LOWELL, Mass.--(BUSINESS WIRE)--Jan 28, 2026--
RevBio, Inc., announced that it has received investigational device exemption (IDE) approval from the FDA to conduct a multi-center randomized controlled pivotal clinical trial to use TETRANITE® to reintegrate cranial bone flaps, which are portions of the skull that are temporarily removed by neurosurgeons to perform brain surgery.
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This clinical trial is designed to demonstrate that TETRANITE can immediately fixate cranial flaps and enable bone fusion in craniotomy and cranioplasty procedures to improve cosmesis, increase flap stability for patient comfort, and help prevent cerebrospinal fluid leaks, which can cause significant pain and lead to serious infections. All of these complications are known limitations of the current standard of care which consists of plate and screw fixation systems.
“This novel regenerative adhesive has the potential to change how cranial restoration procedures are performed and significantly improve outcomes for patients,” said Timothy R. Smith, MD, PhD, MPH, Director, Computational Neuroscience Outcomes Center and practicing neurosurgeon at Brigham and Women’s Hospital in Boston, Massachusetts.
This clinical trial, known as RevBio’s T-RESTORE II trial, will enroll up to 204 patients. Half of these patients will receive TETRANITE and the other half will receive standard cranial plate and screw systems to fixate their cranial bone flaps. Typically, craniotomy procedures are required to remove a brain tumor, treat an aneurysm, relieve intracranial pressure, or perform deep brain stimulation. Cutting into the skull leaves a kerf line, a continuous gap between the bone flap and surrounding skull. The flap is temporarily removed to conduct the brain surgery. In the surgical closure process, the cranial flap is secured back into place with titanium plates and screws. The kerf line, however, is typically not filled or sealed, which compromises the ability of the flap to integrate with the surrounding bone because the width of the kerf is too great a gap for bone cells to cross. As a regenerative bone adhesive placed into the kerf, TETRANITE immediately fixates the bone flap in its desired position, fills the gap, and provides a biological bridge for bone cells to travel from the surrounding skull. This allows bone fusion to occur and the bone flap to solidly heal.
The FDA approved up to 15 clinical sites to participate in this study. Currently, RevBio is actively recruiting sites based on feedback from its neurosurgical advisory board members. This approval was largely predicated on the successful pivotal preclinical study, surgeon handling testing, and successful pilot clinical trial (T-RESTORE I) conducted by the company.
“This pivotal IDE trial allows us to conduct the final testing required for the commercial approval of our lead indication in the $10 billion market of targeted bone glue applications,” said Brian Hess, CEO and founder of RevBio, Inc. “The fact that RevBio now has two active pivotal stage programs highlights our ability to scale this technology as a platform.”
About RevBio, Inc.
RevBio, Inc., is a clinical stage medical device company engaged in the development and commercialization of TETRANITE®, a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive. The company is initially developing this technology for use in the dental, cranial, and broader orthopaedic markets as well as applications in the animal health market. RevBio's TETRANITE technology is not yet approved for commercial use.
This clinical trial is designed to demonstrate that TETRANITE® can immediately fixate cranial flaps and enable bone fusion in craniotomy and cranioplasty procedures to improve cosmesis, increase flap stability for patient comfort, and help prevent cerebrospinal fluid leaks, which can cause significant pain and lead to serious infections.
Secretary of State Marco Rubio plans to warn Congress that President Donald Trump is ready to take new military action against Venezuela if the country’s interim leadership strays from U.S. expectations.
In prepared testimony for a hearing before the Senate Foreign Relations Committee, Rubio says the U.S. is not at war with Venezuela and that its interim leaders are cooperating, but notes that the Trump administration won't rule out using additional force if needed following its raid to capture former President Nicolás Maduro and bring him to New York City for trial.
Also, Homeland Security Secretary Kristi Noem faces rising calls for her firing or impeachment. From Democratic Party leaders to the nation’s leading advocacy organizations to even the most centrist lawmakers in Congress, the calls are mounting for her to step aside. At a defining moment in her tenure, few Republicans are rising to Noem’s defense.
