Three Candidates in Running to Become FDA Commissioner, Including Acting Chief Ned Sharpless

September 16, 2019 Issue 161

Three Candidates In Running To Become FDA Commissioner, Including Acting Chief Ned Sharpless

hile four former FDA com- von Eschenbach (2006-2009) and Mark Photo credit: M.D. Anderson Cancer Center Center Cancer Anderson M.D. credit: Photo missioners on 3 September McClellan (2002-2004) praised acting com- STEPHEN HAHN endorsed Ned Sharpless, the missioner Sharpless’ “ability to execute the W MD Anderson Cancer Center oncologist agency’s acting commissioner, to be the critical and complex work of the agency.” Trump administration’s permanent choice The former commissioners said in the to lead the agency, an MD Anderson Can- letter that “it is imperative that FDA have a cer Center oncologist or Harvard Univer- permanent leader,” as the agency regulates sity dermatologist may also be chosen. a quarter of products consumed in the US, Besides Sharpless, the other two candi- “including lifesaving therapies and the na- dates being considered to lead the FDA tion’s food supply.” The former commis- are Harvard University dermatology pro- sioners added that on a permanent basis, fessor Alexa Boer Kimball and MD Ander- “Sharpless’ expertise will enable new ac- son Cancer Center radiation oncologist tivities in such key areas as cancer treatment

Stephen Hahn. and prevention, and precision medicine.” Harvard University credit: Photo Sharpless became acting commis- Gottlieb, who also has been an enthu- ALEXANDRA “ALEXA” BOER KIMBALL sioner on 8 April when former FDA chief siastic backer of Sharpless for the perma- Harvard University dermatologist Scott Gottlieb stepped down from the nent post, was prevented from signing post to end a long weekly commute be- onto the 3 September letter due to post- tween Washington, DC, and his Westport, FDA employment restrictions preventing CT, home. Sharpless previously served him from contacting federal health offi- as director of the National Institutes of cials, he told Medtech Insight’s sister pub- Health National Cancer Institute (NCI). lication The Pink Sheet. (Also see "Former (Also see "NCI Director And Former Dx Commissioners Push For Sharpless Nomina- Start-Up Founder Sharpless Will Helm FDA" tion, Confirmation" - Pink Sheet, 4 Sep, 2019.) - Medtech Insight, 12 Mar, 2019.) In their letter to President Trump and KIMBALL IS CHAMPION OF

US Department of Health and Human EXPANDED PATIENT ACCESS archives Informa credit: Photo Services secretary Alex Azar, former FDA Alexandra Boer Kimball, who goes by NORMAN “NED” SHARPLESS commissioners Robert Califf (2016-2017), “Alexa,” is a respected clinician, re- Current acting FDA commissioner Margaret Hamburg (2009-2015), Andrew CONTINUED ON PAGE 5

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POLICY & REGULATION COMMERCIAL R&D Final guidance clarifies HDE process, Intuitive Surgical opens new Abbott launches TriClip pivotal trial in “probable benefit,” p. 9 UK/Ireland HQ in Oxfordshire, p. 18 the US, p. 22 Book your table Medtech Insight Awards 2019

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SPONSORSHIP AND TABLE BOOKING ENQUIRIES: Christopher Keeling T: +44 (0) 20 3377 3183 E: [email protected]

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JN2412 Medtech Awards 2019 Book your Table Advert US Letter.indd 1 2019/08/12 15:35 8 10 16 Book your table explore more: inside: Cover / Three Candidates In Running To Become FDA Medtech Insight exclusive online content Commissioner, Including Acting Chief Ned Sharpless ResMed’s 2025 strategy EDITORS’ PICKS http://bit.ly/2mc98q9 5 Device Sterilization, Duodenoscopes Focus Of Planned In an interview with Medtech Insight, ResMed CEO Mick Meeting – US hospitals would have to reveal their standard Farrell outlined the company's 2025 strategy: double-digit charges and insurer-negotiated prices for a long list of Awards 2019 growth, drive the user base to 250 million people and procedures and lab tests under a new proposed rule. become the leading digital health company in both sleep apnea and chronic obstructive pulmonary disease. 6 New FDA Guidance Expands HUD Patient Limit – Devices to treat diseases and conditions affecting many more De novo guidance Americans are eligible for Humanitarian Use Device status http://bit.ly/2kfgOaw under a new guidance document. The US FDA published a final guidance that goes into 6 UK’s Own Medtech Regs: Political Turmoil Could Make Monday, September 23, 2019 | State Room, Boston effect in early October that lists items sponsors should November Deadline Redundant – Brexit-related dates are submit when filing a de novo application. https://pharmaintelligence.informa.com/mti_awards2019 up in the air for the UK. Reimbursement in Turkey POLICY & REGULATION http://bit.ly/2kuMrgw 7 Australia To Improve Compliance For Device Systems After recent intervention from the medical device industry, and Procedure Packs – The Therapeutic Goods the Turkish government has finally done something Administration is seeking feedback on proposals affecting to address calls for systematic and comprehensive manufacturers of packages containing therapeutic goods. SPONSORSHIP AND TABLE BOOKING ENQUIRIES: improvement of medtech reimbursement prices. Christopher Keeling 8 Danish Regulator Offering Free Advice On How to Dreem 2 launched T: +44 (0) 20 3377 3183 Comply With New EU Regulations – The Danish Medicines http://bit.ly/2lIknqb E: [email protected] Agency is testing a new regulatory advice service for Dreem 2 is Dreem’s newest biofeedback headband with medical device SMEs. seven sensors that measure brain activity, heart rate, GENERAL ENQUIRIES: respiration and movement that works with a mobile app 9 Final Guidance Clarifies HDE Process, ‘Probable Benefit’ – Jo Kirkpatrick to help users improve the quality of their sleep. The US FDA has finalized a guidance document on the humanitarian device exemption process. T: +44 (0) 20 7017 7180 Execs On The Move E: [email protected] http://bit.ly/2kfhkW0 9 FDA’s Quality System Regulation Is Mapped To ISO Headline Sponsor CFO of neurovascular device-maker Penumbra adds 13485 In New Report From AAMI – A new Technical president title to job description; PerkinElmer promotes Information Report from the Association for the COO to CEO; chronic liver disease management company Advancement of Medical Instrumentation compares Echosens poaches AxoGen exec for North America CEO regulatory requirements found in the US FDA’s QSR quality spot; and more. systems standard ISO 13485:2016.

In partnership with 10 Policy Experts Predict Minor Changes To HHS Price medtech.pharmaintelligence.informa.com Transparency Rule – Health policy predict the US HHS will require hospitals and insurers to display typical procedure prices.

medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 3

JN2412 Medtech Awards 2019 Book your Table Advert US Letter.indd 1 2019/08/12 15:35 14 Rep. Shimkus, Author Of ‘Cures’ Device Provisions, Joins Exodus Of House Republicans – Illinois Rep. John Shimkus, a well-known pro-medtech industry bill sponsor, SHAWN M. SCHMITT @MEDTECHSHAWN announced on 30 August joins at least 15 Republican House [email protected] members who have announced their departure. REED MILLER @MEDTECHREED [email protected] 15 So You Think You Want to Work At A Notified Body? – In AMANDA MAXWELL @MEDTECHAMANDA an interview with Medtech Insight, Elena Kyria, founder of [email protected] UK-based recruiting firm Elemed, explained what is driving MARION WEBB @MEDTECHMARION notified body-related recruitment moves and what to expect. [email protected] SUE DARCEY @MEDTECH_INSIGHT 16 AI Focus At NHSX Lets Clinicians ‘Function At The Top Of [email protected] Their License’ – Less than 2% of NHS England’s budget is FERDOUS AL-FARUQUE @MEDTECH_DANNY spent on digital technology, NHS chief information officer [email protected] Simon Eccles told delegates at the NHS Health and Care ELIZABETH ORR @ELIZABETHJORR Innovation Expo. [email protected] COMMERCIAL CATHERINE LONGWORTH @MEDTECHCATE [email protected] 18 Intuitive Surgical Opens New UK/Ireland HQ In Oxfordshire – Surgical robotics giant Intuitive Surgical has opened a new ASHLEY YEO @ASHLEYPYEO [email protected] UK and Ireland headquarters and training suite in Oxford. MAUREEN KENNY @SCRIPREGMAUREEN 19 Stryker Closes Gap With Competitors In Strategic Spinal [email protected] Robotics Acquisition – Stryker is acquiring Mobius Imaging NEENA BRIZMOHUN @SCRIPREGNEENA and spine Cardan Robotics in a deal worth up to $500m. [email protected] VIBHA SHARMA @SCRIPREGVIBHA 19 FDA Approves Axonics’ Neuromodulation Device [email protected] For Incontinence – The US FDA has approved r-SNM ANDREA CHARLES CUSTOM CONTENT sacral neuromodulation system for treating chronic fecal [email protected] incontinence. JANET HANIAK SENIOR DESIGNER 20 Molecular Diagnostic Firms Curetis And OpGen Announce GAYLE REMBOLD FURBERT HEAD OF PUBLICATION DESIGN Merger – The combination of the molecular diagnostic RICHARD FAINT HEAD OF MEDTECH companies is structured as an acquisition of Curetis by OpGen. [email protected] PHIL JARVIS MANAGING DIRECTOR 21 Verily And iRhythm Agree To Collaborate On Atrial TO SUBSCRIBE, VISIT Fibrillation – Verily Life Sciences and iRhythm Technologies medtech.pharmaintelligence.informa.com have agreed to co-develop diagnostics combining TO ADVERTISE, CONTACT iRhythm’s artificial intelligence system for diagnosing [email protected] arrhythmias with Verily’s health data analytics technology. EDITORIAL OFFICE: 601 Third Avenue, New York, NY 10158 US R&D phone 212-520-2700 22 Abbott Launches US Pivotal Trial Of TriClip CUSTOMER CARE: Transcatheter Tricuspid Valve Repair System – The [email protected] 700-patient TRILUMINATE Pivotal will compare Abbott’s US Toll-Free...... +1 888 670 8900 TriClip transcatheter tricuspid valve repair device to US Toll...... +1 908 547 2200 medical therapy alone. UK & Europe...... +44 (20) 337 73737 Australia...... +61 2 8705 6907 23 Biotronik’s Orsiro Stent Beats Abbott’s Xience In Japan...... +81 3 6273 4260 BIOSTEMI Trial – Acute STEMI patients treated with All stock images in this publication courtesy of www.shutterstock.com unless otherwise stated Biotronik’s Orsiro sirolimus-eluting stent had a significantly © 2019 Informa Business Intelligence, Inc., an Informa company. lower rate of target vessel failure than patients treated with All rights reserved. Abbott’s Xience everolimus-eluting stent. No part of this publication may be reproduced in any form or incorporated into any information retrieval system without the writ- ten permission of the copyright owner.

