Category Archives: Nano medicine

It is my opinion that over the next 5 to 10 years the delivery of medicine will change dramatically. The pharmacist of the future will become the pharmacist of the past. Many years ago, before the incredible sophistication of the pharmaceutical industry, many pharmacists compounded medications in their own facility.

I foresee a situation where a person will go to the doctor following a full assessment of their own genome. A treatment plan will be formulated based on the persons own genetic abnormalities and predispositions. Rather than taking a number of separate pharmaceutical pills and, for those so inclined, vitamin supplements, the doctor will administer a personalised prescription for the person. This will be taken to their pharmacist and, using nanotechnology, all of these therapies will be delivered within the one small pill, taken once daily.

The technology would be advanced to the point where each separate medication within the nano-pill would be released at the appropriate time into the circulation. We are well aware that computer technology power doubles every 18 months and the advances in nanotechnology appear to be mirroring this.

On a separate, but similar, note, the University of Pittsburgh has released recently in the Journal of Investigative Dermatology, a fingertip patch with 400 microneedles for vaccine delivery for live or attenuated vaccines.

The microneedles are made from three-dimensional sugar structures incorporated into what is known as a multicomponent dissolving microneedle array. Interestingly, this not only induces an antibody response but also improves the cellular response better than standard vaccines given via injection. It appears from the preliminary studies that this will induce a strong and long-lasting immunity. The researchers trialled this in mice administering a live adenovirus with encoded antigens and a specific immune stimulant to enhance the local immune response.

In the last few weeks, researchers at the University of Oxford in England have started a trial of a vaccine for the Coronavirus. It may be that, in the very near future, rather than the needle jab, we are using these micro patches instead for all vaccines.

Researchers from Harvard University in the USA are also working on a similar patch technology for the management of diabetes. The patch not only delivers insulin through the skin but also measures real-time blood sugar levels.

At present, the vast majority of insulin-dependent diabetics need to constantly prick their fingers to monitor blood sugar levels and then inject themselves on multiple occasions throughout the day. Again, over the next few years, the management of diabetes will be revolutionised by the use of these micro patches.

For many chronic conditions affecting millions of people, especially over the age of 50, the future of chronic medical management is very bright. When I started medical school in the 1970s, our medical and surgical therapies were modestly effective and I have seen a revolution in the management of chronic illnesses, such as cardiovascular disease and cancer, over the past 40 to 50 years.

With these extraordinary advances mentioned above, which are only a portion of what we will see over the next decade, the future of medicine is looking very bright indeed.

Read more:
The future of medicine - Switzer Financial News

Face masks can be unexpectedly complicated, especially for those who are new to wearing them.

Navigating which ones you should buy and understanding who they protect, figuring out if you can reuse them and how to get your little ones to wear them are daunting tasks.

Social distancing is still our best bet to prevent further spread of the coronavirus. But since April 3, Americans have been encouraged by the US Centers for Disease Control and Prevention to wear "cloth coverings" in places where distancing guidelines are hard to maintain.

But is your bandana really helping you? Should only people who know they're infected wear masks? And what if your kids throw a tantrum when you ask them to put one on?

We answer every question readers have been asking about face masks.

On April 3, the CDC shifted its guidelines to recommend that we should wear "cloth coverings" in public places where other social distancing measures are difficult to maintain, such as grocery stores and pharmacies.

The updated guidance was in light of new evidence of the high percentage of people spreading the virus asymptomatically. This means the virus can easily spread between people interacting in close proximity by coughing, sneezing or even talking -- even if those people aren't exhibiting symptoms.

Some states require citizens to wear masks in public spaces -- such as Connecticut, Hawaii, Maryland, New Jersey, New York, Pennsylvania and Rhode Island, as of April 20. Some countries, including Germany, Turkey and Jamaica, have required to some degree that people wear masks.

The benefit of wearing masks in public isn't to protect you from getting sick. It's to protect others from exposure if you are sick or if you're an asymptomatic carrier. But if we all wear masks, we could help each other, said Dr. Joseph Vinetz, a professor in the infectious disease section at Yale School of Medicine.

"The idea about the face mask is to prevent the virus from coming out of somebody's mouth and nose, mostly out of their mouth," Vinetz said. "They prevent somebody, when they talk or sometimes when they sneeze or cough, from expelling virus and leading to infection in other people."

Wearing a mask doesn't totally prevent you from getting infected, Vinetz added. The virus can live on surfaces for hours, and in trace amounts up to three days, and it's easy to touch your face when you're not wearing a mask.

Even if you wear a mask, maintaining 6-feet social distancing is still important to slowing the spread of the virus. The CDC considers face masks an additional, voluntary public health measure -- but remember to refer to your home state's guidance as well.

Though the CDC recommends we wear masks, we shouldn't buy surgical masks or N95 respirator masks. Those types are desperately needed by health care workers and first responders who are in constant proximity with coronavirus patients every day, and supplies in some areas are dwindling.

You can, however, easily make your own cloth mask from old clothes or other common materials and household items. And you don't even have to sew. You can make one using a bandana and coffee filter. US Surgeon General Jerome Adams showed us how to make face masks with a T-shirt and rubber bands in this CDC video.

"Ultimately, it's about having some form of barrier with multiple layers," said CNN Chief Medical Correspondent Dr. Sanjay Gupta in a CNN video on why masks in addition to physical distancing are important.

Masks made with a combination of cotton with natural silk or chiffon may also effectively filter out aerosol particles, according to a new study published Friday in the American Chemical Society Nano journal. Our respiratory droplets form in a range of sizes, but the tiny ones, called aerosol particles, can slip through the gaps between certain cloth fibers.

You could substitute the chiffon with natural silk or flannel, or use a cotton quilt with cotton-polyester insulation, to achieve similar results, the study said.

There are also disposable cloth masks you can buy in a store or online. They're not made for surgery or hospitals, but they are effective for your needs and widely used.

"When we talk about face coverings, there are the surgical masks I wear in the hospital to protect patients from my own germs and avoid any splashes," said Gupta, who works as a neurosurgeon.

N95 respirators are masks that must be fitted to the faces of health care workers to protect them during certain procedures, Gupta added.

"It's the only one of these masks that prevents most very small particles from getting in, when used properly," he continued. "We need to keep those masks in their hands."

Medical-grade masks are more effective, but that "doesn't mean we should dismiss the benefit of cloth masks," Gupta said.

Because of how far our respiratory droplets travel when we talk, cough or sneeze, face masks can still help to contain the range of those droplets.

The researchers in the Nano study used sodium chloride to replicate respiratory particles ranging in size, and blew with a fan the particles across material samples at a rate similar to a person's resting breath. They measured the number and size of particles in the air before and after they passed through the fabric.

