Gates-backed Vicarious Surgical targets Intuitive, J&J, Medtronic in abdominal robotic surgery

 With financial backing from Bill Gates and Becton Dickinson, among others, robotics startup Vicarious Surgical has garnered attention from Wall Street as it looks to take on bigger, established players in the abdominal robotic surgery market.

Vicarious in April announced it has merged with a special purpose acquisition company, giving it a New York Stock Exchange listing and $425 million from investors. The funding will support development of an FDA breakthrough-designated robotic device meant to improve current approaches to abdominal surgical procedures by, among other features, enabling surgeons to access all of the cavity through a single 1.5 cm incision with 9 degrees of freedom per arm and 360-degree visualization.

CEO Adam Sachs, who co-founded the company seven years ago, told MedTech Dive he wants to improve both the cost and efficiency of abdominal procedures as well as patient outcomes. 

Sachs contends legacy robotic platforms were introduced with a promise of solving the challenges of open surgery. However, after more than two decades on the market, the CEO contends these surgical robots have fallen short due to prohibitive costs of adoption, limited mobility and capabilities in the body and required space, as well as set up time and lengthy training. 

Vicarious is aiming to make a 510(k) submission in 2023 and grow sales to $1 billion by 2027 but will face strong competition from medtech giants such as Intuitive Surgical, Johnson & Johnson and Medtronic.

This interview has been lightly edited for clarity and brevity.

MEDTECH DIVE: What are the current challenges with abdominal surgical procedures? 

ADAM SACHS: You have open procedures, which for abdominal procedures has a 20% incision complication rate. You have laparoscopic procedures, which are incredibly difficult to perform really because of the motion and the way that the system pivots about the abdominal wall. And, that's still true for legacy multi-port surgical robots, where the surgeon essentially needs to define the motion profile of the robot for every procedure. That's why we see such disparity between people who perform a thousand procedures with a legacy surgical robot and a hundred procedures, which is a huge barrier to entry.

You also have single-port surgical robots. The existing ones have all been designed around flexible robotics, which have incredible limitations. Existing single-port systems are 25 cm or greater resulting in complication rates from incision of at least about 8%. And, they're incredibly limiting in their motion degrees of freedom and force capabilities. All of this has left [surgeons] doing over 50% open surgery and only about 3% robotic surgery.

How is Vicarious Surgical looking to improve abdominal robotic surgery?

SACHS: We've completely reinvented the way actuators themselves work. It's something that we call a decoupled actuator. What that allows us to do is essentially to have many more joints in motion all inside of the abdomen with incredible force capabilities and all through a 1.5 cm incision. So, we have two arms and a camera. The arms have the same joints as the surgeon's body. The camera pans and tilts following the motion of the surgeon's head.                    

How do you hope to differentiate your company from competitors and capture market share from behemoths like Intuitive, J&J and Medtronic? 

SACHS: We really believe that the fundamental architecture of multi-port surgical robots is what's limited their adoption. When you think about the way that motion works, you have a "wrist on the end of stick" with a legacy system and then most of the motion is essentially generated by the surgeon by pivoting, inserting in and out, and turning within the trocar. That means the surgeon literally defines that kinematic profile of the robot so that it is a different surgical robot for every procedure, depending on where the surgeon makes the incision. From extensive market research, we know that's the thing that leads to it being so challenging for surgeons to perform and learn robotic procedures resulting in procedural times that are much longer and frankly outcomes that are pretty similar. 

With our technology, the surgeon can learn what we're doing easily. You just put one incision anywhere in the abdomen and then the robot just works the same way that it's worked every time they've practiced, regardless of where they want to operate. We've proven out our ability to do advanced abdominal wall reconstruction in a fraction of the amount of time and have actually been able to fit multiple additional procedures per day in time testing that we've done.                

A recent meta-analysis comparing robot-assisted abdominal pelvic surgery with laparoscopy, open surgery, or both, found that robotic platforms are costly and result in longer operative duration than laparoscopy, but with no obvious difference versus open surgery in terms of the quality of evidence and outcomes. How does Vicarious hope to address the cost issue?

SACHS: All of these are limitations of the existing robotic procedures. That's why we're focused on procedures that have extremely low laparoscopic adoption and are performed with mostly open technique today, where the benefit is pretty obvious. It's all about what you compare it to. [Intuitive's] main technology is like many other legacy systems ... a multi-port system that essentially has these "wrists on a stick."

We targeted a huge reduction in cost of goods. Our cost is 5x to 10x lower and that's literally comparing our cost today in low volume to their cost in production. That really comes from the fact that ours is a much smaller, much simpler device that is less complex than four gigantic robotic arms. 

