The medical device sector of the health care industry in the United States was denied access to doctors and hospitals for long periods of time as the successive waves of COVID infections swept through the country starting in early 2020. The establishment of new medical device procedures, whether or not approved by the FDA, was severely constrained by the lack of any ability to train medical professionals, let alone access to patients. These three CEOs describe how the kept their medical device companies alive through the global pandemic.
Joseph Sardano is CEO of Sensus Health Care, Inc. (NASDAQ:SRTS).
A recognized leader in the medical device sector of the health care industry, Mr. Sardano has spent more than 30 years in management and marketing. He has a successful history of introducing and commercializing new technologies and services in many areas, including electronic brachytherapy, PET and PET/CT, SPECT, MRI, lithotripsy and digital radiography. Before joining Sensus Health care, Mr. Sardano held leadership and management roles at CTI Molecular Imaging, GE Medical Systems, Siemens Medical Systems, Elscint Inc. and Toshiba America Medical Systems, among others.
“Over the past year up to date, we have achieved four straight quarters of profitability, which is a big deal for our company. Mostly, this was due to increased reimbursement provided by Centers for Medicare and Medicaid Services, along with a new leasing program called fair market value lease that we’re providing to our customers. It allows our customers to now purchase our more expensive product, which has a breakeven of approximately a little less than two patients a month for treatment of skin cancer…
We’re selling to the dermatology and plastic surgery space. And we do have approximately 50 hospitals, mostly teaching hospitals around the country that have the system as well.
So the product technique or technology, the characteristic of the technology, is that it uses radiation to treat skin cancer, but it’s a very mild radiation, which is the reason why they call it superficial radiation therapy.
And the characteristic of that radiation is that it’s proton therapy.
And so proton therapy is a lot different than electron beam, which is used for all the other cancers.
The proton therapy only penetrates five millimeters below the surface of the skin, which makes it ideal for skin cancer or other skin inflammatory diseases. And then it dissipates — it goes away. It only kills the cancer cells, but allows all the healthy cells to remain and to continue to work in the body.
It’s a product with technology that actually has existed for decades. And metaphorically, we’ve taken it from what the old telephones look like to now the telephones that we have today. So we’ve modernized it quite a bit, and we’ve made it pretty much foolproof to operate.”
Keith C. Valentine has served as Chief Executive Officer of SeaSpine Holdings Corp. (NASDAQ:SPNE), a publicly traded medical device company focused on spinal implants and orthobiologics, since May 2015.
John J. Bostjancic has served as Chief Financial Officer of SeaSpine Holdings Corp. since March 2015, and in May 2022 Mr. Bostjancic was appointed to his expanded role of Chief Operating and Financial Officer.
“Spine surgery typically requires two things: one, some sort of implant system that is used to stabilize the disease pathology, and two, an orthobiologic that’s used to permanently fuse that stabilized area.
We develop and market both our spinal implants systems and orthobiologics products but outsource the production of our spinal implant systems to third party machine shops.
On the orthobiologics side, we manufacture those products ourselves in our Irvine, California, facility.
We also recently acquired 7D Surgical, based out of Toronto, which developed our market-leading FLASH Navigation with 7D Technology.
The history of the company is that we were once part of a much larger company called Integra LifeSciences, that decided to spin off its spine business back in 2014. And so, a number of our current management team were brought on board to help with the spinoff and SeaSpine became an independent, publicly traded company in July 2015.
For every three shares an investor owned of Integra LifeSciences, they received one share of SeaSpine.
But generally, investors that owned Integra didn’t necessarily want to be investors in a pure-play spine company, so we hosted an IPO-like process to create broader investment interest in our story as an independent growth-focused company…
Today we’re very proud of the fact that more than 80% of our spinal implant revenue comes from products launched since the spinoff, those products and systems that we have put our fingerprint on from a development perspective.
Throughout the years, we have worked very closely with leading surgeons to design those products to meet their evolving clinical needs. We’re also quite proud of the fact that now we are a completely new company from a development and innovation capabilities perspective.”
Barton P. Bandy is President and Chief Executive Officer of ReShape Lifesciences Inc. (NASDAQ:RSLS).
Mr. Bandy brings extensive leadership experience in health care, specifically in the bariatric and minimally invasive surgery segments. Most recently, Mr. Bandy was President and Chief Executive officer of BroadSpot Imaging Corporation, a privately held ophthalmic imaging company, and prior to that he was President of the Wellness Division at Alphaeon Corporation.
He previously spent 10 years as the senior executive leading the Inamed and Allergan Health Divisions through the launch, growth and transition of LAP-BAND®. Mr. Bandy formerly held positions of increased responsibility in sales, marketing and professional education at Ethicon Endo-Surgery and Karl Storz Endoscopy, America.
“It’s an exciting time for ReShape. There’s not a lot of similar competitors out there.
That’s good news as there’s not really anything in the works for laparoscopic or minimally invasive laparoscopic surgery that will be competing against us. And even if something was to get through the FDA process and get an approval in the next year or two, it’s going to take them significant time and cost to gain reimbursement from the insurance carriers. We’re really creating a new market, an expanded market.
Trying to go to war with them and compete for five minutes in the OR with a surgeon to try and change their preferences — that’s just not the model that was going to work for us.
Therefore, focusing on the patient flow and guiding these patients to their practices, in addition to the patients that these practices were seeing for their stapling procedures is additive. It’s helping more people, it’s creating a new market, it’s creating more business for the practices, it’s providing education to patients that maybe didn’t know they had preferable options before.
We did some focus groups and many people in their 30s didn’t even know what the Lap-Band was, because for the last decade or so, it wasn’t really marketed well, and people now in their 30s were in high school or college back then.
Weight loss and bariatric surgery wasn’t really part of their attention span. For some, now it is. And our demographic, primarily, is a female that’s 30 to 50 that has gotten to that point where they want to do something, but they don’t really want to have something that’s major or aggressive surgery.
We have so many benefits with what the Lap-Band offers.
It’s often performed in an outpatient setting. Doctors and patients both like that, especially in the wake of COVID, they don’t have to go to the hospital.
You can go in and get your procedure in the morning, go home that afternoon, and in a few days go back to work.
It’s very confidential and it’s not a big disruption to your life and your responsibilities. That’s something that’s highly desirable to many.
It’s adjustable with a small port connected to the Lap-Band that’s just on top of the abdominal wall underneath your skin. With a simple office procedure, the doctor can either inject or remove saline from the inner balloon of your band, allowing it to be tightened or opened.
What this facilitates, if you think of a sand timer with the Lap-Band around the top of your stomach, you have a much smaller stomach to fill up with that same sensation of being full.
So you become full faster.”
Get the complete picture on these dynamic medical device companies by reading the entire interviews, only in the Wall Street Transcript.
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