And a man has been arrested after spraying an unknown substance on Democratic U.S. Rep. Ilhan Omar. The man was tackled to the ground Tuesday during a town hall in Minneapolis after Omar had called for the abolishment of ICE and for Noem to resign or face impeachment. Omar insisted on continuing to speak after the attack, saying she would not be intimidated by bullies.
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It remains unclear what Trump will decide about using force against Iran, though he laid down two red lines — the killing of peaceful demonstrators and the possible mass execution of detainees.
At least 6,221 people have been killed in Iran’s bloody crackdown on demonstrations, with many more feared dead, activists said Wednesday.
“Hopefully Iran will quickly ‘Come to the Table’ and negotiate a fair and equitable deal - NO NUCLEAR WEAPONS - one that is good for all parties,” Trump wrote on his Truth Social platform on Wednesday. “Time is running out, it is truly of the essence!”
Mentioning the June strikes on Iran, Trump wrote: “The next attack will be far worse!”
Iranian officials reached out to the wider Middle East on Wednesday over the threat of a possible U.S. military strike on the country, a month since the start of protests in Iran that soon spread nationwide and sparked a bloody crackdown.
Saudi Arabia and the United Arab Emirates signaled they won’t allow their airspace to be used for any attack. But the USS Abraham Lincoln and several guided missile destroyers are now in the region and can launch attacks from the sea.
Idaho Republican Sen. Jim Risch plans to open Tuesday’s hearing by lauding Trump and Rubio for making Americans safer with the military actions in and around Venezuela and saying they were legal.
“These actions were limited in scope, short in duration, and done to protect U.S. interests and citizens,” Risch’s prepared remarks say. “What President Trump has done in Venezuela is the definition of the president’s Article II constitutional authorities as commander-in-chief.”
The committee’s top Democrat, New Hampshire Sen. Jeanne Shaheen, will question whether removing Maduro was worth it, since most of his top aides and lieutenants still run the country.
“The U.S. naval blockade around Venezuela and the raid have already cost American taxpayers hundreds of millions of dollars … and yet the Maduro regime is still in power,” Shaheen’s opening statement said.
The president said on Truth Social that Minneapolis Mayor Jacob Frey is “PLAYING WITH FIRE” by not participating in the Trump administration’s federal immigration crackdown.
After talking Tuesday with Trump’s border czar Tom Homan, Frey said he “appreciated the conversation” but repeated that his “main ask” is for Homeland Security to end its operation in the city “as quickly as possible.”
“Minneapolis does not and will not enforce federal immigration laws,” Frey said. “We will remain focused on keeping our neighbors and streets safe.”
Trump asserted Wednesday in his social media post that “this statement is a very serious violation of the Law.”
Local authorities in the U.S. typically do not arrest people solely for immigration violations. Some local law enforcement agencies voluntarily assist federal operations. Trump has pressured and threatened so-called “sanctuary cities” to more aggressively take part in its immigration crackdown.
Prices for gold and silver soared early Wednesday ahead of an interest rate decision by the U.S. Federal Reserve. The expectation is that the central bank will hold its main interest rate steady for now.
The price of gold jumped 3.5% to $5,263 per ounce and silver’s price jumped 6.2%, to $112.50, putting both near record highs. Precious metal prices are rising as investors including major central banks sell dollars and park their money in assets considered to be relatively safe in times of turmoil.
The dollar has weakened since Trump threatened tariffs against European countries opposed to his taking control of Greenland. Such threats, along with worries about the U.S. government’s heavy debt, have periodically pushed global investors to step back from U.S. markets.
The caucus is calling on Republicans to “de-escalate the dangerous rhetoric that fuels attacks” like the one against their Democratic colleague.
“There is absolutely no excuse for violence and intimidation in our politics,” a caucus statement says. “Despite being subjected to constant right-wing attacks, she continues to lead and represent Minnesota’s 5th District with dignity and courage.”
The attack on Omar is the second in less than a week against a caucus member. Democratic Rep. Maxwell Frost of Florida, who identifies as Afro-Latino, was allegedly punched in the face by a man who said Trump was going to deport him.
A man sprayed an unknown substance on Democratic Rep. Omar and was tackled to the ground Tuesday during a town hall in Minneapolis.
