Medovex – From the Dean of Healthcare Entrepreneurism – at NASS

Steve Gorlin, 80 years old, is the dean of American healthcare entrepreneurism. He personally founded or backed dozens of start-up companies—six of which surpassed a billion dollars in valuation.^[1] One company, Medivation sold for $13.25 billion. (See details in the footnote below).

Along with his commercial work, Steve serves on numerous charitable and scientific boards including Mass General’s prestigious Research Institute Advisory Council.

And, one of his latest ventures is in spine and its management team will be hosting an information session at Business Suite Booth # E2107 during NASS.

The company’s name is Medovex. It’s technology is an innovative approach to treating chronic back pain associated with facet joint arthritis.

Gorlin’s involvement makes Medovex definitely worth checking out if you’re attending NASS.

The Gorlin Magic

Gorlin has earned a special place in the annals of healthcare by supporting hundreds, even thousands of physicians-inventors, engineers and other entrepreneurs – with serial success.

Probably no other healthcare entrepreneur is responsible for more products or millionaires than he is.

Here is one of my favorite stories about Steve Gorlin which illustrates part of what makes him so effective and special.

^[1] Steve personally founded dozens of companies worth tens of billions of dollars including HycorBiomedical, Inc. (acquired by Agilent), Theragenics Corporation (NYSE: TGX), CytRx Corporation (NASDAQ: CYTR), Medicis Pharmaceutical Corporation (sold to Valeant for approximately $2.6 billion), EntreMed, Inc. (NASDAQ: ENMD), MRI Interventions (MRIC), DARA BioSciences, Inc. (NASDAQ: DARA), MiMedx (NASDAQ: MDXG), and Medivation, Inc. (NASDAQ: MDVN). Mr. Gorlin served for many years on the Business Advisory Council to the Johns Hopkins School of Medicine and on The Johns Hopkins BioMedical Engineering Advisory Board. He presently serves on the board of directors of the Andrews Institute. Mr. Gorlin founded a number of non-medical related companies, including Perma-Fix, Inc., Pretty Good Privacy, Inc. (sold to Network Associates), and NTC China. He started The Touch Foundation, a nonprofit organization for the blind and was a principal financial contributor to the founding of Camp Kudzu for diabetic children

Twenty years ago Steve invited me to observe the first-in-man test of his venture’s new medical device. The venture, Surgi-Vision, was conducting the test at Johns Hopkins University cardiology unit in Baltimore. As the Managing Director of Life Sciences Research for Stephens, Inc., it was my job to stay on top of new medical technologies and companies so I welcomed the opportunity to see a new device so early in its development.

First-in-man procedures are tricky. Not only must the hospital review boards bless the project which means assuming all risks of putting a basically unproven device in a human, but the patient themselves understand and sign off on every possible adverse scenario.

My first question to Steve when I met him in the lobby of Cardiology unit was about that patient. Demographics? Medical condition? Risks? So on and so forth.

Steve interrupted me. “I’m the patient.” Seriously? “You’re the CEO of this company and you are the test subject for your own device?” “Yes.”

He would not sell something he hadn’t tested on himself.

The procedure took a couple of hours. Steve survived. There was hope.

As we were walking out of the medical center Steve asked me how I was getting back home. At the time I lived in Little Rock, Arkansas. Steve went on to say that he would be happy to give me a ride back in his private plane.

How can you say “no”?

We get to the airport and as we’re walking up to his plane Steve turned to me and said, “Robin, I won’t be able to talk to you very much on the flight. I’m flying the plane.”

I realized then that I was in the presence of the most out-of-the box yet serially successful entrepreneur I’d ever met.

Steve’s Thousand Best Friends

The other measure of a great entrepreneur is his/her ability to reach, connect and draw into their orbit other successful people.

A couple years after watching Steve be guinea pig for his company’s new product, I receive a phone call from him. “Robin, what would you think about a company with eight Nobel Prize winners?”

His new venture had, literally, eight Nobel Prize winners advising him on new technology and gratefully pledging their names and expertise to his project. And they had become his personal friends.

Steve, I said, it would be astonishing.

Steve has a thousand best friends.

Which brings me to his latest venture—Medovex—into which he has attracted a major league roster of top orthopedic executives.

Medovex, the 200-Year Old, New Orthopedic Company

If companies are the sum of their parts, then Gorlin’s Medovex, is a 200-year old emerging orthopedic growth company.

To launch Medovex in 2013, Steve spun his Rolodex and tapped the former President of Smith & Nephew (Larry Papasan), a retired Major Army General (Lou Hennies), the founder of the Andrews Institute (James Andrews, M.D.), the Chief of Staff at Shriner’s Hospital for Children (Randal Betz, M.D.), the former CFO from MiMedx (John Thomas), the former Group President for Global Orthopedics at Stryker (Ron Lawson) and, finally, the Vice-Chancellor for Research and Texas A&M (Jon Mogford Ph.D.).

