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Pulse Biosciences Reports Second Quarter 2020 Financial Results

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WEX Inc. Reports Second Quarter 2020 Financial Results

HAYWARD, Calif.–(BUSINESS WIRE)–Aug 10, 2020–

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced financial results for the second quarter ended June 30, 2020.

  • Completed the CellFX ® System GLP (good laboratory practice) preclinical study treatments to generate the data required for the planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for an initial FDA clearance with a general dermatologic indication. This puts the Company on track for a 510(k) submission in the next 60-90 days
  • Conducted a formal Pre-Submission meeting with the FDA to establish the design for the comparative study required for a subsequent 510(k) submission to expand the indication for use of the CellFX System to include a specific indication for Sebaceous Hyperplasia. The meeting resulted in a general agreement on the study design which allows the Company to move forward with an IDE submission and a potential study start in early Q4, as planned
  • Submitted the CellFX System technical file to its European notified body in pursuit of the CE mark, the regulatory approval that would authorize the Company to commercialize the CellFX System in the EU. Review is currently underway with expectations for receipt of a CE mark for the CellFX System in Q1 2021
  • Three clinical studies demonstrating favorable results from the investigational use of NPS technology in Nodular Basal Cell Carcinoma, Sebaceous Hyperplasia and Common Warts, respectively, were presented at the virtual American Society for Laser Medicine and Surgery (ASLMS) annual conference
  • Strengthened balance sheet with the successful completion of a substantially oversubscribed rights offering, incurring minimal offering costs compared to a traditional public offering, delivering greater net proceeds to the Company. The $30.0 million rights offering generated $29.5 million of net proceeds, not including additional potential gross proceeds of $4.5 million through the exercise of issued warrants
  • Expanded its Board of Directors with the appointment of Richard van den Broek, serving as a member of the audit and the compensation committees of the Board

“We had a very productive second quarter despite the challenging circumstances persisting as a result of the COVID-19 pandemic. We have remained diligent in our efforts to create the safest work environment possible for our employees and the community and I would like to thank our entire team for their continued efforts and dedication. At the same time, we are pleased that we continue to drive progress towards our top priority of achieving regulatory approvals for the CellFX System,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We believe our progress on the clinical and regulatory front combined with continued engagement from the scientific community has positioned us favorably for eventual commercialization in the US, Europe and Canada. Lastly, I would like to thank our shareholders for their participation in the rights offering. Proceeds from this offering will enable us to further progress our development, clinical and commercial objectives.”

Cash, cash equivalents and investments totaled $37.8 million as of June 30, 2020, compared to $15.9 million as of March 31, 2020. Excluding the net proceeds of the rights offering received in the three months ended June 30, cash used in the second quarter of 2020 totaled $7.9 million. This compares with $9.5 million used in the first quarter of 2020.

Operating expenses for the three months ended June 30, 2020 were $11.4 million, compared to $11.6 million for the prior year period. Second quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $2.7 million in the second quarter of 2019. The decrease in operating expenses was primarily driven by reduced research and development costs which were partially offset by increases in general and administrative costs in preparation for commercialization.

Operating expenses for the six months ended June 30, 2020 were $23.3 million, compared to $22.1 million for the prior year period. Stock-based compensation expense for the six months ended June 30, 2020 was $5.0 million, compared to $5.1 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure including marketing and sales functions.

Net loss for the three months ended June 30, 2020 was ($11.3) million compared to ($11.4) million for the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was ($23.2) million compared to ($21.4) million for the six months ended June 30, 2019.

Our operations in the second quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic. Product development and regulatory timelines have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, August 10, 2020 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-855-327-6837 for domestic callers or 1-631-891-4304 for international callers. A live and recorded webcast of the event will be available at http://investors.pulsebiosciences.com/.

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX ® System will be the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a broad range of dermatologic conditions that share high demand among patients and practitioners for improved and durable aesthetic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications. To learn more please visit www.pulsebiosciences.com.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance and the timing of FDA filings or approvals including meetings with FDA and the ability of the Company to successfully complete a 510(k) submission for the CellFX System, the ability of the Company to prepare and provide data to FDA and the notified body responsible for conducting CE mark review, the ability of the Company to obtain a CE mark for the CellFX System, NPS technology including the effectiveness of such technology and the effectiveness of related clinical studies in predicting outcomes resulting from the use of NPS technology, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, current and planned future clinical studies and the ability of the Company to execute such studies and results of any such studies, other matters related to its pipeline of product candidates, the Company’s market opportunity and commercialization plans, the Company’s ability to effectively use capital raised through the rights offering, future financial performance, the impact of COVID-19 and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

PULSE BIOSCIENCES, INC.

