za del Pací co y cuáles son sus principales bene cios?

Market Access Services

O er No. SIB0012021 | Prepared by bioaccess.™ | January 11, 2021

SI-BONE Inc.
Product: iFuse Implant System®

Procedure: Minimally invasive (MIS) sacroiliac (SI) joint fusion (SIJF) for the treatment of lower back pain (LBP)

with a diagnosis of sacroiliac joint disruption or degenerative sacroiliitis. 

Dear Tony Recupero,

Thank you for your interest in partnering with us to help SI-BONE, Inc.access the Latin American market with

its pioneering sacropelvic surgical solutions (the "Products"). With bioaccess™, you will be able to know the

size of SI-BONE's market opportunity in Argentina, Brazil, Chile, Colombia, and Mexico; and you will be able to

explore the commercialization of SI-BONE's minimally invasive sacroiliac joint fusion surgery procedure using

its iFuse Implant System® in these countries.

We will determine the approximate size of SI-BONE's market opportunity in the above countries by a)

searching and analyzing import data of similar products to assess annual import volumes and the

manufacturer-importer transfer prices, and b) searching any available databases and/or conducting face-to-

face interviews to determine the behavior of the disease and surgical procedure of interest.

We look forward to getting started on this exciting new phase for SI-BONE, Inc. in Latin America.

Thank you!

1
Julio G. Martinez-Clark, CEO

jmclark@bioaccessla.com | +1 (954) 903-7210

bioaccess™| www.bioaccessla.com

About bioaccess™
bioaccess™ is a US-based contract research organization (CRO), regulatory, and market access consulting

company that delivers a full spectrum of clinical research, regulatory, and market access o erings from bench

to commercialization so that life science companies can have long-term success in Colombia and the rest of

Latin America.

bioaccess™ is based in Orlando, FL, and was conceived in 2010 under its previous name as Interventional

Concepts Inc. by Dr. Pedro Martinez-Clark —a Harvard-trained interventional cardiologist, an innovator,

founder, and advisor to several Medtech companies.

Our promise is for innovative foreign life science companies that believe that Latin America o ers untapped

potential to conduct early-stage clinical trials or to sell their products. We focus on forward-looking life science

companies that want to run a rst-in-human clinical trial or want to have long-term sales growth in Colombia

and the rest of Latin America.

We promise that by engaging with us as your CRO, regulatory, and market access consultants, your company

will cost-e ectively get the early clinical data it needs or will be able to quickly obtain regulatory market

clearance at INVIMA to expand its market to Colombia and other countries in Latin America. 

2
 Video content can't be

viewed o ine

VIEW ONLINE

bioaccess™ Client List

Clinical Research Trials Regulatory Product Market Access Consulting

Registration

DirectFlow Abiomed Sanuwave

Avinger Volcano (now Phillips) Omron Healthcare

Mitralign Medimaps Group Biomerica

Mitraspan Biomerica Intuition Imports/Resvent

Kona Medical LumiThera Biomerica

CeloNova Biosciences Sight Diagnostics IDx

Libella Gene Therapeutics Intuition Imports/Resvent WEP Clinical

Flow-FX ClarVista Medical (now Alcon) IOPtima

ReGelTec Biomolecular Sciences

PAVmed BluMaan

ForSight VISION5 Human Med

3
 Hancock Ja e Laboratories Zizion Group International

Establishment Labs BioDerm

BridgeBio/Orfan Biotech Palette Life Sciences

Spine Stabilization Technologies Germitec

Bergstrom Nutrition

Livinguard

Penuma

Read more about our past and present clients here.

Client References

Adrian Wong

Co-Founder & President (Intuition Imports Inc.)

adrwong@gmail.com

William (Bill) Niland

Co-Founder & CEO

bniland@regeltec.com

Dr. Marc Glickman

Senior Vice President & Chief Medical O cer

mglickman@hancockja e.com

4
Shaun ONeill

Chief Commercial O cer

smo@pavmed.com

Eduardo De Melo

Vice President of Business Development

edemelo@hastenllc.com

Amalia Schreier

Regulatory & Quality Director

amalia@sightdx.com

William (Bill) Andrews

President

bandrews@sierrasci.com

Je Mathis

President

Je @libellagt.com

5
Simon Goldbard, Ph.D.

Co-Founder & Chief Business O cer

sgoldbard@orfanbio.com

Larry Wagner

Senior Vice President Business Development

Wagner@humanmed.com

Vitor Alexandre

Executive Vice President Latin America, OHM

President & CEO

vitor.alexandre@omron.com

This embedded content

can't be viewed o ine

VIEW ONLINE

6
bioaccess™ has been vetted

and selected by the U.S.

Department of Commerce to

be a preferred Healthcare &

Life Sciences Business Service

Provider to help U.S.

companies succeed in

Colombia and the rest of Latin

America.

Read more.

