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independent judgment.
Introduction
The red-hot life sciences industry has seen incredible growth in the last
decade as the biomedical revolution of the early 21st century has gained
traction. Key discoveries, ranging from the development of recombinant
protein production to bioprosthetic implants to genome engineering, have
propelled capital investment from VC investors to the tune of $20 billion
annually for the past three years, with over $44 billion already deployed
to life sciences companies in 2021 alone. Given large-cap multinational
companies’ aversion to investing financial and human capital into high-risk
early-stage research & development (R&D) projects, innovation within life
sciences has fallen upon startups and venture-backed companies.
Within the PitchBook Platform, life sciences is defined as a combination of
two industry groups: biotechnology & pharmaceuticals, or “biotech,” and
healthcare devices & supplies, or “medical devices” or “medtech.” Many
within the life sciences industry invest across a broad range of both biotech
and medtech companies, with some investors focusing more heavily on one
subsector or targeting specific therapeutic modalities. Generally speaking,
biotech companies develop biological drugs—such as insulin, antibodies,
and gene therapies—to treat disease, whereas medtech companies develop
medical devices—such as pacemakers, catheters, and nebulizers—to
treat disease.
That said, while the biotech and medtech industry groups come together
to comprise the life sciences industry, they are not necessarily equally
weighted counterparts—particularly from an investment perspective.
Several key differences exist between the two, and alignment with
investors’ timelines and capital expectations is critical. In “Medtech versus
biotech” below, we detail differences between investing in medtech versus
biotech, particularly as each relates to average time to market, the Food
and Drug Administration (FDA) regulatory approval process, the average
associated costs, whether clinical trials need to be conducted, and the
platform scalability and versatility.
Taking the Pulse of Medtech Innovation
Medtech versus biotech: A capital investment comparison of the life
sciences subsectors
PitchBook is a Morningstar company. Comprehensive, accurate, and hard-to-find data for professionals doing
business in the private markets.
Contents
Introduction 1
The numbers 4
Is medtech innovation dead? 11
Outlook 12
Credits & contact
PitchBook Data, Inc.
John Gabbert Founder, CEO
Nizar Tarhuni Senior Director,
Institutional Research & Editorial
Dylan Cox, CFA Head of Private Markets
Research
Institutional Research Group
Analysis
Joshua Chao, Ph.D. Senior Analyst, Venture
Capital
joshua.chao@pitchbook.com
pbinstitutionalresearch@pitchbook.com
Data
Alex Warfel Data Analyst
Publishing
Designed by Megan Woodard and
Drew Sanders
Published on December 9, 2021
1: “Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of
Medical Devices,” JACC: Basic to Translational Science, Gail A. Van Norman, June 27, 2016.
2: Ibid.
3: “FDA Impact on US Medical Technology Companies: A Survey of Over 200 Medical
Technology Companies,” PricewaterhouseCoopers LLP, Josh Makower, Aabed Meer, and Lyn
Denend, November 2010.
4: “The Cost of New Drug Discovery and Development,” Discovery Medicine, Michael Dickson
and Jean Paul Gagnon, June 20, 2009.
5: “21st Century Cures Act,” US FDA, January 31, 2020.
Within the PitchBook
Platform:
•	Medtech (5.1 Healthcare
Devices and Supplies)
includes the following
subgroups of companies:
diagnostic equipment,
medical supplies,
monitoring equipment,
surgical devices, and
therapeutic devices.
•	Biotech (5.4
Pharmaceuticals and
Biotechnology) includes
the following subgroups of
companies: biotechnology,
healthcare discovery
tools, drug delivery,
drug discovery, and
pharmaceuticals.
Medtech Biotech
Average time to market Three to seven years1
12 years2
FDA regulatory approval process
510(k) pathway for devices with a
“substantially equivalent” product
already on market
OR
Premarket Approval (PMA) pathway for
Class III devices
New Drug Application (NDA) for small
molecule drugs
OR
Biologics License Application (BLA) for
biological drugs
Average associated costs
$31 million for 510(k) devices &
$94 million for PMA devices3
$800 million per drug4
Clinical trial requirement
Not required for 510(k) devices; required
for PMA devices
All new drugs required to undergo
clinical trials
Platform versatility
Low versatility as most Class III devices
are location or procedure specific
High versatility to test drugs in a variety
of clinical indications
Medtech versus biotech*
Source: PitchBook | Geography: US
*As of November 30, 2021
Innovation within life sciences has boomed in the past couple of decades.
Key inflection points, such as mapping the human genome and functional
organ transplantation, have been instrumental in ushering the next
generation of therapeutics and medical devices, respectively. These
inventions have also been augmented by huge bounds in digital technology
that have enabled more precise instrumentation and testing capabilities. In
recent decades, the industry’s collective knowledge behind the mechanism
of various diseases has also developed, which has improved the industry’s
ability to both devise therapeutics with improved druggable targets and
invent devices to target specific locations within a diseased tissue.
