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CRYOPRESERVED AMNIOTIC MEMBRANE ALLOGRAFT INJECTIONS

Amniotic membrane has been successfully used in treatments for decades.

About Us

SURGENEX® DELIVERS THE MOST INNOVATIVE AMNIOTIC
MEMBRANE PRODUCTS IN REGENERATIVE MEDICINE


READ OUR RESPONSE TO THE NEW NON-BINDING FDA GUIDANCE HERE

Our Mission


Rekindling hope for patients through innovation and dedication

SURGENEX® is committed to turning innovative science into medical solutions that bring value and hope to patients worldwide. Every day we work together to address unmet medical needs and therapeutic applications, while leveraging new research technologies with amniotic membrane allograft treatments. We remain dedicated to meeting patients' needs, and support for them will never waiver.

At SURGENEX®, we’re focused pioneering the future today.
Click here to learn more about SURGENEX® mission statement





SURGENEX® Capability

SURGENEX® is the producer and distributor of the highest quality amniotic membrane tissue allograft in the industry. Human Amniotic Tissue (hAM) is used in a wide variety of clinical settings including:

  • Orthopaedics
  • Sports Medicine
  • Podiatry
  • Pain Management
  • Joint Care

SURGENEX® has developed innovative processes and safety protocols, which deliver the highest quality and safety standards. With these safety and quality standards, SURGENEX® is the leader of amniotic membrane tissue allografts in the field of regenerative medicine.

The SURGENEX® proprietary Excellion® process is used to produce SurForce®. This patent pending process is a highly manual and surgical harvesting procedure which generates the highest yield of amniotic tissues.

Our placenta recovery processes start where life begins. Qualified mothers donate their placenta for medical treatments and research. These donors are selected through a strict screening process which includes an extensive patient questionnaire, serological testing, and a medical staff interview to ensure donor eligibility. The Excellion® process honors these donations by meticulously collecting the amniotic membrane and carefully removing unwanted tissues such as the chorion. This highly technical process produces the highest quality and the best amniotic tissue allograft in the industry.

We Deliver Results

Our Company has developed innovative processes and safety protocols,
which deliver the highest quality and safety standards.
With these safety and quality standards, SURGENEX® is poised
to become the leader of amniotic membrane allografts
in the field of regenerative medicine.



Our products

SurForce® Amniotic Tissue Allograft

SurForce® | Go To SurForce Website

SurForce® is a minimally manipulated, morselized flowable amniotic membrane tissue allograft designed to be the best product on the market today. It is an injectable allograft for homologous use only that allows the physician freedom to make precise applications.

SurForce® is thoroughly tested for safety in clinical procedures. Our donor serology test panel is the most extensive in the industry, testing for several potential pathogens that could be missed by less extensive testing observed in competitive industry products. SURGENEX® conducts a 14-day bacterial/fungal test performed by a third party lab, to confirm our products are free of bacterial and fungal contaminants. These safety barriers verify that SurForce® is the cleanest and safest amniotic membrane tissue allograft product on the market.

ITEM NUMBER

1050
1100
1200

AVAILABLE SIZES

1/2 CC
1 CC
2 CC

CONTRAINDICATIONS

SurForce® should not be injected into the spinal canal, in vital organs (including the heart and other areas of the central nervous system), nor the circulatory system. This product is not intended to be used as a bone substitute. SurForce® should not be injected in active infections nor patients that have conditions that would cause substantial risk of using this product. SurForce® has not been tested in combination with other products.

RECOMMENDED INSTRUCTIONS FOR SURFORCE®

The following are suggested recommendations as a guide and are not intended to supersede the professional and clinical judgment of the treating physician concerning patient care.

PREPARATION INSTRUCTIONS

Open the pouch containing the vial and allow the solution to thaw for optimal results at 37C for up to 3 minutes or at room temperature for up to 20 minutes. Once completely thawed, aspirate SurForce® using a 16g or 18g needle. Inject the allograft in the patient using a 22g or larger gauge needle.