One layer of a tightly woven cotton sheet combined with two layers of polyester-spandex chiffon filtered out the most air particles, between 80% to 99%. According to the study, its effectiveness was close to an N95 mask.

Tightly woven fabrics such as cotton can be a mechanical barrier to particles, while fabrics with a static charge, such as natural silk or chiffon, act as a electrostatic barrier, the study said.

However, a very small gap reduced the efficacy of the mask by at least 50%, emphasizing the importance of a properly fitted mask, the study said.

Homemade masks can be reused because they're washable, Vinetz said.

You should launder the masks before and after each use to clean off any germs you may have picked up in public. Hand-wash the masks or put them in a mesh wash bag in the washing machine so they don't come apart, and use a high-heat setting.

If you already have a disposable surgical or medical-grade mask, those can be reused, too. To disinfect it, leave it in a clean, safe place in your house for a couple days, Vinetz suggested. After that, it should no longer be infectious.

If you're thinking you might be able to nuke your mask to kill germs, that's "not a great idea," Vinetz said.

"We have no evidence about that," he said. "If there's a metal piece in an N95 or surgical mask and even staples, you can't microwave them. It'll blow up. If you have a homemade or cloth mask or what's called a face covering, you just wash it. Microwaving it is not going to work."

For those who wear glasses, wearing a mask means figuring out how to avoid our humid breath blocking us from seeing across the grocery store. Or from seeing anything, really.

"To avoid fogging up your glasses -- I have the problem myself -- short of getting Lasik surgery, you have to fold the mask around your nose so that the air coming out of your mouth or nose doesn't rise to your glasses," Vinetz said. (He's not recommending anyone get elective surgery right now.)

If your child refuses to wear a mask, takes it off and throws it down, chews on it or otherwise, his actions could defeat the point of wearing a mask and raise the risk of infection, said Christopher Willard, a psychiatry lecturer at Harvard Medical School and author of "The Breathing Book," a breathing practice book for kids.

Kids may be apprehensive about wearing a face mask because they're more sensitive to new things than adults are, Willard said.

"There's also the weird psychological aspect of not being able to see their own face or other people's faces and facial expressions," he added, "which really interferes with communication and signals that they [feel are safe]."

To ease their mask fears, buy or make coverings with appealing fabrics, or draw something cool with markers to make them look more fun. Try drawings of your child's favorite superheroes or ninjas wearing masks as they go about helping other people. Show your child your own mask and how, by wearing one, he'll be just like Mom or Dad. See if you can find pictures of your kid's favorite celebrities wearing masks.

Doing so could make your kids feel like the masks are "theirs" and give them a sense of ownership, making them more excited and more likely to wear them, Willard said.

"I think also knowing that they are protecting others can help, and making it fun by talking about it as dressing up like superheroes or something."

And altruism isn't only for kids, but for everyone wearing a mask for the public good.

"It's part of our social contract to look after one another," Vinetz said. "It's social solidarity for everybody in a public place, when told to by public health and political authorities, [to] wear a face covering according to what's recommended."

The rest is here:
All your questions about how to wear a face mask -- answered - Action News Now

MILPITAS Feb 11, 2020 (Thomson StreetEvents) -- Edited Transcript of Onto Innovation Inc earnings conference call or presentation Thursday, February 6, 2020 at 9:30:00pm GMT

Onto Innovation Inc. - Senior Director of IR, Corporate Communications & Marketing Research

* Michael P. Plisinski

Onto Innovation Inc. - CEO & Director

* Steven R. Roth

Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary

* J. Ho

Stifel, Nicolaus & Company, Incorporated, Research Division - MD of Technology Sector

B. Riley FBR, Inc., Research Division - Associate Analyst

D.A. Davidson & Co., Research Division - MD & Senior Research Analyst

Good day, and welcome to the Onto Innovation Fourth Quarter Earnings Release Conference call. During today's call, there will be a question and answer session. (Operator Instructions) Today's conference is being recorded.

At this time, I would like to turn the conference over to Michael Sheaffer, Investor Relations. Please go ahead, sir.

Michael Sheaffer, Onto Innovation Inc. - Senior Director of IR, Corporate Communications & Marketing Research [2]

Thank you, Karina. Good afternoon, everyone. Onto Innovation issued its 2019 fourth quarter and full year financial results this afternoon, shortly after the market closed. If you have not received a copy of the release, please refer to the company's website at http://www.ontoinnovation.com, where a copy of this release is posted. Joining us on the call today are Michael Plisinski, Chief Executive Officer; and Steven Roth, Chief Financial Officer.

As is always the case, I need to remind you of the safe harbor regulations. Any matters today that are not historical facts, particularly comments regarding the company's future plans, objectives, forecasts and expected performance consist of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such estimates, whether expressed or implied are being made based on currently available information and the company's best judgment at this time. Within these is a wide range of assumptions that the company believes to be reasonable. However, it must be recognized that these statements are subject to a range of certainties that can cause the actual results to vary materially. Thus, the company cautions that these statements are no guarantee of future performance. Risk factors that may impact Onto Innovation's results are currently described in both Rudolph Technologies Form 10-K report and Nanometrics Form 10-K report for the year ended December 2018 as well as other filings with the Securities and Exchange Commission. Onto Innovation does not update forward-looking statements and expressly disclaims any obligation to do so. Today's discussion of our financial results will be presented on a non-GAAP financial basis, unless otherwise specified. A detailed reconciliation between GAAP and non-GAAP results can be found in today's earnings release.

And now I'll go ahead and turn the call over to Mike Plisinski. Mike?

Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [3]

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Thank you, Mike. Good afternoon, everyone, and welcome to Onto Innovation's fourth quarter earnings call. I'll start with an update on the most exciting event for the fourth quarter, the merger of Nanometrics and Rudolph Technologies, which resulted in the launch of Onto Innovation. Onto Innovation is positioned to benefit from nearly every major technology inflection across the semiconductor value chain from the continued evolution of advanced nodes in both memory and logic fabs to the growth of specialty devices for sensing and communications and the essential advanced packaging that opens the door for greater levels of integration and performance in a smaller form factor. We closed on this transformational merger in late October. And since then, Onto Innovation team has been working diligently to integrate our businesses and form the foundation for future innovation and shareholder value creation. In these past 3 months, we have integrated our talented and customer support teams in order to more efficiently leverage our combined infrastructure, and ultimately, improve our customers' experience with our portfolio solutions. We have identified and implemented $14 million in annualized synergies and we are confident in ending this year with $20 million of annualized cost synergies with additional synergies to follow. Finally, our technology teams have been busy exploring potential revenue synergies to strengthen our core markets and expand our SAM. Of course, it will take time for these benefits to be fully realized, but the effort is progressing very well.

