the early 1900s, diabetes therapy was based on the assumption that since individuals with diabetes could not safely metabolize the sugary and starchy foods in their diet, they should abstain from eating them. In this pre-insulin era, the only meaningful advice physicians could deliver their patients was dietary, variations on Rollo’s approach: sugars, grains, starches, even legumes were prohibited because they are carbohydrate-rich: meats, ideally as fatty as possible, butter and eggs, along with green leafy vegetables (boiled three times to remove the digestible carbohydrates) could be eaten to satiety.

Throughout Europe and America, this was known was “the animal diet,” endorsed by virtually every major diabetes specialist of the 19th Century. Physicians believed that the more calories their diabetic patients consumed, and ideally the more fat (because protein is composed of amino acids, some of which the liver converts to carbohydrates), the healthier they would be.  “Patients were always urged to take more fat,” is how this was described in 1930 by the Harvard physician Elliot Joslin, who was then, far and away, the most influential diabetes authority worldwide. “At one time my patients put fat in their soup, their coffee and matched their eggs with portions of fat of equal size. The carbohydrate was kept extraordinarily low….”

This thinking only changed in the years before World War I, when Joslin embraced and disseminated the idea promoted by a Harvard colleague, Frederick Allen, that diabetic patients, still without insulin, were best served if they were semi-starved—avoiding carbohydrates and fat. In short, patients suffering from a disease in which one characteristic symptom is ravenous hunger would be treated by making them go even hungrier than otherwise. The approach was unsurprisingly controversial. Joslin and others, though, came to believe they could keep their young Type 1 patients alive longer with Allen’s starvation therapy, even while the high fat, animal-based diet seemed more than adequate for their older Type 2 patients. Allen’s starvation therapy was in turn challenged between 1920 and 1923, when University of Michigan physicians Louis Newburgh and Robert Marsh reported in a series of articles that it was simply unnecessary, that even young patients with severe diabetes could thrive on the high-fat, carbohydrate-abstention approach if properly administered. By then, though, it was too late.

Insulin therapy had arrived in the winter of 1922. It launched what medical historians would call a “therapeutic revolution,” as close as medicine had ever come, and maybe ever has, to a miracle. Patients, often children, on the brink of death, horribly emaciated by the disease and the starvation therapy, would recover their health in weeks, if not days on insulin therapy. They were resurrected, to use the biblical terminology, which physicians of the era often did.

Diabetes certified realized that insulin therapy was not a cure of the disease, but it allowed their patients to metabolize carbohydrates and held the promise of allowing them to eat whatever and however they wanted. “Were I a diabetic patient,” wrote Frederick Banting in 1930, by then a Nobel Laureate. “I would go to the doctor and tell him what I was going to eat and relieve myself of the worry by demanding of him a proper dose of insulin.”

That thinking, for better or worse, has governed diabetes therapy ever since.

While diabetes certified still had no conception of the long-term complications of living with diabetes—the damage to large and small blood vessels that results in heart disease, strokes, kidney disease, neuropathy, amputations, blindness, dementia—they would advocate for ever more liberal carbohydrate diets and ever higher insulin doses to cover them. Patients would be taught to count the carbohydrate content of each meal, but only so they could properly dose their insulin. Diets would be prescribed, and still are, to allow for the drugs to be used freely, not to minimize their use. Patients, in turn, were allowed to eat anything, which physicians assumed they would do anyway.

Whether the patients lived longer, healthier lives because of it, would never be tested.  As diabetes certified began to understand the burden of the disease they were treating, the wave of microvascular and macrovascular complications that set in after 10 or 20 years, they would rarely, if ever, ask the question, whether these complications were mitigated by their dietary approach or perhaps exacerbated by it. They would only test drug therapy.

In 1971, the American Diabetes Association institutionalized this philosophy with dietary guidelines that would commit the organization to this approach ever after: diabetic patients would be told to restrict dietary fat—by then thought to cause heart disease—rather than carbohydrates, the one macronutrient they could not metabolize safely without pharmaceutical help. “Medical Group, in a Major Change, Urges a Normal Carbohydrate Diet for Diabetics,” was the headline in The New York Times. By taking the ADA’s advice, diabetic patients would trade off blood sugar control for cholesterol, assuming this would prevent heart disease and lengthen their lives. While the guidelines explicitly acknowledged that the ADA authorities had no idea if this was the right thing to do, the advice would be given anyway.

Read More: Why You're Not Losing Weight

By 1986, the ADA was recommending diabetic patients get “ideally up to 55-60% of total calories” from carbohydrates, while researchers led by the Stanford endocrinologist Gerald Reaven had established that such a diet was almost assuredly doing more harm than good. That same year, the NIH held a “consensus conference” on diet and exercise in Type 2 diabetes. The assembled authorities concluded that, at best, the nature of a healthy diet for diabetes remained unknown. The conference chairman, Robert Silverman of the NIH, summed the state of affairs up this way: “High protein levels can be bad for the kidneys. High fat is bad for your heart. Now Reaven is saying not to eat high carbohydrates. We have to eat something.” And then he added, “Sometimes we wish it would go away, because nobody knows how to deal with it.”

