trends in fda medtech regulatory environment · evaluatemedtech world preview 2015, outlook to 2020...

Copyright © 2015 Evaluate Ltd. All rights reserved.

Trends in FDA Medtech Regulatory Environment: 2014 Recap and 2015 YTD activity

Debbie Paul, CEO Americas, EvaluatePharma, USA Inc.

December 9, 2015


Agenda

• About Evaluate

• Overview of data sources

• Review of key industry trends for 2020

• Review of FDA approvals in 2014 versus historic trends

• Assessment of FDA approvals for 2015

• Rundown of interesting 2015 findings

• Check-up on regional activity

• Summary


About Evaluate

• Founded in 1996 by Dr. Jonathan de Pass, Headquarters in London, UK

• Offices in Boston, San Francisco and Tokyo

• A life science market analytics and intelligence company, known for its

consensus sales forecasts – became a gold-standard benchmark

• Three premier services

– EvaluatePharma®

– EvaluateClinical Trials®

– EvaluateMedTech®

» standardizes & integrates Devices@FDA data for easy tracking & screening

– Plus Custom Analytical & Technical Services

• Award winning editorial team of EP Vantage write daily commentary and analysis

including special reports


EvaluateMedTech World Preview 2015, Outlook to 2020

• 2014 Commercial Analysis

• Consensus sales forecasts of the

top 20 companies in 2020

• Device Segment Forecasts to 2020

• R&D spend current and future

• FDA approvals

• M&A, Venture financing

• IPO Analysis

• Complimentary copies can be downloaded at:

www.evaluategroup.com/MedtechWP2015

Author: Ian Strickland, Product Manager EvaluateMedTech

http://www.evaluategroup.com/MedtechWP2015


EP Vantage reports: 2014 Medtech Full Year Review & & 2015 Medtech Half Year Review

• Access EP Vantage complimentary reports and articles available at:

http://www.evaluategroup.com/public/NewsAndInsight.aspx

Authors: Elizabeth Cairns & Madeleine Armstrong, EPVantage journalists

http://www.evaluategroup.com/public/NewsAndInsight.aspx


Top 10 Device Areas in 2020

6

• In Vitro Diagnostics projected to be the number one device area in 2020

Note: not shown on chart is Neurology, ranked 15th device area by revenue with the largest growth rate of 6.9%


Top 10 Companies in 2020 by Worldwide Medtech Revenues

7

• Medtronic forecast to be the number one medtech company in 2020, following its acquisition of Covidien in January 2015

• 2020 sales expected to reach $34.9bn (7.3% share of entire medtech market at $478 bn)


Top 10 Companies in 2020 by Worldwide Medtech R&D Spend

8

• Medtronic also forecast to take the number one spot from Johnson & Johnson for R&D spend in 2020

Note:

• Only Stryker & Danaher from the list of top 10 companies by revenue are not included in top for R&D spend

• Boston Scientific & St. Jude Medical are not included in top 10 by revenue but are in the top 10 by R&D spend


Increases in All FDA Medtech Approvals in 2014 vs. 2013

9

• PMAs & HDEs Up 43% to 33 total in 2014

• 510(k) Clearances up 5% to 3,244 hitting a peak since 2007

• Supplementary PMAs up 5% to 2,455 also hitting peak since 2007


Medtronic Again has Highest Number of Approvals & Clearances in 2014, with 831…

10

…more than double the number obtained by Boston Scientific, in second place with 396

Note: Top 10 companies account for 1/3 of all PMAs or 11 of 33

Copyright © 2015 Evaluate Ltd. All rights reserved. Copyright © 2015 Evaluate Ltd. All rights reserved. 11

2015 YTD Medtech


2015 First PMA & HDE Approvals already higher than 2014

12

• 2015 could see the most device approvals in a decade

• 45 1st PMA & HDE approvals currently through November

Nov 2015

Projected 2015 total

X


First PMA & HDE Approval Times in H1 2015 Highlights by the Numbers

• 17.1 months: the average PMA approval time in H1 2015 vs. 16.7 months in 2014

– however a significant improvement over the 26.9 months approval time in 2013

• 14.7 months: the average HDE approval time in H1 2015, beating the 17.1 for PMAs – however, there were only 2 HDEs in this time period:

− Kaneka’s Lixelle, a blood filter used to treat a rare protein-folding condition associated with chronic kidney failure, took more than two years to gain its HDE

− Abiomed’s Impella RP right-side heart pump got its HDE after just 4.4 months

• 10 devices granted De Novo clearance in H1 2015 with average approval time under 12 months

13


First-time PMAs & HDEs by Therapy Area from 2013 to H1 2015

14

The sector with most approvals was cardiology: 11 approvals for heart

devices in H1 2015, or same as total in 2014


Average Review Times for PMAs & HDEs by Therapy Area

15

• Cardiology devices got the go-ahead in average of 15.2 months in H1 2015, vs. overall average of 17.1 months

• Only imaging devices & wound management products were faster


Rising Stars H1 2015

16

Abiomed (Danvers, MA)

• Heart pump developer Abiomed’s shares jumped

73% in the first six months of 2015 after US

approval of its first Impella RP temporary heart

pump and then its flagship Impella 2.5 device.