Turning to the specifics of our fourth quarter, the Onto Innovation team delivered solid results with revenue coming in at $120.6 million, which was above the midpoint of our forecasted range. Non-GAAP earnings per share came in at $0.41 at the high end of our guidance. As a reminder, we will be reporting our results in 3 categories. The first category is advanced semiconductor nodes, which includes DRAM, NAND and logic, including foundry. The second category is specialty devices and advanced packaging, which includes those categories in our nascent silicon wafer manufacturing market. And our third category is software and services.

For the fourth quarter, advanced nodes declined slightly overall. Atlas III+ metrology sales doubled over the third quarter, predominantly to support the ramping of 10-, 7- and 5-nanometer logic nodes by 2 of the top 5 semiconductor manufacturers. The Atlas platform's increased throughput and more sensitive broad spectrum optical metrology is well suited to help customers control the increasingly more complex 3D measurements required for yields at the leading edge. The growth in logic mostly offset the decline in memory we projected last quarter after strong demand from NAND customers in the third quarter.

Revenue from our specialty device and packaging -- advanced packaging segment increased 7% from the third quarter. As a reminder, this is generally a unit volume-driven business, where growth is typically through expansions to meet higher chip volume versus technology transitions. As a result, the business is generally more susceptible to the effects of seasonality with Q4 and Q1 typically being the slower quarters. However, revenue in the fourth quarter reflects a growing demand for 5G-enabled devices with advanced packaging revenue increasing 5%.

The Dragonfly inspection system achieved record revenue in the quarter and enjoyed broad adoption across the most demanding advanced packaging applications, including multiple tools shipped to a top 5 memory manufacturer for stack DRAM packaging applications. Other wins included 2D inspection with clarifying technology and 3D bump inspection for top 5 logic and foundry customers in support of their announced 5G and high-performance computing applications. Rounding out the customer wins, several OSAT customers took delivery of their first Dragonfly system for bump inspection to support expansion of their packaging lines for mobility products. Revenue from silicon wafer manufacturers grew by over 50% in the fourth quarter, driven by record shipments of our QS series FTIR metrology systems to substrate manufacturers worldwide. Also contributing to the growth were multiple shipments of NovusEdge in the quarter, including to a new customer. In the last year, NovusEdge has been adopted by 4 of the top 5 silicon wafer manufacturers and our QS series FTIR is positioned on all of the top 5. We believe this will position us well for continued growth in 2020.

Also during the fourth quarter, we delivered and recognized a second JetStep Lithography System for a panel packaging customer who is increasing capacity for 2020. This customer has developed a reputation for high-quality and high-yielding advanced panel processes and has attracted a growing number of customers for devices, such as power management and RF modules, microcontrollers and FPGAs. This customer is also incorporating our Firefly inspection tool to provide feed-forward metrology data to the JetStep Lithography System using our StepFAST software solution as they begin to move toward high-volume manufacturing in mid-2020.

Finally, rounding out the quarter, our software and services business continues to grow as each company had invested in infrastructure and technology to provide more value-enhancing services to our customers. As mentioned at the start of the call, we see opportunities to leverage our broader infrastructure to improve efficiencies and deliver more value-enhancing services.

In summary, over the full year, our new products helped to strengthen our position in core markets and open opportunities in new markets. The Atlas III+ expanded our optical metrology position across the leading-edge logic and memory customers. We have now secured tooler record positions with leaders in logic, 3D NAND and DRAM, resulting in a more balanced foundation from which to grow in 2020. Likewise, we are pleased with the selection of Dragonfly inspection by 15 new customers in 2019 across diverse markets in advanced packaging and across a wide variety of applications such as packaging RF wireless power devices and automotive.

Shipments of our NovusEdge inspection and FTIR metrology product lines more than doubled from 2018 to 2019. We believe this market will continue to grow and be a more meaningful part of our business in 2020. Combined, these new products resulted in over $130 million of revenue in 2019 and provide a strong base to grow from as we look ahead to 2020.

Specific to the first quarter of 2020, we see specialty devices and packaging segment continuing to grow into the first quarter. We see DRAM spending increasing in the first quarter, offsetting a pause in logic and NAND and leading to revenue in the range of $136 million plus or minus 6%. In this revenue range, earnings per share would be $0.23 to $0.41 per share. The midpoint of this revenue range represents an increase of 13% over the reported fourth quarter after being adjusted downward to reflect the projected impact of the coronavirus on the timing of our shipments to China. Absent that adjustment, we expected our midpoint in the upper half of our guidance range. By now, many of you are aware that the rapid spread of the coronavirus has resulted in a mandated extension of the Chinese Lunar New Year holiday to February 10. Strict quarantine of a number of cities and provinces and other travel restrictions across the country. This has delayed some of our planned shipments in February. Our guidance reflects the best information available from our customers as to when they believe travel restrictions will be lifted and shipments to their factories can resume. It's important to note that we do not see any impact on demand at this time. The impact is only on the timing of shipments. And as we manage through this situation and assess timing, our first priority will be to the safety and well-being of our staff and their families.

Looking more broadly at 2020, we see demand for 5G-enabled devices and high-performance computing sparking a broader recovery in the market. Gartner forecasts that worldwide, mobile phones will see a modest increase this year versus a decline in 2019. Driving the majority of that increase are the 5G-enabled handsets, which Gartner predicts will account for 12% of all mobile phone shipments in 2020, increasing to 43% of all mobile phones in 2022. As a result, we expect to see a number of Onto Innovation markets expand in 2020. The most obvious impact of this growth is in our specialty devices and advanced packaging segment. Underscoring this opportunity is our release from earlier in this -- in the month announcing the receipt of orders for 15 inspection systems from 2 customers rapidly expanding advanced packaging capacity to support wafer-level packaging of 5G devices. We see continued growth in these markets in 2020, driven by volume increases as well as additional devices migrating to advanced packaging. We also see 5G and high-performance computing, benefiting our advanced node segments in which leaders, such as SK Hynix, recently forecast 5G smartphones will drive a 25% increase in DRAM content per phone, while NAND will benefit from 20% increase per phone. And TSMC recently cited growing demand for their 5-nanometer process from 5G processors, RF front-end modules and advanced computing. We expect our advanced semiconductor nodes segment to grow modestly with sustained levels of logic foundry spending and a pickup in memory spending starting with DRAM.