In the past few years, Congress’ emphasis on innovation has been a major
tailwind for the life sciences industry. The 21st Century Cures Act, passed
in December 2016, authorized $6.3 billion in funding to accelerate medical
product development and bring innovations and advances to patients who
most need them.5
This has been coupled with the maturation of several
key technologies used in core R&D projects, such as the plunging cost
of DNA sequencing technologies, adoption of lab automation tools, and
the integration of artificial intelligence & machine learning (AI & ML) to
streamline workflows.
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 2
In this note, we examine the capital investment differences between
medtech and biotech. Given the importance of robust seed- and early-
stage VC funding to the lifeblood of young life sciences startups, we delve
into why biotech has overshadowed medtech in recent years, as well as
what medtech’s future holds. Furthermore, we explore the question: Is
investing in medtech startups slowly being written out of the life sciences
playbook, or should investors take a second look at a possible resurgence
in medtech innovation?
0
10
20
30
40
50
60
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021*
Original PMA approvals (medtech) Novel drug approvals (biotech)
Medtech and biotech FDA approval count by product type
Source: US FDA | Geography: US
*As of November 20, 2021
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 3
The numbers
VC-backed life sciences companies
When reviewing companies based on their primary and secondary
industries, we found that out of the 4,448 US-based VC-backed life
sciences companies, 1,785 are medtech companies, 2,303 are biotech
companies, and 360 are dual-tagged as both industry groups.
Of the 1,785 medtech companies, 232 last raised seed financing, 517 last
raised an early-stage VC financing round, and 620 last raised a late-
stage VC financing round. The remainder either last underwent a private
secondary transaction, debt financing, or raised capital from other
nondilutive funding sources such as grants. The universe of VC-backed
medtech companies ranges from those working on at-home genetic testing
kits to cardiac diagnostic tools to handheld ultrasound devices.
Of the 2,303 biotech companies, 310 last raised seed financing, 919 last
raised an early-stage VC financing round, and 617 last raised a late-stage
VC financing round. The universe of VC-backed biotech companies also
ranges widely, including those working on advanced biopharmaceutical
manufacturing tools to precision-targeted cancer therapies to AI-driven
drug discovery platforms.
To note, the universe of the 360 dual-tagged companies is unique given
the limited overlap between the two modalities. Examples of VC-backed
companies that are tagged as both medtech and biotech include Mammoth
Biosciences, a company utilizing CRISPR technology to develop diagnostic
platforms, and Emulate, a company building next-generation organ-on-a-
chip systems to emulate human physiology.
VC-backed medtech
companies
n=1,785
VC-backed biotech
companies
n=2,303
VC-backed
dual-tagged companies
n=360
US-based VC-backed life sciences companies*
Source: PitchBook
*As of November 19, 2021
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 4
VC deal activity
Biotech companies attract the lion’s share of life sciences capital
investment. In YTD 2021, 80.7% of life sciences VC deal value poured
into biotech companies—a record-breaking $35.8 billion out of a total of
$44.4 billion. This is the highest proportion that biotech companies have
ever received out of aggregate life sciences funding. This has also already
surpassed 2020’s standout year, during which biotech companies raised a
record $26.7 billion. To note, medtech companies also raised a record $7.9
billion in 2020. Both aggregate yearly totals have already been broken in
YTD 2021, indicating the standout year that 2021 has been for both life
sciences subsectors.
While life sciences deal value totals skew more heavily toward biotech
companies on a 3:1 basis in recent years, we discussed earlier in this
research note that the drug discovery and development process undergone
by biotech companies typically has significantly higher burn rates than
medtech companies developing medical devices. This, in turn, has applied
upward pressure on biotech deal sizes. The median and average biotech
deal sizes in 2021 are more than double that of medtech, notching an all-
time high of $10.0 million and $36.9 million, respectively, compared with
medtech’s median and average of $3.9 million and $12.6 million.
Equity financings, while extremely common, are not the only avenue for life
sciences startups to raise capital. We have detailed in a previous research
note the rising prevalence of venture debt in life sciences—reaching a
record $4.5 billion of debt value in 2020.
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021*
$0
$5
$10
$15
$20
$25
$30
$35
$40
$45
Medtech Biotech
Life sciences VC deal value ($B) by subsector
Source: PitchBook | Geography: US
*As of December 1, 2021
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 5
Biotech
Medtech
$3.2
$3.9
$7.9
$10.0
$0
$2
$4
$6
$8
$10
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021*
$11.7
$12.6
$28.2
$36.9
$0
$10
$20
$30
$40
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021*
Biotech
Medtech
Median life sciences VC deal size ($M) by subsector Average life sciences VC deal size ($M) by subsector
Source: PitchBook | Geography: US
*As of December 1, 2021
Source: PitchBook | Geography: US
*As of December 1, 2021
VC pre-money valuations
Given that most early-stage life sciences companies generate little to
no revenue, valuing a privately backed startup is always challenging—
particularly when using valuation frameworks that rely on revenue
multiples. Investors thus must rely on the projected growth and market
penetration of products undergoing clinical trials.
