OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced preliminary unaudited revenue for 2022. Preliminary revenue for full year 2022 was approximately $2.7 million, which falls within the most recent guidance range the Company had provided in its Q3 earnings call. The year-end cash position as of December 31, 2022 amounted to approximately $7.4 million. On January 11, 2023, the Company successfully closed a public offering of securities raising gross proceeds of $7.5 million and net proceeds of approximately $6.8 million after deduction of placement agent commission and transaction related expenses.
OpGen also provides the following updates on important aspects of its business and reported on the accomplishment of key milestones in Q4-2022 and early 2023:
Closed a $7.5 million public offering of approximately 2.6 million shares of common stock, or pre-funded warrants in lieu thereof, at $2.90 each, along with accompanying Series A-1 and Series A-2 warrants with an exercise price of $2.65 per share.
Implemented a 1 for 20 reverse stock split to regain compliance with Nasdaq’s minimum bid price rule in advance of the February 2023 deadline.
Achieved several key milestones and deliverables under the collaboration with the Foundation for Innovative New Diagnostics (FIND), which triggered a milestone payment in early 2023.
Following successful completion of patient sample enrollment into the Unyvero Urinary Tract Infection (UTI) clinical trial in the U.S., OpGen completed its initial analysis and published strong top-line data with an overall weighted average sensitivity of 96.4% and an overall weighted average specificity of 97.4%. The Company also initiated the full data analysis and began preparation of its FDA submission package which is expected to be submitted in the coming months. Furthermore, OpGen began next generation sequencing of over 1,000 bacterial isolates from its UTI clinical trial.
OpGen initiated a collaboration with Swiss-based BioVersys by training their internal team, as well as members of the clinical research organization (CRO) that will be supporting the BioVersys phase II clinical trial, on the Unyvero platform and use of the Unyvero HPN pneumonia panel.
Signed second Acuitas AMR Gene Panel customer contract and successfully installed first two Acuitas systems.
Progressed multiple potential commercial agreements and contracts for Acuitas as well as Unyvero LRT BAL and UTI in the U.S. and intend to obtain signatures subject to customer approval. First commercial purchase orders from new customer accounts were already received and processed in Q4-2022.
Launched ARESiss next generation sequencing service from OpGen’s Rockville, Maryland lab and successfully executed large pilot project on isolates from the UTI trial.
Ares added several new commercial customer accounts for ARES services globally.
IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today announced selected preliminary financial results for the fourth quarter that ended December 31, 2022. Fourth-quarter revenue is expected to be approximately $14.9 million, up 25% from the prior year and above the Company’s fourth-quarter guidance of $14.1 million - $14.8 million.
“We are very pleased to announce these fourth quarter 2022 preliminary results, which is our highest quarterly revenue ever and continues our string of six consecutive quarters of record revenues. Additionally, I’d like to add that orders booked in the fourth quarter exceeded shipments, again growing the backlog and providing added visibility as we enter 2023. For the full-year 2022, revenue grew 27.5% over last year. We continue to see growing demand for our products and expect this to carry on through 2023,” said Roger Susi, President and Chief Executive Officer of the Company.
Financial Guidance
For the full year 2023, the Company expects to report revenue of $61 million to $63 million, GAAP diluted earnings per share of $1.10 to $1.20, and non-GAAP diluted earnings per share of $1.23 to $1.34.
For the first quarter of 2023, the Company expects to report revenue of $14.6 million to $14.9 million, GAAP diluted earnings per share of $0.23 to $0.25, and non-GAAP diluted earnings per share of $0.26 to $0.28.
Organized criminal gangs active in the Netherlands and France, mostly made up of Moroccan migrants, are blowing up ATMs in Germany at a record pace in highly professional robbery operations. In 2022, government statistics indicate that they blew up 500 such machines, with statistically more than one machine being blown up every day.
Cash remains popular with Germans, and to feed this demand, banks operate nearly 100,000 ATMs located throughout the country, with the machines routinely containing between €50,000 and €100,000. Criminal gangs are taking advantage of this, and they are willing to use extreme methods to gain access to this money. These criminal networks are said to meticulously plan their operations out, including initial surveillance, demolition, and the getaway. Police also say they act with brutality and ruthlessness, putting human lives at risk.