The modern era of the diabetes-diet relationship began 25 years ago, with the awareness that the nation was in the midst of an obesity epidemic. Physicians, confronted with ever more obese and diabetic patients and the apparent failure of conventional advice—eat less, exercise more—suggested instead the only obvious options, the approaches suggested by popular diet books. Many of these—Dr. Atkins’ Diet Revolution, Protein Power, Sugar Busters—were touting modern incarnations of Rollo’s animal diet.

The Diet Trials

The result was a series of small, independent clinical trials, comparing, for the first time, the conflicting dietary philosophies of a century before. Is it better for patients with Type 2 diabetes, specifically, to avoid dietary fat and, if they’re gaining weight, restrict total calories (both carbohydrates and fat), or will they do better by avoiding carbohydrate-rich foods alone and perhaps entirely? The earliest trials focused on treating obesity, but many of the participants also struggled with Type 2 diabetes. In 2003, physicians at the Philadelphia VA Medical Center published the results from the first of such trials in the New England Journal of Medicine: patients with both obesity and diabetes counseled to eat as much food as they desired but to avoid carbohydrates, became both leaner and healthier than patients counseled to eat the low-fat, carbohydrate-rich, calorie-restricted diet prescribed by both the American Heart Association and ADA. The numerous trials since then have concluded much the same.

Among the profound assumptions about Type 2 diabetes that these trials have now challenged is that it is, indeed, a progressive, degenerative disorder. This may only be true in the context of the carbohydrate-rich diets that the ADA has recommended. In 2019, researchers led by the late Sarah Hallberg of the University of Indiana, working with a healthcare start-up called Virta Health, reported that more than half of the participants in their clinical trial were able to reverse their type 2 diabetes by eating what amounts to a 21^st century version of Rollo’s animal diet or the Newburgh and Marsh approach. They were able to discontinue their insulin therapy and all but the most benign of their diabetes medications (known as metformin) while achieving healthy blood sugar control. A third of these patients remained in remission, with no sign of their disease, for the five years, so far, that their progress has been tracked.

As for Type 1 diabetes, in 2018, a collaboration led by the Harvard endocrinologists Belinda Lennerz and David Ludwig reported on a survey of members of a Facebook Group called TypeOneGrit dedicated to using the dietary therapy promoted by Dr. Richard Bernstein in his book Dr. Bernstein’s Diabetes Solution. Bernstein’s approach requires patients to self-experiment until they find the diet that provides stable healthy levels of blood sugar with the smallest doses of insulin. Such a diet, invariably, is very low in carbohydrates with more fat than either the ADA or AHA would deem healthy. Both youth and adults in the Harvard survey maintained near-normal blood sugar with surprisingly few signs of the kind of complications—including very low blood sugar, known as hypoglycemia—that make the life of a patient with Type 1 diabetes so burdensome. The TypeOneGrit survey, Lennerz said, revealed “a finding that was thought to not exist. No one thought it possible that people with type one diabetes could have [blood sugar levels] in the healthy range.” This does not mean that such diets are benign. They may still have the potential to cause significant harm, as Lennerz and Ludwig and their colleagues made clear. That, again, has never been tested.

One consequence of the diabetes associations embracing and prescribing a dietary philosophy in 1971 that has only recently been tested is that we’re back to the kind of situation that led to the evidence based medicine movement to begin with: enormous variation in therapeutic options from physician to physician and clinic to clinic with potentially enormous variations in benefits, harms and costs.

Even the ADA advice itself varies from document to document and expert panel to expert panel. In 2019, for instance, the ADA published two consensus reports on lifestyle therapy for diabetes. The first was the association’s consensus report on the standard of care for patients with diabetes. The authors were physicians; their report repeated the conventional dietary wisdom about eating “vegetables, fruits, legumes, whole grains….” It emphasized “healthful eating patterns”, with “less focus on specific nutrients,” and singled out Mediterranean diets, Dietary Approaches to Stop Hypertension (known as the DASH diet) and plant-based diets as examples that could be offered to patients. This ADA report still argued for the benefits of low-fat and so carbohydrate-rich diets, while suggesting that the “challenges with long-term sustainability” of carbohydrate-restricted eating plans made them of limited use.

Three months later, the ADA released a five-year update on nutrition therapy. This was authored by a 14-member committee of physicians, dietitians and nutritionists. Among the conclusions was that the diets recommended as examples of healthful eating patterns in the lifestyle management report—low-fat diets, Mediterranean diets, plant-based diets and the DASH diet—were supported by surprisingly little evidence. In the few short-term clinical trials that had been done, the results had been inconsistent. As for carbohydrate-restricted high fat eating patterns, they were now “among the most studied eating patterns for Type 2 diabetes,” and the only diets for which the results had been consistent. “Reducing overall carbohydrate intake for individuals with diabetes,” this ADA report stated, “has demonstrated the most evidence for improving glycemia [high blood sugar] and may be applied in a variety of eating patterns that meet individual needs and preferences.”

