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WEDNESDAY, NOVEMBER 5, 2014 VOLUME 18, NO. 214
MEDICAL DEVICE DAILYTM
THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE
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See Cardinal, page 6 See Svelte, page 7
See Latin America, page 8 See Beltway, page 9
INSIDEINSPIREMD REPORTS DIRECT OFFERING FOR ALMOST $8M PAGE 2STRYKER TO PAY AT LEAST $1.4 BILLION TO SETTLE HIP REPLACEMENT CASES PAGE 3
THE MDD INTERVIEW
LATIN AMERICA INSIDE THE BELTWAY
Washington Editor Mark McCarty on one of med-tech’s key sectors
Read this week’s Wednesday Special
ONCOLOGY EXTRA
Svelte Medical aims to dominate transradial stenting stenting market By John Brosky, Europe Editor
The President & CEO of Svelte Medical (New Providence, Rhode Island), Jack Darby, brings a deep experience in medical devices for interventional procedures. He headed the Bayer Interventional (Whippany, New Jersey) business unit, was Global Vice President of Sales and Marketing at AGA Medical that was subsequently acquired by St. Jude Medical (St. Paul, Minnesota) and held a series of roles with increasing responsibility at Cordis Cardiology (Bridgewater, New Jersey) including Vice President of Commercial Operations and Global Stent Marketing. Medical Device Daily spoke to him from his office at Svelte’s headquarters.
Caracas asked Interpol to issue red notice against alleged med-tech hoardersBy Sergio Held, Staff Writer
The Venezuelan government asked Interpol last week to issue a red notice to detain three people whom, it claims, are hoarding medical devices in the Latin American country.
“Those bourgeois left the country months ago. I’m going to apply for an Interpol red notice, and I swear as my name is Nicolás Maduro that I will bring them prisoners to Venezuela . . . [It is] enough with the abuses against the people! This is a battle of all, nobody guard down!,” exclaimed Venezuelan president Nicolás Maduro in a public speech at a warehouse full of med-tech that was raided by government officials, led by the president himself,
Cardinal Health receives approval foradditional indications for MynxGripBy Omar Ford, Staff Writer
Cardinal Health (Dublin, Ohio) said that its MynxGrip Vascular Closure Device recently received FDA approval for use to close femoral veins. The MynxGrip device is now indicated for use to seal 5F, 6F and 7F femoral arterial and femoral venous access sites.
The venous indication could help interventional healthcare providers increase efficiency of their labs and minimize potential complications associated with venous closure by replacing the need for manual compression. The MynxGrip device is intended to reduce times to hemostasis and ambulation, thereby potentially shortening post-procedure recovery times.
“This indication fits our mission to deliver great patient
CMS creates new HCPCS codes for breast tomography in OPPS for 2015By Mark McCarty, Washington Editor
The Centers for Medicare & Medicaid Services (CMS) released the final Medicare physician fee schedule for calendar year 2015, adding in a new code under the healthcare common procedural coding system for 3-D mammography. The news is a big gain for at least two firms in the tomosynthesis space, Hologic (Bedford, Massachusetts) and GE Healthcare (Chalfont, UK), and was abetted at least in part by correspondence from Congress urging CMS to break open a new code for the technology.
CMS released its proposal for the 2015 MPFS at the beginning of July, and published the final along with the final
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 2 OF 10
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FINANCINGS
See Financnings, page 6
InspireMD reports direct offering for almost $8MStaff Report
InspireMD (Boston), a developer of in stent embolic protection systems (EPS), has entered into a definitive agreement to sell approximately 6.2 million shares of common stock and warrants to purchase up to almost 3.1 million shares of common stock in a registered direct offering. The common stock will be sold at a negotiated purchase price of $1.30 per share, and each purchaser will receive a warrant to purchase 0.5 of a share of common stock for each share of common stock that it purchases in the offering. The warrants shall be non-exercisable for six months and have a term of exercise of 42 months from the date of issuance and an exercise price of $1.75. The company expects to receive gross proceeds from the offering of approximately $8 million, before deducting placement agents’ fees and estimated offering expenses.
The offering is expected to close on or about Nov. 7, subject to customary closing conditions.
H.C. Wainwright & Co., served as the exclusive placement agent for this offering.
The company intends to use the net proceeds from this offering to advance the development of its MGuard drug-eluting stent platform and develop the CGuard rapid exchange platform,
commercially launch CGuard EPS, and for general corporate purposes.
InspireMD seeks to use its proprietary MGuard with MicroNet technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
In other financing news: • Healthcare Trust of America (HTA; Scottsdale, Arizona)
reported the pricing of its underwritten public offering of 8,000,000 shares of its common stock at a price to the public of $12.55 per share. HTA has granted the underwriters a 30-day option to purchase up to 1.2 million additional shares of its common stock.
HTA will receive approximately $100.4 million in gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses. HTA intends to use net proceeds from the offering to repay a portion of the outstanding indebtedness under the senior unsecured revolving credit and term loan facility and for general corporate purposes, including, without limitation, working capital and investment in real estate. Closing is expected to occur on or about Nov. 7, subject to customary closing conditions.
J.P. Morgan and Wells Fargo Securities are acting as the joint book-running managers for the offering. BMO Capital Markets, PNC Capital Markets and Raymond James are acting as the lead
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 3 OF 10
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COURT REPORT
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Stryker to pay at least $1.4 billionto settle hip replacement casesStaff Report
Stryker (Kalamazoo, Michigan) said it has reached a settlement agreement to compensate U.S. patients who had surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem before Nov. 3. Stryker said it expects to pay at least $1.425 billion to resolve the cases but that the ultimate cost to entirely resolve the matters will depend on “many factors that are difficult to predict and may be materially different than the amounts accrued to date.” The company said it expects to make most of the payments under the agreement by the end of 2015.
The settlement follows a early mediation program initiated by New Jersey Superior Court Judge Brian Martinotti and efforts by the chief mediator, former United States Magistrate Judge Diane Welsh. The mediation process led to the resolution of multiple suits and claims pending in the federal courts and other states, Stryker noted. The settlement involved the company’s subsidiary, Howmedica Osteonics (Mahwah, New Jersey), doing business as Stryker Orthopedics.
“The health and well-being of patients is Stryker’s top priority,” said Bill Huffnagle, president of the reconstructive division at Stryker Orthopaedics. “Following our voluntary recall and our patient support program for recall related care, this settlement program provides patients compensation in a fair, timely and efficient manner.”
