August 3, 2021
Newsletter: Tips, Quips, and Sunken Ships | August 3, 2021
Tips, Quips, and Sunken Ships


Hey readers— it’s been awhile!

 

Before we dive in, big shout out to our TMC neighbors, Imran Alibhai, Ron DePhino, and the Tvardi Therapeutics team, for securing $74 million. Big-time Series B for big-time pipe! Couldn’t have happened to nicer guys.

 

We’re making our own moves over here at Proxima, and we’re excited to share these updates with you in the upcoming weeks.

 

In the meantime, here’s the latest in MedTech and biotech.

 

Stay safe and healthy,

 

Kevin Coker and the team at Proxima CRO


Owner of a Fatty Heart 

 

A newly developed AI tool from a team of researchers out of Queen Mary University of London can measure the amount of fat around the heart from an MRI image scan.

 

Side-stepping an obstructed view 

 

Measuring fat around internal organs provides a better picture of fat in the body, but it's been impossible to measure. This obstacle has forced medical professionals to rely on Body Mass Index (BMI), which only measures the amount of fat underneath the skin, but as an indicator— it doesn’t really show the whole picture. 

 

With the use of this AI tool, researchers found that the more fat around your heart, the greater the odds for diabetes— regardless of age, sex, or BMI, as published in the journal,Frontiers in Cardiovascular Medicine. 

 

Retooling the future 

“Unfortunately, manual measurement of the amount of fat around the heart is challenging and time-consuming. For this reason, to date, no-one has been able to investigate this thoroughly in studies of large groups of people...To address this problem, we've invented an AI tool that can be applied to standard heart MRI scans to obtain a measure of the fat around the heart automatically and quickly, in under three seconds. This tool can be used by future researchers to discover more about the links between the fat around the heart and disease risk, but also potentially in the future, as part of a patient's standard care in hospital," says Zahra Raisi-Estabragh, Lead Researcher, Queen Mary University of London. 

Don’t eat your heart out, kid! But if you do, Queen Mary’s got you covered.

 

Hate  Needles? Good news for you…

Here’s  an exciting prospect for millions of people who hate being pricked with  needles.  

 

Becton  Dickinson and Co. recently acquired Velano Vascular and  will aid the company in bringing their needle-free blood drawing  experience to the masses.

 

You heard right! No needle needed! 

 

Velano Vascular’s single-use PIVO device removes the anxiety and discomfort that  comes with drawing blood at the hospital. Their vision is to create a less  invasive experience for patients with their “One-stick Hospital  Stay.”  

 

Sounds good, right? Well, here’s how it  works 

 

After  placing the initial IV line, the PIVO is snaked through the peripheral IV,  past the end of the catheter, and directly into the vessel to collect blood.  The PIVO collects blood without getting any debris, medications, or fluids in  the mix— eliminating the need to get pricked over and over again and allowing  medical professionals to collect as much blood as needed. 

 

Needle-free is the way to be 

“As a global leader in both blood collection and vascular access, BD has been on  the forefront of innovations that both reduce needle sticks and improve the  patient experience... The addition of Velano Vascular, which is an  innovative, needle-free blood-draw technology, will reduce the pain and  discomfort of multiple needle sticks and really creates a new standard of  care,” says Rick Byrd, President of Medication Delivery Solutions at  BD. 

So, the next time your palms get sweaty thinking about dull  needles jabbing your arm— just know that help is on the way! 


Speaking of pain—Ouch, Biogen—that’s gotta hurt! 

 

Biogen’s footing a $542 million bill for impairment charges after flubbing two high-profile gene therapy trials. 

 

Unable to correct vision or meet secondary goals, Biogen was given a dent to their pocketbook— in the sum of $350 million— for the phase 3 failure of BIIB111(timrepigene emparvovec) in the eye disease Choroideremia. The second blow to the gut is a $192 million fine for the X-linked retinitis pigmentosa gene therapy BIIB112 (cotoretigene toliparvovec), which was unable to increase retinal sensitivity in the phase 2/3 trial at 12 months post-treatment. 

 

Other eyes on the prize 

 

These failures are especially disappointing for Biogen as their competitors, Johnson &JohnsonAllergan, and others continue to work on making strides in treating the rare eye disease, X-linked retinitis pigmentosa.  

 

With all that’s going on with Biogen, 2022 has got to be a sight for sore eyes. 


Knowledge Base Highlights:

Learn what the top 3 benefits and risk to consider for breakthrough devices subject to PMA here.

FDA Highlights:

Want to learn about a cool solution for burnt, damaged skin? The FDA recently approved StrataGraft for the treatment of adults with therma burns.

Are you down with BDD? Yeah, you know me!

 

Take our zodiac personality  quiz to figure out if Breakthrough Device Designation is for you!

Just kidding, but we do  have a quick, interactive quiz that lets you know if the BDD path is right  for you and your device in under two minutes! 

 

BDD Quiz 

Wanna know more about Breakthrough Device Designation? Tune in with the experts...

greenlightpodcast 400px

Take a listen as our very own Isabella Schmitt discusses process, timeline, and potential roadblocks in the BDD submission process.

 

She joins John Speer, the founder of Greenlight Guru, on this episode of Global Medical Device Podcast.

Approximately in the center of  it all! 

 

Look, Ma! We're in the  news!

 

Read an  interview with Proxima Clinical Research co-founder, Larry Lawson,  as he discusses the effects of Covid, his vision for making Houston a hub for  startups, innovators of devices and drugs, and much more! 

Catch us at the 2021 MD&M West Conference!

Find out which Proxima team members will be at this conference and learn more about the IVDR Compliance Panel Isabella Schmitt is participating in!

Catch us at our next event! We'd love to see you.

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