Plus Steve and the other members of Medovex’s team, this company have more than 200 years of healthcare and management experience.

Medovex’s first product is DenerveX®—a CE Marked system for debriding facet joints of the spine.

DenerveX®

DenerveX, which has CE mark and is cleared for sale in Australia, is beginning the FDA clearance process and, says Jesse Crowne, the company’s executive co-chairman, should have an FDA decision sometime over the course of the next 24 months.

The product is designed to ameliorate facet joint pain resulting from the degenerative effects of arthritis in the spine.

The system applies a novel method of facet debridement to this difficult problem of chronic back pain originating in the facet joint.

Scott Haufe, M.D., who is practicing physician affiliated with Healthmark Regional Medical Center and Sacred Heart Hospital in Destin, Florida and is board certified in three disciplines—anesthesiology, hospice care, palliative medicine and pain medicine, tested facet nerve debridement on 174 patients and here is what he learned^[2].

Using Debridement Instead of Ablation for Facet Nerve Pain

DenerveX’s approach to chronic back pain due to degenerative facet joint arthritis is to use a debridement approach as opposed to, for example, nerve ablation, rhizotomy or cryo denervation.

Dr. Haufe conducted a retrospective, observational and open label study which reviewed the experience of using debridement on 174 patients with chronic back pain originating with the facet joint.

The patients (77 women, 97 men; mean age 64, range 22-89) reported facet pain in cervical (45 patients) thoracic (15 patients) and lumbar (114 patient) locations.

All patients were treated at Dr. Haufe’s clinic using endoscopic facet debridement and had a minimum of three years follow-up.

The test to determine whether the pain patients were reporting was, in fact, due to facet joint nerves was as follows: 1 ml of 0.25% bupivacaine was injected by the investigators using a 22 gauge needle with fluoroscopic guidance into the joints near their reported pain. Patients with at least 75% improvement in their back pain immediately following injection were diagnosed by Dr. Haufe and his colleagues as having facet pain.

At final follow-up, 77%, 73%, and 68% of patients with cervical, thoracic, or lumbar disease, respectively, showed at least 50% improvement in pain.

The average operating time per joint was 17 minutes (range, 10-42).

The average blood loss was 40 ml (range, 10-100).

The complications from the procedure included suture failure in two patients, requiring re-closure of the incision. There was no infection or nerve damage beyond what was intended.

Dr. Haufe and his colleague concluded: “Our results demonstrate a comparable efficacy of endoscopic facet debridement compared to radiofrequency ablation of the dorsal nerve branch, with durable results.”

Source: Scott Haufe, M.D.

The Future

Steve is justifiably proud of Medovex’s progress since he founded the company. While he is not involved in day-to-day operations, he has a strong team in place to do just that. In August, Jesse Crowne, who was formerly president of Vavotar Life Sciences and a managing partner of the Gorlin Companies, joined Medovex as its director and executive co-chairman of the board. Jesse had been acting as Medovex’s vice president of business development. Medovex’s CEO is Jarrett Gorlin, formerly president of Judicial Correction Services, President and COO is Patrick Kullmann, formerly senior director at Medtronic in their $2.3 billion Cardiovascular Division.

Next year Medovex will truly become an emerging growth company when, say the analysts who are tracking this company, sales can move into the $7-8 million annual run rate.

See Medovex at Business Suite Booth # E2107 during next week’s NASS meeting in Orlando.

And connect with the latest from America’s greatest healthcare entrepreneur.

^[1] Steve personally founded dozens of companies worth tens of billions of dollars including HycorBiomedical, Inc. (acquired by Agilent), Theragenics Corporation (NYSE: TGX), CytRx Corporation (NASDAQ: CYTR), Medicis Pharmaceutical Corporation (sold to Valeant for approximately $2.6 billion), EntreMed, Inc. (NASDAQ: ENMD), MRI Interventions (MRIC), DARA BioSciences, Inc. (NASDAQ: DARA), MiMedx (NASDAQ: MDXG), and Medivation, Inc. (NASDAQ: MDVN). Mr. Gorlin served for many years on the Business Advisory Council to the Johns Hopkins School of Medicine and on The Johns Hopkins BioMedical Engineering Advisory Board. He presently serves on the board of directors of the Andrews Institute. Mr. Gorlin founded a number of non-medical related companies, including Perma-Fix, Inc., Pretty Good Privacy, Inc. (sold to Network Associates), and NTC China. He started The Touch Foundation, a nonprofit organization for the blind and was a principal financial contributor to the founding of Camp Kudzu for diabetic children

^[2] Haufe SMW, Mork AR. Endoscopic Facet Debridement for the treatment of facet arthritic pain – a novel new technique. Int J Med Sci 2010; 7(3):120-123. doi:10.7150/ijms.7.120. Available from http://www.medsci.org/v07p0120.htm