SpaceOAR® Hydrogel Approved Content

Feel free to use any of the content below to educate your website visitors on SpaceOAR® hydrogel:

Download Image and Animated Assets
Video Assets (Embed)
Terms of Use
Download Patient Brochure
Press Release Template
Social Media Template
SpaceOAR Hydrogel Slide Deck/Presentation

Please visit our Digital Patient Brochure Page for the latest patient-friendly copy and content.  (Note: please include references if you use any of the copy)

What is SpaceOAR® Hydrogel?

SpaceOAR® hydrogel is an option for men who undergo radiation treatment for prostate cancer. It acts as a spacer providing space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment. Patients may be awake or asleep under general anesthesia for the procedure. SpaceOAR® hydrogel remains stable during radiation therapy and then is gradually absorbed by the body after radiation therapy has been completed.

Risk Statement

SpaceOAR is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR hydrogel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment. It is completely absorbed by the patient’s body over time.

Clinical data comparing patients with and without SpaceOAR hydrogel demonstrated the benefits of SpaceOAR hydrogel to include reduction of rectal toxicity resulting in improved bowel function, improvements in urinary function, and a higher likelihood to maintain sexual function.

Potential complications associated with SpaceOAR hydrogel include but are not limited to pain associated with SpaceOAR hydrogel injection; pain or discomfort associated with SpaceOAR hydrogel, needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of SpaceOAR hydrogel into the bladder, prostate, rectal wall, rectum, or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency.

Video Assets

*To embed a video on your website, right click one of the videos below and select “copy embed code” and then paste that code into the body of your webpage.

Daniel’s Story- 2:20 Version

 Daniel’s Story- :45 Version

Data that Matters

Sources

1. Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; Dec. 2016 DOI

2. Hamstra D, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol 35, 2017 (suppl 6S; abstract 69)

Terms of Use

Please read the Terms and Conditions of Use for this SpaceOAR® System Toolkit (Toolkit) carefully and completely.

BY ACCESSING THIS SITE AND TOOLKIT, YOU ACKNOWLEDGE THAT YOU HAVE READ THE TERMS AND CONDITIONS OF USE, UNDERSTAND THESE TERMS AND CONDITIONS, AND AGREE TO BE BOUND BY THESE TERMS AND CONDITIONS OF USE.
These terms and conditions of use apply to the Toolkit. By viewing or using the Toolkit, you agree to be bound by these terms
and conditions of use without limitation. If you do not agree to be bound by these terms and conditions of use, discontinue
viewing this website and related Toolkit. If you violate any of these terms and conditions of use, your permission to use the Toolkit and all information within the Toolkit automatically terminates and you must immediately destroy any copies you
have made of the Toolkit materials. Augmenix reserves the right to revise any or all of these terms and conditions of use at
any time and without notice. Your use of the Toolkit is subject to any such revisions, and you should periodically visit this
web page to review the current terms and conditions of use. These terms and conditions were last updated on December 22,
2015.

Nothing contained in this Toolkit should be construed as promoting the use of SpaceOAR System in any particular manner not
authorized by relevant law or regulatory agency in your jurisdiction.

The terms ‘we’, ‘our’, ‘us’ and ‘Augmenix’ mean Augmenix, Inc. ‘You’ means you, the user of this Toolkit.

USE THE TOOLKIT AT YOUR OWN DISCRETION AND RISK

The information in this Toolkit relates to the SpaceOAR System offered by Augmenix, Inc. The materials in this Toolkit are
for your general information and may contain information relating to various medical conditions and their treatment. Such
information is provided for informational purposes only and is not meant to be a substitute for advice provided by a doctor or
other qualified healthcare professional. Augmenix does not practice medicine or provide medical services or advice and the
information in this Toolkit should not be considered medical advice. Patients should always be directed to speak with a health
care professional regarding diagnosis and treatment.

Downloadable materials are provided for informational and educational purposes only. This notification serves as permission
to download and post copies only for the uses stated herein and not for any other purpose without the express written
consent of Augmenix.

As a condition of use, you must mark ‘images, graphics and/or animations’ which you reproduce and utilize in further
communications as ‘Reprinted with permission from Augmenix, Inc.’

The interviews and quotations in this Toolkit from patients, surgeons and administrators describe individual experiences with
SpaceOAR. As you read, please remember that the experience is specific to the individual.
This Toolkit and any files transmitted with it are intended solely for the use of the individual or entity to whom permission is
granted by Augmenix. Please notify Augmenix immediately by e-mail if you have received access to this Toolkit by mistake.
If you are not the intended recipient you are notified that disclosing, copying, distributing or taking any action regarding the
contents of this Toolkit information is strictly prohibited.