We'll be rolling out a variety of procedures over the course of a few years. We're starting with hernia repairs, then moving to gynecology, biliary procedures. We will be targeting most abdominal procedures, focused primarily and initially on the markets where legacy surgical robots have had very little penetration and where open surgery is actually the dominant way of performing procedures. 

It's a huge market and it's mostly performed with open techniques today or laparoscopy. Only 3% of addressable abdominal procedures are performed with robotic techniques worldwide. We have some pretty amazing cost of goods advantages that enable significant price advantages. When we initially launch, our average selling price will be $1.2 million including discounts.   

https://www.medtechdive.com/news/bill-gates-backed-vicarious-surgical-targets-intuitive-jj-medtronic/606122/

'Despite evidence delta variant reduces effectiveness, covid shots keep people out of hospital'

 Research published Friday by the Centers for Disease Control and Prevention shows that unvaccinated people are significantly more likely to not only become infected with Covid-19, but also die from the virus.

Two other reports from the agency, also published Friday, found the vaccines have largely retained their ability to keep infected patients out of the hospital, even amid the highly contagious delta variant.

One study found that when the delta variant became dominant in the summer, unvaccinated people were 4.5 times more likely to become infected, more than 10 times more likely to be hospitalized, and 11 times more likely to die of Covid.

That CDC research, based on data collected by the agency's hospitalization surveillance network, examined more than 600,000 Covid cases reported across the country from April to July, particularly as the delta variant quickly took hold.

Dr. Fauci on the effectiveness of a vaccine booster

AUG. 18, 202102:20

A second study, on vaccine effectiveness, looked at more than 1,000 Covid hospitalizations. Some of those infections occurred earlier in April, when the alpha variant of the virus was circulating widely. Others occurred from July through August, when the delta variant dominated.

The shots remained highly effective — more than 90 percent — against hospitalization among those under age 65. That protection appeared to wane a bit, however, for those ages 65 and older, where it fell to just under 80 percent.

"These vaccines still remain extremely effective at preventing what we are most concerned about: severe infection, hospitalization and death," said Dr. Richard Besser, president of the Robert Wood Johnson Foundation and former acting CDC director.

The third study had similar findings, showing that, in general, the vaccines' effectiveness for keeping Covid patients out of the hospital was 86 percent. That effectiveness was lower, however, among adults over age 75, at 76 percent.

Besser said he was not surprised by this finding; it is not unexpected to see a decline in vaccine effectiveness in the elderly, as the immune system tends to weaken as people age.

That third assessment was based on studies of about 32,000 people who were hospitalized or had visited urgent care clinics for any reason in the summer.

When researchers looked specifically at which vaccine people had received, effectiveness against hospitalization was highest among those who had the Moderna shots, at 95 percent, followed by the shots from Pfizer-BioNTech, at 80 percent, and the Johnson & Johnson shot at 60 percent.

The research is likely to be scrutinized next Friday when advisers to the Food and Drug Administration are scheduled to meet to discuss the safety and effectiveness of a third dose.

The Biden administration said in August it intended to offer these booster doses to all eligible Americans starting Sept. 20. Boosters would be available to people eight months after they had received their second dose.

The effort would likely mirror the original vaccine rollout, with health care workers, nursing home residents and people over age 65 first in line.

The CDC will also need to sign off on the plan before recommending those extra doses.

Federal health officials, as well as most major medical groups, strongly encourage Covid vaccinations for everyone ages 12 and older.

“Vaccination works and will protect us from the severe complications of Covid-19,” CDC director Dr. Rochelle Walensky said during a White House Covid task force briefing Friday.

The message echoed that of President Joe Biden who, on Thursday, outlined a broad plan to increase vaccinations nationwide, including executive orders mandating the shots for employees of both the federal government and other large businesses.

As of Friday, the CDC reported that 62.5 percent of the U.S. population eligible for the shots had been fully vaccinated. Seventy-three percent had received the first dose.

https://www.nbcnews.com/health/health-news/cdc-studies-find-vaccines-still-offer-powerful-protection-severe-covid-rcna1968

Why did CDC change its definition for ‘vaccine’? Agency explains move as skeptics lurk

 Social media is calling bluff on the Centers for Disease Control and Prevention for modifying its definition of the words “vaccine” and “vaccination” on its website.

Before the change, the definition for “vaccination” read, “the act of introducing a vaccine into the body to produce immunity to a specific disease.” Now, the word “immunity” has been switched to “protection.”

The term “vaccine” also got a makeover. The CDC’s definition changed from “a product that stimulates a person’s immune system to produce immunity to a specific disease” to the current “a preparation that is used to stimulate the body’s immune response against diseases.”

Some have speculated that the unannounced changes were the CDC’s attempt to hide the fact COVID-19 vaccines are not 100% effective at preventing coronavirus infection. U.S. Representative Thomas Massie of Kentucky said in a popular tweet the CDC has “been busy at the Ministry of Truth.”

