Tissue Transplants Utilizing
Extracellular Matrix Preservation
(BioECM) Technology

Skye Biologics commercializes and is further developing BioECM allografts for transplantation of age zero tissues into a recipient’s mature tissues while preserving the functionality of human placenta grafts.

Skye Biologics Holdings is a complete vertically integrated regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care market, with future products for Surgical & Sports Medicine markets, like no other in this space.

Current market tissue products are processed through our sister company Human Regenerative Technologies, which is an AATB licensed tissue bank.

Through that division, we are processing industry leading unique tissue transplants that are shelf stable, preserving integrity while maintaining their natural properties. Traditionally, procedures have used biologically passive approaches to repair injured tissues by removing, re-attaching or stabilizing damaged, severed, fractured or problematic tissues with sutures, stabilization or fixation devices. Common post-op complications and challenges are due to variables beyond their control, including the severity of the injury, co-morbidities, patient biology, compliance and other factors, and the body is unable to heal properly to its original state.

Skye Biologics BioECM® preservation utilizes the richest natural intact allograft tissue known to exist. With our novel HydraTek® technology, we can maximize preservation and potential through our unique preservation system, to further advance medical treatments. Skye® products provide distinct tissue and safety advantages over traditional human allograft or xenograft tissue sources. Placental tissues provide the most abundant source of an extracellular matrix (ECM).

Tissue Transplants for Unique Clinical Challenges

Complex clinical challenges demand a wide range of solutions.

At Skye, we are continually perfecting our BioECM® transplant preservation to maximize utility across many clinical specialties and procedures.

DISCOVER THE PRODUCTS DESIGNED FOR YOUR CLINICAL NEEDS

HydraTek Innovation

HydraTek® has made significant advances in tissue processing to develop our leading, next-generation BioECM technology and produce the industry's most advanced and innovative allograft products. HydraTek® technology is working on advancing the processing of these ideal native placental biologics beyond simple ocular and wound covering membranes to create the industry's leading product line designed to meet the significant demands of a broad range of procedures and conditions. Our improved science and technology allow Skye to preserve a richer tissue source and produce more powerful solutions for enhanced clinical potential. HydraTek® has been independently studied to see how well this advanced hydration system preserves these native tissue transplants and to provide unsurpassed patient safety. HydraTek® has developed a series of scientific methods to provide a distinct advantage in handling, safety, quality and performance of its transplants.

Unsurpassed Handling & Delivery

As a result, HydraTek® is able to deliver unique easy to handle tissues exceeding industry standards and commercially available options.

The Preserved Source

Only HydraTek® processes tissue transplants from the beneficial areas of the placental organ in their natural state, thus maximally maintaining their natural properties and providing a market leading allograft transplant option.

The Utmost in Safety

HydraTek® provides an outstanding standard of safety through its stringent donor screening, testing, and strict quality control, providing stable and sterile native tissues. All testing and safety standards meet or exceed the FDA requirements.
View a detailed list of safety testing**

Unique Allograft Delivery Forms

Advanced Tissue Transplants

HydraTek® is the only process designed to harvest and preserve The Complete Placental Connective Tissue Matrix® from age zero placental tissues in an ideal native tissue allograft transplant form with the recipient in mind, giving doctors a very ready to use allograft that is easy to handle and apply.

Industry First: Room Temperature Connective Tissue Transplant

HydraTek® invented a revolutionary way to preserve this connective tissue matrix in ambient (room temp) form – an industry first that gives surgeons ideal delivery options, unparalleled ease of use without compromising quality and integrity.

Excellerate® Technology

This rich Connective Tissue Matrix transplant creates an ideal environment. This tissue matrix can be precisely applied to areas of damaged connective tissue and provides improved resorption and incorporation.

BioAware® Membrane Preservation System

HydraTek® has designed the unique BioAware® preservation system to optimize the structural tissue integrity, handling and performance of its membrane-based allografts. This system scientifically controls the moisture levels in both dehydrated and non-dehydrated membrane products, and carefully preserves the natural tissue structure without compromising it through traditional lyophilization (freeze drying), heat-baking, chemical cross-linking or other disadvantageous methods.

The result is a lineup of membrane products that maintain ideal structure and integrity when used dry or hydrated. These products are omni-directional, meaning they can be applied up or down, without orientation issues. The dehydrated membranes adhere extremely well naturally, but are also strong enough to allow for suture fixation as needed. In addition, a non-dehydrated option is available, with load-bearing strength and added thickness for additional support. HydraTek® membranes are FastActing®, meaning they resorb faster.

FastActing® Membrane Performance

HydraTek® BioAware® Technology is designed to protect the biomechanical structure of the membrane tissue matrix versus other membranes which may be cross-linked or collapsed due to their inferior processing methods. This produces FastActing® membrane products that provide an immediate covering at the site, then resorb quickly to incorporate into the patient’s tissues sooner.

Not all Placental Allografts are Created Equal

Placental tissues have been shown in the literature to be naturally anti-inflammatory, anti-fibrotic, anti-microbial, to modulate inflammation, promote tissue remodeling and reduce scar tissue formation in clinical applications. They have been used medically for decades and one reason they are an excellent transplant is they are also an immunoprivileged tissue type. They have been shown to not cause a host rejection.

Since the early 1900's, amniotic membranes have been used clinically as wound coverings to treat chronic and acute wounds. Over the last few decades, tissue banks have made some basic membrane products commercially available, derived from individual amniotic membranes and produced using traditional processing methods.

These preliminary membrane products are developed specifically to treat topical wound applications. However, more significant injuries, degeneration, and surgical conditions require richer biologic solutions and improved product and delivery forms. Advanced transplants demand new processing technology, as traditional processing is limited by older methods and not designed to effectively process and preserve these unique age zero tissue transplants in their native state.

Adhering to strict safety standards, HydraTek® obtains its source tissues from healthy mothers who are under the care of a licensed OB/GYN physician at a partner facility. All donations are sourced from U.S.-based donors, and only after live, healthy cesarean birth delivery. No maternal or fetal tissues are collected during the process. Intensive safety testing is used to screen both the donor and donated tissues before processing.

Improved Tissue Integrity

HydraTek® Delivers Proven Tissue Transplant Potential.

Skye Biologics products have been independently validated to maximize the preservation of the rich natural biologic potential of connective tissues. HydraTek® BioAware® membrane products are shown to better preserve the tissues natural biomechanical structure versus other membrane products. *comparison data on file

Tissue Transplants UtilizingExtracellular Matrix Preservation(BioECM) Technology