Disclaimer

Effective date: August 3, 2026

1. Read This First

RediCell Biologics is a trading name of Auvum LLC, doing business as RediCell ("RediCell," "we," "us"). Everything RediCell supplies is a human cell-derived preparation supplied to licensed practitioners, medical practices, research institutions and laboratories. This page states the limits on what our products are and how they may be used. It applies to this website, to every product description, technical document and written quotation we issue, and to everyone who uses this website, applies for an account, requests a quotation or purchases from us.

2. For Physicians and Clinical Use Only

All products RediCell offers are for physicians and clinical use only. They are supplied only to licensed healthcare practitioners, medical practices, research institutions and laboratories, for use by or under the direct supervision of a qualified professional acting within their own scope of practice and licence.

RediCell is a supplier of material. RediCell does not practise medicine, does not direct patient care, and does not participate in any clinical decision. Every decision about whether, when, how and to whom any material is used is made solely by the licensed practitioner, on their own professional judgement and their own responsibility.

3. Not Approved, Licensed or Cleared

RediCell products are not approved, licensed or cleared by the U.S. Food and Drug Administration or by any other regulatory authority in any country. No product is the subject of an approved marketing application, biologics license, premarket clearance or premarket approval. No statement on this website has been evaluated by the FDA.

4. No Approved Indication

No RediCell product has an approved indication. Nothing on this website, and nothing supplied by RediCell, states or implies that any product treats, cures, prevents, mitigates or diagnoses any disease or condition. RediCell makes no claim of safety or efficacy for any product, for any use, in any person.

5. The Practitioner Bears Clinical Responsibility

Where a licensed practitioner elects to use a RediCell product in the course of their practice, that decision and everything that follows from it are the practitioner’s alone. The practitioner is solely responsible for:

• determining that any use is lawful in their jurisdiction and permitted under their licence and scope of practice;
• obtaining any regulatory authorization their intended use requires, including where applicable an Investigational New Drug application and institutional review board oversight;
• patient selection, informed consent, and every clinical judgement made;
• their own protocols, preparation, handling and technique;
• monitoring, follow-up and the reporting of any adverse event.

RediCell supplies none of the above and will not supply any of it on request.

Resale, or transfer to any person who is not a licensed practitioner or a qualifying institution, is prohibited.

6. Human Investigation Requires an IND and IRB Oversight

An investigation in human subjects using a material of this kind requires an effective Investigational New Drug application under 21 CFR Part 312 and oversight by an institutional review board. RediCell holds no such application, sponsors no clinical investigation, and supplies no product under an IND. Obtaining and maintaining any regulatory authorization, approval or oversight that a given use requires is solely the responsibility of the practitioner or institution, and RediCell makes no representation that any particular use is authorized or lawful.

7. No Medical Advice

Nothing on this website, in our product literature, or in any communication from RediCell personnel is medical advice, clinical guidance, a dosing recommendation or a treatment protocol. RediCell does not provide clinical, dosing or protocol guidance and will not do so on request. If you have a medical question, consult a licensed physician. This website does not create a physician-patient relationship.

8. No Guarantee of Results

Research results depend on the design, execution and conditions of your own experiments. RediCell does not guarantee that any product will perform in your hands as described in any publication, data sheet or example, that any particular experimental result will be obtained, or that a product is fit for any purpose you have in mind. Specifications describe the material as released by RediCell; they are not a promise of experimental outcome.

9. Your Responsibility as the Purchaser

You are responsible for using RediCell products lawfully and safely. By requesting a quotation, placing an order or receiving any product, you accept responsibility for:

• determining that the product is suitable, lawful and appropriate for your intended use;
• complying with all applicable federal, state, local and foreign laws, regulations, import and export controls, and institutional policies;
• holding any license, permit, registration or biosafety approval your work requires;
• handling the material as potentially infectious, under appropriate biosafety practices and containment;
• correct receipt, storage at the stated temperature, thawing, handling and disposal of the material and its packaging, including dry ice;
• the acts of your employees, students, contractors and anyone to whom you transfer the material.

Products are cryopreserved and ship on dry ice. Once shipped, they are not returnable.

10. Donor and Manufacturing Statements

Where this website or our documentation describes donor screening, donor eligibility, testing or processing conditions, those descriptions are informational statements about the material only. They are not a determination that any product is safe or effective for any use in any person, are not a claim of regulatory approval, licensure or clearance, and do not change the limitations stated in Sections 2 to 5 above. Any certificate of analysis or test report we supply describes testing performed on the identified lot only, and is not a representation about any other lot or about performance in your hands.

11. No Protected Health Information

This website is not intended to receive protected health information, patient records, or any individually identifiable health information, and you must not submit any. The account application, the request-for-quote form and the sales-team application ask only for business contact and shipping details. If you send us protected health information despite this, you do so on your own initiative; we are not acting as a covered entity or a business associate in relation to it under the Health Insurance Portability and Accountability Act, and we will delete it when we identify it. Nothing on this website creates a treatment, diagnostic or clinical relationship with any person.

12. Photography and Illustrations

Unless a caption expressly states otherwise, photographs, renderings and other imagery on this website are illustrative only. They should not be taken to depict RediCell facilities, equipment, personnel, donors or actual product, and nothing should be inferred from them about our operations, capacity or processes.

13. Applications, Quotes and Orders

Applying for an account does not create an account. Prices and volume tiers shown to approved users are for information and may change. A request for quote is not an order and is not a contract. An order arises only when RediCell issues a written quotation and you accept it in writing. RediCell may decline any application, quote request or order at its discretion. Submitting a sales-team application does not create an employment, agency or representative relationship of any kind.

14. Relationship to Our Other Terms

This Disclaimer is part of, and should be read with, our Terms of Use and Privacy Policy. If a specific term in those documents conflicts with this page on a point the other document addresses in detail, that document controls on that point. The limitation in Section 2 (For Physicians and Clinical Use Only) and the allocation of clinical responsibility in Section 5 (The Practitioner Bears Clinical Responsibility) control in all cases.

15. Changes

We may update this Disclaimer at any time. The effective date above shows when it was last revised. Continued use of this website after a change means you accept the revised version.

16. Contact

Questions about this Disclaimer may be sent to office@redicell.com or 512-541-2026, Monday through Friday, 8:00 a.m. to 4:00 p.m. Eastern. Written notices should be sent to 1005 Congress Ave, Suite 925, Austin, TX 78701.