The settlement resolves more than 3,000 Stryker hip lawsuits and the company will pay a base award of $300,000 per failed implant, with additional compensation for those who suffered complications during revision surgery to remove the hip implant.
The Stryker hip implant lawsuits were filed on behalf of patients who received the Rejuvenate and ABG II Modular-Neck Hip Stems and allege the hip implants cause tissue damage, metal poisoning, degeneration of bone tissue and other serious health complications. The Stryker hip lawsuits contend that the medical devices are defective and many patients required revision surgery to remove their Stryker artificial hip implant while other patients will likely need revision surgery in the future.
Stryker recalled its Rejuvenate and ABG II Modular-Neck Hip Stems in July 2012 due to the potential of the medical devices to fret and corrode at the modular-neck junction. In its explanation for the recall, Stryker said the neck components of the Rejuvenate and ABG II are made of chromium and cobalt, and the stems are coated with titanium. According to Stryker, the neck components can wear against each other and create metallic debris, which is released into an implant recipient’s tissue or bloodstream. The shedding of metallic debris can result in patients experiencing adverse local tissue reactions,
swelling, pain and other problems, according to Stryker. Stryker recommended that surgeons consider performing blood work and imaging on their patients who received the recalled hip implant devices regardless of whether their patients are experiencing pain or swelling. //
• BIND Therapeutics (Cambridge, Massachusetts), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins, has named Hagop Youssoufian as chief medical officer. In this position, Youssoufian will be responsible for overseeing the clinical development and operations of BIND’s internal pipeline. Edward Schnipper, who has been serving as interim CMO since January, will continue in an advisory role. Prior to joining BIND, Youssoufian served as executive VP of R&D at Progenics Pharmaceuticals.
• Relmada Therapeutics (New York), a clinical-stage company developing therapies for the treatment of chronic pain, said it has named Michael Becker as senior VP of finance and corporate development, effective immediately. Becker brings more than 20 years of experience as a C-level industry executive and Wall Street securities analyst. Most recently, he was founder and president of the consulting firm MDB Communications. Relmada Therapeutics makes novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of pain.
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 4 OF 10
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DAILY M&A
AGREEMENTS/CONTRACTS
Vascular Solutions to distribute PolarCath dilatation systemStaff Report
Vascular Solutions (Minneapolis) has entered into an agreement with NuCryo Vascular (Sunnyvale, California) under which Vascular Solutions will serve as exclusive distributor of the PolarCath Peripheral Dilatation System in the U.S.
Vascular Solutions expects to begin sales of PolarCath to customers through its direct U.S. sales force during the first quarter of 2015. Vascular Solutions is projecting between $3 million to $5 million in PolarCath sales during 2015.
The PolarCath Peripheral Dilatation System has FDA clearance to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath system is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
“We are very excited to add PolarCath to our broad line of clinical solutions for the treatment of vascular disease,” said Howard Root, CEO of Vascular Solutions. “PolarCath, an FDA cleared device with more than a decade of extensive clinical experience, is an important tool for the treatment of peripheral arterial disease. The product is a natural fit for our U.S. direct sales force and our focus on meeting the needs of interventional physicians.”
The PolarCath Peripheral Dilatation System consists of a disposable catheter, an inflation unit, and a nitrous oxide cartridge. The system is used to perform balloon cryoplasty, a catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery. PolarCath is used to dilate peripheral arteries with the same basic technique as balloon angioplasty, except that PolarCath uses nitrous oxide to inflate the balloon rather than liquid. The nitrous oxide cools the balloon to minus ten degrees Celsius, which freezes the built-up plaque in the artery. The PolarCath system was invented by James Joye, Chief Medical Officer of the Fogarty Institute at El Camino Hospital (Mountain View, California).
Vascular Solutions is a medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures.
In other agreements: Foundation Medicine (Cambridge, Massachusetts) and COTA (Hackensack, New Jersey) reported an agreement to capture and analyze comprehensive genomic, clinical outcome, and cost data from patients who have undergone testing with FoundationOne. The resulting dataset is designed to provide health care providers and payers with the supporting clinical outcomes and costs evidence that inform value-based reimbursement decisions and cancer treatment.
“Eliminating inefficiencies and improving patient care requires actionable insights supported by complete, integrated data,” said Eric Schultz, CEO of COTA. “This unprecedented collaboration with Foundation Medicine incorporates the most comprehensive genomic profiling data with COTA’s unique real-world, longitudinal clinical outcomes and cost of care data to provide insights that enable both physicians and payers to move toward value-based treatment and reimbursement practices.”
The collaboration will first capture clinical outcomes for patients with Stage IV non-small cell lung cancer (NSCLC), the leading cancer killer of men and women in this country, who have undergone testing with FoundationOne. The resulting longitudinal data will aim to further demonstrate the clinical utility of comprehensive genomic profiling for patients with Stage IV NSCLC and to inform potential value-based reimbursement decisions from payers. The combination of genomic data, clinical information, outcomes data and economic data will provide critical insights for both payers and physicians to fully endorse the clinical and economic benefits associated with the application of comprehensive genomic profiling in this disease setting.
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer.
FoundationOne is a genomic profile for solid tumors used by oncologists to identify the molecular alterations in a patient’s tumor and match those alterations with relevant targeted therapies and clinical trials. //
American CareSource completesacquisition of MedHelp Urgent CareStaff Report
American CareSource (Dallas), operator of urgent care centers and a national network of ancillary healthcare providers, said it has completed its acquisition of MedHelp Urgent Care (Alpharetta, Georgia), a full-service urgent and primary care provider.
The MedHelp facility provides urgent and primary care and occupational medicine. In addition, the facility serves a growing population of military veterans that reside throughout the southeastern United States.
The company now has eight total centers throughout the southeastern U.S., three of which are in the greater Atlanta metropolitan area.
“We anticipate system-wide growth by capitalizing on the centers’ strategic opportunities,” said Richard Turner, chairman/CEO. “We also expect to leverage MedHelp’s existing staff to create efficiencies with our other Atlanta-area centers.” //
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 5 OF 10
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WORLD IN REVIEW
STAAR gains final step in regulatory approval for Visian ICL product in China Staff Report
STAAR Surgical (Monrovia, California) a developer of implantable lenses and delivery systems for the eye, reported that it has received the Approval Certification from CFDA to market its Visian ICL with CentraFLOW technology in China effective Nov. 3. The Visian ICL with CentraFLOW uses a proprietary port in the center of the ICL optic, KS-AquaPORT, intended to optimize the flow of fluid within the eye without affecting the quality of vision. The CentraFLOW technology eliminates the need for surgeons to perform a YAG peripheral iridotomy procedure days before the ICL implant, simplifying the procedure and increasing patient comfort while providing the superior visual outcomes of the ICL.
