SYNDAVER LABS INC.
TAMPA, FLORIDA

SynDaver Labs manufactures the world’s most sophisticated synthetic human tissues and body parts. Our SynDaver Synthetic Human bleeds, breathes, and employs hundreds of replaceable muscles, bones, organs, and vessels which are made from materials that mimic the mechanical, thermal, and physicochemical properties of live tissue. This validated technology is used to replace live animals, cadavers, and human patients in medical device studies, clinical training, and surgical simulation. SynDaver Labs was founded in 2004 to commercialize a novel system of synthetic human body parts for the medical device industry. These sophisticated models replicate human anatomy in great detail, including individual muscles, tendons, veins, arteries, nerves and organs, all made from complex composites that mimic the properties of discrete living tissues. Made from water, fibers, and salts, each of these tissues have been validated for mechanical, chemical, thermal, and dielectric properties against the relevant living tissue. In fact, SynDaver Labs maintains the world’s largest database of LIVE tissue properties, and our products are used in such diverse fields as surgical training, medical device testing, consumer products evaluation, and ballistics testing. Our focus to date has been the development of synthetic human tissues for use in medical device verification and validation tests. However, we are now in the process of simultaneously increasing the number of tissues in our library, expanding the body of live tissue data upon which these materials are based, and reducing the overall cost of the technology. Our ultimate goal is the replacement of live animals and human cadavers in medical education and training with synthetic analogs which are more cost-effective than the relevant animal or human model. We are also developing a family of synthetic humans which breathe, bleed, and react to stimulus with autonomy – some purely synthetic and some with living cells. . Such studies are sometimes called simulated use tests because they involve the evaluation of device function, safety, and efficacy in a simulation of the actual use (human) environment. Live animals are often employed in these tests because they have traditionally been the best model available for simulating the complexity of human anatomy and physiology. However, SynDaver and SynTissue brand products possess a unique feature set allowing them to be substituted for live animals, human cadavers, and other models in these tests. SynDaver Labs’ products may be substituted for traditional models in such tests by nature of their similarity to the actual use environment. This resemblance is characterized by a matching of mechanical, physical, and chemical properties, geometry, and organ-to-organ interaction. On the simplest level, individual synthetic organs (rectus femoris muscle, small intestine, abdominal aorta, etc) are constructed so that they replicate the geometry (shape, diameter, wall thickness etc) of a particular portion of the target anatomy. In addition, the individual synthetic tissue analogs used to fabricate these components are formulated so that they exhibit chemical and physical properties (water, fiber, and salt content, strength or modulus in shear, coefficient of static or dynamic friction, surface energy, dielectric properties, heat capacity, porosity, etc) that mimic the properties of the target tissue. Finally, the model components are assembled in such a way that the interaction between adjacent components is similar to that expected in the target tissue. That is, the body part is designed so that interfacial properties such as the coefficient of dynamic friction (inter-organ) and mechanical attachments mimic those exhibited in the target anatomy. SynDaver Labs’ synthetic human tissues are designed to mimic one or more properties of a specific target tissue, and in order to develop each analog two sets of design inputs (modeled properties and data source) must be defined. The modeled properties are determined by prioritizing the chemical, physical, mechanical, and other properties that the analog must mimic, and strictly speaking these may vary depending on the type of device being tested or procedure being simulated, the target anatomy, and the objective of the exercise. For example, if one objective is to determine the intimal damage caused by a device tracking through the femoral artery, abrasion resistance would be included in the target list for the tissue analog. In addition, if it was also desired to simulate the tendency of the device to penetrate the artery then penetration resistance or shear strength of the shell (a related mechanical property) would be included in the list as well. Any number of properties may be added to this list. However, as the number of modeled properties grows it becomes progressively more difficult to simultaneously satisfy all of the design requirements. In fact, if a particular tissue or organ must mimic more than three mechanical properties it will typically be necessary to employ multiple analogs to meet design requirements. SynDaver and SynTissue brand products are designed to mimic specific human tissues and organs. The chemical, physical, mechanical, electrical, and optical properties these tissues mimic are based on data derived from testing Now that the targeted properties list has been finalized and data source has been selected the testing begins. The simple femoral model discussed previously involves at least two components (artery and support tissue) made from two different tissue analogs. We will assume for the sake of discussion that this model will be used primarily to evaluate abrasive tissue damage and the ease of tracking through the artery. If it is further assumed that the analog materials will be designed around porcine tissue properties then the animal must be sourced to collect the required samples for testing. It is important to remember here that tissue begins to decompose immediately after death so preserved samples cannot be used. It is best practice to collect data from tissues in situ using specialized instruments. However, when this is not possible the samples must be surgically removed (minimizing trauma), fixtured in a heated blood bath, and tested immediately after harvest to keep the sample alive during testing. In the current example the tests performed would include intimal abrasion resistance and coefficient of dynamic friction, as well as shear strength and penetration resistance of the vessel wall. However, other properties might be included as well. Of course, the desired end product is a set of analog materials that mimic the physical properties of the target tissue, so after the analogs are formulated their performance will be validated by performing the same tests under identical conditions.