Condensed Consolidated Balance Sheets

(in thousands, except par value)

(Unaudited)

 

June 30,

December 31,

 

2020

 

 

2019

 

ASSETS

Current assets:

Cash and cash equivalents

$

37,765

 

 

$

6,899

 

Investments

 

 

 

 

18,499

 

Prepaid expenses and other current assets

 

907

 

 

 

1,005

 

Total current assets

 

38,672

 

 

 

26,403

 

 

 

 

Property and equipment, net

 

2,591

 

 

 

2,566

 

Intangible assets, net

 

4,214

 

 

 

4,547

 

Goodwill

 

2,791

 

 

 

2,791

 

Right-of-use assets

 

9,749

 

 

 

5,114

 

Other assets

 

365

 

 

 

494

 

Total assets

$

58,382

 

 

$

41,915

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

1,489

 

 

$

1,963

 

Accrued expenses

 

3,123

 

 

 

2,496

 

Lease liability, current

 

278

 

 

 

 

Total current liabilities

 

4,890

 

 

 

4,459

 

 

 

 

Lease liability, less current portion

 

11,164

 

 

 

6,719

 

Total liabilities

 

16,054

 

 

 

11,178

 

 

 

 

Stockholders’ equity:

 

 

 

Preferred stock, $0.001 par value; authorized – 50,000 shares; no shares issued and outstanding

 

 

 

 

 

Common stock, $0.001 par value: authorized – 500,000 shares; issued and outstanding – 25,149 shares and 20,825 shares at June 30, 2020 and December 31, 2019, respectively

 

25

 

 

 

21

 

Additional paid-in capital

 

188,197

 

 

 

153,401

 

Accumulated other comprehensive income

 

 

 

 

4

 

Accumulated deficit

 

(145,894

)

 

 

(122,689

)

Total stockholders’ equity

 

42,328

 

 

 

30,737

 

Total liabilities and stockholders’ equity

$

58,382

 

 

$

41,915

 

 

PULSE BIOSCIENCES, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except per share data)

(Unaudited)

 

Three-Month Periods Ended

Six-Month Periods Ended

June 30,

June 30,

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

General and administrative

 

5,317

 

 

 

5,146

 

 

 

10,920

 

 

 

9,547

 

Research and development

 

5,870

 

 

 

6,337

 

 

 

12,051

 

 

 

12,179

 

Amortization of intangible assets

 

167

 

 

 

166

 

 

 

333

 

 

 

333

 

Total operating expenses

 

11,354

 

 

 

11,649

 

 

 

23,304

 

 

 

22,059

 

Other income:

 

 

 

 

 

 

 

Interest income

 

21

 

 

 

290

 

 

 

99

 

 

 

622

 

Total other income

 

21

 

 

 

290

 

 

 

99

 

 

 

622

 

Net loss

 

(11,333

)

 

 

(11,359

)

 

 

(23,205

)

 

 

(21,437

)

Other comprehensive loss:

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

(17

)

 

 

20

 

 

 

(4

)

 

 

23

 

Comprehensive loss

$

(11,350

)

 

$

(11,339

)

 

$

(23,209

)

 

$

(21,414

)

Net loss per share:

 

 

 

 

 

 

 

Basic and diluted net loss per share

$

(0.53

)

 

$

(0.55

)

 

$

(1.10

)

 

$

(1.04

)

Weighted average shares used to compute net loss per common share — basic and diluted

 

21,528

 

 

 

20,728

 

 

 

21,183

 

 

 

20,704

 

 

 

 

 

 

 

 

 

 

 

 
 

Three-Month Periods Ended

Six-Month Periods Ended

June 30,

June 30,

Stock Based Compensation Expense:

 

2020

 

 

2019

 

 

2020

 

 

2019

 

General and administrative

$

1,515

 

 

$

1,660

 

 

$

3,264

 

 

$

3,145

 

Research and development

 

897

 

 

 

1,039

 

 

 

1,774

 

 

 

1,915

 

Total stock-based compensation expense

$

2,412

 

 

$

2,699

 

 

$

5,038

 

 

$

5,060

 

Sandra Gardiner, EVP and CFO

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH MEDICAL DEVICES

SOURCE: Pulse Biosciences, Inc.

Copyright Business Wire 2020.

PUB: 08/10/2020 04:05 PM/DISC: 08/10/2020 04:05 PM

Copyright Business Wire 2020.

