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Wednesday, August 10, 2022

Catalyst Pharma results and update

 Achieved Record Q2 2022 FIRDAPSE® Net Product Revenues of $53.0 Million, a 57.7% YoY Increase

Cash and Short-Term Investments at June 30, 2022 were $220.8 Million, with No Funded Debt

Completed Acquisition of Ruzurgi® U.S. and Mexico Commercial Rights

Advanced Plans to Diversify Portfolio and Invest in Innovative Rare Disease Opportunities

Provides Guidance that Full-Year 2022 Adjusted EBITDA to be Between $100-105 Million

Listing New Orange Book Patent Potentially Extends FIRDAPSE Patent Protection to 2037

Company to Host a Conference Call and Webcast on August 10, 2022, at 8:30 AM EDT

2022 Financial Guidance: The Company continues to forecast that its full year 2022 total revenues will be in the range of between $195 million and $205 million, representing a 38% - 45% increase in total revenues compared to 2021, with cash operating expenses for the full year 2022 expected to be in the range of $65 million to $70 million and adjusted EBITDA (calculated in the same manner as non-GAAP net income) expected to be in the range of $100-105 million. Key guidance assumptions included in these forecasts reflect, among other risks, continued recovery in healthcare activity throughout 2022 as it relates to the current COVID-19 environment.

The Company will host a conference call and webcast on Wednesday, August 10, 2022, at 8:30 AM ET to discuss the financial results and provide a business update.

US/Canada Dial-in Number: (877) 407-8912
International Dial-in Number: (201) 689-8059

A webcast and accompanying materials will be accessible under the investor section on the Company's website at www.catalystpharma.com. A webcast replay will be available on the Catalyst website for 30 days following the date of the event.

https://finance.yahoo.com/news/catalyst-pharmaceuticals-delivers-strong-second-202500720.html

OraSure: Revenue of $80.2 Million Growing 39% Year-Over-Year

 InteliSwab® revenue of $43.1 million in Q2, up 95% sequentially with significant scaling in production

InteliSwab® gross margins improve sequentially by over 2,000 basis points

GAAP gross margin of 34.4%, a decrease of 200 basis points sequentially; non-GAAP gross margins improve 250 basis points sequentially to 40.1% despite headwinds

Q2 GAAP EPS of ($0.26) and non-GAAP EPS of ($0.00)

Company expects to generate positive cash flow in the 4Q22

Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET

Financial Guidance

The Company is guiding toward 3Q22 revenue of $90 to $95 million representing 67% to 76% growth relative to the third quarter of last year. The Company also anticipates continued improvements in gross margins, and improved cash flow from operations in the third quarter. As such, the Company is guiding to having positive cash flow from operations beginning in the fourth quarter of this fiscal year.

The Company will host a conference call and audio webcast for analysts and investors to discuss the Company’s second quarter 2022 results and certain business developments, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Carrie Eglinton Manner, President and Chief Executive Officer, Lisa Nibauer, President Diagnostics, Kathleen Weber, President Molecular Solutions, Ken McGrath, Chief Financial Officer, and Scott Gleason, SVP Investor Relations and Corporate Communications. The call will include prepared remarks by management and a question and answer session.

In order to listen to the conference call, please dial (866) 374-5140 and reference Conference ID #11565698 or go to OraSure Technologies’ web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. A replay of the call will be archived on OraSure Technologies’ web site shortly after the call has ended and will be available for 14 days. It is recommended to dial-in 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on OraSure’s Investor Relations page.

https://finance.yahoo.com/news/orasure-reports-2q22-record-revenue-200500821.html

Facebook gave teen’s private messages about alleged abortion to Nebraska police

Meta gave police access to private Facebook messages that allegedly detailed a Nebraska teen’s plans to get an illegal abortion, bolstering local authorities’ cases against the girl and her mother. 

Mark Zuckerberg’s social-networking giant — which has promised to cover travel costs for its own employees looking to access abortions following the Supreme Court’s decision to overturn Roe v. Wade — complied with a search warrant from Norfolk, Nebraska police in early June, according to court records obtained by The Post. 