Physician awarenessof the potential benefits of carbohydrate-restriction for Type 2 diabetes, meanwhile, still often comes from their patients, not their professional organizations. In the United Kingdom, for instance, David Unwin, a senior partner in a medium-sized practice began suggesting carbohydrate-restricted high fat diets to his patients in 2011, after seeing the results in one such patient who chose to do it on her own and lost 50 pounds. When results of her blood tests came back, says Unwin, they both realized that she was no longer suffering from diabetes. Both the weight loss and the reversal of diabetes were unique in Unwin’s experience. After memorizing up on the burgeoning literature on carbohydrate restriction, Unwin began counseling his diabetic patients to follow a very-low-carbohydrate, high-fat eating pattern. In 2017, the UK’s National Health Service awarded Unwin its “innovator of the year” award for applying a 200-year-old approach to diabetes therapy, as Unwin says, that “was routine until 1923.” Unwin has now published two papers documenting the experience in his medical practice. As of last year, 20 percent of the clinic’s diabetic patients—94 in total—had chosen to follow this restricted dietary approach and put their Type 2 diabetes into remission.

If the diabetes community is to solve the formidable problems confronting it, even as drug therapies get ever more sophisticated, it will have to accept that some of its fundamental preconceptions about diabetes and diet may indeed be wrong. As it does so, it will have to provide support for those living with diabetes who decide that what theyhave been doing is not working. Some patients, when confronted with the choice between following a restricted eating pattern that seemingly maximizes their health and wellbeing or eating whatever they want and treating the symptoms and complications with drug therapy, will prefer the former. For those who do, the informed guidance of their physicians and diabetes educators will be  invaluable.

When I interviewed individuals living with Type 1 diabetes, among the most poignant comments I heard was from a nutrition consultant diagnosed in 1977 when she was eight years old. She told me that she finally had faith she could manage her blood sugar and live with her disease when she met a physician who said to her “What can I do to help you?” That’s what changed her life, as much as any technology or medical intervention. In the context of the dietary therapies we’re discussing, that requires practitioners who are themselves open-minded and willing to spend the necessary time and effort to truly understand an approach to controlling diabetes that is, by definition, unconventional and, in Type 1 diabetes, still lacking clinical trials that test (or testify to) its safety and efficacy. Easy as it is for physicians to continue believing that what they should be doing is what they have been doing, they do not serve their patients best by doing so.

Adapted from Gary Taubes' new book Rethinking Diabetes: What Science Reveals About Diet, Insulin and Successful Treatments

"It is a paradoxical truth that tax rates are too high today and tax revenues are too low, and the soundest way to raise the revenues in the long run is to cut the tax rates."–John F. Kennedy

The fiscal crisis following with foreign exchange issues in 2021 have thrown the spotlight on the capacity of Sri Lankan Governments to find their spending commitments and meeting debt obligations. Tax revenue mobilisation remains essential to achieve economic growth, meeting bilateral creditors’ conditions. Moreover, it is important to meet Sustainable Development Goals. A majority of citizens and companies are reluctant to comply with their tax obligations, however, changing their views on taxes is not an easy task for governments. Why do the public evade tax liability? If people evade taxes because tax rates are too high, efforts must be made to reduce tax rates. If people evade taxes because of the perception that they do not receive much in benefits, and is a waste of tax money from their tax payments, governments need to increase the benefit-to-cost ratio. If people evade taxes because they view their government as corrupt or inefficient, governments must make an attempt to become more efficient and less corrupt. Another grave perception is private sector tax money being used to feed government sector employees and SOEs. Tax revenues are the primary source of public financing for any country, and play a vital role in helping them support economic development and social well-being. But governments are frequently confronted with citizens and companies that refuse to pay their taxes, and the consequences are fiscal, economic and social.

A major blow to the Sri Lankan economy comes from different dimensions, mainly lack of fiscal discipline, weak governance and corruption, leading to pitiable public trust on the system. The Government struggles to maintain sufficient spending on public services and infrastructure needed to combat poverty and create a more equal society. In dire need of increased domestic revenue, and under pressure from a growing fiscal deficit, Sri Lanka needs to adopt out of the box and pragmatic strategies to enhance the tax net. To ensure efficiency and equity in revenue mobilisation, governments need to design better tax policies, modernise revenue administrations, and implement country-specific structural reforms. It is imperative to maintain key principles of tax concept fairness, certainty, convince efficiency and neutrality. These are the basics. Considering the dire situation in fiscal discipline and tax collection all stakeholders should assess the situation profoundly and arrive at an acceptable pragmatic approach.

The 2024 Budget presented on 13 November 2023, anticipates a 45% increase in total revenue, with total expenditure growing by 24%, thereby reducing the budget deficit to 7.6% of GDP from the 8.4% of GDP expected for 2023. Sri Lankan budgets have consistently overestimated the capacity to raise revenue, which would continue this time as well. The Budget also outlines important administrative measures to expand the tax base in terms of personal income tax. How are we going to achieve numbers?  The exact increase in VAT is not the sustainable solution; that would lead to more and more issues and contract economic growth and ignite socio- economic issues.  It’s high time to address this situation and implement some pragmatic and progressive structural transformation as stated below:.