In fact, these migrant gangs are blowing up banks with such powerful explosives, that they are destroying entire buildings. In some cases, they have blown bank vault doors up to 30 meters away, underlining how powerful these blasts can be. Police say the danger facing Germans is unprecedented, as many of these banks are located in residential buildings.
Record number of cases
Although the final number of such bank heists has not yet been released for 2022, according to police sources obtained by Welt Am Sonntag, there were 500 such attacks, reaching a record high. Germany’s interior ministry is now holding high-level meetings on the issue, but it appears the robbery crews show little sign of slowing down. In 2021, the Federal Criminal Police reported that there were 414 cases of attempted or successful demolitions, while 2020 saw similar numbers.
Authorities describe how the gangs are most active in the west of Germany, with the most populous state, North-Rhine Westphalia, along with Lower Saxony, the most popular targets. For one, these regions are the closest states to the Netherlands, where the gangs are most active — although some gangs also operate out of France, which is also nearby.
How do the gangs operate?
The gangs tend to target banks located close to major motorways in order to make a quick getaway, with most banks targeted in the early morning hours when the roads are mostly empty.
They usually work in teams with each member playing a specific role. In one case near the small town of Heusenstamm in Hesse, the gang doused garbage bins in gasoline and set them on fire in the middle of the road, effectively creating a roadblock for both lanes of traffic. This roadblock would later hinder the police from pursuing the getaway vehicle.
Another two men, wearing face masks and tracksuits, pried the door open of the Commerzbank. They were filmed breaking open the ATM’s cash slots and then using a hose to fill the machine with acetylene and oxygen, which serve as the two ingredients for their bomb. Another individual who then detonated the bomb was in a BMW 320d behind the bank.
The men worked “with the precision and speed of a racing team at a pit stop,” according to Welt.
However, that is just one incident. Such explosions are rocking Germany nearly every night, and often the damage is far worse than thousands of euros lost from the machines.
A report from Die Welt details how powerful explosions have badly damaged buildings and led to residents being evacuated from their homes. Videos of explosions in buildings, supermarkets, and other public spaces routinely run on German news the next morning.
In one court trial for a gang member police managed to arrest, a judge from Hesse described “war-like damage” in German inner cities during sentencing. Police investigators from the prosecutor’s office described the gang as conducting “explosive attacks in public spaces.”
As a result, the line between robbery and terrorism is beginning to blur in such cases.
“It’s a miracle that there haven’t been any deaths yet,” says Swen Eigenbrodt, the lead investigator of a special new unit in the Hessian State Criminal Police Office (LKA). The unit has been actively targeting the gangs who have participated in the ATM heists seen in the state.
Some perpetrators have been brought into custody, often through small but legally devastating mistakes. For example, some have left fingerprints at the scene, others have been caught by speed-trap cameras while trying to race away from the scene, and sometimes they are apprehended with their smartphones, which provide movement data. Nevertheless, an arrest at the scene of the crime is very rare, as the teams move so fast, and despite some arrests, there are enough teams active that the demolitions continue to rise.
Utrecht is a hotspot
The Dutch city of Utrecht is prosperous, but it also faces pockets of poverty and in some neighborhoods, up to 60 percent of the population has a migration background. Now, Dutch and German law enforcement are working together to stop these organized gangs, as many of them come from this city.
Dutch criminologist Cyrille Fijnaut, a professor emeritus, has been observing these ATM heist crews for 20 years and actively advises the Dutch government. He said that the network of criminals consists of about 200 to 400 young men and that “many of them have Moroccan roots.” He said they often follow in the footsteps of older boys in their neighborhoods, who sport expensive watches and sports cars.
A few years ago, one of the top gang bosses set up his own training center for ATM demolition crews. He simply rented out a factory building, ordered discarded ATMs online, and began training members in what served as a sort of school for gang members. However, these criminal networks are also active in cities such as Amsterdam and Alkmaar.
A famed Dutch defense lawyer, Vito Shukrula, also said that these types of heists are actually used as “seed” money to enter into the Dutch cocaine trade. He described it as “easy money” for these teams.
As Remix News has previously reported, the Moroccan Mafia earns billions in revenue every year from the drug trade in the Netherlands. The criminal group has assassinated not only rivals, but also state witnesses and even journalists. The group has become so feared that 18-year-old Dutch Princess Amalia went into hiding over credible kidnapping and assassination threats just months ago. Dutch Prime Minister Mark Rutte has also beefed up his security due to threats from the group.