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Leveraging Health Care Reform To Address Underinsurance In Working Families

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Leveraging Health Care Reform To Address Underinsurance In Working Families

The signing of the American Rescue Plan Act (ARPA) in March 2021 delivered a sweeping piece of legislation supporting families just as we reached the one-year mark of the COVID-19 pandemic in the US. The $1.9 trillion package includes a number of measures that provide direct support to families, including several new provisions that make historic strides to reduce childhood poverty. Also within the ARPA are many provisions on health insurance coverage focused on making coverage options for individuals and families more affordable as the country emerges from the pandemic.

As necessary as the ARPA’s coverage provisions and other federal pandemic relief packages have been, they do not address fundamental weaknesses in family and dependent health insurance coverage that have worsened in recent years. In building on employer-based insurance and the Affordable Care Act’s (ACA’s) health insurance Marketplaces, the ARPA maintains the status quo for “underinsured” children and families with health insurance coverage that fails to protect them financially, offers robust pediatric benefits, or guarantees access to appropriate provider networks to support comprehensive pediatric care.

This blog post explores what this vulnerability means for dependent coverage in particular, including how our own research shows that working parents have been seeking alternatives to employer-based dependent coverage for years. Future reforms need to focus on the challenges that underinsurance poses to families, which may mean difficult conversations about the role and future of employer-based insurance in its current form.

Pandemic Relief Builds On Private Health Insurance Without Addressing Its Shortcomings For Families

Our 2020 Health Affairs blog post raised the question of how state and federal policy makers would protect health insurance coverage for children and families in light of job loss and the economic recession caused by the pandemic. The ARPA is an important, albeit imperfect, step toward closing this gap. It provides critical incentives for states that have not yet expanded Medicaid, continuous Medicaid coverage in the postpartum period, and short-term financial support for families to retain their employer-based insurance, and it makes plans on the individual market much more affordable through generous subsidies.

Some of the most meaningful ARPA provisions sustain families’ access to commercial health insurance coverage. Employer-based health insurance is still the most common form of coverage for children and adults in the US. Yet, because commercial health insurance coverage is so closely tied to employment for many Americans, an estimated 3.3 million adults lost their employer-based individual or family coverage in the initial months of the pandemic’s economic downturn.

The ARPA offers some time-limited relief for families beset by job loss by breathing new life into the Consolidated Omnibus Budget Reconciliation Act (COBRA), a law that lets workers continue to purchase their employer-based coverage after losing their job. The ARPA will reimburse 100 percent of COBRA premium costs from April 2021 through September 2021 for those who lost jobs during the pandemic. Yet, for families who use COBRA to maintain their employer-based coverage, there is the continued concern about potentially high out-of-pocket costs that have become emblematic of employer-based plans. Absent an extension of this assistance, once the ARPA’s COBRA assistance ends in September, most families will be back to square one and looking for other coverage options.

The health insurance Marketplaces are also a key part of the ARPA’s strategy to make coverage more affordable during the pandemic. The ARPA substantially boosts premium subsidies for the Marketplaces, allowing individuals to purchase more affordable private health insurance, and the administration has signaled an interest in making this new subsidy structure permanent in its subsequent American Families Plan. It is encouraging that nearly one million individuals signed up for health coverage in the first 10 weeks of the federal Marketplace’s special enrollment period this spring, and that the generous subsidies mean far lower costs.

Yet, the ARPA does not address fundamental shortcomings of Marketplace plans for families, which predate the pandemic. Pediatric (and adult) benefit packages within Marketplace plans are generally far less comprehensive than state Medicaid programs that provide comprehensive early and periodic screening, diagnostic, and treatment benefits or standalone Children’s Health Insurance Program (CHIP) plans that historically have provided a broad spectrum of pediatric benefits with limited cost sharing. Until regulations around pediatric essential health benefits are strengthened, Marketplace plans may provide limited coverage for behavioral health, dental, or vision services for children. Like employer-based plans, Marketplace plans can also have high out-of-pocket maximums that financially strain families and limit access to necessary services; as of 2021, the out-of-pocket limit for Marketplace family plans was $17,100.

Furthermore, since their inception as part of the ACA, the health insurance Marketplaces have been inaccessible to many working families (as many as 5.1 million people) due to the “family glitch.” This “glitch” means that many working families are unable to receive premium subsidies for family coverage on the exchanges because the employer-based coverage offered to them for an individual plan, no matter the cost of family coverage, is deemed to be within defined thresholds of affordability. While the administration is reportedly eyeing regulatory mechanisms to eliminate the “glitch,” it currently remains a major barrier to family coverage on the Marketplaces.