Medtech companies are able to create devices that undergo the FDA’s
510(k) “substantially equivalent” pathway, thereby bypassing the necessity
of conducting clinical trials, drastically reducing costs and shortening
their time to market, and allowing for revenue generation early on. Even
the PMA pathway that new Class III devices go through is notably shorter
than the clinical trial timeline for the new biological drugs that biotech
companies develop.
That said, the potential for a biotech drug to cure an unmet medical need is
greater, which explains why biotech startups tend to have higher valuations
than medtech startups. In YTD 2021, the median and average VC pre-
money valuations for biotech financings reached $49.8 million and $145.3
million, respectively, compared with $22.5 million and $88.7 million for
medtech financings.
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 6
$20.0
$22.5
$30.0
$49.8
$0
$10
$20
$30
$40
$50
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021*
Biotech
Medtech
$63.6
$88.7
$106.8
$145.3
$0
$50
$100
$150
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021*
Biotech
Medtech
Median life sciences VC pre-money valuation ($M) by
subsector
Average life sciences VC pre-money valuation ($M) by
subsector
Source: PitchBook | Geography: US
*As of December 1, 2021
Source: PitchBook | Geography: US
*As of December 1, 2021
Medtech BiotBiotech
Company
Last known
valuation*
Last financing
date*
Company
Last known
valuation*
Last financing
date*
Color $4.6 billion November 9, 2021 Resilience $5.7 billion June 9, 2021
Everly Health $2.9 billion March 23, 2021 Insitro $2.5 billion April 7, 2021
HeartFlow $2.4 billion July 15, 2021 XtalPi $2.0 billion August 11, 2021
Neuralink $2.1 billion July 30, 2021 Cambrian $1.9 billion October 26, 2021
Inscripta $1.3 billion April 5, 2021
Element
Biosciences
$1.6 billion June 29, 2021
Imperative Care $1.3 billion July 15, 2021 EQRx $1.6 billion August 6, 2021
BioIntellisense $900.0 million July 28, 2021 Rakuten Medical $1.6 billion July 16, 2021
Visby Medical $866.0 million February 3, 2021
Vividion
Therapeutics
$1.5 billion August 5, 2021
Twin $840.0 million October 6, 2021
Generate
Biomedicines
$1.5 billion November 18, 2021
Xenex Disinfection
Services
$800.0 million August 4, 2020 Immunai $1.4 billion October 27, 2021
Top 10 highest valued VC-backed medtech and biotech companies
Source: PitchBook | Geography: US
*As of November 20, 2021
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 7
VVC & RVVC
Investors measure value creation using two quantitative metrics: the
velocity of value creation (VVC), the annual increase in valuation between
rounds, measured in dollars; and the relative velocity of value creation
(RVVC), the annualized percent increase in valuation between rounds. This
is an indication of how quickly a startup’s valuation is growing. In both VVC
and RVVC, the biotech subsector of life sciences has consistently been
higher than medtech in the last decade. In YTD 2021, the median VVC and
RVVC reached $24.1 million and 49.3%, respectively, for biotech financings
and $5.7 million and 25.9% for medtech financings.
$3.6
$5.7
$12.0
$24.1
$0
$5
$10
$15
$20
$25
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021*
Biotech
Medtech
23.2%
25.9%
32.8%
49.3%
0%
10%
20%
30%
40%
50%
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021*
Biotech
Medtech
Median life sciences VVC ($M) by subsector Median life sciences RVVC by subsector
Source: PitchBook | Geography: US
*As of December 1, 2021
Source: PitchBook | Geography: US
*As of December 1, 2021
Unique, active VC investors within life sciences
Medtech and biotech investors play a key role in identifying next-
generation technologies that propel the life sciences industry forward. Our
data indicates that from 2010 to 2015, the number of investors participating
in life sciences transactions shows parity between medtech and biotech
companies. However, beginning in 2016 and continuing to YTD 2021,
biotech transactions consistently attract more investors than medtech
transactions. This is likely attributed to investors’ increased interest in
therapeutics in recent years and could also be a byproduct of the larger
financing rounds seen in biotech, which require more investors to syndicate
to meet capital investment needs.
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 8
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021*
926 954
1,322 1,291
0
200
400
600
800
1,000
1,200
1,400
Biotech
Medtech
VC investor count in medtech and biotech companies by subsector
Source: PitchBook | Geography: US
*As of December 1, 2021
Note: Groups are not mutually exclusive, as a single investor could have invested in both industry groups.