The parent of Facebook and Instagram handed over the records just weeks before the high court’s ruling — and weeks before Zuckerberg reportedly told a company all-hands meeting that “protecting people’s privacy” was “extra salient” in the wake of the Supreme Court decision.

Meta — which has has also reportedly told its employees not to discuss abortion at work — gave police access to two accounts belonging to a 17-year-old named Celeste Burgess and her mother, 41-year-old Jessica Burgess, according to court documents. 

A police detective then found messages between the Burgesses allegedly confirming plans for Celeste to take pills to induce an abortion in April — around 23 weeks into her pregnancy. Nebraska’s legal cutoff for abortion is 20 weeks. Jessica Burgess were charged with felonies after Meta handed over private messages.

Jessica Burgess and her daughter were charged with felonies after Meta handed over private messages.
Mark Zuckerberg
Mark Zuckerberg said in June that “protecting people’s privacy” was “extra salient” after Roe v. Wade was overturned.
Getty Images for SXSW

“Are we starting it today,” Celeste asked in one of the messages, which were included in court filings. 

“We can if u want the one will stop the hormones,” Jessica responded. 

Later on, Celeste allegedly wrote, “Remember we burn the evidence.” 

“Yep,” Jessica responded. 

Celeste Burgess, who is now 18, has been charged with removing/concealing/abandoning a dead human body, concealing the death of another person and false reporting.

Her mother has been charged with performing or attempting an abortion greater than 20 weeks, performing an abortion when not a licensed doctor, removing/concealing/abandoning a dead human body, concealing the death of another person and false reporting. 

Meta
Meta turned over private Facebook messages about the alleged abortion that were then cited in court documents.

Police documents show Meta turned over the Burgesses’ messages on June 9 — about two weeks before the Supreme Court overturned Roe v. Wade on June 24. 

A Meta spokesperson defended the decision to hand over the private conversations.

“Nothing in the valid warrants we received from local law enforcement in early June, prior to the Supreme Court decision, mentioned abortion,” said Meta spokesperson Andy Stone.

“The warrants concerned charges related to a criminal investigation and court documents indicate that police at the time were investigating the case of a stillborn baby who was burned and buried, not a decision to have an abortion,” he added in a series of Twitter posts.

At a Meta all-hands meeting on June 30, Zuckerberg addressed an employee question about steps the company is taking to protect users who are seeking abortions, CyberScoop reported

“Protecting people’s privacy is always important, I get that this is extra salient right now [with] the Supreme Court decision and that specifically bearing on privacy,” Zuckerberg reportedly said. “But it just has always been a thing that we care about.”

Zuckerberg added that encrypting users’ messages “is actually one of the ways that you keep people safe from bad behavior or, or over-broad requests for information or things like that.”

Norfolk, Nebraska police
Norfolk, Nebraska police delivered a search warrant for the mother and daughters’ Facebook messages.

Yet antitrust watchdogs say Meta handing over the Burgesses’ messages shows the company doesn’t care about protecting abortion rights. 

“These tech giants have accumulated an unfathomable amount of sensitive data on each and every one of us,” Jesse Lehrich, co-founder of Accountable Tech, told The Post. “They are going to dutifully comply with subpoena requests like this in a post-Roe world.”

“It turns their ubiquitous products into weapons that will be wielded against their own users,” Lehrich added.

Meta has also caught flak from abortion advocates for removing posts about abortion pills from Facebook and Instagram directed toward women who may not be able to access them following the Supreme Court’s decision, Vice reported in June.

Both advertisers and regular users offering to mail pills to users in states where abortion is illegal have had their posts removed for violating the sites’ community standards, according to the outlet. 

Stone said in response to the Vice story that the company will not allow individuals to gift or sell pharmaceuticals on its platform, but will allow content that shares information on how to access pills.