BlackRock, the world's biggest asset manager, has faced increasing backlash about environmental, social, and governance (ESG) investing. A handful of US states have pulled billions of dollars from BlackRock funds over accusations of "greenwashing," hurting the fossil fuel industry and turbocharging America's "woke" culture.
On Tuesday, BlackRock's Larry Fink told Bloomberg TV at the World Economic Forum in Davos that ESG investing has been tarnished:
"Let's be clear, the narrative is ugly, the narrative is creating this huge polarization.
Fink continued:
"We are trying to address the misconceptions. It's hard because it's not business any more, they're doing it in a personal way. And for the first time in my professional career, attacks are now personal. They're trying to demonize the issues."
The Republican crusade, including states such as Florida, Louisiana, and Missouri, said they would pull funds out of BlackRock, citing that the asset manager's ESG efforts could impact investor returns.
In December, Florida made the most significant withdrawal, pulling $2 billion from BlackRock.
"Using our cash to fund BlackRock's social-engineering project isn't something Florida ever signed up for.
"It's got nothing to do with maximizing returns and is the opposite of what an asset manager is paid to do," Jimmy Patronis, Florida's chief financial officer, said in a recent statement.
Meanwhile, Texas Lt. Gov Dan Patrick has urged state officials to label BlackRock as a hostile entity for its action in the attempt to crush the oil and gas industry.
BlackRock is "capriciously discriminating'" against fossil fuel firms, Patrick said as he called for the asset manager to be added to the list of financial firms that "boycott" fossil fuels.
Several other states are pushing back on BlackRock.
Recall Tesla CEO Elon Musk called ESG a "scam" last year after the electric-vehicle maker was excluded from an S&P Global ESG index.
Musk followed up with a tweet earlier this week that said, "The S in ESG stands for Satanic."
However, in the interview, Fink said BlackRock took in $230 billion in 2022 from US clients, and the outflows were small, though he takes the issue "very seriously" and was trying to address the negative mood around ESG:
"We are doing everything we can to change the narrative."
While Fink tries to save the ESG narrative, a former BlackRock senior executive, Terrence R. Keeley, recently opined in a WSJ article that after "trillions of dollars have poured into environmental, social and governance funds in recent years ... there is astonishingly little evidence of its tangible benefit."
More than half of trans women who have 'bottom' surgery are in so much pain years later they need medical attention, a study suggests.
Up to a third of patients also struggled to use the toilet or suffered sexual issues 12 months after the operation, which sees patients transitioning from male to female given a surgically constructed vagina.
Researchers from the Women's College Hospital (WCH) in Ontario, Canada, analyzed the medical records of 80 patients who sought care from the clinic between three months and five years after having the operation.
Of the 80 trans women sampled in the Canadian study, almost 54% reported ongoing pain up to two years after their vaginoplasty surgery. Many had more than one symptom, which included vaginal dryness, numbness, malodor and issues with the wound's healing
Research in October indicated the number of patients going under the knife increased more than 150-fold between 2010 and 2018.
It is thought that the reduced stigma and heightened awareness around trans issues have contributed to the rise.
In the latest study, Canadian researchers looked at the medical records of patients who sought care between 2018 and 2020 at WCH's newly opened Postoperative Care Clinic.
All 80 patients had the original vaginoplasty procedure outside of the Women's College health system but were experiencing symptoms that needed follow-up care.
Some had traveled as far as India and Thailand to have the operations, which the researchers say may explain the relatively high number of medical complaints.
The most common symptoms reported by post-op patients were pain (53.5 percent), bleeding (42.5 percent) and dilation issues (46.3 percent).
Severe side effects were much rarer, but in 12 cases - or 15 percent - patients experienced vaginal stenosis, the narrowing and shortening of the vagina.
In two other cases, patients had severe infections around the surgical site, and another two were hospitalized with mental health problems.
Much more common were minor outcomes like difficulty urinating (22.5 percent), sexual problems (33.8 percent), and poorly healing wounds (21.3 percent).
A total of 15 patients (18.8 percent) also told the clinic they were dissatisfied with the appearance of their new vulva and wanted some cosmetic revision.
Most complaints of ongoing pain were treatable with topical medication or more regular check-ups.
Although classified as 'minor' in medical records, many of these symptoms had the potential to grow into much more serious difficulties had patients not sought treatment, the study emphasized.
