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Hi, everyone. This is Lucas Voss with the

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Becker's healthcare. Thanks so much for tuning in

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to the Becker's healthcare podcast series.

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Today, we're talking about innovations in bone healing,

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how science

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is shaping

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the future of regeneration.

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I'm so excited

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to welcome doctor James Riebe. He's the principal

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scientific advisor at Orthofix and brings more than

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thirty years of experience in pharmaceutical and medical

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device development.

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He's a member of the American Academy of

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Orthopedic Surgeons and is widely recognized for his

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expertise in bone healing and bone growth therapies.

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Doctor Ibe, welcome to the podcast. It's so

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great to have you.

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Well, thank you for the invitation, Lucas.

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I'm excited to be here today.

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It's great to have you. We have so

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much to talk about. So much has happened

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in your field

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over the last couple of decades, I'd argue.

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Again, you've been at the forefront of all

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of this, including a lot of the innovations

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that we've seen.

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Looking back to the early days of bone

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growth stimulation,

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what first sparked interest in exploring

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elect the electrical and mechanical signals as therapeutic

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tools here?

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Well, I think the the most interesting thing

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really went back to the early discoveries

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about when you bent bone,

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you actually

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generated

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a electrical signal. So

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Mhmm. Obviously,

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this started in Japan with

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piezoelectric

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signals, but then followed up here in The

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US by

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the group at University of Pennsylvania

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in Philly

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showing that these electric potentials

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were really

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streaming potentials. And, of course,

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this open this whole

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area

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up of

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do cells

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really

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respond to these electrical

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signals.

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And then

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years later, the same thing happened with mechanical,

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signals,

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and that led to really development of ultrasound.

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So I think

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to really

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summarize,

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it was the ability

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to talk to cells and tissues

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without having to provide

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a drug or a protein

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to

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basically

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activate

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the healing process.

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And so

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that was really, really

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exciting. And I can remember some of the

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first

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presentations

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we made, for example, at the,

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academy meeting, the AAOS

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meeting

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on this and really the audiences

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that we were able

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to draw to see this new data

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and really

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get excited about it.

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Yeah. So when you're describing it, it sounds

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really futuristic. It was it's really a step

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forward for and, again, less less invasive. It

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gives people a chance to to have better

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therapy. And I wanna touch on the the

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technology piece of this a little bit more

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in detail, specifically pulsed electromagnetic

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field technology or PEMF as we might refer

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to it. It's become an important approach

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in bone healing itself.

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From your perspective, what were some of those

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key scientific or clinical milestones that help

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validate PMF as a credible

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evidence based therapy?

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Well, I think,

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scientifically,

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it was really when

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several

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labs showed

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that you could with

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post electromagnetic

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fields, you could

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actually

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stimulate

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cells and tissue culture

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to make growth factors like

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insulin like growth factor, TGF

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beta,

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bone morphogenetic

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protein. And some of this work was

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done by Roy Aaron, for example, at Brown

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University

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and Barbara Boyan at the time

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at Georgia Tech.

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So these were really key scientific things, but

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I think the most important

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clinical evidence

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was really in spine fusion,

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and that was

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the use of post electromagnetic

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fields for both

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lumbar fusion and the cervical fusion

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based on

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multicenter

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placebo.

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So these were double blind placebo

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controlled

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clinical trials that really showed very strongly

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the positive benefit of

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pemph stimulation

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for spine fusion.

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And that's something that it actually, the first

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placebo

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the first double blind placebo

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controlled

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prospective

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multicenter

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study,

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ever in the spine fusion was on pulsed

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electromagnetic

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fields.

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The other thing I wanna bring up and

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not to host

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any particular company,

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but

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what the FDA

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particularly

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liked was that

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there was independent

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blinded

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radiographic

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review,

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and this was done by

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a group of surgeons and radiologists

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that

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had no

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knowledge of who was randomized

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to the

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active PEMF device

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or the control PEMF device.

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And I think

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that those studies

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really set the stage

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for the growth of PEMF technology

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really across the country.

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You you've touched on the ultrasound aspect of

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this as well, again, in the in the

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early days and and that this was essentially

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what was focused on in the ultrasound based

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therapy, such as low intensity pulse ultrasound, introduced

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a a different mechanism of action compared to

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PEMF.

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How did the growing understanding of cellular signaling

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and bone biology influence the development

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of ultrasound based bone healing technologies then?

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Well well, when you go back to some

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of my earliest

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comments, you know,

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the

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mechanosensing

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effects of bone

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have been known for over a hundred years.

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You know,

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originally, wolf's law, but

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there there has always been this tremendous

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interest

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in direct mechanical

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effects on bone.

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The work of Alan Goodship and John Kenwright

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in The UK

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really showed

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how important this was, and this was followed

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by

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people, you know, Lutz Klyse and Ulm, Germany.