The Nebraska abortion case was first reported by the Lincoln Journal Star.

https://nypost.com/2022/08/09/facebook-gave-teens-private-messages-about-alleged-abortion-to-police/

Tuesday, August 9, 2022

Study identifies potential targets for treating venous ulcers

 New insights into the role that small molecules called microRNAs play in human skin wound healing have been published today in eLife.

The study, which includes the first resource detailing the role of microRNAs in the wound-repair process, shows that aberrant levels of a trio of microRNAs may impair  in venous ulcers. The findings suggest that drugs targeting these microRNAs could help facilitate healing in patients.

Venous ulcers commonly occur in the legs, caused by poor blood flow. These painful and slow-to-heal lesions can significantly impair an individual's mobility and quality of life. Previous research in animals has shown that persistent inflammation and insufficient cell growth and migration may contribute to the poor healing of these wounds, but few studies have looked at the role of gene regulation in these processes in humans.

"MicroRNAs regulate hundreds of genes and play a crucial role in skin wound repair," says co-first author Zhuang Liu, a postdoctoral researcher at the Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden. "But a limited amount of information about how microRNAs regulate  in human wounds has hampered the identification of microRNAs that could be useful therapeutic targets."

To fill this gap, the team collected 20 wound tissue samples from healthy volunteers with healing wounds on their legs and patients with venous ulcers. The samples were taken at three different time points to track the . The team then used RNA sequencing to compare the expression of microRNAs and other molecules, called messenger RNAs, in healing and non-healing wounds at these time points.

They discovered that 22 microRNAs and 221 messenger RNAs were expressed at higher levels in venous ulcers than in healing wounds, while 10 microRNAs and 203 messenger RNAs were expressed at lower levels. They also found that 17 microRNAs with elevated or abnormally low levels in patients with venous ulcers target genes involved in the condition.

Next, the researchers conducted a series of experiments on human skin cells, called keratinocytes, collected from another set of healthy volunteers and patients with venous ulcers. These experiments confirmed the abnormal expression of several of these microRNAs and their gene targets in wound healing.

Finally, they demonstrated that the elevated expression of three microRNAs in particular—microRNA-34a, microRNA-424 and microRNA-516—increased the , as well as slowed the growth of new cells and the migration of cells needed to help close a wound.

"Our work opens the door to developing new treatments for venous ulcers that reduce the levels of this microRNA trio to help restore normal wound healing in patients," says co-first author Letian Zhang, a Ph.D. student at the Center for Molecular Medicine, Karolinska Institutet. "MicroRNA-targeting therapies could be more effective and have fewer side effects in patients than some existing therapies for venous ulcers."

Documenting the microRNAs at different time points in the healing process is particularly important, adds co-senior author Pehr Sommar, a senior physician at the Department of Plastic and Reconstructive Surgery, Karolinska University Hospital, Stockholm, Sweden. "Elevated microRNA expression might promote healing at one point in the process and hinder it at another, so timing will be essential for potential microRNA-targeting therapies," he says. "But we first need more studies looking at microRNAs in individual skin cells to validate our findings before we can test the effectiveness of this approach in patients."

As part of their study, the team created a compendium of their findings and made it available online to help other researchers who study the wound-healing process. "We hope this resource will help scientists learn more about how microRNAs regulate tissue repair, as well as accelerate studies of potential microRNA-targeting wound treatments," concludes co-senior author Ning Xu Landén, associate professor in experimental dermatology at the Department of Medicine Solna, Karolinska Institutet.


Explore further

Targeting a protein to combat slow wound healing

More information: Zhuang Liu et al, Integrative small and long RNA omics analysis of human healing and nonhealing wounds discovers cooperating microRNAs as therapeutic targets, eLife (2022). DOI: 10.7554/eLife.80322
https://medicalxpress.com/news/2022-08-potential-venous-ulcers.html

New test may predict COVID-19 immunity

 Most people in the United States have some degree of immune protection against Covid-19, either from vaccination, infection, or a combination of the two. But, just how much protection does any individual person have?