Tax awareness and tax education

 Taxpayer education with a particular focus on youth combined with better communication remains the most appropriate tool for encouraging people to pay their taxes. Teaching tax compliance to youth is a tool that would certainly support to inculcate a conducive tax culture in a country. Age is one of the main determinants of tax compliance worldwide; ideally tax education should integrate into the school curriculum or through the use of art.  I believe it should start from Grade 8. Focus on strategies to increase trust between taxpayers and tax administrations could lead to higher “tax morale” and, when implemented alongside reforms to boost enforcement and Strengthen facilitation, could trigger higher rates of compliance. Youth should understand that free education comes from the proceeds of tax money. Thus, they have the moral duty to pay back to society as a loyal tax payer. Unfortunately, this understanding is not in our culture, mainly trade unions, political ideologists, student societies, before they ask for their rights, they need to show their moral responsibility and commitment towards the nation.

Capture informal sector

 Many individuals that engage in high paying self-employment, categorised as informal sector employment are not properly captured by the tax net. Absorbing such individuals into the tax net is a difficult task as such businesses are not required to prepare annual accounts while some transactions take place outside banking channels, allowing them to under report income. Bringing such informal activities into the tax net requires long term strategies. Providing incentives to individuals to register with the IRD, encouraging informal sector businesses to register for VAT, simplifying the tax calculation and adopting withholding taxation mechanisms on certain payments and income can be identified as a few steps to bring the high earning informal sector into the tax net.

Establishment of large taxpayer office/HNWI

The High-Net-Worth Individual (HNWI) tax consultation unit in the IRD would support to collect more revenue. The HNWI unit embarked on a thorough and proactive process of personal face-to-face meetings with each of these potential targets, to educate them on their rights and obligations as taxpayers, and to signal that their tax affairs were under scrutiny. This has been very successful in Uganda and many developing countries. 

Panoramic view untapped segments and crackdown on tax evaders

Deploy young professionally qualified Inland Revenue Department (IRD) team in key income earning entities such as private hospitals, private education institutes, professional associations, etc. It is a known fact that professionals like medical practitioners, lawyers, tutors make sizable income that are not being accounted for as annual taxable income. As a strategy, private hospitals should not make any cash payments to doctors/consultants. Have a minimum fees threshold for every surgery, add a certain percentage for specialty/complexity.  But it should be clearly disclosed that hospitals should share these details with the IRD office. Propose to set up 24*7 IRD office at major private hospitals and income generating entities. 

Financial system support 

Banks and other financial institutes have a major role to play towards enhancing the tax net. They can support the system in many ways, e.g. at the time of lending, allowing import and exports, opening of accounts, etc. Discourage lending and advice clients who maintain two sets of financials. It is common knowledge that banks indirectly support businesses to evade taxes. How do they lend substantial amount to clients showing distorted and doctored financials. It is ethically and morally wrong to encourage these types of clientele. Further, banks should not encourage or allow imports by individuals /or companies that do not have tax files. In some business entities they open multiple accounts under their workers, family members and route business through such accounts. Moreover, they close the account within a short period of time and open new accounts under different names, the main purpose being to evade tax payments. Also they make minimum cash deposit through bank counters to CAP Rs. 200K or Rs.300K. Control and compliance should not be exceptional to few banks, it should be common to all banks. 

Ground level close scrutiny

Carry out inspection of each and every shop (door to door) in major commercial hubs, e.g. Main Street, in the Pettah, and educate the business community and get compulsory registration for tax.  Post follow up is very essential to ensure proper tax payment. The IRD can cluster the area and assign officers as relationship managers (RMs) to support the business community. IRD officials should not deprive their moral duty and obligation. Heavy penalty should be imposed for breach of trust and professional negligence, even cancel professional memberships. Propose to set up IRD office in major economic centres and identified business hubs in Sri Lanka.  This would help IRD officials to get hands-on-experience on the ground situation and close scrutiny in respective businesses- mainly cash movements, trade, book keeping and different business dynamics. 

Meticulous monitoring mechanism on BOI registered companies 

 Another key tax bleeding sector is BOI approved companies. Evaluate all BOI registered companies and see the progress and tax payment records. Certain companies still show loss and do not comply with BOI directions/expectations, while deliberately trying to conceal genuine financial performances. Most of the companies show negative returns to hoodwink the system and get maximum benefits. Appoint IRD/ BOI team in clusters to advice and collect taxes. 

Introduce windfall tax 

Impose one-off windfall tax on industries that make supernormal profits. A windfall tax is a one-off tax levied by governments against certain industries when economic conditions allow those industries to experience above-average supernormal profits. In other words, introduce one-off solidarity wealth taxes and windfall taxes to end crisis profiteering. It was observed that certain sectors recorded exorbitant revenue and profits during crisis time. The idea is that extra revenues can be ear-marked to support low-income families during the cost-of-living crisis. This should not be used as a tool to collect tax in the long run, otherwise it would discourage capital investments, R and D, investor confidence, challenge “fairness of tax, “etc. Windfall tax is very common in every country. 25 European countries announced windfall tax, Russia, Pakistan, India also implemented windfall tax.