We didn't have much knowledge and expertise in the Latin American

medical device market. We were looking for market access consultancies

to help us enter the Colombian market with the resvent line of respiration

healthcare products. We quickly found that bioaccess' service capabilities

are not present in the traditional regulatory consultancies that operate in

Latin America. bioaccess helped us gather market intelligence, obtain

regulatory market clearance at INVIMA, search, conduct due diligence,

select, and quickly execute a distribution agreement with a reputable

distribution business partner in Colombia. The best thing about bioaccess

is its team of expert market access professionals who have in-depth

knowledge of the Latin American medical device regulatory and

commercial sector. The bioaccess team was professional, helpful, and

delivered the results we were expecting on time. I would easily

recommend bioaccess to foreign manufacturers of medical devices that

are looking for guidance on how to succeed in Latin America.

7
– Adrian Wong, President & CEO, Intuition Imports, Inc., master distributor for resvent in Latin America.

This decision to engage Interventional Concepts [now bioaccess™] was

made to increase our focus and visibility within South America. It is of the

utmost importance that we partner with distributors that have in uence

and a good track record within the Colombian market. We also need

speedy access to potential clinical trials to ensure we add value with our

product o ering as well as clinically proven outcome. These factors will

lead to faster market entry and closer ties with identi ed Key Opinion

Leaders (KOL's).

– Andre Mouton, Vice President International Sales, and Relations, SANUWAVE Health, Inc.

Goal and Objective

Goal : To know the size of SI-BONE's market

opportunity in Latin America.

Objective : To use primary and secondary sources

to research import prices of competing products

and the annual number of SI joint fusion surgeries

for the treatment of lower back pain (LBP), to know

the size of SI-BONE's market opportunity in Latin

8
America by mid-Q1 2021.

Scope of Work

This o er includes the following activities in relation

to achieving our goal and objective.

Most countries in Latin America don't have centralized claims databases for epidemiological and health

outcomes research (bene ciaries’ encounters with the health care system and receipt of therapeutic

interventions, including medications, procedures, and services). This forces us to rely on the results of an

epidemiological survey/questionnaire (administered at a face-to-face interview) to gather the disease behavior

data we need. The overriding need in an epidemiological survey is to examine a representative sample of

adequate size in a standardized and su ciently valid way. 

We'll focus our research on Argentina, Brazil, Chile, Colombia, and Mexico (individually, the "Country", and

collectively, the "Countries"). The following are the activities that we will carry out to reach our goal and

objective:

 Research and analysis of public customs databases to determine historical import data for Medtronic's

Rialto SI Joint Fusion System.

 Research and analysis of public and private databases to determine the epidemiology of the disease of

interest in the Countries (where available): lower back pain with a diagnosis of sacroiliac joint disruption or

degenerative sacroiliitis.

 De nition of the study hypothesis in relation to gathering data about the market for minimally invasive

(MIS) SI joint fusion for the treatment of lower back pain with a diagnosis of sacroiliac joint disruption or

degenerative sacroiliitis.

 Library search.

 Determination of the study sample size.

 De nition and identi cation of the type of individual subjects or groups in the Countries we will want to

interview and make decisions about inclusion and exclusion criteria.

 De nition of the type of interviewee reward and plan for the payment of such.

 Determination of primary and secondary outcomes.

 Development of interview questions.

 Planning and deployment of the invitations to candidate interviewees in the Countries.

 Conduction of face-to-face interviews with in-country experts.

 Data gathering and analysis.

 Final conclusions.

 Reporting of all study ndings.

9
Deliverables
We'll know we're successful when these A slide deck with answers to the following questions

documents are manifested for each Country:

1. Population

2. Public/Pvt Payer Mix

3. Payor Challenges (low/med/high [e.g., coverage

and/or payments])

4. Import/Transfer Price

5. Volume of SIJF Procedures

6. Volume of Lumbar Fusion/Spine/Ortho

Procedures

7. Surgeon Adoption Potential

8. Reimbursement Rate

9. Suggested Selling Price per Procedure

10. Notes

Timeline  30-60 days

Note: A "day"is considered every o cial workday of the week (Monday-Friday excluding public holidays).

10
Team
Our team is comprised of international senior regulatory, business development, and sales & marketing

professionals specialized in the life science industry with extensive experience in Latin America. They have a

proven record of developing and implementing regulatory and business strategies in the region.

We have a team of experts to lead your market

access initiative in Latin America.

Julio G. Martinez-Clark

Chief Executive O cer (CEO)

Julio has been working with US medical device

companies for over 10 years helping them design

and implement successful clinical trial, regulatory,

and market access winning strategies. Julio is a

recognized medical device expert and his insights on

the medical device industry have been featured on

the industry-leading Med Device Online publication.

Julio's latest published article is titled Succeeding In

The Latin American Medtech Market: Three Tips, Five

Trends. He is the host of the LATAM Medtech

Leaders podcast: A conversation with leaders who

have succeeded in Latin America. Julio has a B.S.

degree in electronics engineering and a master's in

business administration (MBA). Read more about

Julio here.

Video content Video content

can't be viewed can't be viewed

o ine o ine

VIEW ONLINE VIEW ONLINE

Hernán Orjuela —a famous Colombian TV presenter Listen to Jason A. Duprat, MBA, MSA, BSN, CRNA

— Interviews Julio G. Martinez-Clark, bioaccess™, (USNR) interview Julio G. Martinez-Clark on his

CEO. Learn more. podcast (The Healthcare Entrepreneur Academy).