INTELLECTUAL PROPERTY RIGHTS

The materials in this Toolkit belong to or are licensed to Augmenix. The entire contents of Toolkit are protected by United
States and foreign copyright laws. There are some important rules about copying these materials. You may e-mail, download,
or print copies of the materials in this Toolkit only as set forth herein. When you e-mail, download, or print a copy of the
materials in this Toolkit, you must also include all copyright and other notices that are in the materials. We also own the
names we use for our products and services in this Toolkit, and these names are protected by United States and foreign
trademark laws. An ‘®’ following a name indicates that the trademark has been registered in the United States. A ‘™’ following
a name indicates that it is an unregistered trademark. All trademarks are the property of their respective owners.
Except as expressly provided above, use of the materials or trademarks in this Toolkit in a way that is not clearly allowed by
these Terms of Use, is a violation of your agreement with us and may be a violation of copyright, trademark, and other laws.
In the case of any violative use, we automatically revoke your permission to use this Toolkit. Title to the materials remains
with Augmenix or with the authors of the materials contained in this Toolkit. All rights not expressly granted are reserved.

NO WARRANTIES

Augmenix makes no representations or warranties that use of this Toolkit will be uninterrupted or error-free. You are
responsible for taking all precautions necessary to ensure that any content you may obtain from this Toolkit is free of viruses
and any other potentially destructive computer code.
The toolkit is provided “as is” without warranty of any kind, either express or implied, including but not limited to implied
warranties of merchantability, fitness for particular purpose, or non-infringement. Augmenix makes no representations about
the accuracy, reliability, completeness, or timeliness of the materials. The materials in this Toolkit may contain inaccuracies or
typographical errors.

LIMITATION OF LIABILITY

You agree to defend, indemnify, and hold harmless Augmenix, its affiliates, officers, directors, employees and agents, from
and against any claims, actions or demands, including without limitation reasonable legal and accounting fees, alleging or
resulting from your use of the Toolkit materials or your breach of these terms and conditions of use.
In no event shall Augmenix, its officers, directors, employees, affiliates, suppliers, agents, collaborators or any third parties
mentioned or otherwise associated with Augmenix be liable for any damages whatsoever (including, without limitation,
direct, indirect, punitive, special, incidental and consequential, exemplary, and punitive damages, personal injury/wrongful
death, lost profits, or damages resulting from lost data or business interruption) resulting from the use or inability to use the
materials in this Toolkit, whether based on warranty, contract, tort, strict liability, or any other legal theory and whether or
not Augmenix is advised of the possibility of such damages.
In no event shall Augmenix’s total liability to you for all damages, losses, causes of action (whether in contract, tort, including
without limitation negligence, or otherwise) exceed the amount paid by you, if any, or U.S. $ 100.00 (whichever is less) for
accessing the Toolkit or participating in any activity related to the Toolkit. The limit of liability may not be effective in some
states or jurisdictions, and accordingly may not apply to you.

UNITED STATES RESIDENTS

This TooLkit is intended to comply with the laws and regulations in the U.S. The Toolkit may accessible to users outside of the
U.S. Other countries may have laws, regulatory requirements and medical practices that differ from those in the U.S. If you
are a non-U.S. resident you are responsible for compliance with local laws and regulations. Augmenix reserves the right to
limit provision of our products or services to any person, geographic region or jurisdiction and/or to limit the quantities or any
products or services we provide.

CHOICE OF LAW

These Terms of Use are governed by the internal substantive laws of the Commonwealth of Massachusetts, without respect
to its conflict of laws principles. Any action related to these terms and conditions of use shall be brought only in the state
courts of and federal courts in the Commonwealth of Massachusetts and all parties waive any objection to the personal
jurisdiction of and venue in such courts. In the event of any conflict between foreign laws, rules and regulations and those of
the United States, the laws, rules and regulations of the United States shall govern.

SEVERABILITY

If any of these terms and conditions of use shall be deemed to be invalid, void, illegal or for any reason unenforceable, that
term or condition shall be deemed severable and shall not affect the validity and enforceability of the remaining terms and
conditions.

PRODUCT COMPLAINTS, ADVERSE EVENTS AND MDRs

If you have any questions about the terms of use, you may contact Augmenix by using the Contact Augmenix feature of the
Augmenix website, or at:
Augmenix, Inc.
201 Burlington Rd
Bedford, MA 02451
0r, customerservice@augmenix.com
Attn: Compliance