MIT researchers have now developed an easy-to-use test that may be able to answer that question. Their test, which uses the same type of “lateral flow” technology as most rapid antigen tests for Covid-19, measures the level of neutralizing antibodies that target the SARS-CoV-2 virus in a blood sample.

Easy access to this kind of test could help people determine what kind of precautions they should take against Covid infection, such as getting an additional booster shot, the researchers say. They have filed for a patent on the technology and are now hoping to partner with a diagnostic company that could manufacture the devices and seek FDA approval.

“Among the general population, many people probably want to know how well protected they are,” says Hojun Li, the Charles W. and Jennifer C. Johnson Clinical Investigator at MIT’s Koch Institute for Integrative Cancer Research. “But I think where this test might make the biggest difference is for anybody who is receiving chemotherapy, anybody who’s on immunosuppressive drugs for rheumatologic disorders or autoimmune diseases, and for anybody who’s elderly or doesn't mount good immune responses in general. These are all people who might need to be boosted sooner or receive more doses to achieve adequate protection.”

The test is designed so that different viral spike proteins can be swapped in, allowing it to be modified to detect immunity against any existing or future variant of SARS-CoV-2, the researchers say.

Li, who is also an attending physician at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, is the senior author of the study, which appears online today in Cell Reports Methods. Guinevere Connelly, a former Koch Institute research technician who is now a graduate student at Duke University, and Orville Kirkland, a research support associate at the Koch Institute, are the lead authors of the paper.

A simple test

Li, who joined the Koch Institute in the fall of 2019, studies blood cell development and how blood cells become cancerous. When SARS-CoV-2 emerged, he started thinking about ways to help combat the pandemic. Many other researchers were already working on diagnostic tests for infection, so he turned his attention to developing a test that would reveal how much immune protection someone has against Covid-19.

Currently, the gold standard approach to measuring immunity involves mixing a blood sample with live virus and measuring how many cells in the sample are killed by the virus. That procedure is too hazardous to perform in most labs, so the more commonly used approaches involve noninfectious modified “pseudoviral” particles, or they are based on a test called ELISA (enzyme-linked immunosorbent assay), which can detect antibodies that neutralize a fragment of a viral protein.

However, these approaches still require trained personnel working in a lab with specialized equipment, so they aren’t practical for use in a doctor’s office to get immediate results. Li wanted to come up with something that could be easily used by a health care provider or even by people at home. He drew inspiration from at-home pregnancy tests, which are based on a type of test called a lateral flow assay.

Lateral flow assays generally consist of paper strips embedded with test lines that bind to a particular target molecule if it is present in a sample. This technology is also the basis of most at-home rapid tests for Covid-19.

Li did not have experience working with this type of test, so he reached out to two MIT faculty members with expertise in devising diagnostics based on lateral flow assays: Hadley Sikes, an associate professor of chemical engineering, and Sangeeta Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and of Electrical Engineering and Computer Science, and a member of the Koch Institute.

With their help, his lab developed a device that can detect the presence of antibodies that block the SARS-CoV-2 receptor binding domain (RBD) from binding to ACE2, the human receptor that the virus uses to infect cells.

The first step in the test is to mix human blood samples with viral RBD protein that has been labeled with tiny gold particles that can be visualized when bound to a paper strip. After allowing time for antibodies in the sample to interact with the viral protein, a few drops of the sample are placed on a test strip embedded with two test lines.

One of these lines attracts free viral RBD proteins, while the other attracts any RBD that has been captured by neutralizing antibodies. A strong signal from the second line indicates a high level of neutralizing antibodies in the sample. There is also a control line that detects free gold particles, confirming that the solution flowed across the entire strip.

To develop the reagents needed for the test, members of Li’s lab worked with the labs of Angela Koehler, an associate professor of biological engineering, and Michael Yaffe, a David H. Koch Professor in Science, who are both members of the Koch Institute.