4 | Medtech Insight | September 16, 2019 © Informa UK Ltd 2019 � COVER STORY �

CONTINUED FROM PAGE 1 Kimball received her undergraduate He served as a senior investigator and searcher and health-care executive who degree in molecular biology from Princ- commander in the NCI’s US Public Health was named CEO of Harvard University eton University, her medical degree from Service from 1989-1995 and was chief of Medical Faculty Physicians in July 2016. Yale University School of Medicine, and NCI’s prostate cancer clinic from 1993- A professor of dermatology at Harvard completed her residency at Stanford 1995.. Hahn is also an active member Medical School, Kimball is an interna- Hospitals and Clinics. of the Radiation Research Society, the tional expert on psoriasis and hidradeni- American Society of Photobiology and tis suppurativa who has published more HAHN WAS INVESTIGATOR the American Association for Cancer Re- than 250 peer-reviewed papers. Also, OF NCI GRANTS search, and serves on the board of the “Kimball is a champion for improved Stephen Hahn is a radiation oncologist American Society for Radiation Oncology. patient services and expanded patient currently serving as chief medical ex- Hahn received his undergraduate de- access to health-care service,” said Mary ecutive of the University of Texas MD gree in biology from Rice University, his Ann Stevenson, chief of radiation oncol- Anderson Cancer Center in Houston. He medical degree from Temple University ogy at Beth Israel Deaconess Medical remains an active clinician at MD Ander- School of Medicine, and completed his Center, where Kimball served as senior son, specializing in treatment of thoracic residency at NCI in Bethesda, MD. VP of the Massachusetts General Physi- and genitourinary cancers, and in the use cian Organization. of photodynamic therapy. Published online 5 September 2019

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environmental agencies shut down two device sterilization facilities because they exceeded the limits for how much EtO can safely be released into the environment. The closures have contributed to at least one device shortage already and may cause others, the FDA says. In July, the agency issued an innovation challenge for new device sterilization methods that could reduce or replace the need for EtO. (Also see “Got A Better Idea? US FDA Seeks Help Tackling Ethylene Oxide Troubles” - Medtech Insight, 16 Jul, 2019.) And duodenoscopes have been in the crosshairs since they were linked to an- Device Sterilization, Duodenoscopes tibiotic-resistant superbug infections in hospital patients several years ago. The flexible, lighted tubes used to treat gall- Focus Of Planned Meeting stones and other gastric conditions in- ELIZABETH ORR [email protected] clude small crevices that are notoriously difficult to clean. Most recently, the FDA takeholders are being asked to announced in a 4 September Federal recommended caregivers transition from weigh in on certain risks tied to de- Register notice. using fixed endcap duodenoscopes to S vice sterilization and reprocessed Panelists will discuss ethylene oxide ones where the cap can be switched out, duodenoscopes as part of the lead-up to (EtO) sterilization of medical devices, which carry a lower infection risk. (Also a November advisory panel meeting set with a specific focus on ways to reduce see “Continued Risks Of Duodenoscopes to focus on those subjects. toxic EtO emissions to the environment Leads FDA To Recommend Disposable Cap The US Food and Drug Administra- without compromising device safety Devices” - Medtech Insight, 29 Aug, 2019.) tion’s General Hospital and Personal Use or efficacy. Additionally, the panel will Comments are open at Regulations.gov Devices Panel of the Medical Devices review recommendations on reducing through 6 December. Advisory Committee is set to meet 6 the risk of infection tied to reprocessed The FDA plans to offer a webcast of the and 7 November in Gaithersburg, MD. A duodenoscopes. meeting. docket has been opened to collect com- Both subjects have been the focus of ments before the meeting, the agency recent government actions. In February, Published online 4 September 2019

medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 5 � EDITORS’ PICKS � New FDA Guidance Expands HUD Patient Limit

ELIZABETH ORR [email protected]

new final guidance from the US ber and (preferably) email address of agnostics, the 8,000 limit applies to the Food and Drug Administration the primary contact person; total number of people who would be A doubles the limit on how many • A description of the rare disease screened for the condition – not the num- patients can be eligible for devices ap- or condition that the device treats ber who would test positive. proved to treat rare diseases. or diagnoses, with an emphasis on Devices that are granted a HUD desig- The Humanitarian Use Device (HUD) the specific aspects of the disease nation may be approved via the Humani- designation, created in 1990, initially ap- or condition relevant to the func- tarian Device Exemption (HDE) process, plied only to devices to treat diseases or tionality of the device, as well as the which allows for devices to be approved conditions experienced by no more than device’s proposed indications for use with a greater level of uncertainty. A 4,000 Americans per calendar year. But in and the reasons why it is needed; separate guidance document issued last 2016, the 21st Century Cures Act raised the • A description of the device and a weak tweaked the FDA’s HDE policies to upper limit to 8,000. The final guidance, discussion of the scientific rationale meet other requirements set by the 21st issued on 5 September, formalizes that behind its use; and Century Cure Act, including a more thor- change as part of FDA policy. • Documentation demonstrating that ough explanation of the term “probable The document also explains the pro- the disease or condition for which the benefit.” (Also see “Final Guidance Clarifies cess of applying for HUD status. Sponsors device is intended manifests in no HDE Process, ‘Probable Benefit’” - Medtech begin the process by submitting a re- more than 8,000 Americans per year. Insight, 6 Sep, 2019.) quest for HUD designation to the FDA. In If the condition occurs in more than A flowchart included in the guidance addition to a statement that the applicant 8,000 people, the request should document shows the process by which is requesting the designation, the request establish that an orphan subset for the FDA reaches HUD determinations. should also include: whom the device is needed exists. • The name, address, title, phone num- The guidance also explains that, for di- Published online 11 September 2019

deal withdrawal. But Johnson is reported to UK’S OWN MEDTECH REGS: be trying to find ways around this.

A RELIEF FOR MEDTECH? Political Turmoil Could Make If these opposition party legislative initia- tives successfully delay the impending 31 November Deadline Redundant October Brexit date, it will be somewhat AMANDA MAXWELL [email protected] of a relief to many in the medtech sector who are trying to keep one eye on the o sooner is there news that the The opposition parties are attempting rapid fire of developments related to the UK’s own medtech regulations to prevent a no-deal Brexit withdrawal Medical Device and IVD Regulations, and N are going to be rushed into law, from the EU on 31 October by forcing the the other on what is happening in the UK. than we have developments that throw government to seek an extension to the With the threat of regulations being all of that into question. Brexit leaving date by three months, to 31 introduced in the UK that have not been But that is the nature of UK politics at January 2020. properly considered, it would be yet an- the moment. It is a hotbed of uncertainty. But even if Prime Minister Boris John- other expensive and complex challenge Only a day after Medtech Insight reported son’s government does seek a delay to the ahead. that the government set 1 November 2019 Brexit date, such a move would have to be Of course, the advice from the UK for the UK medtech regulations to apply, agreed unanimously by all the other 27 EU government, via the Medicines and the situation is that opposition parties and member states. There are too many ifs and Healthcare products Regulatory Agency some Conservative backbenchers are in buts for anyone to have any real indication (MHRA), has long been for the sector to the driver’s seat and gunning to change of the likely developments ahead. prepare for the worst-case no-deal sce- the Brexit outcome. And this may affect The opposition is also resisting Johnson’s nario, and most have done that – the the timing of when the UK’s go-it-alone call for an early election on 15 October. Its competent authorities, the notified bod- medtech regulations are passed and apply. primary focus right now is to stop the no- ies and the medtech industry, although

6 | Medtech Insight | September 16, 2019 © Informa UK Ltd 2019 � EDITORS’ PICKS � not all. And there has been no public seven weeks to read, digest and ensure An additional three months to prepare in-depth analysis of the impact of the they are compliant with the part of the would be a welcome reprieve – although amended UK regulations. amended UK regulations related to the not enough for many. Therefore, manufacturers that wish Medical Devices Directive (MDD). And But with all the political shenanigans to continue operating in the UK now they will need to ensure they are heading in the UK, timings remain uncertain and have a wake-up call if they have not al- in the right direction for compliance with things may not become clear for some ready studied the terms of the UK’s own the requirements of the UK’s device rules time. medtech regulations. which mirror, but are not identical to, the They may have a matter of just some EU’s Medical Device Regulation. Published online 6 September 2019

