Obesity is a killer disease, #1 cause of preventable death after smoking, 21 or more healthcare condition stem from obesity. In 90s and early 2000s obesity was becoming an epidemic and proliferating in urban China, India and emerging wealthy countries. In early 2000s, it was hard to imagine that obesity is going to be a worldwide problem. W.H.O now reports the following:
- More than 1.4 billion adults, 20 and older, were overweight in 2008
- Of these overweight adults, over 200 million men and nearly 300 million women were obese.
- Overall, more than 10% of the world’s adult population was obese
- More than 75% of overweight children live in developing countries
Since AMA declared obesity as a disease in June 2013 there has been a reversal of mind set, even the FDA is working on a fast track designation for obesity interventions, gastric band acquisitions were huge (no pun intended) over a $1 Billion, which made many innovators and investors rich. Bariatric physicians and surgeons who treat obese patients have studied the clinical trials involving use of medical devices like the gastric bands and comparing them to the current drugs treating obesity.
Results were mind boggling, medical devices generated over 40% excess weight loss (EWL) with no compromise on other organs. Some data showed resolution of diabetes in patients with gastric band. Weight loss pills or drugs can help with 10% excess weight loss at the most and the weight loss lasts as long as the drugs are taken. Not to mention the adverse events associated with the appetite suppressing drugs.
A
new research report
forecasts that the weight loss and obesity management market in North
America will increase to $139.5 billion in 2017, up from $102 billion in
2012.
With the life science IPO boom, investors are exploring the medical device space which has higher predictability than the drugs and quicker upsides. The question remains to be seen whether American Medical Association's decision
to consider obesity a disease will create a deluge of IPOs in obesity medical technologies in this very large market. When the June decision from the AMA came down, it marked a
real enthusiasm amongst investors to invest in medical devices treating obesity. GiDynamics a MA based company trades on Australian stock exchange, J&J has a gastric band, other companies that are very promising but are not in the public market are Onciomed and Reshape medical. Onciomed based in Irvine which is known as the medical device innovation hub. ReShape Medical, Inc. was formerly known as Abdominis, Inc. The company
was founded in 2005 and is based in San Clemente, California
Top Obesity
Technology Picks 2014
Bariatric
Surgeons: Long Term Implants /Permanent Implants
|
Gastro-enterologist: Temporary Implants
(9 Month implants)
|
Gastric Band-Technologies acquired by J&J and Allergan (Irvine,
Ca) for over $1 Billion. FDA approved, #1 seller in the US and Internationally
Recently, lap-band technology
sold to Apollo
|
GI Dynamics
Listed on Australian Stock Ex
|
|
In clinical trials.
|
Reshape (Orange County, Ca) completed clinical trials
Obalon (Carlsbad, Ca)
|
Enteromedics (ETRM)- Awaiting FDA approval
|
Baranova
|
Reshape medical (San Clemente, Ca) has a duo balloon that has completed clinical trials. This technology is a temporary implant and can benefit low BMI patients.
The Duo balloon provides more feeling of fullness while it is in the stomach. The balloons are filled with saline and implanted by a gastroenterologist vs a bariatric surgeon who are experts in laparoscopic surgery.
Onciomed, Inc the name is based on the unit measure of weight "Ounce". The company has a very innovative long term yet reversible medical device implant for bariatric surgeons. This company to date has been funded by private investors including physicians. The company showcased its GVS system for bariatric surgeons for the first time at the Cleveland Clinic Medical Innovation Summit late 2013 and got many cheers and applauds as the GVS could become a game changer and replace the invasive gastric surgery. The GVS technology imitates gastric surgery without cutting and removing portions of the stomach. Other advantages the company claims is short procedure time of 40 min based on their early clinical experience.
Onciomed plans to enter the EU, Latin America and Asia Market before entering the US market.
Enteromedics (ETRM) is a neuro stimulating device pending FDA approval. Working on multiple ongoing clinical trials, including the ReCharge Study, the
Company's VBLOC® vagal blocking therapy Premarket Approval (PMA)
application is pending. The technology is designed to intermittently block the vagus nerves using
high-frequency, low-energy, electrical impulses. VBLOC allows people
with obesity to take a positive path towards weight loss, addressing the
lifelong challenge of obesity and its comorbidities without sacrificing
wellbeing or comfort. EnteroMedics' Maestro Rechargeable System has received CE Mark and is listed on the Australian
Register of Therapeutic Goods.
Medical device regulatory experts in a survey suggested that companies filing for FDA approvals needs to revisit their regulatory strategy, they suggest that the well funded companies continue to make mistakes like Satiety, Inc.
Satiety which had a promising technology called TOGA made several study design mistakes, one of them was by setting the clinical end points too hard to accomplish clinically, if any company makes lofty claims to the FDA, you have to prove it to obtain approval. Experts think that TOGA would be on the market, if those claims were modulated to reasonable expectations and met user needs of a low profile device. Look at drug companies, they get approvals by suggesting that the drug can help with 10% excess weight loss.(not body weight loss). Obesity companies started in early 2000 were ahead of its time.
Today, obesity and diabetes is the hottest sector in the US and OUS.(Outside U.S.A.). Post AMA decision in June of 2013, this sector has the opportunity to get devices quickly approved, and reimbursed. Patients are ready to pay out of pocket to get treated. All this means $$$$ for investors.
Large players like Medtronic, Abbott, Bard and Boston Sci don't have any presence in the obesity space. J&J, Covidien are dominating the space. Large non-US medical device players may jump in and acquire these prospective companies. Even Private Equity and drug companies are exploring to take the path that Allergan a drug maker did in 2006 by acquiring lap band from California based Inamed.
Investment bankers are exploring IPO deals.
The same debate has spilled over to a
discussion on the LinkedIn Medical Devices Group.
Politics aside, what is salient about the discussion is that some users
of the group believe the growing market holds great promise for medical
device inventors.
Take user
Paul Stein
for instance. A medical device professional, formerly with St. Jude
Medical, Stein believes that medical devices will succeed in tackling
the epidemic that is obesity where pharmaceutical companies have failed.
Here is an edited version of his comments:
"For us in the medical devices industry, we need to look
at this as a tremendous opportunity to create the next generation of
medical devices.
The current set of drugs, along with their toxicities, do very
little. And, the one marketed medical device, the Lap Band, has proven
its worth in treating obesity. But, the most important fact that needs
to be soberly understood is that the little medical device company that
invented that device was paid $1.2B by Allergan for it. Yes, that's a B."
One of the other very popular treatments for obesity, the vertical
sleeve gastrectomy, uses several thousands of dollars of linear staples
(Covidien, J&J) per procedure. Performed over a million times per
year, you do the math.
The first National Obesity Summit
was held May 7–10 at the Delta Lodge in Kananaskis, Alberta. This was
Canada's first "all-obesity" meeting and was a huge success. Almost 500
delegates attended the conference, which surpassed the venues capacity.
Researchers, practitioners and other stakeholders from a wide range of
disciplines and interests came to Kananaskis to share with and learn
from their peers in a unique and interactive environment. The oral
presentations, poster sessions, workshops and seminars represented a
fascinating cross-section of thought and novel findings on many of the
key issues in obesity today. Plenary Sessions included: 1) Obesity and
Mental Health, 2) Behavioural and Biological Determinants of Obesity, 3)
Obesity Management and 4) Health Economics & Policy of Obesity.
Please see the final programme for further details.
Gi doctors are not laparoscopic surgeons so cannot insert a gastric band. 
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