Financial sector 

The CBSL’s latest report indicates that investment in Treasury bills by the banking sector has increased by 11.8% (Q-o-Q) Rs. 1.46 trillion by the end of the third quarter from Rs. 1.29 trillion by end June. Treasury bill investments have increased by 57.3% in the nine months of 2023. This clearly shows that FIs are still making good money from TB interest income instead of core banking business which in return is a burden to the Government and tax payers. Introduce a withholding tax (WHT) or a super gains tax on Treasury bill trading for primary dealers and large corporate investors with a minimum investment threshold. It is clear that interest earned on government securities will have to be declared by individuals in their individual income tax files and pay the personal income tax rate based on which slab the investor falls into. FD investors should pay WHT as well as declare interest income on personal income tax. 

Attractive tax amnesty 

Extend tax amnesty for people who declare assets and liquid funds that should be used for investments in startup projects, various industries, etc. The Government could accord them a special tax slab for a specific period. This would certainly support in three ways (1) raise revenue quickly; (2) increase future tax compliance (e.g., by encouraging taxpayers to declare and pay previously undeclared tax, file tax returns, or register to pay taxes, and stay current on their tax obligations) (3) induce the repatriation of FX earnings to the country.

Ease pressure on APIT payees

 Avenues to make a downward adjustment to Advance Personal Income Tax (APIT) slabs. Salaried segment spending habit and pent-up demand would drive the economy. It would not be effective if the Government taxed monthly fixed income earners. They are the people who actively spend in an economy. They pay direct and indirect tax aggregating 50%-60%. If the Government puts more pressure and burden on Payee tax payers it would certainly have ripple effects on economic activities. Progressive personal income tax rates (12 to 20 %) could be introduced with a flat rate of 20 %. If we fail to do so economic contraction and social unrest would be inevitable in the future.

Progressive wealth tax

It is reported that a top 1% of Sri Lankans own 31% of the personal wealth in the country Without exerting much burden on high net worth individuals, the Government could introduce tax payer friendly wealth tax system depending on the wealth measurement used and transparent wealth tax thresholds. Tax rates should not be detrimental to the payer and should not keep on changing from time to time. The Government can introduce this tax either for a specific period or continue with a very minimal rate. It should not discourage high net worth tax payers and induce capital flight. 

User friendly online Tax return system

The current system is not at all user friendly and the ordinary person cannot understand. Many citizens and business owners are often unfamiliar with the technical jargon of tax-related topics. Hence, it is imperative for revenue agencies to have plans to reduce taxpayers’ compliance burden by making it easy for them to understand the system. Even professionals get confused and the system operation itself discourages tax payment. In addition, there are many technical and process improvements in the current system.   

Inculcate customer relationship management concept in IRD

 Compulsory assignment of IRD tax officials to all businesses and corporate offices is needed. This is basically an introduction of the Customer Relationship Management (CRM) concept. These officers could liaise with auditors, banks, tax consultants and other institutions. The process would lead to a very transparent way to calculate taxes. They could also support individual tax payers in an organisation.

Revenue Collection Authority 

 This is a good initiative by the Government.  The Authority should consist of private and public sector professionals with high integrity and an unwavering record. It should not be filled with the traditional set of people who have limited experience and would not think out of the box.

Outsource tax collection

 It is evident and observed that at present the IRD staff is not sufficient to go into minute cases.  In this regard, delegate to the private sector the collection of minor amounts of delinquent taxes that would also save tax administration money. Just as it is often advisable to turn tax collection over to banks, it would be worthwhile to place collection of minor delinquent taxes in the hands of specialised agencies. The same idea is behind both propositions: to free up resources in order that the tax administration may concentrate on its basic functions.

Capture through mobile connections

Effective and strong communication through proper source of communication mode.  As per GSMA intelligence shows there were 36 million mobile connections in Sri Lanka in 2023 which indicates that mobile connections in Sri Lanka were equivalent to 165.5 % of the total population in January 2023. This is the best mode of communication to create awareness of the importance of taxes and use tactical strategy to exert pressure to register as a tax payer. Clients that have multiple connections must be in a position to afford high mobile bills, which means they are liable to pay tax from their income. It should be mandatory to register as a tax payer if one has an average mobile bill up to a certain amount. Necessary legal provisions should be enacted for mobile network providers to disclose necessary information and customer segments, high value clients etc. 

Enhanced audit and verification program/Work ethics and punishment

 All stakeholders should adhere to professional ethic compliance, transparency that is  important in the process of enhancing the tax net and revenue. Breach of trust in profession, support “tax cheat “and fraudulent act, aggressive tax avoidance should be seriously dealt with and penalised to the maximum. The IRD should introduce a new “name and shame” policy whereby names, addresses, and tax settlement amounts are published in newspapers.

Reliable data and MIS

Carry out a profound study and census to identify business entities in   each geographical area, proper segmentation in business, Micro, individual business, SME, corporate, etc. Deploy IRD officials in each provincial secretariat divisions to educate and push them for tax assessment and payments.