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has been applied to all individual prod- Australia To Improve Compliance For ucts included in the pack by their original manufacturers, and that the individual components are intended to be included Device Systems And Procedure Packs in the pack in their original, market-ready, NEENA BRIZMOHUN [email protected] finished state, as if they were being supplied under their own individual ARTG ustralian regulators are looking nula and or grafts, a percutaneous electrical entries. It reflects the expected low risk to improve compliance with their lead, and external electronic components. associated with the production process A regulations on medical devices Alternatively, a blood glucose monitoring required for assembling the final product that are put together for use as a unit ei- system may consist of a blood glucose me- (SOPP) under these conditions. ther in combination as a system or for use ter that connects to a smart phone, a soft- On the other hand, manufacturers of in a medical or surgical procedure. ware app, blood glucose test strips, blood SOPPs for which the special conformity There are many different types of sys- glucose controls, and lancets. assessment procedure does not apply tems and procedure packs (SOPPs) avail- Procedure packs can include, for in- must use the conformity assessment able that contain therapeutic goods, at stance, first-aid kits that contain a collection procedures appropriate to the classifi- least one of which is a medical device or of equipment and materials intended to be cation of the SOPP (which includes an IVD, according to the Therapeutic Goods used in an emergency for the rapid, initial independent assessment and certifica- Administration. treatment of an injury. Alternatively, sterile tion/approval of the manufacturer by an But the current regulatory require- surgical procedure packs may contain such assessment body/overseas regulator for ments are not sufficiently clear regard- things as clamps, drapes, sutures, needles, any devices higher than class I). These ing the criteria for, and application of, forceps, scalpels, gauze and dressings. SOPPs are still able to be supplied under the TGA’s special conformity assessment a single ARTG entry, rather than an entry procedure (self-declaration) for some of ‘SPECIAL PURPOSE’ for every medical device in the pack, but these SOPPS – ie, those that fall under the According to the new consultation, the the evidence for including the pack in the regulatory category of “medical devices TGA wants, among other things, to clarify ARTG is an official conformity assessment used for a special purpose.” its requirements regarding SOPPs that fit document, rather than a self-declaration. The TGA has therefore launched a pub- the criterion of a medical device used for The TGA notes that there are risks as- lic consultation on proposed regulatory a special purpose as per Regulation 3.10 sociated with SOPPs, and says the current amendments intended to clarify its exist- in the Australian MD Regulations. requirements are not sufficiently clear ing requirements, facilitate better regula- It explains that manufacturers of class I regarding the criteria for, and application tory compliance and improve the safety medical devices, class 1 IVDs and medical of, the special conformity assessment and performance of these products. The devices that are used for a special purpose procedure for SOPPS that are medical de- plan is to align requirements in Australia currently self-declare compliance – ie, they vices used for a special purpose. with those of the EU’s new Medical De- are not required to be assessed by an in- It is proposing to align with the EU MDR vice Regulation (MDR) wherever possible. dependent assessment body or a regula- on this front and require that manufactur- SOPPs can be marketed under different tor. Only one ARTG (Australian Register of ers of these types of SOPPs obtain confor- names, such as “system,” “kit,” “pack” or Therapeutic Goods) entry is needed for mity assessment documents (ie, from the “tray.” For example, systems include such the SOPP, rather than one entry for each TGA, a comparable overseas regulator or things as implantable ventricular circulato- medical device included in the SOPP. assessment body) for each medical de- ry assist systems, which contain an implant- The special conformity assessment vice included in the SOPP, and provide able pump, implantable connecting can- procedure recognizes that risk mitigation these documents to the TGA if requested. medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 7 � POLICY & REGULATION �

“This is to demonstrate that procedures NEW DEFINITIONS to issues and risks associated with the appropriate for their devices have been The agency also wants to add new defini- use of systems and procedure pack,” the applied for inclusion of a medical device tions for "system" and "procedure pack." agency warns. For example, some of the in the ARTG, and to demonstrate ongoing It notes that the EU’s MDR pro- issues raised in the latest consultation compliance with the conditions applying vides separate definitions for these are relevant to procedure packs but not automatically on inclusion of a medical terms, whereas the Australian legisla- necessarily to devices supplied as sys- device in ARTG,” the TGA says. tion currently provides one definition tems, it says. There would be no change for manu- covering both terms and uses them The agency is also proposing to in- facturers of SOPPs that are not medical interchangeably. troduce a definition for “compatibility,” devices used for a special purpose. These “While usually referring to systems which is defined in the EU MDR. SOPPs will still require a valid conformity and procedure packs as one broad cat- The deadline for submitting comments assessment document for inclusion in, egory of medical devices may be accept- to the consultation is 17 October. and to demonstrate ongoing compliance able, in some cases it may create misun- for, the ARTG, the TGA says. derstanding, especially when referring Published online 5 September 2019

number of requests received nationally as well as internationally,” the spokesperson added.

ONE-HOUR ONSITE OR TELECONFERENCE MEETINGS The advice will be provided via one- hour, one-to-one meetings with the agency that can either take place at the DMA’s premises or be conducted as a teleconference. As well as compliance with the MDR and IVDR, the agency will also provide advice with respect to the EU’s current medtech directives that the new regulations are replacing. “We will initially focus on regulatory Danish Regulator Offering Free guidance in terms of compliance with directives and the coming regulations on medical devices including guidance about Advice On How to Comply With requirements and processes regarding applications for clinical investigations in New EU Regulations regard to specific products,” the DMA said. Under the pilot, the company/applicant NEENA BRIZMOHUN [email protected] will take minutes of the meeting and send them to the DMA at the latest a week af- he Danish Medicines Agency is run- view to its potential continuation. ter the meeting. The agency will com- ning a pilot project offering free The agency said it was offering the ment on the minutes and approve them T advice to medical device SMEs and advice in response to an increasing de- once agreed. start-ups on how to comply with Europe’s mand from medical device companies “The advice does not cover approval new regulations governing medtech prod- for regulatory advice on the new Medical of products, assessment of specific prob- ucts and “get off on the right foot.” Device and In Vitro Diagnostics Regula- lems or other matters in which the Danish The pilot project, which began in Au- tions, which will fully apply in the EU Medicines Agency can take a decision," gust, is open to companies based any- member states from May 2020 and 2022, the agency said. In addition, the advice is where in the world, a spokesperson for respectively. not binding on the DMA or the company/ the DMA told Medtech Insight. For the initial period, no fees will be applicant. It will run until the end of the year, at charged for the advice, the DMA said. which point it will be evaluated with a “As part of the pilot we will assess the Published online 6 September 2019

8 | Medtech Insight | September 16, 2019 © Informa UK Ltd 2019 � POLICY & REGULATION � Final Guidance Clarifies HDE Process, ‘Probable Benefit’

ELIZABETH ORR [email protected]

he US Food and Drug Administration has given develop- PMA or de novo request, both of which require a demonstration ers of devices to treat rare diseases additional clarity on of reasonable assurance of safety and effectiveness, it is antici- T what it wants to see before approving the devices. pated that there will generally be greater uncertainty surround- The recommendations came via a final guidance document, ing the benefit-risk profile based on the evidence submitted in “Humanitarian Device Exemption (HDE) Program: Guidance for an HDE application.” Industry and Food and Drug Administration Staff,” which was is- The final guidance includes a filing checklist to clarify the infor- sued on 5 September. It fulfills a requirement set by 2016’s 21st mation needed for the FDA to consider an HDE application suffi- Century Cures Act that the agency explain what criteria it uses to ciently complete to allow substantive review, as well as checklists determine whether devices being reviewed via the HDE pathway to help ensure review staff make consistent decisions. It also offers have demonstrated probable benefits of health. additional guidance on such aspects of the HDE process as adverse Devices that are intended to help treat or diagnose diseases or event reporting, eligibility for profit and pediatric use of HDEs. conditions that affect no more than 8,000 Americans per year are The 57-page document was first issued as a draft on 13 June eligible for HDE approvals. The Cures Act doubled the patient limit, 2018. It supersedes a 2010 guidance document on HDE regula- which had been set at 4,000 people per year. Devices approved via tion. (Also see "US FDA Tackles HDE 'Probable Benefits' Question In the HDE pathway are known as Humanitarian Use Devices, or HUDs. Draft Guidance" - Medtech Insight, 12 Jun, 2018.) Most benefit-risk considerations for HDEs are the same as While the final guidance is highly similar to the draft, it incorpo- those for PMAs or de novo applications, the FDA states in the rates additional clarification on a few areas. For example, the final guidance. Relevant factors may include the nature and size of guidance specifically mentions that “investigations using labora- the target patient population; the patient population’s tolerance tory animals, investigations involving human subjects, nonclinical for risk; and what alternative treatments or diagnostics are cur- investigations, and analytical studies for invitro diagnostics” are ac- rently available. More uncertainty may be acceptable for devices ceptable forms of evidence to support an HDE application. The fi- targeting a smaller patient population, the agency says. nal guidance also includes expanded sections discussing IRB com- The guidance also instructs FDA staff to look at probable ben- mittees and the FDA’s policy on withdrawal of HUD designation. efit in terms of type of benefit; magnitude of benefit; probability A total of 76 devices have been approved via the HDE process of a patient experiencing benefit; duration of effects; and patient over the past two decades, with the most recent being Zimmer and caregiver perspectives. Biomet Holdings Inc.’s Tether device to treat pediatric scoliosis. “Among other differences, the HDE pathway accepts greater (Also see "Pediatric Scoliosis Device Nabs HDE Approval" - Medtech uncertainty premarket because a reasonable assurance of effec- Insight, 16 Aug, 2019.) tiveness is not required for a device approved under an HDE application,” the guidance states. “Therefore, when compared to a Published online 6 September 2019

FDA's Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI SHAWN M. SCHMITT [email protected]

new Technical Information Report (TIR) from the Asso- they're compliant with the standard from the International Orga- ciation for the Advancement of Medical Instrumentation nization for Standardization (ISO). A (AAMI) compares regulatory requirements found in the ISO 13485:2016 is used by device firms to ensure quality systems US Food and Drug Administration's Quality System Regulation to compliance with regulators in a variety of countries, including those in international standard ISO 13485 – and vice versa. Canada, Japan, Australia and the 28 member states of the Europe- AAMI TIR102:2019, released on 30 August, aims to help be- an Union. The standard also serves as the regulatory base for the fuddled US device-makers that operate under the QSR ensure burgeoning Medical Device Single Audit Program (MDSAP), which medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 9 � POLICY & REGULATION � allows firms to undergo one audit by an accredited third party to and the standard], which may have impact beyond a specific satisfy quality regulations in five different countries. (Also see "MD- section." SAP Is A Snap If Your Firm Follows Quality Systems Standard ISO 13485, The so-called key considerations include information on train- Auditor Says" - Medtech Insight, 31 Jan, 2019.) ing and competence; approvals versus signatures; risk manage- Former FDAer Kim Trautman, who authored the QSR in the ment; and corrective and preventive action (CAPA) versus im- 1990s, weighed in on AAMI's new TIR on LinkedIn, noting that provement process. it's "an officially recognized mapping tool for the medical device The TIR also includes two tables mapping the QSR to ISO 13485, global industry." and vice versa. Trautman, who is now executive VP of medical device interna- "The mapping is provided in two directions purposefully," the tional services for consulting firm NSF International, added that document says. "When evaluating the two quality management "the mapping tool is bi-directional to assist in identifying the systems, the full intent and similarities can only be determined regulatory requirements in [the] Quality System Regulation to be by comparing in both directions. Therefore, both tables should addressed through an ISO 13485-compliant QMS [quality man- be reviewed in their entirety." agement system]." The TIR points to differences in approach to vendor quality agree- But the TIR will also be helpful for the FDA, she wrote, as the ments in the QSR (under supplier controls) and the ISO standard (un- agency works to harmonize its Quality System Regulation with the der outsourced suppliers and purchasing controls) as an example ISO standard. The FDA announced in May 2018 that it would up- for why it's important to understand the two-way mapping. date the QSR, with a draft of the revised rule coming this month. "While there are no incongruities among the requirements for Trautman, who is part of an AAMI quality systems workgroup the quality management systems, there may be some verbiage or that developed the TIR, has long maintained that merging the directed differences. This difference may not have been noticed re- QSR with ISO 13485 will be an uphill climb for the FDA that could viewing the requirements in only one direction," the TIR explains. take years to complete. (Also see "QSR Author Kim Trautman Pre- "The requirements of both the QS Regulation and ISO dicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485:2016 require quality agreements and allow a risk-based 13485 Might Look Like" - Medtech Insight, 15 Aug, 2018.) approach to meet this requirement (ie contracts, purchase or- ders, drawings or specifications)," the document continues. "The KEY CONSIDERATIONS AND A CROSSWALK requirements of both [the QSR and the standard] can be met The "Key Considerations" section of the 146-page TIR "discuss- with flexible risk-based solutions and fulfill the obligation of both es notable differences between the QS Regulation and ISO quality management systems." 13485:2016," the document says. "This part also includes nar- rative relative to any systemic differences between the [QSR Published online 9 September 2019