In conclusion, semiconductor markets are becoming more diverse every year. We see chip innovations and cameras, sensing and communications, enabling new customer products such as smart home, smart grids and wearable health monitors. We see innovations in the advanced nodes for both memory and logic, enabling data centers and AI engines to open up entirely new markets such as medicine, autonomous driving and energy. We see a growing number of customers increasing their focus on advanced packaging technology to unlock the full potential of new chip designs and more tightly integrated and high-performing form factors. Across the spectrum, Onto Innovation is an important partner to our customers. Our merger strengthens our ability to provide value-enhancing services to our customers, increase our pace of product innovation and deliver more comprehensive, integrated solutions to challenges further down our customers' road map. We are only at the very start of this journey, but we are committed to maximizing our potential to the benefit of all of our stakeholders, customers, shareholders and our team.

With that, I'll turn the call over to Steve Roth to review the financial highlights.

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Steven R. Roth, Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary [4]

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Thanks, Mike. Before I begin my financial remarks today, I want to remind you, as usual, the financial results discussed here will be provided on a non-GAAP basis. And that our non-GAAP presentation for the new merged company no longer excludes stock-based compensation as the former Rudolph financials did. In addition, as detailed in our last conference call, Rudolph was deemed the financial acquirer in the merger. And therefore, the combined financial results presented today represent the results of Rudolph for the full fourth quarter but only the results of former Nanometrics since the closing of the merger on October 25. I recognize that this partial quarter makes comparability of prior period somewhat difficult and I'll try to bridge those differences for comparative purposes to the prior periods.

As Mike mentioned, our reported fourth quarter revenue was $120.6 million, above the midpoint of our guidance. That revenue excludes both $10 million of Nanometrics October shipments and $1.7 million of deferred revenue that would have rolled into the quarter, but was eliminated in the merger accounting. Therefore, on a total quarter basis, as if the merger was completed at the beginning of the quarter, our full quarter revenue would have been $132.3 million. That's a 3% decrease from the $136 million in combined revenue, if you add the 2 separate companies' third quarter reported revenue together.

Breaking the revenue down by market. Revenue from advanced nodes account for 44% of revenue with strength in logic and foundry offset by lower memory business. Specialty devices and advanced packaging customers accounted for 35% of revenue, and the remaining 21% of revenue came from our software and services business. We had 1 customer in the fourth quarter representing 10% or greater sales. As we have discussed, one of the benefits of the merged company is the broad and diverse customer base, with over 150 customers from silicon wafer manufacturers all the way to advanced packaging customers.

Turning to gross margin. Fourth quarter gross margin was 51% and was impacted by the cleanup of inventory items as we prepare to go live with the new ERP system in January, which we did not non-GAAP out. Excluding those inventory adjustments, our Q4 gross margin would have been approximately 52%. As we look forward to our first full combined quarter in Q1, we see the revenue volume per Mike's guidance, or that Mike just provided, and product mix primarily affecting the margin. And therefore, expect our gross margins to be in the range of 50% to 52%.

Fourth quarter operating expenses, as reported, were $40.7 million and excluded $8.7 million of fourth quarter Nanometrics expenses prior to the closing. On a full quarter basis, total operating expenses would have been approximately $49.4 million.

Operating expenses reported by each separate company in the third quarter of 2019, when combined, equaled $51.8 million. Portion of the decrease between the periods is due to the merger synergies, having a partial positive effect on Q4 expenses. Historically, operating expenses increased quarter-over-quarter from Q4 to Q1, as during the first quarter we perform our annual compensation reviews and equity grants and bonus plans and payroll taxes reset for the year. We have also implemented a significant portion of our synergies mainly around business rationalization, streamlining corporate overhead and eliminating duplicative public company costs, which on an annual basis totals $14 million and puts us well on our way to achieving our stated goal of $20 million by the end of 2020. The quarterly benefit of those synergies will partially offset the normal Q1 operating expense increases I just mentioned. And based on that, we are currently forecasting our Q1 operating expenses to be in the range of $49.5 million to $51.5 million. Net income for the fourth quarter was $18.1 million or $0.41 per share and at the higher end of our guidance. That per share amount was based on 43 million diluted shares outstanding due to the deal being closed in the middle of the quarter. For the first quarter, we are estimating a diluted share count of approximately 50.5 million shares in our earnings per share calculations. That share count difference negatively impacts Q1 guidance by approximately $0.04 per share when compared to Q4.

Now turning to cash and investments, which are on a GAAP basis. We ended the year with a cash position of $320.2 million after paying out approximately $25 million in merger expenses. On a 50.5 million diluted share count, that equates to $6.34 per share. As the industry continues to improve and we begin to benefit from the synergies in our operations and improve our working capital metrics, we're targeting cash flow to be approximately 20% of revenue in 2020.

Now I'd like to open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) We'll take our first question from Patrick Ho with Stifel.

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J. Ho, Stifel, Nicolaus & Company, Incorporated, Research Division - MD of Technology Sector [2]

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Thank you for the color in helping to get the financials in order on a going-forward basis. Mike, first off, in terms of your front-end metrology business, can you give a little bit of color -- one on the NAND flash environment and maybe on the timing of when you believe broader base NAND flash spending will come? And secondly, on the DRAM side, some of the comments you made, I think from the metrology end, obviously, there's been increasing capital intensity trends related to metrology use as layers increase, how do we look at the DRAM market, in -- specifically on the metrology and in terms of capital intensity -- how that plays out?

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [3]

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So I'll start with the 3D NAND. So after relatively strong first several quarters of 2019, we had the pause in the fourth quarter. We see 3D NAND picking -- staying or a little bit pause for the first half and picking up more in the second half. And the magnitude of which could determine, obviously, the strength of the year-over-year comparison. But for sure, strengthening in the second half from what we're seeing.

On the DRAM side, we see a little bit of the opposite. We see stronger demand in the first half, starting in the first quarter. And part of that is bringing in equipment for some of the -- I think, it's well publicized, Samsung has announced Beyontec expansion. And going into the second and third quarter, and you know obviously bring in the metrology equipment sooner than the process equipment to help qualify that process equipment, so -- does that...

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J. Ho, Stifel, Nicolaus & Company, Incorporated, Research Division - MD of Technology Sector [4]

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Great. That's helpful. Yes, it does. And maybe, Steve, in terms of OpEx management, actually looks really good in Q1 relative to some of the expectations I have. How do you see that progressing? And what I'm trying to get at is the cost synergies are still going to be put into place. I'm sure you're looking at new investments. How do we look at the trends as 2020 progresses for OpEx management?