Miscellaneous sources

  Compulsory tax file should be introduced for air ticket issuance, credit card, event organising companies, club membership. Charge certain percentage (One –off or monthly) on professionals who leave the country for permanent stay.  This is to recover certain percentage based on the expenses incurred for free education.

The writer holds a PhD (MSU-Malaysia), MBA(University of Wales), MCIM (UK), AIB(SL), PgDip (Cranfield University School/CA SL), SLIM

Copyright 2023 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

On a sunny morning in Taipei last August, I joined a few dozen other people at the headquarters of the Kuma Academy for an introductory course in civil defense. We broke into groups to introduce ourselves. As our group leader presented us to the room, she mistakenly called me a “war correspondent.”

“No, no, that’s not right,” I interjected. “I’m here because I precisely don’t want to become a war correspondent in the future.” 

The Kuma Academy, established in September 2022, trains citizens in the basic skills they might need to survive and help their compatriots in the event of an attack. Civil defense has been on many people’s minds in Taiwan since Russia’s full-scale invasion of Ukraine in 2022. “If China Attacks,” a book covering potential scenarios for a Chinese invasion — co-written by Kuma Academy co-founder Puma Shen — has become a bestseller. 

Many of the attendees at the academy seem like regular office workers or homemakers. The youngest person I talk to is a high school student. A great deal of the curriculum is practical — basic medical training, contingency planning for an invasion, even what kind of material you should hide behind to protect yourself from gunfire. But a lot of the training is less about skills and more about shoring up the sense of agency that regular people feel: making them understand that they have the power to resist.  

In the face of Chinese propaganda and disinformation, that could be as important as weapons drills and first aid. Taiwan holds elections this month, pitting the pro-autonomy Democratic Progressive Party (DPP) against the more pro-Beijing KMT. The outcome of the vote has huge consequences for relations across the Taiwan Strait and for the future of an autonomous Taiwan, whose independence Beijing has vehemently opposed — and threatened to violently reverse — since the island first began to govern itself in 1949. Successfully interfering in the democratic process using what the Taiwanese government calls “cognitive warfare” could be a way for Beijing to achieve its goals in Taiwan without firing a shot. 

Despite — or because of — the stakes, Taiwan’s response to the challenge of Chinese election interference isn’t siloed in government ministries or the military. Just as civil resistance has to be embedded in society, the responsibility of defending the information space has been entrusted to an informal network of civil society organizations, think tanks, civilian hackerspaces and fact-checkers. 

“We’re often asked by international media if Taiwan has an umbrella organization for addressing disinformation-related issues. Or if there is a government institution coordinating these kinds of responses,” said Chihhao Yu, one of the co-founders of Information Environment Research Center (IORG), a think tank in Taiwan that researches cognitive warfare. “But first, there’s no such thing. Second, I don’t think there should be such an institution — that would be a single point of failure.”
Disinformation from China is hardly new in Taiwan. During the Cold War, before the term “disinformation” was in the common lexicon, the Chinese Communist Party injected propaganda into the public sphere, trying to instill the idea that reunification was inevitable, and it was futile to resist. This is spread through many channels, including newspapers, magazines and radio. But, as in the rest of the world, social media has made it easier to reach a wide audience and spread falsehoods more rapidly and with greater deniability. Disinformation now circulates on international platforms including Facebook, Instagram, X and the South Korean-owned messaging app Line, which is popular in Taiwan, as well as on local forums such as PTT and DCard.

Disinformation from China used to be easy to spot. Its creators would use terms that weren’t part of the local Taiwanese lexicon or write with simplified Chinese characters, the standard script in mainland China — Taiwan uses a traditional set of characters instead. However, this is changing, as information operations become more sophisticated and better at adapting language for the target audience. “Grammar, terms, and words are more and more similar to that of Taiwan in Chinese disinformation,” said Billion Lee, co-founder of the fact-checking organization Cofacts.

With the election approaching, the Chinese government has increased its efforts to localize its propaganda, recruiting social media influencers to spread its messaging and allegedly buying influence at the grassroots level by subsidizing trips to China for local Taiwanese politicians and their constituents. Over 400 trips took place in November and nearly 30% of Taipei’s borough chiefs — the lowest level of elected officials — have participated in them. 

The medium used to spread propaganda and disinformation has evolved as well. Cofacts started out in 2016 by building a fact-checking chatbot on Line, focusing on text-based falsehoods. Now, it has to work across multiple platforms and formats, including TikTok reels, Instagram stories, YouTube shorts and podcasts.

The aim of this election disinformation is often fairly obvious — boosting Beijing’s preferred candidates and discrediting those it considers hostile. 

In late November, 40 people were detained by Taiwanese authorities on voting interference charges for operating a web of accounts across Facebook, YouTube and TikTok that worked to prop up support for the pro-China KMT. The so-called “Agitate Taiwan” network also attacked third-party candidate Ko Wen-je, whose party favors closer relations with China, but whose candidacy may divide the vote in a way that leads to a victory for the historically independence-leaning DPP. 

