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CRYOPRESERVED AMNIOTIC MEMBRANE ALLOGRAFT INJECTIONS

Amniotic membrane has been successfully used in treatments for decades.



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AMNIOTIC MEMBRANE SHEET

Biological protective covering to aid in wound management.

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.



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.

Committed To The Highest
International Standards

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



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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