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Steven R. Roth, Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary [5]

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Yes. I mean, I would say you can -- it models down quarter-over-quarter, the way we look at it right now. Obviously, some of the synergies timing come in, like you said, they phase in. But yes, I would say that, right now, the guidance that I gave for Q1 is a high point because, as I said, there's a lot of cost -- some of the costs are not linear. So there's always this uptick in the first quarter. And then I would expect them to trail down from here, Patrick, from that guidance.

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Operator [6]

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And we'll take our next question from Quinn Bolton with Needham.

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [7]

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Congratulations on the nice results in the first quarter as a combined company. I wanted to start just kind of with WFE and sort of how you see the profile of spending across the advanced nodes and the specialty side of the business first half versus second half. Certainly, sounds like advanced foundry logic, maybe front-half loaded. You talked about NAND being stronger in the second half, DRAM being a little bit more steady in Q2, Q3. So when you put all that together, how do you see the pattern of revenue on a sequential basis or a half-over-half basis in 2020?

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [8]

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You're speaking specifically about us, correct? So we're seeing...

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [9]

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Correct.

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [10]

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Yes. And that will depend, obviously, on customer mix, application strength, market share, et cetera. So from our perspective, we're seeing logic -- so we'll start with logic foundry to give you a kind of a complete picture. Logic foundry has maintained relatively high levels, and we see that continuing into 2020. And then the DRAM we see picking up rather nicely into 2020. And then 3D NAND is really the -- I'd say the wild card a little bit. That's -- certainly, we see a pickup in the second half over the first half and the magnitude of which we'll determine is it going to grow over -- year-over-year or is it going to stay a little bit depressed?

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [11]

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Okay, great. And then second question, you mentioned that without the coronavirus you would have probably guided closer to the middle or upper middle part of the first quarter revenue range. Wondering on that coronavirus effect whether you're seeing delays in the tool deliveries to one of the larger NAND players in China. Is that a specific risk? Or are you just sort of generally trying to be conservative with the March quarter guidance, given everything that's going on with the outbreak?

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [12]

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No, that's a specific risk. That's -- I mean, they're, obviously, right in the center of ground zero. So clearly, we've had a lot of detailed discussions there. And we're working with the customers to, obviously, balance the demands that they still have with the realities of the situation on the ground.

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [13]

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Great. And then last one for me, just as we come through the year. So it sounds like gross margin in the first quarter at 50% to 52%, it sounds like there's some mix or some sort of quarter-specific factors. How do you see that gross margin trending beyond the first quarter?

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Steven R. Roth, Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary [14]

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The rest is here:
Edited Transcript of NANO earnings conference call or presentation 6-Feb-20 9:30pm GMT - Yahoo Finance

KANAZAWA, Japan, Feb. 10, 2020 /PRNewswire/ -- Researchers at Kanazawa University report in the Journal of Thoracic Oncology a promising novel approach for a combined treatment of the most common type of lung cancer and associated secondary cancers in the central nervous system. The approach lies in combining two cancer drugs, with one compensating for a resistance side effect of the other.

In 20 40% of patients with cancer, metastasis (the development of secondary tumors) in the central nervous system (CNS) occurs. CNS metastatis impacts negatively on a patient's quality of life, and is associated with a poor health prognosis. In a form of cancer known as ALK-rearranged non-small-cell lung cancer (NSCLC), CNS metastatis is known to persist when drugs targeting primary tumors are used.Now, Seiji Yano from Kanazawa University and colleagues have investigated the origins for the resistence to such drugs, and tested a new therapeutic strategy on a mouse model.

The researchers looked at the drug alectinib.Although used in standard treatments for advanced ALK-rearranged NSCLC, approximately 20 30% of patients treated with alectinib develop CNS metastatis, which is attributed to acquired resistance to the drug.

By treating mice first injected with tumor cells with alectinib daily for 16 weeks, the scientists obtained a mouse model displaying alectinib resistance.By biochemical analyses of the mouse brains, Yano and colleagues were able to link the resistance to the activation of a protein known as epidermal growth factor receptor (EGFR).This activation is, in turn, a result of an increase in production of amphiregulin (AREG), a protein that binds to EGFR and in doing so 'activates' it.

Based on this insight, the researchers tested the effect of administering drugs used for inhibiting the action of EGFR in combination with alectinib treatment.The experiments showed that a combination treatment of alctinib with either erlotinib or osimertinib two existing EGFR-inibiting drugs prevented the progression of CNS metastasis, controlling the condition for over 30 days.

The scientists conclude that the combined use of alectinib and EGFR-inhibitors could overcome alectinib resistance in the mouse model of leptomeningeal carcinomatosis (LMC), a particular type of CNS metastasis.Quoting Yano and colleagues: "Our findings may provide rationale for clinical trials to investigate the effects of novel therapies dual-targeting ALK and EGFR in ALK-rearranged NSCLC with alectinib-resistant LMC."

Background

Non-small-cell lung cancer

Non-small-cell lung carcinoma (NSCLC) and small-cell lung carcinoma (SCLC) are the two types of lung cancer. 85% of all lung cancers are of the NSCLC type. NSCLCs are less sensitive to chemotherapy than SCLCs, making drug treatment of the highest importance.

Alectinib is a drug used for treating NSCLC, with good efficiency. However, 20-30% of patients taking the drug develop secondary cancer in the central nervous system (CNS), which is associated with an acquired resistance to alectinib.Seiji Yano from Kanazawa University and colleagues have now made progress towards a novel therapy against this resistance: a combination of alectinib with other drugs.

Epidermal growth factor receptor inhibitors

The drugs that Yano and colleagues tested in combination with alectinib on a mouse model were of a type known as epidermal growth factor receptor (EGFR) inhibitors, including osimertinib and erlotinib. Both are being used as medication for treating NSCLC.The former was approved in 2017 as cancer treatment by the U.S. Food and Drug Administration and the European Commission.Yano and colleagues obtained results showing that EGFR inhibitors counteract resistance to alectinib and have therefore potential in novel therapies for NSCLC and secondary cancers in the CNS.

Reference

Sachiko Arai, Shinji Takeuchi, Koji Fukuda, Hirokazu Taniguchi, Akihiro Nishiyama, Azusa Tanimoto, Miyako Satouchi, Kaname Yamashita, Koshiro Ohtsubo, Shigeki Nanjo, Toru Kumagai, Ryohei Katayama, Makoto Nishio, Mei-mei Zheng, Yi-Long Wu, Hiroshi Nishihara, Takushi Yamamoto, Mitsutoshi Nakada, and Seiji Yano. Osimertinib overcomes alectinib resistance caused by amphiregulin in a leptomeningeal carcinomatosis model of ALK-rearranged lung cancer, Journal of Thoracic Oncology, published online on January 21, 2020.

