Fractyl Laboratories Archives - Medical Design Sourcing

Fractyl Health touts preliminary data from diabetes reversal study

Fractyl Health this week announced encouraging interim feasibility data from its diabetes reversal technology study.

Lexington, Massachusetts-based Fractyl’s Revita-T2Di long-term open-label cohort assessed eight patients followed through at least four weeks having been treated with the company’s Revita system for resurfacing the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes.

Get the full story at our sister site, Drug Delivery Business News.

FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech

Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system.

Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420.

Get the full story at our sister site, Drug Delivery Business News.

Fractyl activates 10th clinical site in diabetes reversal tech trial

Fractyl Health announced today that it activated the 10th clinical site in its pivotal REVITA-T2Di trial in the U.S. and Europe.

Lexington, Mass.-based Fractyl’s trial is enrolling patients with type 2 diabetes who are currently on insulin therapy at sites in New Jersey, Louisiana, Texas, Massachusetts and New York to add to the initial U.S. site at Indiana University Health. Additionally, enrollment is ongoing in Belgium, Italy and the Netherlands.

Get the full story at our sister site, Drug Delivery Business News.

Fractyl raises $100M for diabetes reversal tech, renamed as Fractyl Health

Fractyl Labs today announced the closing of a $100 million Series F financing round in addition to a name change to Fractyl Health.

Lexington, Mass.-based Fractyl Health received contributions to the round from new investors Maverick Capital, M28 Capital and Population Health Partners, while other new and existing investors participated, too.

Get the full story at our sister site, Drug Delivery Business News.

MedTech 100 roundup: Turnaround for the industry?

A turgid month for the medtech industry might be drifting into the past after the past week indicated a slight turnaround as summer nears.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week at 107.74 points, marking a 1.4% rise from the 106.22-point mark set one week prior.

Having endured its largest slide of 2021 in recent weeks, the index is already demonstrating signs of a rebound after April brought the industry’s all-time best performance.

Despite the setbacks that have plagued the industry over the past month or so, medtech’s performance continues to reflect a rebound from the struggles brought on by the COVID-19 pandemic. Overall, it has registered a 16.7% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 73.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall markets were on the opposite end of the spectrum over the p…

How Fractyl Labs is “reversing” type 2 diabetes to reduce or eliminate insulin injections

Fractyl Labs CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections.

Insulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix with Fractyl Labs.

“We started to think hard about what is the root cause of type 2 diabetes and how might we develop therapies that might target the root cause to change the trajectory of disease and not just put a band-aid on its symptoms,” Rajagopalan told Drug Delivery Business News. “That’s what led us to start Fractyl about 10 years ago.”

Get the full story at our sister site, Drug Delivery Business News.

How Fractyl Labs is “reversing” type 2 diabetes to reduce or eliminate insulin injections

Fractyl Labs CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections.

Insulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix with Fractyl Labs.

“We started to think hard about what is the root cause of type 2 diabetes and how might we develop therapies that might target the root cause to change the trajectory of disease and not just put a band-aid on its symptoms,” Rajagopalan told Drug Delivery Business News. “That’s what led us to start Fractyl about 10 years ago.”

Get the full story at our sister site, Drug Delivery Business News.

FDA grants breakthrough nod for Fractyl’s type 2 diabetes treatment

Fractyl Laboratories announced today that it received FDA breakthrough device designation for its Revita DMR type 2 diabetes treatment.

Lexington, Mass.-based Fractyl’s Revita DMR treatment is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Preliminary clinical findings suggest that the treatment could decrease insulin resistance, improve glucose control, lower weight and reduce liver fat.

Get the full story at our sister site, Drug Delivery Business News.

Fractyl enrolls first patient in Revita DMR treatment for Type 2 diabetes

Fractyl Laboratories announced today that it enrolled the first patient in the trial for its Revita DMR Type 2 diabetes treatment.

The Revita-T2Di trial will evaluate a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control. The company will seek to use the trial as the basis of a marketing application to the FDA, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

MedTech 100 roundup: Stocks were practically unchanged last week

Despite plenty of ups and downs coming in the stock market for the medtech industry, there was hardly any movement from week to week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.6 points at the end of last week (Aug. 21). Overall, medtech stocks saw a -0.2% decrease from the 89.77-point total at the same time a week prior (Aug. 14).

Once again, the index nearly reached a high point during the COVID-19 pandemic, as on Aug. 18, it hit 90.4 points for the second time in as many weeks, a total that nearly poked past the previous mid-pandemic high (90.45), which came on Aug. 5.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -2.9% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 0.72% increase from Aug. 14 to Aug. 21, having reached record highs on Aug. 18. Meanwhil…

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

DeviceTalks Weekly, powered by MassDevice

In this week’s episode of the DeviceTalks Weekly podcast, co-hosts Tom Salemi, editorial director of DeviceTalks, and Chris Newmarker, executive editor of life sciences, review this week’s Top 5 medtech stories, aka “Newmarker’s Newsmakers,” with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer.

We also hear from two executives from Fractyl Laboratories — CEO Dr. Harith Rajagopalan and CFO Lisa Davidson — about its recent $55 million Series E round of financing and the strides they’re making in developing a device to treat diabetes.

In a second interview, bioelectronic device company Cala Health CEO Renee Ryan gives us an update on the Cala Trio’s clinical success in treating essential tremors and how the start-up is working through COVID-19.

Finally, Chris and Tom hint at an upcoming event for the DTW communit…

DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?

In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer.

We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is making great strides in developing a device to treat diabetes.

Cala Health CEO Renee Ryan returns to the podcast to give us an update on the Cala Trio’s clinical success in reducing essential tremors and how the start-up is working through COVID-19.

Finally, Chris and Tom hint at an upcoming event for the DTW community.

Subscribe today on Apple Podcasts, Spotify, and other players.

DeviceTalks by MassDevice · Can Fractyl Labs and Cala Health go where only drugs have gone before?