Top 10 most active medtech and biotech VC investors since 2006
Medtech Biotech
Investor Medtech VC deals* Investor Biotech VC deals*
Versant Ventures 132 OrbiMed 278
New Enterprise Associates 120 Alexandria Venture Investments 226
Keiretsu Forum 119 ARCH Venture Partners 215
Life Science Angels 77 RA Capital Management 181
SV Health Investors 77 New Enterprise Associates 172
Kleiner Perkins 76 Polaris Partners 171
Johnson & Johnson Innovation - JJDC 70 MPM Capital 151
Innova Memphis 69 Domain Associates 149
Domain Associates 69 Atlas Venture 137
Delphi Ventures 67 Novo Holdings 131
Source: PitchBook | Geography: US
*As of December 1, 2021
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 9
Patent activity
Intellectual property (IP) is both the economic moat and unique value
proposition for many young life sciences startups. Patents act as a form of
defensibility against competition given the length of medical device and
drug R&D timelines. Over the last decade, the number of patents granted
to VC-backed medtech companies has steadily outpaced those granted
to VC-backed biotech companies. In 2020, 3,490 patents were granted to
medtech companies compared with 2,742 patents to biotech companies—
both all-time highs. As the rapid pace of innovation continues to attract
more VC dollars and competition for next-generation therapies gets fiercer,
companies must remain vigilant that core IP is protected.
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021*
3,490
2,996
2,742
2,495
0
500
1,000
1,500
2,000
2,500
3,000
3,500
Biotech
Medtech
Count of patents granted to VC-backed life sciences companies by subsector
Source: PitchBook | Geography: US
*As of December 1, 2021
Summary of the numbers in YTD 2021*
Source: PitchBook | Geography: US
*As of December 1, 2021
Medtech Biotech
VC deal value $8.6 billion $35.8 billion
Median deal size $3.9 million $10.0 million
Average deal size $12.6 million $36.9 million
Median pre-money valuation $22.5 million $49.8 million
Average pre-money valuation $88.7 million $145.3 million
Median VVC $5.7 million $24.1 million
Median RVVC 25.9% 49.3%
Unique investor count 954 1,291
Patents granted 2,996 2,495
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 10
Is medtech innovation dead?
As growth in biotech investments have greatly outpaced medtech
investments in the last decade and value in the therapeutics space is being
created at an extremely rapid clip, should life sciences investors focus
their portfolios solely on biotech and write off investing in the medtech
subsector? Or is there still room for true medtech innovation?
We do not believe medtech investments should be completely written
off by life sciences investors. While some investors argue that medtech
startups in the 21st century are producing only iterative improvements,
the medtech industry, albeit not the booming industry it was just a few
decades ago, continues to tackle some of the most challenging diseases
to date—particularly in areas such as neurovascular disease, sepsis, and
cancer. Furthermore, while medtech has lagged biotech in many of the
aforementioned metrics, capital deployment by VC investors and valuations
are not the only measures of innovation.
Admittedly, disruptive medtech innovation is difficult in this day and age.
The medtech industry preceded much of the biotech industry, and that
has allowed the current state of care to be executed at an extremely high
standard, particularly in diseases wherein medical devices are the gold
standard of intervention and treatment. Devices such as transcatheter
aortic and mitral valve replacement systems or trabecular micro-
bypass stents for cataract surgery have built upon years of iteration and
improvement and currently improve the lives of millions of patients globally.
Emerging technologies surrounding digital therapeutics, digitally
connected medical devices, and other consumer goods that fall into the
democratization of health and monitoring have spurred innovation within
medtech. Companies creating products such as the Oura Ring, the WHOOP
fitness band, and the Apple Watch are vigilant in stating that their flagship
products are not, in fact, medical devices and thus need not be regulated
as such. Yet, the large-scale analysis of health and biometric data at this
level is priming the technology industry to create FDA-regulated medical
devices in the near future.
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 11
Outlook
It is likely an oversimplification to state that one industry group—medtech
or biotech—is the better investment. Each carries its own set of risks,
and investors with the appropriate risk tolerance and expertise within
their respective fields can achieve positive financial returns in either—or
both—medtech and biotech. As with any investment, both upside and
downside exists.
Compared with biotech investments, medtech investments tend to have
lower burn rates, require less upfront capital, and have a shorter average
time to market. Medtech startups with certain devices can also leverage the
510(k) approval pathway that bypasses the need for clinical trials, further
accelerating their path to commercialization and revenue generation.
However, the reimbursement costs tend to be lower, and medtech devices
have poor versatility because they tend to be narrowly restricted to one
area of the body.
On the other hand, biotech investments tend to possess the versatility to
be developed into a “platform” technology. Whether it’s a small molecule
drug or a biological drug, biotech companies can test their products in a
vast array of clinical diseases and determine which diseases are likely to
produce the highest possibility of success—thus effectively multiplying
their likelihood of success with a single drug product. Conversely,
however, biotech companies tend to be much more capital intensive,
have significantly higher burn rates, and take longer to get their products
market approved.
Ultimately, while the pastures of biotech innovation may be more expansive,
medtech innovation still remains a stalwart within the life sciences industry.
Investors looking for shorter investment horizons and potentially less risk
are likely to turn toward medtech over biotech to fill out their portfolios.
Life sciences more broadly has captured the interest of many generalist
investors in recent years. We believe that the medtech subsector still
represents a solid choice for generating returns, and while innovations
within medtech do not shimmer as much as biotech innovations do, there
are still areas within medtech that are ripe for disruption.
PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 12

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Taking The Pulse of Medtech innovation_Pitchbook, Dec, 2021

  • 1. COPYRIGHT © 2021 by PitchBook Data, Inc. All rights reserved. No part of this publication may be reproduced in any form or by any means— graphic, electronic, or mechanical, including photocopying, recording, taping, and information storage and retrieval systems—without the express written permission of PitchBook Data, Inc. Contents are based on information from sources believed to be reliable, but accuracy and completeness cannot be guaranteed. Nothing herein should be construed as investment advice, a past, current or future recommendation to buy or sell any security or an offer to sell, or a solicitation of an offer to buy any security. This material does not purport to contain all of the information that a prospective investor may wish to consider and is not to be relied upon as such or used in substitution for the exercise of independent judgment. Introduction The red-hot life sciences industry has seen incredible growth in the last decade as the biomedical revolution of the early 21st century has gained traction. Key discoveries, ranging from the development of recombinant protein production to bioprosthetic implants to genome engineering, have propelled capital investment from VC investors to the tune of $20 billion annually for the past three years, with over $44 billion already deployed to life sciences companies in 2021 alone. Given large-cap multinational companies’ aversion to investing financial and human capital into high-risk early-stage research & development (R&D) projects, innovation within life sciences has fallen upon startups and venture-backed companies. Within the PitchBook Platform, life sciences is defined as a combination of two industry groups: biotechnology & pharmaceuticals, or “biotech,” and healthcare devices & supplies, or “medical devices” or “medtech.” Many within the life sciences industry invest across a broad range of both biotech and medtech companies, with some investors focusing more heavily on one subsector or targeting specific therapeutic modalities. Generally speaking, biotech companies develop biological drugs—such as insulin, antibodies, and gene therapies—to treat disease, whereas medtech companies develop medical devices—such as pacemakers, catheters, and nebulizers—to treat disease. That said, while the biotech and medtech industry groups come together to comprise the life sciences industry, they are not necessarily equally weighted counterparts—particularly from an investment perspective. Several key differences exist between the two, and alignment with investors’ timelines and capital expectations is critical. In “Medtech versus biotech” below, we detail differences between investing in medtech versus biotech, particularly as each relates to average time to market, the Food and Drug Administration (FDA) regulatory approval process, the average associated costs, whether clinical trials need to be conducted, and the platform scalability and versatility. Taking the Pulse of Medtech Innovation Medtech versus biotech: A capital investment comparison of the life sciences subsectors PitchBook is a Morningstar company. Comprehensive, accurate, and hard-to-find data for professionals doing business in the private markets. Contents Introduction 1 The numbers 4 Is medtech innovation dead? 11 Outlook 12 Credits & contact PitchBook Data, Inc. John Gabbert Founder, CEO Nizar Tarhuni Senior Director, Institutional Research & Editorial Dylan Cox, CFA Head of Private Markets Research Institutional Research Group Analysis Joshua Chao, Ph.D. Senior Analyst, Venture Capital joshua.chao@pitchbook.com pbinstitutionalresearch@pitchbook.com Data Alex Warfel Data Analyst Publishing Designed by Megan Woodard and Drew Sanders Published on December 9, 2021
  • 2. 1: “Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices,” JACC: Basic to Translational Science, Gail A. Van Norman, June 27, 2016. 2: Ibid. 3: “FDA Impact on US Medical Technology Companies: A Survey of Over 200 Medical Technology Companies,” PricewaterhouseCoopers LLP, Josh Makower, Aabed Meer, and Lyn Denend, November 2010. 4: “The Cost of New Drug Discovery and Development,” Discovery Medicine, Michael Dickson and Jean Paul Gagnon, June 20, 2009. 5: “21st Century Cures Act,” US FDA, January 31, 2020. Within the PitchBook Platform: • Medtech (5.1 Healthcare Devices and Supplies) includes the following subgroups of companies: diagnostic equipment, medical supplies, monitoring equipment, surgical devices, and therapeutic devices. • Biotech (5.4 Pharmaceuticals and Biotechnology) includes the following subgroups of companies: biotechnology, healthcare discovery tools, drug delivery, drug discovery, and pharmaceuticals. Medtech Biotech Average time to market Three to seven years1 12 years2 FDA regulatory approval process 510(k) pathway for devices with a “substantially equivalent” product already on market OR Premarket Approval (PMA) pathway for Class III devices New Drug Application (NDA) for small molecule drugs OR Biologics License Application (BLA) for biological drugs Average associated costs $31 million for 510(k) devices & $94 million for PMA devices3 $800 million per drug4 Clinical trial requirement Not required for 510(k) devices; required for PMA devices All new drugs required to undergo clinical trials Platform versatility Low versatility as most Class III devices are location or procedure specific High versatility to test drugs in a variety of clinical indications Medtech versus biotech* Source: PitchBook | Geography: US *As of November 30, 2021 Innovation within life sciences has boomed in the past couple of decades. Key inflection points, such as mapping the human genome and functional organ transplantation, have been instrumental in ushering the next generation of therapeutics and medical