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DOI: 10.1016/j.jtho.2020.01.001

URL: https://www.sciencedirect.com/science/article/pii/S1556086420300228

About Nano Life Science Institute (WPI-NanoLSI)

https://nanolsi.kanazawa-u.ac.jp/en/

Nano Life Science Institute (NanoLSI), Kanazawa University is a research center established in 2017 as part of the World Premier International Research Center Initiative of the Ministry of Education, Culture, Sports, Science and Technology. The objective of this initiative is to form world-tier research centers. NanoLSI combines the foremost knowledge of bio-scanning probe microscopy to establish 'nano-endoscopic techniques' to directly image, analyze, and manipulate biomolecules for insights into mechanisms governing life phenomena such as diseases.

About Kanazawa University

http://www.kanazawa-u.ac.jp/e/

As the leading comprehensive university on the Sea of Japan coast, Kanazawa University has contributed greatly to higher education and academic research in Japan since it was founded in 1949. The University has three colleges and 17 schools offering courses in subjects that include medicine, computer engineering, and humanities.

The University is located on the coast of the Sea of Japan in Kanazawa a city rich in history and culture. The city of Kanazawa has a highly respected intellectual profile since the time of the fiefdom (1598-1867). Kanazawa University is divided into two main campuses: Kakuma and Takaramachi for its approximately 10,200 students including 600 from overseas.

Further information

Hiroe Yoneda Vice Director of Public Affairs WPI Nano Life Science Institute (WPI-NanoLSI) Kanazawa University Kakuma-machi, Kanazawa 920-1192, Japan Email: nanolsi-office@adm.kanazawa-u.ac.jpTel: +81-(76)-234-4550

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Kanazawa University Research: Combined Drug Treatment for Lung Cancer and Secondary Tumors - Yahoo Finance

LOS ANGELES, Feb. 4, 2020 /PRNewswire/ --Immix Biopharma, Incannounced today that the first patient in the USA was dosed successfully in its flagship phase 1b/2a clinical trial testing Imx-110 in patients with refractory solid tumors.To-date, the trial has accrued patients across tumor types. The expansion of the study to the US builds upon Immix' results from Australia, wherein six cohorts were dosed with no treatment-related serious adverse events observed and dose escalation is continuing.

The first US patient was dosed at Sarcoma Oncology Research Center in Santa Monica, California - led by Dr. Sant Chawla, a world renowned expert in sarcoma treatment and clinical research. Based on his extensive experience with anthracycline-based experimental therapies for sarcoma, including CytRx' Aldoxorubicin, Dr. Chawla shared his optimism for Imx-110 as an investigational candidate both from the standpoint of superior efficacy and a lower risk of cardiac complications associated with older formulations of doxorubicin.Dr. Chawla's colleague, Dr. Erlinda Gordon is the Principal Investigator leading the study at Sarcoma Oncology Research Center in Santa Monica.

Dr. Gordon is a Diplomate of the American Board of Pediatric Hematology/Oncology and previously a Tenured Associate Professor for 24 years at USC and currently a Professor Emeritus at the USC Keck School of Medicine, Los Angeles, California. She is a co-inventor of more than 150 patents in biomedical research, and patented the first targeted gene delivery system for cancer in the USA, Europe and the Philippines. She has authored more than 100 original peer-reviewed articles and served as Editor-in-Chief of the International Journal of Pediatric Hematology-Oncology, Director of the Red Cell Defects Program and the NIH-funded Comprehensive Hemophilia Center at Children's Hospital of Los Angeles and the NIH-funded Children's Oncology Group. Dr. Gordon was co-founder of two biotechnology companies and is a pioneer in the development of targeted gene therapy products.

For more information on the Imx-110 study, please visit clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03382340.

Immix also has an open call for investigator initiated studies where the company will provide Imx-110 at no charge.

About Imx-110Imx-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis. Imx-110 contains NF-kB/Stat3/pan-kinase inhibitor curcumin combined with a small amount of doxorubicin encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties, allowing it to deliver even more payload to tumors or other cell populations of interest, if needed. Imx-110 showed preclinical efficacy in glioblastoma, multiple myeloma, triple-negative breast, colorectal, ovarian, and pancreatic tumor models with the mechanism of action being a 5x increase in cancer cell apoptosis compared to doxorubicin alone, and a wholesale shift in the tumor microenvironment post administration.

About the CompanyImmix Biopharma, Inc. is a privately-held, biopharmaceutical firm focused on developing safe and effective therapies for cancer patients. The company was founded by Vladimir Torchilin, Ph.D., D.Sc., Director of the Center for Pharmaceutical Biotechnology and Nanomedicine at Northeastern University; physician-scientist and clinical researcher Ilya Rachman, MD, PhD, MBA; and Sean D. Senn, JD, MSc., MBA, a senior biotechnology patent attorney. Immix's founding investor is a family office focused on harnessing scientific advances in order to engineer transformative and effective cancer treatments. For more information visit http://www.immixbio.com.

Media ContactRyan Witt+1 (888) 958-1084info@immixbio.com

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SOURCE Immix Biopharma, Inc.

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Immix Doses First Patient in USA in its Phase 1b/2a Trial in Patients with Advanced Solid Tumors - BioSpace

In this article we will discuss about Nano Medicine:- 1. Meaning of Nano Medicine 2. Advantages of Nano Medicine 3. Disadvantages.

The application of nanotechnology in medicine is often referred to as Nano medicine. Nano medicine is the preservation and improvement of human health using molecular tools and molecular knowledge of the human body. It covers areas such as nanoparticle drug delivery and possible future applications of molecular nanotechnology (MNT) and Nano-vaccinology.

The human body is comprised of molecules. Hence, the availability of molecular nanotechnology will permit dramatic progress in human medical services. More than just an extension of molecular medicine, Nano medicine will help us understand how the biological machinery inside living cells operates at the Nano scale so that it can be employed in molecular machine systems to address complicated medical conditions such as cancer, AIDS, ageing and thereby bring about significant improvement and extension of natural human biological structure and function at the molecular scale.

Nano medical approaches to drug delivery centre on developing Nano scale particles or molecules to improve drug bioavailability that refers to the presence of drug molecules in the body part where they are actually needed and will probably do the most good. It is all about targeting the molecules and delivering drugs with cell precision.

The use of Nano robots in medicine would totally change the world of medicine once it is realized. For instance, by introducing these Nano robots into the body damages and infections can be detected and repaired. In short it holds that capability to change the traditional approach of treating diseases and naturally occurring conditions in the human beings.

