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Cardiologist invests US$60 m<br />
in DEB device firm<br />
An Indian-American<br />
cardiologist and<br />
entrepreneur, Dr Kiran Patel,<br />
has invested $60 million<br />
in a medical company that<br />
develops sirolimus-coated<br />
balloons as an alternative<br />
to stents used in coronary<br />
angioplasty.<br />
Concept Medical Inc, a<br />
Florida-based medical device<br />
company, has approached<br />
USFDA for an Investigational<br />
Device Exemption (IDE) for the<br />
world’s first sirolimus-coated<br />
balloon.<br />
The company can<br />
commence clinical studies<br />
to determine the safety and<br />
efficacy of the device after<br />
obtaining IDE from the US<br />
drug regulatory agency.<br />
According to the company,<br />
the investment by Dr Kiran<br />
Patel will pave way for clinical<br />
studies using the device.<br />
The fund will be utilised<br />
to augment clinical data and<br />
clinical registries to qualify<br />
for re imbursement in the<br />
European markets, where the<br />
company has commercially<br />
launched the product, said<br />
Concept Medical Inc.<br />
MagicTouch-DEB, the<br />
sirolimus -coated balloon with<br />
application in coronary and<br />
peripheral artery disease, is<br />
currently available in many<br />
parts of the world.<br />
Extended applications<br />
of MagicTouch-DEB in renal<br />
transplant, erectile dysfunction<br />
and Arteriovenous Fistula/<br />
Arteriovenous Graft (AVG)<br />
for renal dialysis patients are<br />
under ongoing clinical trials.<br />
The company has initiated<br />
a series of global clinical<br />
programmes for MagicTouch-<br />
DEB including Nanolute,<br />
Eastbourne, Transform-I,<br />
Transform-II. They are also<br />
pursuing regulatory pathways<br />
in Japan and China.<br />
Concept Medical has a<br />
manufacturing subsidiary in<br />
India, Envision Scientific Pvt.<br />
Ltd., where all their products<br />
are made. A portion of the<br />
funds will also be utilized to<br />
bolster the manufacturing<br />
operations. The company’s<br />
global distribution and<br />
marketing network is operated<br />
from offices in India, Singapore,<br />
Netherlands and Brazil. ESPL<br />
also has an India-focused,<br />
marketing and distribution<br />
business.<br />
A Board-certified<br />
cardiologist, Dr. Patel<br />
completed his residency<br />
in Internal Medicine in<br />
New Jersey after obtaining<br />
a medical degree from<br />
Gujarat University in India<br />
and an internship in Africa.<br />
In 1982, he completed his<br />
fellowship in Cardiology from<br />
a Columbia University-affiliated<br />
programme.<br />
Dr. Patel subsequently<br />
entered the managed care<br />
industry and was the chairman<br />
of WellCare of Florida till 2002.<br />
Chan Zuckerberg and Gates<br />
Foundation partner to track<br />
infectious diseases<br />
The Chan Zuckerberg<br />
Biohub (Biohub) and<br />
the Chan Zuckerberg<br />
Initiative (CZI) have<br />
launched IDseq, an open<br />
source cloud-based<br />
analysis platform to detect<br />
and respond to infectious<br />
disease outbreaks around<br />
the world.<br />
The tool works by<br />
rapidly combing through<br />
terabytes of metagenomic<br />
data for pathogens<br />
in a given sample. By<br />
identifying diseasecausing<br />
pathogens,<br />
IDseq can provide an<br />
actionable report of what<br />
is happening on the<br />
ground in labs and clinics<br />
anywhere in the world.<br />
In a recent pilot<br />
project, IDseq has been<br />
employed to identify<br />
the presence of the<br />
mosquito-borne viral<br />
chikungunya disease in<br />
the spinal fluid of patients<br />
at Dhaka Shishu Hospital,<br />
the largest paediatric<br />
hospital in Bangladesh.<br />
Based on this information,<br />
follow-up testing<br />
identified additional<br />
cases of neuroinvasive<br />
chikungunya from the<br />
same time period that<br />
were previously labeled<br />
“mystery cases.”<br />
To enable broader<br />
access to IDseq and<br />
valuable on-the-ground<br />
feedback, the Bill &<br />
Melinda Gates Foundation<br />
announced a new<br />
funding opportunity for<br />
global health workers<br />
via the Bill & Melinda<br />
Gates Foundation Grand<br />
Challenges Explorations<br />
Initiative. Awardees will<br />
receive molecular biology<br />
and bioinformatics<br />
training and free access<br />
and compute on the<br />
IDseq platform supported<br />
by CZI, along with the<br />
necessary equipment<br />
and supplies immediately<br />
needed to begin work in<br />
their own countries.<br />
The Biohub and<br />
CZI plan to make IDseq<br />
available within the<br />
next year to partner<br />
organizations, and then<br />
more broadly afterward.<br />
The software itself is<br />
open-source and freely<br />
available.<br />
The CZ Biohub is<br />
a non-profit medical<br />
research organization<br />
collaborating with the<br />
University of California,<br />
Berkeley, Stanford<br />
University and the<br />
University of California,<br />
San Francisco.<br />
The Chan Zuckerberg<br />
Initiative, founded by Mark<br />
Zuckerberg and Priscilla<br />
Chan is a philanthropic<br />
organization.<br />
<strong>NOVEMBER</strong> <strong>2018</strong> / FUTURE MEDICINE / 11
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