Predicting immunity

Along with a testing cartridge, which contains the paper test strip, the testing kit also includes a finger prick lancet that can be used to obtain a small blood sample, less than 10 microliters. This sample is then mixed with the reagents needed for the test. After about 10 minutes, the sample is exposed to the test cartridge, and the results are revealed in 10 minutes.

The output can be read two different ways: One, by simply looking at the lines, which indicate whether neutralizing antibodies are present or not. Or, the device can be used to obtain a more precise measurement of antibody levels, using a smartphone app that can measure the intensity of each line and calculate the ratio of neutralized RBD protein to infectious RBD protein. When this ratio is low, it might suggest that another booster shot is needed, or that the individual should take extra precautions to prevent infection.

The researchers tested their device with blood samples collected in December 2020 from about 60 people who had been infected with SARS-CoV-2 and 30 people who had not. They were able to detect neutralizing antibodies in the samples from people previously infected to the virus, with accuracy similar to that of existing laboratory tests. They also tested 30 serial samples from two people before they received an mRNA Covid-19 vaccine and at several time points after vaccination. The level of neutralizing antibodies in the vaccinated individuals peaked around seven weeks after the first dose, then began to slowly decline.

Previous studies of SARS-CoV-2 and other viruses have shown a strong correlation between the amount of neutralizing antibody circulating in an individual’s bloodstream and their likelihood of infection.

The test could be easily adapted to different variants of SARS-CoV-2 by swapping in a reagent that is specific to the RBD from the variant of interest, Li says. The researchers now hope to partner with a diagnostics company that could manufacture large quantities of the tests and obtain FDA approval for their use.

###

The research was funded by the Koch Institute Support (core) Grant from the National Cancer Institute, an American Society of Hematology Scholar Award, the National Institutes of Health, and the Charles and Marjorie Holloway Foundation.

 

Patients Who Engage in Risky 'Chemsex'

 When it comes to chemsex, the findings of various international studies all agree: 20% to 30% of men who have sex with men (MSM) engage in this practice, which is becoming more and more prevalent. Chemsex combines sex, drugs, and smartphones, and physicians know very little about it. Dedicated consultations were instituted in the fall of 2019 at the Infectious Diseases Department at the Saint-Louis Hospital in Paris. It's estimated that 1000 persons who were patients there practice chemsex.

Alexandre Aslan, MD, is one of the department's physicians; he is also a sexologist and psychotherapist-psychoanalyst. At the ALBATROS International Congress of Addiction, which took place in the French capital in June, he presented the results of a study of patients who engage in chemsex and who regularly attend those consultations. Through this research, light is being shed on the phenomenon.

Medscape French Edition invited Aslan to discuss the issues connected with this practice.

Medscape: What exactly is chemsex, also known as party 'n' play (PnP)?

Aslan: Hearing the word "chemsex," one would automatically think that it is what it sounds like it is: having sex while on drugs. That's not really what it is. According to the definition that's been published in the scientific literature, chemsex is a practice seen among men who have sex with men (MSM), where they take some very specific substances during sexual activity to sustain, enhance, or intensify the sexual experience, but also to "manage" issues related to intimacy, performance, and concerns about sexually transmitted infections (STIs). The substances are most commonly a cocktail of three drugs: GHB [gamma-hydroxybutyrate], cathinones, and crystal meth. In chemsex, smartphones play a central role as well, through the use of social networking and dating applications — those location-based apps that allow users to instantly find partners.

Medscape: In what ways does meeting through apps influence the sexual relationship and the use of substances?

Aslan: Because the plan to meet up for sex is being made through these kinds of apps, the promise to have sex is often implied — and this is before the individuals even meet up in real life. Let me explain. It's not an encounter or a person that's going to trigger sexual desire. Instead, it's something within — the sexual "urge" inside of the individual — that's going to drive them toward sexual activity. Now, finding yourself promising to have sex with someone — someone you don't know, haven't spoken to, and haven't actually met — in an environment where it's possible that you'll meet several people and where the moments in which the sexual acts take place are predominantly characterized by pornography-related performance scripts: this can push you to take substances so you can "let go" and get to the point where you're able to adapt to the requirements of the situation. Seeking to perform well and to not be overly inhibited, these individuals have found that this drug cocktail proves to be quite explosive, imparting a very strong capacity for experiencing excitement and even bringing about new sexual practices.