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So

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so we knew

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forty plus years ago that

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mechanosensitivity

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of bone

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was a real thing,

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and it was really that

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that allowed

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ultrasound

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as a micro mechanical

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stimulus.

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And then

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all the work that labs were doing around

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the world on cellular

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signaling with

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micromechanical

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loads

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really drove that. You know, a lot of

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this is based

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on integrins, and integrins

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were

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a class of

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protein

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receptors that really,

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you know, allowed the ultrasound

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field to grow

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very well. And then again,

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there were

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randomized

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placebo controlled

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clinical trials conducted

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of the pulse ultrasound

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technology.

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And at that point, it was sort of

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accepted

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from an FDA standpoint that the right way

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to do the research, the clinical research,

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was in fact to do these

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randomized

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placebo controlled trials,

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which as you know

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had been the standard in pharmaceutical

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development

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for many, many years.

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I loved your description earlier of the conference

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that you had mentioned, where this was first

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described and first presented and and sort of

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the some of the reactions that you've saw.

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And and non invasive bone growth stimulation devices

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have really moved from early skepticism to to

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broader clinical adoption now.

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What were some of the biggest challenges in

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in gaining physician acceptance there? And and for

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us, physicians

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evaluating whether to do this, whether to incorporate

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technologies

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like this today,

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what factors should they be considering?

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Well, the biggest challenges

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really had to do with

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getting

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thought leader surgeons

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to speak

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about their use of these technologies.

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And that took

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some time because

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the reality is

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the clinicians

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who

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originally

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were approached about these technologies

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are all surgeons.

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And I think

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just to say in a very

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gentle way,

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most surgeons

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believe that their surgery

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is gonna be successful.

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You know, they trained

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for years and years. You know, most of

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them were,

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you know, five years of residency,

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then spine fellowships or trauma

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fellowships,

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and they worked with

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great institutions.

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So

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to say to a surgeon that

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you might need this adjunctive

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bones

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growth stimulation

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technology

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on top of your excellent surgery,

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that was clearly a challenge

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in the early days.

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And so

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today,

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if I'm out giving a lecture,

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I really focus on comorbidities.

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So

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if you have a, for example, a two

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level

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lumbar spine fusion patient or

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a adult deformity

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spine fusion patient

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that maybe

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is being treated for diabetes,

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maybe they were a former smoke smoker,

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maybe they have peripheral vascular disease,

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osteopenia,

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or osteoporosis.

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All of these risk factors,

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clearly, there's publication

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showing that these risk factors

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are a negative

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influence

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on successful,

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for example, spine fusion

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or fracture healing. And I think

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that's where we

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really emphasize. It's not for the healthy

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45 year old who might need a one

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level

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lumbar fusion due to

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maybe work injuries

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or

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or sporting injuries.

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These devices

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really

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are

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for those patients that have

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a lot of risk factors that negatively

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affect their ability to heal.

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Earlier on our conversation, we've talked a little

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bit about the evolution of this and the

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evolution of these technologies

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and the development of them as well.

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As we look to the future now

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and looking back at the technologies themselves,

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for you personally, what lessons stand out about

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translating

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the some of the venture research that we've

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talked about into real world clinical solutions right

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now?

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Well, it you know, very good question, Lucas.

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So

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translating

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bench research

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is always

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tricky,

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but

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I think our approach

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with pulse electromagnetic

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fields was really

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to do the bench research

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with

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some of the most highly respected labs in

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the country. So

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when we

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were investigating

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pulse electromagnetic

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fields as an adjunct

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stimulation

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to rotator

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cuff repair,

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we worked with Lou Zyslowski's

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group, which included

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Andy Coombs at University of Pennsylvania.

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And they're widely

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considered one of the best shoulder

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research labs in the world

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with tens and maybe hundreds of publications

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over the last

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twenty years.

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And the the reason why we did that

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is then when we went to a

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clinical site

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and we were able to show them all

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of the

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basic research that went into this potential new

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clinical application,

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we never had

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a shoulder surgeon say to us,

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I don't wanna be in this clinical trial.

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They were when they saw the

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the

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basic research data,

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which included animal studies,

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they were so enthusiastic

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to sign up to participate

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in the clinical trial.

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Doctor Ravey, thank you so much for joining

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us. It's been so great to have you.

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Well and I I appreciate the opportunity, Lucas,

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and

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wish you always the best at Becker's

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because, it's

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00:14:33,835 --> 00:14:36,794
something that I read every morning when I

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open up my Outlook.

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So great to hear that, and we're certainly

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grateful that you do. And we also want

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to thank our podcast sponsor Orthofix.

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00:14:46,350 --> 00:14:47,870
You could tune in to more podcasts from

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00:14:47,870 --> 00:14:50,429
Becker's Healthcare by visiting our podcast page at

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00:14:50,429 --> 00:14:53,009
beckershospitalreview.com.