Policy Experts Predict Minor Changes To HHS Price Transparency Rule, Year-End Device Tax Decision SUE DARCEY [email protected]

plan by the US Department of Health and Human Ser- vices (HHS) and the US Centers for Medicare and Medic- A aid Services (CMS) requiring US hospitals to publicly post their typical prices for surgical procedures will likely become final by mid-January next year, health policy experts say. The consultants and health-care policy attorneys also predict- ed another suspension of the device tax by the year’s end. “This first piece of a larger rule on hospitals’ role in pricing transparency was part of the OPPS (Outpatient Prospective Payment System) proposed rule that required prices for 300 ‘shoppable’ services,” said Yvette Fontenot, a partner with Avenue Solutions, during an Alliance for Health Policy webinar on 28 August. “My guess is that it will be finalized with limited changes to it,” she added. (Also see "Device-Related Procedure Costs To Be Revealed Under CMS Proposed Payment Rule" - Medtech Insight, 31 Jul, 2019.)

10 | Medtech Insight | September 16, 2019 © Informa UK Ltd 2019 � POLICY & REGULATION �

Sam Baker, health-care editor for Axios, agreed, but noted: “If “What’s going on with attempts to expand Medicaid in the you are part of an organization representing an industry that states is pretty big. It has become more of a welfare program, HHS and CMS are trying disclose pricing around, you will prob- and we could see more attention to that area,” Baker said. ably be against this forthcoming rule.” But overall, “expectations for the legislative side will be low One of those industries opposed could include medical device next year, and it will also be low on the administrative side,” pre- and diagnostics manufacturers, but to date, none of the device dicted Whitlock. or diagnostics trade groups have publicly stated they are op- “Let’s just look back at the last election, in 2018, when health- posed to the proposed HHS transparency regulation. care affordability was the big issue,” commented Fontenot. “I The second part of the forthcoming HHS/CMS hospital pricing believe there will also be a lot of attention to that issue in the transparency rule will be the requirement that all insurers in the upcoming election year.” US disclose their negotiated coverage arrangements and prices Fontenot pointed to publicity around the upcoming presi- for different hospital procedures – information that would also dential Democratic debates in mid-September in Houston, to be made available on a public website. ongoing hospital and insurance industry opposition to the HHS Rodney Whitlock, VP of McDermott Consulting, said the “chal- transparency rule, and to news stories about the outcome of lenge” with a policy like this is determining which prices and the Texas v. Azar legal case in the courts on maintaining the le- services to include, adding that “consumers with good insurance gal viability of remaining portions of the ACA that haven’t been will react by saying, ‘So what?’” struck down yet by Congress, as points that candidates in the “It will be difficult to calculate what an individual’s exact cost 2020 elections will raise. for a procedure would be, because of peoples’ different deduct- ibles,” Baker added. UNTIL SUPREME COURT RULES, QUESTIONS ON TEXAS V. AZAR REMAIN DEVICE TAX TO BE REPEALED WITH In Texas v. Azar, 20 Republican state attorneys general argued in OTHER ACA TAXES AT YEAR’S END a Texas federal court on 5 September 2018 that insurers should Another prediction from the Alliance for Health Policy speakers be able to turn away, or charge more money for, coverage to for the fall 2019 regulatory and legislative outlook, was that a de- customers with preexisting conditions – a counter to ACA pro- vice tax repeal, along with a delay in implementation of a health visions requiring health insurers to only issue policies supplying insurance tax and a “Cadillac tax” imposed on companies that preexisting conditions coverage. (Also see "Newly Elected Dems provide expensive health-care coverage for employees, would Will Defend Preexisting Conditions, May Fight Device Tax Repeal " - not be addressed by Congress until the end of 2019. Medtech Insight, 20 Nov, 2018.) “The health insurance tax and device tax have been delayed in On 15 December, the Texas court agreed with the Republican prior years, but by [31 December], Congress will have to extend state AGs, and struck down the ACA in its entirety, including the those delays, along with the Cadillac tax repeal or suspension. coverage-of-preexisting-conditions clauses. However, the court Those three taxes are always lumped together and addressed at did not issue an injunction against the federal government car- the end of the year,” said Fontenot. rying out the preexisting coverage mandate or retaining health- Nonetheless, an estimate released on 30 August by the Con- care taxes imposed by ACA. gressional Budget Office (CBO) on how reductions in federal tax- Instead, the Trump administration announced, based on the es would affect the national deficit, revealed that federal deficits court’s ruling, that it would continue to administer the law until would be larger in the upcoming 2020 election year and beyond, a formal decision is made by the US Supreme Court, “which will if the three health-care taxes are delayed once again. not occur until 2020 at the earliest, after additional legal steps are The CBO wrote: “Deficits would be larger if delays in imple- completed,” according to an analysis of the case last December menting certain taxes established by the Affordable Care Act by the American Medical Association. (ACA) are extended or made permanent. The taxes were enacted Whitlock said to Fontenot: “You always overstate Texas v. Azar; I in 2010, but in most years since they either have not taken effect think its greatly overstated, in general. I don’t think we should take it or have been temporarily suspended.” seriously until you see [Supreme] Court Justice [John] Roberts aban- In addition, according to the CBO, “Permanently repealing don the carefully crafted compromise over maintaining parts of the those taxes would increase the deficit by a total of $387bn over ACA and jettisoning others that he made several years ago.” the 2020-2029 period.” Published online 4 September 2019 LAWMAKING LIKELY TO SLOW AS 2020 ELECTION CYCLE RAMPS UP All three policy experts agreed there will be a general slowdown in legislative activity – except for a few lingering issues drawing LET’S GET SOCIAL attention – as candidates for the House, Senate and presidency @Medtech_Insight increase their electioneering efforts.

medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 11 Medtech Insight Awards Monday, September 23, 2019 Finalists 2019 State Room, Boston