Medscape: Can you speak a bit about drug-enhanced sex?

Aslan: We sexologists consider it to be a very particular type of sex. People who engage in it feel that the sex is very intense, with unbelievable experiences, and that they have a deeper connection with their partner. In fact, it's a type of sex where taking these substances does away with the very principles of sexual physiology — in other words, desire followed by excitement, plateau, orgasm, and resolution. Little by little, one's sexual partner is no longer going to exist in the sex session, and the benefit is a succession of partners whose sole purpose is to keep the fire of excitement burning, an excitement that's also reinforced by the substances taken. It's "sex" under the influence rather than a sexual encounter linked to desire.

Medscape: What impact does it have on health?

Aslan: This practice brings with it numerous complications, such as STIs, but also physical injuries, as these sessions can last for 24 to more than 48 hours. There are also psychological complications, because these drugs can bring about depression, paranoia, self-harm, and even episodes of decompensation. And then, it should be noted that later on, the spotlight gets pulled away from the sex — the pretext from the very beginning — and shifts toward the taking of drugs: the individuals will no longer be able to separate the sexual encounter from the taking of drugs. Then, in a few years, there's no longer the sexual encounter, only the taking of drugs. In the United States, between 2021 and 2022, there was a decrease in the number of deaths caused by heroin and prescription opioids. On the other hand, since 2020, the overdoses that have exploded in number are those related to fentanyl, nonprescription opioids, and stimulants — cocaine and methamphetamine, which can come back into the practices particularly through the seemingly "playful" arena of sex.

Medscape: How is it that things have gone from being a practice that's under control to full-on drug addiction?

Aslan: You still have people who manage to keep things under control. But the kinds of drugs that are taken are highly addictive and compel the individual to take even more. It's one big circle: the exciting sexual relationship itself, to which you add substances that cause even more dopamine to be released, and a smartphone screen with excitatory pornographic images on it all the time. In all the patients we see, we notice a trajectory that looks like the trajectory of every drug. When they're at the beginning — in other words, the first year — after a first experience that they consider to be explosive, they may not return to the scene right away, and then they do return to it. They realize that it's perhaps not as marvelous as the first time, but they're going to give it another try. During this novelty phase, a strategy is pursued whereby they adapt and make adjustments in an attempt to feel again what they felt the first time. At the end of a year or two, they become disillusioned and they refocus on all activities having to do with drug use. Our hospital department conducted a survey where we asked detailed questions to over 100 individuals. It showed that people noticed the negative consequences that chemsex had on their work (60%), on their private lives and sex lives (55%), and on their relationships with friends and family (63%). This means that people are well aware of the negative effects that this practice has in very important areas of their lives. But even if they notice all of that, even if they resolve to have a certain number of sexual relations without drugs involved, these substances are so powerful in releasing a rush of dopamine that that very fact can sweep away any capacity the individual may have had to make a decision and stick to it, and they're going to feel practically "compelled" to use. This is what's called a craving.

Medscape: How do you identify patients who engage in chemsex among the patients in your infectious diseases department?

Aslan: As a rule, all patients admitted to our department are asked a series of questions. Do you use drugs to engage in sexual relations? Which drug do you prefer? How do you take it? Do you have a good time? Do you find that it's good for you? Are you okay with how much you're using? We also ask patients to tell us when they last had drug-free sex. It's a very important question, because if we can identify someone who has had 10 or so partners a month but hasn't had drug-free sex for over a month, we'll try to steer the conversation to where they'll come to think that it might not be such a bad idea to talk about it.

Medscape: Should a physician be asking younger patients whether they're engaging in chemsex?