“China is currently the largest market in the world for refractive procedures and the approval of the Visian ICL with the CentraFLOW technology builds on the momentum of our already quickly growing line of ICL products in this important focus market” said Don Todd, president of the Asia Pacific Region. “We have seen a very positive impact in other markets with the introduction of the CentraFLOW technology. Visian ICL procedures today represent about 2% of the more than 875,000 annual refractive procedures in China. We now have the opportunity to further expand our share and growth in China, which included a 27% ICL revenue growth milestone in the most recent quarter. The first orders for the Visian ICL with CentraFLOW have been placed and will begin to ship this week.”
STAAR Surgical personnel in China began marketing the new technology on Monday. To date, the company said in a statement that more 400 surgeons have been trained on the Visian ICL technology and additional surgeon training is already underway. There will be a CentraFLOW training course in China for surgeons in November followed by two additional training courses before year end. Distributors in China were trained at a recent meeting in September and additional training will take place in November.
The steps this year in the CentraFLOW’s approval process in China started with a successful Experts Panel Meeting on May 15 which was followed by the Technical Recommendation from CMDE on Sept. 24 and the Marketing Approval from the CFDA on Oct. 29. The approval includes both the Myopic ICL and the Toric ICL with expanded approval ranges for both myopia and astigmatism. This increases the potential number of patients that can be treated with the Visian ICL in China. The range of myopia correction approved is -0.5 diopters to -18.0 diopters vs. the previous range of -2.5 diopters to -18.0 diopters equivalent in BSS. The range of astigmatism correction approved is +0.5 to +6.0 diopters versus the previous range of +0.75 to +4.75 diopters equivalent in BSS. The previously approved ICL was stored in sodium chloride while the Visian ICL with CentraFLOW will be stored in BSS.
Cardiovascular Systems receives CE mark for Stealth 360º OAS
Cardiovascular Systems (CSI; St. Paul, Minnesota) reported that it has received the CE mark for its Stealth 360º Orbital Atherectomy System (OAS). Stealth 360º is a percutaneous OAS that is indicated to treat patients who suffer from peripheral arterial disease (PAD).
“Securing CE Mark for Stealth 360º greatly expands our market opportunity and is an important milestone toward benefiting patients in Europe suffering from PAD—especially those with critical limb ischemia, (CLI) who have been underserved by other treatment options,” said David Martin, CSI president/CEO. “A determining factor for CLI is calcium buildup in leg arteries, particularly small vessels below the knee. Our technology, with its unique mechanism of action, has demonstrated it can safely and effectively treat this complex disease, with lasting results.”
Stealth 360º will be available in Europe with a 0.014” guide wire platform, and crown sizes of 1.25 mm, 1.50 mm, 1.75 mm and 2.00 mm. The system consists of the following main components: Orbital Atherectomy Device, Saline Pump, Atherectomy guide wire and Atherectomy lubricant—all of which received CE mark. //
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For sales Inquiries: http://ip-science.interest.thomsonreuters.com/bioworld_sales_Inquiry. NorTh amerICa, Tel: +1-800-336-4474. outside of the u.s. and Canada, Tel. +44-203-684-1796. For Customer service Inquiries, NorTh amerICa, Tel: +1-800-336-4474. outside of the u.s. and Canada, Tel. +44-203-684-1796. or email [email protected]. Copyright ©Thomson reuters. reproduction is strictly prohibited. Visit our website at www.medicaldevicedaily.com
See GE Healthcare, page 5 See Beltway, page 6
See Asia, page 7 See ESC, page 8
insideAcuFocus completes $21 millionFunding in oversubscribed round page 2novAtion enters heArt vAlve cAtegory Along with edwArds page 3
InSIdE tHE BEltwAy
REpoRt FRom ASIA EuRopEAn SoCIEty oF CARdIoloGy 2014
executive editor holland Johnson on one of med-tech’s key sectors
Read this week’s thursday Special
orThopedICs eXTra
Advamed ‘gravely concerned’ about features of march classification ruleBy Mark McCarty, Washington Editor
FdA’s march 25 announcement in the Federal Register regarding a proposed overhaul to the medical device classification regulation has prompted some pushback, including from the advanced Medical Technology association (Advamed; washington). Among the concerns expressed by the association is that the agency’s calculation of the time needed to prepare a pmA for a device shifted from class ii to class iii is off by almost an order of magnitude, but Advamed also said it is “gravely concerned regarding the wide-ranging impact of these proposed revised regulations.”
with better regulation, India steps up into global device marketBy T.V. Padma, Contributing Writer
india, which has the fourth largest market in Asia for medical devices and diagnostics, is planning a series of steps to strengthen regulation of the sector whose products range from small thermometers and surgical needles; to implantable heart valves, stents, heart lung machines and large magnetic resonance imaging machines.
the indian government is engaged in improving regulation of drugs, cosmetics and devices, said nandini Kumar, former deputy director general at indian council of medical research and adjunct professor at Kasturba medical college in manipal.
philips retools ultrasound platform to target broad marketBy John Brosky, Europe Editor
After introducing a new ultrasound architecture at last year’s congress of the european society of Cardiology (esc; sophia Antipolis, France) with the premium epiQ system, philips Healthcare (Amsterdam, the netherlands) extended the line at esc 2014 by introducing a reconfiguration of the platform as the new Affiniti brand.
targeting clinics with high patient through-put, the two new Affiniti models provide a range of options to lower the price, expressed as the total cost of ownership.
“we studied this group extremely well because we really
FdA approves GE’s SenoClaire for sharper 3-d breast imagingBy Amanda Pedersen, Senior Staff Writer
the FdA has approved a new breast tomosynthesis solution from ge Healthcare (chalfont, uK) that is designed with a 3-d imaging technology. ge developed senoclaire in collaboration with Massachusetts general Hospital (mass general; boston). the technology uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a step-and-shoot method, removing the potential motion from the tube, helping to reduce blur and increase image sharpness, the company said.
daniel Kopans, a senior radiologist in the breast imaging division of the radiology department at mass general, said the approval marks a key milestone towards providing “cutting
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 6 OF 10
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CardinalContinued from page 1
Financings Continued from page 2
care while being fiscally responsible,” Ariel Sutton, VP of marketing for Cardinal Health Interventional Solutions,” told Medical Device Daily. “With the MynxGrip device physicians can achieve hemostasis more quickly and ambulate patients sooner compared to manual compression. What this means is that institutions can increase throughput, which in turn allows for more procedures in a single day.”