• Combined, these could bring in peak sales of $3bn

a year, according to some of the more optimistic

analysts.

Share Price Market Cap (B)

YE 2014 H1 2015 Change H1 2015 6M Change

Abiomed $38.06 $65.73 73% 2.743 1.187

Abiomed’s closing share price on 12/7/15 at $79.82 with market cap of $3.386 B


Rising Stars H1 2015

17

DexCom (San Diego, CA)

• DexCom received FDA clearance via the De Novo

route for first system of mobile medical apps for

continuous glucose monitoring.

• The Share Direct Secondary Displays enable care

providers and doctors to track a patient’s blood

sugar levels.

• Excitement over the much-vaunted artificial

pancreas, a field in which DexCom is

collaborating, has no doubt helped the company’s

stock more than double in the past 18 months.

Share Price Market Cap (B)

YE 2014 H1 2015 Change H1 2015 6M Change

DexCom $55.05 $79.98 45% 6.342 2.127

DexCom’s closing share price on 12/7/15 at $87.23 with market cap of $7.091B


Business Activity in the “Spot-light” with potential to impact future regulatory filings

18

• DENTSPLY announcing the acquisition of Sirona Dental for $5.6 billion in stock in September 2015 was the last big merger

• The single biggest M&A trend this year was probably the various mitral valve technology purchases by the following companies:

− Boston Scientific

− HeartWare

− Medtronic

− Abbott Laboratories

− Edwards Lifesciences

• 2015 has seen limited early venture funding

− Shrinking investment values in seed funding and series A & B rounds continue as a downward trend

Copyright © 2015 Evaluate Ltd. All rights reserved. Copyright © 2015 Evaluate Ltd. All rights reserved. 19

Regional Analysis


2014: 510(k) Clearances Regional Analysis

20

• California had most 510(k) Clearances in 2014 with 541 (21%)

• Massachusetts second with 226 (9%)

2014 510(k) Clearances By State

541

226

159

158 156

1303

CA

MA

PA

FL

MN

Other


2015 YTD: 510(k) Clearances Regional Analysis

21

• California has most 510(k) Clearances YTD 2015 with 428 (23%)

• Massachusetts second with 151 (8%)

2015 YTD 510(k) Clearances By State

428

151

123

120 108

948

CA

MA

FL

MN

PA

Other


2014: Massachusetts 510(k) Clearances by Therapy Area

22

• Total of 226 in 2014 with FDA Review Time average of 4.6 months

2014 MA 510(k) Clearances By Therapy Area

36

29

18

16 15

112

General & Plastic Surgery

Cardiology

Dental

Nephrology

Diagnostic Imaging

Other


2015 YTD: Massachusetts 510(k) Clearances by Therapy Area

23

• Total of 151 through Nov 2015 with FDA Review Time average of 4.1 months

2015 YTD MA 510(k) Clearances By Therapy Area

30

21

19 14

9

58

General & Plastic Surgery

Orthopedics

Cardiology

Dental

Diagnostic Imaging

Other


Massachusetts 510(k) Clearances by Company

24

• Medtronic, Boston Scientific, J&J and AngioDynamics most active in MA

Company No. of 510(k)

Clearances

Percentage of YTD 2015

Total

Medtronic 11 7%

Boston Scientific 9 6%

Johnson & Johnson 9 6%

AngioDynamics 8 5%

Straumann 7 5%

YTD 2015 MA 510(k) Clearances By Company – Top 5 (151 total)

2014 MA 510(k) Clearances By Company – Top 5 (226 total)

Company No. of 510(k)

Clearances

Percentage of 2014 Total

Johnson & Johnson 18 8%

Boston Scientific 13 6%

Medtronic 13 6%

AngioDynamics 7 3%

Asahi Kasei/ ZOLL Medical 7 3%

Total 44

Total 58


YTD 2015 Massachusetts HDE and First PMA Approvals

25

Company Product FDA Review

Time, Months Therapy Area

1st

PMA Abiomed 1. Impella 2.5 12.1 Cardiology

HDE Abiomed 2. Impella RP

System 4.4 Cardiology

1. 2.


YTD 2015 Massachusetts 510(k) (De Novo) Approvals

26

Company Product FDA Review Time,

Months Therapy Area

Alcresta 1. Relizorb 10.6 Gastroenterology

Augmenix 2. SpaceOar System 6.0 Radiology

INVO Bioscience 3. Invocell 8.3 Obstetrics/Gynecology

1. 2.

3.


Summary

27

• FDA productivity continues to improve with approval times decreasing even as submissions for medical technologies approvals are rising

• Total number of PMAs approved YTD 2015 is at peak rate over the past decade

• 1st ever system of mobile medical apps approved by the FDA for continuous glucose monitoring via De Novo route

• Massachusetts maintains its strong position with the 2nd most 510(k) clearances in 2014 & YTD 2015

A special thank you to Ian Strickland, Elizabeth Cairns and Madeleine Armstrong for their reports that this

presentation is based on and their contribution to finalizing this presentation.


Thank you

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®

Debbie Paul

[email protected]

+1 617-573-9453

trends in fda medtech regulatory environment · evaluatemedtech world preview 2015, outlook to 2020...

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