However, a CDC spokesperson told McClatchy News the “slight changes in wording over time … haven’t impacted the overall definition.”

The previous definitions could have been “interpreted to mean that vaccines were 100% effective, which has never been the case for any vaccine, so the current definition is more transparent, and also describes the ways in which vaccines can be administered,” the spokesperson said.

“It’s also important to note that the modifications to the definition of ‘vaccine’ don’t change the fact that vaccines and the act of vaccination has prevented millions of illnesses and saved countless lives,” the spokesperson said in an email.

There remains the misconception that COVID-19 vaccines were designed to prevent infections altogether, leading people to believe the vaccines aren’t working as they should when they learn about breakthrough infections among the vaccinated.

But the coronavirus vaccines are doing exactly what they were designed to do, which is to prevent severe disease, including the need for hospitalization, and death — even in the presence of more dangerous versions of the virus such as the delta variant.

While data show the coronavirus shots are preventing infections in many outbreak scenarios, the fact breakthrough infections are happening doesn’t suggest failure, some 'experts' are now saying.

https://www.miamiherald.com/news/coronavirus/article254111268.html

White House scrambles to quell rising consumer prices as inflation surges

 The Biden administration is rushing to tamp down rising consumer prices. A new White House competition council created in July is slated to hold its first meeting on Friday, where participants are expected to highlight at least 18 actions taken to help consumers and potentially lower prices, according to the Associated Press, citing two people familiar with the matter. 

The goal is to ultimately create a more dynamic economy in which competition among companies leads to increased transparency, more choice and potential savings for customers.

Among the matters the council plans to discuss are a new report about airlines that wrongfully denied refunds to customers whose flights were changed or canceled; an inquiry into excessive fees charged by ocean carriers; and a nearly 20-fold increase in fines for hospitals that fail to disclose their prices to the public. 

The council – led by White House economic adviser Brian Deese – also intends to tackle corporate mergers, landlords who prevent renters from shopping around for internet services and removing requirements by companies such as John Deere that stop independent repair shops from fixing broken tractors and other machines, the AP reported.

The administration's supply chain disruptions task force is having conversations with businesses across the food supply chain to identify possible bottlenecks in the supply chain, a White House official told FOX Business. 

"We are committed to working with all industry participants to identify ways we can help alleviate those bottlenecks," the official said.  

Deese previewed the administration's efforts to tamp down skyrocketing meat prices, which he blamed on profiteering by major industry players, rather than economy-wide inflation. During the White House press briefing on Wednesday, Deese noted that beef and veal prices are up 15% since January 2020, while pork is up about 14% and poultry up 12.%. By comparison, the broader category of food to be eaten at home is up just 6.5%.

"It raises a concern about pandemic profiteering — about companies that are driving price increases in a way that hurts consumers who are going to the grocery store, and also isn't benefiting the actual producers — the farmers and the ranchers," Deese said.

The meeting comes in light of a new Labor Department report released Friday morning, which showed that inflation at the wholesale level surged at the highest known level since August 2010. The producer price index, which measures inflationary pressures before they reach consumers, climbed 0.7% last month to 8.3%.

Excluding volatile food and energy prices, so-called core inflation jumped 5.4% in July compared to the previous year. Still, month-over-month, the consumer price index climbed 0.3% in July – well below June's increase of 0.9%, a sign that inflation could be plateauing. 

Inflation has accelerated as the economy recovers from last year's brief, but extremely severe, recession.

Federal Reserve Chairman Jerome Powell has largely attributed the spike in consumer prices to pandemic-induced disruptions in the supply chain, a shortage of workers that's pushed wages higher and a wave of pent-up consumers flush with stimulus cash. Still, he's maintained the rise in inflation is like "transitory" and has warned about the dangers of the Federal Reserve acting superfluously to lower the benchmark federal funds rate.

https://www.foxbusiness.com/economy/white-house-consumer-prices-inflation

Mersana hit on interim data on ovarian cancer Phase 1 trial

 

• Mersana Therapeutics Inc 
  MRSN +35.78%
   (Get Free Alerts for MRSN) stock is moving lower during the market trading session. Investors are reacting to interim data from the ovarian cancer Phase 1 trial evaluating Upifitamab Rilsodotin (UpRi, previously XMT-1536).
• See the related Company presentation here.
• Complete response was observed in 2 patients with platinum-resistant ovarian cancer at the lower dose. A confirmed objective response rate (ORR) of 34% and disease control rate (DCR) of 87% in NaPi2b high population was observed.
• Interim data showed that 67% of patients (n=73 evaluable patients) had reductions in target tumor lesions.
• Notably, a heavily pre-treated patient with BRCA1/2 negative high-grade serous ovarian cancer received nine cycles of UpRi at a lower dose of 36 mg/m2.
• The patient achieved a confirmed partial response (PR) with almost 41.4% tumor reduction.
• Mersana said similar efficacy was observed across the three dose levels, with a trend toward higher efficacy with a lower dose.
• Mersana plans to take 36 mg/m2 up to a maximum of ~80 mg dose strength forward further evaluation.

