2. THURSDAY, JULY 31 , 2014 MEDICAL DEVICE DAILY™ PAGE 2 OF 9
MEDICAL DEVICE DAILY
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DAILY M&A
FINANCINGS
See M&A, page 6
Thermalin Diabetes raises $5.9M
to support new insulin products
Staff Report
Thermalin Diabetes (Cleveland) has received $5.9 million
in fresh capital from private investors in the first tranche of a
Series B round. The company says it is developing new types
of insulin and the new funds will augment the company’s $1.5
million grant from the National Institutes of Health’s National
Institute of Diabetes and Digestive and Kidney Diseases.
The company also said it plans to begin studies for a highly-
concentrated, rapid-acting insulin for people who need higher
insulin doses to control their blood sugar. The product would
allow insulin pumps to be much smaller, reducing the insulin
reservoir 80%, according to the company.
The infusion of cash will also support large animal studies
for Thermalin-biphasic, a next-gen replacement for pre-mix
insulins which doesn’t require refrigeration. Thermalin Diabetes
is also in partnership with the Juvenile Diabetes Research
Foundation to find a ultra-fast-acting insulin candidate to be
used in an artificial pancreas.
In other financing activity: EDG Partners (Atlanta), a private
equity firm, reported a growth equity investment in MMIS
(Portsmouth, New Hampshire), a technology company that
makes compliance and collaboration software solutions for
pharmaceutical and medical device companies. The investment
will be used to help facilitate the continued market growth
of MMIS and further enhancement of its current technology
leadership position.
MMIS offers a cloud-based modular platform that helps
its clients to aggregate, manage, and analyze data across an
enterprise. The MediSpend Global Compliance Platform, the
company’s signature product, was developed by legal experts
and IT specialists with healthcare compliance experience. //
GTCR acquires Xifin to enhance
cloud-based software and technology
Staff Report
Private equity firm GTCR (Chicago), reported that it has
acquired Xifin (San Diego), a provider of cloud-based software
and services to diagnostic service providers for an undisclosed
sum.Xifin’stechnologyplatformenablesend-to-endconnectivity
from patient to payor, linking together the many stakeholders
in healthcare delivery and optimizing for the best business and
patient outcomes.
The company’s customers occupy a diverse set of industry
segments, including molecular diagnostics, pain management/
toxicology, anatomic pathology, radiology, hospital outreach,
medical device and clinical laboratories.
Built on a secure, web services-based technology platform,
Xifin’s core product is a cloud-based workflow application
10. THURSDAY, JULY 31, 2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 1 OF 2
Keeping you up to date on recent developments in orthopedics
By Holland Johnson, Executive Editor
ORTHOPEDICS EXTRA
Continues on next page
Surgeons create ‘new’ knee
cartilage from stem cells in hip
Surgeons in Southampton have pioneered a new knee
operation that could prevent the development of arthritis – and
extend sporting careers.
The procedure, which is currently being trialled at
Southampton General Hospital (Southhampton, UK), involves
coating damaged cartilage with stem cells, taken from a
patient’s own hip, and surgical glue.
Known as ABICUS – Autologous Bone Marrow Implantation
of Cells University Hospital Southampton – the technique, if
successful, will regenerate the remaining tissue and create a
permanent, “like-for-like” replacement for the first time.
Cartilage is a tough, flexible tissue that covers the surface
of joints and enables bones to slide over one another while
reducing friction and acting as a shock absorber.
Damage to the tissue in the knee is common and occurs
mainly following sudden twists or direct blows, such as falls or
heavy tackles playing sports such as football and rugby, but can
also develop over time through gradual wear and tear.
Around 10,000 people a year in the UK suffer cartilage
damage serious enough to require treatment due to pain,
‘locking’ and reduced flexibility. If left untreated, it can progress
to arthritis and severely impair leg movement.
Currently, the most commonly used procedure to repair
the injury – microfracture – involves trimming any remaining
damaged tissue and drilling holes in the bone beneath the
defect via keyhole surgery to promote bleeding and scar tissue
to work as a substitute.
However, the technique has variable results, with studies
in the U.S. suggesting the procedure offers only a short term
benefit (the first 24 months after surgery), and does not lead to
the formation of new cartilage.
Patients who undergo the ABICUS operation have the
cartilage cut and tidied and undergo microfracture, but their
cartilage tissue is then coated with a substance made up of bone
marrow cells, platelet gel and hyaluronic acid.
During the 30-minute procedure, the bone marrow
sample is spun in a centrifuge in the operating theater to give a
concentrated amount of the patient’s own stem cells.
These cells are then mixed with the gel and acid to create
a ‘glue’ substance which is placed over the cartilage defect and
allowed to set.
Gorav Datta, a consultant orthopedic surgeon at
Southampton General Hospital and the study’s principal
investigator, said, “The development of this technique and the
study we are conducting could revolutionise the treatment of
common cartilage injury by creating a like-for-like, identical
cartilage replacement for the first time.
“So far, treatments developed to combat the long-term
problems associated with cartilage damage have had varied
outcomes, resulting in knee pain for many people in older age
and shortened careers for many amateur and professional
sports players.”
The study at University Hospital Southampton NHS
Foundation Trust will compare the results of 40 patients aged
between 18 and 65 years, half who will undergo ABICUS and
half microfracture alone.
Orthopedic outcomes affected by activity level
According to a literature review in the July issue of the
Journal of the American Academy of Orthopaedic Surgeons
(JAAOS), patients’ activity level is a strong predictor for how well
they will do with certain treatments and how well they recover
from injuries after treatment. Patients are encouraged to ask
their orthopaedic surgeon if activity level is an important factor
in their treatment decision. For example, more active patients
are at a higher risk of re-injury after an anterior cruciate ligament
(ACL) reconstruction, and activity level should be considered
when deciding which graft to use in the ACL repair.