Executive of the Year Medtech Partnership of the Year Most Innovative Team or Innovator of the Year CHRIS HERMANN, CLEAN HANDS – SAFE HANDS BIOANALYTIX AND PROTAGEN PROTEIN SERVICES Chris Hermann, Ph.D., is the founder and CEO of Clean Hands - Safe Hands (CHSH). During graduate school, he became aware of the problem of Germanbased rotagen rotein Serices S and ambridge, JOHNS HOPKINS MEDICINE, THRIVE EARLIER hand hgiene and its impact on hospitalacired infections Is. e started and led the mltiinstittion research collaboration that deeloped the Mbased ionalti merged in pril 2019 to form an integrated DETECTION core technolog sed in the S sstem. In S’s most recent consectie 14 hospital installations, Is hae dropped b an aerage of 66.5, global analytics company, now off ering an expanded footprint preventing human suff ering, saving lives and reducing health-care costs. Thanks to Hermann’s leadership, CHSH was ranked among the “Best Place and range of adanced analtical serices in the US and in Erope. Thrie enisions a ftre in hich blood dran at an annal phsical to Work” in 2018 (among small companies) by the Atlanta Business Chronicle. S and ionalti ill no or directl and more broadl ith is used to fi nd early-stage cancer. When found early, cancer is often leading biopharmacetical companies in designing, generating and eff ectively treated or even cured. Thrive’s goal is to integrate early cancer screening into rotine medical care, helping to proide GEOFF GROSS, MEDICAL GUARDIAN deliering integrated analtical data pacages, and strategic spport along the fll deelopment continm, from deelopabilit and lead naigation for the care process. Since the inception of Medical Guardian in 2005, founder and CEO Geoff Gross has approached each day with a sense of urgency to do more within optimiation, clone selection and process deelopment, etended his bsiness and for his cstomers and emploees alie. perating throgh grit, passion and persistence, Gross has bilt and positioned Medical characteriation and comparabilit, stabilit testing for control strateg SIGRID THERAPEUTICS Guardian diff erently than competitors in the market. Gross is focused on creating a company that is not only the fastest growing in the industry, but design and CMC fi lings through commercialization and full GMP also the best hen it comes to engaging and protecting cstomers, constant prodct innoation and proiding bestinclass cstomer serice. Sigrid Therapetics aims to deelop an entirel ne class of therapies testing of commercial prodcts. for metabolic diseases b sing highl engineered silica particles. s ell as technical challenges, this also presents all inds of alidation IAN CROSBIE, SEQUANA MEDICAL MEDTRONIC AND ALIGHT and reglator isses, hich the team has met ith enthsiasm and Ian Crosbie has been CEO of Sequana Medical since January 2018, having previously served as its chief fi nancial offi cer. Ian has played a critical role ingenit to alread tae Siore15 into proofofconcept trials ithin in what has been a transformational year for the company. He led it through a successful initial public off ering on Euronext Brussels in a challenging Humanitarian workers are drawn to the fi eld out of compassion for fi ve years. global eit maret, raising 27.5m from eisting and highalit ne inestors. These ne fnds are being sed to spport the deelopment and their fello hmans. et, fnding directies and antit metrics limit their abilit to proide compassionate care. Institting compassionate commercialization of Sequana’s innovative alfapump® medical device for the management of fl uid overload in liver disease, heart failure, malignant TIVIC HEALTH: CLEARUP ascites and other fl uid imbalance disorders. care as a core bsiness ale is tied to improed otcomes not only for patient health, but also for staff , recruitment and resource learU is a gamechanging sins treatment. This small, handheld deice ses gentle microcrrent aeforms to redce allerg JARED B. BAUER, PROLUNG allocation. light and Medtronic partnered to se hmancentered design to better understand compassion in diff erent settings, from related sinus pain for the 40-60 million Americans suff ering from s interim E of roLng, ared aer is a leader ho is not afraid of bad nes or rolling p his sleees to or sholder to sholder ith his team. refugee camps in Rwanda to a head offi ce in Minnesota, then defi ne allergies. learU is a conenient and ic option that is drgfree, is commitment to transparenc and open commnication demonstrates his hmilit. and refi ne areas of opportunity for delivering compassionate care. noninasie, portable and aailable for oertheconter prchase. Clinically proven and FDA cleared, four out of fi ve experience sinus MARTIN FROST, CMR SURGICAL OSSO VR AND SMITH & NEPHEW pain relief after one fi ve-minute treatment. Note that ClearUP is intended for adlts 18 ears of age and older, is resable and Martin Frost leads CMR Surgical, the British company building the next-generation surgical robot Versius. He has built CMR around an ambitious oboticassisted deices hae great potential for improing srger vision: to bring the life-changing benefi ts of minimal access surgery to everyone who needs it. That vision has allowed Frost to build and scale one of rechargeable, and can be used at work, home or while traveling. Don’t otcomes, bt reire srgeons to learn entirel ne concepts. se if o are pregnant or hae a metallic implant. the fastestgroing companies in the UK, ith 350 emploees and record leels of fnding. The bsiness as named one of the UK’s top 10 fastest Recognizing the need for more eff ective, accessible and frequent groing companies in 2018 and has operations across for continents. training options, sso and Smith ephe partnered to lanch the fi rst virtual reality-based immersive coaching for a robotic-assisted MICHAEL FERGUSSON, AYOGO HEALTH deice, the I Srgical Sstem. This ne, ondemand approach Michael Fergusson is the CEO of Ayogo Health Inc. which has developed a dynamically adaptive digital intervention platform that tailors content to to training increases confi dence through learning for new medical a patient’s nie selfmanagement needs. This ear, ogo signed one of the largest digitalhealth contracts eer b a anadian startp, helping deices b proiding realistic, hapticenhanced interactions in an prevent CKD patients from failing treatment. Fergusson’s reputation is putting Vancouver on the international map as a thought leader in the immersie training enironment. medtech space. We are on a mission to build products that change the world for the better, and a culture that will empower the people who are part of it to achiee greatness. ZILICO AND SHEFFIELD TEACHING HOSPITAL NHS FOUNDATION TRUST RICHARD HAUSMANN, ELEKTA A collaboration between Sheffi eld Teaching Hospital NHS Foundation When he joined Elekta as CEO in 2016, Richard Hausmann faced the challenge of positioning a more than 70-year-old company for continued success Trust and the University of Sheffi eld, resulted in the development in the 21st Century. Hausmann has succeeded in it by fi nding new ways to execute on Elekta’s niche in precision radiation medicine. He doesn’t want of EIS electrical impedance spectroscop, hich is the technolog to or at a compan that is onl focsed on deeloping cancer treatment soltions for matre marets, companies and healthcare settings. e behind ZedScan, Zilico’s fl agship product. EIS provides an electrical strives to lead a company that is committed to making advanced cancer care and technologies accessible to every patient who may benefi t from signature for the diff erent stages of disease, from normal, to early and them, regardless of their geograph. laterstage precancer to cancer, proided in real time, hich allos clinicians to better manage their patients. edScan detects more high VINCE BURGESS, ACUTUS MEDICAL grade precanceros abnormalities in omen referred to colposcop, providing clinicians with additional information and off ers diagnostic ince rgess has sccessfll casted his ision for the ftre deelopment of cts Medical and inspired the entire team to assist in achieing that confi dence, meaning they can treat at fi rst visit or return patients to ision. e has inspired his team to accomplish achieements in the past ear inclding arios std pblications spporting the science behind the rotine sreillance hen no disease is present. AcQMap system, FDA clearance, CE mark, multiple partnerships, an acquisition and most recently, $170m fi nancing. Burgess doesn’t only infl uence eadline Sponsor his team but he infl uences the entire EP industry to achieve more. He has led a health-care company to IPO and has the drive and vision to make cts a top proider in electrophsiolog.

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JN2464 Medtech Awards 2019 Shortlist Advert DPS D.indd 1 2019/09/02 12:23 Medtech Insight Awards Monday, September 23, 2019 Finalists 2019 State Room, Boston

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JN2464 Medtech Awards 2019 Shortlist Advert DPS D.indd 1 2019/09/02 12:23 � POLICY & REGULATION � Rep. Shimkus, Author Of 'Cures' Device Provisions, Joins Exodus Of Republicans Retiring In 2020 From US House SUE DARCEY [email protected]

group of Republicans sitting on Shimkus was amply rewarded by device key US House panels that passed and diagnostic companies for his legisla- A bills favorable to medtech firms tive contributions during the 2016 elec- in 2016 just announced their planned re- tion season, garnering $53,940 in indus- tirements prior to the 2020 elections, in- try contributions for the 2016 election. cluding Rep. John Shimkus of Illinois, who The campaign contributions that year sponsored several pro-industry bills that made Shimkus the fifth-highest recipient are now part of the 21st Century Cures Act. of all medtech industry campaign dollars, Among the 15 House GOP members behind two House leaders, a committee planning to leave the chamber next year chairman, and Democratic Minnesota are six who sit on the two committees House candidate Angie Craig, a former St. responsible for crafting health-care legis- Jude Medical executive. lation. They are Reps. Shimkus, Bill Flores During the 2018 election season, when of Texas, Susan Brooks of Indiana, Greg all health-product company contribu- Gianforte of Montana and Pete Olson of Rep. John Shimkus, R-IL, is retiring tions were tallied, Shimkus received Texas, who all sit on the Energy and Com- from the US House in January $153,132 for the two years prior to the No- merce Committee, and Kenny Marchant vember 2018 elections from all pharma- of Texas, who sits on the Ways and Means These provisions – later folded into the ceutical/ medical device firm political ac- Committee, which has jurisdiction over Cures Act that was passed into law in De- tion committees (PACs), according to the Medicare and Medicaid issues. cember 2016 – have allowed third-party Center for Responsive Politics’ OpenSe- All 15 House Republicans who are re- quality audits to replace 510(k)s for minor crets.org website. tiring next year are cosponsors of H.R. modifications to devices, and reformed the 2207, a 2019-2020 session bill to repeal types of data permissible to be considered REPUBLICAN REASONS FOR the medical device tax, which has been “valid scientific evidence.” (Also see "Despite EARLY RETIREMENT VARY pending in the Ways and Means Com- Cures Boost, Lingering Appropriations Means The Republican House members’ planned mittee since April. Over the last three FDA Device Funding Still An Unknown For retirements before the 2020 election sessions of Congress, between 90%-96% 2017" - Medtech Insight, 15 Dec, 2016.) likely signals a belief inside the party of Republicans in the House voted for Other provisions championed by Shim- that it expects Democrats to win more device-tax repeal when it came to a vote kus that became part of the Cures law re- seats next year and continue to control before the entire House, while only 30% vitalized FDA reviewers’ use of the “least the House, which means GOP members of Democrats did, so the hemorrhaging burdensome standard” when consider- would be severely hampered in passing of so many Republicans could mean H.R. ing new applications for medtech clear- legislation in line with their expectations. 2207 will never make it out of committee, ances and approvals, and encouraged But others, such as Indiana’s Susan or fail if it comes before the full House for FDA to recognize international consensus Brooks, said, “I believe in term limits and a vote. (Also see "Device Tax-Repeal Bill In- standards to facilitate the premarket re- in the power of new talent,” and that it troduced In House With 227 Co-Sponsors" - view of devices. (Also see "Rep. John Shim- was time for another Republican to lead Medtech Insight, 10 Apr, 2019.) kus, Architect Of Cures Bill Device Reform her congressional district. She has served Provisions" - Medtech Insight, 16 Feb, 2015.) Indiana’s fifth district for four terms. SHIMKUS INTRODUCED “Several device provisions I contributed And Bill Flores of Texas also cited term SEVERAL MEDTECH PROVISIONS to the 21st Century Cures Act … would limits as a reason for retiring from the NOW PART OF CURES ACT speed up FDA’s review and approval pro- house. “When I started running for Con- In 2015 and 2016, Shimkus introduced cesses by reducing the agency’s work- gress in 2009, I was firm in my commit- a packet of bills addressing medical de- load and improving training,” Shimkus ment that I would run for six or fewer vice review processes at the US Food and said in 2015.Together, “these and other terms,” he said. As it turns out, Flores will Drug Administration, with an eye toward [medtech] improvements to FDA’s review end his fifth term in January. making medtech clearances and approv- process will help maintain American lead- als go quicker and smoother. ership in medical device innovation.” Published online 9 September 2019

14 | Medtech Insight | September 16, 2019 © Informa UK Ltd 2019 � POLICY & REGULATION �

RECRUITMENT FOCUS 2, PART 1: So You Think You Want to Work At A Notified Body? AMANDA MAXWELL [email protected]

hat is it like right now to work for an EU notified body? What are W notified bodies looking for in terms of new recruits? And why are so many staff leaving notified bodies right now? These are a few of the questions that Elena Kyria, founder of Elemed, a UK- based recruitment firm, addressed during an interview with Medtech Insight. Kyria believes that notified bodies have a very particular need when it comes to recruiting staff and that, contrary to pop- ular belief, they are not hiring from the same medtech regulatory talent pool as everyone else.