Aslan: Yes, but the physician has to be very careful. We often have a tendency to believe that we're capable of speaking with our patients about relevant matters related to sex. We see ourselves as that kind of person, not to mention we're open-minded. Now, as in all fields of medicine, we have to educate ourselves about how best to approach patients — in this case, about their sexual health. Because sometimes, despite our best intentions, we can do harm. The idea that we have of our own sexual behavior does not necessarily help provide counsel regarding another person's sexual behavior, particularly when there are differences between the two. If you're interested in the issue, you need to be trained on all the answers that could come up. There are training courses online. There's a module on sexual health and chemsex at a site designed to give private practice physicians guidance about PrEP. It's at least a place to start. This way, physicians will know what questions they can ask and when they should reach out to a specialist, such as a sexologist with training in these specific issues.

Medscape: What is the treatment based on?

Aslan: The traditional approach taken by addiction medicine physicians may not be comprehensive enough. Likewise, a sexologist's approach alone can only go so far. It's impossible to get by thinking that a single discipline can hold the solution, all the answers. So, it's a multidisciplinary sexual health treatment. There should be a psychiatrist or addiction medicine physician who knows the drugs and is capable of navigating through this landscape of psychiatric comorbidities (such as psychoses and ADHD).

There also has to be a sexologist for the treatment of any sexual dysfunctions there may be. At Saint-Louis Hospital, 60% of patients who engage in chemsex said that engaging in the practice was related to a sexual problem that they noted — but never went to see a doctor about — before the first time they used. Be that as it may, it's still the case that if these patients had been able to see a sexologist — who would have treated the problem — the drug may perhaps not have taken hold.

There also has to be a practitioner who can focus on risk reduction. In other words, someone capable of helping the patient get to the desired level of use where the craving, the need for instant gratification, can be kept in check.

In practice, one can sometimes, in addition to all of that, turn to medical treatments to manage the craving or medical comorbidities, an approach based on sexology to provide care for the sexual dysfunction or even to help the person learn how to evoke sexual or erotic fantasies without drugs, and an approach based on addiction medicine or psychotherapy, as some of our patients experienced sexual abuse in childhood. In the end, chemsex is just the outer layer — a problem that only seems to pertain to sex but that, in reality, covers up a wide range of issues. And not only sexual issues or issues that are related to drugs like chemsex is.

Medscape: What are the outcomes of this multidisciplinary treatment?

Aslan: Before we finish, I must point out and just state that the patients, when they're cared for and when they're provided with the appropriate treatment, change their practices. Some of our patients, even those with more advanced cases in terms of frequency, how often they're injecting drugs — every 30 minutes over the course of 24 or 48 hours, with complications such as thrombosis, sepsis, and abscesses — they've completely stopped after several months of treatment. They now lead lives that, as they've told us, work better for them. So, those of us in the healthcare industry, we have to get organized and set things up in a way that will allow us to focus our efforts on treating these patients.

https://www.medscape.com/viewarticle/978929

ClearPoint Says FDA Clears Maestro Brain Model

 Shares of ClearPoint Neuro Inc. were higher after hours Tuesday, following news the U.S. Food and Drug Administration gave 510(k) clearance for ClearPoint Maestro Brain Model.

"Maestro is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. This software is intended to automate the process of identifying, labelling, and quantifying the volume and shape of brain structures visible in MRI images," the company said.

At 5:06 p.m. ET, shares were trading 6.75% higher at $15.50. The stock finished the day's regular session with a 2.88% loss, closing at $14.52.

After the bell Tuesday, the company reported a second- quarter loss per share of 18 cents on revenue of $5.2 million. In the year-ago period, the company reported a loss of 17 cents per share on revenue of $3.41 million.

ClearPoint also reaffirmed its 2022 revenue guidance of $21 million to $22 million.

https://www.marketscreener.com/quote/stock/CLEARPOINT-NEURO-INC-30444363/news/ClearPoint-Says-FDA-Clears-Maestro-Brain-Model-Shares-Rise-6-41258313/