Learn more.

11
Juan J. Muñoz

Director of Market Access Projects

Juan is an experienced international life sciences and

healthcare business development, sales, marketing,

and management executive. Juan had leadership

positions at Baxter Laboratories and Boston Scienti c

creating, managing, and leading pro table sales

operations in Colombia, Venezuela, Ecuador, and

Peru. Juan is an expert at formulating market access

strategies that allow foreign Medtech companies to

successfully penetrate the challenging Latin

American market. Juan has a B.S. in microbiology

from Javeriana University and an M.B.A. degree from

ICESI; both leading universities in Bogota, Colombia.

Read more.

12
 Budget
United States Dollars (USD)

Section 1

Market Research Services SUBTOTAL

$0.00
Sacroiliac Joint Dysfunction Market in Mexico

Description Item Quantity Price

Research and analysis of import data from $0.00 1 Unit $0.00

public customs databases in the Countries.

Search and analysis of any available public $0.00 1 Unit $0.00

and private databases; and plan, design, and

deploy a round of interviews to research and

analyze the behavior of the sacroiliac joint

dysfunction disease in the Countries. This

includes the activities outlined in the Scope of

Work section of this O er.

13
Section 2
SUBTOTAL

Third-Party Costs $0.00

Description Item Quantity Price

Payment to interviewees. $0.00 8 Unit $0.00

Section 3
SUBTOTAL

General & Administrative $320.00

Description Item Quantity Price

Third-
General and Administrative (G&A) 20% G&A 1600 Party $320.00
Costs
Overhead: Includes processing fees

including, but not limited to, international

wire transfer bank fees, currency exchange

uctuations, and the processing of

payments to third parties in the Countries.

Invoiced as 20% of third-party costs.

14
 Total Excluding Tax $320.00

Total $320.00

Terms & Conditions

 Acceptance of this O er: You will accept this O er subject to bioaccess™ and you (the “Parties”)

executing a mutual non-disclosure and con dentiality agreement (the "Con dentiality Agreement" or

MNDA") and a master services agreement (the “Agreement" or "MSA), it is understood that if you accept

this O er, the Parties shall in good faith use their best e orts to execute the Agreement as soon as

possible. See our standard MNDA here and our MSA here.

 This project is non-cancelable, and agreed-upon payment terms are due as described. However, you may

postpone or delay any part of the work in progress without penalty.

 Validity: Because fees may change over time, the quoted O er fees have a limited 30-day validity.

 Payment terms: Upon acceptance of the O er,

 bioaccess™ will invoice 50% of the fees under the Budget section of the O er and the remaining 50%

upon delivery of the nal report.

 bioaccess™ will invoice in advance (at the start of the project) 100% of the third-party fees within the

Third-Pary Cost section.

 Your responsibilities: Designate a project leader to act as a liaison and main contact between you and

bioaccess™; timely approve and provide any request of information and documentation; ongoing

availability and collaboration to participate in scheduled meetings and project management activities;

facilitate meetings with key personnel and decision-makers.

 Exclusions of the O er: The O er excludes,

 Project-related expenses such as national and international shipping & handling, courier services,

photocopying, printing.

 Travel-related expenses such as airfare, lodging, ground transportation, meals.

 Translations of letters, certi cates, and legal documents.

 Translations of technical documents.

 Third-party costs: Third-party costs (e.g., survey respondents) are estimated and may change. bioaccess™

will invoice these items before they occur or pass these fees directly to you. bioaccess™ will add a 20%

administrative fee to third-party payments including payments to private parties including but not limited

to survey respondents.

15
 Delivery times are estimates and may vary. bioaccess™ is not responsible for lack of performance due to

major events beyond its control.

Click on the images below to review our standard

MNDA and MSA

Mutual Non-Disclosure Agreement (MNDA) Master Services Agreement (MSA)

We’re excited to work with you! 

By clicking on the button below, you are agreeing to the terms & conditions of the O er as set out in this

document. 

Accept

TAKEOFF FOR LATIN AMERICA?

bioaccessla.com| info@bioaccessla.com

16
 Audit Trail

Project Details

Link Secret EQZcZIc4ReSv

Currency USD

Accepted Total 320

Total Recurring Costs

Backup Time Wed Feb 16 2022 13:45:36 GMT+0000

(Coordinated Universal Time)

Backup Hash VpXNWrvmuYYm4LOqbaU8S8QpEAL8Qw

Number of Accepters 1

Total One Off Costs 320

vincent

IP 197.156.190.165

Wed Feb 16 2022 13:36:27 GMT+0000

Session Time
(Coordinated Universal Time)

Visit Token nYbWAkn7QjmF

Email sales.africa@spmmedicare.com

Name vincent

Organization Name

Wed Feb 16 2022 13:45:36 GMT+0000

Accept Time
(Coordinated Universal Time)

197.156.190.177, 130.176.36.150,
identi cation.ip
130.176.36.150

17
 Wed Feb 16 2022 13:36:27 GMT+0000
identi cation.time
(Coordinated Universal Time)

18