Medtech Insight: Given the enormous pressure right now Kyria: There are a couple of different reasons why people on notified bodies as they gear up under the MDR [Medical leave notified bodies and, indeed, companies in general. One Device Regulation] at at the same time as having to cope with we refer to as “churn,” ie, people leaving the business because increased workload against the current directives, how are no- they’ve been there for a certain amount of time and now they tified bodies responding to recruitment needs? want a new career opportunity. We are also seeing people who are wondering if the grass is greener elsewhere. Elena Kyria: When it comes to notified bodies, they generally But I also think it is a very challenging time right now to have a preference to hire on the permanent side at the moment. work for a notified body because of the work/life balance challenge and the amount of work pressure; there is a lot of talk What will happen if the 26 May 2020 MDR date of application of burnout. On the other hand, there isn’t any other job quite arrives and there are not enough notified bodies or codes relat- like it! I speak to people in notified bodies who, despite the ing to specific areas of testing? pressure, really enjoy what they are doing; they are getting great training and it is an exciting time to be in that sort of Kyria: This is also a challenge. It depends on the amount of role – especially if that notified body is investing in its people. available talent they have specializing in those codes. We might Right now, industry is really interested in candidates that are have a situation where not all codes are covered, or where coming from notified bodies because they bring the “regulator” codes are covered, but by only one notified body. This is some- perspective to industry, which is a competitive advantage. thing that has been brought up already. We are expecting the pool of notified bodies that cover all codes to be pretty small. Is it true that notified bodies, manufacturers and consultancies Manufacturers should not only be looking at how many no- are fishing for talent from the same pool? Or what different -ex tified bodies are designated under the MDR or IVDR, but how perience are they looking for? many there are covering the specific codes they will need. Notified bodies have a minimum requirement of the num- Kyria: I go to many regulatory events, and I hear that all the ber of people they need to have in place covering any one time. It’s a myth. You hear that people are all fishing from the code. One person is not sufficient. Then the question is, what same talent pool but that’s not true. Notified bodies tend to happens if there aren't enough people hired within the time have a strong interest in people leaving notified bodies, or if frame we have? And that is a question I can’t answer. they’re coming from manufacturers, that they have experience in R&D. It doesn’t mean that they’re taking regulatory What is causing so many staff to leave notified bodies? What people. For notified bodies, it’s important that candidates would your advice be for anyone considering working for a no- have a detailed understanding of the product specifically, so tified body for the first time? it makes more sense for notified bodies to take someone who medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 15 � POLICY & REGULATION �

has worked in R&D in a cardiovascular company rather than Kyria: The priorities for people from notified bodies when someone from regulatory. they are job searching tend to be the location of the next job; the attitude of management toward investing in people in Can you explain a typical career path for someone in working the business; ensuring their new employer is hiring enough for a notified body compared with someone working within people to deal with the demands; and concern over the future regulatory affairs at a company? sustainability of the new organization. When people approach their job search they are really looking Kyria: In regulatory affairs within a company, there is for the best fit for them personally and in terms of their career de- much more transverse movement; so, you could get some- velopment, so if that means they can make an internal move and body who has worked with class III implants in orthopedics it works, they do that. But, sometimes a move to another division in regulatory affairs, and move them onto a cardiovascular might involve a lengthy recruitment process or even a move to company with high-risk products, because the products another country, so you might as well go to another company they are dealing with are still class III. They may then work because you still need to go through an interview process. on a cardiovascular high-risk device and then move to a co- Some companies seem to think candidates are somewhat chlear implant company that specializes in active implant- blinkered and looking only at one option, but they are looking able medical devices and be able to apply all that earlier at a whole range of options and have a great deal of choice. experience. In other words, in regulatory affairs the candidates are characterized by experience from a product risk How long does it take to train a new auditor to work on devices perspective. of different risk classes, IIa, IIb, and III, at a notified body, and For notified bodies, it’s more about the actual product specifically on the requirements of the MDR and IVDR? area itself; so, it would be more interesting for them to take somebody who specializes, for example, in cardiovascular, Kyria: It really depends on which notify body you’re look- and who has maybe worked in four or five different cardio- ing at and what their hiring strategy is. Some smaller notified vascular companies in R&D because they then understand bodies prefer to hire somebody directly from another notified that product area in depth. A lot of notified bodies have suc- body and hire somebody who’s experienced because it takes cessfully brought people in from R&D and transitioned them them less time to train. Other notified bodies would rather into product specialists. hire directly from industry and put that person through a very stringent training process that can take at least four to five With many notified bodies closing shop, are their staff tend- months. We have lots of opportunities right now in notified ing to transfer to other notified bodies or go to other sectors bodies and it is a great time to join and get that training. within the same notified bodies, or just leaving the sector? And what is influencing their choice? Published online 9 September 2019

AI Focus At NHSX Lets Clinicians 'Function At The Top Of Their License'

ASHLEY YEO [email protected]

K National Health Service chief executive Simon Ste- vens was rushing through the list of new NHS England U achievements small and large as he addressed the huge crowds in two separate arenas at the NHS Expo 2019. He listed, for example, the Christie NHS Foundation Trust’s treatment of 80 patients in its proton beam therapy unit since it began receiving patients in December 2018. It is the first of two PBT centers being set up by NHS England. He also pointed to NICE’s recommendation that the NHS use Novartis’ Luxturna gene therapy in children with vision loss caused by inherited retinal dystrophy from confirmed RPE65 gene mutations. (Also see "Luxturna Secures English Reimburse-

16 | Medtech Insight | September 16, 2019 © Informa UK Ltd 2019 � POLICY & REGULATION � ment In Record Time" - Pink Sheet, 4 Sep, 2019.) der the NHSX’s remit. Harnessing technologies to aid clinicians The treatment costs half a million pounds, he said, but the in the basic but vital tasks is an opportunity that must be seized. partnership with Novartis AG to ensure affordability was a vital “The routine use of data and digital tools will be normal practice success factor. The company “got it right; the NHS can’t simply within the next decade,” she said. write a blank check,” he said. Elsewhere, he referred briefly to health secretary Matt Han- cock being tasked with improving the NHS’ health check, aimed “The routine use of data and digital at spotting the early signs of stroke, kidney disease, heart disease, type 2 diabetes or dementia in 40- to 74-year-olds; and tools will be normal practice within to professor Sir Mike Richards being given the job of indepen- the next decade.” – Tara Donnelly dently reviewing national cancer screening programs under the NHS Long Term Plan. It seemed that he wanted the centerpiece of his speech to be the £6.2bn ($7.5bn) spending review cash for 2019/20 announced for NHS England that very day (4 September) by chancellor of the The AI Lab will create an ecosystem and encourage spread, exchequer Sajid Javid. But lack of time and the UK’s current politi- helping innovators take the steps they need to. Charities, indus- cal machinations bringing with them long-term uncertainties ap- try and the wider health-care sector all have a role. The AI Lab has peared to preclude that. The UK ABHI says it will do an in-depth four big applications: examining imaging data, initially, to secure analysis of the spending review, which earmarks £2bn for capital earlier diagnoses; easing the burden on NHS staff by allowing the projects and hospital upgrades and a gives a share of a £250m automation of some jobs; helping to plan and deliver care more grant to the new AI Lab, as announced last month. (Also see "AI effectively while saving money; and aiding new drug discovery Tops The Tech Priorities For UK NHS With New Govt Funding Pledge" by analyzing patterns of illness. - Medtech Insight, 8 Aug, 2019.) Parts of the NHS are putting AI into practice, for instance: trial- The latter is "new" money; not all of the overall pledge is. ing new machine learning software to predict the prognosis of ovarian cancer – reported to be up to four times more accurate AI LAB WILL SIFT AND SCALE BEST IDEAS than current methods – and predicting which treatment is likely The AI Lab must sift the wheat from the chaff, NHS England CIO to work best in individual women; studying AI as a second reader Simon Eccles said at a panel earlier in the day. The NHS puts just of mammograms, supporting clinician decisions about whether 2% of its budget into digital tools, half or less than other econom- to recall a patient; using AI to forecast blood and plasma needs ic sectors allocate to it. “Our attitude to technology is wrong,” in a hospital, cutting waste by half; and detecting condions that he said. The hope is that the new AI Lab will change that. It will cause blindness, if missed. Moorfields Eye Hospital is publishing evaluate AI ideas to see if they can be scaled, and analyze how AI a study on how deep learning platforms can be used by clinicians can be used in demand prediction. with no programming skills to build algorithms of their own. Having digital support tools will enable clinicians to function A balance must be struck between regulating the space while at the “top of their license,” said Eccles. It will also allow them to allowing freedom for the necessary research to proceed. Indeed, draw up care records and care plans with the patient, and pro- regulators must be involved from the very earliest stages, so mote prevention and earlier diagnosis, in turn allowing earlier they are not playing catch-up. The AI Lab must also breed the interventions, he added. confidence that the technology works, and is safe to use. Issues “AI gives the correct diagnosis in more case than humans can like privacy, bias and liability will also need to be addressed. Indi- alone,” said panel chair Professor Steve Powis, NHS national vidual patient data will only be used or shared after it has been medical director. He added that the next round of applications anonymized, Donnelly asserted. for NHS Innovation Accelerator (NIA) Fellowships had opened AI is evolving rapidly and will eventually surpass human intel- on 4 September. ligence in terms of speed and accuracy. But it is a simply a tool Tara Donnelly, NHSX chief digital officer, said the need for and not a care delivery option, which is a job only humans can digital tools was compelling. The intensity and pace of work at do, said Donnelly. a much busier NHS “is starting to feel unsustainable,” she said in a late afternoon panel devoted to the AI Lab, which comes un- Published online 6 September 2019

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medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 17 � COMMERCIAL �

Attendees at the opening of Intuitive Surgical's new UK HQ in Oxford Science Park

engaged and trained, as well. So, we are Intuitive Surgical Opens New UK/ ramping up operations to seriously cap- ture the next generation." Ireland HQ In Oxfordshire Intuitive’s new facility at the Oxford Sci- ence Park is close to the offices of several CATHERINE LONGWORTH [email protected] other UK medtech companies, including Sensyne Health and Oxford Nanopore. ntuitive Surgical Inc. has landed its first Sebastian Johnson, Head of Innovation UK headquarters and training suite in Intuitive “fits perfectly & Inward Investment at Oxfordshire Lo- I Oxford in a bid to penetrate the UK and with our existing cal Enterprise Partnership (OxLEP), said Ireland markets further. the close links to Oxford’s tech ecosystem The Sunnyvale, CA-based company ecosystem and is could spur further innovation. first introduced da Vinci robotic surgi- "We will be encouraging Intuitive to be cal systems in the UK in 2000 and has exactly the type of working with other organizations across placed more than 85 da Vinci surgical Oxford to collaborate and look at any op- systems across UK and Ireland hospitals, business we want to portunities to really develop other stuff. with plans to expand its presence further. We want to support them to grow their The new center in Oxford will offer train- attract to Oxfordshire.” operation here,” Johnson told Medtech ing and education programs to improve Insight. "It’s great to work with Intuitive the company's links with UK and Ireland – Sebastian Johnson here in Oxford and fits with our drive to health services. be a global innovation ecosystem. The Last year, Intuitive appointed Phil Brad- kind of innovative business that Intuitive shaw as its first general manager in the is fits perfectly with our existing ecosys- UK and Ireland. Joining from Medtron- tem and is exactly the type of business we ic’s integrated health solutions division, want to attract to Oxfordshire." Bradshaw previously held a senior posi- OxLEP focuses on developing Oxford- tion in Stryker UK’s neurosurgery divi- dramatically, and we now need to put shire’s economy by fostering relationships sion. Speaking to Medtech Insight at the infrastructure behind it, to support that," between businesses, academia and the opening of the facility, Bradshaw said the Bradshaw told Medtech Insight. public sector. "We’ve got it all here in Ox- new center would help robotic-assisted "The vision of the new HQ is to create ford, but if we’re serious about our mission, surgery become a standard option for UK a home and a training center for Intui- we need to be attracting companies from and Irish surgeons. tive to work with the next generation of the US and globally into Oxford,” added "Intuitive’s UK and Ireland business has surgeons. We will be introducing resident Johnson. “Intuitive joining us is a great case gotten to that tipping point where the courses, introductory courses to robotic- study to share, both nationally and interna- business has grown and is substantial. assisted surgery and nursing courses. tionally, of that pull of Oxford." We now have 85-plus systems out in the Robotic assisted surgery is a ‘team sport’ marketplace. The salesforce has grown and I think it’s important that nurses are Published online 4 September 2019

