FMT-Life: Investigational FMT for Recurrent C. difficile

FMT-Life: Leading Innovation in FMT Treatments

FMT-Life, in collaboration with the University of Minnesota, provides investigational FMT (Fecal Microbiota Transplantation) preparations under an Investigational New Drug (IND) application. This cutting-edge treatment is available for patients with recurrent C. difficile infections that have not responded to standard therapies. Access to these preparations is limited to registered physicians within the FMT-Life Clinical Network.

Order Investigational FMT

Explore our range of investigational FMT treatments and learn how to place an order. Follow the steps below to request preparations for your patients.

• Learn About Investigational FMT Treatment Options

• Join the FMT-Life Clinical Network

• Registration Instructions

• Place An Order

• FAQ

• Invoice Payment

Investigational FMT Treatment Preparations

FMT-Life offers various investigational FMT preparations designed for complex cases of recurrent C. difficile infections. These preparations are manufactured by the University of Minnesota and comply with stringent regulatory standards.

Explore Our Preparations:

• Manufacturer Details: Learn about the University of Minnesota’s role in producing FMT preparations.

• Delivery Modalities: Understand the different methods of delivery available.

• Pricing Information: Find out about the costs associated with investigational FMT preparations.

Step 1: Join the FMT-Life Clinical Network

Join the Network: To access investigational FMT preparations, your practice or medical facility must first join the FMT-Life Clinical Network. Complete the registration form, ensuring all shipping locations within your health system are recorded. Approved registrants will receive a partner ID number.

Important Note: Even if you are already a registered FMT-Life partner, you must complete the UMN-specific registration form to access UMN-manufactured investigational FMT.

Register For Investigational FMT Manufactured by UMN

Detailed Registration Instructions:

1. Complete the Form: Fill out pages 1-2 with your clinical information.

2. Review Terms: Pages 3-5 must be reviewed and initialed by an authorized purchaser (not generally clinicians).

3. Sign and Submit: Page 6 requires a signature. Send the completed form to info@fmt.life or fax to 617-575-2201.

Step 2: Place an Order

As a registered clinical partner, you can place orders for eligible patients. Orders can be kept in stock at your facility.

Submit Orders:

• By Email: Send your order to orders@fmt.life

• By Fax: Send to 617-575-2201

• Use the FMT-Life order form or an internally generated purchase order.

Place An Order

Frequently Asked Questions

1. What regulations govern the use of investigational FMT distributed by FMT-Life?

Investigational FMT preparations distributed by FMT-Life are governed by regulations under the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application. These regulations require that investigational FMT preparations are used only in clinical settings where patients meet specific eligibility criteria and under the supervision of a licensed physician. The use of these preparations must comply with all applicable federal, state, and institutional regulations to ensure patient safety and effective treatment.

2. Is my patient eligible to receive investigational FMT?

To determine if a patient is eligible to receive investigational FMT, they must meet the criteria set forth by the FDA IND guidelines. Generally, this includes having recurrent C. difficile infections that have not responded to standard therapies. Physicians must evaluate each patient’s medical condition and history to confirm eligibility. It is recommended to consult with FMT-Life’s clinical team for detailed eligibility requirements and to ensure that the investigational FMT aligns with the patient’s treatment plan.

3. How do I check my order status?

To check the status of an order, contact FMT-Life’s clinical support team directly. You can reach out via email at orders@fmt.life or by phone at 617-575-2201. Provide your order reference number and any relevant details to receive updates on your order's progress.

4. When will I receive my order?

The delivery time for investigational FMT preparations typically depends on the order's processing and shipping requirements. Once an order is confirmed, FMT-Life will provide an estimated delivery date. Standard shipping usually takes between 3-5 business days, but expedited options may be available if needed. For specific delivery timeframes, please refer to your order confirmation or contact our support team.

5. How are investigational FMT preparations shipped to my facility?

Investigational FMT preparations are shipped using secure, temperature-controlled methods to ensure their efficacy upon arrival. The shipping process is designed to maintain the integrity of the preparations throughout transit. FMT-Life coordinates with specialized courier services to handle the sensitive nature of the shipments and ensure timely delivery.

6. What are FMT-Life’s shipping terms?

FMT-Life’s shipping terms include:

• Delivery Time: Typically 3-5 business days, with expedited options available.

• Shipping Method: Secure, temperature-controlled delivery.

• Shipping Costs: Costs are generally included in the pricing of the investigational FMT preparations. For specific shipping fees or additional charges, please refer to your order details or contact our support team.

• Delivery Location: Shipments are made to the registered address provided during the order process.

7. How will we be billed?

Billing is managed through an invoice system. Once your order is processed, you will receive an invoice detailing the cost of the investigational FMT preparations, shipping fees, and any other applicable charges. To pay your invoice, use the “Pay Now” button on our website to access our secure online payment portal hosted by FattMerchant. For billing inquiries or assistance, contact our Accounts Receivable team at accountsreceivable@fmt.life or 617-575-2201 x 5.

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• Email: info@fmt.life

• Phone: 617-575-2201

• Fax: 617-575-2201

Note: The investigational FMT treatments discussed are not approved or licensed by the U.S. Food and Drug Administration or any other regulatory authority and are not commercially available. FMT-Life acts solely as a distributor of investigational FMT preparations manufactured by the University of Minnesota under an FDA-reviewed IND application. Physicians must comply with regulatory requirements and be added as an investigator to the research IND before placing an order.