CONTENTS AND DESCRIPTION

SurForce® is a cryopreserved flowable allograft tissue matrix available in a variety of vial sizes. Each vial is visually inspected and carefully tested for quality assurance before delivery. If you received an open or broken vial, do not use it. Immediately contact SURGENEX®, LLC customer service. SurForce® is intended to be used on a single patient, as a one-time use only. Once SurForce® is properly thawed, it must be used immediately or promptly discarded.

SurForce® has been tested for relevant communicable diseases in accordance with the required FDA standards for tissue donation. SURGENEX®, LLC may test beyond this FDA minimum for additional pathogens at its discretion in order to ensure patient safety. Additionally, before delivery, the product is tested using a bacterial and fungal culture as an added precaution.

NOTICE

Federal law requires HCT/P to be sold by or on the order of a licensed physician. Any violation will be subject to Federal law. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent

Following use, dispose of any unused product and packaging following current accepted medical practices and follow all relevant local, state and federal laws and regulations.

DONOR ELIGIBILITY REQUIREMENTS

An allograft of donated human tissue is deemed qualified for transplantation by an authorized recovery agency by meeting the following criteria:

Results from the donor pre-screening lab tests specify the donor to be free from risk factors and active infections of applicable communicable disease agents and diseases as required by the FDA.

Donor results from the pre-screening lab tests must be negative and/or non-reactive for the following applicable communicable disease agents.

Prescreening

HIV I/II AB
HIV/HCV/HBV NAT
HBC AB
HBS AG
RPR
HCV AB
HTLV I/II

DONOR SELECTION PROCESS

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, all contracted laboratories performing human specimen tests are certified and meet the requirements as determined by the Centers for Medicare and Medicaid Services (CMS).

All donor recoveries meet and adhere to the regulations requisite to HCT/P recovery and the screening and testing of the tissue donor as verified through the tests noted in the section of pre-screening lab tests above.

Utilizing the U.S. Public Health Service guidelines, the donor’s relevant medical history and behavioral risk assessments are obtained preceding donation.

The qualified recovery agency evaluates the results of the blood sample tests, the relevant medical history, and the examinations pertaining to donor tissue eligibility. Discussions with either physicians or the donor mother are performed to identify situations that may disqualify the donor.

These results conclude that the donor suitability criteria meet the standard requirements for transplantation. Specific and detailed information of the testing laboratories, required infectious disease tests results, listings of documents reviewed as part of the pertinent medical records, and all necessary donor medical information of any specific allograft tissue recovered via SURGENEX®, LLC is stored in our facilities and/or affiliated facilities.

STORAGE REQUIREMENTS

It is the responsibility of the clinician to store SurForce® in its original packaging until ready for use. SurForce® can be maintained at -18°C or colder for three months or until expiration date printed on product packaging, whichever comes first. Recommended long-term storage is at – 80°C using an ultra-low temperature freezer or liquid nitrogen until the expiration date is reached.

Following use, dispose of any unused product and packaging following current accepted medical practices and follow all relevant local, state and federal laws and regulations.

HCT/P TRACKING

The Joint Commission and FDA requires patient records to be properly maintained by storing the allograft ID number (LOT NUMBER) for purposes of tracking the allograft post treatment.  Please go to our website www.surgenex.com/records and register by using the lot number provided.

RETURN POLICY

SURGENEX®, LLC accepts no returns of SurForce®. Although SURGENEX®, LLC has taken great measures to ensure the safety of our allograft product, current technologies cannot preclude the transmission of certain diseases known or unknown, therefore, SURGENEX®, LLC can make no claims concerning the biological properties and safety of allograft tissue. All tissues have been collected, processed, screened, tested, stored, and distributed in compliance with all current FDA regulations concerning HCT/Ps.

Application and use of any allograft tissue may potentially have negative outcomes. Occurrence of complications at the affected site may transpire post-treatment without early warning signs. These include, but are not limited to 1) transmission of communicable diseases, 2) transmission of infectious disease agents such as: bacteria and fungus, viruses; and 3) immune rejection of, and/or allergic reaction to, injected HCT/P.

PRECAUTIONS

Caution should be taken when administering this product to immunocompromised individuals, such as patients suffering from HIV or other highly immunocompromised conditions.