The MynxGrip Vascular Closure Device uses an extravascular grip sealant that actively adheres to the vein for a secure mechanical closure and dissolves within 30 days, leaving nothing permanently behind in the healed vein. The safety profile of this secure extravascular sealant makes the MynxGrip device uniquely for venous closure, as it does not leave behind an intravascular component.
“In addition, there are no changes to the MynxGrip device design,” she said. “So there are no changes in how the physicians are really utilizing the product. We will be spending some time educating the market and informing them that we now have a new indication.”
Shaden Marzouk, VP of Clinical Affairs for Cardinal Health noted, “The venous indication for the MynxGrip Vascular Closure Device is an example of innovative applications for an interventional suite offering that is differentiated in the marketplace. We know that these high quality, value-priced and patient-centered solutions are extremely important in today’s evolving healthcare landscape.”
Cardinal Health said that it now has the ability to reach a larger patient populace with the indication.
“We’ll expand the market for the device,” Sutton, told MDD. “It really opens the market to closing veins and there’s no other vascular closure device on the market today that’s promoting this kind of indication.”
The original Mynx device received the CE mark in January 2007 and received initial FDA approval in May 2007. The device uses a soft, sponge-like sealant material to close the small hole in the femoral artery. The sealant works by rapidly absorbing blood and fluids around the puncture site, swelling in size and covering the hole. This seals the hole and stops the bleeding.
The sealant material consists of polyethylene glycol (PEG), a water-soluble, non-thrombogenic, conformable, bio-inert polymer. PEG has an established safety profile and various forms of PEG are commonly used in a range of consumer and medical products including toothpaste, skin cream and lubricant eye drops.
Cardinal Health first gained access to the MynxGrip Vascular Closure Device, when it revealed its intent to acquire AccessClosure (Santa Clara, California) back in April (Medical Device Daily, April 4, 2014). Cardinal acquired the small private firm for $320 million.
Cardinal has recently been successful in its growth efforts. Last year the firm’s medical business had $2.8 billion in revenue in its fiscal second quarter, a 13% increase from the previous year. Profit was up 40%, to $131 million. AccessClosure’s annual sales are more than $80 million, driven by a direct sales force.
For a little more than a year Cardinal Health has been expanding its role on the med-tech landscape. In February 2013, the company made substantial inroads into into the sector when it reported plans to acquire AssuraMed (Twinsburg, Ohio), a provider of medical supplies to patients in the home, for $2.07 billion, or $1.94 billion, net of the present value of tax benefits (Medical Device Daily, Feb. 15, 2013). The acquisition came on the heels of AssuraMed’s acquisition of InvaCare (Elyria, Ohio) in December 2012 for $150 million. //
managers for the offering.HTA is a full-service real estate company focused on
acquiring, owning and operating high-quality medical office buildings that are predominantly located on or aligned with campuses of nationally or regionally recognized healthcare systems in the U.S.
• Fuel3D (Oxford, UK), a maker of 3-D scanning solutions, reported that it has closed a funding round totaling $6.4 million (£4 million). This funding builds on the company’s initial $2.6 million (£1.6 million) funding secured earlier this year and paves the way for the commercial launch of the company’s consumer scanner product in 2015.
The funding round was led by Chimera Partners and will be used to ramp-up Fuel3D’s production, customer support and international retail distribution after it delivers on its Kickstarter and pre-order commitments.
In addition, Fuel3D will use the funding to expand the scope of the company’s technology to address commercial opportunities in a range of vertical markets through its Fuel3D Labs division, including biometrics and eyewear.
“The initial interest shown by investors in Fuel3D has only been increased since the first funding round and we are very pleased to have been oversubscribed in this round of fundraising,” said Ben Gill of Chimera Partners and Chairman of Fuel3D. “The company continues to impress with its commitment to product development goals and has also made very significant inroads into developing new commercial applications and relationships.”
In 2013, Fuel3D raised more than $300,000 for the development of an affordable, high resolution handheld 3-D scanner through its successful crowdfunding campaign on Kickstarter. The company has expanded rapidly in response to global demand and now has distributors in 23 countries around the world as well as manufacturing operations in Asia. //
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 7 OF 10
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SvelteContinued from page 1
MDD: What drew you to Svelte Medical?Darby: When I was approached by Svelte’s chairman of the
board, Bob Croce, my initial reaction was ‘does the world really need another drug-eluting stent’ (DES)? The DES market is fairly mature with highly refined technology and clinical data pretty much a wash across all platforms. But after stepping back to thoughtfully assess the opportunity, I realized Svelte had something truly remarkable. By incorporating a stent onto an integrated wire platform, the Integrated Delivery System (IDS) simplifies percutaneous coronary intervention. Reducing the number of steps necessary to complete a procedure extracts time and cost from interventions. This benefits all constituents involved with stenting procedures – patients, physicians, providers and payers. No other stent technology does this.
The roughly $5 billion stent market also surprisingly lacks real product differentiation. With the world’s lowest profile system, Svelte has the ability to come in and own the transradial, or slender-stenting segment of the market. Transradial interventions represent the fastest growing segment of the U.S. coronary stent market and already have a large global following. Our ability to facilitate the transradial approach and lower procedural costs by 15% to 20%, given the health economic pressures we all face today, well, I love that story and agreed to join the company.
MDD: What is the opportunity in owning the transradial segment for coronary stenting?
Darby: In the U.S. transradial represents 22% to 25% of stenting procedures, whereas just a few years ago less than 5% were being done through the wrist. Transradial is used in about 45% of all procedures in Europe, while in Japan it is around 65%. For patients, trans-radial provides greater comfort and shorter time to ambulation. Patients can get up and walk away after the procedure with a small compression bandage around their wrist. With a trans-femoral approach, a closure device or suturing is commonly used to seal the access site, often requiring patients to remain in bed for an extended period of time. More importantly, bleeding complications are significantly less with the radial approach than the femoral.
We are increasingly seeing health systems train their physicians on the trans-radial approach because it enhances patient comfort and saves about $180 per procedure over a transfemoral procedure. Add to this the opportunity for a same day discharge versus an overnight stay, which can save about $1,100 per procedure, and reducing bleeding complications, which cost about $11,000 per event, and you can quickly see the potential the transradial approach provides to reduce hospital costs. Include the Svelte IDS, and hospitals can immediately extract costs from stenting procedures.