1. Advanced therapies with reduced degree of invasiveness.

2. Reduced negative effects of drugs and surgical procedures.

3. Faster, smaller and highly sensitive diagnostic tools.

4. Cost effectiveness of medicines and disease management procedures as a whole.

5. Unsolved medical problems such as cancer, benefiting from the Nano medical approach.

6. Reduced mortality and morbidity rates and increased longevity in return.

1. Lack of proper knowledge about the effect of nanoparticles on biochemical pathways and processes of human body.

2. Scientists are primarily concerned about the toxicity, characterization and exposure pathways associated with Nano medicine that might pose a serious threat to the human beings and environment.

3. The societys ethical use of Nano medicine beyond the concerned safety issues, poses a serious question to the researchers.

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Nano Medicine: Meaning, Advantages and Disadvantages

Nanomedicine, refers to highly specific medical intervention at the molecular level for curing disease or repairing damaged tissues. Though in its infancy, could we be looking at the future of medicine? Early clinical trials certainly look promising.How Nanomedicine Works

- Nanomedicine works by injecting nanoparticles into the body- Can be used to:- Deliver medicine- Find and treat disease- Repair damaged cells

One human hair is approximately 80,000 nanometers wideApplications of Nanomedicine

- Drug Delivery- Using nanotechnology to deliver medicine, diabetic rats kept stable blood sugar levels for 10 days after injection- Cancer Diagnosis and Treatment- Using microRNA from a patient's blood plasma and nanotechnology:- Medical professionals can determine if lung cancer is present- Begin treatment the same day- Using Nano-Therm therapy to overheat brain cancer cells helps to destroy them- In clinical trials, those with recurrent glioblastoma survived a median of 13 months- More than double the survival rate of those not receiving Nano-Therm therapyNanotechnology is already commonly used in sunscreen and to make tennis balls more bouncy

- Flu Testing- Today's flu tests are:- Time consuming- Inaccurate- Nanomedicine gold flu testing provides:- Instant results- Immediate treatment cycle to avoid spreading to others- commercial nanotech testing no more than 5 years away- Cell Feedback- Nanomedicine can be used to test cell's response to drugs offering new drug testing methods- Provides instant feedback to how cells respond to medicine- Can save years and millions of dollars on testing and clinical trials- Can improve current medications

In a 1956, Arthur C. Clarke first envisioned the concept of nanotechnology in a short story, The Next TenantsAdvantages of Nanomedicine

- Faster diagnosis of many ailments- More precise treatments of conditions such as cancer- Repair tissue deep within the body- Target only diseased organs, lessening the need for drugsSources

- https://commonfund.nih.gov/nanomedicine/overview.aspx- http://www.understandingnano.com/medicine.html- http://pubs.acs.org/doi/abs/10.1021/nn400630x- http://www.nature.com/nnano/journal/v6/n10/full/nnano.2011.147.html- http://www.dana.org/news/features/detail_bw.aspx?id=35592- http://pubs.rsc.org/en/Content/ArticleLanding/2011/AN/C1AN15303J- http://onlinelibrary.wiley.com/doi/10.1002/smll.201001642/abstract- http://www.clinam.org/benefits.html

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The Future Of Nano Medicine

Originally Published in Asia Times in different format

by Stephen Bryen

Harvard scientist Charles Lieber was arrested last week and charged with one count of giving materially false, fictitious and fraudulent statements to the U.S. government and the FBI.

What marks the case as unusual is that a prestigious specialist at one of Americas top universities was criminally charged for what appears to be a less-than-candid response to questions about government contracts.Typically, paperwork problems would be dealt with administratively, as the US would be reluctant to lose the services of a distinguished scientist.Instead, Liebers case is lumped together with two China-related cases of spying and smuggling.

[Also charged were two Chinese citizens, one allegedly secretly a member of the Peoples Liberation Army (PLA), charged with visa fraud, making false statements, acting as a foreign agent in the United States, and with conspiracy; and a second person charged with smuggling biological material to China.]

Lieber is a specialist in nanotechnologies, a field that is getting billions of investment dollars from the United States government, including the Defense Department (DOD), and from the private sector.The U.S. sees itself in a tense competition with China in this field for both commercial and national security reasons.

This competition, and specificallythe potential military applications, are creating considerable anxiety in the U.S. military as China becomes more deeply involved in investment and the possible theft of Americanknow-howand technology. Criminal, rather than administrative, charges against Lieber suggest U.S. authorities were deeply alarmed by his activities in China and were aimed at ending his professional association with that country.

The specific specialty developed by Lieber and of possible strategic interest to DOD is mesh technology at nano-scale.A nano-scale mesh device offers considerable opportunitiesover rigid electrodes implanted in the human brain. Lieber, wrote one medical professional, has made a huge difference with ultra-flexible mesh electronics, which promise to deliver what he calls precision electronic medicine. These hardly activate an immune response, but remain very close to the cells they are intended to spy on.

Lieber is one of the top scientists involved withElon Muskin a rather secretive startup company calledNeuralink. Musk has invested $100 million of his own money and raised another $58 million for Neuralink, which now has a staff of 90.The company isexploring brain machine interfaces, using what Musk calls flexible threads thathave the potential of transferring a higher volume of data, according to a White Paper credited to Musk & Neuralink. The abstract notes that the system could include as many as 3,072 electrodes per array distributed across 96 threads.The threads are 4 to 6 m in width, which makes them considerably thinner than a human hair. In addition to developing the threads, Neuralinks other big advance is a machine that automatically embeds them.

There are many applications of this futuristic technology including improved medical therapies for brain-related disorders and bridging connections between man and machines.

Why would this be of interest to the U.S. military or to China?

Robotics, artificial intelligence (AI), and nanotechnology are at the forefront of weapons-building programs, with China the main current competitor to the U.S. LTG Robert P. Ashley, Director of the Defense Intelligence Agency (DIA) addressed the subject before the Association of the US Army. He focused directly on China, warning that China is mergingartificial intelligence with humans using nanotechnology as the connectivebridge.DIA, he said, sees this as a major concern for the future of warfare.

Using nanotechnology to link the brain to machines and sensors, and AI to arbitrate the linkage, has roots that go back decades and involve the use of drugs and psychological techniques to manipulate the human brain.Horrid experiments were carried out by Nazi Germany on concentration camp inmates. Japan did the same through its infamous chemical and biological weapons operation called Unit 731, which conducted experiments on prisoners.The Nazis and Japanese shared information on the results.