Stryker Closes Gap With Competitors In Strategic Spinal Robotics Acquisition

CATHERINE LONGWORTH [email protected]

tryker Corp. has agreed an all-cash transaction to buy The acquisitions of Mobius and Cardan now provides Stryker point-of-care technology company Mobius Imaging and with immediate entry into the intraoperative imaging segment S its sister company Cardan Robotics. and offers a robotic arm in development. In a 4 September note to The company has agreed to pay $370m upfront and up to investors, BMO Capital Markets analyst Joanne Wuensch said the $130m in contingent payments for Mobius and Cardan in order deal closes the gap between its competitors who have commer- to boost its spinal robotics division. Mobius Imaging, founded in cialized robotic solutions for the spine on the market, including 2008, offers integrated advanced imaging technologies. Its Airo Medtronic and Zimmer Biomet. (Also see "Zimmer Biomet Continues TruCT scanner is a mobile, real-time, computed tomography (CT) Turnaround Lead by ROSA Robot" - Medtech Insight, 31 Jul, 2019.) imaging system. "This acquisition brings expertise in advanced imaging and ro- Cardan Robotics, founded in 2015, is developing robotics and botics, as well as a robust product pipeline that add to Stryker’s navigation technology systems for surgical and interventional portfolio and will allow the Spine division to provide more com- radiology procedures. The company’s flagship Orion surgical plete procedural solutions, including sales, service and support," suite integrates with the Mobius CT scanner, creating a full im- said Spencer Stiles, Stryker’s group president, orthopedics and aging, navigation and robotic solution for spine procedures, ac- spine in a statement. cording to the company. The transaction is expected to have an immaterial impact to Stryker currently markets the Mako robotic orthopedic sur- Stryker's net earnings in 2019 and is expected to close in the gery platform, which competes with systems from Smith & fourth quarter of 2019. Nephew and Zimmer Biomet. During Stryker's last earnings call M&A activity in robotics is thriving lately. Siemens Health- on 2 August, its VP of strategy and investor relations said Stryker ineers’ acquired of Corindius Vascular Robotics for $1.1bn in Au- is developing new Mako tools for spine and shoulder surgery, but gust. (Also see "Siemens Snaps Up Corindus Vascular Robotics For that the the launch of those products were "a ways off.” (Also see $1.1Bn" - Medtech Insight, 8 Aug, 2019.) "Mako Robot Sales Drive Stryker’s Orthopedics Business In Second Quarter" - Medtech Insight, 2 Aug, 2019.) Published online 6 September 2019

FDA Approves Axonics’ Neuromodulation Device For Incontinence

REED MILLER [email protected]

he US Food & Drug Administration approved Axonics The r-SNM system is an implantable neurostimulator about the Modulation Technologies Inc.’s rechargeable sacral size of a USB stick. It uses four electrodes to stimulate the sacral T neuromodulation (r-SNM) system for treating chronic nerves in the pelvis to “correct” erroneous nerve messages that fecal incontinence in patients who have failed or are not can- contribute to fecal and urinary incontinence. It is implanted in the didates for more conservative treatments, the company an- upper buttock area in a short surgical procedure. Under the FDA- nounced on 9 September. approved labeling, the r-SNM system is qualified to last 15 years The FDA is also reviewing another PMA for r-SNM for the in- in the body and is compatible with magnetic resonance imaging. dications of overactive bladder – both urinary urgency inconti- The company has built a 145-person US commercial team in nence and urinary urgency frequency – and urinary retention. anticipation of the FDA approval and plans to begin shipping The company expects the agency to complete the review of r-SNM systems to US physicians and hospitals during the fourth those indications in September or October. quarter of 2019, he said. The FDA has confirmed there are no outstanding technical or “The number of patients seeking SNM treatment will expand clinical deficiencies with the second PMA so the company is con- dramatically over the next few years given our fuss-free, long- fident it will be approved soon, Axonics CEO Raymond Cohen lived, full body MRI-compatible device,” Cohen said. The compa- said during a 9 September conference call. ny has been preparing for this day since it was founded in 2014.

medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 19 � COMMERCIAL �

“We believe we are well-positioned to not only compete in the stim – the only device on the market previously – including SNM space but, over time, obtain the leadership position in this significantly smaller size, rechargeability, and 15-year life,” underpenetrated market.” Lewis wrote. Cohen said the MRI-compatibility, rechargeability and dura- bility of r-SNM will allow many physicians to double the number APPROVAL SUPPORTED BY ARTISAN SNM of SNM implants they perform in a year. The FDA’s approval of r-SNM is based on technical data, pub- “The patients are out there and looking for solutions,” he lished studies of sacral neuromodulation and the safety results said. “In every single discussion with a patient who has urinary from the 129-patient ARTISAN SNM pivotal trial, which was de- or frequent incontinence, the physicians are going to be able to signed to evaluate sacral neuromodulation in the treatment of offer a much more attractive alternative.” the symptoms of urinary urgency incontinence in patients who The r-SNM system earned a CE mark in 2016. The company have failed or could not tolerate more conservative treatments. reported $1.5m in revenue from sales of r-SNM in Europe and (Also see “Results Recap: PRODIGY Supports Medtronic’s Opioid- Canada in the second quarter of 2019, a 38% increase over sales Related Risk Predictor; Axonics SNM System For Incontinence Suc- in the first quarter of 2019. In a 5 August conference call, Co- ceeds” - Medtech Insight, 22 Feb, 2019.) hen said, ”Commercial feedback from physicians and patients One-year data from the trial, published in August, showed continues to be very positive confirming our belief that, based that 89% of patients implanted with r-SNM responded to the on the unique features of our system and quality of our field therapy, with response defined as at least 50% reduction in ur- personnel, we cannot only compete, but over time, we believe gency incontinence episodes. There were no serious adverse we can dominate the markets we enter.” device-related events or unanticipated device-related events. Cohen said the sacral neuromodulation market is worth The one-year results showed consistent symptom decrease, about $650m annually. quality of life improvement, and patient satisfaction as the pre- The only sacral neuromodulation device to treat inconti- viously reported six-month results. nence currently on the market is Medtronic PLC’s Interstim, Axonics is also developing a second-generation sacral neuro- which is not rechargeable and has to be replaced every three stimulator that can be connected to Medtronic leads that are to five years. (Also see “INS 2017: Positive Initial Data Put Axonics already implanted. Cohen said he expects that product to be On Next Big Wave Of Sacral Neuromodulation Growth” - Medtech available in 2020. The company is also developing a new non- Insight, 30 May, 2017.) rechargeable device, which it hopes to launch in 2021. In a 9 September analyst note, Morgan Stanley’s David Axonics r-SNM system won the award for “Best Technological Lewis projected that Axonics will have about 20% of the US Innovation, Therapeutic Device” at the Medtech Insight Awards sacral neuromodulation market by 2022, which compares fa- in September 2018. vorably to the company’s market share outside the US. “Axo- nics’ device offers key advantages over Medtronic’s Inter- Published online 9 September 2019

Molecular Diagnostic Firms Curetis And OpGen Announce Merger

REED MILLER [email protected]

aithersburg, MD-based OpGen Inc. and Amsterdam- tioned for “strong growth and sustained value creation” and expect based Curetis NV plan to merge to become a transatlan- to significantly reduce their net loss starting in 2020, OpGen and Cu- G tic molecular diagnostics and bioinformatics company retis said. The combined revenue of the companies in 2019 will be be- focused on infectious disease and microbial resistance, the com- tween $5m and $6m, but the companies expect that to grow to $10m panies announced on 4 September. to $15m in 2020 following the merger, according to the companies. In a combined presentation to investors, the companies said Curetis’s main product is the Unyvero rapid molecular diag- the rationale for the merger is to establish a leading precision nostic platform using multiplex polymerase chain reaction (PCR) medicine business with a broad portfolio of diagnostics and an- technology to detect a wide variety of toxins, microorganisms timicrobial resistance bioinformatic technologies. and antibiotic resistance markers for severe infectious diseases For 2018, Curetis reported a loss of €814,000 ($898,000) from rev- such as pneumonia. The company is also developing a smaller, enue of €1.4m ($1.55m). OpGen reported a net loss of $13.4m from faster version of Unyvero to provide rapid quantitative results for $2.9m in revenue in 2018. The combined companies will be posi- a select group of critical disease targets.