Other themes, Lee said, include trying to undermine the DPP leadership and casting them as inept by insinuating, falsely, that they failed to secure vaccines during the Covid-19 pandemic, and alleging that the DPP only pushed for the development of Taiwan’s domestically produced vaccine, Medigen, because it had made illicit investments in the company. Messaging also often targets Taipei’s relationship with the U.S., suggesting that America would abandon Taiwan in the event of a war.

These overtly political messages intersect with other influence operations and more traditional espionage. In November, 10 Taiwanese military personnel were arrested after allegedly making online videos pledging to surrender in the event of a Chinese invasion. One of those charged, a lieutenant colonel, was allegedly offered $15 million by China to fly a Chinook helicopter across the median line of the Taiwan Strait to a waiting Chinese aircraft carrier. Such defections and public promises not to resist, weaponized and spread on social media, are clearly aimed at undermining public morale in Taiwan. 

Those efforts can be oddly targeted. In May, Cynthia Yang, the deputy secretary-general of a nonprofit in Taiwan , received a series of calls from people with mainland Chinese accents after she ordered a copy of “If China Attacks” from the Taiwanese bookseller Eslite. The callers claimed to be from customer service, but they questioned Yang about her “ideologically problematic” purchase. It seemed to be an effort at psychological intimidation. After the incident was reported on by Taiwanese media, the book’s co-author Puma Shen quipped on social media that his next book would be titled “If China Calls.”

Fighting back against this full-spectrum influence campaign is hard. Chinese disinformation tactics have fed into a broader polarization in Taiwan, which is fragmenting the internet.  “Everyone uses a different internet these days,” Lee said. There’s increasing recognition online that people inhabit echo chambers comprising their peers, which are difficult to break out of. 

It means that the organizations — mainly civil society groups — arrayed against a superpower desparate on undermining Taiwan’s democratic processes face a complex task.  Often these groups are small and scrappy, run by volunteers or just a handful of staff. They’re in an arms race that they can’t win — or at least, that they can’t win alone.

To compete, they’re collaborating. “Even if we don’t know each other, we can work together without directly cooperating,” said Yu from the Information Environment Research Center. “To use Cofacts as an example, we don’t directly coordinate with Cofacts. But because Cofacts has an open database with an open license, we can use their datasets of rumors and community fact-checking to conduct research, and we continue to do so.”

Cofacts has emerged as an important piece of infrastructure for Taiwan’s fact-checking ecosystem. The organization has used its Line bot as a way to build an enormous database of disinformation spotted in the wild, which it makes available to other groups via an application programming interface. Crucially, the bot allows users to collect disinformation that wasn’t circulating on open social media, such as Facebook or Twitter, but in closed-door messaging apps such as Line or Facebook Messenger. 

Systematically collecting that data allows other organizations to conduct more sophisticated analysis, spot patterns and respond strategically, rather than chasing down every lie and fact-checking it.

This collaborative approach can be traced back to g0v, the influential civic hacker community, from which a number of innovative initiatives have emerged in the past decade — from digitizing historical documents significant to contemporary Taiwanese politics to gamifying the identification of satellite images to find illegal factories on farmland. 

The g0v community runs decentralized hackathons for developing project ideas , taking place in classrooms and offices and bringing together anywhere from a few dozen to a few hundred people. Not all ideas make it to fruition, but some of the projects that come out of g0v — including those that tackle disinformation — may begin with just a small breakout group huddled in the corner of a hackathon.

It is these small civil society groups that Taiwan relies on to stay ahead of Chinese innovations in disinformation, with the hope that by being nimble and adaptable, they can hold back the tide. Bigger threats are coming. The rise of generative artificial intelligence, which can quickly create text, images, videos and more at scale, could allow China to increase the volume of propaganda it produces and make it seem more authentic by accurately using Taiwanese idioms and references. Certainly, there is no shortage of materials produced out of Taiwan’s open and free Internet for generative AI to learn from. 

Still, the solution may be precisely in the decentralized and networked nature of these efforts to combat Chinese disinformation campaigns. After all, a set-up in which a number of differing solutions emerge at once, often organically and spontaneously, has no single point of failure, as to borrow Yu’s words. 

“We wanted to connect people who wrote code and people concerned with society to work together,” Lee said, when asked about why she and her collaborators began Cofacts. Perhaps it’s faith in society to know for itself what’s best that keeps such groups going. And this may be the best weapon against authoritarianism — the belief that the connections between people can be enough to deal with a much larger enemy. The fight is on.

ALACHUA, Fla. and TAMPA, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) --  Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the promotions of three research and development team members. The promotions are:

• Erick DeVinney to Chief Innovation Officer

  Mr. DeVinney joined Axogen in April of 2007 as Director of Clinical Research. During his tenure, he has held positions of progressive responsibility in Clinical Research, Research and Development, Product Development, Medical Education, and Medical Affairs. Mr. DeVinney has more than 16 years of experience driving innovation in peripheral nerve injury diagnosis and repair, including clinical and regulatory development strategies, portfolio development, and scientific thought leadership. He has a diverse background, including academic research and the development of tissue technologies, medical devices, pharmaceuticals, and biologics. Mr. DeVinney has been involved in research at the Virginia Commonwealth University Medical College of Virginia Hospitals, University of Utrecht, National Clinical Research, PRA International, and Angiotech. He has been involved in the successful submission of eight IDE or NDA applications, as well as numerous 510(k)s. Mr. DeVinney also serves as a Board Member for the Global Nerve Foundation. He has a B.S. degree in Chemistry from Virginia Commonwealth University.