MDD: These sound like cost savings, but what do you mean by “immediately extract costs from stenting procedures?”
Jack Darby President/CEO of Svelte Medical
Darby: By integrating a balloon and stent on a steerable guide wire, the Svelte IDS obviates the need for a steerable wire, pre- and post-dilatation balloons, and in some cases, even guiding catheters. In a standard rapid exchange stenting intervention there are 14 steps. Our procedure takes just 5 steps. We have seen physicians place our stent literally within one minute of completing diagnostic angiography by delivering the IDS through the diagnostic catheter. The IDS requires less back-up support than traditional systems and has been used fairly routinely by physicians
through sheathless guides and diagnostic catheters as small as 4 French. Simply put, the IDS requires fewer steps and takes a lot of equipment out of a procedure. Everything we have done today demonstrates we are in the 15% to 20% savings range per procedure. Data from a study in Bern Switzerland showed about $495 saved per procedure when using our technology.
MDD: If transradial is already expanding, what differentiates Svelte?
Darby: We have a very good product in terms of the safety and efficacy. Our first-in-man as well as randomized, controlled clinical trial data are at least equivalent, if not better, than everyone else. But having the world’s lowest profile stent system, and ability to facilitate the trans-radial approach while reducing ancillary product use, uniquely positions us to change the discussion from safety and efficacy, where stent providers are essentially equivalent, to saving money, reducing procedure time and improving lab turnaround. The Svelte IDS improves interventions through the wrist, which enhances patient comfort, simplifies the treatment of complex lesions while reducing procedure times, which benefits physicians, and extracts hard and soft costs from stenting procedures, which continues to be a priority for hospitals and payers. Value is added to all parties involved in coronary stent procedures, and no other stent technology does this.
MDD: What is your timeline for moving the company forward?
Darby: We have submitted the IDS technology for CE mark certification and expect to get that the summer of 2015. In parallel we are working with FDA and Japan’s PMDA to have approval to conduct pivotal clinical studies in those countries in 2016. Going into Europe, our priority is to further validate our technology and compile large-scale data on the economic benefits of our technology through robust post-market studies.
With our initial launch in Europe and approvals to conduct clinical studies in the U.S. and Japan in-hand, we will consider strategic acquisition or an IPO, pursuing whichever provides the best valuation of our company and reasonable return to our stakeholders. //
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 8 OF 10
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Latin AmericaContinued from page 1
in the city of Santos Michelena in the state of Aragua.“The republic invests to bring [these products] from abroad.
We have the dollars [to bring this]. And we have seized [these medical supplies]. They had them unlawfully stored, hoarded, so a vacuum effect could be created [in the market]. . . . The people who are liable for this are being sought by our security forces,” said Maduro during his one and a half hour speech after the raid.
“The insatiable bourgeoisie and now this oligarchic fraction of smugglers, plunder the people. They believe there is no law for them, and of course there is one and they will pay. All of their assets have been confiscated and all of their bank accounts have been frozen,” Maduro said.
“We’ve granted the dollars so there can be a perfect supply of all what´s needed and what the republic does not produce,” he said. “Will they argue now that they are politically repressed and go the United Nations?”
The raid and the president’s incendiary speech surprised the Venezuelan medical device industry.
Two device distributors were directly affected by the government’s actions to confiscate their holdings. The two companies, Suministros Médicos Jayor (Caracas, Venezuela) and Suplidora Hospimed 2004 (Caracas, Venezuela), are both affiliated with the Venezuelan Association of Distributors of Medical, Odontological and Lab Devices (Avedem; Caracas, Venezuela).
The shortage of medical devices and supplies in Venezuela has, over the past year, grown dire. Industry stakeholders say surgical procedures have had to be put on hold as a result of the shortage. At the heart of the problem is a lack of foreign currency, which the government controls. Without access to foreign currency, Venezuelan distributors cannot pay for imports of fresh supplies. The country’s combined debt in the space now tops $245 million and most multinationals have stopped supplying Venezuelan distributors. (Medical Device Daily March 10, 2014; June 2, 2014; Aug 19, 2014)
“If [the government] finds itself beset, because everyone is complaining of a shortage in medical supplies, they go and chase a scapegoat to make it look like the government has granted the dollars and that [everything is fine on the government side],” said Antonio Orlando, president of Avedem in a phone interview with Medical Device Daily.
“Suministros Médicos Jayor is a 25-year-old company and Suplidora Hospimed 2004 is four years old,” said Orlando.
Hospimed is the main supplier of saline solution in the country. its owner is Jacob Serfati Benzadon. It was his father who was in charge of the inventory at the Aragua warehouses “but he had a heart attack four weeks ago and he rushed to a hospital in Miami. And while he is abroad, [the government] did what it did,” said Orlando. “The state has to do the legal controls
and inspections, but the right to a legitimate defense must be guaranteed.”
“[These entrepreneurs] are serious businessmen as far as we know, they don’t have the need of get in trouble by hoarding supplies and devices,” he said.
The government said it seized as many as 100 million items from a 9,000 square meter warehouse during the raid last week in Santos Michelena.
“When the government talks about what was found in those warehouses, they say that with all that stock, Aragua could be supplied for a year or Venezuela for six months,” said Orlando, who is skeptical about the figures released by the government. “[The government says that] there were 17 million syringes seized, but Venezuela consumes more than 300 million syringes per year. They manipulate the figures for the media, to make ordinary people believe that it was a giant operation. Everything is manipulated,” he said.
Since August, the Venezuelan government has been dealing with various device distributors in the country but none of them have been able to access the foreign currency they need to pay off international suppliers.
“They staged a show to feature that they were paying and one of the companies that received a partial payment actually was Suministros Médicos Jayor, which had an international overdue debt of about $20 million. Now their debt is about $4 million to $6 million,” he said.
Representatives from the sector met with Alejandro Fleming, president of Cencoex (the office of international commerce that releases foreign currency), who assured them that all their debts would be covered by the end of this year. However, members of the sector who attended the meeting said that Fleming remarked that the priority of Cencoex is to meet the demand for Christmas goods and supplies.
Meanwhile, Serfati Benzadon, who is allegedly in the U.S., faces up to 10 years in prison if he returns to Venezuela or is arrested by Interpol, said Pedro Viloria, lawyer and partner at Viloria Consultores in a phone interview from Caracas.