The audience cheered as the man was pinned down and his arms were tied behind his back. In video of the incident, someone in the crowd can be heard saying, “Oh my god, he sprayed something on her.”
Just before that, Omar had called for the abolishment of ICE and for Secretary Noem to resign or face impeachment.
“ICE cannot be reformed,” Omar said, seconds before the attack.
Minneapolis police said officers saw the man use a syringe to spray an unknown liquid at Omar. They immediately arrested him and booked him at the county jail for third-degree assault, spokesperson Trevor Folke said. Forensic scientists responded to the scene.
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Two federal officers fired shots during the encounter that killed ICU nurse Alex Pretti over the weekend in Minneapolis, a Customs and Border Protection official told Congress in a notice sent Tuesday, while Ecuador’s minister of foreign affairs filed an objection saying immigration agents tried to enter the country’s consulate in the city without permission.
Officers tried to take Pretti into custody and he resisted, leading to a struggle, according to a notification to Congress obtained by The Associated Press. During the struggle, a Border Patrol agent yelled, “He’s got a gun!” multiple times, the official said.
A Border Patrol officer and a CBP officer each fired Glock pistols, the notice said.
Investigators from CBP’s Office of Professional Responsibility conducted the analysis based on a review of body-worn camera footage and agency documentation, the notice said. The law requires the agency to inform relevant congressional committees about deaths in CBP custody within 72 hours.
The developments came a day after Trump ordered border czar Tom Homan to take over his administration’s immigration crackdown in Minnesota.
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Homeland Security Secretary Kristi Noem speaks about the man in Minneapolis who was killed by a federal immigration officer earlier in the day during a news conference at the Federal Emergency Management Agency headquarters, Saturday, Jan. 24, 2026, in Washington. (AP Photo/Julia Demaree Nikhinson)
A groundswell of voices have come to the same conclusion: Kristi Noem must go.
From Democratic Party leaders to the nation’s leading advocacy organizations to even the most centrist lawmakers in Congress, the calls are mounting for the Homeland Security secretary to step aside after the shooting deaths in Minneapolis of two people who protested deportation policy. At a defining moment in her tenure, few Republicans are rising to Noem’s defense.
“The country is disgusted by what the Department of Homeland Security has done,” top House Democratic Reps. Hakeem Jeffries of New York, Katherine Clark of Massachusetts and Pete Aguilar of California said in a joint statement.
“Kristi Noem should be fired immediately,” the Democrats said, “or we will commence impeachment proceedings in the House of Representatives.”
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Rubio plans to warn that the Trump administration is ready to take new military action against Venezuela if the country’s interim leadership strays from U.S. expectations.
In prepared testimony for a hearing before the Senate Foreign Relations Committee, Rubio says the U.S. is not at war with Venezuela and that its interim leaders are cooperating, but he notes that the Trump administration would not rule out using additional force if needed following a raid to capture former President Nicolás Maduro early this month.
As he often is called to do, Rubio, a former Florida senator, will aim to sell one of Trump’s more contentious priorities to former colleagues in Congress. With the administration’s foreign policy gyrating between the Western Hemisphere, Europe and the Middle East, Rubio also may be called to smooth alarm that has emerged in his own party lately about efforts like Trump’s demand to annex Greenland.
By JON GAMBRELL
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White House deputy chief of policy Stephen Miller walks from Marine One after arriving on the South Lawn of the White House, Tuesday, Jan. 27, 2026, in Washington. (AP Photo/Alex Brandon)
Rep. Ilhan Omar, D-Minn., speaks during a town hall in Minneapolis, Tuesday, Jan. 27, 2026. (Richard Tsong-Taatarii/Star Tribune via AP)
President Donald Trump waves as he walks from Marine One after arriving on the South Lawn of the White House, Tuesday, Jan. 27, 2026, in Washington. (AP Photo/Alex Brandon)
FILE - Secretary of State Marco Rubio speaks to reporters while meeting with Armenian Foreign Minister Ararat Mirzoyan at the State Department in Washington, Jan. 13, 2026. (AP Photo/Cliff Owen, File)
