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Bbt0211.pdf

Our 34th year of providing
med-tech news & analysis
BIOMEDICAL
The
Inside

Formerly
Newsletter
TECHNOLOGY
Cleveland area seen as
hotbed of medical innova-
tion. Story on page 5.

Braunstein sees promise in
2011, but notes that chal-
7KH %% 7 LQWHUYLHZ
lenges still abound. Story
on page 9.

Biosense completes first
clinical cases using
Chris Rivera
ThermoCool, Smart-
President of Washington state life sciences association International
sees local gains from having a global health perspective Report, page 15.
Boston Scientific to
By JIM STOMMEN, BB&T Contributing Editor
acquire Atritech. Acquisi-
Chris Rivera has been president of the Seattle-based Washington Biotech- tons & Agreements. page
17.

nology & Biomedical Association (WBBA) since January 2009. Prior to joining the WBBA, he was the founder and CEO of Hyperion Therapeutics, a specialty ❏ Sapien trial data prod
FDA, firms to review
biopharmaceutical company focused on the development and commercializa- valve studies. Market
tion of therapies for gastroenterology and hepatology diseases.
Developments, page 18.
Prior to starting Hyperion, Rivera was senior vice president of commercial ❏ Pretzel-shaped tube may
operations at Tercica, where he was responsible for developing and overseeing help deliver bladder dis-
ease drug. Product Briefs,