devices, respectively. These inventions have also been augmented by huge bounds in digital technology that have enabled more precise instrumentation and testing capabilities. In recent decades, the industry’s collective knowledge behind the mechanism of various diseases has also developed, which has improved the industry’s ability to both devise therapeutics with improved druggable targets and invent devices to target specific locations within a diseased tissue. In the past few years, Congress’ emphasis on innovation has been a major tailwind for the life sciences industry. The 21st Century Cures Act, passed in December 2016, authorized $6.3 billion in funding to accelerate medical product development and bring innovations and advances to patients who most need them.5 This has been coupled with the maturation of several key technologies used in core R&D projects, such as the plunging cost of DNA sequencing technologies, adoption of lab automation tools, and the integration of artificial intelligence & machine learning (AI & ML) to streamline workflows. PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 2
  • 3. In this note, we examine the capital investment differences between medtech and biotech. Given the importance of robust seed- and early- stage VC funding to the lifeblood of young life sciences startups, we delve into why biotech has overshadowed medtech in recent years, as well as what medtech’s future holds. Furthermore, we explore the question: Is investing in medtech startups slowly being written out of the life sciences playbook, or should investors take a second look at a possible resurgence in medtech innovation? 0 10 20 30 40 50 60 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* Original PMA approvals (medtech) Novel drug approvals (biotech) Medtech and biotech FDA approval count by product type Source: US FDA | Geography: US *As of November 20, 2021 PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 3
  • 4. The numbers VC-backed life sciences companies When reviewing companies based on their primary and secondary industries, we found that out of the 4,448 US-based VC-backed life sciences companies, 1,785 are medtech companies, 2,303 are biotech companies, and 360 are dual-tagged as both industry groups. Of the 1,785 medtech companies, 232 last raised seed financing, 517 last raised an early-stage VC financing round, and 620 last raised a late- stage VC financing round. The remainder either last underwent a private secondary transaction, debt financing, or raised capital from other nondilutive funding sources such as grants. The universe of VC-backed medtech companies ranges from those working on at-home genetic testing kits to cardiac diagnostic tools to handheld ultrasound devices. Of the 2,303 biotech companies, 310 last raised seed financing, 919 last raised an early-stage VC financing round, and 617 last raised a late-stage VC financing round. The universe of VC-backed biotech companies also ranges widely, including those working on advanced biopharmaceutical manufacturing tools to precision-targeted cancer therapies to AI-driven drug discovery platforms. To note, the universe of the 360 dual-tagged companies is unique given the limited overlap between the two modalities. Examples of VC-backed companies that are tagged as both medtech and biotech include Mammoth Biosciences, a company utilizing CRISPR technology to develop diagnostic platforms, and Emulate, a company building next-generation organ-on-a- chip systems to emulate human physiology. VC-backed medtech companies n=1,785 VC-backed biotech companies n=2,303 VC-backed dual-tagged companies n=360 US-based VC-backed life sciences companies* Source: PitchBook *As of November 19, 2021 PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 4
  • 5. VC deal activity Biotech companies attract the lion’s share of life sciences capital investment. In YTD 2021, 80.7% of life sciences VC deal value poured into biotech companies—a record-breaking $35.8 billion out of a total of $44.4 billion. This is the highest proportion that biotech companies have ever received out of aggregate life sciences funding. This has also already surpassed 2020’s standout year, during which biotech companies raised a record $26.7 billion. To note, medtech companies also raised a record $7.9 billion in 2020. Both aggregate yearly totals have already been broken in YTD 2021, indicating the standout year that 2021 has been for both life sciences subsectors. While life sciences deal value totals skew more heavily toward biotech companies on a 3:1 basis in recent years, we discussed earlier in this research note that the drug discovery and development process undergone by biotech companies typically has significantly higher burn rates than medtech companies developing medical devices. This, in turn, has applied upward pressure on biotech deal sizes. The median and average biotech deal sizes in 2021 are more than double that of medtech, notching an all- time high of $10.0 million and $36.9 million, respectively, compared with medtech’s median and average of $3.9 million and $12.6 million. Equity financings, while extremely common, are not the only avenue for life sciences startups to raise capital. We have detailed in a previous research note the rising prevalence of venture debt in life sciences—reaching a record $4.5 billion of debt value in 2020. 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* $0 $5 $10 $15 $20 $25 $30 $35 $40 $45 Medtech Biotech Life sciences VC deal value ($B) by subsector Source: PitchBook | Geography: US *As of December 1, 2021 PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 5