OpGen’s products include the Acuitas Lighthouse informatics of Curetis GmbH, a wholly owned subsidiary of Curetis NV, which software for identifying, tracking and predicting antibiotic-resistant owns all of the Curetis Group businesses. Following approvals by infections based on genetic information. It draws on genotype and shareholders and regulatory authorities, Curetis GmbH will be- phenotype data from 15,000 clinical isolate samples from around come a wholly owned subsidiary of OpGen and Curetis NV will the world. OpGen is also developing the Acuitas AMR gene panel receive 2,662,564 new shares of common stock of OpGen, repre- for rapid diagnosis of antimicrobial resistance and AdvanDx tests for senting about 72.5% of the outstanding equity of OpGen. early identification of bacteria and yeast in patient blood cultures. The terms of the deal reflect a valuation of the combined busi- The initial focus for the new company will be the development ness of roughly $24m, OpGen and Curetis said. of rapid diagnostics for lower respiratory infection and urinary OpGen shares rose 69% in response to the news of the merger tract infection, as well as bioinformatics and next-generation se- and opened on 5 September trading at $7.90. Curetis shares were quencing services for antimicrobial resistance. trading at €0.64 prior to the announcement and opened on 5 OpGen CEO Evan Jones said: “We are convinced that the com- September at €0.77. bination of OpGen and Curetis will help maximize value for our The combined company´s new headquarters will be in Gaith- stockholders and will result in an organization with a robust ersburg, while the company’s European operations will be run pipeline of molecular diagnostic and bioinformatics products, from Holzgerlingen, Germany. Ares Genetics GmbH, the Curetis significant management experience, and proprietary assets for subsidiary that provides next-generation sequencing services, developing and commercializing novel data-driven solutions in will remain in Vienna. infectious disease diagnostics.” Schacht will be the CEO of the combined company while Jones Curetis CEO Oliver Schacht said Curetis will provides access to will join the board of directors in a non-executive role. OpGen’s cur- US capital markets, which is “essential to accelerate the develop- rent CFO, Timothy Dec, will be the CFO of the combined company. ment of our proprietary molecular diagnostic platforms and so- The transaction is expected to close by early 2020, according lutions for microbiology.” to the companies. Both companies’ boards of directors have approved the deal, which calls for OpGen's to acquire all of the liabilities and assets Published online 5 September 2019

Verily And iRhythm Agree To Collaborate On Atrial Fibrillation

REED MILLER [email protected]

erily Life Sciences LLC and iRhythm Technologies Inc. sis of atrial fibrillation in these patients. The trial also showed have agreed to work together on technology for the di- that monitoring with Zio SR can reduce the number of emer- V agnosis and management of atrial fibrillation. gency-room visits and hospitalizations, while also increasing The deal, announced on 4 September, calls for iRhythm to pay the number of cardiology outpatient visits in the study popu- Verily $5m upfront, plus up to $12.75m upon the achievement of lation. (Also see “ACC Results Recap Part II: CardioMEMS Post- various development and regulatory milestones. Approval Trial Shows Monitoring Reduces Heart-Failure Hospital- Verily is a subsidiary of Alphabet, Google’s parent company. izations; Medtronic’s Tyrx Envelope Reduces Infections” - Medtech Alphabet launched Verily in 2015 to develop technologies that Insight, 20 Mar, 2019.) leverage health data to improve health outcomes. iRhythm has Verily chief medical and scientific officer Jessica Mega said: developed continuous-care electrocardiography monitors inte- “With the high prevalence of cardiovascular-related health is- grated with “deep learning” artificial intelligence to improve the sues, we have an opportunity to not only improve how we di- detection and identification of cardiac arrhythmias. agnose, manage and monitor conditions like atrial fibrillation, The companies plan to co-develop solutions for providing ear- but also develop patient-centric solutions that could ultimately lier warnings for atrial fibrillation that can also help patients man- prevent serious cardiac events.” age the condition. About 10 million Americans have atrial fibril- Added iRhythm CEO Kevin King: “Verily’s patient-centric ap- lation, but it is often undiagnosed until the patient has a cardiac proach to disease management and advanced hardware capabili- event like a stroke. ties will prove critical in providing patients and providers with the Results of the mSToPS study showed continuous cardiac tools needed to increase the efficiency of heart health care.” monitoring of symptomatic patients with iRhythm’s Zio SR electrocardiogram patch significantly improved the diagno- Published online 9 September 2019 medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 21 � R&D � Abbott Launches US Pivotal Trial Of TriClip Transcatheter Tricuspid Valve Repair System REED MILLER [email protected]

he TRILUMINATE Pivotal trial of Abbott Laboratories Inc.'s Outcomes In TRILUMINATE" - Medtech Insight, 31 May, 2019.) TriClip transcatheter tricuspid valve repair system for Tricuspid regurgitation is backward flow of blood from the heart’s T treating severe tricuspid regurgitation has begun with the right ventricle through the tricuspid valve into the right atrium. first patients being treated at Abbott Northwestern hospital in About 3% of people over the age of 65 in the US have moderate to Minneapolis, MN, Abbott announced on 5 September. severe tricuspid regurgitation, which can lead to right-heart failure. The 700-patient trial will compare tricuspid repair with TriClip "Patients with symptomatic tricuspid regurgitation are often to medical therapy only in patients with severe tricuspid regurgi- at an increased risk for conventional surgery. As a result, many tation who would be at intermediate or high risk for death if they are not referred for intervention," said TRILUMINATE Pivotal co- underwent tricuspid valve surgery. primary investigator David Adams from Mount Sinai Health Sys- The trial will have three arms. In addition to the main random- tem. "The opportunity to assess how we can better treat these ized cohort, the trial will have an experimental roll-in arm for patients with a minimally invasive approach is critical and we're physicians that need additional training prior to treating patients excited about the potential for this therapy in improving the in the randomized arm. Also, if the treating physicians believe the quality of life for these patients." severity of a patient’s tricuspid regurgitation cannot be reduced Abbott launched TRILUMINATE Pivotal after the initial results to "moderate” or better, the patient will be treated with TriClip in of the TRILUMINATE single-arm trial showed the potential for Tri- a separate non-randomized arm. Clip to reduce the severity of tricuspid regurgitation. The primary endpoint for TRILUMINATE Pivotal will be a hier- In TRILUMINATE, 85 patients with symptomatic moderate or archical composite of the number of participants with all-cause severe tricuspid regurgitation were treated with TriClip at 21 mortality or the number of participants with tricuspid valve sur- centers in the US and Europe. One-month results from the trial, gery, the rate of heart failure hospitalizations and an assessment presented at the EuroPCR meeting in Paris in May, showed Tri- of patients’ improvement in quality of life. The primary endpoint Clip reduced tricuspid regurgitation by at least one grade – from will be assessed at the 12-month follow-up. severe to moderate or moderate to mild – in 86.6% of patients. TriClip is a version of Abbott’s MitraClip mitral valve repair Before the trial, about a quarter of the patients had New York device adapted to treat tricuspid regurgitation. It has the Heart Association class I or II heart failure, and the rest had class same clip as MitraClip, but a different delivery system. Deliv- III or IV heart failure. A month after the TriClip procedure, more ery of MitraClip requires a transseptal puncture to access the than 80% of the patients were in class I or II heart failure, a signifi- left atrium, while the TriClip is delivered to the tricuspid valve cant improvement. through the right atrium without a septal puncture. (Also see "Tricuspid Version of Abbott’s MitraClip Improves Short-Term Published online 6 September 2019

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Biotronik’s Orsiro Stent Beats Abbott’s Xience In BIOSTEMI Trial

REED MILLER [email protected]

ne-year results from the BI- and clinically indicated target lesion re- OSTEMI trial showed Biotronik vascularization, within 12 months of the O SE & Co. KG’s ultrathin Orsiro index procedure. coronary stent was superior to Abbott The target lesion failure rate in the Laboratories Inc.’s Xience stent for the Orsiro groups was 4% at one year com- endpoint of target lesion failure in pa- pared to 6% in the Xience group. The tients suffering an acute ST-elevation “The BIOSTEMI target vessel failure rates were 4% in myocardial infarction (STEMI). trial proves what the Orsiro group and 8% in the Xience In February, the US Food and Drug group. A prespecified Bayesian statisti- Administration approved Orsiro based the BIOSCIENCE cal analysis showed the posterior prob- on the two-year results of the 1,334-pa- ability that Orsiro is superior to Xience tient randomized BIOFLOW V trial. BIO- STEMI subgroup was 98.6%. FLOW V showed patients treated with The Bayesian analysis of BIOSTEMI in- Orsiro had a 37% lower rate of target analysis had corporated historical data from 407 pa- lesion failure than patients treated with already suggested: tients with acute STEMI in BIOSCIENCE, Xience. (Also see "FDA Approves Biotron- a randomized trial comparing Orsiro to ik’s Thin-Strut Orsiro Coronary Stent" - Different [stent] Xience in 2,008 patients with chronic Medtech Insight, 22 Feb, 2019.) stable coronary artery disease or acute BIOSTEMI is the first randomized trial platform designs coronary syndromes. The pre-specified comparing two “newer generation” can really make a analysis of 407 STEMI patients in BIOSCI- drug-eluting stents in patients suf- ENCE showed a significantly lower rate fering acute STEMI, according to Juan difference.” of target lesion failure with Orsiro than Fernando Iglesias of Geneva University with Xience. "The BIOSTEMI trial proves Hospitals in Switzerland. He presented – Juan Fernando what the BIOSCIENCE STEMI subgroup the BIOSTEMI results at the European Iglesias analysis had already suggested: Differ- Society of Cardiology congress in Paris ent [stent] platform designs can really on 1 September, and the results are also make a difference," Iglesias explained. published in The Lancet. In BIOSTEMI, the difference in the pri- "Based on the data, compared to the mary endpoint was driven by clinically Xience stent, Orsiro is a superior solution indicated target lesion revasculariza- for STEMI patients. In this patient group, tion – 1% in the Orsiro group an 3% in vascular healing is a challenge due to the the Xience group. In The Lancet, Iglesias complex pro-thrombotic and inflammatory and colleagues pointed out that the milieu,” Iglesias said. “With Orsiro, we can BIOFLOW V trial also showed a lower incrementally improve their care path." 12-month rate of target lesion failure BIOSTEMI is a randomized superiority in patients treated with Orsiro than in trial initiated by investigators at 10 hos- the patients treated with Xience. But pitals in Switzerland. The trial randomized 1,300 patients with the difference in target lesion failure in BIOFLOW V was driven acute STEMI to treatment with either Orsiro or Xience. Orsiro is an by the difference in target vessel myocardial infarction rather ultra-thin cobalt chromium coronary stent that elutes sirolimus than lesion revascularization. from a bioresorbable polymer. Xience is a cobalt-chromium thin “The absence of a robust difference in the incidence of tar- strut stent that elutes everolimus with a durable polymer. (Also get vessel myocardial reinfarction between the two treatment see "Results Recap: CRT In DC Features New Biotronik Stent Data, groups in our study might be explained by the difficulty in de- Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal tection of periprocedural myocardial reinfarction in the setting Denervation" - Medtech Insight, 8 Mar, 2019.) of acute STEMI,” Iglesias et al. suggest. BIOSTEMI’s primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction, Published online 4 September 2019 medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 23 D

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