Dr. Randy Mills is co-founder of Elutia (NASDAQ: ELUT) and has served as CEO since June 2022.
Dr. Mills is an internationally recognized expert in regenerative medicine who led three companies through IPO, creating more than $1 billion in shareholder value.
He ran some of the nation’s most respected medical institutions, including the $5.5 billion California Institute for Regenerative Medicine and Be The Match.
He also serves as a Command Pilot for Angel Flight, transporting patients in remote locations to treatment facilities.
Dr. Mills holds a Ph.D. in Pharmaceutical Science and a B.S. in Microbiology from the University of Florida and completed an internship in Clinical Pathology at Shands Hospital at the University of Florida.
The CEO of Elutia (NASDAQ: ELUT) has a specific plan and the experience to execute upon it.
“I have a Ph.D. in drug discovery and development from the University of Florida.
More specifically, my research was centered on the creation of drug-eluting biologic constructs to address infections in orthopedic surgery.
I was a founder or CEO of three public companies, starting with a company called RTI Surgical, a company I helped start with Jamie Grooms at U.F., and was ultimately sold to a private equity firm for $440 million.
After 10 years of growing RTI, I went on to Osiris Therapeutics as CEO, took them public, and led a team that really created a commercial revolution in the use of biologics in orthopedics and wound care.
Osiris was eventually sold to Smith & Nephew for $660 million.
And so that was the first 20 years of my career.
From there, I went into public service and ran some of the country’s most-respected medical institutions, including the California Institute for Regenerative Medicine, or CIRM, and Be The Match, an organization that handles all bone marrow transplantation in the United States.
And it was during that time that I co-founded Elutia with Kevin Rakin.
I came in as CEO last year, mostly because we saw an opportunity to create another revolution in the industry, by returning to where I started my career with drug-eluting biologics.
And I think this is our biggest opportunity yet…
I believe in pretty serious market discipline.
We won’t take our [Elutia (NASDAQ: ELUT)] technology into a market where we don’t see it offering a pretty clear and obvious value proposition, to either the patient, the physician, or the payor.
In the case of CanGarooRM, Medtronic has actually done a beautiful job of demonstrating the market demand for a drug-eluting envelope in the pacemaker and internal defibrillator space.
We estimate that they have about $300 million in sales of their antibiotic-eluting pouch.
They’re the only company with an antibiotic-eluting pouch on the market right now in the space.
But their pouch is made of a synthetic polymer that dissolves and degrades in the body over time.
Our data demonstrates that if you make that pouch out of a natural biologic material instead, it will remodel into the patient’s own healthy tissue.
That leads to less scar tissue being formed around the device.
It makes things like pacemaker change-outs easier for the patient and the physician.
We also have a lot of market data that shows that while physicians like the idea of using an antibiotic pouch, for the remodeling benefits I mentioned, they would much rather use a pouch made from a biological material versus one made from a synthetic material that dissolves in the body.
We view this market dynamic as highly advantageous for us.
There are currently only four primary players in the pacemaker industry.
Medtronic has about 35% of that market and offers its own antibiotic envelope.
We think the addressable market for antibiotic-eluting envelopes is about $600 million in the U.S. alone with the majority of that untapped.
We plan to introduce CanGarooRM into this market, not as a follow-on or as a me-too, but as a superior product.
We estimate that we will essentially have the remaining 65% of the U.S. market as white space without any direct competition.”
The CEO of Elutia (NASDAQ: ELUT) emphasizes the superiority of his company’s proprietary technology over that of Medtronics (NYSE:MED).
“Our proprietary biomaterials have three key advantages.
First, they’re excellent at device stabilization.
For example, with a pacemaker being placed into someone’s chest wall, oftentimes that pacemaker will migrate down the patient’s chest as a result of gravity and motion, and that can actually cause tension and pull on the leads and actually dislodge them from where they’re supposed to be making contact in the heart.
And that can lead to device failure.
The first thing that these biomatrices are able to do is help stabilize devices.
Whether that be a pacemaker or whether that be a breast implant, patients in either case are at risk of suffering from complications of device migration, and our products can prevent that.
The second has to do with the anti-inflammatory properties of using a biological material versus a synthetic.
Reducing inflammation ultimately leads to less fibrosis or scar tissue formation.
Again, whether it’s a pacemaker or it’s a breast implant, pathologic fibrosis can actually have pretty serious consequences for the patient.
In breast reconstruction, this leads to something called capsular contracture, which oftentimes will require an additional surgery to explant the device.
There’s also capsular formation around the pacemaker, which makes change-out of the pacemaker very difficult and increases the chance of infection.
So, reducing inflammation and fibrosis is the second key benefit.
The third is preventing device erosion.
If you’ve ever seen an older patient with a pacemaker that has really thin skin, where the pacemaker rubs up against the patient’s skin, they actually have a pretty significant chance of eroding through and being expelled.
Putting a natural biological pouch around these devices helps decrease the chance of erosion and significantly increases patient comfort.”
Elutia (NASDAQ: ELUT) has some important near term milestones.
“Our R&D teams have been developing this drug-eluting technology for some time now.
The CanGarooRM line for pacemaker protection is by far our most advanced.
In fact, we actually have a drug-eluting version of it on the market in Europe and have had that since 2021.
In the U.S. though, we will file for market clearance of CanGarooRM with the FDA this quarter and we hope to have that review complete and have a favorable decision within the first half of 2024.
Approval of CanGarooRM — and it’s named RM because it slowly releases the powerful antibiotics rifampin and minocycline — would give us a launch of what we would expect to be our first blockbuster product, with sales reaching potentially into the hundreds of millions of dollars.
Behind that, we have SimpliDermRM for use in breast reconstruction.
I think it’s probably worth pointing out that both of these drug-eluting versions are actually being built on the back of already successful products that are on the market and generating sales of over $25 million annually and are growing without the drug-eluting version in excess of 20%.
We really see this as a good-to-great story.”
Read the complete interview with Dr. Randy Mills, co-founder and CEO of Elutia (NASDAQ: ELUT), exclusively in the Wall Street Transcript.
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