  • 6. Biotech Medtech $3.2 $3.9 $7.9 $10.0 $0 $2 $4 $6 $8 $10 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* $11.7 $12.6 $28.2 $36.9 $0 $10 $20 $30 $40 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* Biotech Medtech Median life sciences VC deal size ($M) by subsector Average life sciences VC deal size ($M) by subsector Source: PitchBook | Geography: US *As of December 1, 2021 Source: PitchBook | Geography: US *As of December 1, 2021 VC pre-money valuations Given that most early-stage life sciences companies generate little to no revenue, valuing a privately backed startup is always challenging— particularly when using valuation frameworks that rely on revenue multiples. Investors thus must rely on the projected growth and market penetration of products undergoing clinical trials. Medtech companies are able to create devices that undergo the FDA’s 510(k) “substantially equivalent” pathway, thereby bypassing the necessity of conducting clinical trials, drastically reducing costs and shortening their time to market, and allowing for revenue generation early on. Even the PMA pathway that new Class III devices go through is notably shorter than the clinical trial timeline for the new biological drugs that biotech companies develop. That said, the potential for a biotech drug to cure an unmet medical need is greater, which explains why biotech startups tend to have higher valuations than medtech startups. In YTD 2021, the median and average VC pre- money valuations for biotech financings reached $49.8 million and $145.3 million, respectively, compared with $22.5 million and $88.7 million for medtech financings. PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 6
  • 7. $20.0 $22.5 $30.0 $49.8 $0 $10 $20 $30 $40 $50 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* Biotech Medtech $63.6 $88.7 $106.8 $145.3 $0 $50 $100 $150 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* Biotech Medtech Median life sciences VC pre-money valuation ($M) by subsector Average life sciences VC pre-money valuation ($M) by subsector Source: PitchBook | Geography: US *As of December 1, 2021 Source: PitchBook | Geography: US *As of December 1, 2021 Medtech BiotBiotech Company Last known valuation* Last financing date* Company Last known valuation* Last financing date* Color $4.6 billion November 9, 2021 Resilience $5.7 billion June 9, 2021 Everly Health $2.9 billion March 23, 2021 Insitro $2.5 billion April 7, 2021 HeartFlow $2.4 billion July 15, 2021 XtalPi $2.0 billion August 11, 2021 Neuralink $2.1 billion July 30, 2021 Cambrian $1.9 billion October 26, 2021 Inscripta $1.3 billion April 5, 2021 Element Biosciences $1.6 billion June 29, 2021 Imperative Care $1.3 billion July 15, 2021 EQRx $1.6 billion August 6, 2021 BioIntellisense $900.0 million July 28, 2021 Rakuten Medical $1.6 billion July 16, 2021 Visby Medical $866.0 million February 3, 2021 Vividion Therapeutics $1.5 billion August 5, 2021 Twin $840.0 million October 6, 2021 Generate Biomedicines $1.5 billion November 18, 2021 Xenex Disinfection Services $800.0 million August 4, 2020 Immunai $1.4 billion October 27, 2021 Top 10 highest valued VC-backed medtech and biotech companies Source: PitchBook | Geography: US *As of November 20, 2021 PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 7
  • 8. VVC & RVVC Investors measure value creation using two quantitative metrics: the velocity of value creation (VVC), the annual increase in valuation between rounds, measured in dollars; and the relative velocity of value creation (RVVC), the annualized percent increase in valuation between rounds. This is an indication of how quickly a startup’s valuation is growing. In both VVC and RVVC, the biotech subsector of life sciences has consistently been higher than medtech in the last decade. In YTD 2021, the median VVC and RVVC reached $24.1 million and 49.3%, respectively, for biotech financings and $5.7 million and 25.9% for medtech financings. $3.6 $5.7 $12.0 $24.1 $0 $5 $10 $15 $20 $25 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* Biotech Medtech 23.2% 25.9% 32.8% 49.3% 0% 10% 20% 30% 40% 50% 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* Biotech Medtech Median life sciences VVC ($M) by subsector Median life sciences RVVC by subsector Source: PitchBook | Geography: US *As of December 1, 2021 Source: PitchBook | Geography: US *As of December 1, 2021 Unique, active VC investors within life sciences Medtech and biotech investors play a key role in identifying next- generation technologies that propel the life sciences industry forward. Our data indicates that from 2010 to 2015, the number of investors participating in life sciences transactions shows parity between medtech and biotech companies. However, beginning in 2016 and continuing to YTD 2021, biotech transactions consistently attract more investors than medtech transactions. This is likely attributed to investors’ increased interest in therapeutics in recent years and could also be a byproduct of the larger financing rounds seen in biotech, which require more investors to syndicate to meet capital investment needs. PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 8
  • 9. 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* 926 954 1,322 1,291 0 200 400 600 800 1,000 1,200 1,400 Biotech Medtech VC investor count in medtech and biotech companies by subsector Source: PitchBook | Geography: US *As of December 1, 2021 Note: Groups are not mutually exclusive, as a single investor could have invested in both industry groups. Top 10 most active medtech and biotech VC investors since 2006 Medtech Biotech Investor Medtech VC deals* Investor Biotech VC deals* Versant Ventures 132 OrbiMed 278 New Enterprise Associates 120 Alexandria Venture Investments 226 Keiretsu Forum 119 ARCH Venture Partners 215 Life Science Angels 77 RA Capital Management 181 SV Health Investors 77 New Enterprise Associates 172 Kleiner Perkins 76 Polaris Partners 171 Johnson & Johnson Innovation - JJDC 70 MPM Capital 151 Innova Memphis 69 Domain Associates 149 Domain Associates 69 Atlas Venture 137 Delphi Ventures 67 Novo Holdings 131 Source: PitchBook | Geography: US *As of December 1, 2021 PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 9