• Ivica Ducic, M.D., Ph.D., to Chief Medical Officer 

  Dr. Ducic joined Axogen as Medical Director in January 2017. He is a board-certified plastic surgeon, with additional training and expertise in peripheral nerve surgery. He received his medical degree in 1991 from the University of Zagreb School of Medicine (Croatia, Europe), and a Ph.D. degree in 1995 in neuroscience. Upon completing plastic surgery training at Georgetown University Hospital in 2002, he entered a one-year peripheral nerve surgery fellowship. He then joined the full-time faculty practice at Georgetown University Hospital Department of Plastic Surgery in August 2003, where he served as a professor of plastic surgery and neurosurgery. In 2014, Dr. Ducic established his own practice, the Washington Nerve Institute in McLean, Virginia. Among his many accomplishments, Dr. Ducic is the Past-President of the American Society for Peripheral Nerve, has served on many committees, published more than 100 peer-reviewed papers, authored 17 book chapters, and has been a prolific invited educator both nationally and internationally on the diagnosis and treatment of peripheral nerve injury. During his past seven years at Axogen, Dr. Ducic has been an instrumental leader in the development of new technologies, applicable surgical techniques, surgeon education, as well as providing strategic guidance for the core company mission – improving the quality of life of patients with nerve injuries.
  

• Stacy Arnold to Vice President of Product Development and Clinical Research   

  Ms. Arnold has served as Vice President of Clinical Research for Axogen since June 2019. She initially joined Axogen in April 2018 as Vice President of Program Management. She has been leading the research, development, and execution of clinical strategies to strengthen and advance the body of evidence for new technologies and clinical applications to restore nerve function and quality of life to patients with peripheral nerve injuries. Ms. Arnold previously served as Senior Director of R&D and Program Management at Artivion (formerly CryoLife), driving global innovation and new product development of medical devices, biologics, and tissue technologies, while leading successful program management processes and business strategies to drive growth and deliver shareholder value. Ms. Arnold serves as a Board Member on Mercer University’s National Engineering Advisory Board. She has an M.S. in Engineering from the University of Toledo and a B.S. in Biomedical Engineering from Mercer University. She also holds a global Project Management Professional Certification from the Project Management Institute.
  

In addition, the Company is announcing the departure of Angelo Scopelianos, Ph.D., Axogen’s Chief Research and Development Officer, in the first quarter of 2024.

“We want to thank Angelo for his contributions in new programs that led to innovations like the launch of Axoguard HA+ Nerve Protector^TM and the upcoming launch of Avive+ Soft Tissue Matrix^TM and we are pleased to announce the internal promotions of these leaders in our research and development team,” said Karen Zaderej, Axogen’s Chairman, CEO and President. “This is a strong, highly accomplished group that has worked together closely for many years and demonstrated great success in supporting our mission of improving the lives of patients with peripheral nerve injuries. The continuity of this expert team will also be important to Axogen as we move through the BLA submission process of Avance^® Nerve Graft toward the next commercial phase of our business as a biologic.

About Axogen

Axogen (AXGN) is the leading Company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products that are used across two primary application categories: scheduled, non-trauma procedures and emergent trauma procedures. Scheduled procedures are generally characterized as those where a patient is seeking relief from conditions caused by a nerve defect or surgical procedure. These procedures include providing sensation for women seeking breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of painful neuromas, oral and maxillofacial procedures, and nerve decompression. Emergent procedures are generally characterized as procedures resulting from injuries that initially present in an ER. These procedures are typically referred to and completed by a specialist either immediately or within a few days following the initial injury.

Axogen’s product portfolio includes Avance^® nerve graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector^®, a porcine submucosa ECM coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector^®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; and Axoguard Nerve Cap^®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Cautionary Statements Concerning Forward-Looking Statements

This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events, or results based on various assumptions and management's estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include the statement about the upcoming launch of Avive+ Soft Tissue Matrix, the departure of Angelo Scopelianos in the first quarter of 2024, and the continuity of the expert team as we move through the BLA submission process of Avance^® Nerve Graft toward the next commercial phase of our business as a biologic. genuine results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, potential disruptions caused by leadership transitions, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, processing facility transition timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, exact geopolitical conflicts in the Middle East, as well as those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on Form 10-Q for the most recently ended fiscal quarter. Forward-looking statements are not a guarantee of future performance, and genuine results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements.

For more information, visit www.axogeninc.com.

Contact:

Axogen, Inc.

Harold D. Tamayo, VP of Finance and Investor Relations

htamayo@axogeninc.com