“The government of Venezuela has taken the path of price caps and it created the Superintendency of Fair Prices with a huge quantity of prosecutors and inspectors, to control some prices in the market. [The regulation] mandates a limit of 30 percent of revenue,” Viloria added.
Venezuela´s government will introduce a reform to make the punishment tougher for hoarders and profiteers.
“There will be some kind of parallelism with the anti narcotics law,” said Viloria. It is expected that the reform will increase the punishment for hoarders to up to 14 years in prison.
To date, there are no red notices posted in Interpol’s website seeking the arrest of Serfati Benzadon or other Venezuelan medical device distributors.
Nancy Pérez, Minister of Health of Venezuela announced on October 27 that all the supplies seized, including more than 5,000 wheelchairs would be distributed through the country´s public health system. //
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 9 OF 10
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BeltwayContinued from page 1
outpatient prospective payment schedule (OPPS) on Halloween. Congress had weighed in on the matter of tomosynthesis via a Sept. 29 letter to CMS urging the agency to create new codes to cover the additional cost of tomosynthesis when added to full field digital mammography (FFDM) versus FFDM alone (Medical Device Daily, Oct. 31, 2014).
Among the points made by the signers of the letter, all of which were Democrats, was that a paper appearing recently in the Journal of the American Medical Association had claimed that tomosynthesis can shave $10,000 off the cost of screening for every 1,000 screened women, an article that enjoyed considerable esteem given that one of the authors was Etta Pisano of the Medical University of South Carolina (Charleston, South Carolina). Pisano is one of the best known experts in the field and was one of those who argued for the reclassification of FFDM systems into class II during an FDA hearing in which she advanced a similar argument for tomosynthesis (MDD, May 25, 2006).
CMS explains in the MPFS final that it had provided an add-on code to the common procedural terminology (CPT) coding system for tomosynthesis, which the agency said is “consistent with the FDA requiring a 2-D mammography when tomosynthesis is used for screening purposes.” The final rule notes that the new CTP code, 77063, would be valued on an interim basis pending a set of recommendations from the relative value update committee (RUC) on other mammography codes. CMS said it had assigned CPT 77063 an interim final work relative value of 0.60 “as recommended by the RUC.”
The American College of Radiology (ACR; Reston, Virginia) published an Oct. 31 brief on the OPPS final to its members, affirming that the agency has assigned a 0.6 physician work relative value unit (RVU) to both the new screening tomosynthesis CPT code and a new add-on code (G-2079) “to be used with the existing digital diagnostic mammography G codes to reflect the extra work of tomosynthesis when provided with digital mammography.” ACR said CMS will continue the practice of paying separate rates for digital and film mammography as well.
Hologic published an Oct. 31 statement noting that the additional codes for tomosynthesis for breast cancer will allow providers in the U.S. to file reimbursement claims specific to screening and diagnostic 3-D mammography,” but also that the news “creates a pathway for private insurers to explore broader coverage and payment options.”
On the subject of practice expense inputs for stereotactic radiosurgery (SRS), CMS noted that it had “summarized comments received about whether CPT codes 77372 and 77373 would accurately reflect the resources used in furnishing the typical SRS delivery” – assuming there were no differences in
coding between robotic and non-robotic delivery methods – as part of the CY 2014 final rule. The agency noted that it had considered deleting two contractor-priced G codes (0339 and 0340) “in future rulemaking,” but noted that most commenters expressed the view that the CPT codes “accurately described both services” and that the RUC was of the view that the practice expense inputs “accurately accounted for the resource costs” invoked in providing the referenced services.
CMS concluded that it lacked sufficient data to justify deleting the G codes and will instead work with stakeholders to “identify an alternate approach” and take the matter up in future rulemaking.
The agency remarked that for calendar 2014, it had established relative value units for three “newly created” CPT codes (37236, 37237, and 37238) as interim final values, but that it had not agreed with the RUC recommendation for the relative value for 37239, which takes up the placement of intravascular stents in additional veins. CMS argued that the work for placement of an additional stent in a vein “should bear the same relationship to the work of placing an initial stent in the vein as the placement of an additional stent in an artery to the placement of the initial stent in an artery.” CMS held to this position in the final rule despite some comment to the contrary, including one recommendation that the agency refer the matter to refinement panel review. The agency declined, stating that the situation did not qualify for such a review.
CMS affirmed the proposed schedule’s discussion of payment for anesthesia services provided in conjunction with certain colorectal cancer screening tests to “include anesthesia that is separately furnished.” The agency remarked that the change would “further reduce our beneficiaries’ cost-sharing obligations under Part B” thanks to the U.S. Public Services Task Force recommendation on CRC screening, which under the Affordable Care Act eliminates co-pays.
In a fact sheet accompanying the release of the MPFS final rule, CMS reported a change to the hardship exceptions for the Medicare electronic health record (EHR) incentive program, said to consist of an interim final rule with a request for public comment. The fact sheet indicates that the interim rule “provisionally adopts changes to the regulatory language about hardship exceptions from the Medicare payment adjustment” included in the EHR incentive programs.
The agency said that it had reopened the submission period for hardship exception applications in October to avoid loss of payment for not demonstrating meaningful use objectives. CMS explained that eligible parties that have never met meaningful use standards up to now may reapply if they had been unable to fully roll out the 2014 edition of the Certified Electronic Health Record Technology (CEHRT) standard “due to delays in 2014 Edition CEHRT availability, and could not attest by the early attestation deadline for new participants.” //
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ PAGE 10 OF 10
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PRODUCT BRIEFS
• Covidien (Dublin, Ireland) reported FDA clearance for the HawkOne directional atherectomy system. The latest addition to Covidien’s directional atherectomy portfolio, the HawkOne system is designed to provide physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD). Covidien said its directional atherectomy portfolio includes the TurboHawk and SilverHawk systems and is backed by more than 15 peer-reviewed studies.
• Intact Vascular (Wayne, Pennsylvania), a medical device company and developer of products for minimally invasive peripheral vascular procedures, reported its completion of the TOBA-BTK study, Tack Optimized Balloon Angioplasty – Below the Knee Study. This multi-center pilot study focused on gathering data supporting the safety and performance of the Tack Endovascular System in subjects with critical limb ischemia (CLI) due to vascular disease below the knee. Thirty-five subjects were enrolled in this study which targeted diseased tibial vessels for treatment. CLI is an advanced stage of peripheral artery disease in which patients suffer from inadequate blood flow to the lower leg and foot. The Tack Endovascular System has been designed to leave minimal foreign material in the artery, to apply only the minimum outward force required to repair tissue tears within the lumen, and to allow spot treatment only where needed. The system is composed of a delivery catheter containing three self-expanding nitinol tacks.