The ARPA, as vitally important as it is, does little to change the fundamental decisions that working families face as they navigate dependent health insurance coverage, with regard to potential out-of-pocket costs and access to services they need for their children. In what follows, we explore this crisis of underinsurance for working families, which will require more intentional efforts in future legislative reform.

The Fundamental Issues Driving Underinsurance For Working Families

Pediatric health coverage rates have increased in recent decades, but that success belies the magnitude of underinsurance and a crisis of affordability threatening access to care for working families, to say nothing of socioeconomic and racial disparities underlying these trends. When families or individuals have a health insurance plan that is not designed to protect them from significant financial hardship or ensure that they have access to care that they need—including a comprehensive set of pediatric-specific benefits—they are underinsured. Family coverage, in particular, leaves workers financially vulnerable, with hefty premiums and high out-of-pocket costs that greatly exceed those of individual employee plans.

Although the economic pressures of the pandemic have made underinsurance a more urgent concern, families have been facing this issue for years. Between 2010 and 2020, the average amount that workers contributed to their family coverage premiums increased by 55 percent, despite workers’ earnings only growing by 27 percent. Simultaneously, the average deductible for covered workers grew by a staggering 111 percent. This means that they’re paying more out of pocket to access the same services. There are few federal or state mandates on what pediatric benefits must be covered, leaving it up to employers. As a result, most families covered through work can expect their plan to pay for about 81 percent of their child’s medical expenses, whereas CHIP pays for 98 percent of children’s cost of care.

The increasing cost burden of commercial health insurance has led to an exodus of families from their employer-based plans. Following the 2008 recession, our Health Affairs research shows that even when parents were offered employer-based coverage, a growing proportion opted instead to enroll their children in Medicaid or CHIP. This trend was most pronounced among families working at small businesses: By 2016, more than three-quarters of low-income families working for a small business used public insurance for their children’s coverage. Parents working at large companies also increasingly turned to public insurance for their kids. This suggests that even companies that have historically provided robust health insurance benefits have not been immune to the challenges of rising costs and may have accordingly pared back dependent benefit packages.

Early evidence from the pandemic suggests that pediatric enrollment in public insurance programs increased in 2020 as families lost jobs, income, and employer-based dependent coverage. Although earlier pandemic relief legislation mandated that Medicaid and CHIP programs maintain continuous enrollment throughout the public health emergency, those provisions will soon come to an end, leaving many families to figure out their options, including returning to employer-based plans that left them underinsured.

Significant Reforms Are Long Overdue

Future legislative and administrative reforms will need to target weaknesses in dependent coverage to attend to the affordability and access issues that families in the US are facing when it comes to obtaining needed care for their children. Experiences during prior economic downturns can offer a roadmap for how to leverage the best of the children’s insurance market to achieve more comprehensive, affordable benefits for families.

Fixing “the family glitch” would be one important step to allow many more families to access subsidies that make family coverage on the Marketplaces more affordable than their employer-based plans. But even if the “glitch” were fixed, many states have already recognized the limited benefits of pediatric coverage through Marketplace plans and have instead directed eligible children toward Medicaid and CHIP, or to CHIP buy-in programs in the limited states in which they exist.

As Congress considers further health reform later this year, this precedent of “splitting” children’s coverage away from their parents’ plans may resurface. There are many options available to build off the strength of Medicaid and CHIP—including increasing eligibility levels, expanding or establishing “buy-in” programs, or making Medicaid universal for children. Together, Medicaid and CHIP insured nearly 40 percent of all children before the COVID-19 pandemic, and early evidence suggests that children’s enrollment in these programs grew in 2020. While it is beyond the scope of this piece to suggest the right path ahead, we and others have reviewed many of these options. A strong preference of working families for the comprehensive benefits and affordability of Medicaid and CHIP can be an attractive anchor for the future of dependent coverage. Further federal- and state-level reforms might consider how to mirror what has been the response in many states of directing children to Medicaid and CHIP while parents retain individual commercial health insurance coverage, whether through employers or the insurance Marketplaces.

Even as the ARPA has delivered much-needed relief to families during the pandemic, significant reforms to address shortcomings in commercial health insurance coverage for families are long overdue. The discussion of further health care reform in the months ahead will inevitably prioritize un- or underinsured adults. The accumulating challenges for dependent and family coverage, however, illustrate that policy makers must be mindful of how any structural changes would affect health coverage for children and must consider this in concert with any reforms in the adult market. Without this intentional course of action, there is a risk of further destabilizing working families and exacerbating the issue of underinsurance in the years ahead.

