Privacy Policy

Privacy Policy

VERICEL CORPORATION  WEB SITE PRIVACY POLICY AND COOKIE NOTICE
(Updated and Effective: December 2019)

Vericel Corporation and affiliates (together, "Vericel" or "we") are committed to privacy for our web site users. Please read this Privacy Policy before using or submitting information on any of our web sites. BY ACCESSING AND USING ANY VERICEL WEB SITE, YOU AGREE TO BE BOUND BY THE TERMS OF THIS POLICY AND THE TERMS OF USE. Your access of any Vericel web site for the limited and exclusive purpose of reviewing this Privacy Policy and Cookie Notice does not constitute your acceptance unless you make any further access or use of our web site.

Updates to Policy

This Policy is subject to change without prior notification. Any changes will be posted on this page, and we will update the "Updated and Effective" date to reflect the date of the changes. By continuing to use the Vericel web site after the posting of such changes, you accept the Policy as modified.

Collection of Information, including Personally Identifiable Information

For purposes of this Privacy Policy, "Personally Identifiable Information" means information by which you can be individually identified, including, but not limited to, your name, address, e-mail address, and telephone number. This Privacy Policy does not apply to information collected from offline resources and communications, except in cases where such information is consolidated with Personally Identifiable Information collected by Vericel through Vericel web sites. This Privacy Policy does not apply to any third party web sites linked to Vericel web sites. Vericel is not responsible for the privacy practices or the content of third party sites.

Intended Users

This web site and policy are intended exclusively for users in the United States of America. It is not our intent to gather Personally Identifiable Information from individuals residing outside the U.S. Your access to and use of the website constitutes acceptance of this Privacy Policy and consent to Vericel's collection and use of your information as outlined below.

Vericel websites are not intended for children age 17 or younger. Vericel does not knowingly collect Personally Identifiable Information from children. If the parent or guardian of a child age 17 or younger has reason to believe that a child has provided us with Personally Identifiable Information, the parent or guardian should contact Vericel in accordance with the contact information provided in the section titled “Contacting Vericel” to request deletion of this data from our files.

Technical Information That Is Always Collected

We collect and store certain information with the goal of improving the content and services offered on our web sites during each user visit ("session") but do not use this information to personally identify you. This Technical Information includes: (i) the domain and host from which you access the Internet; (ii) the Internet address of the web site from which you linked directly to the Vericel web site, if applicable; (iii) the date and time you arrived at our web site and how long you spent on the web site and which pages you visited; (iv) your Internet Protocol (IP) address; and (v) your computer's operating system and browser software.

For more information about technical tracking technology used on our web sites, please see the section on Cookies and Related Technology.

Information That Is Collected Only if You Submit It to Us

We collect your Personally Identifiable Information on our web site only if you choose to provide it. We will collect and store the information you enter through interaction with Vericel web sites, including if you: (i) register and create a profile, create a user name and password, or sign up for a contest; (ii) send us an e-mail; (iii) use the chat rooms and forums or other products and services that are or may be available on our web site; (iv) log in to any of our sites; or (v) otherwise voluntarily submit Personally Identifiable Information to Vericel.

Please note that while you are logged in to a Vericel web site, your actions in that browsing session may be associated with your information.  We may combine the Personally Identifiable Information you share with us through this website with other information you have shared with us, both online and offline.  We may also combine this Personally Identifiable Information with records provided by third parties. We use this consolidated information to help us better design Vericel products, to communicate information to you, to enhance our marketing and research activities, and to facilitate other business functions.

 

Use and Disclosure of Information, Including Personally Identifiable Information

Use and Storage of Information

Technical Information may be used for improving the content and services offered on our web sites. Personally Identifiable Information collected on our web sites may be used by Vericel personnel, or a third party working on behalf of Vericel, to: (i) contact you to obtain more information; (ii) improve the web site; (iii) personalize your experience on the web site; (iv) comply with legal requirements; (v) provide you with information or services that you have requested; or (vi) provide you with additional information that Vericel believes may be of interest to you.

Vericel or its affiliates, subsidiaries, business partners, and vendors who assist Vericel in providing services to you (collectively, the "Service Providers”), may use such information for the purposes of carrying out the services described in this Policy. Vericel reserves the right to maintain all information in electronic and/or an offline form, for archival purposes and as otherwise required by law.

Disclosure to Third Parties

Vericel does not provide Personally Identifiable Information about our web site visitors to third parties except: (i) Service Providers, as defined above; (ii) in connection with security or law enforcement investigations or in the course of cooperating with authorities; (iii) to comply with legal requirements or to establish or exercise our legal rights or defend against legal claims; (iv) when we believe it is necessary to share information in order to assist in an investigation regarding, or to prevent, illegal activities, suspected fraud, or potential threats to the safety of any person; and (v) upon a sale or merger of our business or upon a sale or liquidation of assets that includes the web sites.

