FDA Approves Abbott’s Dissolvable Stents

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It’s estimated that as many as 20 million Americans may suffer from peripheral artery disease, a condition where a person’s arms or legs don’t receive enough blood to keep up with what they need. Severe cases of this disease can lead to strokes and heart attacks or to a condition called critical limb ischemia, which can have an extremely high mortality rate if the limb is not amputated. When this disease impacts the lower legs, the standard of care is balloon angioplasty, which can be helpful but is not sustainable.

On Monday, the FDA approved a new treatment developed by Abbott for patients with this condition below the knee: a dissolvable stent that opens up the artery to deliver a drug, everolimus, which helps prevent the growth of plaques that cause the disease. In a clinical study, this system, called Espirit BTK, showed significantly greater efficacy than balloon angioplasty and was over 30% more likely to prevent a need for amputation compared to that standard of care. Additionally, because the stent can be reabsorbed into the body, it’s easier for doctors to deliver the treatment again if necessary.

“This was the first trial to show that there was a therapy that can exceed what is offered to patients,” Jennifer Jones-McMeans, Abbot’s VP of global clinical affairs, told Forbes. “It leaves so much opportunity for patients and physicians to have a new tool to combat this disease.”

This Biotech Startup Aims To Speed Up Drug Testing On Animals

When developing new therapies for diseases, biotech researchers are often limited by two time-consuming steps: first, screening thousands of drug candidates in test tubes and second, taking the best candidates and testing them on multiple animals to make sure it’s safe and effective. Combined, these steps can be slow and expensive.

A startup called Gordian Biotechnology has debuted a technology that could make this process better for both animals and people:a new animal screening platform which allows multiple gene therapies to be tested at the same time with just one animal. Instead of the gene treatment being given to the animal and affecting an entire area of its body, Gordian’s innovation enables it to test a drug inside of a single cell. That means one mouse could potentially support the evaluation of hundreds of possible new gene therapies in a way that’s faster and impacts fewer animals with less risk of harm to them.

“We’ve got a platform that allows us to essentially parallelize the hardest part of the drug discovery process, the animal testing process,” Gordian CEO Francisco LePort told Forbes.

Pipeline & Deal Updates

Back Pain: The FDA cleared Medtronic’s Inceptiv spinal cord stimulator for chronic pain treatment. What’s different about Medtronic’s new system is that it’s capable of sensing a patient’s body position and adjusts the amount of electrical stimulation accordingly, improving quality of life. “This is a new generation of devices that fundamentally makes life easier for patients,” David Carr, VP of pain operations, told Forbes.

Next Gen Biologics: Enlaza Therapeutics, which is developing a new class of biologics that can chemically bond to drug targets for better precision, announced it has raised a $100 million series A led by J.P. Morgan.

Gene Editing: Regeneron announced that it’s entered into a research collaboration with Jennifer Doudna-cofounded CRISPR company Mammoth Biosciences to develop new gene editing therapies. As part of the deal, Regeneron will be providing a $100 million upfront payment ($95 million of which is an equity investment) and is eligible for up to $370 million in milestone payments per target, plus royalties.

Autoimmune Disorders: Bristol Myers Squibb has entered into a research agreement with Repertoire to develop vaccines for three different autoimmune diseases. Repertoire is receiving an upfront payment of $65 million and the whole deal is potentially worth up to $1.8 billion in milestone payments plus royalties.

Mental Health: Amae Health, a value-based care startup treating severe mental illness, raised a $15 million Series A funding round led by Quiet Capital. Amae’s first clinic in Los Angeles has reduced ER readmissions, boosted medication adherence and has an 80% patient retention rate, according to the company.

Walmart To Close Health Clinics In Latest Blow To Retail Healthcare

Walmart is closing its in-person clinics and virtual care business, saying it doesn’t see a sustainable business model in primary care. It’s the latest blow to the retail health clinic model, with the retail giant saying it will close its 51 Walmart Health centers in five states and Walmart Health Virtual Care, which is the retailer’s telehealth business. The centers will close in the next 30 to 90 days.

Other Healthcare News

The U.S. Preventive Services Task Force said breast cancer screenings should start at age 40—a decade earlier than previous recommendations.

Pfizer’s 44% decline in profits still tops estimates as stock bounces back from decade low.

The Federal Trade Commission is challenging hundreds of alleged “junk” pharmaceutical patent listings, including from Novo Nordisk, which the federal agency said is delaying cheaper generic options.

Novo Nordisk’s Wegovy is back in stock in the U.S. after months of limited supplies, according to an update on the FDA’s website, though shortages are set to continue.

South Dakota could vote on legalizing abortion this year.

CVS Health reported $1.1 billion in first quarter profits – nearly half of last year’s – due to higher costs to treat seniors in Medicare Advantage plans.