  • 10. Patent activity Intellectual property (IP) is both the economic moat and unique value proposition for many young life sciences startups. Patents act as a form of defensibility against competition given the length of medical device and drug R&D timelines. Over the last decade, the number of patents granted to VC-backed medtech companies has steadily outpaced those granted to VC-backed biotech companies. In 2020, 3,490 patents were granted to medtech companies compared with 2,742 patents to biotech companies— both all-time highs. As the rapid pace of innovation continues to attract more VC dollars and competition for next-generation therapies gets fiercer, companies must remain vigilant that core IP is protected. 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* 3,490 2,996 2,742 2,495 0 500 1,000 1,500 2,000 2,500 3,000 3,500 Biotech Medtech Count of patents granted to VC-backed life sciences companies by subsector Source: PitchBook | Geography: US *As of December 1, 2021 Summary of the numbers in YTD 2021* Source: PitchBook | Geography: US *As of December 1, 2021 Medtech Biotech VC deal value $8.6 billion $35.8 billion Median deal size $3.9 million $10.0 million Average deal size $12.6 million $36.9 million Median pre-money valuation $22.5 million $49.8 million Average pre-money valuation $88.7 million $145.3 million Median VVC $5.7 million $24.1 million Median RVVC 25.9% 49.3% Unique investor count 954 1,291 Patents granted 2,996 2,495 PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 10
  • 11. Is medtech innovation dead? As growth in biotech investments have greatly outpaced medtech investments in the last decade and value in the therapeutics space is being created at an extremely rapid clip, should life sciences investors focus their portfolios solely on biotech and write off investing in the medtech subsector? Or is there still room for true medtech innovation? We do not believe medtech investments should be completely written off by life sciences investors. While some investors argue that medtech startups in the 21st century are producing only iterative improvements, the medtech industry, albeit not the booming industry it was just a few decades ago, continues to tackle some of the most challenging diseases to date—particularly in areas such as neurovascular disease, sepsis, and cancer. Furthermore, while medtech has lagged biotech in many of the aforementioned metrics, capital deployment by VC investors and valuations are not the only measures of innovation. Admittedly, disruptive medtech innovation is difficult in this day and age. The medtech industry preceded much of the biotech industry, and that has allowed the current state of care to be executed at an extremely high standard, particularly in diseases wherein medical devices are the gold standard of intervention and treatment. Devices such as transcatheter aortic and mitral valve replacement systems or trabecular micro- bypass stents for cataract surgery have built upon years of iteration and improvement and currently improve the lives of millions of patients globally. Emerging technologies surrounding digital therapeutics, digitally connected medical devices, and other consumer goods that fall into the democratization of health and monitoring have spurred innovation within medtech. Companies creating products such as the Oura Ring, the WHOOP fitness band, and the Apple Watch are vigilant in stating that their flagship products are not, in fact, medical devices and thus need not be regulated as such. Yet, the large-scale analysis of health and biometric data at this level is priming the technology industry to create FDA-regulated medical devices in the near future. PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 11
  • 12. Outlook It is likely an oversimplification to state that one industry group—medtech or biotech—is the better investment. Each carries its own set of risks, and investors with the appropriate risk tolerance and expertise within their respective fields can achieve positive financial returns in either—or both—medtech and biotech. As with any investment, both upside and downside exists. Compared with biotech investments, medtech investments tend to have lower burn rates, require less upfront capital, and have a shorter average time to market. Medtech startups with certain devices can also leverage the 510(k) approval pathway that bypasses the need for clinical trials, further accelerating their path to commercialization and revenue generation. However, the reimbursement costs tend to be lower, and medtech devices have poor versatility because they tend to be narrowly restricted to one area of the body. On the other hand, biotech investments tend to possess the versatility to be developed into a “platform” technology. Whether it’s a small molecule drug or a biological drug, biotech companies can test their products in a vast array of clinical diseases and determine which diseases are likely to produce the highest possibility of success—thus effectively multiplying their likelihood of success with a single drug product. Conversely, however, biotech companies tend to be much more capital intensive, have significantly higher burn rates, and take longer to get their products market approved. Ultimately, while the pastures of biotech innovation may be more expansive, medtech innovation still remains a stalwart within the life sciences industry. Investors looking for shorter investment horizons and potentially less risk are likely to turn toward medtech over biotech to fill out their portfolios. Life sciences more broadly has captured the interest of many generalist investors in recent years. We believe that the medtech subsector still represents a solid choice for generating returns, and while innovations within medtech do not shimmer as much as biotech innovations do, there are still areas within medtech that are ripe for disruption. PitchBook Analyst Note: Taking the Pulse of Medtech Innovation 12