https://www.benzinga.com/general/biotech/21/09/22886737/why-are-mersana-therapeutics-shares-trading-lower-on-friday

Florida Landlord Requires Tenants Get Vaccinated, Defying DeSantis Ban

 

 A landlord in southeastern Florida is requiring that his tenants get vaccinated for COVID-19, a move Governor Ron DeSantis’ office said could defy the state’s vaccine mandate ban.

Santiago A. Alvarez and his family own eight apartment complexes, which contain a total of around 1,200 housing units in Broward and Miami-Dade counties. The Sun-Sentinel reported on Sunday that Alvarez enacted a policy on August 15 that will automatically deny applications from potential new tenants if they’re not vaccinated. Additionally, if anyone is unvaccinated when their lease comes up for renewal, they will have to move out.

The rule not only applies to tenants in Alvarez’s apartments, but it also extends to employees in the complexes, who similarly must show proof that they’ve received at least one dose of a COVID vaccine.

The Sun-Sentinel reported that Alvarez’s policy makes him the “first large-scale landlord known to national housing experts to impose a vaccine requirement not only for employees, but also for tenants.”

Alvarez told the newspaper that his main objective is keeping people healthy. He said around a dozen of his tenants have died of COVID-19 and many others were sick. Reaction from people living in his apartments has been divided in regards to the new policy, and at least two tenants indicated they contacted local eviction defense attorneys about challenging the rule in court.

Another challenge may come from DeSantis, whose vaccine passport ban prohibits businesses from requiring customers to be vaccinated. The Republican governor has repeatedly said that requiring proof of vaccinations violates civil liberties and violates the rights of people to keep medical information private.

When contacted by the Sun-Sentinel, DeSantis’ press secretary, Christina Pushaw said she conferred with the governor’s legal counsel. She said the counsel thought Alvarez’s policy may run afoul of the DeSantis-backed ban on businesses requiring vaccine documentation.

“Our counsel thinks that would be a violation of the vaccine passport ban,” Pushaw told the paper in an email.

Each violation of that ban—which became state law after DeSantis issued it as an executive order in March—could result in a $5,000 fine for each violation. The Florida Department of Health stated last week it would start enforcing the vaccine passport ban on September 16.

The Sun-Sentinel wrote that Alvarez’s attorney recently replied to one tenant’s attorney by saying that the vaccine policy does not violate DeSantis’ executive order banning vaccine passports. The lawyer argued the ban applies to businesses wanting vaccine documentation from “patrons or customers.”

The attorney, Juan C. Zorrilla of the Fowler White Burnett firm, said Alvarez’s policy does not fall under that distinction because tenants are not patrons or customers. Whereas patrons or customers are transient and only on the premises for a temporary amount of time, the occupant of a dwelling is there for a much longer amount of time.

https://www.american-apartment-owners-association.org/property-management/florida-landlord-requires-tenants-get-vaccinated-defying-desantis-ban/

Lawmakers urge companies to 'openly rebel' against Biden's new vaccine mandates

 Following President Biden announcing his new plan to combat COVID-19, a number of Republican lawmakers are urging companies to “openly rebel” against it.

Biden announced on Thursday that private companies that employ more than 100 people will be required to mandate COVID-19 vaccinations or weekly testing, and all federal employees and contractors must be fully vaccinated. Federal employees and contractors have 75 days to do so, with limited exceptions for health or religious reasons.

“Those businesses should openly rebel against any such rule,” Texas Rep. Chip Roy (R) tweeted.

 

“Are you people trying to start a full on revolt? Honestly what the hell is wrong with Democrats?” Texas Rep. Dan Crenshaw (R) tweeted. “Leave people the hell alone. This is insanity.”

“I encourage America’s job creators – large and small – to challenge this insane ‘order.’” Republican Florida Sen. Rick Scott tweeted. “We cannot allow this unhinged administration to do even more irreparable harm to American workers, businesses and our economy.”

Coronavirus cases in the United States have continued to surge, with almost 300 percent more hospitalized COVID-19 patients over Labor Day weekend compared to a year ago, according to data from Johns Hopkins University. Only 53.4 percent of the U.S. population is fully vaccinated against the coronavirus.

"This is not about freedom or personal choice," Biden said in his announcement. "It's about protecting yourself and those around you."

https://thehill.com/changing-america/well-being/prevention-cures/571679-lawmakers-urge-companies-to-openly-rebel-against