Biomedic and Surgenex move forward with plans to introduce the advanced wound care allograft in Saudi Arabia following a product classification decision by the country's health regulator.
-- Biomedic announced that the Saudi Food and Drug Authority (SFDA) has classified SurGraft XT, an amniotic tissue allograft manufactured by Surgenex LLC, marking a step toward the product's potential introduction to the Saudi Arabian market.
The classification, issued Oct. 22 under reference number PCS-CP-202610-3088, comes as Biomedic and Surgenex prepare for the next stage of the regulatory process. SurGraft XT has not yet received SFDA registration, which is required before the product can be marketed in Saudi Arabia.
For Biomedic, the decision allows the company to advance its planning with Surgenex while the registration process remains underway. The two companies intend to coordinate product supply, regulatory documentation and other preparations associated with entering the Saudi market.
"Saudi Arabia is an important market for our international expansion efforts, and receiving this classification gives us a clearer path for the work ahead," said Lana Batchaeva, managing partner of Biomedic. "There are still regulatory steps to complete, but this decision allows us to move forward with our preparations alongside Surgenex."
SurGraft XT is a dual-layer allograft made from human amniotic tissue. It serves as a protective covering for wounds and is described by its manufacturer for use in managing chronic, nonhealing diabetic, pressure and venous ulcers.
The product is manufactured by Surgenex, a U.S.-based tissue manufacturer whose processing methods are designed to preserve the natural structure of donated tissue. Its manufacturing procedures include donor screening, laboratory testing, controlled tissue processing and quality review before products are released.
According to Surgenex, SurGraft XT is processed in compliance with the U.S. Food and Drug Administration's current Good Tissue Practice regulations and standards established by the American Association of Tissue Banks.
In the United States, Surgenex identifies the product as regulated under Section 361 of the Public Health Service Act and Title 21, Part 1271 of the Code of Federal Regulations. These requirements govern certain human cells, tissues and cellular and tissue-based products.
Biomedic's planned role in Saudi Arabia centers on coordinating access to the product and supporting relationships with healthcare providers and institutions. Surgenex will continue to oversee manufacturing, while both companies address the requirements associated with eventual distribution.
"Our focus is on making sure the regulatory and supply arrangements are properly established before the product reaches the market," Batchaeva said. "We want to approach this carefully, working with the manufacturer and following the requirements set by Saudi authorities."
The SFDA classification does not permit immediate importation or commercial sale. Those activities remain subject to registration and other applicable regulatory requirements. Biomedic has not announced an anticipated date for commercial availability.
About Biomedic
Biomedic is an advanced wound care company based in Boca Raton, Florida. It supplies biological and bioengineered skin substitutes and medical device technologies to hospitals, wound care clinics and healthcare institutions. Its product portfolio includes allografts manufactured by Surgenex.
The company also operates Biomedic365, a provider support program offering product education, technical assistance and reimbursement guidance. More information is available at www.biomedic.com.
Contact Info:
Name: Lana Batchaeva
Email: Send Email
Organization: Biomedic
Phone: 8888082466
Website: http://www.biomedic.com
Release ID: 89207489
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