Easily administered, standardized scales for the shoulder,
hip, knee and ankle are commonly used in orthopedics to
quantify a patient’s activity level. But, the measures of how
often, rather than how well, a task is performed do not account
for symptoms, functional disabilities, age, weight, overall
health and other factors which also may impact prognostic and
outcome variables.
“In orthopedics, we want to restore function to take away
pain and to help patients return to activity,” said orthopaedic
surgeon and lead study author Robert Brophy. “We’re still
learning about how to best use, quantify and measure activity
levels to optimize prognostics and outcomes.”
The strongest predictors for failure in rotator cuff tears were
patient expectations on the efficacy of physical therapy and
baseline activity level.
After a rotator cuff tear, patients who were active were less
likely to respond to nonsurgical treatment.
Preoperative activity levels, age, male gender and lower
body mass index (BMI) were predictors of higher activity level at
one and five years following total hip replacement surgery.
Physical activity – including occupational lifting and
standing – may accelerate the development and increased risk
of osteoarthritis.
Higher baseline activity, lower baseline BMI and higher
11. THURSDAY, JULY 31 , 2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 2 OF 2
ORTHOPEDICS EXTRAContinued from previous page
level of athletic competition were associated with higher activity
levels two years after ACL reconstruction.
Female gender, smoking in the 6-month period before
surgery, and revision ACL reconstruction were associated with
lower activity level.
Following ACL reconstruction, patients were significantly
less satisfied if they had a lower post-surgical activity level.
Increased incidences of knee injury and trauma in the
athletic population, rather than participation in physical activity,
may cause an increased risk of knee OA.
“There’s not just one activity level variable” in these
measurements, said Brophy. “It depends on the population,
the injury you’re studying, etc. We’re making progress, and the
progress varies depending on what you’re looking at.”
Genetics involved with menarche may hold
keys to preventing diabetes or osteoporosis
A novel study shows that the age girls reach puberty is
influenced by ‘imprinted genes’ – a subset of genes whose
activity differs depending on which parent contributes the gene.
This is the first evidence that imprinted genes can control the
rate of development after birth and details of this study were
published in the journal Nature.
Age of the first period, known as menarche, is a marker for
the timing of puberty in females. Medical evidence shows that
the onset of menses varies between girls, is an inherited trait,
and is linked to breast cancer, diabetes and heart disease risks.
“This research is the first step in understanding the genetics
involved with the onset of puberty in girls,” said Douglas Kiel,
director of the musculoskeletal research center at Harvard
Medical School-affiliated Hebrew SeniorLife Institute for Aging
Research (IFAR; Boston). “By uncovering which genes influence
menarche, we can then focus on its link to increased disease
risks, such as osteoporosis or diabetes, in later life.”
The findings come from an international study of more
than 180,000 women involving scientists from 166 institutions
around the globe. The researchers identified 123 genetic
variations that were associated with the timing of when girls
experienced their first menstrual cycle by analyzing the DNA
of 182,416 women of European descent from 57 studies. Six
of these variants were found to be clustered within imprinted
regions of the genome.
The activity of imprinted genes differs depending on which
parent the gene is inherited from – some genes are only active
when inherited from the mother, others are only active when
inherited from the father. Both types of imprinted genes were
identified as determining puberty timing in girls, indicating
a possible biological conflict between the parents over their
child’s rate of development. Further evidence for the parental
imbalance in inheritance patterns was obtained by analyzing
the association between these imprinted genes and timing of
puberty in a study of over 35,000 women in Iceland, for whom
detailed information on their family trees were available.
David Karasik, an associate scientist with Hebrew SeniorLife
IFAR who also was involved with the study adds, “The genetics
involved in female reproductive maturation is complex. Our
findings extend knowledge of genetic influences that could
contribute to the development of age-related conditions
including menopause and osteoporosis.”
Study reveals the atomic structure
of key muscle component
Actin is the most abundant protein in the body, and when
you look more closely at its fundamental role in life, it’s easy
to see why. It is the basis of most movement in the body, and
all cells and components within them have the capacity to
move: muscle contracting, heart beating, blood clotting, and
nerve cells communicating, among many other functions. And,
movement can turn harmful when cancer cells break away from
tumors to set up shop in distant tissues.
Adding to the growing fundamental understanding of the
machinery of muscle cells, a group of biophysicists from the
Perelman School of Medicine at the Univerity of Pennsylvania
describe in the journal Science – in minute detail – how actin
filaments are stabilized at one of their ends to form a basic
muscle structure called the sarcomere.
With the help of many other proteins, actin molecules
polymerize to form filaments that give rise to structures of many
different shapes. The actin filaments have a polarity, with a plus
and minus end, reflecting their natural tendency to gain or lose
subunits when not stabilized.
Actin is one of the two major proteins (together with myosin)
that form the sarcomere – the contractile structures of cardiac,
skeletal, and smooth muscle cells. In sarcomeres, actin filaments
are stabilized at both ends by capping proteins. At the minus end
of the filament, the universal capping protein is tropomodulin.
“While the existence of this protein has been known for
almost 30 years, we still did not know how it actually works,” said
senior author Roberto Dominguez, professor of physiology. His
lab is dedicated to deciphering the fundamental mechanisms of
proteins responsible for movement, and how these components
fit together at the atomic level.
“We describe how tropomodulin interacts with the slow-
growing end of actin filaments,” says coauthor Yadaiah Madasu,
a postdoctoral fellow in the Dominquez lab. “From a clinical
point of view, we know that mutations in tropomodulin can
trigger an accumulation of irregular actin filament bundles,
which contribute to nemaline myopathy or other skeletal muscle
disorders typified by delayed motor development and muscle
weakness.”