Tercica’s global commercialization strategies and was intimately involved in the development and consummation of an international cross-licensing col- As senior vice president of Genzyme Therapeutics, he was largely respon- sible for building the company’s U.S. renal division and assisted in the launch of Renagel (sevelamer hydrochloride) globally. Earlier in his career, he helped build the initial commercial organizations at Centocor and Cephalon.
Now available online: Go to www.medicaldevicedaily.com for details
Copyright 2011 by AHC Media. Unauthorized photocopying or distribution is strictly prohibited by law. Biomedical Business & Technology
FEBRUARY 2011
in particular, “We’re going to set up shop in those coun- Cleveland area
tries where we know we’re going to have to file first.” So FDA regulation really has some long-term implications seen as hotbed of
that may be very negative if not really thought through strategically.
medical innovation
BB&T: Is there a question I haven’t asked that you
By JEFFREY BERG, PhD
wish I had?
BB&T Contributing Writer
CLEVELAND – The medtech community in Cleve- Rivera: Not so much a question as a comment in land and the surrounding region is experiencing dy- closing. One of the things we’re trying to work on and namic growth from its expanding network of world-class hopefully can get out is that the citizens of Washington research and clinical facilities along with financial firms that aren’t a part of this industry hopefully can see the and government programs that collectively support value and benefit that it brings and has the potential to the creation and growth of companies in many medical bring. This is potentially like having a Boeing emerge in fields, most notably cardiovascular, imaging, neurology the 1940s and 1950s, or having Microsoft in the 1970s and 1980s. We’re at that stage where we can as an industry be- Today, the region is home to 600+ biomedical busi- come the next Boeing or Microsoft or Weyerhaeuser and nesses with more than 230,000 healthcare and bioscience workers. The origin of many of these companies can be We already are one of the top five industries in the traced to research programs initiated at the nationally state and fastest-growing, but we really have an oppor- ranked medical institutions, hospitals and universities tunity here in Washington, especially with where things in northeastern Ohio which encompasses Cleveland and are going with global health and personalized medicine, Akron (see Table 1). As evidence of its growing medi- we really do have an opportunity to become the next cal community, sixteen cardiovascular companies have huge industry and job-creator for the citizens of the moved into the region in the past two years. The region state. It’s an exciting time to be here, but it’s also a time attracts more that $150 million a year in healthcare invest- where decisions that are made in Washington, DC, and Olympia are going to have a long-term impact one way The Cleveland Clinic, a world renowned health
system, established in 2007 the Global Cardiovascu- The challenge with life sciences is that we usually are lar Innovation Center (GCIC) which was formed after not manufacturing consumer products that people are receipt of a $60 million grant from the State of Ohio’s going to see on the shelves of a store, so you don’t know Third Frontier Program. It is a cardiovascular product us and what we do unless you’re taking Enbrel or unless development consortium that is focused on the forma- you’re having an ultrasound treatment. That’s a matter of tion, attraction, expansion and retention of cardiovas- education – we’re working to increase that kind of aware- cular companies and whose aim is to create jobs and facilitate economic development in the State of Ohio. It has resulted in the construction of a new incubator facility to house start-up companies developing in-novative solutions for the diagnosis and treatment of cardiovascular disease. GCIC’s portfolio comprises 21 The Cleveland Clinic hosts the annual Medical In- novations Summit, a major conference that features pre-sentations by the CEO’s of the largest medical device companies and attracts more than 1,000 investors, entre-preneurs, business development executives, clinicians The Cleveland Medical Mart and Convention Center is expected to transform Cleveland and the surrounding For advertising opportunities in
area into a globally competitive location for attracting Medical Device Daily, please contact
and growing biomedical companies. It is scheduled to Stephen Vance at (404) 262-5511 or
open in 2013 and will be one of the only facilities in the stephen.vance@ahcmedia.com
nation targeted specially to the medical and healthcare industries, housing 120,000 sq. ft. of permanent show- Copyright 2011 by AHC Media. Unauthorized photocopying or distribution is strictly prohibited by law. Biomedical Business & Technology
FEBRUARY 2011
Hospitals and Research Universities in Cleveland and Akron
search services. Its 20-member profes-sional staff provides ongoing assistance Cleveland
and guidance in a wide range of areas to these portfolio companies but does not assist that have strong growth potential. It assists these companies in developing their businesses and specifically in their fund raising efforts, but is itself not an rooms for major medical manufacturers and service pro- viders. The showrooms will focus on cardiology, surgery, and environs a national center for medical innovation. imaging, orthopedics, Ob/Gyn, sterilization, healthcare The region can be compared to the established med-tech furnishings, patient care, and healthcare IT. The center is community, known as Medical Alley, around Minneapo- expected to host more than 50 healthcare-related confer- lis and the drug and biotechnology hub around Research BioEnterprise’s portfolio includes several Israeli Biomedical engines of innovation
med-tech companies which it has attracted for setting up BioEnterprise (Cleveland) is a leading institution that
