A Life’s Journey Comes Full Circle

In my adolescence, I had planned to be an engineer or researcher. However, taking a teen tour of Europe, I met a boy who was born with Hemifacial Microsomia. His mother had German measles in her first trimester of pregnancy and he was born with congenital facial deformities. As he was the only one on the tour who could beat me in chess, we became fast friends. This friendship recast my life journey into being plastic and reconstructive surgeon as I saw the changes in his personality that accompanied his plastic surgical improvements. I wanted to be able to save others like my new friend from being outcasts due to facial deformity. I went to Cornell University, then Cornell Medical School, did both my residencies and chiefships at the Presbyterian New York Hospital, became a board certified general surgeon, and then a board certified plastic surgeon. My love of research persisted and was continued in undergraduate Chemistry honors and then as principal investigator of both animal and clinical studies during and my after surgical residency.

Fast forward to the early days of liposuction, when we thrust a rigid tube attached to a vacuum back and forth underneath the skin thousands of times an hour. I knew there had to be mechanical solution easier on both patient and Doctor. That led to the first in my series of tissue aspiration patents. A non-exclusive license of it to Mentor reached the market as the ARC II Reciprocating Cannula® which lessened the surgeon’s exertion and speeded patient recovery. That license ultimately found its way into Ethicon’s portfolio and created the $500 Million per year power assisted liposuction market.  Since I was at Lincoln Center almost every night with my love of ballet and music, I added a few evenings at Fordham Law School to become an IP attorney to help me manage those licenses of what was now a growing and worldwide patent portfolio from a R&D company I set up, Rocin Laboratories.

BioSculpture Technology, Inc. was founded as device company to capitalize on my subsequent tissue aspiration improvements. These advanced designs had an inner tube rapidly reciprocating inside an outer sheath. The aspirating hole was aligned with a slot, enabling sufficient tissue contact to aspirate fat, but sparing the patient of the trauma of the advancing inner cannula tip and the surgeon from the drudgery of having to reciprocate the cannula him or herself, literally unleashing the artist in the surgeon®. The mechanical advantage of this tube-within-a-tube technology was embodied in the Airbrush® Liposculptor II which further reduced surgeon’s exertion and patient trauma, speeding recovery and lessening bruising and swelling. My practice was so successful in my landmarked townhouse at 8 E 62nd St. in Manhattan that every now and then, I simply needed and took a break from it as I grew the medical device business.  Then I would miss operating and surgery, and enthusiastically emmerce myself back into clinical practice again.  I picked up an MBA from Columbia Business School to help manage the growing business which gave me opportunities to travel, lecture and market at places as remote as South Korea.

Though liposuction is generally considered an operation of inches and not one measured in pounds, the Airbrush® Liposculptor’s mechanical advantage allowed the surgeon to effortlessly remove as much as 10 lbs. in an hour, being limited only by the hemodynamic shifts caused by larger fat removals, generally carried out in an outpatient setting such as my townhouse.

As I had a busy practice in Manhattan and used our own equipment, I began operating on overweight and then frankly obese patients. I was struck by the fact that a significant amount of ”belly” fat was not subcutaneous where I could get to it with liposuction but deep inside the abdomen. I began to study fat metabolism and learned that deep, visceral fat underneath the muscles secretes noxious cellular hormones and one of them, resistin, antagonizes insulin. This poison prevents sugar from entering the cells so the blood sugar rises and it is eliminated in the urine, causing type 2 Diabetes, the kind 90% of diabetics have. The patient is resultantly hungry, has a “brain fog”, and has no energy, proving the old concept of obese patients as just having no will power to be a total misconception. The patient with visceral fat is “chemically challenged” with metabolic syndrome. He or she is likely to have sleep apnea, gastric reflux, hypertension, type 2 Diabetes, a bad lipid profile, and be more likely to have vascular disease, autoimmune diseases or cancers. His or her life is shortened and its quality reduced.

To address what I saw as a new challenge, I turned my attention to finding a safe way to remove this visceral or “belly” fat to cure the metabolic problem and eliminate the cause of type 2 diabetes. Fortunately, our tube-within-a-tube technology is easily transformed from a wand into a pistol configuration and customized as the EVL® device for the minimally invasive laparoscopic removal of the visceral fat in the intestinal mesentery deep within the abdomen. BioSculpture Technology, Inc. now has eight allowed US Patents, and others pending, which protect both the method and the device for the endoscopic removal of this noxious visceral fat.