Any third party with whom we share your Personally Identifiable Information shall be required to treat such information in accordance with this Privacy Policy.

Aggregate Data

We may use or share aggregate data (information about our base of users in general, from which all Personally Identifiable Information has been removed) for any purpose.

 

Your Right to Control Access to Your Personally Identifiable Information

Opting In / Permission to Contact You

Vericel and our Service Providers will use the Personally Identifiable Information we collect to respond to your inquiries and/or to send you information/newsletters, fulfill e-mail messaging programs, and notify you about new content or services on our web sites. Your request for information or services is also known as "opting in" to receive communications. By opting in to Vericel e-mails, you also agree to the use of e-mail analytics (described below).

Opting Out/Unsubscribing

If you decide you no longer wish to receive promotional e-mail communications from Vericel, you may opt out at any time by using the contact information below or following the opt-out instructions contained in promotional email communications from Vericel. You may opt out of other types of promotional communications by contacting us through one of the methods described under "Contacting Vericel," below. If you opt out of receiving promotional communications from Vericel, you may continue to receive non-promotional communications, such as information about safety warnings or changes to savings programs in which you are enrolled. If you have opted out of promotional Vericel communications and subsequently request information from Vericel, Vericel will contact you to answer your request.

Updating Personally Identifiable Information

Vericel is committed to maintaining accurate Personally Identifiable Information. You may always contact us to update or request the correction of your Personally Identifiable Information. Vericel will make reasonable efforts to comply with your correction/update request.

Residents of California have the right to request that Vericel delete their Personally Identifiable Information. If you are a resident of California and would like to make such a request, please review the section titled “Your California Privacy Rights.”

Contacting Vericel

If you have any questions or concerns about the way your Personally Identifiable Information is used and handled, or would like to update or remove your Personally Identifiable Information, please e-mail us at privacy@vcel.com, call 1-888-556-4026 or write to:

Vericel Corporation
Attn: Customer Care
64 Sidney Street
Cambridge, MA 02139

Security

Vericel takes reasonable precautions to keep all information obtained from web site visitors secure against loss, misuse, and unauthorized access, disclosure, alteration, or destruction, including encrypting Personally Identifiable Information during the transmission of such information. Nevertheless, Vericel makes no guarantee as to the security of your Personally Identifiable Information and disclaims to the fullest extent permitted by law all liability and damages caused by its loss, misuse, and unauthorized access, disclosure, alteration, or destruction.  Please be aware that there is always some risk involved when submitting data over the Internet. We recommend that you take any available precautions to protect Personally Identifiable Information you submit on this website.

Public Forums/Social Media

This web site may make chat rooms, forums, Listservs and message boards available to its users. Please remember that any information that is disclosed in these areas becomes public information. You should exercise caution when deciding to disclose your personal information and you should not disclose the personal information of anyone other than yourself. Vericel cannot ensure or warrant the security of any information provided by you in such forums, and you do so at your own risk.

Social Plugins

This site may use social plugins (e.g., the Facebook "Like" button) to enable you to easily share information with others. When you visit our site, the operator of the social plugin may be able to place a cookie on your computer, enabling that operator to recognize individuals who have previously visited our site.  The social plugin may allow that social media web site to receive information that you have visited our web site. The social plugin may also allow the social media web site to share information about your activities on our web site with other users of their social media web site. For more information about the information shared via a particular social media plugin, you should refer to that social media site's privacy statement.

Third-Party Web Sites

For your convenience, our sites may contain links to third-party web sites. Vericel does not endorse any third-party site and is not responsible for the privacy practices of or the content included on third-party web sites. Third-party web sites are not covered by this Policy. You should examine the terms of use and privacy policies of other web pages whenever you leave a Vericel web site.

Use of "Cookies" and Related Technology

Our web sites use cookies to maintain user session identity and to store your username and password locally for ease of access to personalize sessions for you. "Cookies" are small pieces of information that are stored by your browser on your computer's hard drive. Most web browsers automatically accept cookies, but if you prefer, you can edit your browser options to block them in the future. If you disable cookies, however, some functionality of our web sites may not work for you, and our web sites will not remember your customizations. If you accept cookies, you can delete them later by going to the preferences, tools or options menus of your browser.

Vericel sites may use the following types of cookies and tracking technology:

From time to time, we may contract with third parties to place cookies on your computer. We use third party advertising companies to place ads on other websites. These companies may use data about your visits to this and other websites in order to measure advertising effectiveness and to provide advertisements about our goods and services that may be of interest to you. Additionally, some third party companies, such as owners of the web site links we may provide for your convenience, may use cookies to track your activities once you leave Vericel's web sites. Again, Vericel is not responsible for the policies of any third party sites.