operations in Cleveland and for using local hospitals to is driving the development of the biomed and medtech conduct clinical trials. BioEnterprise partners with sev- industries in Cleveland’s metro area. BioEnterprise is a eral venture funds that are housed within its facility. The business formation, recruitment and acceleration initia- Bridge Investment Fund, which also has an office in Tel tive designed to grow healthcare companies and com- Aviv, specifically invests in Israeli medical device compa- mercialize bioscience technologies. Its founders and part- nies that have completed their initial clinical trials and are ners are: Case Western Reserve University, Cleveland
looking to the U.S. market for further clinical validation Clinic, University Hospitals, Summa Health System
and to establish a U.S. sales and marketing organization. and the Austen BioInnovation Institute in Akron. Ben-
Additional on-site venture firms at BioEnterprise include efited by a team effort with these institutions, and sus- Arboretum Ventures, RiverVest Venture Partners, Medi- tained by an entrepreneurial ecosystem, BioEnterprise cal Growth Fund and Johnson & Johnson’s COSAT (Cor- has succeeded in accelerating more than 100 companies porate Office of Science and Technology).
of which half are medical device companies and the re- Twelve of the Cleveland region’s health care compa- Cleveland Region Healthcare Acquisitions Since 2008
Acquirer
Fund II. It has made investments in 30 companies and currently fills an important niche as first round investors of seed capi- Integra LifeSciences (Plainsboro, New Jersey) Boston Scientific (Natick, Massachusetts) based Simbionix, a leading pro-vider of medical education and Copyright 2011 by AHC Media. Unauthorized photocopying or distribution is strictly prohibited by law. Biomedical Business & Technology
FEBRUARY 2011
The Austen BioInnovation Institute in Akron (ABIA) Centers of Innovation within
is also contributing to the growth in the Cleveland-Ak- Austen BioInnovations Institute
ron corridor. It was launched in 2008 with an announce-ment of $80 million in commitments, as follows: $20 mil- lion from the John S. and James L. Knight Foundation; $20 million from the State of Ohio ; $20 million from oth- • Center for Clinical and Community Health Improvement er founding members (Akron Children’s Hospital, Ak-
• Center for Simulation and Integrated Healthcare Education ron General Health System, Northeastern Ohio Uni-
versities
Colleges of Medicine and Pharmacy, Summa
ment to stimulate the economy and create jobs. Health System, and the University of Akron); $10 mil-
BioEnterprise’s medical device companies
lion from First Energy; and $10 million from other sourc- A diverse sample of medical device companies with- es including federal agencies and private foundations. in the BioEnterprise portfolio are reviewed below: ABIA is focused on patient-centered innovation and • MDG Medical (Aurora, Ohio and Lod, Israel) mar-
commercialization at the intersection of biomaterials and kets systems that automate the dispensing of medications medicine. It is comprised of four Centers of Innovation by health professionals in hospitals. Some sales are also (see Table 3) that are interrelated in that they are designed made to long-term care and correctional facilities. MDG’s to accelerate translational research to biomedical innova- flagship product, ServRx, is a complete medication man- tion and commercialization as well as community trans- agement system consisting of automation software, med- formation, thereby encompassing the entire life cycle for ication cabinets, supply cabinets, bedside solutions and computerized order entry devices. This system provides In September 2010, ABIA received a $2.6 million re- a closed loop solution for medication management by search and commercialization grant for biomedical sen- tracking from the order entry to the actual administration sor technology at Cleveland State University’s Wright of medication. Its modular design allows for the instal- Center for Sensor Systems Engineering through Ohio’s lation of individual components. The principal benefits Third Frontier initiative, a technology investment pro- of MDG’s systems are increasing patient safety by reduc- gram which grants funds to companies that have also ing human error when medicating patients and greater received private capital and have a partnership with an cost efficiencies by reducing paperwork and improving Ohio institution. Grants are typically $1 million. medication inventory management. MDG can be distin- ABIA was also the recipient, together with the Uni- guished from its competitors, CareFusion (San Diego)
versity of Akron Research Foundation, of the i6 Challenge and Omnicell (Mountain View, California), because its
which is awarded by the U.S. Department of Commerce systems allow for the patient’s safety to be taken directly for research programs that epitomize innovation and minimize the time from ideation to commercialization of • Quality Electrodynamics (QED ; Mayfield Village,
Ohio), established in 2006, is an engineering and manu- The University of Akron has an established reputa- facturing company that is an OEM supplier of radio fre- tion as an innovator in biomaterials and polymer science. quency coils used in MRI scanners. The coils translate sig- Several of the nearby large chemical and industrial com- nals received from patient anatomies into images used for panies are utilizing the university’s polymer technology diagnostic purposes. QED produces state-of-the-art ad- and getting involved in medical devices such as Lubrizol vanced clinical coils that are dedicated for use in imaging and Parker Hannifin. Additional beneficiaries are the the head, neck, knee, heart, shoulder, foot, spine and ab- medical companies, Steris (Mentor, Ohio), a provider of
domen. QED works closely with its two main customers, sterilization and sanitation products, Invacare (Elyria,
Siemens Healthcare (Erlangen, Germany) and Toshiba
Ohio), a marketer of rehabilitation equipment, and Nor-
Medical Systems Corporation (Tochigi, Japan). The com-
man Noble (Highland Heights, Ohio), a contract manu-