For this reason, 'surgical centers should be providing ongoing post-operative care, especially in the first year after surgery,' researchers urged.
This is especially crucial given the rise in popularity of the procedure in recent years and its high cost, which can push those seeking the surgery to cheaper and less well-regulated surgeons overseas.
The above map shows the population of transgender adults and children across America in 2020, according to the Williams Institute at the University of California, Los Angeles. Its estimate for children aged 13 to 17 has doubled since 2017. It shows the highest population is in southern states, followed by those along the east coast
Bottom surgeries such as vaginoplasties and phalloplasties - genital reconstruction undergone by women transitioning to men - cost around $25,000.
'It is quite clear from the most up-to-date studies that vaginoplasty and other genital surgeries don’t work in the way that people hope they will,' says Stella O'Malley, psychotherapist and director of campaign group Genspect.
'The reason why there is so many problems is because this is an incredibly difficult surgery. Young vulnerable people need to know about the challenges they will face post surgery but few of them do.'
In recent years, an increasing number of de-transitioners - those who regret their decision to transition and later reverse it - have spoken out about medical side effects to the procedures that they were not previously made aware of.
One such detransitioner by the name of Shape Shifter claimed he regretted his mastectomy and vaginoplasty after they led to fistula and other painful consequences. He says he realized he was simply a gay man who liked showing his feminine side, and began to detransition.
A Massachusetts-based detransitioner who goes by the name Shape Shifter transitioned from male to female, but encountered appalling medical issues. He has since detransitioned, identifying as a gay man with a feminine look
In Canada, the first country to collect and publish data on gender diversity from a national census, 100,815 transgender individuals make up 0.33 percent of over-15s.
There are approximately 1.6 million transgender and non-binary adults living in the US, which makes up around 0.5 percent of the adult population.
Gender-affirmative care for US adults and adolescents can include a number of medical, behavioral and social changes, as well as surgery.
For adolescents who have not yet gone through puberty, puberty-blocking medication can suppress the release of the sex hormones testosterone and estrogen, which halts the development of secondary sex characteristics like breasts and facial hair.
Whether or not original puberty was blocked, trans adults and adolescents can also begin hormone therapy, which essentially initiates the puberty of their gender identity. These hormones can be taken as pills, patches and gels, and are taken continuously throughout adulthood, or until the desired physical traits are achieved.
Surgical options include facial, chest and genital altering procedures, and are generally the last step of the transition process.
According to the World Professional Association for Transgender Health, anyone seeking bottom surgery is recommended to have completed certain criteria such as: reaching the age of adulthood in their location; having persistent, diagnosed gender dysphoria; having the capacity to make an informed decision; and completing 12 continuous months of hormone therapy while living the congruent gender identity.
Vaginoplasty - the procedure undergone by patients in the new study - is a particularly invasive procedure, requiring a surgery during which the penis and testicles are removed and a functional vagina is created.
The most common form of vaginoplasty is a Penile Inversion, whereby skin removed from the penis is inverted to form a pouch and inserted into a cavity created between the urethra and rectum. The urethra is then partially removed, shortened, and repositioned.
The surgery tends to take between two to five hours, and is done under general anesthesia.
For female-to-male genital reconstruction, doctors can construct a penis by using a flap of skin, fat, nerves and arteries - usually taken from the arm or thigh - and grafting it on to the groin. In some cases, surgeons will lengthen the urethra to allow for urination from the tip of the penis, or add testicle implants and an erectile device.
Moderna chief executive Stephane Bancel said he would like to have factories making vaccines based on its messenger RNA technology on every continent as the U.S. company prepares to build four facilities.
"We're talking to a couple more countries because I would really like on every continent to have MRNA capacity," he said on a panel at the World Economic Forum annual meeting in Davos.
The company is building or planning to build factories in Canada, Australia, Britain and Kenya, he said.
Its COVID-19 vaccines are made in the United States and Switzerland.
Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said on Tuesday.
Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March.
"Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said.
Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says.
The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said.
Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.
Kyriakides said the EU is deploying all regulatory options and talking to companies to increase production and mitigate shortages.
She added that the Health Emergency Preparedness and Response Authority (HERA), the EU health crisis body established during the COVID-19 pandemic, could procure medicines and medical supplies on behalf of member states to address shortages