• SeraCare Life Sciences (Milford, Massachusetts), a provider of biological materials that help optimize diagnostic performance, reliability and repeatability across the IVD lifecycle, reported seven new AccuSpan molecular linearity panels for the detection of Adenovirus (ADV), Varicella Zoster Virus (VZV), JC Virus (JCV), Herpes Simplex Virus 1 (HSV1), Herpes Simplex Virus 2 (HSV2), Epstein Barr Virus (EBV), and BK Virus (BKV). These new linearity panels from SeraCare help assay developers thoroughly challenge their transplant assays from extraction phase through amplification. Each panel consists of four members: one negative, one low positive, one medium positive, and one high positive sample. These panels are provided in a ready-to-go single-use format with target concentrations that cover the dynamic range of most molecular assays and are consistent within each lot and across batches. SeraCare partners with diagnostics researchers, IVD manufacturers and clinical laboratories to shape the future of precision medicine.
• Stratasys (Minneapolis), a provider of 3-D printing and additive manufacturing solutions, introduced the Fortus 450mc and Fortus 380mc 3-D production systems, designed to provide improved reliability, speed and accessibility. Using FDM technology, both 3-D production systems are designed to provide high-quality engineering grade parts that can be used to reduce the time to bring a product to market, create jigs and fixtures for manufacturing, as well as produce low volume end-use parts. The Fortus 450mc can make parts up to 15% faster than its
predecessor, Stratasys said. It has a build envelope of 16 in. x 14 in. x 16 in. (406mm x 355mm x 406mm), and it can produce layer resolutions ranging from 0.005 in. to 0.013 in. (0.127mm to 0.330mm). The Fortus 450mc has capacity for two model material and two support material canisters, and the usage level can be monitored using the touch screen. Industries including aerospace, government, military and medical, requiring complex functional prototypes, production aides and end-use parts in specialized materials may benefit by using the Fortus 450mc. The Fortus 380mc has the same advanced features as the Fortus 450mc including even temperature distribution in the build chamber and a digital touch screen. On average, the 3-D printer can build parts up to 20% faster with a build envelope of 14 in. x 12 in. x 12 in. (355mm x 305mm x 305mm) with the same layer resolutions as the Fortus 450mc.
• VisionCare Ophthalmic Technologies (Saratoga, California), a maker of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), reported the Centers for Medicare and Medicaid Services (CMS) will reimburse the Implantable Miniature Telescope under a revised ambulatory payment classification designation, APC 0351, Level V Intraocular Procedures. The report was included as part of CMS’ CY 2015 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Payment System final rule. The outpatient surgical procedure for telescope implantation has been restricted to hospitals until now due to current reimbursement rules, despite the fact that approximately 80% of ophthalmic surgical procedures are performed in local ASCs. The CMS ruling provides the mechanisms needed for broad ASC adoption of the therapy, which will significantly improve patient access and bolster ophthalmologist and healthcare provider efficiency. When the new designation for APC 0351 code takes effect on January 1, 2015, reimbursement payment levels will increase overall and ASC payment levels will be comparable to those paid to hospital outpatient departments. VisionCare Ophthalmic Technologies VisionCare’s Implantable Miniature Telescope was invented by company founders Yossi Gross and Isaac Lipshitz.
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WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 1 OF 2
Keeping you up to date on recent developments in oncology By Mark McCarty, Washington Editor
ONCOLOGY EXTRA
Continues on next page
New approach could kill tumor cells in the brain better and avoid side effects
Every year, about 100,000 Americans are diagnosed with brain tumors that have spread from elsewhere in the body. These tumors, known as metastases, are usually treated with surgery followed by chemotherapy, but the cancer often returns.
A new study from MIT, Brigham and Women’s Hospital, and Johns Hopkins University suggests that delivering chemotherapy directly into the brain cavity may offer a better way to treat tumors that have metastasized to the brain (Intracranial microcapsule chemotherapy delivery for the localized treatment of rodent metastatic breast adenocarcinoma in the brain, PNAS, (www.pnas.org/cgi/doi/10.1073/pnas.1313420110). Testing their new approach in mice, the researchers found that the chemotherapy drug temozolomide (TMZ) was more effective when delivered via tiny capsules implanted inside the skull. This suggests that a similar approach might be more effective in human patients, says Michael Cima, the David H. Koch Professor of Engineering at MIT and a senior author of the study, which appears this week in the Proceedings of the National Academy of Sciences. “Metastatic disease should be sensitive to chemotherapy, but systemic chemotherapy has not proven effective because it’s not getting to the brain at a high enough dose for a long enough period of time,” says Cima, who is also a member of MIT’s Koch Institute for Integrative Cancer Research. “We’re showing we get much higher degrees of tumor cell death when we deliver the drug locally.”
Targeted delivery: The researchers delivered chemotherapy drugs via implantable microcapsules made of a biocompatible material called liquid crystal polymer. The capsules are small cylinders with a 1.5-milliliter drug capacity; the drug diffuses out through a small hole. The researchers tested 2 chemotherapy agents: TMZ, which is a first-line treatment for brain metastasis and gliomas, and doxorubicin, a common treatment for breast cancer, which often metastasizes to the brain.
Zone of influence: Working with mice implanted with tumors similar to human brain metastases, the researchers found that TMZ delivered directly to the brain prolonged survival by several days compared with TMZ administered by injection. They also found higher rates of apoptosis, or programmed cell death, in tumor cells near the capsules.
The Global Incidence and Prevalence Report from the Incidence and Prevalence Database (IPD), states that worldwide, 800,000 patients are on chemotherapy. In England, the number of patients receiving chemotherapy each year is increasing. An estimated 65,000 chemotherapy programs (a planned period of repeated cycles of treatment) are delivered
annually. In the US, with over 25 million doses administered annually, oral chemotherapy is an expanding and potentially hazardous treatment for cancer patients. In a 2006 survey of US cancer centers, only 1 in 4 centers had standard prescribing safeguards in place for oral chemotherapies, and fewer than 1 in 5 had measures to ensure safe administration and monitoring.