pany has 66 employees. It will achieve sales of $16 mil- facturer of medical devices including stents and orthope- lion in 2010 and has been profitable from year two (i.e., 2007). More than 90% of products are shipped outside the JumpStart is a nationally recognized non-profit or- U.S. and they are distributed worldwide by Siemens and ganization that offers intensive entrepreneurial develop- Toshiba. QED plans to enter the renewable energy mar- ment assistance to Northeast Ohio entrepreneurs leading ket with the launch of eQED in 2011 and with the intro- high potential, early-stage companies. It is funded by the duction of next-generation inverters that change sunlight state, corporations and hospitals and provides early stage energy from DC to AC and are integrated in solar pan- companies with grants of $500,000, which have been els. QED was named 11th in the nation in 2009 by Forbes awarded so far to 50 companies. This program exists in magazine’s American Most Promising Top 20 companies several other states and was created by the U.S. govern- and was also cited by Inc magazine as one of America’s Copyright 2011 by AHC Media. Unauthorized photocopying or distribution is strictly prohibited by law. Biomedical Business & Technology
FEBRUARY 2011
Top 500 Fastest Growing Private Companies and 13th in life. The Smartpatch system consists of a skin-mounted external stimulator, percutaneous lead and small adhe- • CardioInsight Technologies (Cleveland) is de-
sive patches that contain the power source for the sys- veloping the first non-invasive, real-time, beat-to-beat tem. It delivers peripheral nerve stimulation (PNS) for simultaneous mapping and localization solution for the up to 30 days after placing the lead through the skin treatment of cardiac arrhythmias and heart failure. The into the muscle in an outpatient procedure. The patches company’s electrocardiographic mapping technology are replaced regularly, based on the prescribed dosage. was licensed from Case Western Reserve University. It is A 510(k) submission is pending for the Smartpatch PNS being developed for intra-procedural guidance of abla- system. Also under development is the fully implant- tion therapy for arrhythmias and cardiac resynchroniza- able SPR long-term system which is being investigated in tion therapy for heart failure. Its targeted conditions are for treating atrial fibrillation and congestive heart failure. • AxioMed Spine (Garfield Heights, Ohio) devel-
The patient wears a disposable multi-electrode vest that ops devices designed for restoring function to patients is used in conjunction with a CT scan to provide a 3-D who have symptomatic degenerative spine disease. map of the heart’s electrical topography and enables the The company’s Freedom lumbar disc is the first one- physician to determine where to ablate. The company piece elastomeric total disc replacement. It is based on plans to launch its product in Europe in June 2011 and an invention of surgeons at the Cleveland Clinic and is anticipates receipt of 510(k) clearance by the end of 2011. cleared under an IDE for ongoing clinical trials random- The regulatory approval is not expected to be onerous be- ized against the ProDisc-L from Synthes Spine (West
Chester, Pennsylvania). The Freedom one-piece design • NDI Medical (Cleveland), established in 2002, has
utilizes a proprietary metal-polymer bonding technol- a 22-member staff that focuses on generating ideas for in- ogy. The company has an exclusive license for the Car- novative neurodevices that can be used to inhibit, accel- boSil polymer, a proprietary polymer that is supplied by erate or restore lost neurological function. It holds 150 is- the Polymer Technology Group (Berkeley, California),
sued or pending patents and has raised $25 million from a subsidiary of DSM Biomedical (Geleen, the Nether-
about 20 research grants and private investment. NDI’s lands). The Freedom lumbar disc has the CE mark and objective is to spin off individual companies and to assist is being marketed in the UK, Germany and Switzerland. these companies in the areas of research & development, In the U.S., the company needs a 2-year follow up before manufacturing and quality assurance. NDI also is an in- filing for a PMA with the FDA. AxioMed is developing vestor in the companies that it creates. Its first product, the Freedom cervical disc that is more anatomically cor- the MedStim bladder pacing system for control of uri- rect in fit and function than existing commercial cervical nary urge incontinence, was acquired in April 2008 by discs. Both devices incorporate titanium endplates and Medtronic (Minneapolis) for $42 million. NDI continues
their viscoelastic mechanical properties mimic the natu- to create high-growth companies. Its 2nd and 3rd operat- ral disc. It plans to file for the CE mark in the fall of 2011 ing companies, Checkpoint Surgical and SPR Therapeu-
tics, are housed on-site at NDI.
Checkpoint Surgical has developed a single-use
stimulator/locator for applying electrical stimulation to exposed motor nerves and muscle tissue to locate and evaluate nerves during surgery. The stimulation intensity can be varied, allowing for the activation of nerves and muscles at different depths and through surrounding tis- Follow MDD on Twitter to keep on top of
sue. The principal applications of the device are for use the latest med-tech updates!
during surgery on upper extremities such as the shoul-der and elbow, ENT and oncology procedures, and for nerve and tendon transfers. The Checkpoint stimulator/locator received 510(k) clearance from the FDA and has been used in a pilot launch by 40 surgeons in the U.S. in www.twitter.com/meddevicesdaily
over 300 procedures. The company plans to expand its U.S. sales and launch its device in Canada, Europe and Australia in 2011. • SPR Therapeutics is commercializing the patented,
short-term Smartpatch system to reduce or eliminate pa-tient’s severe pain and improve their overall quality of Copyright 2011 by AHC Media. Unauthorized photocopying or distribution is strictly prohibited by law.

Source: http://www.bioenterprise.com/resources/uploaded/bbtclevelandareaseenashotbedfeb2011_5a82.pdf

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