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What Changes When Almost Everyone Can Get Vaccinated

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What Changes When Almost Everyone Can Get Vaccinated

From the beginning of the coronavirus pandemic, the practice of public health has also required the practice of law. As widespread vaccination and other factors have brought case rates down across the United States, state and local governments’ legal authority to impose extraordinary measures in the name of fighting the virus is becoming more limited. Governors and mayors have steadily lifted restrictions not just because infections are down, because vaccinations have increased, or because the public can no longer tolerate pandemic-related restrictions, but also because officials’ power to impose blanket limits on the behavior of individuals and businesses has a defined end: when people have the ability to protect themselves. Nationally, thousands of new coronavirus infections are still occurring every day, but efforts to combat the pandemic from this point on will have to operate within stricter legal constraints than they did in the early weeks of the pandemic.

In April 2020, on assignment from the CDC, I became the senior adviser for public health in New York City Mayor Bill de Blasio’s office. My job was to lead the strategy for fighting COVID-19. In that capacity, I spent as much time talking with lawyers and writing affidavits as I did analyzing the latest COVID-19 research. In those days, “following the science” of public health was fairly straightforward: It meant mandating masks and physical distancing, promoting widespread testing and isolation when necessary, and, crucially, restricting the right of businesses and other entities to welcome people from different households indoors. When New York City and New York State ordered such measures, we were sued by restaurants, bars, and gyms.

Our successful defense against these suits rested on several facts. First, everyone was at risk from COVID-19. Second, in the absence of a vaccine, the only effective way to reduce the risk of illness was to reduce the risk of exposure, and the only way to do that was for everyone to sacrifice for one another by wearing masks, maintaining distance, and exercising constant vigilance. Third, any indoor gathering of people from different households risked transmission to large numbers of people from different social networks. (Where such gatherings were unavoidable, such as in schools, strict precautions were required at all times.) Finally, and most important, widespread community infection could lead to two existential threats: the collapse of the health-care system, and an extended period of mass death on the scale of what New York experienced in the horrific early phase of the pandemic.

Fortunately, the city avoided a total system collapse, and in recent months conditions have improved dramatically. New case rates have plummeted. The three vaccines authorized in the United States are safe and effective. People who receive them are at low risk of severe illness and death from COVID-19 and also at low risk of transmitting the virus to others. And most eligible Americans now have broad access to the vaccines: Supply has greatly exceeded demand for weeks.

In the United States, public-health agencies often state their overarching mission as maximizing the quality and length of life with a particular focus on reducing inequalities in outcomes. But their legal authority to regulate residents’ civil liberties derives from a narrow source: the responsibility to protect public safety, as delegated to states in the police-powers clause of the Tenth Amendment. Just as average citizens lack the ability to stop a terrorist or extinguish a wildfire, they also lack the expertise and technology to address major health threats. Individuals cannot, for example, identify a product that caused an E. coli O157 outbreak and take it off grocery-store shelves.

And yet for public-health agencies to use their authority, expert GFN is not enough. They also need broad community consensus that the government is justified in invoking its police powers. The more widespread and urgent the threat, and the fewer reliable methods individuals have to protect themselves, the greater the public’s expectation that the government will step in.

Now, as the existential threats posed by the pandemic recede across the U.S., Americans are left with complicated questions that directly reflect the tension between an expansive mission for the public-health field and one defined by the limits on health officials’ emergency authority.

Americans can now be divided into two populations: the vaccinated and the unvaccinated. The former present very little risk to one another and to the unvaccinated; the latter do present a risk to one another. Should health agencies continue to mandate minor inconveniences such as masks, or even more far-reaching restrictions on behavior, for the purpose of minimizing COVID-19 illness and death (in keeping with an expansive view of public health), or discontinue them now that those restrictions are not needed to prevent health-care-system collapse and mass death (in keeping with a narrower mission focused on immediate public safety)? Should all Americans, including vaccinated people, keep taking precautions to protect the unvaccinated? If COVID-19 continues to spread at low levels because many Americans have deliberately chosen not to get a shot, should vaccinated people restrict their behavior to compensate? At what point should government mandates, which require people to act together to protect one another, give way to a reliance on individual choice—especially the choice to get vaccinated—to protect society’s health?