Finally, Vericel uses certain analytical services, including but not limited to Google Analytics, a service by Google, Inc. ("Google"), to analyze Non-Personally Identifiable Information to learn about how visitors interact with Vericel web sites (also known as "session tracking"), to help us improve user experience. Google Analytics uses cookies to analyze use patterns and may collect information about your use of the website, including your IP address. You may find more information about Google Analytics and Google's privacy policy by visiting Google's web site here.

In addition, our sites use two Google Analytics Advertising Display Features, which collect information through cookies: Remarketing with Google Analytics and Demographics and Interests reporting.  If you would like to opt-out of having your data used by these cookies, please use the Google Analytics opt-out available here.

Other information on opt-outs for targeted advertisement delivery is available below.

E-mail Analytics

To help us better improve the user experience, Vericel uses e-mail analytics services to track certain information about how you access, engage with, and dispose of Vericel e-mails to which you have opted-in (subscribed). Such data may include, but is not limited to, your e-mail and IP addresses, the browser and e-mail client you use, the city in which you are located, and details about how you engage with the email, such as whether you opened, read, forwarded, or printed the e-mail. By opting in to Vericel e-mails, you agree to the use of e-mail analytics.

Do Not Track Signals

Certain web browsers and other programs may be used to signal your preferences to Vericel about how or whether Vericel or third parties may collect information about your online activities. Currently, Vericel web sites do not respond to such signals.

Nevertheless, the Digital Advertising Alliance maintains a web site where consumers can opt out from receiving interest-based advertising from some or all of the network advertising companies participating in the program explained here.

Your California Privacy Rights

California Civil Code Section 1798.100, the California Consumer Privacy Act (“CCPA”), provides California residents with the right to request that Vericel disclose, no more than twice in a 12-month period, the Personally Identifiable Information it has collected, used, disclosed, or sold about its consumers. While Vericel does not sell your Personally Identifiable Information, and will not do so without your explicit consent, California residents may request that Vericel disclose the following information:

  1. The categories of Personally Identifiable Information Vericel has collected about you;
  2. The specific pieces of Personally Identifiable Information Vericel has collected about you;
  3. The categories of sources from which the Personally Identifiable Information is collected;
  4. The business or commercial purpose for the collection of your Personally Identifiable Information;
  5. If applicable, the categories of your Personally Identifiable Information Vericel disclosed for a business purpose; and
  6. If applicable, the categories of third parties to whom Vericel disclosed your Personally Identifiable Information.

Known as the Right to Request Deletion, California residents may also request that Personally Identifiable Information be permanently deleted by Vericel and, if applicable, by third parties with whom Vericel has shared it.

If you are a resident of California and would like to make a request for information or request for  deletion, you or a designated agent may contact, toll-free, 1-888-556-4026 or complete and submit the form located here. Vericel will notify you of the status of your request within 10 days of receipt. Following that, Vericel will verify your identity to ensure that you are who you say you are. This may entail Vericel requesting that you provide specific pieces of information, already held by Vericel and known to you, to demonstrate your identity. To designate an agent to submit requests to Vericel on your behalf, please submit a request in writing to Vericel identifying your authorized agent. Vericel will contact you to confirm your identity and that of your authorized agent.

Vericel collects, maintains, and discloses your Personally Identifiable Information in accordance with the following:

You have a right to not receive discriminatory treatment by businesses for the exercise of the privacy rights conferred by the CCPA. Vericel will not discriminate against any consumer for exercising any of their rights under the CCPA.

For questions or concerns regarding this Privacy Policy, to make a request regarding your information, or if you are an individual with a disability and would like to exercise your right to receive this Policy in an alternately accessible format, contact, toll-free, 1-888-556-4026 or complete and submit the form located here.

I am a patient and my doctor has taken a biopsy of my knee cartilage for MACI

I am a US health care provider
 

Indication and Important Safety Information

Important Safety Information

MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is also not indicated for use in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.

MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.

The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.

Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue. Universal precautions should be employed when handling the biopsy samples and the MACI product.

Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.

To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI.

Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.

The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.

Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established.

The most frequently occurring adverse reactions reported for MACI (≥5%) were arthralgia, tendonitis, back pain, joint swelling, and joint effusion.

Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.

Please see Full Prescribing Information for more information.

Indication

MACI® is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured. The implantation of MACI is to be performed via an arthrotomy to the knee joint under sterile conditions.

The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect. The implantation membrane is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.

Limitations of Use

Effectiveness of MACI in joints other than the knee has not been established.

Safety and effectiveness of MACI in patients over the age of 55 years have not been established.