DMSO is used as a cryoprotectant. Therefore, SurForce® should not be used by patients with known sensitivities or allergies to DMSO.

SURGENEX®, LLC and its affiliates furnish this allograft product without any express or implied warranties. All statements or descriptions are informational only and are not to be interpreted or implied as a warranty of the allograft product. SURGENEX®, LLC and its affiliates make no guarantee regarding the biological characteristics of this product. The end user shall be held responsible for determining the appropriate application and usage of this product.

Committed To The Highest
International Standards

SURGENEX® is the producer and distributor of the highest quality of amniotic membrane tissue allograft in the industry.



Manufacturing

SURGENEX® uses a patent pending process to produce its minimally manipulated product
which conforms to the regulations and the FDA’s definition found in HTC/P 361 products in accordance
with FDA Article 21 CFR Part 1271. Following these standards allows SURGENEX®
to sell approved allograft products with confidence to Healthcare Providers.

DONOR PROCEDURES/FDA TESTING

SURGENEX® allograft products produced from donated human tissue are deemed qualified for transplantation by an authorized recovery agency by meeting the following criteria:

Results from the donor pre-screening lab tests specify the donor to be free from risk factors and active infections of applicable communicable disease agents and diseases as required by the FDA.

Donor results from the pre-screening lab tests for the following applicable communicable disease agents are negative and/or non-reactive for the following:

Prescreening Lab Testing

HIV I/II Ab
HIV/HCV/HBV NAT
HBc Ab
HBs Ag

COMPLIANCE & QUALITY ASSURANCE

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, all contracted laboratories performing human specimen tests are certified and meet the requirements as determined by the Centers for Medicare and Medicaid Services (CMS).

All donor recoveries meet and adhere to the regulations requisite to HCT/P recovery and the screening and testing of the tissue donor as verified through the tests noted in the section of pre-screening lab testing above.

Utilizing the U.S. Public Health Service guidelines, the donor’s relevant medical history and behavioral risk assessments are obtained preceding donation. The qualified recovery agency evaluates the results of the blood sample tests, the relevant medical history, and the examinations pertaining to donor tissue eligibility. Discussions with either physicians or the donor mother are preformed to identify situations that may disqualify the donor. These results conclude that the donor suitability criteria meet the standard requirements for transplantation. Specific and detailed information of the testing laboratories, required infectious disease tests results, listings of documents reviewed as part of the pertinent medical records, and all necessary donor medical information of any specific allograft tissue recovered via SURGENEX®, LLC is stored in our facilities and/or affiliated facilities.

SURGENEX® and its affiliates are currently in the FDA Establishment Registration and Listing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P) as required by the Federal Drug Administration. We hold ourselves to a higher standard to perform above and beyond the minimum requirements in the industry, ensuring best practices and superior product outcomes.

Research

Current research in amniotic membrane allografts
is shaping the future of healthcare.

Amniotic Membrane Research

Amniotic membrane allograft tissue has been an accepted method of treatment since the early 1900s. The healthcare community has benefited from the tissue regeneration outcomes in specialties such as surgery, orthopaedics, pain management, burn care, eye, as well as dental. More recently, Podiatric Physicians have been effectively applying these allografts to patients with diabetic foot ulcers. These treatments are yielding paradigm-shifting outcomes for their patients.

Amniotic membrane tissue injections have been growing in popularity over the past few decades Research and development have increased opportunities and discovered a variety of ground-breaking applications.

Utilizing the latest research and implementing efficient operations, SURGENEX® will focus on innovative research-proven products.


Explore the research and articles below involving the use of amniotic allograft tissue and how it plays an impactful role in the future of regenerative medicine.

New Patients Process

If you have additional questions or need help finding a doctor go to our SurForce® Website

1

Find a Doctor

2

Contact Your Doctor

3

Consult with Doctor

4

Treatment

5

Recovery

Contact Us

SURGENEX® LLC
PO Box 4664
Scottsdale, AZ 85261
Corporate: 877.880.1862
Sales: 877.880.1862 ext 1

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