Evidence behind complementary therapies is mixedCancer is frightening enough to prompt a lot of speculation
as to what might cure or treat it, a parade of offerings that probably did not start with Laetrile. A recent statement by Columbia University (New York) takes up the matter of these alternative therapies, stating that some score well, while others fall short. As might be expected, “meditation, yoga, and relaxation with imagery were found to have the strongest evidence supporting their use” compared to some treatments, earning a grade of A, including for routine use to aid in dealing with anxiety and other mood disorders often encountered by breast cancer patients. Acupuncture scored a grade of B for controlling chemotherapy-induced nausea and vomiting and can be recommended to most patients. On the other hand, more than two dozen other interventions, a list said to include “some natural products and acupuncture for other conditions,” offered slimmer bases of evidence “due to either small study sizes or conflicting study results, and received a C grade,” the statement notes. Among the modern abject failures is acetyl-l-carnitine, marketed to prevent chemotherapy-related neuropathy, but which actually increased risk for the condition.
French team picks up early lung cancer cells with ISETResearchers at the French Institute of Health and Medical
Research (Institut national de la santé et de la recherche médicale, or Inserm), have made headway in the effort to provide early detection of lung cancer with ISET filtration-enrichment techniques, a development that could beat CT scanning to a definitive diagnosis by “several months, and in some cases several years,” according to an Inserm statement. The statement explains that the study tracked 245 people without cancer, including 168 deemed at risk due to COPD, and the blood test picked up circulating cancer cells in five patients (3%) despite that imaging did not show any nodules in the lungs. In these five patients, a nodule became detectable between one and four years after detection of circulating cancer cells by the ISET filtration method, and they each immediately underwent surgery with biopsy of the removed lesion confirming the diagnosis. A one-year check-up showed no sign of recurrence in the five patients, and no nodules were detected during monitoring
WEDNESDAY, NOVEMBER 5 , 2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 2 OF 2
ONCOLOGY EXTRAContinued from previous page
of subjects who did not have circulating cancer cells, while no cancer cells were detected in the bloodstream of “control” subjects without COPD. This research appears in Plos One under the title “Sentinel Circulating Tumor Cells Allow Early Diagnosis of Lung Cancer in Patients with Chronic Obstructive Pulmonary Disease.”
Louisiana State University snaresaward for breast cancer support
The Louisiana State University (LSU; Baton Rouge) School of Public Health has been awarded a $2.2 million grant to increase the availability of health information and support services for young breast cancer survivors in the American Gulf South, according to a Nov. 3 LSU statement. The Centers for Disease Control and Prevention made the award, which will be paid out over five years, to support the development and implementation of strategic and integrated multi-media health education and awareness campaigns to address the health information needs of these patients. LSU will use the money to bring together a three-state coalition from organizations in Louisiana, Mississippi, and Alabama that will go by the name of the Gulf States Young Breast Cancer Survivors Network. LSU’s Donna Williams, will serve as the principal investigator in the program, which is tasked with developing and disseminating “pertinent and culturally sensitive health information via social media.” Messages will address family history and genetic risks, psychosocial health and support, reproductive health and fertility, family support, health monitoring and evidence-based preventive lifestyle behaviors like maintaining a healthy weight, reducing tobacco use and excessive alcohol use.
NSAIDs fight cancer by inducing apoptosisAspirin has seemed for decades like a mystery drug, but a
recent statement by the University of Pittsburgh (Pittsburgh) School of the Health Sciences explains how salicylic acid and other non-steroidals influence colorectal cancer (CRC). The statement notes that a recent study appearing in the Proceedings of the National Academy of Sciences consisting of experiments in animal models and tumor samples from patients who had taken NSAIDs and those who hadn’t suggests that NSAIDs activate the “death receptor pathway.” This pathway is credited with selectively triggering a suicide program in intestinal stem cells that have a mutation in the APC gene that renders the cells dysfunctional. Healthy cells lack the mutation, so NSAIDs exert no effect on those cells. In that manner, the drugs instigate the early auto-destruction of cells that could lead to pre-cancerous polyps and tumors. Senior investigator Lin Zhang, said the study “identifies a biochemical mechanism that could explain how this preventive effect occurs,” adding, “these findings could help us design new drugs to prevent colorectal cancer, which is the third leading cause of cancer-related deaths in the country.”Eribulin shown to extend survival in breast cancer
Makers of companion diagnostics may have more reason to invest in a test associated with eribulin (or Halaven, made by Eisai of Tokyo) thanks to a recent statement by Cancer Research UK (London). The statement explains that this drug, which was developed from chemicals found in sea sponges, may offer women with advanced triple negative breast cancer an average of five extra months of life. Researchers looked at two major clinical trials of more than 1,800 women with breast cancer that had started to metastasize, and the phase III trials compared the survival of women treated with eribulin to those given standard treatment. The two studies showed an overall improvement in survival of more than two months for women treated with eribulin. The most significant improvement was seen in women with the advanced triple negative form of breast cancer, where there are limited treatment options; these women’s survival improved by nearly five months. There was also a survival boost of more than two months for women with the HER2 negative form of breast cancer.
East, West Coast institutes win genomic pilot contractThe Broad Institute of MIT and Harvard (Boston) and two
institutions in the California state university system have won an award from the National Cancer Institute Cancer Genomics Cloud Pilot that will go toward the building of a system that will enable large-scale analysis of The Cancer Genome Atlas (TCGA) and other datasets by co-locating the data and the required computing resources in one cloud environment. This co-location will enable researchers across institutions to bring their analytical tools and methods to use on data in an efficient, cost-effective manner, thereby promoting democratization and collaboration across the cancer genomics community, the statement explains. Large-scale sequencing efforts are helping researchers understand the genetic changes that lead to cancer and have led to the development of several successful, targeted chemotherapies. These developments show that identifying mutations that drive cancer can translate into therapeutics. However, three main challenges remain: first, processing massive sequence datasets requires costly computational infrastructures for which few groups have the resources; those that do have the resources often end up duplicating each others’ engineering and analysis efforts. Second, data generation is outpacing the development of tools and methods that can be used on such large datasets: already, petabytes of data exist, and exabytes are on the near horizon. Finally, data is being collected and stored in silos, minimizing the potential for synergy, data sharing and integrated analysis. Gad Getz, of the Broad Institute said the pilot “will allow the cancer research community to collaborate in a way that has not been possible before. We’ll now be able to share data and tools and jointly learn from the totality of cancer genomics data. Our cloud system will democratize access to computational tools for non-experts as well as empower developers with a platform for creating the next generation of analytical methods.”