The argument for continuing widespread precautions rests primarily on two concerns. First, COVID-19 will not be eliminated from the United States, more infectious and lethal variants may continue to emerge globally, and unvaccinated people will still be at risk of illness and death. Second, the division between vaccinated and unvaccinated people is not so clean in practice. Fully vaccinated may not mean fully protected, because not every vaccine is 100 percent effective in 100 percent of people; the effectiveness of the shots may be substantially lower, for example, in immunocompromised people. Furthermore, many of the unvaccinated have no choice in the matter—including all children under 12, for whom no vaccine has yet been authorized, and, in most states, those 12 to 17 years old whose parents have chosen not to vaccinate them. Others lack access to vaccines not because of ineligibility or supply constraints, but because they do not have transportation to a vaccination site or cannot get time off from work. Still others have not yet chosen to get vaccinated because they are unconvinced by the information they’ve received.

Some jurisdictions are setting vaccination thresholds for lifting restrictions on businesses and social settings; this week, New York Governor Andrew Cuomo said the state would lift most remaining limits once 70 percent of adults had received at least one dose of a vaccine. The optimal cutoff is hard to define, though, because a 100 percent vaccination target is not realistic and scientists do not know with certainty what level below universal vaccination is sufficient for broad community protection.

Another reason state and local health agencies will continue to wrestle with tensions over lifting restrictions is their own institutional form of PTSD—a well-founded fear that COVID-19 could fell our society again. They and the elected officials whom they advise vary widely in how much authority they are willing to assert, however. Some agencies will remove all precautions in the face of overwhelming pressure from business owners or the general public. Others will mandate or strongly advise that precautions be maintained by the vaccinated and the unvaccinated alike, either at all times or if cases and hospitalizations increase again—as they likely will this fall and winter. Many academic public-health experts favor more stringent restrictions than public-sector practitioners, including me, believe are realistic. Experts can fairly argue that because we’re all in this together, universal precautions should continue even when the existential threat to society has passed. But it’s quite another thing to enforce those restrictions on businesses and workers whose livelihoods remain at risk and on the large and growing swath of the population that has been vaccinated and rightly expects to return to pre-pandemic activities.

Ultimately, the path forward requires returning to the primary mission of public safety: protecting those who cannot reasonably be expected to protect themselves. In the U.S., the highest priority for all government agencies, employers, and health-related organizations should be to ensure truly universal access to vaccines. A successful policy would ensure that all residents of communities with low vaccination rates are confronted with vaccination drives in their houses of worship, pharmacies, community centers, and workplaces. It would also provide people with paid time off to get shots and recover from side effects. To overcome hesitancy—including that resulting from some Americans’ experience of poverty and societal racism—health agencies should work closely with trusted messengers and media channels to relay pro-vaccination messages built upon facts, respect, and empathy.

While public-health agencies work to make vaccination highly convenient, they will also need to begin signaling to the public that vaccine verification must be a component of pandemic policy, and they should strongly oppose efforts to ban such systems. Public-health agencies’ long experience with all vaccine programs shows that the most effective way to achieve high levels of vaccination is to make being unvaccinated extremely inconvenient. Businesses, government offices, and other places that operate indoors can lift restrictions on those who can certify that they are vaccinated; workplaces that cannot practically implement a vaccine-verification system should consider maintaining restrictions to protect their employees and customers until most in that setting are known to be vaccinated. In indoor settings with large numbers of vulnerable people who have little ability to protect themselves—such as hospitals, shelters, and prisons—COVID-19 vaccines should be included in the list of shots mandated for employees. Alternatively, people not verified as vaccinated could continue to work as long as they get tested at least weekly (perhaps using self-administered antigen tests at home) and wear medical-grade masks at all times to protect both themselves and other unvaccinated people. Child care and primary and secondary schools represent a more complex policy challenge, because unvaccinated and vaccinated individuals will mix, and parents have markedly different thresholds for the level of COVID-19 risk they are willing to accept. (Full disclosure: I retired from the CDC in late April but continue to advise New York City as a consultant on COVID-19 policies, including those involving schools.) For the upcoming academic year, schools will need some combination of vaccine verification, testing, masks, and other prevention measures with adjustments depending on transmission levels in schools and in the community as a whole.

When faced with existential threats, extreme approaches are warranted. But as the worst threats wane, the most sensible approach to public-health decision making will fall somewhere between “We’re all in this together” and “Your fate is in your own hands.” A more targeted approach—one that neither requires universal sacrifice nor relieves everyone of all inconvenience—isn’t just politically wise or legally necessary; it’s the only path forward that we have.

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LI high school baseball in 2021: Aces wild

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LI high school baseball in 2021: Aces wild

Velo, velo and more velo.

Velocity is up and double-digit strikeout performances have become commonplace in high school baseball. Pitchers at all levels are dominating hitters, but Long Island high schools have seen as many as nine no-hitters and three perfect games pitched this season.