At the end of WWII, underOperation Paperclip, the CIA and Defense Department brought Nazi scientists back to the United States, including many who were engaged in using concentrationcamp inmates as subjects. One, BG (Generalarzt)Walter Paul Emil Schreiber served in the Nazi Wehrmachtand the SS, where hewas involved in assessing results of human testing at Dachau. Once in the U.S., he worked at theAir Force School of Medicine atRandolph Air Force BaseinTexas. When his background was exposed by news reporters, the US Air Force slipped him and his family out of the country on a military plane to Argentina, where there were many other former Nazis operating including the killer-doctor Josef Mengele.

Meanwhile, the CIA continued experimenting with humans, using both psychological techniques and psychotropic drugs for another twenty-two years (1953-1975) when brain research activity was apparently discontinued after Congressional hearings by the Church Committee (formally theSenate SelectCommitteeto Study Governmental Operations with Respect to Intelligence Activities).

Have the man-machine interface, nano-technology, robotics, and AI taken the place of earlier experimentation with drugs for mind control? It is impossible to say, but it is clear the U.S. believes China is in pursuit of this technology for military use. Charles Liebers work with the Chinese, and his alleged failure to fully disclose the fact, certainly triggered the Defense Department and intelligence communitys concerns and more than likely they pushed the FBI and the Department of Justice to bring about Liebers indictment, using what appear to be numerous email and communications intercepts to build their case, many of which are in the unsealed indictment.

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Is the Lieber Arrest Linked to Military Brain Research and China? - Bryen's Blog

When biotech or pharmaceutical companies win approvals from the United States Food and Drug Administration, the stock prices almost always go up, and that is what happened with VVUS stock this morning. VVUS is normally a thinly traded nano-cap stock, but this morning, the stock soared after it emerged that the FDA has granted the approval of VIVUS, Incs (NASDAQ:VVUS) new product.

The product in question is a new formulation of Pancreaze (pancrelipase), and there is a 36-month shelf life for it across the range of different dosages.

The approval granted by the FDA is actually a supplemental New Drug Application (sNDA), which is granted to products that are an improvement on an existing formulation. VIVUS got the sNDA approval for its improved formulation of Pancreaze (pancrelipase). The company collaborated with its manufacturing partner Nordmark Arzneimittel GmbH & Co. KG on this project.

>> Penny Stocks to Watch: Trillium Therapeutics and Callon Petroleum

This is a hugely significant development for the company, and the reaction from the market is not a surprise at all. VVUS stock soared by as much as 70% to $3.89 in morning trade as investors piled onto the stock, and it is likely that VVUS is going to be in sharp focus for the rest of the trading session.

The medicine in question is meant for treating exocrine pancreatic insufficiency (EPI) that is brought about by cystic fibrosis or other conditions. The Chief Executive Officer of the company, John Amos, stated that approval is an important milestone for the company and also for patients who suffer from EPI. He went on to state, It highlights our ability to derive additional value from our marketed products and allows patients to store PANCREAZE for longer periods of time, which may help to reduce their out-of-pocket expenses.

The developments today have been a landmark for VIVUS, and market watchers will, no doubt, be following VVUS stock closely over the coming weeks.

>> Read More Biotech News

Featured image: DepositPhotos VitalikRadko

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VVUS Stock Jumps 70% on FDA Nod for New Formulation of Pancreaze - MicroSmallCap

Yaser H Gholami, 1 4 Lee Josephson, 3 Eman A Akam, 5 Peter Caravan, 5 Moses Q Wilks, 3 Xiang-Zuo Pan, 3, 6 Richard Maschmeyer, 1 Aleksandra Kolnick, 3, 7 Georges El Fakhri, 3 Marc D Normandin, 3 Zdenka Kuncic, 1, 4, 8Hushan Yuan 3

1The University of Sydney, Faculty of Science, School of Physics, Sydney, NSW, Australia; 2Bill Walsh Translational Cancer Research Laboratory, The Kolling Institute, Northern Sydney Local Health District, Sydney, Australia; 3Gordon Center for Medical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; 4Sydney Vital Translational Cancer Research Centre, St Leonards, NSW, Australia; 5The Institute for Innovation in Imaging and the A. A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States; 6Bouve College of Health Sciences, CaNCURE Program, Northeastern University, Boston, MA, USA; 7Internal Medicine Residency Program, Lahey Hospital and Medical Center, Burlington, MA, USA; 8The University of Sydney Nano Institute, Sydney, NSW, Australia

Correspondence: Hushan YuanGordon Center for Medical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 149 13 th Street, Charlestown, MA 02129, USATel +1 617-643-1963Email hyuan@mgh.harvard.edu

Purpose: Using our chelate-free, heat-induced radiolabeling (HIR) method, we show that a wide range of metals, including those with radioactive isotopologues used for diagnostic imaging and radionuclide therapy, bind to the Feraheme (FH) nanoparticle (NP), a drug approved for the treatment of iron anemia.Material and methods: FH NPs were heated (120C) with nonradioactive metals, the resulting metal-FH NPs were characterized by inductively coupled plasma mass spectrometry (ICP-MS), dynamic light scattering (DLS), and r 1 and r 2 relaxivities obtained by nuclear magnetic relaxation spectrometry (NMRS). In addition, the HIR method was performed with [ 90Y]Y 3+, [ 177Lu]Lu 3+, and [ 64Cu]Cu 2+, the latter with an HIR technique optimized for this isotope. Optimization included modifying reaction time, temperature, and vortex technique. Radiochemical yield (RCY) and purity (RCP) were measured using size exclusion chromatography (SEC) and thin-layer chromatography (TLC).Results: With ICP-MS, metals incorporated into FH at high efficiency were bismuth, indium, yttrium, lutetium, samarium, terbium and europium (> 75% @ 120 oC). Incorporation occurred with a small (less than 20%) but statistically significant increases in size and the r 2 relaxivity. An improved HIR technique (faster heating rate and improved vortexing) was developed specifically for copper and used with the HIR technique and [ 64Cu]Cu 2+. Using SEC and TLC analyses with [ 90Y]Y 3+, [ 177Lu]Lu 3+ and [ 64Cu]Cu 2+, RCYs were greater than 85% and RCPs were greater than 95% in all cases.Conclusion: The chelate-free HIR technique for binding metals to FH NPs has been extended to a range of metals with radioisotopes used in therapeutic and diagnostic applications. Cations with f-orbital electrons, more empty d-orbitals, larger radii, and higher positive charges achieved higher values of RCY and RCP in the HIR reaction. The ability to use a simple heating step to bind a wide range of metals to the FH NP, a widely available approved drug, may allow this NP to become a platform for obtaining radiolabeled nanoparticles in many settings.

Keywords: nanomedicine, radiolabeling, radionuclide therapy, HIR, Feraheme

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