Today, launching production of this EVL® device as well as sleeker, electromagnetic versions of the earlier two cosmetic devices (Airbrush®  Liposculptor IIE and Airbrush® Liposculptor III) and establishing Centers of Excellence about the globe which can help these patients both cosmetically and metabolically, has become my new life goal. It allows me to utilize all my aptitudes and knowledge and will be my way of giving back to a medical profession that has been so very good to me.

And coming full circle, though we’re so evenly matched we seldom play chess any more and there are few traces of his earlier deformity, my childhood friend is the second largest investor, after myself, in my medical device company, sharing in this goal of bringing this disruptive technology to the millions of patient who can benefit from it.


CDC Reports the U.S. is Supersized

The CDC reports that 7 out of 10 Americans are overweight or obese and almost 4 out of 10 Americans are obese.

There is an underlying pattern of racial and ethnic disparity.  Almost half of Hispanics and blacks are obese with obesity rates for 2015-2016 of 47% and 46.8% for adult Latinos and non-Hispanic blacks respectively.

Obesity is most readily defined by Body Mass Index (“BMI”) which takes a person’s weight in kilograms and divides it by their height in meters squared.  For adults, those with a BMI between 18.5 and 24.9 are considered to have a normal weight.  A BMI between 25 and 29.9 is considered overweight and anything above 30 is deemed obese.  The NIH provides a calculator for you to determine your own BMI.

It is apparent to anyone following these statistics or even just walking down the street that current efforts to control the obesity problem have failed to reduce obesity rates.

We have learned that visceral fat or “belly” fat within the abdomen hijacks the metabolism by secreting the cytokine resistin.  This cellular hormone antagonizes insulin, blocking sugar from entering cells or reaching the brain.  It saps energy, shuts down the metabolism, causes brain fog, and hunger.    Cellular hormones are secreted directly into the portal circulation and the body’s protein factory, the liver, is commandeered to produce bad lipids which cause strokes and heart attacks.  Mesenteric fat thickness is closely correlated with carotid intimal narrowing.  Belly fat doesn’t just shorten your life, it reduces its quality with sleep apnea, gastric reflux, type 2 Diabetes mellitus, heart attacks, strokes, autoimmune diseases, and cancers.

New technology facilitates a new approach to the problem.  Rather than just starving this belly fat and letting it remain in place as do current bariatric surgical alternatives, removing it this visceral fat in a minimally invasive procedure may prove to be a simpler, more direct and permanent, safer and highly effective alternative.  Endoscopic visceral lipectomy could be just be what the doctor ordered.   It is clearly time to seek new approaches and fresh solutions as obesity rates continue to rise.


MedTech Status Mundi

Quantum theory holds that everything that can occur happens at the same time until observation fixes the outcome.  The observation is not only determined by the perspective of the observer but also by the precision of the observation.  Since each event subsequent to the first observation plus/minus its margin for error determines one or more subsequent events, we can envision a broadening cone of future events through time determined by that first observation.

It does seem rather hapless to make any prediction based upon the current state of uncertainty in these early days of the Trump presidency, the liberal revolt against it,  and Brexit’s uncertain effect upon the UK and the EU.  That said, let’s venture to do so with an admittedly large margin for error from the perspective of an American medical device company bringing a new product through the F.D.A. approval  process and into the domestic and ultimately the world market.

The pluses.  The hold on the medical device tax and President’s Trump stated intent to ease regulatory burdens and reduce corporate tax rates favors development and production.  We see the U.S. stock market is hitting  new highs in anticipation of these favorable changes with $2.9 Trillion USD added market capitalization.  Uncertainties regarding EU survival and stability and even the terrorist threat from open borders favors foreign investment in U.S. Companies as a safe harbor.  Companies with overseas funds may be able to repatriate overseas cash without onerous tax burdens to spur domestic production and hiring.  If jobs are created, the velocity of money will increase to allow an increased and ready market for the purchase of newly produced products.

The maybes and minuses.   First of course, is the general uncertainty which tends to have a dampening effect on investment.  Even if the lowering of the corporate tax rate is retroactive,  it will be a minimum of a year before it has enough effect on earnings to justify the current stock multiples and valuations.  It is predictable the stock market will have a substantial correction upon the news it has anticipated and priced in as the changes slowly filter down to corporate bottom lines.  The strength of the U.S. dollar and the possibility of  tariff wars may not bode as well for international sales.  Rising interest rates may also add to inventory costs.

So how do we assess this grab bag of uncertainties?  We guage the environment as more positive than negative for domestic sales, corporate profits, regulatory approval times, stock prices, and investment.  And after the anticipated intermediate market correction, we believe the investment environment should be substantially improved without  likelihood of any substantial downside for U.S. medical  device companies in 2017 and 2018.  Time will tell, but this seer is currently wearing rosy glasses.