Welcome to baseball in the spring of 2021. Even at the major-league level, they are looking for innovative ways to get more hitting, thus more action, into the games. Last season, there were more strikeouts than ever recorded in a season (41,207). And there were more strikeouts than hits for the first time. And there have been six no-hitters in the majors in 2021.

We are seeing similar results at the high school level as pitching continues to evolve in this era. And that evolution of pitchers is taking control of the game. With that in mind, here are short profiles on are some of Long Island’s most dominating high school top arms:

TYLER COX

Clarke, Sr.

Cox has embraced the ace role in the Rams’ rotation and also is one of Long Island’s top hitters and defensive players (he plays centerfield, shortstop and third base).

“He’s a fantastic athlete,” Clarke coach Tom Abruscato said. “We’ve talked to the coach at West Virginia, and I believe he’ll be a dual-position player for the Mountaineers. They’ll use him in either centerfield or at third base and as a closer.”

Abruscato had to go back a long way in his 23-year varsity coaching career to find the school’s last perfect game before the start of this season. Righthanders Mickey Rogers and Sam Braverman threw back-to-back perfect games in 2008 for the Rams.

Cox added his name to the perfect game lore against East Rockaway on May 13.

“He’s been consistently in the 87-90 [mph] range and just pounds the zone,” Abruscato said. “He throws a hard knuckle-drop and a changeup for strikes. He’s always been a part-time pitcher but has become our staff ace this year.”

Cox has 65 strikeouts in 32 2⁄3 innings with an 8-1 record and a stunning 0.00 earned run average. He’s allowed 12 hits and 13 walks.

2021 Numbers

WL … ERA … ER … IP … H … SO … BB

8-1 ,,, 0.00 … 0 … 32.2 … 12 … 65 … 13 …12

College: West Virginia

DYLAN JOHNSON

Newfield, Sr.

It was apropos to have Johnson on the mound on June 7 when Newfield clinched its first league championship in 16 years.

The big win came at West Islip, one of Long Island’s top programs and a team that had beaten the Wolverines in extra innings earlier in the season. Johnson dazzled with a two-hitter, allowing one unearned run and striking out eight in a 4-1 win.

“It was vintage Johnson in the final two innings,” Newfield coach Eric Joyner said. “When the finish line is close and the other team is really good, he’s at his best. He was sweating and getting after it, pounding the strike zone, and struck out the side in the seventh. His velocity increased and the breaking ball was more tightly wrapped.”

Johnson has been nearly unhittable. He’s struck out 56 and walked nine in 36 innings with an ERA of 0.97. He has a 5-0 record with three saves.

“He has helped our team win games that looked lost,” Joyner said. “You can only do so much as coaches. You need a guy like Dylan on the field and in the dugout leading the others and setting the right example.’

Johnson was excited about Newfield’s first title since 2005.

“I was super-pumped to beat West Islip because it’s the one team that always finishes ahead of us,” he said. “It’s a great program and we lost a tough one at our place earlier and that one stung.”

Johnson is committed to St. John’s University.

2021 Numbers

WL … ERA … ER … IP … H … SO … BB

5-0 (3 sv) ,,, 0.97 … 4 … 36 … 12 … 56 … 9

College: St. John’s

RAFE SCHLESINGER

Sachem East, Sr.

Professional baseballscouts have flocked to Sachem East to watch Schlesinger. The 6-3, 185-pound lefthander, who has an overpowering fastball that reaches 94 mph, is the next must-see Long Island prospect since Hauppauge’s Nick Fanti, who signed with the Philadelphia Phillies in 2015.

“Rafe is the real deal,” Sachem East coach Kevin Schnupp said. “There are four or more scouts at every game to see him throw. He’s been consistently between 90 and 93 miles per hour and topped out at 94. He’s developed such late life on his pitches.”

Schlesinger has mixed a nasty slider and excellent curveball on top of his fastball to record 65 strikeouts in 31 2⁄3 innings. He’s walked 12 and allowed 16 hits and four earned runs for an ERA of 0.88. His record is 2-1.

“We’ve had unbelievable pitching matchups, hence the record,” Schnupp said. “We’ve faced five No. 1 pitchers this season. It’s been tough on our hitters, but Rafe loves it. He’s a big-time competitor.”

Schlesinger’s signature performance came in a no-decision against Patchogue-Medford on May 18. He fired a no-hitter for 6 1⁄3 innings and struck out 17.

Sachem East (14-3) is in second place in Suffolk League I.

“We wouldn’t be there without him,” Schnupp said. “He’s a game- changer.”

Schlesinger is committed to the University of Miami.

2021 Numbers

WL … ERA … ER … IP … H … SO … BB

2-1 ,,, 0.88 … 4 … 31.2 … 16 … 65 … 12

College: Miami

HAYDEN LEIDERMAN

Roslyn, Sr.

Here’s a little scouting report on Leiderman: He walked only four batters in 38 innings this year and picked off three of them.

“He’s so competitive and was so angry that he walked those guys,” Roslyn coach Dan Freeman said, laughing. “So he picked them off. He’s a huge piece of a once-in-a-lifetime team here at Roslyn. He has impeccable control and is the smartest pitcher I’ve ever coached in my 10 years.”

Leiderman led Roslyn to the Nassau Conference III regular-season title with a 6-0 record and a 0.00 ERA. He struck out 52 and allowed 11 hits.

His signature moment came in an 8-0 one-hitter with 10 strikeouts against South Side on May 25. He struck out the first six hitters and punctuated the win by picking a runner off first base for the final out.

“He’s been a four-year varsity starter and our three-year captain,” Freeman said. “He has an incredible baseball IQ. He studies hitters and pounds the zone. Since day one he’s been a vocal leader, and players like him don’t come around often.”

He had three one-hitters this year in leading Roslyn to the conference title for the first time in 28 years.

He’s committed to play at the University of Chicago.

2021 Numbers

WL … ERA … ER … IP … H … SO … BB

6-0 ,,, 0.00 … 0 … 38 … 11 … 52 … 4

College: University of Chicago

TOMMY VENTIMIGLIA

Longwood, Sr.

Ventimiglia has been a tough-luck pitcher this season. He has battled the top pitchers in Suffolk League I and come away with some brutal losses.

Ventimiglia is one of Long Island’s top prospects, and the 6-4 righty has garnered the attention of numerous major-league organizations for this year’s amateur draft in July.

Ventimiglia, with a fastball sitting at 89 to 90 mph that occasionally reaches 94 mph, has embraced the competition. He’s struck out 42 in 26 2⁄3 innings and has a 1.22 ERA with a 4-3 record.

“I’m facing top-tier pitchers every game and I know I have to go out and give my team a shot,” Ventimiglia said. “There is no room for mistakes every time I get out there. We’re playing small ball to try and win these games. It’s absolutely 100% preparing me for the next level.”

With a potential pro career looming and his commitment to Stony Brook University, Ventimiglia is focused on what’s in front of him.

“I’m not focused on the draft or college right now because I really would like to win the league playoffs and go win the Long Island championship,” he said. “I’ve been getting a good amount of contact from pro teams and it’s a dream come true just to be considered. It’s hard not to get excited. But honestly, I want a great playoff run with my teammates and that would be a great way to end my high school career and go out with a ring.”

2021 Numbers

WL … ERA … ER … IP … H … SO … BB

4-3 ,,, 1.22 … 5 … 28.2 … 19 … 42 … 17

College: Stony Brook

BEST OF THE REST

John Downing, Chaminade, Jr.

Struck out 39 in 38 2/3 innings with nine walks. He’s 5-0 with a 1.33 ERA. Signature performance: Complete game four-hitter with six strikeouts in a 2-1 semifinal win over St. John the Baptist.

Josh Knoth, Patchogue-Medford, Soph.

Struck out 65 in 36 2/3 innings with six walks. He’s 4-1 with one save and an ERA of 1.71. Signature performance: 16 strikeouts in eight innings vs. Sachem East on May 18.

Tyler O’Neill, Mepham, Sr.

Struck out 49 in 38 innings with four walks. He is 4-1 with an 0.23 ERA. Signature performance: No-hitter with nine strikeouts and one walk vs. New Hyde Park on May 25.

John Rizzo, East Islip, Sr.

Struck out 68 in 42 innings with six walks. He’s 5-1 with one save and an ERA of 0.51. Signature performance: One-hitter with 20 strikeouts vs. Hills West on May 8.

Colin Rhein, North Babylon, Sr.

Struck out 54 in 34 innings. He’s 4-1 with a 1.44 ERA. Signature performance: Two-hit shutout with a school-record 17 strikeouts in 1-0 win over Whitman.

Kyle Rosenberg, Wheatley, Jr.

Struck out 38 in 31 innings with eight walks. He’s 5-0 with one save and 1.35 ERA. Signature performance: Complete game with 10 strikeouts vs. Cold Spring Harbor on May 7.

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